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

Logo FABAHISTIN® 50 mg (Tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FABAHISTIN® 50 mg (Tablets)

COMPOSITION:
Fabahistin 50 mg tablets each contain 76 mg Mebhydrolin Napadisylate, equivalent to 50 mg
Mebhydrolin Base.

PHARMACOLOGICAL CLASSIFICATION:
A.5.7.1. Antihistaminics.

PHARMACOLOGICAL ACTION:
Mebhydrolin is a highly effective, well tolerated antihistamine.

INDICATIONS:
Mebhydrolin gives prompt relief in allergic diseases such as hayfever, urticaria, conjunctivitis, allergic bronchial asthma, eczema, itching, drug rash, insect bites. It is suitable for concomitant treatment for hyposensitisation, especially in the early stages.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Prostatic hypertrophy, narrow-angle glaucoma.
Safety in pregnancy and lactation has not been established.

WARNING:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients undergoing treatment with this drug should not take charge of vehicles, other means of transport or machinery or perform hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Unless otherwise prescribed, the following doses are recommended:
Adults and children over 10 years old:
2-6 (50 mg) tablets daily in divided doses.
Treatment should be given in several divided doses daily. Fabahistin 50 mg tablets are swallowed whole during or shortly after meals.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Lassitude, dizziness, hypotension, muscular weakness and incoordination, nausea, vomiting, diarrhoea or constipation and epigastric pain may occur.
Other side effects include headache, blurred vision, tinnitus, elation or depression, irritability, allergic reactions especially of the skin, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands.
In infants and children, mebhydrolin may act as a cerebral stimulant. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions. Large doses may precipitate fits in epileptics.
If fever, sore throat, influenzal symptoms or marked lassitude occur, these may be signs of agranulocytosis or haemolytic anaemia. In this case the drug should be withdrawn and a doctor consulted. Self-treatment with analgesics or antipyretics should not be initiated. These reactions are dangerous and require immediate medical care. Haematologic controls are necessary in these cases.
Drug interactions:
The effects of atropine and tricyclic anti-depressants may be enhanced by mebhydrolin.
Mebhydrolin may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In cases of overdosage, hospitalisation for 1-2 days is recommended in order to exert a rigorous control of the heart and respiration. Further treatment is supportive and symptomatic.

IDENTIFICATION:
Fabahistin 50 mg tablets are orange, sugar-coated tablets.

PRESENTATION:
20 or 100 tablets in glass bottles

STORAGE INSTRUCTIONS:
Keep out of reach of children. Store below 25°C.

REFERENCE NO:
C804 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Bayer (Pty) Ltd
Wrench Road Isando 1600
Reg. No. 68/11192/07

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1970

®= Registered trade mark of Bayer AG, Germany.
5403/ZA/2        Davbar Dbn.
4        C4311/0296

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