Zantac 75 Relief Dissolve

Ranitidine hydrochloride 84mg (equivalent to 75mg ranitidine)

For excipients, see 6.1.

Effervescent tablet

Symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity.

The product is not indicated in the following people without seeking their doctor's advice:

• Those with difficulty swallowing, persistent stomach pain or unintended weight loss in association with symptoms of indigestion.

• Those who are middle-aged or elderly with new or recently changed symptoms of indigestion.

Route of Administration

Oral

Dosage

Adults (Including The Elderly) and children 16 years of age and older:

One Zantac 75 Relief Dissolve tablet should be dissolved in water (see 6.6 Instructions for Use/Handling) and taken as soon as symptoms appear. If symptoms persist for more than one hour another tablet can be taken as before. Do not take more than two tablets in 24 hours.

Do not take the tablets for more than 6 consecutive days without the advice of a pharmacist or doctor.

Children under 16 years

Not recommended for children under 16 years of age.

Ranitidine is contraindicated for people known to be hypersensitive to the drug or any of the ingredients of Zantac 75 Relief Dissolve tablets.

Treatment with a histamine H₂-antagonist such as Zantac 75 Relief Dissolve tablets may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.

Zantac 75 Relief Dissolve tablets contain aspartame and therefore they should be taken with caution in patients with phenylketonuria.

People taking non-steroidal anti-inflammatory drugs, especially the elderly, should not self-medicate with Zantac 75 Relief Dissolve tablets but seek their doctor's advice before use.

People with a history of porphyria should avoid use of the product.

Consumers will be advised not to purchase a second pack of tablets without the advice of a pharmacist or doctor.

Ranitidine does not inhibit the hepatic Cytochrome P450-linked mixed function oxygenase system at therapeutic doses. Accordingly, ranitidine does not potentiate the actions of drugs which are inactivated by this enzyme; these include diazepam, lidocaine, phenytoin, propranolol, theophylline and warfarin.

Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress. Like other over the counter drugs, Zantac 75 Relief Dissolve tablets should not be taken during pregnancy without consulting a doctor or pharmacist. Ranitidine is also excreted in human breast milk and women who are breast-feeding will be advised to speak to their doctor before taking Zantac 75 Relief Dissolve tablets.

No known effect.

The following convention has been utilised for the classification of undesirable effects: very common ( >1/10), common ( >1/100, <1/10), uncommon ( >1/1000, <1/100), rare ( >1/10,000, <1/1000), very rare (1/10,000).

Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.

Zantac is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.

Ranitidine is a specific rapidly acting histamine H₂-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion. Ranitidine has a long duration of action and a single 75mg dose suppresses gastric acid secretion for up to twelve hours.

Clinical studies have shown that Zantac 75 mg can relieve the symptoms of excess acid production for up to twelve hours.

The bioavailability of ranitidine is consistently about 50%. Absorption of ranitidine after oral administration is rapid and peak plasma concentrations are usually achieved 2-3 hours after administration. Absorption is not significantly impaired by food or antacids. Ranitidine is not extensively metabolised. Elimination of the drug is primarily by tubular secretion. The elimination half-life of ranitidine is 2-3 hours. In balance studies with 150mg 3H-ranitidine 60-70% of an oral dose was excreted in urine and 26% in faeces. Analysis of urine excreted in the first 24 hours after dosing showed that 35% of the oral dose was eliminated unchanged. About 6% of the dose is excreted as the N-Oxide, 2% as the S-Oxide, 2% as desmethyl ranitidine and 1-2% as the furoic acid analogue.

Extensive studies have been carried out in animals. The pharmacology of ranitidine hydrochloride shows it to be a surmountable H₂ receptor antagonist which produces an inhibition of gastro acid secretion. Extensive toxicological investigators have been conducted which predicted a very safe profile for clinical use. This safety has been confirmed by extensive use in patients for many years.

Monosodium citrate anhydrous

Sodium bicarbonate

Aspartame

Povidone K30

Sodium Benzoate

Orange flavouring IFF No. 6

Grapefruit flavouring IFF 18 C 222

None known

24 months

Do not store above 30°C

Store in the original package

Aluminium/polythene foil strips packed into cartons of 2, 6 or 12 tablets.

Zantac 75 Relief Dissolve tablets should be placed in a glass of water (minimum of 75ml) and allowed to dissolve completely (by swirling the glass if necessary) before swallowing.

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as

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

PL 00079/0622

15 August 2007

15 August 2007