SERC 8 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-09-2015
Summary of Product characteristics
(SPC)
26-01-2017
Active ingredient:
BETAHISTINE HYDROCHLORIDE
Available from:
BGP Products Ltd
ATC code:
N07CA01
INN (International Name):
BETAHISTINE HYDROCHLORIDE
Dosage:
8 Milligram
Pharmaceutical form:
Tablets
Administration route:
oral use
Units in package:
120 tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic group:
Anti-vertigo preparations
Therapeutic area:
Antivertigo preparations
Therapeutic indications:
Vertigo, tinnitus and hearing loss associated with Ménière's syndrome
Authorization status:
Authorised
Authorization date:
2015-03-27
Patient Information leaflet
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
Read the complete document
Summary of Product characteristics
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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Read the complete document
