INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo HEXAMET 200 TABLETS
HEXAMET 400 TABLETS
HEXAMET 800 TABLETS
HMP6

SCHEDULING STATUS:
S3 and S2 (please refer to indications)

PROPRIETARY NAME
(and dosage form):

HEXAMET 200 TABLETS
HEXAMET 400 TABLETS
HEXAMET 800 TABLETS

COMPOSITION:
Each tablet contains 200, 400 or 800 mg of cimetidine.

PHARMACOLOGICAL CLASSIFICATION:
A.11.4.3 Antacids: Other

PHARMACOLOGICAL ACTION:
Cimetidine is a histamine H2-receptor antagonist. It inhibits basal (fasting) secretion and nocturnal secretion and also that stimulated by food. Cimetidine reduces the volume of gastric juice secreted and its hydrogen ion concentration. It also reduces pepsin output.
Cimetidine is rapidly absorbed after oral administration. Peak concentrations in plasma are attained in approximately 2 hours. Cimetidine is excreted primarily in the urine.

INDICATIONS:
Schedule 3
Treatment of benign gastric and duodenal ulcers, reflux oesophagitis, Zollinger-Ellison syndrome and other conditions associated with hypersecretory states such as systemic mastocytosis and multiple endocrine adenomas.
In patients with a history of recurrent duodenal ulceration, relapse after healing is prevented during treatment at reduced dosage for up to 1 year.
Schedule 2
Short-term symptomatic relief of heartburn, dyspepsia and hyperacidity.

CONTRA-INDICATIONS:
Schedule 3 and Schedule 2
Sensitivity to cimetidine or any related agent.
Schedule 2
Not to be taken during pregnancy and lactation.
Do not use if suffering from impaired renal function.
Patients suffering from any other illness or taking any other medications unless prescribed by a doctor.
Patients middle-aged or older with new or recently changed dyspeptic symptoms. Consult a doctor.
Patients suffering from dyspepsia with unintended weight loss. Consult a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Schedule 3 Indications:
Adults:
Treatment should be continued for at least 4 weeks.
Day-time doses should generally be taken with meals.
Treatment of duodenal and benign gastric ulceration:
200 mg three times a day with meals and 400 mg at bedtime. Alternatively, 400 mg twice daily, or a single bedtime dose of 800 mg may be given.
Treatment should be continued for at least 4 weeks in the case of gastric ulcers.
Maintenance dose for recurrent duodenal ulcer:
400 mg at bedtime. Some patients may require 400 mg twice a day.
Reflux oesophagitis:
400 mg four times daily.
Gastric hypersecretory conditions (e.g. Zollinger-Ellison syndrome, systemic mastocytosis, multiple endocrine adenomas).
200 mg three times daily with meals and 400 mg at bedtime. Dosage may be increased to 400 mg four times daily.
Children
Clinical experience with Hexamet in children is limited. Hexamet is not recommended for use in children.
Note
The dosage of Hexamet should be reduced in patients with impaired renal function.
Suggested dosages according to creatinine clearance are:
Creatinine clearance of
        0 - 15 mL/minute: 200 mL twice daily
        15 - 30 mL/minute: 200 mL three times daily
        30 - 50 mL/minute: 200 mL four times daily
        > 50 mL/minute: normal dosage

Schedule 2 Indications:
Adults and children aged 16 years and older:
Do not exceed the maximum daily dosage of 800 mL.
Do not take for longer than 2 weeks without consulting your doctor, since persistent symptoms can indicate other medical problems.
Do not take more than four 200 mL tablets in a period of 24 hours.
Patients must seek medical advice:
- if symptoms fail to respond
- if symptoms persist after 2 weeks treatment
- if symptoms recur following self-treatment.
Short-term symptomatic relief of heartburn, dyspepsia and hyperacidity:
200 mL three times daily with meals. Dosage may be increased to 200 mL four times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects are diarrhoea, dizziness, tiredness and skin rashes.
Reversible confusion states, slurred speech, hallucinations, delirium and coma have been reported, especially in the elderly or in seriously ill patients such as those with renal failure or organic brain syndrome.
Gynaecomastia and impotence have been reported in patients receiving high doses.
Other adverse effects which have been reported are allergic reactions, arthralgia and myalgia, interstitial nephritis, headache, hepatotoxicity, pancreatitis, fever and increases in serum transaminase.
Blood disorders which have been reported include agranulocytosis, granulocytopenia, thrombocytopenia and aplastic anaemia.
Increases in plasma creatinine have been reported.
Before giving cimetidine to patients with gastric ulcers the possibility of malignancy should be excluded since cimetidine may mask the symptoms. Cimetidine should be given in reduced dosage to patients with impaired renal function. Dosage should be reduced according to creatinine clearance.
Circulating cimetidine levels are reduced by haemodialysis. Cimetidine should therefore be administered at the end of dialysis.
On current evidence it is recommended that no anticholinergic agents should be administered concurrently with cimetidine for maintenance treatment because of the possibility of medicine interactions. In view of a report that glucose handling was impaired after long-term cimetidine administration, caution should be observed in the treatment of diabetics or elderly patients with cimetidine.
Other interactions which are considered to be of clinical significance are with lignocaine, phenytoin, theophylline and warfarin where the blood concentrations of these medicines may be increased to such a degree that a reduction in their dosage may be necessary. Increased blood concentrations of some of the following medicines have also been reported: anti-arrhythmics, benzodiazepines, beta-blockers and vasodilators.

KNOWN SYMPTOMS OF OVERDOSAGE AD PARTICULARS OF ITS TREATMENT:
See “side effects and special precautions”. Treatment is symptomatic and supportive.

IDENTIFICATION:
HEXAMET 200: Greyish-green, round and biconvex tablet with a score notch on one side and engraved “C200”.
HEXAMET 400: Greyish-green, oval and biconvex tablet with score notches on both sides and engraved “C400”.
HEXAMET 800: Greyish-green, oblong and biconvex tablet with score notches on both sides and engraved “C800”.

PRESENTATION:
HEXAMET 200 is blister-packed in strips of 10 tablets or securitainers of 56 & 150 tablets.
HEXAMET 400 is blister packed in strips of 10 tablets or securitainers of 60 tablets.
HEXAMET 800 is blister packed in strips of 10 tablets or securitainers of 30 tablets.

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

REGISTRATION NUMBER:
HEXAMET 200:         27/11.4.3/0207
HEXAMET 400:         27/11.4.3/0208
HEXAMET 800:         27/11.4.3/0209

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Hexal Pharma (SA) (PTY) Ltd.
10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 May 1993

Updated on this site: May 2005
Source: Pharmaceutical Industry

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