Betanil forte

Package Leaflet: Information for the Patient

BETANIL FORTE

24 mg, tablets

Betahistini dihydrochloridum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• In case of any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What Betanil Forte is and what it is used for
• 2. Important information before taking Betanil Forte
• 3. How to take Betanil Forte
• 4. Possible side effects
• 5. How to store Betanil Forte
• 6. Package contents and other information

1. What Betanil Forte is and what it is used for

What Betanil Forte is

Betanil Forte contains betahistine. It is a medicine used to treat dizziness.

What Betanil Forte is used for

Betanil Forte is used to treat symptoms of Meniere's disease, such as:

• dizziness (with nausea, vomiting),
• progressive hearing loss (hearing problems),
• tinnitus.

Betanil Forte is also used to treat dizziness of vestibular origin.

2. Important information before taking Betanil Forte

When not to take Betanil Forte

• if the patient is allergic to betahistine or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been diagnosed with a rare tumor of the adrenal gland (pheochromocytoma).

Do nottake Betanil Forte if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting to take Betanil Forte, discuss it with your doctor:

• if the patient has stomach or duodenal ulcers or has had them in the past,
• if the patient has asthma,
• if the patient has hives, rash, or rhinitis caused by an allergy, as these conditions may worsen,
• if the patient has low blood pressure.

If any of the above applies to you (or if you have any doubts), consult your doctor or pharmacist before taking Betanil Forte. Your doctor may want to monitor your condition closely while taking Betanil Forte.

Children and adolescents

Betanil Forte is not recommended for use in children and adolescents under 18 years of age.

Betanil Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines.
Interactions can occur when medicines or substances affect the way other medicines or substances work, or cause side effects when taken at the same time.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines - they may (theoretically) affect the action of Betanil Forte. Betanil Forte may also reduce the action of antihistamines.
• monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may enhance the action of Betanil Forte.

If any of the above applies to you (or if you have any doubts), consult your doctor or pharmacist before taking Betanil Forte.

Betanil Forte with food and drink

Betanil Forte can be taken with or without food. However, Betanil Forte may cause mild stomach discomfort (listed in section 4). Taking Betanil Forte with food may help reduce stomach discomfort.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
It is not known whether betahistine is safe during pregnancy and breastfeeding. Therefore, betahistine should not be used during pregnancy or breastfeeding unless absolutely necessary.

Driving and using machines

It is unlikely that Betanil Forte will affect your ability to drive or use machines. However, remember that the diseases being treated with Betanil Forte (Meniere's disease and dizziness) can cause dizziness and nausea and may affect your ability to drive or use machines.
Betanil Forte contains lactose(a sugar found in milk).
If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Betanil Forte

Always take this medicine 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.

Recommended dose:
Adults

• Half a tablet to one tablet, twice a day.

If you are taking more than one tablet a day, spread 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 steady amount of medicine in your body.
Taking the medicine at the same time each day will also help you remember to take it.

How to take Betanil Forte

• Swallow the tablet with water.
• Betanil Forte can be taken with or without food. However, Betanil Forte may cause mild stomach discomfort (listed in section 4). Taking Betanil Forte with food may help reduce stomach discomfort.

If you take more Betanil Forte than you should

If you have taken more than the recommended dose, consult your doctor. Take the package leaflet with you.
Symptoms of betahistine overdose include nausea, drowsiness, and stomach pain.

If you forget to take Betanil Forte

• If you miss a dose, wait until it is time for your next dose.
• Do not take a double dose to make up for a forgotten tablet.

Stopping Betanil Forte treatment

Do not stop taking Betanil Forte without consulting your doctor, even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betanil Forte can cause side effects, although not everybody gets them.
The following serious side effects may occur during treatment with Betanil Forte:

Allergic reactions

If an allergic reaction occurs, stop taking Betanil Forte and consult your doctor or go to the nearest hospital immediately. Symptoms may include:

• 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 Betanil Forte and consult your doctor or go to the hospital immediately if you experience any of the above symptoms.

Other side effects include:
Common(occurring in 1 to 10 patients in 100):

• nausea,
• digestive disorders,
• headache.

Other side effects that have been reported during betahistine treatment:

• mild gastrointestinal disorders (e.g., vomiting, stomach and intestinal pain, bloating, and gas). Taking Betanil Forte with food may help reduce stomach discomfort.

Reporting side effects

If you experience any side effects, including any side effects not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the Department}
e-mail: adr@urpl.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Betanil Forte

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C, in the original package.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The expiry date is stated on the carton as "Expiry Date (EXP):" and on the blister as "EXP:". The batch number is stated on the carton as "Batch Number (Lot):" and on the blister as "Lot:".
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.

6. Package contents and other information

What Betanil Forte contains

• The active substance is betahistine dihydrochloride. One tablet contains 24 mg of betahistine dihydrochloride.
• The other ingredients are: povidone K90, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone (type A), and stearic acid.

What Betanil Forte looks like and contents of the pack

White or almost white tablets, round, biconvex, with a score line on one side.
The tablet can be divided into two equal doses.
Tablets are available in a carton containing 20, 30, 40, 50, 60, or 100 tablets, packaged in PVC/PVDC-Aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands:
Betakile
Poland:
Betanil Forte
Date of last revision of the package leaflet:06.07.2016