Patient leaflet - BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS
Betahistine dihydrochloride 8mg and 16mg 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
I If you have any further questions, ask your doctor or pharmacist
I 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
I 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 dihydrochloride Tablets (hereinafter referred to as Betahistine) contain betahistine dihydrochloride which belongs to a group of medicines called a histamine analogue. It works by improving blood flow in the inner ear which reduces the build up of pressure.
Betahistine is used to treat the symptoms associated with Meniere's disease, a condition of the inner ear which causes:
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■ vertigo (dizziness)
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■ tinnitus (ringing in the ears)
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■ hearing loss
2. what you need to know before you take betahistine
Do not take Betahistine:
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■ if you are allergic to Betahistine dihydrochloride or any of the other ingredients of this medicine (listed in section 6)
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■ if you have phaeochromocytoma (a type of tumour).
Warnings and precautions
Talk to your doctor or pharmacist before taking Betahistine
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■ if you have asthma
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■ if you have a stomach ulcer.
Other medicines and Betahistine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
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■ antihistamines to treat allergies and hay fever
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■ monoamine-oxidase inhibitors (MAOI's) to treat depression and Parkinson's disease.
Betahistine with food and drink
Swallow the tablets whole with a drink of water and take with meals.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not breast-feed while taking Betahistine unless your doctor tells you to. It is not known if Betahistine passes into breast milk.
Driving and using machinery
There are no known effects of this medicine on your ability to drive or use machinery. However, vertigo, tinnitus and hearing loss associated with Meniere's disease can make you feel dizzy or be sick, and may affect your ability to drive or use machinery.
Betahistine contains lactose
These 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 product.
3. how to take betahistine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
(continued overleaf)
Adults and the elderly
The usual dose is one tablet (16mg) or two tablets (8mg) three times a day, preferably taken with meals. After you have been taking this medicine for some time, your doctor may reduce the dose. Please follow the doctor's instructions.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Use in children
Betahistine is not recommended for use by those under 18 years of age.
If you take more Betahistine than you should Tell your doctor immediately or go to the nearest hospital casualty department.
If you forget to take Betahistine
If you forget to take a tablet, take one as soon as you remember. Do not take a double dose to make up for a forgotten dose.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Betahistine and contact your doctor immediately if you notice any of the following allergic reactions such as:
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■ Swelling of the face, lips, tongue or neck
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■ Difficulty breathing
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■ Red skin rash, inflamed itchy skin
5. how to store betahistine
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original container.
Do not use these tablets after the expiry date which is printed on the packet. 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. contents of the pack and other information
What Betahistine contains
These tablets contain the active ingredient betahistine dihydrochloride.
Each tablet contains either 8mg or 16mg of betahistine dihydrochloride.
They also contain microcrystalline cellulose, povidone K90, lactose monohydrate, colloidal silicon dioxide, crospovidone, stearic acid.
What Betahistine looks like and contents of the pack
Betahistine dihydrochloride 8mg tablets are round, biplane white or almost white tablets with bevel-edges on both sides. The tablet is marked with „B8“ on one side. Tablets are available in packs of 84 and 120.
Betahistine dihydrochloride 16mg tablets are round, biplanar white or almost white tablets with bevel-edges on both sides. The tablet is marked with „B16“ on one side and a scoreline on the reverse. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Tablets are available in packs of 84.
MA Holder and Manufacturer
Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick CV34 5YA, UK.
Other Formats
To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.
This leaflet was last revised in July 2018
URN: GB33-PIL-21–240718
MANX
Healthcare
Job Betahistine 8mg/16mg PIL – Page 2
Size
210 × 148mm