Ranitidine 75mg Film-Coated Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 75mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg Ranitidine (as hydrochloride)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round biconvex film coated tablets with a break line on one side and the imprint “R75” on the other side.
4.1 Therapeutic indications
Ranitidine 75mg film-coated tablets are indicated for the short term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity.
Ranitidine 75mg film-coated tablets are also indicated for prevention of acid indigestion, indigestion, hyperacidity and heartburn associated with consuming food and drink.
4.2 Posology and method of administration
Dose
Adults (including the elderly) and children 16 years of age and above:
One Ranitidine 75mg film-coated tablet should be taken as soon as symptoms appear. If symptoms persist for more than one hour, or return a second Ranitidine 75mg film-coated tablet should be taken.
The maximum daily dose is four Ranitidine 75mg film-coated tablets
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.
Children:
Ranitidine 75mg film-coated tablets should not be taken by children under the age of 16 years.
Length of Treatment
Do not take the tablets for more than 14 days without the advice of a pharmacist or doctor.
Medical attention should be sought if symptoms worsen.
Method of administration
Ranitidine 75mg film-coated tablets should be swallowed whole with fluid.
4.3 Contraindications
Ranitidine 75mg film-coated tablets should not be given to patients known to have hypersensitivity to ranitidine or any component of the tablet.
Ranitidine 75mg film-coated tablets should not be given to children under 16 years because safety and efficacy have not been established in this patient group.
4.4 Special warnings and precautions for use
Ranitidine is excreted via the kidneys and so plasma levels of the drug are increased in patients with severe renal impairment. Ranitidine 75mg film-coated tablets are not suitable for these patients.
Patients taking non-steroidal anti-inflammatory drugs, especially the elderly, should seek their doctor’s advice before using this product. Current evidence shows that ranitidine protects against NSAID associated ulceration in the duodenum and not in the stomach.
Treatment with a histamine H2-antagonist such as Ranitidine 75mg film-coated tablets may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition.
Administration of ranitidine to patients with a history of acute porphyria should, be avoided.
Patients should consult their doctor before taking Ranitidine 75mg film-coated tablets if:
- the patient has renal and / or hepatic impairment and under regular medical supervision for other reasons.
- the patient is suffering from any other illness or taking medications either physician prescribed or self prescribed.
- the patient has unintended weight loss in association with symptoms of indigestion.
- the patient is middle-aged or elderly with new or recently changed symptoms of indigestion.
4.5 Interaction with other medicinal products and other forms of interaction
At normal therapeutic dose, ranitidine does not inhibit hepatic Cytochrome P450-linked mixed function oxygenase system; although some minor interactions have been seen with some products these have not been shown to be of clinical relevance.
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 Pregnancy and lactation
Pregnancy:
Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without an adverse effect on labour, delivery or subsequent neonatal progress. Like other medicines, ranitidine should only be used during pregnancy if absolutely necessary following appropriate medical consultation.
Lactation:
Ranitidine is found in human breast milk so nursing mothers should speak to their doctors before taking ranitidine.
4.7 Effects on ability to drive and use machines
No known effect.
4.8 Undesirable effects
Ranitidine is well tolerated although as with all drugs, some patients occasionally experience side effects. Listed below are side effects which have been reported for ranitidine. These have not necessarily occurred after taking 75mg ranitidine and could have occurred after taking 150mg and 300mg ranitidine.
Frequency estimate: Very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data)
Cardiac disorders
Very rare: Arrhythmia, such as tachycardia or bradycardia, A-V conduction disturbance
Blood and lymphatic system disorders
Very rare: Leucopenia, thrombocytopenia, agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or aplastic anaemia. These effects are usually reversible.
Nervous system disorders Rare: Headache, dizziness
Very rare: Severe headache and involuntary movement disorders. These have been reported mainly in elderly or severely ill patients.
Gastrointestinal disorders
Very rare: diarrhoea, acute pancreatitis
Renal and urinary disorders Very rare: Acute interstitial nephritis
Skin and subcutaneous tissue disorders (see also Hypersensitivity)
Rare: Skin rash
Very rare: Erythema multiforme, alopecia
Musculoskeletal and connective tissue disorders
Very rare: Musculoskeletal symptoms such as arthralgia, myalgia
Vascular disorders Very rare: vasculitis
Immune system disorders
Rare: Hypersensitivity reactions, including urticaria, fever, hypotension, angioneurotic oedema, bronchospasm, chest pain
Very rare: Anaphylactic shock.
Hepatobiliary disorders
Rare: Transient and reversible changes in liver function test values
Very rare: Hepatitis (hepatocellular, hepatocanalicular or mixed) and with or without jaundice. These were usually reversible.
Reproductive system and breast disorders Very rare: Gynaecomastia, erectile dysfunction
Psychiatric disorders
Very rare: confusion, hallucinations and depression. These have been reported mainly in elderly or severely ill patients.
4.9 Overdose
Complications from overdose are not expected after oral administration.
Treatment for overdose:
Haemodialysis can be used to remove drug from the plasma. Symptomatic and supportive treatment should be given as required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code: A02BA02
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 ranitidine 75mg can relieve the symptoms of excess acid production for up to twelve hours.
5.2 Pharmacokinetic properties
Ranitidine is rapidly absorbed after oral administration with mean peak levels occurring at 2 to 3 hours. Bioavailability of ranitidine tablets is 50% on average.
In the liver ranitidine is metabolised to ranitidine-N-oxide, N-desmethylranitidine, ranitidine S-oxide and a furan acid analogue. About 35% of the orally administered dose is excreted unchanged in the urine within 24 hours, 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.
In persons with normal renal functions the elimination half-life after oral administration is 2 to 3 hours.
Absorption is not significantly impaired by food and 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.
5.3 Preclinical safety data
Ranitidine has a high safety margin. 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. Rapid respiration and muscular tremors with one fatality occurred in dogs receiving 450mg/kg ranitidine. Rats tolerated daily doses of 2,000mg/kg for 78 weeks well.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core
Microcrystalline Cellulose Povidone
Magnesium Stearate Titanium Dioxide (E171)
Coat
Hypromellose Titanium dioxide (E171)
Talc
Macrogol 6000 Methacrylic acid copolymer.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in the original pack. Do not store above 25°C.
6.5 Nature and contents of container
Blister strips of 5 or 6 tablets comprising aluminium foil on both sides.
7
8
9
10
The strips are packed in cartons to contain 5, 6, 10, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
Founts (UK) Pharmacare Ltd First Floor,
2 Victoria Road,
Harpenden,
Hertfordshire,
A15 4EA,
United Kingdom
28/02/2013