Histigen

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging 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.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 should be monitored more 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 more 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 with 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 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 increase 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 child, 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. In case of doubts, the patient should consult their doctor or pharmacist.
Histigen is available in tablets of 8 mg and 16 mg.
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

In case of overdose (taking too much Histigen), the patient should contact their doctor or go to the hospital immediately.

Missing a dose of Histigen

If a dose of Histigen is missed, the patient should take the next dose at the scheduled time. They should not take a double dose to make up for the missed dose.
In case of any further doubts about taking the medicine, the patient 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, which 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 a meal 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department for the 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) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help 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 packaging. The expiry date refers to the last day of the month stated.
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). One tablet contains 16 mg of betahistine dihydrochloride.
• The other ingredients (excipients) are: microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica, talc.

What Histigen looks like and what the packaging contains

Histigen is a white or almost white, round, biconvex tablet with a score line and a diameter of about 8.5 mm.
Available packaging:
PVC/PVDC/Aluminum blisters in a cardboard box, containing 30, 60, or 100 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Netherlands marketing authorization number: RVG 24682

Parallel import authorization number: 623/12 Date of approval of the leaflet: 03.11.2022

[Information about the trademark]