Patient Information Leaflet

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

Keep this leaflet, as you may need to read it again.
Consult your doctor, pharmacist, or nurse if you have any questions.
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. 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

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 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 tumor of the adrenal medulla ("adrenal chromaffin tumor"). The patient should not take Betaserc if any of the above conditions 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 conditions apply (or if there is any uncertainty), the patient should speak with 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), consult 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:
The patient should stop taking Betaserc and inform the doctor if she 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 otherwise advised by the doctor. Driving and using machines It is unlikely that Betaserc affects the ability to drive or operate tools and machinery. However, it should be remembered that the conditions treated with betahistine (Meniere's disease and vertigo) may cause sensations of spinning and nausea, which could impair the ability to drive or operate machinery.

3. How to take Betaserc

Betaserc should always be taken as prescribed 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 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 symptoms.

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 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 ensures a steady level of the 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 prescribed
If you take more Betaserc than recommended, you may experience nausea, drowsiness,
or abdominal pain. If you have any doubts, 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects
Like all medicines, Betaserc can cause side effects, although not everyone will experience them.
The following adverse reactions may occur after taking this medicine:

Allergic reactions
If you experience an allergic reaction, stop taking Betaserc and contact your 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. Stop taking Betaserc and seek immediate medical attention or go to hospital if any of the above symptoms occur.

Other side effects:
Common (occurring in fewer than 1 in 10 people):

nausea
digestive disturbances
headache.

Other side effects reported during Betaserc treatment

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 for 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 side effects helps provide more information on the safety of this medicine.

5. How to store Betaserc

Keep this medicine out of the sight and reach of children.
There are no special requirements regarding the storage temperature of the medicinal product. Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information
6. Contents of the pack and other information
What Betaserc contains

The active substance is 8 mg of betahistine dihydrochloride.
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 (containing betahistine dihydrochloride) are round, flat, white to almost white tablets with bevelled edges. They are 7 mm in diameter and marked with "256" on one side. Betaserc 8 mg is available in packs of 25 or 100 tablets, packed in PVC/PVDC/Al blisters, and contained in a cardboard box.

For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, country of export:
Mylan IRE Healthcare Limited
Unit 35/36, Grange Parade
Baldoyle Industrial Estate
Dublin 13, Ireland
Manufacturer:
Mylan Laboratories S.A.S.
Chatillon sur Chalaronne, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in the Czech Republic, country of export: 83/123/89-C
Parallel import authorisation number: 197/22