Package Leaflet: Information for the Patient
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Betaserc
24 mg, tablets
Betahistini dihydrochloridum
Read the leaflet carefully before taking the medicine, 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 medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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.
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. Contents of the pack and other information
- 1. What is Betaserc and what is it used for
What is Betaserc
Betaserc contains betahistine. Betaserc is a type of medicine called a "histamine analogue".
What is Betaserc used for
Betaserc is used to treat Meniere's disease, which is 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
Do not take Betaserc if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Betaserc.
Warnings and precautions
Before taking Betaserc, consult your doctor or pharmacist if:
- you have ever had stomach ulcers
- you have asthma. If any of the above applies to you (or if you have any doubts), consult your doctor or pharmacist before taking Betaserc. Your doctor may want to monitor you closely while you are taking Betaserc.
Children
Betaserc is not recommended for use in children under 18 years of age.
Other medicines and Betaserc
Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription and herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- 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 any of the above applies to you (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.
Always take Betaserc exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
- Your doctor will adjust the dose according to your condition.
- 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 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.
Taking the medicine at the same time each day will also help you remember to take it.
Taking more Betaserc than prescribed
Missing a dose of Betaserc
- 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.
Like all medicines, Betaserc can cause side effects, although not everybody gets them. After taking this medicine, 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
By reporting side effects, you can help provide more information on the safety of this medicine.
- 5. How to store Betaserc
- keep out of the sight and reach of children.
- store in a temperature not exceeding 25°C.
- 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. 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 betahistine dihydrochloride is a round, biconvex, divisible, white to almost white tablet with a score line on one side. The tablet is 10 mm in size and has "289" engraved on one side of the tablet on either side of the score line. The score line is only to facilitate breaking the tablet to swallow and not to divide it into equal doses.
Betaserc 24 mg is available in packs of 20, 60, or 100 tablets, packaged in PVC/PVDC/Al blisters.
For more detailed information, consult the marketing authorization holder or the parallel importer.
Marketing authorization holder in France, the country of export:
Mylan Medical SAS
40-44 rue Washington
75008 Paris
France
Manufacturer:
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon sur Chalaronne
France
Parallel importer:
Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Czeski Cieszyn, Czech Republic
Repackaged by:
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Euceryna Laboratory Pharmaceutical COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Marketing authorization number in France, the country of export: 34009 355 647 1 9
Parallel import authorization number: 212/12 Date of approval of the leaflet: 21.03.2022