Betahistine 8mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Betahistine dihydrochloride

Fáanlegur frá:

Flamingo Pharma (UK) Ltd

ATC númer:

N07CA01

INN (Alþjóðlegt nafn):

Betahistine dihydrochloride

Skammtar:

8mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04060000; GTIN: 5060464501692

Upplýsingar fylgiseðill

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

Vara einkenni

OBJECT 1
BETAHISTINE 8 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 8mg Tablets
2. Qualitative and quantitative composition
Each tablet contains Betahistine dihydrochloride 8 mg
Excipient(s) with known effect: Each tablet contains 50 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: R3 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 preferably