Betahistine Dihydrochloride 8mg Tablets
PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
Betahistine dihydrochloride 8mg and 16mg Tablets
Betahistine dihydrochloride
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 get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Betahistine is and what it is used for
2. Before you take Betahistine
3. How to take Betahistine
4. Possible side effects
5. How to store Betahistine
6. Further 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:
■ vertigo (dizziness)
■ tinnitus (ringing in the ears)
■ hearing loss
2. Before you take Betahistine
Do not take Betahistine if you:
■ are allergic to Betahistine dihydrochloride or any of the ingredients in these tablets (see section 6 for a full list of ingredients)
■ have phaeochromocytoma (a type of tumour).
Take special care with Betahistine and tell your doctor if you have or have had:
■ asthma
■ a stomach ulcer.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
You must tell your doctor or pharmacist if you are taking any of the following medicines:
■ antihistamines to treat allergies and hay fever.
■ monoamine-oxidase inhibitors (MAOI's) to treat depression and Parkinson's disease.
Taking Betahistine with food and drink Swallow the tablets whole with a drink of water and take with meals.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines. Do not take Betahistine if you are pregnant or think you may be pregnant, unless your doctor has advised it is absolutely necessary.
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 operating 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.
Important information about some of the ingredients in this product 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 Betahistine exactly as your doctor has told you. You should 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. 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
Some people may have side effects when taking this medicine.
Stop taking Betahistine and contact your doctor immediately if you notice any of the following allergic reactions such as:
■ Swelling of the face, lips, tongue or neck
■ Difficulty breathing
■ Red skin rash, inflamed itchy skin
If you notice any of the following side effects speak to your doctor or pharmacist:
Common side effects (likely to affect up to 1 in 10 people)
Nausea, indigestion, headache
Frequency not known
Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Betahistine with food can help reduce any 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 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
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. Further 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. Marketing Authorisation Holder Manx Pharma Ltd., Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA,
United Kingdom.
Manufacturer
Manx Healthcare Limited, Taylor Group House, Wedgnock Lane, Warwick cV34 5YA, United Kingdom.
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 April 2014
WIP URN: 290414-GB33-PIL-17
MANX
Pharma