Histigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Histigen (Betahistine diHCl Mylan)
16 mg, tablets
Betahistini dihydrochloridum
Histigen and Betahistine diHCl Mylan are different brand names of the same medicine.
Please read the entire leaflet carefully before taking 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 pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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 pack 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 medicine 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 which may cause high blood pressure ("pheochromocytoma").

Warnings and precautions
Special warnings
If the patient has been diagnosed with 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 taking betahistine who have or have had a history of 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 related to disorders of the central nervous system.

Taking the medicine with meals may help reduce gastrointestinal discomfort. Consult a doctor or pharmacist before use.
Histigen and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
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 otherwise directed by a doctor.
If a patient discovers she is pregnant while undergoing treatment, she should consult her doctor, who will determine whether continuing treatment is necessary.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Histigen has no effect or is unlikely to have any effect on the ability to drive and operate machinery.

3. How to take Histigen

This medicine should always be taken as directed by your doctor. If in doubt, 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 should be exercised 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.

Administration method
Oral administration.
This medicine should be taken orally during meals to avoid stomach discomfort. Swallow the tablet 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.

Overdose of Histigen
In case of taking too much Histigen (overdose), contact your doctor immediately or go to the nearest hospital.

Missed 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 questions 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 everyone will experience them.
Common adverse reactions (occurring in 1 in 100 but less than 1 in 10 patients):

• nausea
• digestive disturbances
• headaches

Frequency unknown (frequency cannot be estimated from the 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 discomfort, 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.
• Skin allergic reactions, particularly angioed (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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Histigen

Keep this 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 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 components (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 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:
PVDC/Aluminium blisters in cardboard cartons containing 30 or 60 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands
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
Repackaged in:
CEFEA Sp. z o.o. Spółka komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in the Netherlands, the country of export: RVG 24682
Parallel Import Licence number: 80/20