Betahistine 16mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Genesis Pharmaceuticals 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: 5060014442178

Patient Information leaflet

ADULTS
The recommended dose is 16mg three times daily
(48mg), preferably taken with meals.
This medicine may take some time to have its full effect,
so do not worry if you do not feel better right away. Your
doctor may adjust the dose depending on your
response. Do not adjust the dose unless told to do so by
your doctor.
USE IN CHILDREN AND ADOLESCENTS
This medicine should not be given to children under the
age of 18 years.
HOW TO STOP TAKING YOUR MEDICINE
Keep taking your tablets until your doctor tells you to
stop.
Even when you start feeling better, your doctor may want
you to carry on taking the tablets for some time to make
sure that the medicine has worked completely.
IF YOU TAKE MORE OF YOUR MEDICINE THAN YOU SHOULD
If you take more tablets than you should, tell your doctor
immediately or go to the nearest hospital. Take the
medicine pack with you.
IF YOU FORGET TO TAKE YOUR MEDICINE
Take your tablets as soon as you remember. If it is
almost time for your next dose, wait until that is due and
continue as normal. Do not take a double dose to make
up for the forgotten dose. Do not take two doses within
approximately two hours of each other.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Betahistine Dihydrochloride Tablets
can cause side effects although not everybody gets
them.
STOP TAKING BETAHISTINE DIHYDROCHLORIDE TABLETS
AND SEE YOUR DOCTOR OR NEAREST HOSPITAL CASUALTY
DEPARTMENT IMMEDIATELY IF YOU EXPERIENCE:
• an allergic reaction. Symptoms of an allergic reaction
include; skin rashes, inflamed itchy skin, swelling of
the lips, face, throat or tongue, difficulty breathing or
swallowing.
OTHER COMMON SIDE EFFECTS (MAY AFFECT UP TO 1 IN 10)
ARE:
• feeling sick (nausea)
• headaches
• indigestion (dyspepsia)
OTHER SIDE EFFECTS (FREQUENCY NOT KNOWN-CANNOT BE
ESTIMATED FROM THE AVAILABLE DATA)
• mild gastric complaints such as being sick (vomiting)
• abdominal pain and bloating
• stomach upsets
• itchin

Summary of Product characteristics

PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 16mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16mg of betahistine dihydrochloride.
One Betahistine dihydrochloride 16mg Tablet contains 140mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, circular, flat bevelled-edge uncoated tablets, impressed B16 on
one
face with a score line on the reverse.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Betahistine tablets are indicated in the treatment of vertigo,
tinnitus and
hearing loss associated with Ménière's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _
_Initial dosage:_ 1 tablet, 3 times daily, preferably with food.
_Maintenance dose:_ The dose may be adjusted according to response to
a
maintenance dose of between 24 and 48mg daily.
_Elderly:_ No adjustment in dosage is necessary.
_Paediatric population: _Betahistine is not recommended for use in
children
below 18 years due to insufficient data on safety and efficacy.
_Renal impairmen_t: 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.
For oral use.
Betahistine dihydrochloride tablets should be taken with a glass of
water,
preferably with food.
4.3
CONTRAINDICATIONS
Betahistine is contraindicated in patients with phaeochromocytoma. As
betahistine is a synthetic analogue of histamine it may induce the
release of
catecholamines from the tumour resulting in severe hypertension.
Hypersensitivity to betahistine dihydrochloride or any of the
excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Betahistine tablets should be administered with caution in patients
with a history of
peptic ulcer.
Clinical intolerance to betahistine has been demonstr