Mepahist
COMPANY NAME
ARAB COMPANY FOR PHARMACEUTICALS AND MEDICINAL PLANTS
(MEPACO – MEDIFOOD)- Egypt
TRADE NAME
Mepahist
GENERIC NAME
Betahistine dihydrochloride
PHARMACEUTICAL FORM
Tablets
COMPOSITION
Each tablet contains
Active ingredients:
Betahistine dihydrochloride
16 mg
Inactive ingredients:
PVP K 90, Aerosil 200, Acdisol, Lactose monohydrate, Avicel pH 101 and
Magnesium stearate.
PHARMACOLOGY AND TOXICOLOGY
Mepahist exerts a relaxant action on the papillary sphincters of the
microcirculation of the inner ear and thereby increases the blood supply to
the stria vascularis of the labyrinth. Extensive investigations into acute,
subacute and chronic effects of betahistine in animals and widespread
application of betahistine in humans have demonstrated the low toxicity
and safety of this drug.
CLINICAL EXPERIENCE
The effect of betahistine has been widely investigated in controlled trials.
Betahisitne has been shown to reduce both the frequency and the severity
of the vertigo attacks, to have a favorable influence on tinnitus and to stop
or even partially reserve the progressive loss of hearing, especially if
treatment is started early.
Although progress can usually be seen within a few days, the onset of
improvement is sometimes very gradual and clearly noticeable only after
several weeks of treatment.
In both cases continued treatment is recommended as optimal results are
usually obtained after a few months. Long term tolerance of betahistine is
usually excellent.
INDICATIONS
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.
DOSAGE AND ADMINISTRATION
Adults (including the elderly): initially 16 mg three times daily taken
preferably with meals.
Maintenance doses are generally in the range 24-48 mg daily.
Children: no dosage recommendations are made for children.
CONTRAINDICATIONS
Phaeochromocytoma.
Hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND PRECAUTIONS
Caution is advised in the treatment of patients with a history of peptic
ulcer. Clinical intolerance to Mepahist in bronchial asthma patients has
been shown in a relatively few patients. These patients need to be
carefully monitored during the therapy.
SIDE-EFFECTS
 The following undesirable effects have been experienced with the
below indicated frequencies in betahistine-treated patients in placebocontrolled clinical trials [very common ( 1/10); common ( 1/100 to
<1/10); uncommon ( 1/1,000 to <1/100); rare ( 1/10,000 to <1/1,000);
very rare (<1/10,000)].
Gastrointestinal disorders
Common: nausea and dyspepsia

In addition to those events reported during clinical trials, the following
undesirable effects have been reported spontaneously during postmarketing use and in scientific literature. A frequency cannot be estimated
from the available data and is therefore classified as “not known”.
Immune System disorders
Hypersensitivity reactions, e.g. anaphylaxis have been reported.
Gastrointestinal disorders
Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal
distension and bloating) have been observed. These can normally be dealt
with by taking the dose during meals or by lowering the dose.
Nervous System disorders
Headache
Skin and subcutaneous tissue disorders
Cutaneous and subcutaneous hypersensitivity reactions have been
reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.
DRUG INTERACTIONS
No in-vivo interaction studies have been performed. Based on in-vitro data
no in-vivo inhibition on Cytochrome P450 enzymes is expected.
Although an antagonism between Mepahist and antihistamines could be
expected on a theoretical basis, no such interactions have been reported.
PREGNANCY AND LACTATION
Pregnancy:
There are no adequate data from the use of betahistine in pregnant
women.
Animal studies are insufficient with respect to effects on pregnancy,
embryonal/foetal development, parturition and postnatal development. The
potential risk for humans is unknown. Betahistine should not be used
during pregnancy unless clearly necessary.
Lactation:
It is not known whether betahistine is excreted in human milk. There are
no animal studies on the excretion of betahistine in milk. The importance
of the drug to the mother should be weighed against the benefits of
nursing and the potential risks for the child.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Betahistine is regarded to have no or negligible effects on the ability to
drive and use machines as no effects potentially influencing this ability
were found to be related to betahistine in clinical studies.
PACKAGE AND STORAGE
A carton box of 2 strips (PVC-Aluminum) each of 10 tablets and inner
leaflet.
Store in a dry place at temperature not exceeding 30° C.