Betaserc

Patient Information Leaflet

Warning! Keep the leaflet, information on the immediate packaging in a foreign language
Betaserc
8 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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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 you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Table of Contents

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. 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’ of the adrenal gland)

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 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
Tell your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription and herbal medicines.

In particular, inform your 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 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 (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:

• Stop taking Betaserc and inform your 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 instructed otherwise by the doctor.

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 or operate machinery.

3. How to take Betaserc

Betaserc should always be taken exactly as directed by your doctor. If in doubt, 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.
• 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 more than one tablet per day is prescribed, 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 times each day will also help you remember to take it.

If you take more Betaserc than recommended
If you take more Betaserc than prescribed, symptoms such as nausea, drowsiness or stomach pain may occur. 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 the 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 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 will experience 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 lumpy skin rash or inflammatory skin condition 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 (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 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, in a dry place.
• Store in the original packaging to protect from light.
• Do not use Betaserc after the expiry date stated on the carton and blister. 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. 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, containing betahistine dihydrochloride, is a round, flat tablet, white to almost white, with bevelled edges, 7 mm in diameter, and marked with "256" embossed on one side.
Betaserc 8 mg is available in packs of 30 or 100 tablets, packed in blisters made of PVC-PVDC/Al foil 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Romania, country of export, Marketing Authorisation Number: 2192/2009/01
2192/2009/02
Parallel Import Licence Number: 209/24