Histigen

Package Leaflet: Information for the User

Histigen, 8 mg, tablets

Histigen, 16 mg, tablets

(Betahistini dihydrochloridum)

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

• Keep this 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. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1.

What is Histigen and what is it used for

Histigen contains betahistine, which belongs to a group of medicines used to treat vertigo.
This medicine is indicated for the treatment of certain types of vertigo.

2. Important information before taking Histigen

When not to take Histigen

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if your doctor has diagnosed you with a tumor of the adrenal gland, which can cause high blood pressure (pheochromocytoma).

Warnings and precautions

Special warnings

If you have asthma, you should discuss this with your doctor or pharmacist before taking Histigen.
In such cases, patients taking Histigen should be monitored for the risk of bronchospasm.
Patient with a history of peptic ulcer (gastric ulcers) or patients who have had peptic ulcer in the past should be monitored during treatment.
Do not take Histigen for the following types of vertigo:

• mild positional vertigo,
• vertigo associated with central nervous system disorders.

Taking the medicine with food may help reduce gastrointestinal upset.
Before taking the medicine, talk to your doctor or pharmacist.

Histigen and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines, which may reduce the effect of betahistine. Betahistine may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors, used to treat Parkinson's disease. They may increase the effect of Histigen.

Pregnancy, breastfeeding, and fertility

Do not take Histigen during pregnancy, unless your doctor has decided that it is necessary.
If you become pregnant during treatment, consult your doctor, as they will assess whether it is necessary to continue treatment.
If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Histigen is unlikely to affect your ability to drive or use machines.

3. How to take Histigen

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
Dosage
The usual dose is 1 to 2 tablets three times a day. Do not take more than 6 tablets per day.
Caution is advised when giving this medicine to elderly patients.
Use in children and adolescents:
It is not recommended to use betahistine in children and adolescents under 18 years of age.
Method of administration
Oral use.
Take the medicine with food to avoid stomach upset.
Swallow the tablet with a glass of water. Do not chew.

Overdose of Histigen

If you have taken too much of this medicine (overdose), contact your doctor or go to the hospital immediately.

Missing a dose of Histigen

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (occurring in 1 to 10 users):

• nausea
• gastrointestinal disorders
• headache

Frequency not known (frequency cannot be estimated from the available data):

• severe decrease in platelet count
• allergic reactions, which may include swelling of the face, lips, tongue, or throat, causing difficulty in breathing (anaphylaxis)
• mild gastrointestinal upset, such as vomiting, dry mouth, diarrhea, abdominal pain, bloating, and gas. These side effects can be avoided by taking the tablet with food or reducing the dose.
• skin allergic reactions, in particular anaphylaxis, rash, redness, itching

Reporting side effects

If you experience any side effects, including those not listed in this 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,
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 4921 309,
website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to provide more information on the safety of this medicine.

5. How to store Histigen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 Histigen contains

• The active substance is betahistine dihydrochloride (Betahistini dihydrochloridum).
• The other ingredients are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Histigen looks like and contents of the pack

Histigen 8 mg is a white or almost white, round tablet with a diameter of about 7 mm, with a score line and marked "256" on one side.
Histigen 16 mg is a white or almost white, round, biconvex tablet with a score line and marked "267" on both sides of the score line on one side. The diameter of the tablet is about 8.5 mm.
Pack sizes:
PVC/PVDC-Aluminum blisters in a cardboard box, containing 30, 60, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
For further information, contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel. +48 22 54 66 400

Date of last revision of the leaflet: