Betahistine medreg

Patient Information Leaflet

Betahistine Medreg, 24 mg, tablets
Betahistini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Betahistine Medreg is and what it is used for
2. What you need to know 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 Betahistine Medreg is and what it is used for

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

What Betahistine Medreg is used for
Betahistine Medreg is used in the treatment of Ménière's disease, which is characterised by the following symptoms:

• Vertigo (vestibular vertigo) and nausea or vomiting
• Hearing loss or hearing disturbances
• Tinnitus (ringing in the ears)

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 use in adults.

2. Important information before using Betahistine Medreg

When not to use Betahistine Medreg

• if the patient is allergic to betahistine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has an adrenal gland tumour (phaeochromocytoma).

Do not use this medicine if any of the above situations apply to the patient.
If in doubt, talk to a doctor or pharmacist before taking Betahistine Medreg.
Warnings and precautions
Before starting Betahistine Medreg, discuss this with your doctor or pharmacist:

• if the patient has a lung disease causing shortness of breath (bronchial asthma),
• if the patient has or has ever had a stomach ulcer.

If any of the above apply to the patient (or if in doubt), consult a doctor or pharmacist before taking Betahistine Medreg.
The doctor may wish to monitor the patient closely during treatment with Betahistine Medreg.
Children and adolescents
Betahistine Medreg is not recommended for use in children and adolescents under 18 years of age.
Betahistine Medreg and other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• antihistamines (some antiallergy medicines) – these may (theoretically) affect the action of Betahistine Medreg. Betahistine Medreg may also reduce the effectiveness of antihistamines.
• monoamine oxidase inhibitors (used in the treatment of depression or Parkinson’s disease) – these may enhance the effect of Betahistine Medreg.

If any of the above apply to the patient (or if in doubt), consult a doctor or pharmacist before taking Betahistine Medreg.
Taking Betahistine Medreg with food and drink
Betahistine Medreg may be taken with or without food. However, Betahistine Medreg may cause mild gastrointestinal discomfort (listed in section 4). Taking Betahistine Medreg with food may help reduce gastrointestinal discomfort.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
It is not known whether betahistine affects the unborn child:

• Betahistine Medreg should be discontinued and the doctor informed if the patient is pregnant or suspects she may be pregnant.
• Betahistine Medreg should not be used during pregnancy unless the doctor decides it is absolutely necessary.

It is not known whether betahistine passes into human breast milk:

• Breastfeeding should be avoided while taking Betahistine Medreg. Breastfeeding may only be resumed if advised by the doctor.

Driving and using machines
It is unlikely that Betahistine Medreg will affect the ability to drive or operate machinery.
However, the condition for which the patient is being treated with this medicine (Meniere’s disease) may cause dizziness or nausea and may affect the ability to drive or operate machinery.

3. How to use Betahistine Medreg

This medicine should always be used as recommended by your doctor. If in doubt, consult your
doctor or pharmacist.
How to use the medicine
The recommended dose is 1 tablet twice daily.
Your doctor will adjust the dose according to the patient's condition.
If the patient is taking more than one tablet per day, the tablets should be taken evenly throughout
the day. For example, one tablet in the morning and one in the evening.
Method of administration
Tablets should be taken with water.
Betahistine Medreg can be taken with or without food. However, Betahistine Medreg may cause
mild gastrointestinal discomfort (listed in section 4). Taking Betahistine Medreg with food may help
reduce gastrointestinal discomfort.
Try to take the tablets at the same time each day. This will help ensure a constant level of medicine
in the body. Taking the tablets at the same time each day will also help you remember to take them.
Taking more Betahistine Medreg than recommended
In case of overdose, the following symptoms may occur: nausea, drowsiness, or abdominal pain.
Contact your doctor immediately, who will take appropriate measures.
Missing a dose of Betahistine Medreg
If the patient forgets to take a tablet, skip that dose. Take the next dose at the usual scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping Betahistine Medreg
Do not stop taking this medicine. It may take some time before the medicine starts to work.
Do not stop taking Betahistine Medreg without consulting your doctor, even if the patient feels better.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following allergic reactions, treatment with Betahistine Medreg must be stopped immediately and medical help should be sought:

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

Other possible adverse reactions:
Common (may occur in up to 1 in 10 patients):

• headache
• nausea, indigestion

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

• mild gastrointestinal discomfort (e.g. vomiting, stomach pain, stomach pressure, and bloating). These can usually be avoided by taking Betahistine Medreg with food or after meals.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betahistine Medreg

Keep the medicine out of the sight and reach of children.
There are no special requirements regarding storage temperature.
Store in the original packaging 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 stated 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.
• Other components are: mannitol, microcrystalline cellulose, colloidal anhydrous 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 an embossed
mark “J4” on one side and a break line on the other side.
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.
The tablets are supplied in blisters made of PVC/PVDC/Aluminium foil, packed in a cardboard box.
Pack sizes: 20, 28, 30, 50, 56, 60, 90, 98, 100, and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area countries 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 tablets