Betanil forte

Package leaflet: Information for the patient

BETANIL FORTE
24 mg, tablets
Betahistini dihydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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. Contents of the pack 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 vertigo.
What Betanil Forte is used for
Betanil Forte is a medicine used in the treatment of symptoms of Ménière’s disease, such as:

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

Betanil Forte is also used for symptomatic treatment of vestibular-origin vertigo.

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 type of tumour located in the adrenal medulla (pheochromocytoma).

Do not take Betanil Forte if any of the above apply to the patient.
If in doubt, talk to a doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Betanil Forte, discuss with a doctor:

• if the patient has a peptic ulcer of the stomach or duodenum, or has had such a condition in the past,
• if the patient has bronchial asthma,
• if the patient suffers from allergic urticaria, rash or rhinitis, as these conditions may worsen,
• if the patient has low blood pressure.

If any of the above apply to the patient (or if there are any doubts), talk to a doctor or pharmacist before using this medicine. The doctor may wish to closely monitor the patient's condition during treatment with 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 the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines and herbal remedies.
An interaction means that medicines or substances may affect the way other medicines or substances work, or increase the risk of adverse effects when taken together.
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 Betanil Forte. Betanil Forte may also reduce the effectiveness of antihistamine medicines.
• monoamine oxidase inhibitors (MAOIs) – used in the treatment of depression or Parkinson's disease. These may enhance the effect of Betanil Forte.

If any of the above apply to the patient (or if there are any doubts), talk to a doctor or pharmacist before taking Betanil Forte.
Betanil Forte with food and drink
Betanil Forte may be taken with or without food. However, Betanil Forte may cause mild gastrointestinal discomfort (listed in section 4). Taking Betanil Forte with food may help reduce gastrointestinal discomfort.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using 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 clearly necessary.
Driving and operating machinery
It is unlikely that Betanil Forte will affect the ability to drive or operate tools and machinery. However, it should be remembered that the conditions treated with Betanil Forte (Meniere's disease and vertigo) may cause sensations of spinning and nausea, and may affect the ability to drive and operate machinery.
Betanil Forte contains lactose (a sugar found in milk).
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Betanil Forte

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.

• The doctor will adjust the dose according to the patient's condition.
• You should 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 daily.

If more than one tablet per day is taken, 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 time each day. This ensures a constant level of the medicine in the body. Taking the medicine at the same time every 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 gastrointestinal discomfort (listed in section 4). Taking Betanil Forte with food may help reduce gastrointestinal discomfort.

Taking more Betanil Forte than prescribed
If you have taken more than the recommended dose, contact your doctor. Take the medicine packaging with you.
Symptoms of betahistine overdose may include nausea, drowsiness, and abdominal pain.

Missed dose of Betanil Forte

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

Stopping Betanil Forte

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following serious adverse reactions may occur during treatment with Betanil Forte:
Allergic reactions
If an allergic reaction occurs, stop taking Betanil Forte and consult a doctor immediately or
go to the nearest hospital. Symptoms may include:

• red or nodular skin rash or inflammatory skin condition with itching,
• swelling of the face, lips, tongue or neck,
• low blood pressure,
• loss of consciousness,
• breathing difficulties. You must stop taking Betanil Forte and seek immediate medical advice or go to hospital if any of the above symptoms occur.

Other adverse reactions include:
Common (occur in 1 to 10 out of 100 patients):

• nausea,
• digestive disturbances,
• headaches.

Other adverse reactions reported during treatment with betahistine:

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

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above Department}
e-mail: [email protected]
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

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 packaging.
Do not use this medicine after the expiry date stated on the carton and on the blister. The expiry date refers to the last day of the stated month.
The expiry date is indicated on the cardboard box as "Expiry date (EXP):", and on the blister as "EXP:".
The batch number is indicated on the cardboard box as "Batch number (Lot):", and on the blister as "Lot:".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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, round, biconvex tablets with a break line on one side.
The tablet can be divided into two equal doses.
The tablets are available in cardboard boxes containing 20, 30, 40, 50, 60 or 100 tablets,
packed in blisters made of PVC/PVDC-Aluminum foil.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area under the following names:
Netherlands: Betakile
Poland: Betanil Forte