Betaserc

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Betaserc
24 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 so that you can read it again if necessary.
• 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 the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of 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. 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 doctor has diagnosed the patient with a tumour of the adrenal gland (‘chromaffin tumour’). Betaserc should not be taken 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 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 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 symptoms.
Pregnancy, breastfeeding and fertility
It is unknown whether Betaserc affects the unborn child:

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

It is unknown whether Betaserc passes into breast milk:

• Breastfeeding should be avoided while taking Betaserc unless the doctor advises otherwise.

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

Betaserc should always be taken 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.
• You should continue taking the medicine. It may take some time for the medicine 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 discomfort.

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

• Betaserc 24 mg – one tablet twice daily.

If you are taking more than one tablet per day, the doses should be evenly spaced
throughout the day, e.g., 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 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 abdominal pain. If in doubt, contact your doctor.

If you miss a dose of 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 treatment
Do not stop taking Betaserc without consulting your doctor, even if you feel better.

If you have any further 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 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, bumpy rash or inflamed, itchy skin,
• 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
Tel: +48 22 49 21 301; Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to 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.
• 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Betaserc contains

• The active substance is 24 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 tablets containing 24 mg of betahistine dihydrochloride are round, biconvex, scored, white to almost white tablets with bevelled edges. They are 10 mm in diameter and have the imprint "289" on both sides of the break line on one side of the tablet. The break line is intended only to facilitate tablet fragmentation for ease of swallowing and does not ensure equal dose division.
Betaserc 24 mg is available in packs of 20, 60 or 100 tablets, packed in PVC-PVDC/Al foil blisters, contained in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturer:
Mylan Laboratories S.A.S.
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 Romania, country of export: 2717/2010/03
Parallel import authorisation number: 40/19