Package Leaflet: Information for the Patient
Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.
Betaserc
24 mg, tablets
Betahistine dihydrochloride
Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
- Keep this leaflet, so you can read it again if you need to.
- Consult a doctor, pharmacist, or nurse if you have any doubts.
- This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Table of Contents of the Leaflet
- 1. What is Betaserc and what is it used for
- 2. Important information before taking Betaserc
- 3. How to take Betaserc
- 4. Possible side effects
- 5. How to store Betaserc
- 6. Package contents and other information
1. What is Betaserc and what is it used for
What is Betaserc
Betaserc contains betahistine. Betaserc is a type of medication called a "histamine analogue".
What is Betaserc used for
Betaserc is used to treat Meniere's disease, characterized by the following symptoms:
- dizziness (with nausea, vomiting)
- progressive hearing loss
- tinnitus.
In the symptomatic treatment of dizziness of vestibular origin.
How Betaserc works
Betaserc works by improving blood flow in the inner ear. This reduces increased pressure.
2. Important information before taking Betaserc
When not to take Betaserc
Warnings and precautions
Before taking Betaserc, consult your doctor or pharmacist if:
- you have ever had stomach ulcers
- you have asthma. If you have any of the above conditions (or if you have any doubts), consult your doctor or pharmacist before taking Betaserc. Your doctor may want to monitor you closely while taking Betaserc.
Children
Betaserc is not recommended for use in children under 18 years of age.
Other medications and Betaserc
Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, including those obtained without a prescription and herbal medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medications:
- antihistamines - they may (theoretically) affect the action of Betaserc. Betaserc may also reduce the effect of antihistamines.
- monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may enhance the effect of Betaserc. If you have any of the above conditions (or if you have any doubts), consult your doctor or pharmacist before taking Betaserc.
Betaserc with food and drink
You can take Betaserc with or without food. However, Betaserc may cause mild stomach upset (listed in section 4). Taking Betaserc with food may help reduce stomach upset.
Pregnancy, breastfeeding, and fertility
It is not known whether Betaserc affects the fetus:
- stop taking Betaserc and inform your doctor if you are pregnant or think you may be pregnant.
- do not take Betaserc during pregnancy, unless your doctor decides it is necessary.
It is not known whether Betaserc passes into breast milk:
- do not breastfeed while taking Betaserc, unless your doctor allows it.
Driving and using machines
It is unlikely that Betaserc will affect your ability to drive or use machines.
However, remember that the diseases being treated with betahistine (Meniere's disease and dizziness)
can cause dizziness and nausea and may affect your ability to drive or use machines.
3. How to take Betaserc
Always take Betaserc exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
- Your doctor will adjust the dose according to your condition.
- continue taking the medication. It may take some time for the medication to start working.
How to take the medication
- swallow the tablet with water.
- you can take the tablet with or without food. However, Betaserc may cause mild stomach upset
(listed in section 4). Taking Betaserc with food may help reduce stomach upset.
How much to take
Betaserc is available in two strengths: 8 mg and 24 mg. The usual dose is:
- Betaserc, 24 mg - one tablet twice a day.
If you are taking more than one tablet a day, space out the doses evenly throughout the day, e.g., take one tablet in the morning and one in the evening.
try to take the tablets at the same time each day. This will help keep a constant amount of medication in your body. Taking the medication at the same time will also help you remember to take it.
If you take more Betaserc than you should
If you take more Betaserc than prescribed, you may experience nausea, drowsiness, or stomach pain. If in doubt, consult your doctor.
If you forget to take Betaserc
- 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.
4. Possible side effects
Like all medications, Betaserc can cause side effects, although not everybody gets them. After taking this medication, the following side effects may occur:
Allergic reactions
- red or lumpy skin rash or skin inflammation with itching
- swelling of the face, lips, tongue, or throat
- low blood pressure
- loss of consciousness
- difficulty breathing.
Stop taking Betaserc and consult your doctor or go to the hospital immediately if you experience any of the above symptoms.
Other side effects:
Common(occurring in less than 1 in 10 people):
- nausea
- digestive disorders
- headache.
Other side effects that have been reported during treatment with Betaserc
- mild stomach upset such as vomiting, stomach and intestinal pain, bloating, and gas. Taking Betaserc with food may help reduce stomach upset.
Reporting side effects
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help gather more information on the safety of the medication.
5. How to store Betaserc
- keep out of the sight and reach of children.
- no special storage temperature instructions.
- 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 month stated.
- do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Betaserc contains
- the active substance is 24 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 24 mg betahistine dihydrochloride is a round, biconvex, divisible, white to almost white tablet with a score line. The tablet is 10 mm in size and has "289" embossed on one side of the tablet on either side of the score line. The score line is only to facilitate breaking the tablet for swallowing and not to divide it into equal doses.
Betaserc 24 mg is available in packs of 20, 50, 60, 100, or 120 tablets, packaged in PVC/PVDC/Al blisters.
for more detailed information, consult the marketing authorization holder or parallel importer.
Marketing authorization holder in the Czech Republic, the country of export:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer:
Mylan Laboratories S.A.S.
Châtillon-sur-Chalaronne
France
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged by:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Marketing authorization number in the Czech Republic, the country of export:83/368/03-C
Parallel import authorization number: 282/23
Date of leaflet approval: 30.11.2023
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