AGISERC 16

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

BETAHISTINE DIHYDROCHLORIDE

Tersedia dari:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Kode ATC:

N07CA01

Bentuk farmasi:

TABLETS

Komposisi:

BETAHISTINE DIHYDROCHLORIDE 16 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Kelompok Terapi:

BETAHISTINE

Area terapi:

BETAHISTINE

Indikasi Terapi:

Meniere's syndrom. Symptomatic treatment of peripheral vertigo.

Tanggal Otorisasi:

2018-05-31

Selebaran informasi

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s
prescription only.
AGISERC 16
TABLETS
COMPOSITION:
EACH
TABLET
CONTAINS:
BETAHISTINE
DIHYDROCHLORIDE 16 MG
Inactive ingredients in the medicine - see
section 6
"
ADDITIONAL INFORMATION
"
.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE
USING THE MEDICINE. This leaflet contains
concise information about the medicine. If
you have any further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed for your
treatment. Do not pass it on to others. It
may harm them even if it seems to you that
their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is intended for the treatment
of
Meniere’s
syndrome,
symptomatic
treatment of peripheral vertigo.
THERAPEUTIC GROUP: Antivertigo preparations.
Agiserc contains betahistine which is a
histamine analog used to treat symptoms
of Meniere’s syndrome:
Dizziness
)vertigo(,
ringing
in
the
ears
)tinnitus(, hearing loss or difficulty hearing.
Agiserc works by improving blood flow in
the inner ear, which lowers the build up of
pressure.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You
are
hypersensitive
)allergic(
to
betahistine
)the
active
ingredient(
or
to
any
of
the
additional
ingredients
contained in the medicine )see section 6(.
• You suffer from an adrenal gland tumor
)pheochromocytoma(.
SPECIAL WARNINGS REGARDING USE OF
THE MEDICINE
BEFORE TREATMENT WITH AGISERC, CONSULT
THE DOCTOR IF:
• you suffer from asthma
• you suffer from a stomach ulcer
• you are pregnant, think you are pregnant or
are planning to become pregnant
• you are breastfeeding
If any of the conditions above applies to
you, the doctor will advise you whether it is
safe for you to start taking Agiserc.
The doctor may also want to monitor your
asthma during the course of
treatment with Agiserc.
DRUG INTERACTIONS
IF
YOU
ARE
TAKING
OR
HAVE
RECENTLY
TAKEN OTHER MEDICINES, INCLUDING NON-
PRESCRIPTION MED

Karakteristik produk

Summery of Product Characteristics
1. Name of the medicinal product
Agiserc 16
2. Qualitative and quantitative composition
Each tablet contains 16 mg of Betahistine dihydrochloride
For the full list of excipients see section 6.1
3. Pharmaceutical form
Tablets
.
White, round, scored on one side and printed with “Agiserc” on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
Meniere's syndrome.
Symptomatic treatment of peripheral vertigo.
4.2 Posology and method of administration
Adults :
The usual optimal dose for adults (including the elderly) is 16 mg 3
times daily.
An initial dose of 8 mg 3 times daily is possible if required. if a
dose of 8mg is required, other
products registered in Israel containing 16mg beta-histine
dihydrochloride, which can be equally
divided to receive an 8 mg dose, should be used.
The daily dose varies from 24 to 48 mg, and it should be divided into
three doses in order to achieve
less variable plasma concentrations.
It is recommended that the tablets/divided tablets are swallowed
whole.
The dosage should be individually adapted according to the response.
Improvement can
sometimes only be observed after a couple of weeks of treatment. The
best results are sometimes
obtained after a few months. There are indications that treatment from
the onset of the disease
prevents the progression of the disease and/or the loss of hearing in
later phases of the disease.
Paediatric population:
not recommended for use in children below 18 years due to insufficient
data on safety and efficacy.
Geriatric population:
Although there are limited data from clinical studies in this patient
group, extensive post marketing
experience suggests that no dose adjustment is necessary in this
patient population.
_ _
Renal impairment:
There are no specific clinical trials available in this patient
group,but according to post marketing
experience no dose adjustment appears to be necessary.
_ _
Hepatic impairment
:
There are no specific clinical trials available in this patient group,
but according