Betaserc

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

• Keep this leaflet, so that you can read it again if necessary.
• 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. It may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.

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 characterised 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 results in a reduction of elevated 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 (‘chromaffin tumour of the adrenal gland’)

Do not take Betaserc if any of the above apply to the patient. 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 are any doubts), speak to a doctor or pharmacist before taking Betaserc. The doctor may wish to closely monitor the patient during treatment with Betaserc.

Children

Betaserc is not recommended for use in individuals under 18 years of age.

Other medicines and Betaserc

Tell your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription and herbal medicines.

In particular, inform your 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 are any doubts), 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 symptoms.

Pregnancy, breastfeeding and fertility

It is not known whether Betaserc affects the unborn child:

• Stop taking Betaserc and inform your 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 not known whether Betaserc passes into breast milk:

• Do not breastfeed while taking Betaserc unless instructed to do so by a doctor.

Driving and operating machinery

It is unlikely that Betaserc affects the ability to drive or operate tools and machines.

However, bear in mind 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

Betaserc should always be taken exactly as directed by your doctor. If you have any doubts,
you should contact your doctor or pharmacist.

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

How to take Betaserc

• 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 Betaserc 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, the doses should be evenly spaced
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 help maintain a constant level of the medicine in your body. Taking the tablets at the same times each day will also help you remember to take them.

If you take more Betaserc than you should
If you take more Betaserc than recommended, you may experience nausea, drowsiness,
or abdominal pain. If you are in any 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 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 or questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betaserc may cause side effects, although not everybody gets 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 inflamed skin 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 side effects:
Common (occurring in fewer than 1 in 10 people):

• nausea
• digestive disturbances
• headache

Other side effects 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 side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 side effects 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 container. 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. This will help protect the environment.

6. Contents of the packaging 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 are circular, flat, white to almost white tablets with bevelled edges,
measuring 7 mm in diameter, and marked with "256" embossed on one side.
Betaserc 8 mg is available in packs of 100 tablets, packed in PVC/PVDC/Al blisters, contained in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Belgium, country of export:
Viatris Healthcare
Terhulpsesteenweg 6A
B - 1560 Hoeilaart
Belgium

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Belgium, country of export: BE071766
Parallel Import Licence Number: 334/19
Date of revision of the leaflet: 13.08.2024