Benylin Cold & Flu Max Strength Sachets (Non-Drowsy)

1. Name Of The Medicinal Product

Asda Max Strength Cold and Flu Relief Sachets

Boots Cold and Flu Max Relief Sachets

Boots Cold and Flu Max Sachets

Co-op Max Strength Cold and Flu Relief Sachets

Lloyds Pharmacy Max Strength Cold and Flu Relief Sachets

Morrisons Max Strength Cold and Flu Relief Sachets

Moss Max Strength Cold and Flu Relief Sachets

Numark Max Strength Cold and Flu Relief Sachets

Paramed Max Strength Cold and Flu Relief Sachets

Safeway Max Strength Cold and Flu Relief Sachets

Sainsburys Max Strength Cold and Flu Relief Sachets

Somerfield Max Strength Cold and Flu Relief Sachets

Superdrug Max Strength Cold and Flu Relief Sachets

Tescos Max Strength Cold and Flu Relief Sachets

Unichem Max Strength Cold and Flu Relief Sachets

Vantage Max Strength Cold and Flu Relief Sachets

Wilkinsons Max Strength Cold and Flu Relief Sachets

Benylin Cold and Flu Max Strength Sachets Lemon

2. Qualitative And Quantitative Composition

Each sachet contains; 1000 mg Paracetamol

Phenylephrine hydrochloride 12.2 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Powder for oral suspension.

Yellow powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of symptoms of colds and influenza, including the relief of headaches, aches and pains, sore throat, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Adults and elderly: For oral administration after dissolution in water.

Contents of one sachet dissolved in hot water. May be repeated after 4 – 6 hours.

Maximum of 4 sachets in 24 hours.

Children: Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

Severe coronary heart disease. Hypertension.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Use with caution in patients with Raynaud's Phenomenon or diabetes.

Contains aspartame (E951) a source of phenylalanine equivalent to 50 mg/dosage unit. May be harmful for people with phenylketonuria. The content of sucrose on a daily basis of four doses is 7.75 g.

(Label) Immediate medical advice should be sought in the event of an overdose, even if you feel well.

(Leaflet) Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Do not exceed the stated dose. Do not take with other paracetamol containing products. If symptoms persist consult your doctor. Keep out of the sight and reach of children. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

Phenylephrine may adversely interact with other sympathomimetics, vasodilators, and β- blockers. Drugs which induce hepatic microsomal enzymes, such as alcohol, barbituates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Not recommended for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Phenylephrine hydrochloride: Due to the vasoconstrictive properties of phenylephrine the product should be used in caution in patients with history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare (< 1/1000) but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Adverse effects of phenylephrine hydrochloride include raised blood pressure, tachycardia and occasionally bradycardia, insomnia, restlessness, tremor and anxiety have occasionally occurred, as have urinary retention and hallucinations.

4.9 Overdose

PARACETAMOL

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Phenylephrine hydrochloride:

Features of severe overdosage of phenylephrine incude haemodynamic changes and cardiovascular collapse with repiratory depression. Treatment includes early gastric lavage and symptomatic and and supportive measures. Hypertensive effects may be treated with an IV α-receptor blocking agent.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol : Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis in the central nervous system.

Phenylephrine hydrochloride: Phenylephrine is a post-synaptic α-receptor agonist with low cardioselective β-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic Properties

Paracetamol is absorbed rapidly and completely mainly from the small intestine, producing peak plasma levels after 15- 20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a half-life of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (> 80%) which are excreted in the urine.

Ascorbic acid is readily absorbed from the gastro-intestinal tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine hydrochloride is readily and rapidly absorbed from the gastro-intestinal tract. Presystemic metabolism is high at about 60%, resulting in systemic bioavailability of about 40%. Peak plasma levels occur between 1 and 2 hours and the plasma half-life ranges from 2 – 3 hours. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4 – 6 hours.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose

Sodium citrate

Citric acid

Ascorbic acid

Acesulfame Potassium (E950)

Aspartame (E951),

Quinoline yellow (E104)

Lemon flavours

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

This product is packed in laminate sachets comprising paper/polyethylene/aluminium foil/ polyethylene.

Five or ten sachets are contained in a boxboard carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon EX33 2DL

United Kingdom

8. Marketing Authorisation Number(S)

PL 12063/0034

9. Date Of First Authorisation/Renewal Of The Authorisation

19 September 2003

10. Date Of Revision Of The Text

14/12/2006

Boots NicAssist Fruit Fresh 2 mg Gum

1. Name Of The Medicinal Product

Nicorette Freshfruit 2mg Gum

Boots NicAssist Fruit Fresh 2 mg Gum

2. Qualitative And Quantitative Composition

Chewing Gum containing 2mg nicotine, as nicotine resinate.

For excipients, see 6.1.

3. Pharmaceutical Form

Medicated Chewing Gum

A square, coated, whitish piece of gum

4. Clinical Particulars

4.1 Therapeutic Indications

Nicorette Freshfruit 2 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

Nicorette Freshfruit 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.

4.2 Posology And Method Of Administration

Adults and Children over 12 years of age

Nicorette Freshfruit 2 mg Gum should be chewed slowly according to the instructions.

The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.

Nicorette Freshfruit 2 mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.

Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.

Smokers aiming to reduce cigarettes should use Nicorette Freshfruit 2 mg Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.

As soon as they are ready smokers should aim to quit smoking completely.

Maximum daily dose: 15 pieces per day.

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Freshfruit 2 mg Gum are recommended to contact their pharmacist or doctor for advice.

For those using the 4 mg gum, switching to the 2 mg gum may be helpful when stopping treatment or reducing the number of gums used each day.

The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.

4.3 Contraindications

Hypersensitivity to nicotine or any component of the chewing gum.

Nicorette Freshfruit 2 mg Gum is contraindicated in children under the age of 12 years.

4.4 Special Warnings And Precautions For Use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.

Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Freshfruit 2mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Freshfruit 2mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.

Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.

GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.

Renal or hepatic impairment: Nicorette Freshfruit 2mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.

Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.

Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Freshfruit 2mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.

Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.

Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.

Excipients: Nicorette Freshfruit 2mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.

Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Freshfruit 2mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.

4.6 Pregnancy And Lactation

Pregnancy

Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Freshfruit 2 mg Gum may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.

Lactation

The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.

Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.

Nicorette Freshfruit 2mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Freshfruit 2mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.

Excessive consumption of Nicorette Freshfruit 2mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.

Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.

Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.

The chewing gum may stick to, and may in rare cases damage dentures.

Reported adverse events associated with Nicorette 2mg and 4mg gum include:

Body System	Incidence*	Reported adverse event
Nervous system disorders:	Very common:	Headache
	Common:	Dizziness
Cardiac disorders:	Uncommon:	Palpitations
	Very rare:	Reversible atrial fibrillation
Gastrointestinal disorders:	Very common:	Gastrointestinal discomfort, hiccups, nausea
	Common:	Vomiting
Skin and subcutaneous tissue disorders:	Uncommon:	Erythema, urticaria
General disorders and administration site conditions:	Very common:	Sore mouth or throat, jaw-muscle ache
	Rare:	Allergic reactions including angioedema

* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.

4.9 Overdose

Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.

Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Drugs used in nicotine dependence

ATC code: N07B A01

The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Freshfruit 2 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.

Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.

5.2 Pharmacokinetic Properties

Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.

5.3 Preclinical Safety Data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.

There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Core Gum

Chewing gum base, containing butylated hydroxy toluene (E321)

Xylitol

Peppermint oil

Sodium carbonate, anhydrous

Sodium hydrogen carbonate

Acesulfame Potassium

Levomenthol

Magnesium oxide, light

Talc

Sub-coating

Tuttifrutti QL84441

Hypromellose

Sucralose

Polysorbate 80

Purified water

Coating

Xylitol

Acacia

Titanium dioxide (E171)

Tuttifrutti Ql84441

Carnauba wax

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 Years

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/PVDC/Al Blister packed strips each containing 15 pieces supplied in packs of 15, 30, 105 and 210 pieces.

Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.

Blister packed strips each containing 10 pieces supplied in packs of 10 pieces.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Dispose of Nicorette Gum sensibly.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0136

9. Date Of First Authorisation/Renewal Of The Authorisation

18/07/2006

10. Date Of Revision Of The Text

27 September 2011

Boots Derma Care Itch Relief Cream

Boots Derma Care Itch Relief Cream

(Crotamiton)

• Effective relief of itching


• Works for up to 10 hours


• For relief of itching and skin irritation caused by:
  
  • Itchy dermatitis
  
  
  • Dry eczema
  
  
  • Allergic rashes
  
  

A cream for the relief of itching and skin irritation caused by:

• Itchy dermatitis



• Dry eczema



• Allergic rashes



• Chickenpox



• Insect bites and stings



• Hives, nettle rash



• Sunburn



• Heat rashes



• Personal itching

Suitable for adults and children; consult your doctor before use on children under 3 years of age.

Do not use: in or around the eyes, on broken skin, for weeping skin conditions or if you are sensitive to any of the ingredients.

Cautions: Derma Care Itch Relief Cream is not recommended in pregnancy.

Nursing mothers should avoid applying Derma Care Itch Relief Cream in the area of the nipples. Consult your doctor or pharmacist before using Derma Care Itch Relief Cream if you are breast feeding, or suffering from genital itching.

Methyl hydroxybenzoate may irritate the skin, eyes and mucous membranes.

Directions: Apply to the affected area 2 to 3 times daily. Irritation will be relieved for 6 to 10 hours. If symptoms persist consult your doctor. Derma Care Itch Relief Cream can be used for children. For children under 3 years of age consult your doctor before use and do not apply more than once a day.

Unwanted effects: Derma Care Itch Relief Cream may occasionally cause skin irritation or allergy. If this occurs or if you experience other symptoms stop using the product and consult your doctor. If Derma Care Itch Relief Cream is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately.

Keep all medicines out of the reach and sight of children.

Protect from heat. Do not use after the expiry date given.

Active ingredient: Crotamiton 10% w/w

Also contains: methyl hydroxybenzoate E218, phenylethyl alcohol, glycerol, triethanolamine, sodium lauryl sulphate, ethylene glycol monostearate, stearyl alcohol, strong ammonia solution, stearic acid, hard paraffin, white beeswax, perfume and purified water.

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by the Marketing Authorisation holder

Novartis Consumer Health

Horsham

RH12 5AB

PL 00030/0092

Text Prepared: March 2010

For external use only

30 g, 100 g

Boots Cold & Flu Relief Powders Lemon Flavour

1. Name Of The Medicinal Product

Abdine Cold Relief Powder

Bell's Hot Lemon Cold Relief Powders

Abdine Hot Lemon Cold Relief Powders

Cold & Flu Relief Powders Lemon Flavour

Cold Relief Powders Lemon Flavour

2. Qualitative And Quantitative Composition

Paracetamol BP 650 mg

3. Pharmaceutical Form

Powder for oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

To give effective relief from the symptoms of cold and flu.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 12 years: one sachet every four hours to a maximum of 4 sachets in any 24 hour period.

If symptoms persist for more than 3 days, consult your doctor.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic, alcoholic liver disease.

Do not exceed the recommended dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist, consult your doctor.

Keep out of the reach of children.

On the label:

'Do not take with any other paracetamol-containing products'.

'Immediate medical advice should be sought in the event of an overdose, even if you feel well.'

On the leaflet (or label if no leaflet exists):

'Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage'.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

4.9 Overdose

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.

Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

This product is a mixture of active ingredients and excipients in powder form. When the contents of a sachet are passed through a disintegration unit (BP method) none of the granules are left on the wire mesh.

5.2 Pharmacokinetic Properties

Sources: Martindale, The Extra Pharmacopoeia, 29^th Edition.

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to two hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the gluconoride and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ascorbic Acid, Sucrose, Sodium Citrate BP, Citric Acid BP, Tartaric Acid BP, Sodium Cyclamate, Spray Dried Lemon Juice, Lemon Aroma, Starch (modified, edible) and Natural

Colour E100.

6.2 Incompatibilities

None known.

6.3 Shelf Life

As packaged for sale: Three years

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

A trifoil laminated sachet containing 5 g of powder.

Pack size: 5, 8 or 10 sachets per carton.

6.6 Special Precautions For Disposal And Other Handling

Empty the contents of one sachet into a tumbler and fill with hot water. Stir till dissolved.

7. Marketing Authorisation Holder

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside PR9 9AL

8. Marketing Authorisation Number(S)

PL 03105/0069

9. Date Of First Authorisation/Renewal Of The Authorisation

01 March 1999

10. Date Of Revision Of The Text

February 2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)

Benylin Children&rsquo;s Blackcurrant Flavour Cough Syrup

1. Name Of The Medicinal Product

Glycerin and Blackcurrant Soothing Cough Syrup or Glycerin and Blackcurrant Linctus or Benylin Dry Coughs Blackcurrant or CalCough Children's Soothing Syrup or Benylin Children's Blackcurrant Flavour Cough Syrup

2. Qualitative And Quantitative Composition

Active Ingredient	Quantity per 5ml
Glycerin Ph. Eur.	0.75ml
Liquid sugar	1.93ml
(Equivalent to sucrose B.P.	1.7g)

3. Pharmaceutical Form

Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of irritating, tickling dry coughs and sore throats.

4.2 Posology And Method Of Administration

Adults, elderly and children over 5 years: 10ml

Children 1 - 5 years: 5ml

The dose may be repeated three or four times a day.

Children under one year: Not to be given to children under 1 year.

For oral administration.

4.3 Contraindications

Hypersensitivity or intolerance to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Diabetics should take note of the carbohydrate content of this product.

Do not give to children under one year.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of this medicine during pregnancy and lactation has not been established, but is not considered to constitute a hazard during these periods.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

No adverse effects would be anticipated.

4.9 Overdose

Overdosage would not be expected to cause any problems and treatment would be merely symptomatic and supportive.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycerin and sucrose have demulcent properties and will soothe irritated sore throats and possibly block sensory cough receptors within the respiratory tract.

5.2 Pharmacokinetic Properties

Glycerin is readily absorbed from the gastrointestinal tract and undergoes extensive metabolism principally in the liver. It may be used in the synthesis of lipids, and is metabolised to glucose or glycogen or oxidised to carbon dioxide and water. It may also be excreted in the urine unchanged.

Sucrose is hydrolysed in the small intestine by the enzyme sucrase to glucose and fructose which are then absorbed.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid monohydrate gran

Sodium benzoate

Anthocyanin

Blackcurrant Flavour 1740.7107 IFF

Blackcurrant Juice 1740.1436 IFF

Liquid Glucose BPC 1963

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

None stated.

6.5 Nature And Contents Of Container

125ml, 150ml or 200ml white flint glass, or amber glass bottle with an aluminium roll-on pilfer-proof cap with a flowed in liner, or a triseal (LDPE/EPE/LDPE) liner.

Alternative caps: A wadless polypropylene tamper evident cap, or a child resistant polypropylene cap with a LDPE liner.

A double ended measuring spoon of 2.5ml and 5.0ml capacity may optionally be provided with the product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

8. Marketing Authorisation Number(S)

PL 00014/0307

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 14 March 1984

Date of Last Renewal: 25 July 2000

10. Date Of Revision Of The Text

April 2010

Beconase Hayfever

1. Name Of The Medicinal Product

Beconase Allergy

Beconase Hayfever

2. Qualitative And Quantitative Composition

50 Micrograms Beclometasone Dipropionate BP per 100mg actuation.

3. Pharmaceutical Form

Aqueous Nasal Spray

4. Clinical Particulars

4.1 Therapeutic Indications

Beconase Allergy / Hayfever is indicated for the prevention and treatment of allergic rhinitis, including hayfever, in adults aged 18 and over.

4.2 Posology And Method Of Administration

Beconase Allergy / Hayfever is for administration by the intranasal route only.

Adults aged 18 and over: The recommended dosage is two sprays into each nostril morning and evening (400 micrograms/day). Once control has been established, it may be possible to maintain control with fewer sprays. A dosage regimen of one spray into each nostril morning and evening has been shown to be efficacious in some patients. However, should the symptoms recur, patients should revert to the recommended dosage of two sprays into each nostril morning and evening. The minimum dose should be used at which effective control of symptoms is maintained. Total daily administration should not exceed eight sprays (400 micrograms).

Beconase Allergy / Hayfever quickly starts to reduce inflammation and swelling in the nose. But for best effect patients should start to use Beconase Allergy / Hayfever two or three days before they expect to get symptoms to prevent them from developing. For full therapeutic benefit Beconase Allergy / Hayfever should be used regularly.

If symptoms have not improved after 14 days treatment, medical advice must be sought.

Beconase Allergy / Hayfever is not recommended for children or adolescents under 18 years of age.

4.3 Contraindications

Beconase Allergy / Hayfever is contra-indicated in patients with a history of hypersensitivity to any of its components.

4.4 Special Warnings And Precautions For Use

Systemic effects of nasal corticosteroids may occur, particularly at high doses when used for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

This product should not be used continuously for longer than 3 months without consulting a doctor.

Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contra-indication to treatment with Beconase Allergy / Hayfever.

Although Beconase Allergy / Hayfever will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances, necessitate appropriate additional therapy particularly to control eye symptoms.

Medical advice should be sought before using Beconase Allergy / Hayfever in the case of recent injury or surgery to the nose, or problems with ulceration in the nose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Beconase Allergy / Hayfever delivers beclometasone dipropionate directly to the nasal mucosa and so minimises systemic exposure.

The use of beclometasone dipropionate should be avoided during pregnancy unless thought essential by the doctor.

Lactation: No specific studies examining the transference of beclometasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk, but at the dosages used for direct intranasal administration there is low potential for significant levels in breast milk.

Beconase Allergy / Hayfever should not be used during lactation without consulting a doctor.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rare cases of nasal septal perforation have been reported following the use of intranasal corticosteroids.

As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.

Rare cases of raised intra-ocular pressure, glaucoma or cataract in association with intranasal formulations of beclometasone dipropionate have been reported.

Very rare cases of hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and oedema of the eyes, face, lips and throat, anaphylactoid / anaphylactic reactions, dyspnoea and/or bronchospasm have been reported.

4.9 Overdose

The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of hypothalamic-pituitary adrenal (HPA) function. No special emergency action need be taken. HPA function recovers in a day or two after discontinuation of treatment with Beconase Allergy / Hayfever.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Following topical administration, beclometasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects.

BDP is a pro-drug with weak corticosteroid receptor binding affinity. It is hydrolysed via esterase enzymes to the highly active metabolite beclometasone -17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

Beclometasone dipropionate offers a preventative background treatment for hayfever when taken prior to allergen challenge. After which, with regular use, BDP can continue to prevent allergy symptoms from reappearing.

5.2 Pharmacokinetic Properties

Absorption

Following intranasal administration of BDP in healthy males, the systemic absorption was assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following intranasal administration is 44% (95% CI 28%, 70%). After intranasal administration, <1% of the dose is absorbed by the nasal mucosa. The remainder, after being cleared from the nose, either by drainage or mucocilary clearance, is available for absorption from the gastrointestinal tract. Plasma B-17-MP is almost entirely due to conversion of BDP absorbed from the swallowed dose.

Following oral administration of BDP the systemic absorption was also assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following oral administration is 41% (95% CI 27%, 62%).

Following an oral dose, B-17-MP is absorbed slowly with peak plasma levels reached 3-5 hours after dosing.

Metabolism

BDP is cleared very rapidly from the circulation and plasma concentrations are undetectable (< 50pg/ml) following oral or intranasal dosing. There is rapid metabolism of the majority of the swallowed portion of BDP during its first passage through the liver. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclometasone -21-monopropionate (B-21-MP) and beclometasone (BOH), are also formed but these contribute little to systemic exposure.

Distribution

The tissue distribution at steady-state for BDP is moderate (201) but more extensive for B-17-MP (4241). Plasma protein binding of BDP is moderately high (87%).

Elimination

The elimination of BDP and B-17-MP are characterised by high plasma clearance (150 and 1201/h) with corresponding terminal elimination half-lives of 0.5h and 2.7h. Following oral administration of tritiated BDP, approximately 60% of the dose was excreted in the faeces within 96 hours mainly as free and conjugated polar metabolites. Approximately 12% of the dose was excreted as free and conjugated polar metabolites in the urine.

5.3 Preclinical Safety Data

None reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Avicel RC 591
(Microcrystalline Cellulose and Carboxymethylcellulose Sodium)	USNF
Anhydrous Dextrose for parenteral use	BP
Benzalkonium Chloride
(added as Benzalkonium Chloride solution)	BP
Phenylethyl Alcohol	USP
Polysorbate 80	BP
Purified Water	BP

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months. After first opening the shelf life is 3 months.

6.4 Special Precautions For Storage

Beconase Allergy / Hayfever should not be stored above 30°C. Keep container in the outer carton. Do not refrigerate.

6.5 Nature And Contents Of Container

Beconase Allergy / Hayfever is supplied in 17ml or 25ml amber glass bottles fitted with a metering, atomising pump and nasal applicator or in a 20ml or 30ml plastic bottle fitted with a tamper resistant, metering atomising pump and nasal applicator. A combined nasal adaptor/actuator covered with a dust cap is fitted on the pump. The glass bottle provides 80, 100, 180 or 200 metered sprays, and the plastic bottle provides 100, 180 or 200 sprays.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0618

9. Date Of First Authorisation/Renewal Of The Authorisation

23 August 2007

10. Date Of Revision Of The Text

05/10/2011

11. LEGAL STATUS

P

Boots Decongestant Tablets with Paracetamol

1. Name Of The Medicinal Product

Decongestant Tablets with Paracetamol or Otrivine Mu-Cron

2. Qualitative And Quantitative Composition

Active ingredient	mg/tab
Paracetamol Ph Eur	500.0
Pseudoephedrine hydrochloride BP	60.0

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of the symptoms of colds and influenza including feverishness, aches and pains, headache, nasal and sinus congestion (blocked nose and sinuses).

For oral administration.

4.2 Posology And Method Of Administration

Adults and children over 12 years

One tablet to be taken three or four times a day, up to a maximum daily dose of 4 tablets (240mg pseudoephedrine and 2g paracetamol).

Elderly

Although no specific studies have been carried out in this age group, there is no need for dosage reduction in the elderly.

Children 6 to 12 years

Half a tablet to be taken four times a day, up to a maximum daily dose of 2 tablets (120mg pseudoephedrine and 1g paracetamol).

This medicine is contraindicated in children under 6 years of age (see section 4.3).

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Administration in those with hepatic disorders

Care should be taken in administering this product to patients with severe hepatic impairment.

Administration in those with renal disorders

Care should be taken in administering this product to patients with moderate to severe renal impairment.

Warning: Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma or where intraocular pressure is raised

Severe liver disease

Concomitant use of other sympathomimetic decongestants

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

Beta-blockers – (see section 4.5)

Not to be used in children under the age of 6 years

4.4 Special Warnings And Precautions For Use

Caution in moderate to severe renal impairment.

Should be taken with caution by patients with hepatic impairment, prostatic enlargement and alcohol dependence.

If any of the following occur, the product should be stopped:

Hallucinations

Restlessness

Sleep disturbances

Not to be given to children under 6 years.

Do not take for longer than five days, unless your doctor agrees.

If symptoms persist, consult your doctor.

Do not take with any other decongestant-containing products.

Do not take with any other paracetamol-containing products.

Label

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combination label/leaflet

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives (including adrenergic neurone blockers & beta-blockers): this product may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin –risk of hypertension.

Enhances effects of anticholinergic drugs (such as TCAs).

Concomitant use of this medicine with tricyclic antidepressants and sympathomimetic agents such as decongestants may cause a rise in blood pressure.

Paracetamol

Drugs which induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptive steroids, may increase the rate at which paracetamol is metabolised, leading to a reduced plasma concentration of the drug.

Alcohol may reduce the capacity of the liver to metabolise paracetamol.

Chronic use of paracetamol enhances the effects of anticoagulants.

Concurrent use of paracetamol with NSAIDs may increase the risk of adverse renal effects. The prolonged combined use of these compounds may increase the risk of renal damage.

4.6 Pregnancy And Lactation

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided. The amounts of paracetamol and pseudoephedrine secreted into breast milk are considered to be too small to be harmful.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Pseudoephedrine

Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.

Gastrointestinal disorders: Nausea and/or vomiting.

General disorders and administration site conditions: Irritability.

Immune system disorders: Hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics.

Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.

Psychiatric disorders: Sleep disturbance.

Renal and urinary disorders: Urinary retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash.

Vascular disorders: Hypertension.

Paracetamol

Blood and lymphatic system disorders: There have rarely been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Immediate symptoms of overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia, abdominal pain, irritability, restlessness, palpitations, hypertension, difficulty in micturition, thirst and convulsions.

Liver damage may become apparent 12 to 48 hours after ingestion. Though hepatic enzymes may become elevated and prothrombin time prolonged within 10-12 hours of paracetamol overdosage, clinical symptoms may not be apparent for 1 to 6 days following ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatits have been reported.

In paracetamol overdosage with hepatic damage, paracetamol half life is often prolonged from around 2 hours in normal adults to 4 hours or longer. Liver damage and nephrotoxic effects have been reported after the daily ingestion of excessive amounts of paracetamol.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage and activated charcoal administered to reduce paracetamol absorption. As peak plasma concentrations may be delayed by up to 4 hours following overdose, to accurately assess the risk of hepatotoxicity, plasma paracetamol levels should be measured at least 4 hours post-ingestion.

Generally treatment is required if the blood-paracetamol concentration is higher than a line drawn on semi-log/linear paper joining the points 200mg per litre (1.32 mmol/litre) at 4 hours and 30mg per litre (0.2mmol/litre) at 15 hours following ingestion. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after overdose, may be required. It has been proposed that the threshold for treatment with N-acetylcysteine should be reduced by 30-50% in patients taking drugs which induce hepatic enzymes, who abuse alcohol long-term or who are chronically malnourished. These patients may be more susceptible to toxic effects of paracetamol.

Symptomatic and supportive measures should be undertaken, particularly with regard to the cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a peripherally acting analgesic with antipyretic activity.

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose-dependent.

The rate and extent of paracetamol absorption is normal in the elderly but plasma half life is longer and paracetamol clearance lower than in young adults.

In renal impairment though the mean plasma half-life of paracetamol is similar in normal and renally impaired subjects at 2-8 hours, from 8-24 hours paracetamol is eliminated less rapidly. An increase in the interval between doses of paracetamol has been recommended for adults with chronic renal failure.

With severe hepatic impairment the mean plasma half life of paracetamol is significantly prolonged (by approximately 75%). The clinical significance of this is however unclear, as no evidence exists of drug accumulation or hepatotoxicity in patients with liver disease.

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/Kg bodyweight.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pregelatinised maize starch

Microcrystalline cellulose

Sodium lauryl sulphate

Magnesium stearate

Quinoline yellow (E104)

Croscarmellose sodium

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 30°C.

Store in the original package.

6.5 Nature And Contents Of Container

A child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.

Pack sizes: 6, 12.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC	or	The Boots Company PLC
1 Thane Road West		trading as BCM
Nottingham
NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0594

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation: 29 July 1999

10. Date Of Revision Of The Text

March 2009