Betaserc

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Betaserc
8 mg, tablets
Betahistini dihydrochloridum
Please read this leaflet carefully before taking the 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 doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Betaserc is and what it is used for
2. Important information 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 vertigo.
How Betaserc works
Betaserc works by improving blood flow in the inner ear. This leads to a reduction in elevated
pressure.

2. 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 doctor has diagnosed the patient with a tumour of the adrenal medulla (‘phaeochromocytoma’). The patient should not take Betaserc if any of the above apply. If in doubt, speak to 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 not known whether Betaserc affects the unborn child:

• The patient should stop taking Betaserc and inform the doctor if she is pregnant or suspects she may be pregnant.
• Betaserc should not be taken during pregnancy unless the doctor decides it is necessary.

It is not known whether Betaserc passes into breast milk:

• Breastfeeding should be avoided while taking Betaserc unless the doctor permits it.

Driving and operating machinery
It is unlikely that Betaserc affects the ability to drive or operate tools and machinery.
However, it should be noted that the conditions treated with betahistine (Meniere’s disease and vertigo) may cause sensations of spinning and nausea, and may therefore affect the ability to drive and 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 will ensure a constant level of medicine in your body. Taking the medicine at the same time each day will also help you remember to take it.

If you take more Betaserc than recommended
If you take more Betaserc than prescribed, you may experience nausea, drowsiness, or stomach pain. If in doubt, contact your doctor.

If you forget to take Betaserc

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

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

If you have any further doubts or questions 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 adverse symptoms 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 throat,
• low blood pressure,
• loss of consciousness,
• difficulty breathing. If any of the above symptoms occur, discontinue 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,
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to gather further information on the safety of this medicine.

5. How to store Betaserc

• Keep the medicine out of the sight and reach of children.
• Store below 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 8 mg tablets containing betahistine dihydrochloride are round, flat, white to almost white tablets with bevelled edges. They are 7 mm in diameter and marked with "256" on one side.
Betaserc is available in packs of 25 or 100 tablets, packed in blisters made of PVC/PVDC/Al.
For further detailed 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Belgium, country of export: BE071766
Parallel Import Authorisation number: 53/17