Betaserc

Patient Information Leaflet

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Betaserc (Betahistine Viatris)
24 mg, tablets
Betahistini dihydrochloridum
Betaserc and Betahistine Viatris are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:
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 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 reduces elevated pressure.

2. Important information before taking Betaserc e

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 (pheochromocytoma).

Do not take Betaserc 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 and adolescents

Betaserc is not recommended for use in individuals under 18 years of age.

Betaserc with other medicines

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:

• 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 unknown whether Betaserc passes into breast milk:

• Do not breast-feed while taking Betaserc unless advised otherwise by the doctor.

Driving and using machines

It is unlikely that Betaserc affects the ability to drive or operate machinery.

However, bear in mind 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 tools and machines.

3. How to take Betaserc

Betaserc should always be taken exactly as directed 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 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.

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, the 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 constant 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 abdominal pain. If in doubt, contact your doctor.

If you miss 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 the missed dose.

Stopping Betaserc
Do not stop taking Betaserc without consulting your doctor, even if you start to feel better.

If you have any further doubts or questions 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, discontinue taking Betaserc immediately and consult a doctor or go to the nearest hospital without delay. Symptoms may include:

• red or bumpy skin rash or inflammatory skin condition with itching
• swelling of the face, lips, tongue, or neck
• low blood pressure
• loss of consciousness
• breathing difficulties. Discontinue taking Betaserc immediately and contact a doctor or go to hospital if any of the above symptoms occur.

Other adverse reactions:
Common (affects 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 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 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 specified month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. 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, citric acid monohydrate, colloidal anhydrous silica, talc.

What Betaserc looks like and contents of the pack
Betaserc 24 mg tablets are circular, biconvex, divisible, white to almost white tablets with bevelled edges.
They measure 10 mm in diameter and are marked with "289" embossed on both sides of the break line on one side of the tablet. The break line is intended only to facilitate breaking the tablet for ease of swallowing and does not ensure equal dosing.
Betaserc 24 mg is available in packs of 20, 60, 100 or 120 tablets, packed in PVC/PVDC/Al blisters.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Belgium, the country of export:
Viatris GX
Terhulpsesteenweg 6A
B-1560 Hoeilaart
Belgium
Manufacturer:
Mylan Laboratories SAS
Route de Belleville, Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
Madaus GmbH
Lütticher Straße 5
53842 Troisdorf
Germany
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged by:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation Number in Belgium, the country of export: BE353245
Parallel Import Licence Number: 105/26