SERC 8 Milligram Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

BETAHISTINE HYDROCHLORIDE

제공처:

BGP Products Ltd

ATC 코드:

N07CA01

INN (국제 이름):

BETAHISTINE HYDROCHLORIDE

복용량:

8 Milligram

약제 형태:

Tablets

관리 경로:

oral use

패키지 단위:

120 tablets

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 그룹:

Anti-vertigo preparations

치료 영역:

Antivertigo preparations

치료 징후:

Vertigo, tinnitus and hearing loss associated with Ménière's syndrome

승인 상태:

Authorised

승인 날짜:

2015-03-27

환자 정보 전단

1500363_d1
P. Process Black U - 
Cutting Die (not printed)
1500363 CL 2535
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.
• 
serious, or if you notice any side 
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. 
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)
• 
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 docto

제품 특성 요약

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.
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.
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