Betahistine 16mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Flamingo Pharma (UK) Ltd

ATC code:

N07CA01

INN (International Name):

Betahistine dihydrochloride

Dosage:

16mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5060464501708

Patient Information leaflet

BETAHISTINE DIHYDROCHLORIDE
8MG & 16MG TABLETS
LEAFLET SIZE : 160 X 265 MM
MPLLBETXXXXTBCOMFPLXXX026V03
160 mm
265 mm
160 mm
WHAT IS IN THIS LEAET
1. What Betahistine dihydrochloride Tablets is and what it is used for
2. What you need to know before you take Betahistine dihydrochloride
Tablets
3. How to take Betahistine dihydrochloride Tablets
4. Possible side effects
5. How to store Betahistine dihydrochloride Tablets
6. Contents of the pack and other information
FONTS : Arial
FONTS SIZE :
Generic Name font size : 9 pt.
Composition fonts size : 9 pt.
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAHISTINE DIHYDROCHLORIDE 8MG & 16MG TABLETS
Betahistine dihydrochloride
READ ALL OF THIS LEAET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaet. 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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaet. See section 4.
1. WHAT BETAHISTINE DIHYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR
These tablets contain Betahistine dihydrchloride.
They are used to treat vertigo, tinnitus (ringing in the ears) and
hearing loss associated with
Meniere's disease.
They work by reducing the pressure in your inner ear.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE
TABLETS
DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS:
•
if you are allergic (hypersensitive) to Betahistine dihydrochloride or
any of the other ingredients of
Betahistine dihydrochloride Tablets (listed in section 6). The
symptoms of an allergic reaction include
itching, nettle rash, wheezing or swelling of the hands, throat, mouth
or eyelids.
•
if you have phaeochromocytoma (high blood pressure due to adrenal
tumour).
If you think any of the ab

Summary of Product characteristics

OBJECT 1
BETAHISTINE 16 MG TABLETS
Summary of Product Characteristics Updated 08-Apr-2020 | Flamingo
Pharma (UK) Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Betahistine Dihydrochloride 16mg Tablets
2. Qualitative and quantitative composition
Each tablet contains Betahistine dihydrochloride 16mg
Excipient(s) with known effect: Each tablet contains 100 mg lactose
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Tablets for oral administration.
Flat white tablets, with bevelled edge. Markings: R4 on one side
scoreline on the reverse.
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
Betahistine is indicated for the treatment of vertigo, tinnitus and
hearing loss associated with Ménière's
syndrome.
4.2 Posology and method of administration
POSOLOGY:
Adults
_(including the elderly);_
_ _
Initially two tablets three times daily, taken prefera