SERC 16 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
BETAHISTINE HYDROCHLORIDE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
BETAHISTINE HYDROCHLORIDE
Dosage:
16 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
SERC 8MG TABLETS
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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serc 16mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg betahistine dihydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, biconvex, scored, white to almost white tablets imprinted `267' on one face. 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
Initially16 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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