Betahistine Medreg

Package Leaflet: Information for the Patient

Betahistine Medreg, 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 tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Betahistine Medreg and what is it used for
• 2. Important information before taking Betahistine Medreg
• 3. How to take Betahistine Medreg
• 4. Possible side effects
• 5. How to store Betahistine Medreg
• 6. Contents of the pack and other information

1. What is Betahistine Medreg and what is it used for

What is Betahistine Medreg

Betahistine Medreg contains betahistine (dihydrochloride) as the active substance. Betahistine Medreg is a type of medicine called a "histamine analogue".

What is Betahistine Medreg used for

Betahistine Medreg is used to treat Meniere's disease, which is characterized by the following symptoms:

• vertigo (of vestibular origin) and nausea or vomiting
• hearing loss or hearing disturbances
• ringing in the ears (tinnitus)

Vertigo occurs when the part of the inner ear responsible for balance does not function properly (so-called "vestibular vertigo").

How Betahistine Medreg works

It increases blood flow to the inner ear, which may reduce pressure in the inner ear.
Betahistine Medreg is intended for adults.

2. Important information before taking Betahistine Medreg

When not to take Betahistine Medreg

Do not take this medicine if any of the above applies to you.
If you are unsure, consult your doctor or pharmacist before taking Betahistine Medreg.

Warnings and precautions

Before taking Betahistine Medreg, discuss it with your doctor or pharmacist:

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Betahistine Medreg. Your doctor may want to monitor you closely while taking Betahistine Medreg.

Children and adolescents

Betahistine Medreg is not recommended for children and adolescents under 18 years of age.

Betahistine Medreg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• antihistamines (some anti-allergic medicines) - they may (theoretically) affect the action of Betahistine Medreg. Betahistine Medreg may also reduce the effect of antihistamines.
• monoamine oxidase inhibitors (used to treat depression or Parkinson's disease) - they may enhance the effect of Betahistine Medreg.

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Betahistine Medreg.

Taking Betahistine Medreg with food and drink

Betahistine Medreg can be taken with or without food.
However, Betahistine Medreg may cause mild stomach upset (listed in section 4). Taking Betahistine Medreg 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 betahistine affects the unborn child:

• Stop taking Betahistine Medreg and tell your doctor if you become pregnant or think you may be pregnant.
• Do not take Betahistine Medreg if you are pregnant, unless your doctor decides it is absolutely necessary.

It is not known whether betahistine passes into breast milk:

• Do not breastfeed if you are taking Betahistine Medreg. You can only breastfeed if your doctor advises you to.

Driving and using machines

It is unlikely that Betahistine Medreg will affect your ability to drive or use machines.
However, remember that the disease for which you are being treated with this medicine (Meniere's disease) may cause vertigo or nausea and may affect your ability to drive or use machines.

3. How to take Betahistine Medreg

Always take this medicine exactly as your doctor has told you.
If you are unsure, ask your doctor or pharmacist.
How to take the medicine
The recommended dose is 1 tablet twice a day.
Your doctor will adjust the dose according to your condition.
If you take more than one tablet a day, spread the tablets evenly throughout the day. For example, take one tablet in the morning and one in the evening.
Method of administration
Swallow the tablets with water.
Betahistine Medreg can be taken with or without food. However, Betahistine Medreg may cause mild stomach upset (listed in section 4). Taking Betahistine Medreg with food may help reduce stomach upset.
Try to take the tablets at the same time each day. This will help you remember to take them.

What to do if you take more Betahistine Medreg than you should

If you take more than you should, you may experience the following symptoms: nausea, drowsiness, or stomach pain. Contact your doctor immediately, who will take appropriate measures.

What to do if you forget to take Betahistine Medreg

If you forget to take a tablet, skip that dose. Take the next dose at the scheduled time.
Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Betahistine Medreg

Do not stop taking the medicine. It may take some time before the medicine starts to work.
Do not stop taking Betahistine Medreg without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Betahistine Medreg can cause side effects, although not everybody gets them.

If you experience any of the following allergic reactions, stop taking Betahistine Medreg and seek medical attention:

• 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

Other possible side effects:
Common(may affect up to 1 in 10 people):

• headache
• nausea, indigestion

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

• mild stomach upset (e.g. vomiting, stomach pain, pressure in the stomach, and bloating). These can usually be avoided by taking Betahistine Medreg with food or after eating.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell 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 Betahistine Medreg

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicine.
Store in the original package to protect from moisture.
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 the month.
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 Betahistine Medreg contains

• The active substance is betahistine dihydrochloride. Each tablet contains 24 mg of betahistine dihydrochloride, equivalent to 15.63 mg of betahistine.
• The other ingredients are: mannitol, microcrystalline cellulose, anhydrous colloidal silica, povidone K-30, citric acid, crospovidone (type B), talc, and stearic acid.

What Betahistine Medreg looks like and contents of the pack

White or almost white, round, biconvex tablets (10.2 mm ± 0.2 mm) with the imprint "J4" on one side and a score line on the other side.
The score line on the tablet is only to facilitate breaking, to make it easier to swallow.
The tablets are packaged in PVC/PVDC/Aluminum blisters, in a cardboard box.
Package sizes: 20, 28, 30, 50, 56, 60, 90, 98, 100, and 120 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Betahistine Medreg
Poland:
Betahistine Medreg
Slovakia:
Betahistine Medreg 16 mg
Betahistine Medreg 24 mg
Romania:
Betahistină Gemax Pharma 24 mg comprimate

Date of last revision of the leaflet: