- 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
- Administrative data
- 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
Children (3 to 18 years)- Short term treatment of peptic ulcer- Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.See section 4.4. Special warnings and precautions for use.
Adults (including the elderly):
Treatment of duodenal and gastric ulcer:The usual dosage is 150mg twice daily, taken in the morning and evening or a single bedtime dose of 300mg. It is not necessary to time the dose in relation to meals. This may be increased to ranitidine 300mg twice daily without an increased incidence of unwanted effects.In most cases of duodenal ulcer, benign gastric ulcer and post operative ulcer, healing occurs in four weeks. Healing usually occurs after a further four weeks of treatment in those patients whose ulcers have not fully healed after the initial course of therapy.Maintenance treatment at a reduced dosage of 150mg at bedtime is recommended for patients who have responded to short term therapy, particularly those with a history of recurrent ulcer.
Treatment of ulcers following NSAID therapy or associated with continuing NSAIDSIn ulcers following non-steroidal anti-inflammatory drug therapy or associated with continued non-steroidal anti-inflammatory drugs, eight to twelve weeks treatment may be necessary with 150mg bd or 300mg nocte.
Prevention of NSAID induced ulcers:For the prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers, ranitidine 150mg twice daily may be given concomitantly with non-steroidal anti-inflammatory drug therapy.
Treatment of oesophageal reflux disease including prevention of relapse:In the management of oesophageal reflux disease, the recommended course of treatment is either 150mg twice daily or 300mg at bedtime for up to eight weeks or if necessary twelve weeks.In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150mg four times daily for up to twelve weeks. The increased dose has not been associated with an incidence of unwanted effects.For the long-term management of oesophagitis the recommended adult oral dose is 150mg twice daily. Ranitidine is not indicated in patients with complications of reflux oesophagitis e.g. oesophageal stricture or Barrett's oesophagous.In keeping with the recommended clinical practice, it is advisable that patients on long term maintenance therapy receive regular routine assessments by their practitioner (see Section 4.4)
Treatment of Zollinger-Ellison Syndrome:In patients with Zollinger-Ellison Syndrome, the starting dose is 150mg three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6g per day and these doses have been well tolerated.Prophylaxis of haemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration:In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, treatment with Ranitidine 150mg/10ml Oral Solution b.d. may be substituted for Ranitidine Injection once oral feeding commences in patients considered to still be at risk from these conditions.
Prophylaxis of acid aspiration (Mendelson's Syndrome)In patients thought to be at risk of acid aspiration syndrome an oral dose of 150mg can be given two hours before induction of general anaesthesia and preferably also 150mg the previous evening.In obstetric patients at commencement of labour, an oral dose of 150mg may be given followed by 150mg at six hourly intervals. It is recommended that since gastric emptying and drug absorption are delayed during labour, any patient requiring emergency general anaesthesia should be given, in addition, a non-particulate antacid (e.g. sodium citrate) prior to induction of anaesthesia. The usual precautions to avoid acid aspiration should also be taken.
Renal InsufficiencyAccumulation of ranitidine with resulting elevated plasma concentration will occur in patients with severe renal impairment. Accordingly, it is recommended that the daily dose of ranitidine in such patients should be 150mg at night for 4 - 8 weeks. In patients with creatinine clearance of less than 50ml/min the usual dose is 150mg nightly. In patients on dialysis, dosage should be given on completion of dialysis.
Children (3 to 11 years)See Section 5.2 Pharmacokinetic Properties - Special Patient Populations.Ranitidine syrup contains 8%w/v ethanol. Therefore an alternative formulation of ranitidine may be considered necessary for at-risk groups, including children (see section 4.4 Special warnings and precautions for use).
Peptic Ulcer Acute TreatmentThe recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.
Gastro-Oesophageal RefluxThe recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses in a maximum dose of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms). Safety and efficacy in new-born patients has not been established.
Excipient InformationEthanol - This product contains 8%w/v ethanol (alcohol), i.e. up to 405mg per 5ml spoonful which is equivalent to about 11ml of beer or 5ml of wine.It is harmful for those suffering from alcoholism. It should be taken into account in pregnant or lactating women, children (see section 4.2) and high risk groups (those suffering from alcoholism, liver disease, epilepsy, brain injury or disease). It may modify or increase the effect of other medicines. The amount of alcohol in this medicinal product may impair the ability to drive or use machines (see Section 4.7).Alternative formulation of ranitidine may be considered preferential in these populations.Sorbitol - The product contains 700mg per 5ml spoonful of sorbitol which is a source of 175mg fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. It can also cause stomach upset and diarrhoea in large amounts.Sodium -The product contains 11mg of sodium per 5ml spoonful.
|System Organ Class||Common (>1/100, <1/10)||Uncommon (>1/1000,<1/100)||Rare (>1/10,000, <1/1000)||Very rare (≤1/10,0000)||Unknown|
|Blood and the lymphatic system||Blood count changes (leucopenia, thrombocytopenia) these are usually reversible, agranulocytosis, pancytopenia (sometimes with marrow hypoplasia) or marrow aplasia||acute porphyria.|
|Immune system disorders||Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).||Anaphylactic shock. These events have been reported after a single dose.|
|Psychiatric disorders||Reversible mental confusion, depression and hallucinations (especially in the elderly or severely ill)|
|Nervous system disorders||Headache (sometimes severe), dizziness and reversible involuntary movement disorders|
|Eye disorders||Reversible blurred vision. There have been reports of blurred vision which is suggestive of a change in accommodation.|
|Cardiac disorders||As with other H2 receptor antagonists bradycardia, A-V block|
|Gastrointestinal disorders||Abdominal pain, diarrhoea, constipation, nausea (these symptoms mostly improved during continued treatment).||Acute pancreatitis|
|Hepatobiliary disorders||Transient and reversible changes in liver function tests||Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible|
|Skin and subcutaneous tissue disorders||Skin rash||Erythema multiforme, alopecia|
|Musculoskeletal, connective tissue and bone disorders||Musculoskeletal symptoms such as arthralgia, myalgia|
|Renal and urinary disorders||Elevation of plasma creatinine (usually slight; normalised during continued treatment).||Acute interstitial nephritis|
|Reproductive system and breast disorders||Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).|
Special Patient Populations
Children (3 years and above)Limited pharmacokinetic data have shown that there are no significant differences in half-life (range for children 3 years and above: 1.7 - 2.2 h) and plasma clearance (range for children 3 years and above: 9 - 22 ml/min/kg) between children and healthy adults receiving oral ranitidine when correction is made for body weight.
|Closure:||a) HDPE, EPE wadded, tamper evident screw cap. b) HDPE, EPE wadded, tamper evident, child resistant closure.|
Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 246 0738
+44 (0)7836 557 879
+44 (0)113 244 1400
+44 (0)800 919 312