Serc 16 mg tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Betahistine dihydrochloride

Prieinama:

Imbat Limited

ATC kodas:

N07CA; N07CA01

INN (Tarptautinis Pavadinimas):

Betahistine dihydrochloride

Dozė:

16 milligram(s)

Vaisto forma:

Tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Antivertigo preparations; betahistine

Autorizacija statusas:

Authorised

Leidimo data:

2008-09-26

Pakuotės lapelis

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERC
® 16MG TABLETS
(betahistine dihydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any of the side effects becomes serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Serc is and what it is used for
2.
Before you take Serc
3.
How to take Serc
4.
Possible side effects
5.
How to store Serc
6.
Further information
1.
WHAT SERC IS AND WHAT IT IS USED FOR
Serc contains betahistine. Serc is a type of medicine called a
“histamine analogue”.
Serc is used for:
Ménière’s disease – the signs of this include:

feeling dizzy (vertigo)

ringing in the ears (tinnitus)

hearing loss or hearing difficulty
This medicine works by improving blood flow in the inner ear. This
lowers the build up of pressure.
2.
BEFORE YOU TAKE SERC
DO NOT TAKE SERC IF:

you are allergic (hypersensitive) to betahistine or any of the
other ingredients in the tablets (see section 6 for further
details)

you have high blood pressure due to an adrenal gland
tumour (phaeochromocytoma)
If any of the above applies to you, do not take this medicine and
talk to your doctor.
TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF:

you have ever had a stomach ulcer

you have asthma

you are pregnant or planning to become pregnant

you are breast-feeding.
If any of the above applies to you, talk to your doctor or
pharmacist before taking Serc. Your doctor may want to monitor
you more closely while you take Serc. Your doctor will tell you
whether it is safe for you to start taking this medicine.
CHILDREN
Serc is not recommended for those under 18 years old.
TAKING OTHER MEDICINES
Please tell your doct

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serc 16 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg betahistine dihydrochloride.
For a full list of excipients, seen section 6.1.
3 PHARMACEUTICAL FORM
Tablet:
_Product imported form the UK_
Round, biconvex, scored, white to almost white tablets imprinted '267'
on one side and plain on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vertigo, tinnitus and hearing loss associated with Ménière's
syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Initially 16 mg three times daily taken preferably with meals.
Maintenance doses are generally in the range 24 - 48 mg
daily.
Paediatric population:
Serc is 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 to post-marketing experience no dose
adjustment appears to be necessary.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Use in phaeochromocytoma.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with bronchial asthma and history of peptic ulcer need to be
carefully monitored during the therapy.
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