SUMMARY OF PRODUCT CHARACTERISTICS

1. TRADE NAME OF THE MEDICINAL PRODUCT

Medreich Indigestion Relief 75 mg Tablets Tesco Indigestion Relief 75 mg Tablets Morrisons Indigestion Relief 75 mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains ranitidine 75 mg (as the hydrochloride).

For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Film-coated tablets.

White coloured, round, biconvex film coated tablets with k logo on one face and 75 on the other.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Ranitidine tablets are indicated for the short-term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity or the prevention of these symptoms when associated with consuming food and drink.

4.2    Posology and method of administration

Route of Administration

Oral

Dosage

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

Swallow one Ranitidine 75 mg film-coated tablet whole, with a drink of water, as soon as you have symptoms. If symptoms persist for more than one hour or return, take another tablet.

For prevention of acid indigestion, indigestion, hyperacidity and heartburn associated with consuming food and drink, swallow one tablet with water, half to one hour beforehand.

(Patients will be advised not to take the tablets for more than 2 weeks continuously and to consult their doctor if symptoms get worse or persist after 2 weeks treatment).

Children under 16 years

Not recommended for children under 16 years of age.

4.3 Contraindications

Ranitidine is contra-indicated for people known to be hypersensitive to the drug or any ingredients of Ranitidine 75mg Film-coated tablets.

4.4 Special warnings and precautions for use

Treatment with a histamine H₂-antagonist such as ranitidine may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Ranitidine 75 mg film-coated tablet is not suitable for these patients without medical supervision

Patients who are taking non-steroidal anti-inflammatory drugs, especially those with a history of peptic ulcer and the elderly should not self-medicate with Ranitidine 75 mg film-coated tablet but seek their doctor's advice before use. Current evidence shows that ranitidine protects against NSAID associated ulceration in the duodenum and not in the stomach.

Although clinical reports of acute intermittent porphyria associated with ranitidine administration have been rare and inconclusive, ranitidine should be avoided in patients with a history of this condition.

The Patient Information Leaflet and Label advises the patient not to take the maximum daily dose for more than 14 consecutive days unless advised by their doctor.

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

•    Patients with renal impairment (creatinine clearance less than 50 ml/min) and/or hepatic impairment.

•    Patients under regular medical supervision for other reasons.

•    Patients suffering from any other illness or taking medications either physician prescribed or self prescribed.

•    Patients of middle age or older with new or recently changed symptoms of indigestion.

•    Patients with unintended weight loss in association with symptoms of indigestion.

In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia.

A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine alone versus those who had stopped treatment, with an observed adjusted relative risk increase of 1,82 (95% CI 1,26-2,64).

4.5 Interaction with other medicinal products and other forms of interaction

Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

Interactions occur by several mechanisms including: 1) Inhibition of cytochrome P450-linked mixed function oxygenase system:

Ranitidine at usual therapeutics doses does not potentiate the actions of drugs which are inactivated by this enzyme systems such as diazepam, lidocaine, phenytoin, propranol and theophylline.

There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or

decreased prothrombin time is recommended during concurrent treatment with ranitidine.

2) Alteration of gastric pH:

The bioavailability of certain drugs may be affected. This can result in either an increase in absorption or a decrease in absorption.

4.6 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 it should not be taken during pregnancy without consulting a doctor or pharmacist. It is also excreted in human breast milk and women who are breastfeeding will be advised to speak to their doctor before taking Ranitidine 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.

Eye Disorders

Very Rare:    Reversible blurred vision.

There have been reports of blurred vision, which is suggestive of a change in accommodation.

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.

Uncommon:    Abdominal pain, constipation, nausea. (these symptoms mostly improved

during continued treatment).

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.

Rare:    Elevation of plasma creatinine    (usually slight; normalised during

continued treatment)

Reproductive System and Breast Disorders

Very Rare:    Reversible impotence. Breast symptoms and breast conditions (such as

gynaecomastia and galactorrhea).

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage. 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 so a single 75mg dose effectively suppresses gastric acid secretion for 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 within 2-3 hours of 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 approximately 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.

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

Microcrystalline cellulose Magnesium stearate Hypromellose Titanium dioxide.

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

Blister of 6, 12, 18, 24, 30 tablets.

The blisters are made from:

a)    Polyamide/Aluminium/PVC lidded with Aluminium

b)    PVC/PVDC lidded with Aluminium

6.6    Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

MEDREICH PLC 9 ROYAL PARADE,

KEW GARDENS SURREY,

TW9 3QD

8    MARKETING AUTHORISATION NUMBER(S)

PL 21880/0133

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 22/06/2012

10 DATE OF REVISION OF THE TEXT

20/02/2014