Ranitidine 75mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 75mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
75mg Ranitidine (as hydrochloride)
3 PHARMACEUTICAL FORM
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 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ranitidine 75mg Tablets are indicated for the short term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity.
4.2 Posology and method of administration
Adults: One Ranitidine 75mg Tablet should be taken as soon as symptoms appear. If symptoms persist for more than one hour, or return a second Ranitidine 75mg Tablet should be taken. The maximum daily dose is two Ranitidine 75mg Tablets.
Children: Ranitidine 75mg Tablets should not be taken by children under the age of 16 years.
Length of Treatment: Do not take the tablets for more than 6 days without the advice of a pharmacist or doctor. Medical attention should be sought if symptoms worsen.
Method of administration: Ranitidine 75mg tablets should be swallowed whole with fluid.
4.3
Contraindications
Ranitidine 75mg Tablets should not be given to patients known to have hypersensitivity to Ranitidine or any component of the tablet.
Ranitidine 75mg 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
Patients should be advised not to purchase a second pack of tablets without the advice of a pharmacist or doctor.
Patients taking NSAIDS, especially the elderly, should seek their doctor's advice before using this product.
If gastric ulcer has been diagnosed or there is a new or recently changed presentation or dyspeptic symptoms, then the possibility of malignancy should be excluded. Isolated reports suggest a relationship between the intake of Ranitidine 5mg and the occurrence of acute porphyria. Administration of Ranitidine 75mg Tablets to patients with a history of acute porphyria should, therefore be avoided.
Patients should consult their doctor before taking Ranitidine 75mg Tablets if the patient has:
- Unintended weight loss.
- Patient has problems swallowing.
- Constant stomach pains.
And if the patient is middle-aged or elderly with new or recently changed symptoms.
4.5 Interaction with other medicinal products and other forms of interaction
At normal dosage, Ranitidine does not inhibit cytochrome P450; although some minor interactions have been seen with some products these have not been shown to be of clinical relevance.
4.6 Pregnancy and lactation
Pregnancy: There are no adequate studies on the effect of Ranitidine in pregnancy although animal studies have not produced evidence that it will harm the foetus. 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 avoid taking ranitidine.
4.7 Effects on ability to drive and use machines
No effects have been reported
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 75mg Tablets. These have not necessarily occurred after taking Ranitidine 75mg Tablets and could have occurred after taking 150mg and 300mg Ranitidine.
Frequency estimate: Very common: >1/10; common >1/100, <1/10; uncommon >1/1,000, <1/100; rare >1/10,000, <1/1,000; very rare <1/10,000 and isolated reports.
Hypersensitivity reactions:
Rare: Hypersensitivity reactions, including urticaria, fever, hypotension, angioneurotic oedema, bronchospasm
Very rare: Anaphylactic shock, vasculitis or vasculitic rash.
Isolated cases: Acute interstitial nephritis
Blood and lymphatic system disorders:
Very rare: Leucopoenia, thrombocytopenia, agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or aplastic anaemia. These effects were usually reversible.
Cardiac disorders:
Very rare: Arrhythmia, such as tachycardia or bradycardia, A-V conduction disturbance.
Gastrointestinal:
Very rare: Nausea, diarrhoea, acute pancreatitis Hepatobiliary disorders:
Rare: Transient and reversible changes in liver function test values Very rare: hepatitis and jaundice, usually reversible
Musculoskeletal disorders:
Very rare: Arthralgia, myalgia
Nervous system/psychiatric disorders:
Rare: Headache, dizziness
Very rare: Severe headache, confusion, hallucinations, involuntary movement disorders and depression. These have been reported, mainly in elderly or severely ill patients
Skin and subcutaneous tissue disorders (see also hypersensitivity) Rare: Skin rash
Very rare: Erythema multiforme, alopecia
Other :
Very rare: Gynaecomastia, erectile dysfunction, visual disturbances
4.9 Overdose
Complications from overdose are not expected after oral administration. Daily doses of 6300mg of ranitidine administered orally for several months were well tolerated.
Treatment for overdose: If there are signs of intoxication, unabsorbed tablets should be removed by gastric lavage. 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
Ranitidine is a competitive inhibitor of the action of histamine at the histamine H2-receptors. It inhibits basal gastric acid secretion as well as gastric acid secretion stimulated by e.g. histamine, pentagastrin or food. Ranitidine reduces gastric acid secretion as well as to a limited degree total pepsin output and total gastric juice volume.
Studies showed that therapeutic doses of 150 mg ranitidine twice a day, on average, inhibit gastric acid secretion by more than 60% for 24 hours. At night these doses were sufficient to inhibit gastric acid secretion by 70 -90%. Doses of 150 mg in the evening were shown to inhibit gastric acid secretion by 40 -70% for 24 hours on average.
Therapeutic doses necessary to inhibit gastric acid secretion by 50-60% for 24 hours were 300 mg ranitidine. Nocturnal gastric acid secretion was reduced by almost 90%.
5.2 Pharmacokinetic properties
Ranitidine is rapidly absorbed after oral administration with mean peak levels occurring at 1.25 to 3 hours. Bioavailability of ranitidine tablets is 50% on average with an interindividual variability of 28 -76%.
After oral administration of 150 mg ranitidine mean peak plasma levels were about 400 ng/ml. Interindividual variability was observed. After 12 hours, mean plasma levels were 40 ng/ml. After oral administration of 300 mg ranitidine mean peak plasma levels were 700 to 800 ng/ml.
In several studies, the plasma concentration necessary to inhibit 50% of gastric acid secretion in adults was between 73 and 165 ng/ml. Plasma-protein binding is approximately 15%. The volume of distribution is 1.2 -1.8 l/kg in adults and 2.51/kg in children. Mean total clearance is 570 -710 ml/min in adults and about 800 ml/min in children and young persons.
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 2.3 to 3 hours. In patients with impaired renal function elimination half-life maybe 2 to 3 times longer than this. Only smaIl amounts of ranitidine are found in cerebrospinal fluid. Ranitidine passes the placental barrier.
Following intravenous and oral administration of ranitidine during parturition, ranitidine concentrations corresponding to those in the mother's semm have been found in umbilical cord blood of the new-born. Twelve hours later only very small amounts were present.
Ranitidine is found in human breast milk, the ratio milk/plasma concentration being 1.9 (range: 0.6 to 20.9) two hours after administration. Unless otherwise stated, the pharmacokinetics of ranitidine in children is the same as for adults.
5.3 Preclinical safety data
Ranitidine has a high safety margin. In dogs, oral doses of ranitidine of up to 400mg/kg/day for 54 weeks resulted in dose related occasional cases of mild diarrhoea, increased salivation and vomiting. 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.
In animal tests ranitidine has shown no mutagenic, carcinogenic or teratogenic potential and does not impair fertility.
6.1 List of excipients
Microcrystalline Cellulose, Polyvidone, Magnesium Stearate, Methylhydroxypropylcellulose, Titanium dioxide (E171), Talc, Macrogol6000 and Methacrylic acid copolymer.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store in the original package. Do not store above 25°C
6.5 Nature and contents of container
Blister strip comprising aluminium foil on both sides. The strips are packed in cartons to contain 5, 6, 10 or 12 tablets.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Relonchem Limited Cheshire House
Gorsey Lane, Widnes, Cheshire WA8 0RP, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20395/0079
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/07/2011
10 DATE OF REVISION OF THE TEXT
03/02/2014