BETAHECON 16 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
BETAHISTINE DIHYDROCHLORIDE
Available from:
Abbott Healthcare Products Ltd
INN (International Name):
BETAHISTINE DIHYDROCHLORIDE
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
BETAHECON®
8MG TABLETS/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 Betahecon is and what it is used for
2. Before you take Betahecon
3. How to take Betahecon
4. Possible side effects
5. How to store Betahecon
6. Further information
1. WHAT BETAHECON IS AND WHAT IT IS USED FOR
Betahecon contains betahistine dihydrochloride. Betahecon is
a type of medicine called a
“histamine analogue”.
Betahecon is used for:
Ménière’s disease – the signs of this include:
• feeling dizzy (vertigo),
• ringing in the ears (tinnitus)
• hearing loss or hearing difficulty
Betahecon works by improving blood
flow in the inner ear. This lowers the build up
of pressure.
BEFORE YOU TAKE BETAHECON
DO NOT TAKE BETAHECON 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 a
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betahecon 16 mg 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.
A round, biconvex, scored, white tablet, 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
In the management of 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:
Betahecon 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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