Betaserc

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Betaserc (Bétaserc)
24 mg, tablets
Betahistini dihydrochloridum
Betaserc and Bétaserc are different trade names of the same medicine.
Please read carefully the information in this leaflet 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 questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are similar.
• If any adverse effects occur, including any possible adverse effects 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 called 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 results in a reduction of 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 (‘phaeochromocytoma’). The patient should not take Betaserc if either of the above applies. If in doubt, speak to 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 she may be pregnant.
• 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 otherwise advised 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 may affect the ability to drive and operate machinery.

3. How to take Betaserc

Always take Betaserc exactly as directed by your doctor. If you are unsure, 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.
• 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 discomfort.

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, 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 steady level of medicine in your 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 you are unsure, contact your doctor.

Missing a dose of Betaserc

• If you miss a dose of Betaserc, take your 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 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 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 a 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 those 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 the medicine.

5. How to store Betaserc

• Keep the medicine out of the 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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, monohydrate citric acid, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 24 mg is a round, biconvex, scored, white to almost white tablet with bevelled edges. It has a diameter of 10 mm and is marked with "289" on both sides of the breakline on one side of the tablet. The breakline on the tablet is intended only to facilitate crushing for ease of swallowing and does not ensure equal dose division.
Betaserc 24 mg is available in packs of 20, 40, 60, 100 or 120 tablets, packed in PVC/PVDC/Aluminium blisters.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in France, country of export:
Viatris Médical, 1 bis place de la Défense - Tour Trinity, 92400 Courbevoie, France
Manufacturer:
Mylan Laboratories SAS, Route de Belleville, Lieu-dit Maillard, F 01400 Châtillon-sur-Chalaronne, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation numbers in France, country of export: 34009 355 646 5 8
34009 355 647 1 9
34009 563 248 9 7
34009 563 249 5 8
Parallel import authorisation number: 196/23