SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ranitidine Tablets BP 75mg Or

Numark Indigestion Relief Tablets Or

Superdrug Heartburn & Indigestion Relief Tablets Or

Sainsbury’s Indigestion Relief Tablets Or

Numark Excess Acid Relief Tablets Or

Morrisons Indigestion Relief Tablets Or

Wilko Indigestion Relief Tablets Or

Boots Heartburn Relief 75 mg Tablets Or

Lloyds Pharmacy Indigestion Relief Tablets Or

Asda Indigestion Relief Tablets Or

Tesco Indigiestion Relief Tablets

Or

Gavilast 75mg Tablets

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 83.75 mg of Ranitidine Hydrochloride equivalent to 75 mg of Ranitidine.

For excipients see 6.1.

3.    PHARMACEUTICAL FORM

Film-coated tablet.

Light pink, round, biconvex, film-coated tablets printed with “75” in black edible ink on one side.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Ranitidine Tablets BP or Histac Tablets are indicated for the short-term symptomatic relief of acid indigestion and heartburn.

4.2    Posology and Method of Administration

For Pharmacy (P) Packs

Adults (including the elderly) and adolescents of 16 years of age and older.

One Ranitidine tablet 75mg should be taken when symptoms occur, day or night. Do not take more than two tablets in 24 hours.

Patients will be instructed not to take the tablets for more than 2 weeks continuously. They must consult their doctor if symptoms deteriorate or persist after 2 weeks treatment.

Children under 16 years.

The tablets are not recommended for children under 16 years of age.

For General Sales (GSL) Packs

Adults (including the elderly) and adolescents of 16 years of age and older.

One Ranitidine tablet 75mg should be taken when symptoms occur, day or night. Do not take more than two tablets in 24 hours.

Patients will be instructed not to take the tablets for more than 6 weeks continuously. They must consult their doctor or pharmacist if symptoms deteriorate or persist after 6 days treatment. They should not purchase a second pack of tablets without the advice of a pharmacist or doctor.

Children under 16 years.

The tablets are not recommended for children under 16 years of age.

4.3 Contraindications

Ranitidine Tablets or Histac Tablets are contraindicated in case of hypersensitivity to ranitidine or any of its components.

Ranitidine tablets or Histac tablets should not be given to children under 16 years of age.

4.4 Special Warnings and Precautions for Use

The product is not indicated if the patient presents with any of the following without first seeking their doctor’s advice:

Treatment with histamine (H2) antagonists may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. If the patient has been diagnosed as having a gastric ulcer or in middle aged or older patients who have experienced new or recently changed dyspeptic symptoms the possibility of malignancy must be excluded before commencing ranitidine.

Patients who have stomach pain, difficulty in swallowing or unintended weight loss associated with their indigestion symptoms.

Patients with renal and/or hepatic impairment or patients under regular medical supervision for any reason.

Patients suffering from any other illness or taking self-prescribed or physician-prescribed medicines.

Patients taking NSAID’s, especially the elderly, should seek their doctor’s advice before taking ranitidine.

Ranitidine Tablets should be avoided in patients with a history of acute intermittent porphyria.

Patients with a history of peptic ulcer or at risk of developing peptic ulcer should seek their doctor’s advice before taking tablets containing 75 mg ranitidine.

4.5 Interactions with other Medicaments and other Forms of Interaction

Ranitidine may inhibit the hepatic cytochrome P450-linked mixed function oxygenese system to a low degree.

At higher doses of ranitidine, there may be a reduction in excretion of procainamide and N-acetylprocainamide due to inhibition of tubular secretion.

As ranitidine absorption from the gastro-intestinal tract may be reduced by the concurrent use of antacids or sucralfate, ranitidine should be taken about 2 hours before such agents.

In clinical trials, an impairment of the metabolism of theophylline and/ or an elevation of the theophylline plasma concentrations by ranitidine has not been shown. However, there are isolated reports of patients, in whom elevations of theophylline plasma levels and signs and symptoms of theophylline overdosage were observed under concurrent treatment with ranitidine and theophylline. Therefore, during concurrent treatment with ranitidine, the theophylline plasma concentrations should be controlled and the theophylline dosage adjusted if necessary.

In case of concurrent use of drugs, the absorption of which is pH-dependent-such as ketoconazole, the altered absorption of these substances should be borne in mind.

Concomitant treatment of ranitidine and glipizide might result in increased plasma concentrations of glipizide.

The effects of alcohol may be increased by taking ranitidine.

4.6 Pregnancy and Lactation

There are no adequate or well controlled studies in man. A dose equivalent to 160 times the normal human dose showed no adverse effects on the foetus when given to pregnant rats and rabbits.

Ranitidine is excreted in breast-milk, and women who are breast-feeding must be advised to take the advice of their doctor before commencing ranitidine. It also crosses the placenta; but therapeutic doses given to obstetric patients in labour or undergoing caesarean section have not been observed to cause adverse effects on labour, delivery or subsequent neonatal progress. Ranitidine, as other self prescribed drugs, should not be taken during pregnancy without first consulting a doctor.

4.7 Effects On the Ability to Drive and Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Ranitidine has been associated rarely with hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, laryngeal spasm, hypotension, anaphylactic shock, eosinophilia, chest pain), occasionally after a single dose.

As with other H₂ - receptor antagonists, there have been rare reports of bradycardia, tachycardia and A-V block.

The following blood dyscrasias have been associated with the use of ranitidine: leucopenia and thrombocytopenia (which are usually reversible), agranulocytosis, and pancytopenia, sometimes with bone marrow hypoplasia or aplasia.

Skin rash including rare causes of erythema multiforme, alopecia, pruritus and musculoskeletal symptoms, for example arthralgia and myalgia have been reported rarely.

Headache, sometimes severe, dizziness and fatigue have been reported in a small portion of patients. Mental confusion which was reversible, agitation, depression and hallucinations have been observed, mainly in patients with severe illness and the elderly. Rare cases of reversible blurred vision (possibly due to impaired accommodation) have also been reported.

The following gastrointestinal side-effects have been associated with the use of ranitidine: nausea, constipation and diarrhoea.

Transient changes in the results of liver function tests may occur. Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, have occurred occasionally. These effects were usually reversible. Rare cases of acute pancreatitis have been seen. Small increases in serum creatinine have also been reported.

Isolated cases of breast swelling and / or discomfort have been observed in males, some of which have resolved with continued ranitidine use. Discontinuation of therapy may be indicated to establish the underlying cause. No clinically significant changes in endocrine or gonadal function have been observed. Although occasional cases of impotence and loss of libido have been reported in male patients receiving ranitidine, the incidence did not differ from that in the general population.

4.9 Overdose

Treatment should be supportive and symptomatic. Gastric lavage should be carried out and / or emesis induced. Seizures may be managed with diazepam, bradycardia with atropine and ventricular arrhythmias with lignocaine. Ranitidine may be removed from plasma by haemodialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

ATC Code: A02B A (H2-receptor antagonist)

Mode of action

Ranitidine is a specific, histamine H2 - antagonist with a rapid onset of action. Both basal and stimulated gastric acid secretion are inhibited, reducing both the acid content and also to a smaller extent the pepsin content and volume of the gastric juice .

Ranitidine has a relatively long duration of action, a 75 mg dose of ranitidine effectively suppressing gastric acid secretion for up to 12 hours.

5.2    Pharmacokinetic Properties

Ranitidine has a bioavailability of approximately 50%. After oral administration, rapid absorption is followed by the attainment of peak plasma concentrations 2 - 3 hours later.

Ranitidine is metabolised in the liver to Ranitidine-N-oxide, N-Desmethylranitidine, Ranitidine-S-oxide and the furane acid analogue. After oral administration, ranitidine is excreted within 24 hours via the kidneys to approx. 30% as unchanged ranitidine, up to 6% as N-oxide, to a small degree in demethylised and in S-oxidised form, and as furane acid analogue. In patients with normal kidneys, renal excretion is effected predominantly by tubular secretion with a renal clearance of about 490-520 ml/min.

Additionally, ranitidine is excreted via the bile.

After oral intake, mean elimination half-life in patients with normal kidneys is 2.3-3 hours. In patients with renal insufficiency, the half-life is prolonged two-to threefold.

5.3 Preclinical Safety Data

The pharmacological and toxicological properties of ranitidine are well established. There are no additional data from preclinical studies of clinical concern.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Talc

Film coating material:

Castor oil

Opadry OY-S-54902 Pink containing

Hypromellose

Talc

Titanium dioxide (E171)

Red ferric oxide (E172)

Printing ink:

Opacode S-1-17823 Black containing Shellac

Isopropyl alcohol Iron oxide black (E172)

N-Butyl alcohol Propylene glycol

Ammonium Hydroxide 28% 6.2 Incompatibilities

Not Applicable.

6.3 Shelf-Life

3 years.

6.4 Special Precautions For Storage

Keep tablets in outer carton in order to protect from light. Do not store above 25°C.

6.5 Nature And Content Of Container

Ranitidine Tablets or Histac Tablets are packed in cold-form blister sheets (structure from outer to inner side: oriented polyamide/aluminium foil/hard PVC film with a backing of aluminium foil coated with heat seal lacquer), each containing 6 or 7 or 10 tablets.

Packs of 6 or 10 or 12 or 20 or 24 or 28 tablets.

6.6 Instruction For Use, Handling and Disposal

No special requirements.

7.    MARKETING AUTHORISATION HOLDER

Ranbaxy (UK) Ltd.

Buildind 4, Chiswick Park 566 Chiswick High Road London, W4 5YE U.K.

8.    MARKETING AUTHORISATION NUMBER

14894/0041

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21 November 2000

DATE OF REVISION OF THE TEXT

25/09/2012