Histigen

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Histigen(Betahistine diHCl Mylan)

16 mg, tablets

Betahistini dihydrochloridum
Histigen and Betahistine diHCl Mylan are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their illness has the same symptoms.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging and other information

1. What is Histigen and what is it used for

Histigen contains betahistine, which belongs to a group of medicines for 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 the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the doctor has diagnosed the patient with a tumor of the adrenal gland, which can cause high blood pressure (pheochromocytoma).

Warnings and precautions

Special warnings

If the patient has asthma, they should discuss this with their doctor or pharmacist before starting to take Histigen.
In such cases, the patient taking Histigen must be monitored closely due to the risk of bronchospasm.
Patient taking betahistine with a history of peptic ulcer (stomach ulcers) or who have had a peptic ulcer in the past should be monitored closely during treatment.
Histigen should not be used to treat the following types of vertigo:

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

Taking the medicine during meals may help reduce stomach discomfort. Before taking the medicine, the patient should talk to their doctor or pharmacist.

Histigen and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor or pharmacist if they 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 enhance the effect of Histigen.

Pregnancy, breastfeeding, and fertility

Histigen should not be taken during pregnancy, unless the doctor decides it is necessary.
If the patient becomes pregnant during treatment, they should consult their doctor, as they will be able to assess whether it is necessary to continue treatment.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

3. How to take Histigen

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Dosage
The usual dose is 1 to 2 tablets three times a day. The patient should not take more than 6 tablets per day.
Caution should be exercised when administering the medicine to elderly patients.
Use in children and adolescents:
Betahistine should not be used 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 pain. The tablet should be swallowed with a glass of water. Do not chew.
If the patient feels that the effect of Histigen is too strong or too weak, they should consult their doctor.

Taking a higher dose of Histigen than recommended

If the patient has taken too much Histigen (overdose), they should contact their doctor or go to the hospital immediately.

Missing a dose of Histigen

If the patient misses a dose of Histigen, they should take the next dose at the scheduled time. They should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Histigen can cause side effects, although not everybody gets them.
Common side effects (occurring in 1 in 100 but less than 1 in 10 patients):

• nausea
• digestive disorders
• headaches

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

• significant decrease in platelet count
• allergic reactions, whose symptoms may include swelling of the face, lips, tongue, or throat, causing difficulty breathing (angioedema)
• mild gastrointestinal disorders, such as vomiting, dry mouth, diarrhea, abdominal pain, bloating, and gas. These side effects can be avoided by taking the tablet during meals or reducing the dose of the medicine.
• Skin allergic reactions, in particular angioedema, rash, redness, itching

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Histigen

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Histigen contains

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

What Histigen looks like and what the pack contains

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 of the tablet. The diameter of the tablet is approximately 8.5 mm.
Packaging available:
PVDC/Aluminum blisters in a cardboard box, containing 30 or 60 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
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 by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
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 Warsaw
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Netherlands, the country of export: RVG 24682
Parallel import authorization number: 80/20
Date of leaflet approval: 08.12.2022
[Information about the trademark]