Serc 8mg Tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

BETAHISTINE HYDROCHLORIDE

Sẵn có từ:

Mylan IRE Healthcare Limited

Mã ATC:

N07CA; N07CA01

INN (Tên quốc tế):

BETAHISTINE HYDROCHLORIDE

Liều dùng:

8 milligram(s)

Dạng dược phẩm:

Tablet

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Antivertigo preparations; betahistine

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1979-04-01

Tờ rơi thông tin

1503165_d1
P. Process Black U - Cutting Die (not printed)
<<<<<< pharmacode
50
1503165 CL 3289
FRONT
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 medicine

Đặc tính sản phẩm

Health Products Regulatory Authority
23 November 2020
CRN00C1PP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serc 8mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg betahistine dihydrochloride equivalent to
5.21mg betahistine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white to almost white, round, flat tablet, imprinted ‘256’ on
one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vertigo, tinnitus and hearing loss associated with Ménière's
syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual dose is 8 to 16mg, three times daily taken preferably with
meals.
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.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No _in vivo _interaction studies have been performed. Based on _in
vitro _data no _in vivo _inhibition on Cytochrome P450 enzymes
is expected.
Health Products Regulatory Authority
23 November 2020
CRN00C1PP
Page 2 of 5
_In vitro _data indicate an inhibition of betahistine metabolism by
drugs that inhibit monoamino