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Logo RANIHEXAL 150 film coated tablets
RANIHEXAL 300 film coated tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

RANIHEXAL 150 film coated tablets
RANIHEXAL 300 film coated tablets

COMPOSITION:
RaniHexal 150
film coated tablets - each tablet contains 150 mg
ranitidine (as the hydrochloride).
RaniHexal 300 film coated tablets - each tablet contains 300 mg ranitidine (as the hydrochloride).

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3. Medicines acting on the gastro-intestinal tract. Antacids - other.

PHARMACOLOGICAL ACTION:
RaniHexal
competitively and selectively blocks H2 receptors.
Gastric mucous production is unaffected, however the volume and content of pepsin and acid is reduced. The basal and stimulated secretion of gastric acid is reduced. Absorption of RaniHexal is not affected by the presence of food or antacids.

INDICATIONS:
RaniHexal
is indicated for the treatment of
- Duodenal ulcers
- Benign gastric ulcers
- Prevention of duodenal ulceration associated with non-steroidal anti-inflammatory agents.
- Reflux oesophagitis
- Zollinger-Ellison syndrome
- Pre-medication (prior to anaesthesia) - to minimise the consequences of acid aspiration syndrome.

CONTRA-INDICATIONS:
- Hypersensitivity to ranitidine (hydrochloride)
- Pregnancy - safety of use during pregnancy has not yet been established.
- Lactation - safety of use during lactation has not yet been established.
- Avoid administering RaniHexal to patients with a history of acute porphyria.

WARNINGS:
Experience with RaniHexal in children is limited.

DOSAGE AND DIRECTIONS FOR USE:
Peptic ulceration: The recommended adult dose is 150 mg twice daily or a single bedtime dose of 300 mg. This regimen should be continued for 4 weeks. Should healing not occur during this period, a second course of treatment may be administered.
Duodenal ulcers secondary to non-steroidal anti-inflammatory agent usage: 150 mg twice daily or 300 mg given at bedtime for 8 to 12 weeks duration. To prevent these ulcers, 150 mg twice daily may be administered together with non-steroidal anti-inflammatory agent therapy.
Reflux oesophagitis: Recommended regimen 150 mg twice daily or 300 mg at bedtime for 8 to 12 weeks as necessary. The dosage may be increased to 150 mg four times daily for up to 12 weeks.
Zollinger-Ellison syndrome: - Initial dose is 150 mg three times daily and may be increased to 600 mg to 900 mg per day.
Pre-medication: 300 mg given 2 hours before induction. As an alternative - 150 mg 12 hours before induction followed by another 150 mg 2 hours prior to induction.
Maintenance therapy: 150 mg at bedtime.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Changes in liver function tests may occur. These are transient and reversible.
Hepatitis with or without jaundice may occur.
Blood counts can be altered (leucopaenia, thrombocytopaenia).
Agranulocytosis and Pancytopaenia, sometimes accompanied by marrow hypoplasia or aplasia may occur.
Anaphalactoid reactions may occur following a single oral dose of RaniHexal.
Bradycardia, AV block, headache and dizziness, have been reported following oral administration.
Reversible mental confusion, depression, hallucinations, constipation, diarrhoea, nausea and vomiting, skin rashes, acute pancreatitis, arthralgia, and myalgia may occur.
No significant interference with endocrine or gonadal function has been reported, however breast symptoms may occur (discomfort/pain/swelling and gynaecomastica in men).
SPECIAL PRECAUTIONS
Treatment with ranitidine may mask symptoms of carcinoma therefore possibility of malignancy must be excluded before initiation of therapy with RaniHexal.
Renally impaired patients - reduce recommended dosage to 150 mg daily.
During long term therapy, periodic examinations of the patient should be carried out.
Regular supervision of patients who are concomitantly taking non-steroidal anti-inflammatory agents is advisable.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side Effects and Special Precautions.
Treatment is symptomatic and supportive.
RaniHexal is removed from the blood by haemodialysis.

IDENTIFICATION:
RaniHexal 150
film coated tablets: White, round, biconvex tablet, with one side score notch.
RaniHexal 300 film coated tablets: White, oblong tablets with one side score notch.

PRESENTATION:
RaniHexal 150
film coated tablets: Aliminium blisters cartoned into boxes containing either 10 or 30 tablets.
RaniHexal 300 film coated tablets: Aluminium blisters cartoned into boxes containing 30 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
RaniHexal 150
film coated tablets: 31/11.4.3/0529.
RaniHexal 300 film coated tablets: 31/11.4.3/0530.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Hexal Pharma (SA)(Pty) Ltd
46 Mahogany Road
Mahogany Ridge
Pinetown
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1998

        RHP5

Updated on this site: December 2004
Source: Community Pharmacy

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