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Betaserc

Neurology

Betaserc

8 mg or 16 mg tablets

8 mg or 16 mg 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.

 - 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 “possible side effect”.

 What is in this leaflet

1. What Betaserc is and what it is used for

2. What you need to know before you take Betaserc

3. How to take Betaserc

4. Possible side effects

5. How to store Betaserc

6. Contents of the pack and other information

1. What Betaserc is and what it is used for

Betaserc belongs to a group of medicines used to treat vertigo.

Betaserc is used for:

Ménière’s Syndrome as defined by the following core symptoms:

• vertigo (dizziness with nausea/vomiting)

• hardness of hearing or hearing loss

• tinnitus (perception of sound in the ear in the absence of corresponding external sound (e.g. ringing) Symptomatic treatment of vestibular vertigo (feeling of dizziness, often with nausea and/or vomiting, even when standing still).

How Betaserc works

The mechanism of action of Betaserc is known partially. Research shows that Betaserc can prevent or lessen the severity of attacks of Ménière’s disease.

2. What you need to know before you take Betaserc

Do not take Betaserc:

• if you are hypersensitive (allergic) to betahistine (dihydrochloride) or any of the other ingredients of Betaserc (listed in section “What Betaserc contains”);

• if you have phaeochromocytoma (a rare disease of the adrenal gland). Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Betaserc.

Warnings and precautions

Talk to your doctor or pharmacist before taking Betaserc:

• if you have ever had a stomach ulcer;

• if you have asthma. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Betaserc. Your doctor may want to monitor you more closely while you take Betaserc.

Children

Taking Betaserc is not recommended for people under the age of 18 years.

Other medicines and Betaserc

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Antihistamines (medicines primarily used in the treatment of allergy, such as hay fever and sickness). These may (in theory) lessen the effect of Betaserc. Also, Betaserc may reduce the effect of antihistamines.

• Monoamine oxidase inhibitors (MAOIs are medicines used to treat depression or Parkinson’s disease). These may increase your exposure to Betaserc. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Betaserc.

Betaserc with food and drink

You can take Betaserc with or without food. However, Betaserc can cause mild stomach problems (listed in section “possible side effects”). Taking Betaserc with food can help reduce stomach problems. Pregnancy and breast-feeding

It is not known whether Betaserc can harm an unborn baby:

• Stop taking Betaserc and tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

• Do not take Betaserc if you are pregnant unless your doctor deems it necessary. It is not known if Betaserc passes into human milk:

• Do not breast-feed if you are taking Betaserc unless your doctor advises you to do so.

Driving and using machines

Betaserc is used for Ménière’s disease. This disease can affect your ability to drive and use machines. Betaserc is not likely to affect your ability to drive or use tools or machinery.

3. How to take Betaserc

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Your doctor may adjust your dose based on the test results.

• Do not stop taking Betaserc. It may take some time before the medicine works.

How to take Betaserc

• Take the tablets with water.

• Betaserc can be taken with or without food. However, Betaserc can cause mild stomach problems (see section “possible side effects”). These can be lessened if it is taken with food.

Betaserc is available in 8 mg and 16 mg tablets. The usual dose is:

• one to two 8 mg tablets three times a day;

• a half to one 16 mg tablet three times a day.

If you take more than one tablet a day, take your tablets throughout the day, for example one tablet in the morning and one tablet in the evening. Try to take your tablets at the same time each day to ensure that the amount of medicine in your body remains constant. Taking the tablets at the same time each day will also help you remember to take your tablets.

If you take more Betaserc than you should

If you have taken too much Betaserc, you may feel sick or sleepy or have a stomach ache. Please consult your doctor if you have these symptoms.

If you forget to take Betaserc

• If you forget to take a tablet, skip the missed dose. Take your next dose at the usual time.

• Do not take a double dose to make up for a forgotten dose. If you stop taking Betaserc Do not stop taking Betaserc without consulting your doctor, even if you start to feel better. If you have any further questions on the use of this medicine, ask 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 with this medicine:

Allergic reactions

If you have an allergic reaction, stop taking Betaserc and consult a doctor or go to a hospital immediately. The signs may include:

• a red or lumpy skin rash or inflamed, itchy skin;

• swelling of your face, lips, tongue or neck;

• a drop in your blood pressure;

• loss of consciousness;

• difficulty breathing.

Stop taking Betaserc and consult a doctor or go to a hospital immediately if you notice any of the signs described above.

Other side effects may include:

Common (may affect up to 1 in 10 people and more than 1 in 100 people):

• feeling sick (nausea);

• Heartburn;

• headache.

Other side effects that have been reported with the use of Betaserc

Mild stomach problems such as being sick (vomiting), stomach ache, swelling and bloating. Taking Betaserc with food can help reduce stomach problems.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Betaserc

• Do not store above 30° C

• Store in the original package in order to protect from light.

• Keep this medicine out of the reach of children

Shelf Life

3 years

• Do not use this medicine after the expiry date which is stated on the package after abbreviation “EXP” used for expiry date (month and year). The expiry date refers to the last day of that month

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Betaserc contains

• The active substance is betahistine dihydrochloride. Each tablet contains 8 mg or 16 mg of betahistine dihydrochloride.

• The other ingredients are microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silicon and talc.

What Betaserc looks like and contents of the pack

Betaserc 8 mg is a round, flat, white tablet with beveled edges. The tablet is engraved with the number 256 on one side This tablet is for oral administration (to be taken by mouth) and contains 8 mg of betahistine dihydrochloride.

Each pack contains 4 blister strips of 25 tablets.

Betaserc 16 mg is a round, biconvex, scored, white tablet with beveled edges. On one side, the tablet is scored and the number 267 is engraved on either side of the score line. This tablet is for oral administration (to be taken by mouth) and contains 16 mg of betahistine dihydrochloride. The tablet can be divided into equal halves to create two doses of 8 mg each.

Each pack contains 3 blister strips of 20 tablets.

The blisters (bubble packs) are made of PVC/PVDC and aluminum lidding foil.

Manufactured by:

Mylan Laboratories SAS

01400 Chatillon-sur-Chalaronne

France

For:

Abbott Healthcare Products B.V.,

The Netherlands
This leaflet was last revised in March 2015.