Betaserc

Package leaflet: Information for the patient

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

• Keep this leaflet to be able to 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. This 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. 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 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 patient has been diagnosed with a tumour of the adrenal gland (‘phaeochromocytoma’). Do not take Betaserc if either of the above applies to you. If in doubt, speak to your doctor or pharmacist before taking Betaserc.

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

• you have ever had stomach ulcers
• you suffer from bronchial asthma. If any of the above apply to you (or if you are unsure), speak to your doctor or pharmacist before taking Betaserc. Your doctor may wish to monitor you closely 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 if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines – these may (theoretically) affect the action of Betaserc. Betaserc may also reduce the effectiveness of antihistamine medicines.
• 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 to you (or if you are unsure), speak to your 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:

• Discontinue taking Betaserc and inform your doctor if you are pregnant or suspect you may be pregnant.
• Do not take Betaserc during pregnancy unless your doctor decides it is necessary.

It is not known whether Betaserc passes into breast milk:

• Do not breast-feed while taking Betaserc unless your doctor advises otherwise.

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 may affect your ability to drive and operate machinery.

3. How to take Betaserc

Betaserc should always be taken exactly as directed by your doctor. If you are unsure, consult 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.
• 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 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; 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 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 are unsure, 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Betaserc may cause adverse reactions, although not everyone experiences them. The following unwanted 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
• difficulty breathing. If any of the above symptoms occur, stop taking Betaserc immediately and contact a doctor or go to hospital.

Other adverse reactions:
Common (affecting 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 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.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betaserc

• Keep out of the sight and reach of children.
• No special temperature storage requirements.
• Store in the original packaging to protect from moisture.
• 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 pack and other information

What Betaserc contains

• The active substance is 24 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 24 mg tablets are circular, biconvex, divisible, white to almost white tablets with bevelled edges. They are 10 mm in diameter and are marked with "289" imprinted on both sides of the score line. The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not guarantee equal division of the dose.
Betaserc 24 mg is available in packs of 20, 50, 60, 100 or 120 tablets, packed in blisters made of PVC/PVDC/Al.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer:
Mylan Laboratories S.A.S.
Châtillon-sur-Chalaronne
France
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing Authorisation Number in the Czech Republic, country of export: 83/368/03-C
Parallel Import Authorisation Number: 282/23