Virtago

Package Leaflet: Information for the User

Virtago, 8 mg, tablets

Virtago, 16 mg, tablets

Virtago, 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What is Virtago and what is it used for
• 2. Important information before taking Virtago
• 3. How to take Virtago
• 4. Possible side effects
• 5. How to store Virtago
• 6. Contents of the pack and other information

1. What is Virtago and what is it used for

Betahistamine is a medicine called a histamine analogue.
Virtago is used to treat:
Ménière's disease, the symptoms of which include:

• dizziness;
• tinnitus;
• hearing loss or hearing disturbances.

This medicine works by improving blood flow in the inner ear. This reduces pressure.

2. Important information before taking Virtago

When not to take Virtago

• if you are allergic to betahistamine or any of the other ingredients of this medicine (listed in section 6);
• if you have a pheochromocytoma, a rare tumor of the adrenal gland.

Warnings and precautions

Before taking Virtago, discuss it with your doctor or pharmacist.

• if you have stomach ulcers;
• if you have bronchial asthma;
• if you have hives, rash, or nasal discharge caused by an allergy, as these problems may worsen;
• if you have low blood pressure.

If you have any of the above problems, consult your doctor to determine if taking Virtago is recommended.
Such patients should be monitored by a doctor during treatment.

Children and adolescents

Virtago is not recommended for children under 18 years of age.

Virtago and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

• Antihistamines - because betahistamine may not work properly. Also, betahistamine may reduce the effect of antihistamines.
• Monoamine oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. They may increase exposure to betahistamine.

If you are taking any of the above medicines (or are unsure), talk to your doctor or pharmacist before taking Virtago.

Virtago with food and drink

Virtago can be taken with or without food. However, Virtago may cause mild stomach upset (listed in section 4). Taking betahistamine during meals may alleviate stomach problems.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Unless your doctor considers it absolutely necessary, Virtago should not be taken during pregnancy. Consult your doctor.
Unless your doctor advises otherwise, do not breastfeed while taking Virtago. It is not known whether betahistamine passes into breast milk.

Driving and using machines

It is unlikely that betahistamine will affect your ability to drive or use machines.
However, keep in mind that the disease being treated with Virtago (Ménière's disease) can cause dizziness or nausea and affect your ability to drive or use machines.

3. How to take Virtago

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Your doctor will adjust the dose according to your response to treatment.
• Do not stop taking the medicine. The effects of the medicine may appear after some time.

How to take Virtago

• Swallow the tablets with water.
• Take the tablet during or after a meal. However, Virtago may cause mild stomach upset (listed in section 4). Taking Virtago during meals may alleviate stomach problems.

What dose of Virtago to take

Always follow the instructions of your doctor, as the doctor may adjust the dose.
The recommended dose is:
Adults
The recommended dose is 24 mg to 48 mg per day.
8 mg tablets: one or two tablets three times a day.
16 mg tablets: half or one tablet three times a day.
If you take more than one tablet per day, divide the dose evenly. For example: take one tablet in the morning, at noon, and in the evening.
Take the tablets at the same time every day. This will help maintain a constant level of the medicine in your body. Taking the medicine at the same time will help you remember to take the tablets.

Use in children and adolescents

Virtago is not recommended for children and adolescents under 18 years of age.

Taking more than the recommended dose of Virtago

If you take too many Virtago tablets (overdose), you may experience nausea, drowsiness, or stomach pain. Talk to your doctor or go to the hospital immediately.
Take the Virtago package with you.

Missing a dose of Virtago

Wait until it is time for your next dose. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Virtago

Do not stop taking the medicine without consulting your doctor.
Even if you feel better, your doctor may decide to continue treatment with the tablets to ensure that the medicine works properly.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Virtago can cause side effects, although not everybody gets them.
Very few side effects have been reported with betahistamine.
The following serious side effects may occur during treatment with Virtago:

Allergic reactions:

• red or lumpy rash or itchy, inflamed skin;
• swelling of the face, lips, tongue, or throat;
• low blood pressure;
• loss of consciousness;
• breathing difficulties. If you experience any of these side effects, stop taking the medicine and contact your doctor immediately.

Other side effects include:

Common(may affect up to 1 in 10 people):

• nausea;
• indigestion;
• headache.

Other side effects reported with betahistamine

Mild stomach problems, such as nausea (vomiting), stomach pain, bloating, and gas. Taking betahistamine during meals may alleviate stomach problems.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Virtago

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is stated on the label, carton, or bottle after “EXP:”. The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Virtago contains

• The active substance is betahistamine dihydrochloride. Each tablet contains 8 mg, 16 mg, or 24 mg of betahistamine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, mannitol, povidone, crospovidone, anhydrous citric acid, colloidal anhydrous silica, talc, and stearic acid.

What Virtago looks like and contents of the pack

Tablet.
Virtago 8 mg tablets:
White or off-white, round, flat, uncoated tablets with a diameter of 7.0 mm, with the symbol “X” embossed on one side and the number “87” on the other side.
Virtago 16 mg tablets:
White or off-white, round, uncoated tablets with a diameter of 8.5 mm, with the symbol “X” and a score line embossed on one side and the number “88” on the other side. The tablet can be divided into equal doses.
Virtago 24 mg tablets:
White or off-white, round, uncoated tablets with a diameter of 10.0 mm, with the symbol “X” and a score line embossed on one side and the number “89” on the other side. The tablet can be divided into equal doses.
Virtago tablets are available in:
Blister packs of Polyamide/Aluminium/PCW/Aluminium
8 mg: 10, 20, 30, 50, 60, 80, 84, 100, and 120 tablets.
16 mg: 10, 20, 30, 60, 84, 98, and 100 tablets.
24 mg: 10, 20, 30, 60, 98, and 100 tablets.
Bottles of HDPE with a polypropylene cap and a cotton plug
8 mg, 16 mg, 24 mg: 30 and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

Date of last revision of the package leaflet: