Betaserc

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging 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 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 only. Do not give it to others. The medicine may harm another person, 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. See section 4.

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 patient has been diagnosed with a tumour of the adrenal gland (‘phaeochromocytoma’)

Do not take Betaserc if any of the above apply to the patient. 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 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
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 symptoms.

Pregnancy, breastfeeding and fertility
It is unknown whether Betaserc affects the unborn child:

• 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 advised otherwise by the 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, which could affect the ability to drive or operate machinery.

3. How to take Betaserc

Betaserc should always be taken exactly as directed by your doctor. If in doubt,
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 the medicine to start working.

How to take the medicine

• Swallow the tablet with water.
• The tablet can 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.

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 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 ensures a constant level of medicine in the body. Taking the medicine at the same time each day will also help you remember to take it.

Taking 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 the next dose at your 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 about using 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 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 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, 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 the medicine.

5. How to store Betaserc

• Keep this 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 what to do with 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 (E 421), 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, embossed with "256" on one side.
Betaserc 8 mg is available in packs of 25, 30 or 100 tablets, packed in PVC-PVDC/Al blisters in a cardboard box.
For more detailed information, please contact the responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Romania, country of export: 2192/2009/01
2192/2009/02
Parallel import licence number: 278/19