Histigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet; information on the immediate packaging is in a foreign language!
Histigen (Betahistine diHCl Viatris)
16 mg, tablets
Betahistini dihydrochloridum
Histigen and Betahistine diHCl Viatris are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Histigen is and what it is 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 packaging and other information

1. What Histigen is and what it is used for

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

2. Important information before using Histigen

When not to use Histigen

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the doctor has diagnosed the patient with a tumour of the adrenal gland that may cause high blood pressure ("pheochromocytoma").

Warnings and precautions
Special warnings
If the patient has asthma, the use of Histigen should be discussed with a doctor or pharmacist before starting treatment. In such cases, the patient receiving Histigen must be monitored closely due to the risk of bronchospasm.
Patients receiving betahistine who have or have previously had peptic ulcer disease should be monitored closely during treatment.
Histigen should not be used in the treatment of the following types of dizziness:

• mild positional dizziness,
• dizziness associated with disorders of the central nervous system.

Taking the medicine with food may help reduce gastrointestinal discomfort. Consult a doctor or pharmacist before taking the medicine.
Histigen and other medicines
Inform your 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.
In particular, inform your doctor or pharmacist if the patient is 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 in the treatment of Parkinson's disease. These may enhance the effect of Histigen.

Pregnancy, breastfeeding and fertility
Do not take Histigen during pregnancy unless your doctor decides it is necessary.
If a patient becomes pregnant while being treated, she should consult her doctor, as only the doctor can assess whether continuing treatment is necessary.
If a patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Histigen has no or is unlikely to have any influence on the ability to drive and operate machinery.

3. How to take Histigen

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Dosage
The usual dose is 1 to 2 tablets three times daily. Do not take more than 6
tablets per day.
Caution is advised when administering this medicine to elderly patients.
Use in children and adolescents:
Betahistine is not recommended for use in children and adolescents under 18 years of age.
Method of administration
Oral administration.
The medicine should be taken orally during meals to avoid stomach discomfort. The tablet
should be swallowed whole with a glass of water. Do not chew.
If you feel that the effect of Histigen is too strong or too weak, consult your
doctor.
Taking more Histigen than recommended
If you have taken too much Histigen (overdose), contact your doctor immediately or go to the
hospital.
Missing a dose of Histigen
If you have missed a dose of Histigen, 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 doubts about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Common adverse reactions (occurring in 1 in 100 but less than 1 in 10 patients):

• nausea
• digestive disorders
• headache

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

• significant decrease in blood platelet count
• allergic reactions, the symptoms of which may include swelling of the face, lips, tongue or throat, causing difficulty in breathing (angioedema)
• mild gastrointestinal disturbances, such as vomiting, dry mouth, diarrhoea, abdominal pain, bloating and gas. These adverse reactions can be avoided by taking the tablet with food or by reducing the dose of the medicine.
• skin allergic reactions, particularly angioedema, rash, redness, itching

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 4921 309
website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Histigen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
No special storage conditions required.
Medicines must 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 (excipients) are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Histigen looks like and contents of the pack
Histigen 16 mg is a white or almost white, round, biconvex tablet with bevelled edges and a central break line, marked with "267" on both sides of the break line on one side of the tablet. The tablet diameter is approximately 8.5 mm.
Available pack sizes:
Blister packs made of PVC/PVDC/Aluminium in a cardboard box containing 30 or 60 tablets.
For more detailed information, please contact the responsible entity or the parallel importer.

Responsible entity in the Netherlands, the country of export:
Viatris Ltd
Damastown Industrial Park
Mulhuddart
Dublin 15
Dublin, Ireland

Manufacturer:
Mylan Laboratories SAS
Route de Belleville
Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in the Netherlands, the country of export: RVG 24682
Parallel import authorisation number: 189/25