Betaserc

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betaserc
8 mg, tablets
Betahistini dihydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor, pharmacist, or nurse if you have any questions or doubts.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of contents

1. What Betaserc is and what it is used for
2. What you need to know before taking 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

What Betaserc is
Betaserc contains betahistine. Betaserc is a type of medicine known as a "histamine analogue".
What Betaserc is used for
Betaserc is used in the treatment of Ménière's disease, which is characterized by the following
symptoms:

• vertigo (with nausea, vomiting)
• progressive hearing loss
• tinnitus.

For symptomatic treatment of vestibular-origin dizziness.
How Betaserc works
Betaserc works by improving blood flow in the inner ear. This results in a reduction of increased pressure.

2. Important information before taking Betaserc

When not to take Betaserc

• if the patient is allergic (hypersensitive) to betahistine or any of the other ingredients of Betaserc (listed in section 6),
• if the patient has been diagnosed with a tumour of the adrenal gland (‘phaeochromocytoma’). Do not take Betaserc if any of the above apply. If in doubt, consult a doctor or pharmacist before taking Betaserc.

Warnings and precautions
Before taking Betaserc, consult a doctor or pharmacist if:

• the patient has ever had stomach ulcers,
• the patient suffers from bronchial asthma. If any of the above apply (or if there is any uncertainty), speak to a doctor or pharmacist before taking Betaserc. The doctor may wish to monitor the patient closely during treatment with Betaserc.

Children
Betaserc is not recommended for use in individuals under 18 years of age.
Other medicines and Betaserc
Inform the doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription and herbal medicines.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• antihistamines – these may (theoretically) affect the action of Betaserc. Betaserc may also reduce the effectiveness of antihistamines;
• monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson’s disease. These may enhance the effect of Betaserc. If any of the above apply (or if there is any uncertainty), speak to a doctor or pharmacist before taking Betaserc.

Betaserc with food and drink
Betaserc may be taken with or without food. However, Betaserc may cause mild gastrointestinal discomfort (listed in section 4). Taking Betaserc with food may help reduce gastrointestinal discomfort.
Pregnancy, breastfeeding and fertility
It is unknown whether Betaserc affects the foetus:

• Discontinue taking Betaserc and inform the doctor if the patient is pregnant or suspects she may be pregnant.
• Do not take Betaserc during pregnancy unless the doctor decides it is necessary.

It is unknown whether Betaserc passes into breast milk:

• Do not breastfeed while taking Betaserc unless otherwise advised by the doctor.

Driving and using machines
It is unlikely that Betaserc affects the ability to drive or operate tools and machinery.
However, bear in mind that the conditions treated with betahistine (Meniere’s disease and vertigo) may cause sensations of spinning and nausea, and may affect the ability to drive or operate machinery.

3. How to take Betaserc

Always take Betaserc exactly as directed by your doctor. If you have any doubts,
contact your doctor or pharmacist.

• Your doctor will adjust the dose according to your condition.
• Continue taking the medicine. It may take some time for the medicine to start working.

How to take the medicine

• Swallow the tablet with water.
• You may take the tablet with or without food. However, Betaserc may cause mild gastrointestinal discomfort (listed in section 4). Taking Betaserc with food may help reduce gastrointestinal symptoms.

How much medicine to take
Betaserc is available in two strengths: 8 mg and 24 mg. The usual dose is:

• Betaserc 8 mg – one or two tablets three times daily.

If you are taking more than one tablet per day, divide the doses evenly throughout the day; for example, take one tablet in the morning and one in the evening. Try to take the tablets at the same times each day. This ensures a constant level of medicine in your body. Taking the medicine at the same times each day will also help you remember to take it.

If you take more Betaserc than you should
If you take more Betaserc than recommended, you may experience nausea, drowsiness, or stomach pain. If you have any doubts, contact your doctor.

If you forget to take Betaserc

• If you miss a dose of Betaserc, take the next dose at your usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Betaserc
Do not stop taking Betaserc without consulting your doctor, even if you feel better.

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

4. Possible adverse reactions

Like all medicines, Betaserc may cause adverse reactions, although not everyone experiences them.
The following undesirable effects may occur after taking this medicine:

Allergic reactions
If an allergic reaction occurs, stop taking Betaserc and consult a doctor immediately or go to the nearest hospital. Symptoms may include:

• red or bumpy skin rash or inflammatory skin condition with itching
• swelling of the face, lips, tongue or neck
• low blood pressure
• loss of consciousness
• breathing difficulties. If any of the above symptoms occur, stop taking Betaserc immediately and contact a doctor or go to hospital.

Other adverse reactions:
Common (occurring in less than 1 in 10 people):

• nausea
• digestive disturbances
• headache

Other adverse reactions reported during treatment with Betaserc:

• Mild gastrointestinal discomfort such as vomiting, stomach and intestinal pain, bloating and gas. Taking Betaserc with food may help reduce gastrointestinal discomfort.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Betaserc

• Keep out of the sight and reach of children.
• Store at a temperature not exceeding 25°C, in a dry place.
• Do not use Betaserc after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Betaserc contains

• The active substance is 8 mg of betahistine dihydrochloride.
• The other components are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 8 mg tablets are round, flat, white to almost white tablets with bevelled edges, 7 mm in diameter, engraved with "256" on one side.
Betaserc 8 mg is available in packs of 100 tablets, packed in PVC/PVDC/Al blisters.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Belgium, country of export:
Mylan EPD bvba/sprl
Terhulpsesteenweg, 6A
B - 1560 Hoeilaart
Belgium

Manufacturer:
Mylan Laboratories SAS
Route de Belleville
Lieu dit Maillard
01400 Châtillon-sur-Chalaronne
France

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Belgium, country of export: BE071766
Parallel Import Authorisation Number: 120/17