Zantac 75 Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 75 Relief Dissolve
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ranitidine hydrochloride 84mg (equivalent to 75mg ranitidine)
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
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.
4.3 Contraindications
Ranitidine is contraindicated for people known to be hypersensitive to the drug or any of the ingredients of Zantac 75 Relief Dissolve tablets.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Fertility, Pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
No known effect.
4.8 Undesirable effects
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 postmarketing data.
Blood & Lymphatic System Disorders
Very Rare: Blood count changes (leucopenia, thrombocytopenia). These are
usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.
Immune System Disorders
Rare: Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).
Very Rare: Anaphylactic shock
These events have been reported after a single dose.
Psychiatric Disorders
Very Rare: Reversible mental confusion, depression and hallucinations.
These have been reported predominantly in severely ill and elderly patients.
Nervous System Disorders
Very Rare: Headache (sometimes severe),dizziness and reversible involuntary
movement disorders.
Cardiac Disorders
Very Rare: As with other H2 receptor antagonists bradycardia and A-V Block.
Vascular Disorders Very Rare: Vasculitis.
Gastrointestinal Disorders
Very Rare: Acute pancreatitis. Diarrhoea.
Hepatobiliary Disorders
Rare: Transient and reversible changes in liver function tests.
Very Rare Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.
Skin and Subcutaneous Tissue Disorders
Rare: Skin Rash.
Very Rare: Erythema multiforme, alopecia.
Musculoskeletal and Connective Tissue Disorders
Very Rare: Musculoskeletal symptoms such as arthralgia and myalgia.
Renal and Urinary Disorders
Very rare: Acute interstitial nephritis.
Reproductive System and Breast Disorders
Very Rare: Reversible impotence. Breast symptoms in men.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Monosodium citrate anhydrous
Sodium bicarbonate
Aspartame
Povidone K30
Sodium Benzoate
Orange flavouring IFF No. 6
Grapefruit flavouring IFF 18 C 222
6.2 Incompatibilities
None known
6.3 Shelf life
24 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
Aluminium/polythene foil strips packed into cartons of 2, 6 or 12 tablets.
6.6 Special precautions for disposal
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.
7 MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 02855/0085
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/03/2009
31/01/2013