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BETAHISTINE DIHYDROCHLORIDE 24 MG TABLETS

Active substance(s): BETAHISTINE DIHYDROCHLORIDE

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Package leaflet: Information for the user

Betahistine dihydrochloride 8mg Tablets
Betahistine dihydrochloride 16mg Tablets
Betahistine dihydrochloride 24mg Tablets
Betahistine dihydrochloride
Read all of this leaflet carefully before you start taking
this medicine because it contains important
information for you.
! 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 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 leaflet. See section 4.
! This medicine is available under the above product
names but will be called 'Betahistine Tablets' throughout
the package leaflet.
What is in this leaflet:
1. What Betahistine Tablets are and what they are used
for
2. What you need to know before you take Betahistine
Tablets
3. How to take Betahistine Tablets
4. Possible side effects
5. How to store Betahistine Tablets
6. Contents of the pack and other information
1. What Betahistine Tablets are and what they are
used for
Betahistine dihydrochloride, the active substance of
Betahistine Tablets, is similar to histamine, a substance
which is found naturally in the human body. Betahistine
works by reducing signals in the balance centre of the brain
which lead to dizziness.
Betahistine Tablets are used for the treatment of Menière's
syndrome, symptoms of which may include dizziness (often
associated with feeling sick and / or being sick), ringing in
the ear (tinnitus) and hearing loss.
2. What you need to know before you take
Betahistine Tablets

!

if you are taking at the same time other medicines used
to treat allergies or colds - so called antihistamines (see
also section 'Other medicines and Betahistine Tablets').

Other medicines and Betahistine Tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
If Betahistine Tablets are taken at the same time with
certain medicines for the treatment of allergies or colds
(antihistamines) the effects of both medicines may be
reduced. If you are currently taking an antihistamine, the
dose of this medicinal product must be slowly reduced over
about 6 days before you can start taking Betahistine
Tablets.
Betahistine Tablets with food and drink
This medicinal product sometimes causes stomach
disorders; see section 4 'Possible side effects'. The
likelihood of these happening may be reduced by taking
Betahistine Tablets with, or shortly after food.
Pregnancy, breast-feeding and fertility
Betahistine Tablets should only be taken during pregnancy
or breast feeding if your doctor feels it is essential for you.
There is not enough animal and human data available for
use in pregnancy and lactation. You should discuss this
with your doctor if you are, or might be pregnant, or if you
are breast feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
There is no experience whether this medicinal product
impairs the ability to drive and use machines.
Betahistine Tablets contain lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Betahistine Tablets

Do not take Betahistine Tablets
! if you are allergic to betahistine dihydrochloride or any
of the other ingredients of this medicine (listed in
section 6).
! if you suffer from a tumour of the adrenal gland
(phaeochromocytoma).
Warnings and precautions
Talk to your doctor or pharmacist before taking Betahistine
Tablets
! if you suffer from ulcers of the stomach or intestine.
! if you suffer from a chronic disease of the respiratory
tract (bronchial asthma).
! if you suffer from hives, skin rashes, or allergic rhinitis your symptoms may get worse when taking betahistine.
! if you have very low blood pressure.

Always take Betahistine Tablets exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
The usual dose is 24 mg - 48 mg betahistine daily, divided
into 3 equal doses.
Daily dose should not exceed 48 mg and your doctor or
pharmacist will advise you how many tablets to take.
The tablets should be taken, with a glass of water, during or
after meals.
Your doctor will tell you how long to take the medicine. It is
usually a long term treatment and lasts several months as
the tablets may take a while to start to work.

Use in children and adolescents
Betahistine Tablets should not be used by children and
adolescents below the age of 18 years. There is no
information or experience on such use.
If you take more Betahistine Tablets than you should
If you take more tablets than you should, the following
symptoms may occur due to overdose: headache, redness
of the face, low blood pressure, faster heartbeat, breathing
difficulties due to constriction of the lungs (bronchial
asthma), and swelling of the surface of the upper airways
due to water retention (Quincke's oedema).
You must get medical advice urgently if you experience any
of these events. The doctor will provide suitable treatment.
Always take the medicinal product package with you when
getting such advice.
If you forget to take Betahistine Tablets
If you forget to take a dose, just miss out that dose. Take
the next dose the next time you would usually take it.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Betahistine Tablets
Do not stop taking Betahistine Tablets before your doctor
tells you to.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Betahistine Tablets contain
The active substance is betahistine dihydrochloride.
One 8 mg tablet contains 8 mg betahistine dihydrochloride.
One 16 mg tablet contains 16 mg betahistine
dihydrochloride.
One 24 mg tablet contains 24 mg betahistine
dihydrochloride.
The other ingredients are: lactose monohydrate, maize
starch, microcrystalline cellulose (E 460), citric acid
anhydrous (E 330), povidone K 25 (E 1201), crospovidone
type A (E 1202), and hydrogenated vegetable oil.
What Betahistine Tablets look like and contents of the
pack
Betahistine 8mg Tablets are white, flat, round tablets with
bevelled edges, score line on one side, diameter 6.5 mm.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following serious side effects may occur during
treatment with betahistine:
Allergic reactions such as:
! swelling of your face, lips, tongue or neck. This may
cause difficulty breathing.
! a red skin rash, inflamed itchy skin.

Betahistine 16mg Tablets are white, flat, round tablets with
bevelled edges. The tablets have a break-line and the
inscription "BH” on one side of the score and “16” on
the other side of the score, both markings on the same side
of the tablet. The tablet diameter is 9.0 mm. The tablet can
be divided into equal halves.

If any of these side effects occur you should stop treatment
immediately and contact your doctor.

Betahistine 24mg Tablets are white, flat, round tablets with
bevelled edges. The tablets have a break-line and the
inscription "BH” on one side of the score and “24” on
the other side of the score, both markings on the same side
of the tablet. The tablet diameter is 10.0 mm. The tablet
can be divided into equal halves.

Common side effects (at least 1 in 100 and less than 1
in 10 patients):
! Nausea, indigestion, headaches.

Packed in blister packs containing 14, 20, 24, 28, 30, 48,
50, 60, 84, 90, 96, or 100 tablets. Not all pack sizes may be
marketed.

Other side effects:
! Itching, rash, hives, mild gastric complaints such as
vomiting, stomach pain and bloating. Taking the tablets
with food can help reduce any stomach problems.

Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester
LE3 0PA

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this
medicine.
5. How to store Betahistine Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and on the blister package after EXP.
The expiry date refers to the last day of that month.

Manufacturers
Farmaceutisch Analytisch Laboratorium (FAL) Duiven BV
Dijkgraaf 30, Duiven
6921 RL
The Netherlands
Medochemie Limited
Facility A-Z, Miichael Erakleous
Ayios Athanassios Industrial Area
Limassol
Cyprus
This leaflet was last revised in May 2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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