Betahistine Dihydrochloride 8mg Tablets

• 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.

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

• You are allergic to Betahistine dihydrochloride or any of the other ingredients of this medicine (listed in section 6)
• You have phaeochromocytoma (high blood pressure due to an adrenal tumour)

Talk to your doctor before taking Betahistine if:

• You have a peptic (stomach) ulcer
• You suffer from bronchial asthma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by Betahistine:

• Antihistamines, used to treat allergic conditions
• Monoamine-oxidase inhibitors (MAOIs) used to treat depression, such as selegiline

These tablets should preferably be taken with meals.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take Betahistine if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice.

Breast-feeding

Do not breast-feed while using Betahistine unless instructed by your doctor as it is not known if Betahistine passes into breast milk. The benefits to the mother should be weighed against the potential risks for the child.

Betahistine should not affect the ability to drive and use machines. However, if any effects are experienced, do not drive or operate machinery.

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

• The initial dose is 16mg three times daily.
• Maintenance doses are generally between 24-48mg daily.

Not recommended for use in children below 18 years of age.

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of overdose include: feeling sick (nausea), sleepiness or drowsiness (somnolence), stomach pain, fits (convulsions), breathing (pulmonary) or heart (cardiac) complications.

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

It is important that you keep taking Betahistine for as long as your doctor has told you to.

• Allergic reactions: swelling of the face, throat or tongue
• Difficulty in breathing or dizziness (anaphylaxis)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

Common side effects (may affect up to 1 in 10 people):

• Feeling sick (nausea)
• Indigestion (dyspepsia)
• Headache

Other side effects (frequency not known)

• Mild gastric complaints such as being sick (vomiting), stomach pain, bloating. Taking Betahistine with meals can help to reduce these symptoms
• Skin rashes, including with the formation of wheals (urticaria)
• Severe itching (pruritus)

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• Each 8mg tablet contains betahistine dihydrochloride 8mg
• Each 16mg tablet contains betahistine dihydrochloride 16mg

The other ingredients are: lactose, maize starch, microcrystalline cellulose, citric acid, crospovidone, povidone K25 and sodium stearyl fumarate.

Betahistine dihydrochloride tablets are gluten free.

• Betahistine 8mg are flat, white tablets with a bevelled edge, marked ‘R3’ on one side with a score-line on the reverse
• Betahistine 16mg are flat, white tablets with a bevelled edge, marked ‘R4’ on one side with a score-line on the reverse

Betahistine is available in:

Betahistine Tablets are available in blister packs of 84, 100 or 120 tablets.

Not all pack sizes may be marketed.

Product Licence Numbers:

• Betahistine 8mg Tablets: PL 11311/0677
• Betahistine 16mg Tablets: PL 11311/0678