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BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

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:

  • ■ vertigo (dizziness)

  • ■ tinnitus (ringing in the ears)

  • ■ hearing loss

2. what you need to know before you take betahistine

Do not take Betahistine:

  • ■ if you are allergic to Betahistine dihydrochloride or any of the other ingredients of this medicine (listed in section 6)

  • ■ if you have phaeochromocytoma (a type of tumour).

Warnings and precautions

Talk to your doctor or pharmacist before taking Betahistine

  • ■ if you have asthma

  • ■ 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.

  • ■ antihistamines to treat allergies and hay fever

  • ■ 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:

  • ■ Swelling of the face, lips, tongue or neck

  • ■ Difficulty breathing

  • ■ 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

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Betahistine Dihydrochloride used for?

Betahistine Dihydrochloride is primarily prescribed to treat Meniere's disease, a condition that affects the inner ear, causing vertigo, ringing in the ears, and hearing loss.

How does Betahistine work in the body?

Betahistine works by improving blood flow in the inner ear, which helps reduce the frequency and severity of vertigo attacks.

Can I take Betahistine with other medications?

Always consult your doctor or pharmacist before combining Betahistine with other medications, as they can advise on potential interactions.

What should I do if I miss a dose of Betahistine?

If you miss a dose, take it as soon as you remember. If it's close to your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not double up.

Are there any common side effects of Betahistine?

Some people may experience side effects such as headaches, nausea, or digestive issues. If these persist or worsen, contact your healthcare provider.

Is it safe to drink alcohol while taking Betahistine?

It's best to avoid alcohol while taking Betahistine as it may increase some side effects.

Can Betahistine affect my driving or ability to operate machinery?

Some patients may experience dizziness or drowsiness. If you feel affected, avoid driving or operating machinery until you know how Betahistine affects you.

How long does it take for Betahistine to start working?

Many patients notice improvement within a few weeks, but it can vary. Follow your doctor's advice for the best results.

Can I stop taking Betahistine suddenly?

It's important to consult with your doctor before stopping Betahistine suddenly; abrupt discontinuation can worsen symptoms.

Is there a specific time of day when I should take Betahistine?

Taking Betahistine with food can help minimize stomach upset. Your doctor will advise you on the best schedule for your treatment.

What happens if I take too much Betahistine?

In case of an overdose, seek medical attention immediately. Symptoms might include nausea or stomach pain.

Can pregnant or breastfeeding women take Betahistine?

If you are pregnant or breastfeeding, discuss with your doctor before taking Betahistine to weigh the benefits against potential risks.

Are there any dietary restrictions while taking Betahistine?

There are no specific dietary restrictions associated with Betahistine, but a balanced diet can support overall health.

Will I need regular check-ups while on Betahistine therapy?

Yes, regular follow-up appointments are important to monitor your condition and adjust treatment if necessary.

How should I store Betahistine tablets?

Store at room temperature away from moisture and heat. Keep out of reach of children.

Is there a generic version of Betahistine available?

Yes, generic versions of Betahistine are available and are considered equally effective as the branded version.

Can children use Betahistine Dihydrochloride tablets?

Betahistine is generally not recommended for children unless specifically prescribed by a pediatrician.

What lifestyle changes can help manage Meniere's disease alongside medication?

Lifestyle changes such as reducing salt intake, managing stress levels, and avoiding caffeine may help alleviate symptoms alongside medication.

Will my insurance cover my prescription for Betahistine Dihydrochloride?

Insurance coverage varies; check with your insurance provider to see if they cover prescriptions for this medication.

Where can I find more information about my condition and treatment options?

Speak with your healthcare provider or visit reputable medical websites for further information on Meniere's disease and treatment options like Betahistine.