Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Histigen (Betahistine Viatris), 24 mg, tablets
Betahistini dihydrochloridum
Histigen and Betahistine Viatris are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, because
it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Histigen is and what it is used for
Important information before taking Histigen
How to take Histigen
Possible side effects
How to store Histigen
Contents of the pack and other information

1. What Histigen is and what it is used for

Histigen contains betahistine. Histigen is a type of medicine known as a “histamine analogue”.
It is used in the treatment of Ménière’s syndrome, which is characterised by:

dizziness, nausea or vomiting
tinnitus (ringing in the ears)
hearing loss or impaired hearing.

Histigen works by improving blood flow in the inner ear. This reduces elevated pressure.

2. Important information before using Histigen

When not to use Histigen

if the patient is allergic to betahistine or any of the other ingredients of this medicine (listed in section 6)
if the patient has high blood pressure caused by an adrenal gland tumour ("pheochromocytoma").

If any of the above apply to the patient, use of this medicine should be discontinued. In case of
doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting to use Histigen, consult a doctor or pharmacist if:

the patient has or has previously had stomach ulcers
the patient has bronchial asthma

If any of the above apply to the patient, talk to a doctor before using this medicine.
The doctor will decide whether it is safe to use this medicine.
The doctor may recommend monitoring of patients with bronchial asthma taking Histigen.
Histigen with other medicines
Tell the doctor about all medicines currently used, recently used, or planned to be used.
In particular, inform the 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 (such as selegiline), used in the treatment of depression or Parkinson's disease. These may enhance the effect of Histigen

Histigen and food
Histigen may be taken with or without food. However, Histigen may
cause mild gastrointestinal discomfort (see section 4). Taking Histigen
with food may help reduce gastrointestinal discomfort.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
It is not known whether Histigen affects the unborn child.

Discontinue taking Histigen and inform the doctor if the patient is pregnant or suspects she may be pregnant.
Do not take Histigen during pregnancy unless the doctor decides it is necessary.
It is not known whether Histigen passes into breast milk. Do not take Histigen while breastfeeding unless instructed by a doctor.

Driving and using machines
It is unlikely that Histigen affects the ability to drive or operate machinery. However, it should be noted that the condition for which Histigen is used (dizziness, tinnitus, and hearing loss associated with Ménière's disease) may cause dizziness or nausea and may affect the ability to drive or operate machinery.

3. How to use Histigen

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist. The doctor may adjust the dose according to the patient's condition.
Adults
The recommended initial dose is 24 mg (one tablet) twice daily (48 mg per day).
The doctor may reduce the dose to 12 mg (half a tablet) twice daily (24 mg per day).
If more than one tablet per day is prescribed, the doses should be evenly spaced
throughout the day; for example, take one tablet in the morning and one in the evening.
Try to take the tablets at the same time each day. This will ensure a constant level of the medicine
in the body.
Continue taking the medicine as prescribed. It may take some time for the medicine to take effect.
How to take the medicine
Swallow the tablet with water. Histigen may be taken with or without food. However, Histigen
may cause mild gastrointestinal discomfort (see section 4). Taking Histigen with food may help
reduce gastrointestinal symptoms.
The break line on the tablet is intended only to facilitate splitting the tablet if the patient has
difficulty swallowing it whole.
Use in children and adolescents
Histigen is not recommended for use in children and adolescents under 18 years of age.
Taking more Histigen than recommended
If you take more Histigen than prescribed, symptoms such as nausea, drowsiness,
or abdominal pain may occur. If in doubt, contact your doctor.
Missed dose of Histigen
If you miss a dose of Histigen, take the next dose at the scheduled time. Do not take a double dose
to make up for a missed dose.
Stopping Histigen treatment
Do not stop taking Histigen without consulting your doctor.
Even if you feel better, your doctor may advise continuing treatment to ensure
the medicine's effect remains stable.
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.
The following undesirable effects may occur after taking this medicine:

Allergic reactions:
If an allergic reaction occurs, discontinue taking Histigen and contact a doctor immediately or go to the nearest hospital.
Symptoms of an allergic reaction may include:

red or bumpy skin rash or inflamed, itchy skin
swelling of the face, lips, tongue, neck
low blood pressure
loss of consciousness
breathing difficulties

Discontinue taking Histigen and seek immediate medical attention or go to the nearest hospital if any of the above symptoms occur.

Other adverse reactions:
Common (may affect up to 1 in 10 people)

nausea
indigestion
headache

Frequency unknown (frequency cannot be estimated from available data)

mild gastrointestinal disorders such as vomiting, abdominal pain, and bloating. Taking Histigen with food may reduce gastrointestinal discomfort.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

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 stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Histigen contains
The active substance is betahistine dihydrochloride.
Each tablet contains 24 mg of betahistine dihydrochloride.
The other ingredients are: microcrystalline cellulose, mannitol, colloidal anhydrous silica, talc,
monohydrate citric acid.

What Histigen looks like and contents of the pack
Histigen tablets are white or almost white, round, biconvex tablets with bevelled edges and a division line, marked with "289" on both sides of the division line on one side of the tablet.
The medicine is available in blister packs containing 20, 60, or 100 tablets.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Belgium, country of export:
Viatris GX, Terhulpsesteenweg 6A, B-1560 Hoeilaart, Belgium

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
Poland

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

Marketing Authorisation number in Belgium, country of export: BE353245
Parallel Import Authorisation number: 255/25