Betaserc

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Betaserc
24 mg, tablets
Betahistini dihydrochloridum
Please read this leaflet carefully 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 doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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.

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

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 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.

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 gland (‘chromaffin tumour of the adrenal gland’). The patient should not take Betaserc if any of the above apply. If in doubt, speak with 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 with 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 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 effect 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 with 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:

• 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 not known 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, 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.

Betaserc should always be taken exactly as directed by the physician. In case of doubts, contact the physician or pharmacist.

• The physician will adjust the dose according to the patient's condition.
• Continue taking the medication. It may take some time for the drug 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 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 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 the drug in the body. Taking the medicine at the same time 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, symptoms such as nausea, drowsiness, or abdominal pain may occur. In case of doubt, contact your physician.

If you forget to take Betaserc

• If you miss a dose of Betaserc, take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping Betaserc

Do not stop taking Betaserc without consulting your physician, even if you feel better.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

Like all medicines, Betaserc may cause adverse reactions, although not everyone will experience them. The following undesirable 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 nodular skin rash or inflammatory skin condition with itching
• swelling of the face, lips, tongue or throat
• low blood pressure
• loss of consciousness
• breathing difficulties. You must stop taking Betaserc and contact your doctor immediately or go to hospital if any of the above symptoms occur.

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 be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +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.

• 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 specified month.
• Medicines should 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.

What Betaserc contains

• The active substance is 24 mg of betahistine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc tablets containing 24 mg of betahistine dihydrochloride are round, biconvex, scored, white to almost white tablets with bevelled edges. They measure 10 mm and have "289" embossed on one side of the tablet on both sides of the break line. The break line on the tablet is intended only to facilitate crushing for swallowing and does not allow division into equal doses.
Betaserc 24 mg is available in packs of 20, 50, 60, 100 or 120 tablets, packed in PVC/PVDC/Al blisters.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Portugal, country of export:
Viatris Healthcare, Lda.
Avenida D. João II, Edifício Atlantis, nº 44C - 7.3 and 7.4
1990-095 Lisbon
Portugal
Manufacturer:
Mylan Laboratories S.A.S. (Fab. Chatillon-sur-Chalaronne)
Route de Belleville
Lieu dit "Maillard"
01400 Chatillon Sur Chalaronne
France
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation number in Portugal, country of export: 5304381
Parallel import authorisation number: 306/25