BETAHISTINE DIHYDROCHLORIDE 16MG TABLETS
Active substance(s): BETAHISTINE DIHYDROCHLORIDE / BETAHISTINE HYDROCHLORIDE
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAHISTINE DIHYDROCHLORIDE 8 mg and 16 mg TABLETS
The name of your medicine is Betahistine Dihydrochloride Tablets, which will be called Betahistine Tablets
throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1.
What Betahistine Tablets are and what they are used for
2.
Before you take Betahistine Tablets
3.
How to take Betahistine Tablets
4.
Possible side effects
5.
How to store Betahistine Tablets
6.
Further information
1.
WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR
Betahistine Tablets contain 8 mg or 16 mg of the active ingredient betahistine dihydrochloride. Betahistine
Tablets belong to a group of medicines known as histamine analogues, which means it closely resembles
histamine – a chemical found naturally in the body.
Betahistine works by improving blood flow in the inner ear, which reduces the build up of pressure. It is this
pressure in the ear that causes vertigo (dizziness), tinnitus (ringing in the ears), and hearing loss suffered by
people with Ménière's disease.
2.
BEFORE YOU TAKE BETAHISTINE TABLETS
Do not take Betahistine Tablets if you
• are allergic (hypersensitive) to betahistine or any of the other ingredients of Betahistine Tablets (see list
of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• have a phaeochromocytoma (a very rare tumour of the adrenal gland)
Take special care with Betahistine Tablets if you have
• had a peptic ulcer. Your doctor will monitor you closely during your treatment.
• asthma. Your doctor will monitor you closely during your treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Anti-histamines - these may (in theory) lower the effect of Betahistine Tablets. Also, Betahistine
Tablets may lower the effect of anti-histamines.
• Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson’s disease. These may
increase the blood level of Betahistine Tablets.
1
Pregnancy and breast-feeding
Do not take Betahistine Tablets if you are pregnant unless your doctor has decided that it is absolutely
necessary for your treatment.
Do not breast-feed while using Betahistine tablets unless instructed by your doctor. It is not known if
betahistine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Betahistine Tablets are not likely to affect your ability to drive or operate machinery, although the vertigo,
tinnitus and hearing loss associated with Ménière’s syndrome (for which you are taking betahistine) can
make you feel dizzy or be sick, and may affect your ability to drive or use machines. Make sure you know
how this medicine affects you before you drive or operate machines.
Important information about some of the ingredients of Betahistine Tablets
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
Always take Bethahistine Tablets exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water, and are best taken with or after a meal.
The usual dose is:
Adults (including the elderly)
The usual starting dose is 16 mg three times daily.
The usual dose after this is 24-48 mg daily (as three divided doses).
Children
Betahistine Tablets are not recommended for use in children below 18 years.
.
If you take more Betahistine Tablets than you should
It is important to stick to the dose on the label of your medicine. If you or someone else takes too many
Betahistine Tablets all together, contact your doctor, pharmacist or hospital emergency department
immediately. Always take any tablets left over with you and also the box, as this will allow easier
identification of the medicine.
If you forget to take Betahistine Tablets
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a
forgotten dose if it is almost time for your next dose.
If you stop taking Betahistine Tablets
Do not stop taking your medicine without talking to your doctor first, even if you feel better.
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 Tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects have been reported at the frequencies shown:
Common (affecting less than 1 in 10 patients)
• feeling sick
• indigestion
• headache
Frequency not known
• itching, skin rash, or hives (red and sometimes itchy bumps on your skin)
• mild gastric complaints such as being sick, stomach pain, swollen belly or bloating. Taking the medicine
with food can help reduce any stomach problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5.
HOW TO STORE BETAHISTINE TABLETS
Betahistine Tablets should be kept out of the reach and sight of children.
Do not store above 25°C.
Store in the original package.
Do not use Betahistine Tablets after the expiry date which is stated on the carton. The expiry date refers to
the last day of that month.
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
What Betahistine Tablets contain:
The active substance is betahistine dihydrochloride.
The other ingredients are: povidone K90, microcrystalline cellulose, lactose, colloidal anhydrous silica,
crospovidone and stearic acid.
What Betahistine Tablets look like and contents of the pack
Betahistine Tablets are white to almost white tablets.
Betahistine 8mg Tablets are imprinted with ‘B8’ on one side.
Betahistine 16mg Tablets are imprinted with ‘B16’ on one side.
The tablets are packed in blister strips.
Each carton of 8 mg Betahistine dihydrochloride tablets contains 84 or 120 tablets.
Each carton of 16 mg Betahistine dihydrochloride tablets contains 60 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in
January 2013
PL 00289/1544 and 1545
BETAHISTINE DIHYDROCHLORIDE 8 mg and 16 mg TABLETS
The name of your medicine is Betahistine Dihydrochloride Tablets, which will be called Betahistine Tablets
throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1.
What Betahistine Tablets are and what they are used for
2.
Before you take Betahistine Tablets
3.
How to take Betahistine Tablets
4.
Possible side effects
5.
How to store Betahistine Tablets
6.
Further information
1.
WHAT BETAHISTINE TABLETS ARE AND WHAT THEY ARE USED FOR
Betahistine Tablets contain 8 mg or 16 mg of the active ingredient betahistine dihydrochloride. Betahistine
Tablets belong to a group of medicines known as histamine analogues, which means it closely resembles
histamine – a chemical found naturally in the body.
Betahistine works by improving blood flow in the inner ear, which reduces the build up of pressure. It is this
pressure in the ear that causes vertigo (dizziness), tinnitus (ringing in the ears), and hearing loss suffered by
people with Ménière's disease.
2.
BEFORE YOU TAKE BETAHISTINE TABLETS
Do not take Betahistine Tablets if you
• are allergic (hypersensitive) to betahistine or any of the other ingredients of Betahistine Tablets (see list
of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or
swelling of the face, lips, throat or tongue
• have a phaeochromocytoma (a very rare tumour of the adrenal gland)
Take special care with Betahistine Tablets if you have
• had a peptic ulcer. Your doctor will monitor you closely during your treatment.
• asthma. Your doctor will monitor you closely during your treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Anti-histamines - these may (in theory) lower the effect of Betahistine Tablets. Also, Betahistine
Tablets may lower the effect of anti-histamines.
• Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson’s disease. These may
increase the blood level of Betahistine Tablets.
1
Pregnancy and breast-feeding
Do not take Betahistine Tablets if you are pregnant unless your doctor has decided that it is absolutely
necessary for your treatment.
Do not breast-feed while using Betahistine tablets unless instructed by your doctor. It is not known if
betahistine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Betahistine Tablets are not likely to affect your ability to drive or operate machinery, although the vertigo,
tinnitus and hearing loss associated with Ménière’s syndrome (for which you are taking betahistine) can
make you feel dizzy or be sick, and may affect your ability to drive or use machines. Make sure you know
how this medicine affects you before you drive or operate machines.
Important information about some of the ingredients of Betahistine Tablets
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
Always take Bethahistine Tablets exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water, and are best taken with or after a meal.
The usual dose is:
Adults (including the elderly)
The usual starting dose is 16 mg three times daily.
The usual dose after this is 24-48 mg daily (as three divided doses).
Children
Betahistine Tablets are not recommended for use in children below 18 years.
.
If you take more Betahistine Tablets than you should
It is important to stick to the dose on the label of your medicine. If you or someone else takes too many
Betahistine Tablets all together, contact your doctor, pharmacist or hospital emergency department
immediately. Always take any tablets left over with you and also the box, as this will allow easier
identification of the medicine.
If you forget to take Betahistine Tablets
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a
forgotten dose if it is almost time for your next dose.
If you stop taking Betahistine Tablets
Do not stop taking your medicine without talking to your doctor first, even if you feel better.
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 Tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects have been reported at the frequencies shown:
Common (affecting less than 1 in 10 patients)
• feeling sick
• indigestion
• headache
Frequency not known
• itching, skin rash, or hives (red and sometimes itchy bumps on your skin)
• mild gastric complaints such as being sick, stomach pain, swollen belly or bloating. Taking the medicine
with food can help reduce any stomach problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5.
HOW TO STORE BETAHISTINE TABLETS
Betahistine Tablets should be kept out of the reach and sight of children.
Do not store above 25°C.
Store in the original package.
Do not use Betahistine Tablets after the expiry date which is stated on the carton. The expiry date refers to
the last day of that month.
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
What Betahistine Tablets contain:
The active substance is betahistine dihydrochloride.
The other ingredients are: povidone K90, microcrystalline cellulose, lactose, colloidal anhydrous silica,
crospovidone and stearic acid.
What Betahistine Tablets look like and contents of the pack
Betahistine Tablets are white to almost white tablets.
Betahistine 8mg Tablets are imprinted with ‘B8’ on one side.
Betahistine 16mg Tablets are imprinted with ‘B16’ on one side.
The tablets are packed in blister strips.
Each carton of 8 mg Betahistine dihydrochloride tablets contains 84 or 120 tablets.
Each carton of 16 mg Betahistine dihydrochloride tablets contains 60 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in
January 2013
PL 00289/1544 and 1545
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