Ranitidine 75mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 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
Light pink, round, biconvex, film-coated tablets with embossment “75” on one side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Ranitidine Tablets are indicated for the short-term symptomatic relief of heartburn.
4.2 Posology and method of administration
Adults (including the elderly) and adolescents of 16 years of age and older.
One Ranitidine 75mg tablet 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.
4.3 Contraindications
• Hypersensitivity to the active substance ranitidine or to any of the excipients of the medicinal product.
• Ranitidine 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 patients present 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 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 Interaction with other medicinal products and other forms of interaction
Ranitidine may inhibit the hepatic cytochrome P450-linked mixed function oxygenase 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 gastrointestinal 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 Fertility, pregnancy and lactation
Pregnancy
Data on a large number (> 1000) of exposed pregnancies indicate no adverse effects of ranitidine on pregnancy or the health of the foetus/newborn. To date, no other relevant epidemiological data are available. As with other self prescribed drugs, ranitidine should not be taken during pregnancy without first consulting a doctor.
Lactation
The active ingredient is excreted in breast milk. As nothing is known of the effect of ingestion of ranitidine in the infant and the possibility of disturbances of gastric acid secretion cannot be excluded, breast-feeding should be avoided during treatment.
4.7 Effects on the ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. According to the pharmacodynamic properties of ranitidine, no influence on the ability to drive or use machines is expected. However, rare side effects (see section 4.8 Undesirable effects) affecting the CNS and the eye, and an increase in the effects of alcohol with the intake of ranitidine (see section 4.5 Interaction with other medicinal products and other forms of interaction) might adversely affect these abilities.
4.8 Undesirable effects
The following adverse effects have been reported in clinical trials or in routine management of patients treated with ranitidine.
Blood and the lymphatic system disorders :
Rare (>1/10000, <1/1000): agranulocytosis, and pancytopenia, sometimes with bone marrow hypoplasia or aplasia.
Very rare (<1/10000): leucopenia and thrombocytopenia (which are usually reversible)
Psychiatric disorders:
Rare (>1/10000, <1/1000): mental confusion (reversible), agitation, depression and hallucinations. These have been observed, mainly in patients with severe illness and the elderly.
Nervous system disorders:
Common (>1/100, <1/10): headache (sometimes severe) and dizziness.
Rare (>1/10000, <1/1000): reversible blurred vision (possibly due to impaired accomodation).
Cardiac Disorders :
Rare (>1/10000, <1/1000): bradycardia, tachycardia and A-V block.
Vascular disorders:
Very rare (<1/10000), including isolated reports: vasculitis Gastrointestinal Disorders :
Common (>1/100, <1/10): nausea, constipation and diarrhoea.
Hepato-biliary Disorders:
Uncommon (>1/1000, <1/100): transient changes in the results of liver function tests.
Rare (>1/10000, <1/1000): hepatitis (hepatocanalicular or mixed) with or without jaundice (usually reversible), acute pancreatitis..
Skin and subcutaneous tissue disorders :
Rare (>1/10000, <1/1000): erythema multiforme, alopecia and pruritus.
Musculoskeletal, connective tissue and bone disorders:
Rare (>1/10000, <1/1000): arthralgia and myalgia.
Renal and Urinary Disorders:
Rare (>1/10000, <1/1000): small increases in serum creatinine.
Reproductive system and breast Disorders:
Rare (>1/10000, <1/1000): impotence and loss of libido in male patients. Very rare (<1/10000), including isolated reports: breast swelling and / or discomfort in males (some of which have resolved with continued ranitidine use).
General disorders and administration site conditions:
Common (>1/100, <1/10): fatigue
Very rare (<1/10000): hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, laryngeal spasm, hypotension, anaphylactic shock, eosinophilia, chest pain), occasionally after a single dose.
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 lidocaine (lignocaine). Ranitidine may be removed from plasma by haemodialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: H2 - receptor antagonists ATC Code: A02B A 02 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.
The pharmacokinetics of ranitidine are dose proportional in the dose range between 75mg and 300mg.
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 Hypromellose Talc
Titanium dioxide (E171) Red ferric oxide (E172).
6.2
Incompatibilities
Not Applicable.
6.3 Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Ranitidine 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, 24 or 28 tablets.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
ratiopharm GmbH Graf Arco Str. 3 89079 Ulm Germany
8. MARKETING AUTHORISATION NUMBER(S)
PL 15773/0405
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 14/01/2007
10 DATE OF REVISION OF THE TEXT
29/07/2009