Histigen

Package Leaflet: Information for the Patient

Histigen, 24 mg, Tablets

(Betahistini dihydrochloridum)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your 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 pack and other information

1. What is Histigen and what is it used for

Histigen contains betahistine. Histigen is a type of medicine called a "histamine analogue".
It is used to treat Meniere's syndrome, which is characterized by:

• dizziness and nausea or vomiting
• ringing in the ears
• hearing loss or decreased hearing.

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

2. Important information before taking Histigen

When not to take Histigen:

• if you are allergic to betahistine or any of the other ingredients of this medicine (listed in section 6)
• if you have high blood pressure caused by a tumor of the adrenal gland (pheochromocytoma).

If any of the above applies to you, stop taking the medicine. If in doubt, consult your doctor or pharmacist.

Warnings and precautions

Before taking Histigen, tell your doctor or pharmacist if:

• you have or have had stomach ulcers
• you have asthma

If any of the above applies to you, talk to your doctor before taking the medicine.
Your doctor will decide whether it is safe for you to take this medicine.
Your doctor may recommend monitoring patients with asthma who are taking Histigen.

Histigen and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and any you plan to take.
In particular, inform your doctor or pharmacist if you 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 (such as selegiline), which are used to treat depression or Parkinson's disease. They may increase the effect of Histigen

Histigen with food

Histigen can be taken with or without food. However, Histigen may cause mild stomach upset (see section 4). Taking Histigen with food may help reduce stomach upset.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether Histigen affects the fetus.

• Stop taking Histigen and inform your doctor if you are pregnant or think you may be pregnant.
• Do not take Histigen during pregnancy, unless your doctor decides it is necessary.
• It is not known whether Histigen passes into breast milk. Do not take Histigen while breastfeeding, unless your doctor allows it

Driving and using machines

It is unlikely that Histigen will affect your ability to drive or use machines. However, remember that the disease being treated with Histigen (dizziness, ringing in the ears, and hearing loss associated with Meniere's disease) may cause dizziness or nausea and affect your ability to drive or use machines.

3. How to take Histigen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor may adjust the dose of Histigen depending on your condition.

Adults

The recommended initial dose is 24 mg (one tablet), twice a day (48 mg per day).
Your doctor may reduce the dose to 12 mg (half a tablet) twice a day (24 mg per day).
If you are taking more than one tablet per day, spread the doses evenly throughout the day, e.g., 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 steady amount of medicine in your body.
Continue taking the medicine. It may take some time for the medicine to start working.
Taking the medicine
Swallow the tablet with water. You can take Histigen with or without food. However, Histigen may cause mild stomach upset (see section 4). Taking Histigen with food may help reduce stomach upset.
The score line on the tablet is only for ease of breaking the tablet, if you have difficulty swallowing it whole.

Use in children and adolescents

Histigen is not recommended for use in children and adolescents under 18 years of age.

Overdose of Histigen

If you have taken more than the prescribed dose of Histigen, you may experience nausea, drowsiness, or stomach pain. If in doubt, contact your doctor.

Missing a 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 the missed dose.

Stopping treatment with Histigen

Do not stop taking Histigen without consulting your doctor.
Even if you feel better, your doctor may recommend continuing to take the medicine to ensure that the effect of the medicine is maintained.
If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After taking this medicine, the following side effects may occur:

Allergic reactions:

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

• red or lumpy skin rash or skin inflammation with itching
• swelling of the face, lips, tongue, or throat
• low blood pressure
• loss of consciousness
• difficulty breathing

Stop taking Histigen and contact your doctor or go to the nearest hospital immediately if you experience any of the above symptoms.

Other side effects:

Common (may affect up to 1 in 10 people)

• nausea
• indigestion
• headache

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Histigen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicines should 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.
Each tablet contains 24 mg of betahistine dihydrochloride.
The other ingredients are: microcrystalline cellulose, mannitol, colloidal anhydrous silica, talc, citric acid monohydrate.

What Histigen looks like and contents of the pack

White or almost white, round, biconvex tablets with beveled edges and a score line, marked "289" on both sides of the score line on one side of the tablet.
Histigen is available in blister packs of 20, 30, 50, 60, 90, 100, 120, 180, and 200 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

Mylan Laboratories SAS
Route de Belleville, Lieu-dit Maillard
01400 Châtillon-sur-Chalaronne
France
Madaus GmbH
Lütticher Straße 5
53842 Troisdorf
Germany
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 54 66 400
Date of last revision of the leaflet: