Patient Information Leaflet

Keep this leaflet! The 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 for future reference.
Consult your doctor, pharmacist, or nurse if you have any questions.
This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Betaserc is and what it is used for
What you need to know before taking Betaserc
How to take Betaserc
Possible side effects
How to store Betaserc
Contents of the pack and other information

1. What Betaserc is and what it is used for

1. What is Betaserc and what is it used for

What is Betaserc
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 reduces increased 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 medulla (‘chromaffin tumour’). Betaserc should not be taken if any of the above apply. 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 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:

Discontinue taking Betaserc and inform the doctor if the patient is pregnant or suspects pregnancy.
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 the doctor authorizes it.

Driving and using machines
It is unlikely that Betaserc affects the ability to drive or operate tools and machinery.
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 the ability to drive and operate machinery.
3. How to take Betaserc
3. How to take Betaserc
Always take Betaserc exactly as prescribed by the doctor. If in doubt, contact the doctor or pharmacist.

The doctor will adjust the dose according to the patient’s condition.
Continue taking the medicine. It may take some time before the medicine starts to work.

How to take the medicine

Swallow the tablet with water.
The tablet 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.

Dosage
Betaserc is available in two strengths: 8 mg and 24 mg. The usual dose is:

Betaserc 24 mg – one tablet twice daily.

If more than one tablet per day is taken, 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 remember to take it.
Taking more Betaserc than recommended
If more Betaserc has been taken than recommended, symptoms such as nausea, drowsiness or abdominal pain may occur. If in doubt, contact the doctor.
Missing a dose of Betaserc

If a dose of Betaserc is missed, take the 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 the doctor, even if symptoms improve.
If there are any further doubts regarding the use of the medicine, consult the doctor or pharmacist.
4. Possible side effects
4. Possible side effects
Like all medicines, Betaserc can cause side effects, although not everybody will experience them.
The following adverse reactions 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. Stop taking Betaserc immediately and contact a doctor or go to hospital if any of the above symptoms occur.

Other side effects:
Common (occurring in less 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 those not listed in this leaflet, inform the doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of 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 side effects helps provide more information on the safety of the medicine.
5. How to store Betaserc
5. How to store Betaserc

Keep out of sight and reach of children.
Store below 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 should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information
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 (E 421), citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 24 mg of betahistine dihydrochloride is a round, biconvex, white to almost white, scored tablet with bevelled edges. It measures 10 mm in diameter and is marked with “289” on one side of the tablet, on both sides of the break line. The break line is intended only to facilitate tablet swallowing by breaking it into smaller pieces, not for dividing into equal doses.
Betaserc 24 mg is available in packs of 20, 60, 100 or 120 tablets, packed in PVC-PVDC/Al blisters, in a cardboard box.
For more detailed information, contact the responsible party or parallel importer.
Marketing Authorisation Holder in Romania, country of export:
Mylan Healthcare B.V.
Krijgsman 20, 1186 DM Amstelveen, The Netherlands
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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation numbers in Romania, country of export: 2717/2010/01
2717/2010/03
Parallel import authorisation number: 111/22