Ranicalm 75mg Film Coated Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 75mg film coated tablets Lloydspharmacy Heartburn & Indigestion Relief Tablets RaniCalm 75mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ranitidine 75 mg (as the hydrochloride).
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablets.
White to almost white, circular, biconvex, film coated tablets embossed with “BL” on one side and “75” on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity.
4.2 Posology and method of administration
Route of administration Oral
Dosage
The tablets have to be swallowed whole.
Adults (Including the Elderly) and children 16 years of age and older:
Swallow one 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. Do not take more than two tablets in 24 hours.
Do not take the tablets for more than 6 days without the advice of a pharmacist or doctor.
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 contraindicated for people known to be hypersensitive to the drug or any of the ingredients of Ranitidine Film Coated tablets.
4.4 Special warnings and precautions for use Malignancy
The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer [and if indications include dyspepsia; patients of middle age and over with new or recently changed dyspeptic symptoms must be included] as treatment with ranitidine may mask symptoms of gastric carcinoma.
Renal Disease
Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Ranitidine film coated tablets not suitable for these patients.
Patients who are taking non-steroidal anti-inflammatory drugs especially those with a history of peptic ulcer and the should not self-medicate with Ranitidine 75mg 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 of doctor.
The product is not indicated in the following people without seeking their doctor's advice:
Patients with severe renal and/or hepatic impairment.
• Patients under regular medical supervision for other reasons.
• Patients taking medications either physician prescribed or self prescribed.
• 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.
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 therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol 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) Competition for renal tubular secretion:
Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g. such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.
3) Alteration of gastric pH:
The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delaviridine, gefitnib).
There is no evidence of an interaction between ranitidine and amoxicillin, metronidazole or sucralfate.
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 any adverse effect on labour, delivery or subsequent neonatal progress. Like other over the counter drugs, Ranitidine Film Coated Tablets should not be taken only used during pregnancy without consulting a doctor or pharmacist.
Lactation
Ranitidine is also excreted in human breast milk and women who are breastfeeding will be advised to speak to their doctor before taking Ranitidine Film Coated 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: Depression, Reversible mental confusion, 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, diarrhea.
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 galactorrhoea)
Paediatric population
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
Symptoms and Signs
Ranitidine 75 mg film coated tablets is very specific in action and accordingly no particular problems are expected following overdosage with the drug.
Treatment
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 Ranitidine 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
Microcrystalline cellulose
Magnesium Stearate Hypromellose Titanium Dioxide (E171)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Polyamide/ Aluminium/PVC/Aluminium blisters containing 6 tablets. Blisters packaged into outer container to give total of 6 or 12 tablets.
Special precautions for disposal
6.6
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Bristol Laboratories Limited Unit 3, Canalside, Northbridge Road,
Berkhamsted, Herts, HP4 1EG UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 17907/0028
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/06/1993 / 06/03/2007
10 DATE OF REVISION OF THE TEXT
28/10/2011