BETAHISTINE ACCORD 24 mg TABLETS

Introduction

Package Leaflet: Information for the User

Betahistina Accord 24 mg Tablets EFG

Betahistina (betahistina dihydrochloride)

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• Keep this leaflet, as 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 you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Betahistina Accord and what is it used for
2. What you need to know before taking Betahistina Accord
3. How to take Betahistina Accord
4. Possible side effects
5. Storage of Betahistina Accord
6. Contents of the pack and further information

1. What is Betahistina Accord and what is it used for

Betahistina is a type of medicine known as "histamine analogues".

Betahistina is used for:

Meniere's Syndrome - the symptoms are:

• Feeling of dizziness and feeling sick or being sick
• Ringing in the ears
• Hearing loss or ear problems

How Betahistina Accord works

The mechanism of action of betahistina is partially known. Research shows that betahistina can prevent a Meniere's Syndrome attack or reduce the severity of the attacks.

2. What you need to know before taking Betahistina Accord

Do not take Betahistina Accord

• if you are allergic to the active substance betahistina (betahistina dihydrochloride) or to any of the other ingredients of this medicine (listed in section 6).

• if you have pheochromocytoma (a rare disorder of the adrenal glands).

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist for advice before taking this medicine.

Warnings and precautions

Please note the following points before starting to take this medicine:

• if you have symptoms that indicate a stomach ulcer or have had a stomach ulcer in the past,
• if you have bronchial asthma,
• if you suffer from skin rashes and intense itching (urticaria), or a cold caused by an allergy, as these problems may worsen.
• If you have low blood pressure.

If any of the above points apply to you (or you are not sure), consult your doctor or pharmacist before taking this medicine. Your doctor will monitor you more closely if you take betahistina.

Children and adolescents

Betahistina Accord is not recommended for use in children and adolescents under 18 years of age.

Using Betahistina Accord with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription.

Always consult your doctor or pharmacist if you are using any of the following medicines:

Antihistamines (medicines used mainly for the treatment of allergies such as hay fever or motion sickness). This (in theory) may reduce the effect of betahistina.

Betahistina may also reduce the effect of antihistamines.

Monoamine oxidase inhibitors (MAOIs) - medicines for treating depression or Parkinson's disease. This may increase the exposure of betahistina Accord.

If any of the above points apply to you or you are not sure, consult your doctor or pharmacist before using betahistina.

Using Betahistina Accord with food and drinks:

Betahistina can be taken with or without food. However, Betahistina Accord may cause mild stomach upset (see section 4). Taking it with food can help reduce stomach upset.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not known if betahistina affects the fetus.

• Stop taking this medicine and consult your doctor if you are pregnant or think you may be pregnant.
• Do not take betahistina if you are pregnant unless your doctor tells you it is necessary.
• It is not known if betahistina passes into breast milk. Do not take betahistina if you are breastfeeding unless your doctor has recommended it.

Driving and using machines

Betahistina is indicated in Meniere's Syndrome. This disease can negatively affect the ability to drive and use machines. Betahistina is unlikely to affect the ability to drive or use machines.

Betahistina Accord contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Betahistina Accord

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Your doctor will adjust the dose according to your response.
• Do not stop taking this medicine. It may take some time for the medicine to work.

How to take Betahistina Accord?

• Take the tablets with water.
• You can take betahistina Accord with or without food.
• However, Betahistina Accord may cause mild stomach upset (see section 4). Taking it with food can help reduce stomach upset.

The initial treatment is 24-48 mg per day divided into three equal doses, taken preferably with meals. For this purpose, 8 mg and 16 mg doses are available. Maintenance doses can generally be between 24 to 48 mg per day. If a higher maintenance dose is required, the 24 mg dose can be used twice a day (1 tablet in the morning and 1 in the evening). The daily dose should not exceed 48 mg. Try to take the tablets at the same time every day. This will ensure a constant amount of medicine in your body and make it easier to remember to take your medicine.

The tablet can be divided into equal doses.

If you take more Betahistina Accord than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you take more betahistina than you should, you may experience the following symptoms due to an overdose: dry mouth, low blood pressure, nausea, vomiting, indigestion, coordination problems, and if very high doses are taken, convulsions, as well as fatigue, heart or lung problems. Go to the doctor immediately, who will take the necessary measures.

If you forget to take Betahistina Accord:

If you forget to take a dose, wait until the next dose and continue with the normal treatment.

Do not take a double dose to make up for forgotten doses.

If you stop taking Betahistina Accord:

Do not stop taking Betahistina Accord without consulting your doctor, even if you feel better.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur during the use of this medicine:

Stop taking Betahistina Accord and go to your doctor or hospital if you experience any of the following symptoms.

Frequent ()

• Feeling of dizziness (nausea)
• Indigestion (dyspepsia)
• Headache.

Frequency not known (frequency cannot be estimated from the available data)

• Hypersensitivity reactions, such as anaphylaxis (allergic shock)

If you have an allergic reaction, stop taking this medicine and go to your doctor or hospital. The symptoms of an allergy can be:

• Red, swollen, or inflamed skin
• Swelling of the face, lips, tongue, or throat
• Low blood pressure
• Loss of consciousness
• Breathing difficulties

• Dizziness
• Feeling of weakness or lack of energy
• Chest pain
• Palpitations
• Increased heart rate (tachycardia)
• Mild stomach problems such as feeling sick (vomiting), stomach pain, stomach swelling, and bloating. Taking this medicine with food can help reduce stomach problems.
• Swelling of the deeper layers of the skin caused by fluid accumulation (angioedema).
• Skin rashes, including hives (urticaria)
• Intense itching (pruritus)

Reporting side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betahistina Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature. Keep it in the original package to protect it from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Betahistina Accord

The active substance is betahistina in the form of betahistina dihydrochloride.

Each tablet contains 24 mg of betahistina dihydrochloride.

The other ingredients are: lactose monohydrate, povidone K25, anhydrous citric acid (E330), corn starch, microcrystalline cellulose, crospovidone (Type B), and hydrogenated vegetable oil.

Appearance of Betahistina Accord and contents of the pack

White to off-white, round tablet, approximately 10 mm in diameter, biconvex, without a coating, with the inscription "GRI" on one side and a score line on the other.

The tablets can be divided into equal doses.

The tablets are available in PVC/PVDC/aluminum blisters. Packs of 20, 30, 50, 60, 84, 90, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare, S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est, 6ª planta,

08039 Barcelona

Spain

Manufacturer:

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040 Barcelona,

Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,

95-200 Pabianice,

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Date of the last revision of this leaflet

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.