Betaserc

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Betaserc (Serc)
8 mg, tablets
Betahistini dihydrochloridum
Betaserc and Serc are different trade names of the same medicinal product.
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 effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.

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 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. 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 doctor has diagnosed the patient with a tumour of the adrenal gland (‘adrenal chromaffin tumour’)

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

Inform the doctor or pharmacist about all medicines currently taken or recently taken, including prescription and non-prescription medicines, as well as herbal preparations.

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.

Taking 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 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 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 tools and machinery.

3. How to take Betaserc

Always take Betaserc exactly as directed by your doctor. If you have any doubts,
contact your doctor or pharmacist.

• Your doctor will adjust the dose according to your condition.
• Continue taking the medicine as prescribed. 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 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, 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 helps maintain 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 prescribed
If you take more Betaserc than recommended, you may experience nausea, drowsiness,
or abdominal pain. If in doubt, contact your doctor.

If you forget to take 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
Do not stop taking Betaserc without consulting your doctor, even if you feel better.

If you have any further doubts or questions about the use of this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betaserc may cause side effects, although not everybody gets 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 inflamed skin with itching
• swelling of the face, lips, tongue, or neck
• low blood pressure
• loss of consciousness
• breathing difficulties

Stop taking Betaserc immediately and contact a doctor or go to hospital if any of the above symptoms occur.

Other side effects:
Common (affects less than 1 in 10 people):

• nausea
• digestive disturbances
• headache

Other side effects 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 side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department for 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
By reporting side effects, additional information can be gathered regarding the safety of the medicine.

5. How to store the medicine Betaserc

• Keep out of the sight and reach of children.
• Store below 25°C in a dry place.
• 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Betaserc contains

• The active substance is 8 mg of betahistine dihydrochloride, equivalent to 5.21 mg of betahistine.
• 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 (betahistine dihydrochloride) is a round, flat, white to almost white tablet with bevelled edges, 7 mm in diameter, and engraved with "256" on one side.
Betaserc 8 mg is available in packs of 30 tablets, packed in blisters made of PVC/PVDC/Al foil.

For more detailed information, please contact the marketing authorisation holder or the parallel importer:

Marketing Authorisation Holder in Spain, the country of export:
Neuraxpharm Spain S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona, Spain

Manufacturer
Mylan Laboratories SAS
Route de Belleville, Lieu dit Maillard
01400 Châtillon sur Chalaronne
France

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Spain, the country of export: 733469.9
Parallel Import Licence Number: 310/19