- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
DosageAdults (Including the elderly) and children 16 years of age and older:Swallow one Zantac 75 Relief 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.
Children under 16 yearsNot recommended for children under 16 years of age.
|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:||Reversible mental confusion, depression 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.|
|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.|
|Very Rare:||Acute pancreatitis. Diarrhoea.|
|Uncommon:||Abdominal pain, constipation, nausea. (these symptoms mostly improved during continued treatment).|
|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|
|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 galactorrhea).|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
TreatmentSymptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.
ATC CodePharmacotherapeutic group: H2-receptor antagonist, ATC code: A02BA02
Pharmacotherapeutic groupH2-receptor antagonists, ATC code: A02BA02
Mechanism of ActionRanitidine 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
Pharmacodynamic EffectsRanitidine has a long duration of action and a single 75 mg dose effectively suppresses gastric acid secretion for at least 12 hours.
AbsorptionFollowing oral administration of 150 mg ranitidine, maximum plasma concentrations (300 to 550 ng/mL) occurred after 1-3 hours. Two distinct peaks or a plateau in the absorption phase result from reabsorption of drug excreted into the intestine. The absolute bioavailability of ranitidine is 50-60%, and plasma concentrations increase proportionally with increasing dose up to 300 mg.Absorption is not significantly impaired by food or antacids.
DistributionRanitidine is not extensively bound to plasma proteins (15%), but exhibits a large volume of distribution ranging from 96 to 142 L.
MetabolismRanitidine is not extensively metabolised. The fraction of the dose recovered as metabolites includes 6% of the dose in urine as the N-Oxide, 2% as the S-Oxide, 2% as desmethyl ranitidine and 1-2% as the furoic acid analogue.
EliminationPlasma concentrations decline bi-exponentially, with a terminal half-life of 2-3 hours. The major route of elimination is renal. After IV administration of 150 mg 3H- ranitidine, 98% of the dose was recovered, including 5% in the faeces and 93% in the urine, of which 70% was unchanged parent drug. After oral administration of 150 mg 3H-ranitidine, 96% of the dose was recovered, 26% in the faeces and 70% in urine of which 35% was unchanged parent drug. Less than 3% of the dose is excreted in bile. Renal clearance is approximately 500mL/min, which exceeds glomerular filtration indicating net renal tubular secretion.Special Patient Populations• Patients over 50 years of ageIn patients over 50 years of age, half-life is prolonged (3-4 h) and clearance is reduced, consistent with the age-related decline of renal function. However, systemic exposure and accumulation are 50% higher. This difference exceeds the effect of declining renal function, and indicates increased bioavailability in older patients.
Tablet CoreMicrocrystalline Cellulose NF Magnesium Stearate
Filmcoat (Aqueous)Hypromellose (E464)* Titanium Dioxide (E171)*Synthetic red iron oxide (E172)* Triacetin*Purified Water (Not detected in final formulation)*As Opadry Pink YS-1-1441-G
Omega Pharma Ltd
Omega Pharma Ltd, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
+44 (0)203 598 9603
+44 (0)1748 828 860