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Ranitidine Tablets 300mg

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Document: spc-doc_PL 20416-0322 change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ranitidine Tablets 300mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 334.8mg of ranitidine hydrochloride equivalent to 300mg of ranitidine.

For excipients see 6.1.

3    PHARMACEUTICAL FORM

Film-coated tablets.

Round, white, film-coated biconvex tablets engraved 5C3.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Ranitidine tablets are indicated for the treatment of duodenal ulcers (including those associated with Helicobacter pylori infection) and for the treatment of benign gastric ulcers, including those associated with non-steroidal antiinflammatory agents (NSAIDs). Ranitidine tablets are also indicated for the prevention of duodenal ulcers associated with NSAIDs.

In addition, ranitidine tablets are indicated for the treatment of post-operative ulcers, Zollinger-Ellison syndrome and oesophageal reflux disease including the long-term management of healed oesophagitis. Ranitidine treatment may also be beneficial in patients with chronic episodic dyspepsia, characterised by epigastric or retrosternal pain related to meals, or disturbed sleep, but which is not associated with the above conditions.

Ranitidine tablets are also indicated in the following conditions where reduction of gastric secretion and acid output is required: the prevention of recurrent haemorrhage in patients with bleeding peptic ulcers and before administration of a general anaesthetic to patients considered to be at risk of acid aspiration (Mendelson’s syndrome), particularly obstetric patients during labour: and the prevention of gastrointestinal haemorrhage from stress ulceration in seriously ill patients.

Children (3 to 18 years)

- Short term treatment of peptic ulcer

-Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease

4.2 Posology and method of administration

For oral administration.

Adults:

The usual dosage is 150mg twice a day, taken in the morning and evening. Patients with duodenal ulceration, gastric ulceration or oesophageal reflux disease may be treated with a single dose of 300mg at bedtime.

The tablets do not have to be taken in relation to the time of meals. Cases of duodenal ulcer, benign gastric ulcer and post-operative ulcer usually heal in four weeks. In patients whose ulcer has not healed after this initial period of treatment, healing usually occurs after a further four weeks of therapy. Eight weeks of treatment may be required for ulcers associated with NSAIDs.

The healing rates of patients with duodenal ulcers treated with 300mg twice a day for 4 weeks is higher than those after 4 weeks treatment with 150mg twice a day or 300mg at night. The higher dose has not been associated with increased incidence of side effects.

The usual dosage for the prevention of NSAID associated duodenal ulcers is 150mg twice a day given concurrently with NSAID therapy.

Patients with duodenal ulcers associated with Helicobacter pylori infection may be given 150mg twice a day or 300mg at bedtime concurrently with 750mg oral amoxycillin three times a day and 500mg metronidazole three times a day for two weeks. The ranitidine therapy should then continue for a further two weeks. This regimen significantly reduces the frequency of recurrence of duodenal ulcers.

A maintenance dose of 150mg at bedtime is recommended for patients who have responded to short-term therapy, particularly those with a history of recurring ulcers.

The recommended dose for the management of oesophageal reflux disease is 150mg twice a day or 300mg at bedtime for up to 8 weeks, extending to 12 weeks if necessary. For patients with moderate to severe oesophagitis the dosage can be increased to 150mg four times a day for up to 12 weeks. The higher dose has not been associated with increased incidence of side effects. The recommended dose for the long-term treatment of healed oesophagitis is 150mg twice a day. Long term treatment is not indicated in the management of unhealed oesophagitis, with or without Barrett’s epithelium.

The usual staring dose for patients with Zollinger-Ellison syndrome is 150mg three times a day, which can be increased as necessary. Doses up to 6g per day to treat this syndrome have been well tolerated.

The recommended dosage for treatment of chronic episodic dyspepsia is 150mg twice a day for up to six weeks. Patients who do not respond or relapse shortly after treatment should be investigated.

The usual dosage for the prevention of haemorrhage from stress ulceration in seriously ill patients, or the prevention of recurring haemorrhage in patients bleeding from peptic ulceration, is 150mg twice a day.

As ranitidine is excreted via the kidney, plasma levels are increased in patients with severe renal impairment. Therefore a lower dosage regimen of 150mg at night for 4 to 8 weeks is recommended for such patients. The same regimen should be used if maintenance therapy is required. If an ulcer has not healed after treatment following this regimen, the dose should be increased to 150mg twice a day followed by maintenance therapy of 150mg at night if required.

A dose of 150mg can be given to patients considered to be at risk of acid aspiration 2 hours before administration of a general anaesthetic and preferably also 150mg the evening before.

Obstetric patients at the start of labour may be given a dose of 150mg followed by further doses of 150mg every six hours. Since gastric emptying and drug absorption are delayed during labour, it is recommended that any -patient requiring emergency general anaesthesia should also be given a nonparticulate antacid such as sodium citrate, prior to administration of the anaesthetic. Normal precautions to avoid acid aspiration should also be taken.

Children from 3 to 11 years and over 30 kg of weight

See Section 5.2 Pharmacokinetic Properties - Special Patient Populations.

Peptic Ulcer Acute Treatment

The recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.

Gastro-Oesophageal Reflux

The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses in a maximum dose of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).

Safety and efficacy in new-born patients has not been established

Elderly:

The recommended adult dosage is appropriate. Rates of healing of ulcers and the incidence of side effects does not differ from younger patients.

4.3 Contraindications

Hypersensitivity to any of the ingredients of the tablets.

4.4 Special warnings and precautions for use

Symptoms associated with carcinoma of the stomach can be masked by histamine H2-antagonist treatment and may delay diagnosis of the condition. Therefore when gastric ulceration is diagnosed or in patients of middle age or older who have new or recently changed dyspeptic symptoms the possibility of malignancy should be excluded before ranitidine therapy commences.

A reduced dosage regimen is recommended for patients with severe renal impairment (see under ‘posology’).

Regular supervision of patients taking NSAIDs concurrently with ranitidine, especially the elderly, is recommended. Current evidence shows that ranitidine protects against NSAID associated ulceration of the duodenum but not of the stomach.

Ranitidine should be avoided in patients with a history of porphyria, as there have been reports of acute intermittent porphyria associated with ranitidine treatment, although the reports are rare and inconclusive.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Ranitidine should only be used during pregnancy and lactation if considered essential. Ranitidine crosses the placenta, but therapeutic doses have had no adverse effect on labour, delivery or neonatal progress when given to obstetric patients in labour or undergoing caesarian section. Ranitidine is excreted in breast milk.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

There have been rare reports of acute pancreatitis. Transient, reversible changes in liver function tests can occur and there have been occasional reports of hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, which were usually reversible.

Rare cases of leucopenia and thrombocytopenia have occurred but these are usually reversible. Rare cases of agranulocytosis and of pancytopenia, sometimes with marrow hyperplasia, or aphasia have also been reported.

Hypersensitivity reactions involving urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and anaphylactic shock have been observed rarely. These reactions have occasionally occurred after a single dose.

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

In a few patients, headache, which is sometimes severe, and dizziness have been reported. Rare cases of reversible mental confusion, depression and hallucinations have occurred but these have been mainly in the seriously ill and elderly.

There have been reports of skin rashes including rare cases of erythema multiforme. There have also been rare reports of musculoskeletal symptoms such as arthralgia and myalgia.

There have been isolated reports of swelling and/or discomfort of the breasts in men although no clinically significant interference with endocrine or gonadal function has been reported. In some cases the symptoms disappeared as treatment continued, but ranitidine treatment may need to be stopped to establish the underlying cause.

Antibiotic associated diarrhoea may occur when amoxycillin and metronidazole are taken concurrently with ranitidine.

The safety of ranitidine has been assessed in children aged 0 to 16 years with acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults. There are limited long term safety data available, in particular regarding growth and development.

4.9 Overdose

As ranitidine has a very specific action, no particular problems are expected with an overdose. Treatment should be symptomatic and supportive. The drug can be removed from the plasma by haemodialysis if required.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Ranitidine is a specific, rapidly acting histamic H2-abtagonist which inhibits basal and stimulated secretion of gastric acid. It reduces the volume and the acid and pepsin content of the secretion. A single dose of 150mg suppresses gastric acid secretion for 12 hours.

5.2 Pharmacokinetic properties

Ranitidine is readily absorbed from the gastro-intestinal tract with peak plasma concentrations reached within 2-3 hours. The bioavailability of ranitidine is about 50% and the elimination half life from plasma is 2-3 hours. A small proportion of ranitidine is metabolised in the liver and excreted as the N-oxide, the S-oxide, desmethyl ranitidine and as the furonic acid analogue. About 35% is eliminated unchanged.

Special Patient Populations

Children (3 years and above)

Limited pharmacokinetic data have shown that there are no significant differences in half-life (range for children 3 years and above: 1.7 - 2.2 h) and plasma clearance (range for children 3 years and above: 9 - 22 ml/min/kg) between children and healthy adults receiving oral ranitidine when correction is made for body weight.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

The tablets contain:

Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Colloidal silicon dioxide The tablet coating contains:

Macrogol

Hypromellose

Polydextrose

Vanillin

E171

The tablets are also polished with carnauba wax.

Incompatibilities

6.2


Not applicable.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

6.5 Nature and contents of container

Blister strips in packs of 28, 30, 56, 60, 84, 112, 120.

HDPE tablet containers in pack sizes of 100, 250, 500 & 1000 tablets.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Crescent Pharma Limited 3&4 Quidhampton Business Units Polhampton Lane

Overton Hampshire RG25 3ED UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 20416/0322

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

07/08/2000

10 DATE OF REVISION OF THE TEXT

05/12/2014