BETAHISTINE HYDROCHLORIDE 16MG TABLETS

Active substance: BETAHISTINE HYDROCHLORIDE

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BETAHISTINE DIHYDROCHLORIDE
8mg AND 16mg TABLETS

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.

Please read this leaflet carefully before you start to take your medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should 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 get serious, or if you notice any side effects not listed in the
leaflet, please tell your doctor or pharmacist.

Children
This medicine should not be given to children.
How to stop taking your medicine
Keep taking your tablets until your doctor tells
you to stop.

IN THIS LEAFLET
1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Further information

1.

WHAT YOUR MEDICINE IS AND
WHAT IT IS USED FOR

The name of your medicine is Betahistine
Dihydrochloride 8mg or 16mg Tablets.
Betahistine Dihydrochloride is a type of
medicine called a histamine analogue. It is
used as a treatment for Ménière’s syndrome,
a condition caused by the pressure of excess
fluid in the inner ear. Betahistine
Dihydrochloride is thought to work by
improving blood flow in the inner ear, which
reduces the build up of pressure. It is this
pressure in the ear which is thought to cause
the vertigo (dizziness), tinnitus (ringing in the
ears) and hearing loss suffered by people
with Ménière’s disease.

2.

BEFORE YOU TAKE YOUR
MEDICINE

Do not take your medicine without talking
to your doctor if you:
• have ever had an allergic reaction to
Betahistine Dihydrochloride or any of the
other ingredients listed in section 6, Further
information
• have phaeochromocytoma (a tumour
associated with the adrenal gland which
causes high blood pressure)
• have or have ever had a stomach or
intestinal ulcer
• have asthma
• have a condition called porphyria
Taking other medicines
Please inform your doctor or pharmacist if
you are taking, or have recently taken any
other medicine, even those not prescribed by
a doctor. In particular, tell your doctor or
pharmacist if you are taking any of the
following medicines:

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.

• Antihistamines, which are used to relieve
allergic conditions (e.g. terfenadine,
diphenhydramine and chlorpheniramine).
• Monoamine-oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s
disease. These may inhibit metabolism of
Betahistine Dihydrochloride.

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.

Pregnancy and breast-feeding
Do not take Betahistine Dihydrochloride if you
are pregnant unless your doctor has decided
that it is absolutely necessary. Ask your
doctor for advice.

4.

Do not breast-feed while using Betahistine
Dihydrochloride unless instructed by your
doctor. It is not known if Betahistine
Dihydrochloride passes into breast milk.

Like all medicines, Betahistine Dihydrochloride
Tablets can have side effects although not
everybody gets them.

Driving and using machinery
It is unlikely that these tablets will affect your
ability to drive or operate machinery.

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,
swelling of the lips, face, throat or tongue,
difficulty breathing or swallowing.

Important information about one of the
ingredients in your medicine
These tablets contain lactose monohydrate.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

3.

POSSIBLE SIDE EFFECTS

These tablets have been prescribed for you
by a doctor. Take them exactly as he or she
has told you. Please read the label carefully.
The tablets should be swallowed whole with a
sufficient quantity of liquid (e.g. one glass of
water).

HOW TO STORE YOUR MEDICINE

Do not use your medicine after the expiry
date printed on the package. The expiry date
refers to the last day of that month.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not store above 25°C. Store the tablets in
the original package.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6.

FURTHER INFORMATION

Betahistine Dihydrochloride 8mg Tablets:
White, circular, flat tablets marked with B8 on
one side. Each tablet contains 8mg
Betahistine Dihydrochloride.
Betahistine Dihydrochloride 16mg Tablets:
White, circular, flat tablets marked with B16
on one side and a breakline on the other side.
Each tablet contains 16mg Betahistine
Dihydrochloride.
The tablets also contain povidone K90,
microcrystalline cellulose, lactose
monohydrate, colloidal anhydrous silica,
crospovidone and stearic acid.
Pack sizes: 60, 84, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited,
Ballymurray, Co. Roscommon, Ireland.

Manufacturers responsible for batch
release
Kent Pharmaceuticals Limited, Crowbridge
Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.

If any side effects get serious, or if you notice
any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Take the tablet with or after a meal.

5.

Distributor
Almus Pharmaceuticals,
43 Cox Lane, Chessington, KT9 1SN, UK

Other common side effects are:
• feeling sick (nausea)
• being sick (vomiting)
• indigestion (dyspepsia)
• abdominal pain and bloating
• stomach upsets
• headaches
• itching and skin rashes

HOW TO TAKE YOUR MEDICINE

Reporting of side effects
Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to
2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

PL 30464/0019 and PL 30464/0020
This leaflet was last revised in October 2013

A0391/Lt2 A0305/Lt2 A0304/Lt2

Adults
The usual dose is 16mg three times daily,
preferably taken with meals.

PATIENT INFORMATION LEAFLET

DIMENSIONS 140 x 220 mm
REVISED ARTWORK FOR MHRA APPROVAL
VERSION: 2 (KENT/ATHLONE)

Client:

Almus UK

Project:

9255 / A / UK
Betahistine
Dihydrochloride Tablets
8mg x 84
8mg x 120
16mg x 84

DRAFT ISSUE: 1
REASON FOR CHANGE: MEDICAL UPDATE
SUPPLIER ISSUE DATE: 4.10.2013

PHARMA CODE TBA
ALMUS CODE A0391/Lt2
ALMUS CODE A0305/Lt2
ALMUS CODE A0304/Lt2

Item(s):

Colours used:

PMS
280

pmdc
Checked by: Paul Adams

Patient Information Leaflet

Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams
Date: 4.10.2013
This scale measures 100mm when artwork is 100%
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PMDC LLP
Lower Test Studios
Old Hambledon Racecourse
Sheardley Lane, Droxford
Hampshire SO32 3QY
+44 (0)1489 878780
www.pmdc.co.uk

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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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