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BETAHISTINE 8 MG TABLETS

Active substance(s): BETAHISTINE DIHYDROCHLORIDE

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Betahistine 8 mg tablets
Betahistine 16 mg tablets
Betahistine 24 mg 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.
What is in this leaflet
1. What Betahistine is and what it is used for
2. What you need to know before you take Betahistine
3. How to take Betahistine
4. Possible side effects
5. How to store Betahistine
6. Contents of the pack and other information
1. What Betahistine is and what it is used for
Betahistine is a type of medicine called a “histamine analogue”.
Betahistine is used for:
Ménière's disease – the signs of this include:
·
feeling dizzy (vertigo)
·
ringing in the ears (tinnitus)
·
hearing loss or hearing difficulty
This medicine works by improving blood flow in the inner ear. This
lowers the build up of pressure.
2. What you need to know before you take Betahistine
Do not take Betahistine
·
if you are allergic to betahistine or to any of the other
ingredients of this medicine (listed in section 6)
·
if you have a pheochromocytoma, a rare tumour of the adrenal
gland
Warnings and precautions
·
if you have a stomach ulcer (peptic ulcer)
·
if you have asthma
·
if you have nettle rash, skin rash or a cold in the nose caused
by an allergy, since these complaints may be exacerbated.
·
if you have low blood pressure
If you suffer from any of the above conditions, consult your doctor
about whether you may take Betahistine tablets.
These groups of patients should be monitored by a doctor during
treatment.
Children
Betahistine is not recommended for those under 18 years old.
Other medicines and Bethisitine
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:
Anti-histamines – This is because in theory betahistine may not
work properly. Also, betahistine may lower the effect of antihistamines.

P150

P150

Betahistine Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Betahistine Tablets

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Taking Betahistine with food and drink
Betahistine can be taken with or without food. However, Betahistine
can cause mild stomach problems (listed in section 4). Taking
betahistine with food can help reduce stomach problems.
Pregnancy and, breast-feeding and fertility
Do not take betahistine dihydrochloride tablets if you are pregnant
unless your doctor has decided that it is absolutely necessary. Ask
your doctor for advice.
Do not breast-feed while using betahistine dihydrochloride tablets
unless instructed by your doctor. It is not known if betahistine
passes into breast milk.
Driving and using machines
Betahistine is not likely to affect your ability to drive or use tools or
machinery.
However, remember that the disease for which you are being
treated with Betahistine (Ménière's disease) can make you feel
dizzy or sick, and can affect your ability to drive and use machines.
3. How to take Betahistine
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
·
Your doctor will adjust your dose, depending on your progress.
·
Keep taking your medicine. The medicine can take a while to
start to work.
How to take Betahistine
·
Swallow the tablets with water.
·
Take the tablet with or after a meal. However, Betahistine can
cause mild stomach problems (listed in Section 4). Taking
Betahistine with food can help reduce stomach problems.
How much Betahistine to take
Always follow your doctor's instructions because your doctor might
adjust your dose.
The usual dose is:
Adults
The usual dose is 24 mg to 48 mg per day. 8 mg tablets: one or two
tablets three times a day.
16 mg tablets: half or one tablet three times a day.
If you take more than one tablet each day, spread your tablets
evenly over the day. For example, take one tablet in the morning,
one at midday and one in the evening.
Try to take your tablet at the same time each day. This will make
sure that there is a steady amount of the medicine in your body.
Taking at the same time will also help you remember to take your
tablets. Betahistine is not recommended for use in children.
If you take more Betahistine than you should
If you or someone else takes too many Betahistine tablets (an
overdose), you may feel sick (nauseous), sleepy or have stomach
pain. Talk to a doctor or go to a hospital immediately. Take the
Betahistine pack with you.
If you forget to take Betahistine
Wait until you have to take your next dose. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Betahistine
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 have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. Possible Side Effects

Monoamine-oxidase inhibitors (MAOIs) – used to treat depression
or Parkinson's disease. These may increase the exposure of
betahistine.

Like all medicines, this medicine can cause side effects, although
not everybody gets them. Very few adverse effects have been
reported with betahistine.

If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Betahistine.

The following serious side effects may occur during treatment with
Betahistine:

Black

Allergic reactions:
·
a red or lumpy skin rash or inflamed itchy skin
·
swelling of your face, lips, tongue or neck
·
a drop in your blood pressure
·
loss of consciousness
·
difficulty breathing
If any of these side effects occur you should stop treatment
immediately and contact your doctor.
Other side effects include:
Common (affects less than1 in 10 people):
·
feeling sick (nausea)
·
indigestion (dyspepsia)
·
headache.
Other side effects that have been reported with the use of
betahistine
Mild stomach problems such as being sick (vomiting), stomach
pain, stomach swelling (abdominal distension) and bloating. Taking
betahistine with food can help reduce stomach problems.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly (see details below). By
reporting side effects you can help provide more information on the
safety of this medicine.
Malta
The United Kingdom
ADR Reporting
Yellow Card Scheme
The Medicines Authority
Website:
Post-Licensing Directorate
www.mhra.gov.uk/yellowcard
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Betahistine
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated on
the label, carton, bottle after (EXP).The expiry date refers to the
last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Betahistine contains
The active substance is betahistine dihydrochloride.
Each tablet contains 8 mg betahistine dihydrochloride.
Each tablet contains 16 mg betahistine dihydrochloride.
Each tablet contains 24 mg betahistine dihydrochloride.
-

The other ingredients are microcrystalline cellulose, mannitol,
povidone, crospovidone, citric acid anhydrous, colloidal
anhydrous silica, talc and stearic acid.

What Betahistine looks like and the contents of the pack
Tablet.
Betahistine 8 mg tablets
White to off-white round, flat uncoated tablets debossed with 'X' on
one side and '87' on the other side.
Betahistine 16 mg tablets
White to off-white round uncoated tablets debossed with 'X' and a
break line on one side and '88' on the other side.
The tablet can be divided into equal doses.

Betahistine 24 mg tablets
White to off-white round uncoated tablets debossed with 'X' and a
break line on one side and '89' on the other side.
The tablet can be divided into equal doses.
Betahistine Tablets are available in:
Blisters of Polyamide/ Aluminium/ PVC/ Aluminium:
8 mg: 10, 20, 50, 60, 84, 100 & 120 tablets
16 mg: 10, 20, 30, 60 & 84 tablets
24 mg: 10, 20 & 60 tablets
White opaque round HDPE bottle with polypropylene closure
containing cotton coil: 30 and 1000 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
UK_
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
MT_

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last approved in 08/2014.

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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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