Mirvedol

Leaflet included in the packaging: patient information

Mirvedol, 10 mg, coated tablets

Memantine hydrochloride
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you personally. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Mirvedol and what is it used for

Mirvedol contains the active substance memantine hydrochloride. This medicine belongs to a group of medicines
called anti-dementia medicines.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses that carry information in the brain. In the brain, there are so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for the learning process and memory.
Mirvedol belongs to a group of medicines called NMDA receptor antagonists. Mirvedol, by acting on NMDA receptors, improves the transmission of nerve impulses, and thus memory.
Mirvedol is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking Mirvedol

When not to take Mirvedol

• if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Mirvedol, you should discuss it with your doctor or pharmacist:

• if you have had seizures in the past;
• if you have recently had a heart attack (myocardial infarction), or if you have congestive heart failure or uncontrolled high blood pressure.

In these situations, treatment with Mirvedol should be carried out under close medical supervision, and the doctor should regularly assess the effects of the treatment.
When administering memantine to patients with kidney problems, the doctor should closely monitor kidney function and, if necessary, adjust the dosage of the medicine.
You should avoid taking medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (usually used as an anesthetic), dextromethorphan (usually used to treat cough), as well as other NMDA receptor antagonist medicines.

Children and adolescents

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

Mirvedol and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, the use of Mirvedol may affect the action and require modification of the dosage of the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic agents (substances usually used to treat movement disorders or intestinal cramps);
• antiepileptic medicines (substances used to prevent and stop seizures);
• barbiturates (substances mainly used as sedatives);
• dopaminergic agonists (substances such as L-dopa, bromocriptine);
• neuroleptics (substances used to treat mental disorders);
• oral anticoagulants.

In case of hospitalization, you should inform your doctor that you are taking Mirvedol.

Mirvedol with food and drink

You should inform your doctor if you have recently changed or plan to change your diet significantly (e.g., switching from a normal diet to a strict vegetarian diet) or if you have been diagnosed with renal tubular acidosis (RTA, excessive concentration of acidic substances in the blood due to poor kidney function) or severe urinary tract infections (structures through which urine flows). In these cases, it may be necessary to modify the dosage of the medicine by your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Memantine is not recommended for use in pregnant women.
Breastfeeding
Women taking Mirvedol should not breastfeed.

Driving and using machines

Your doctor should inform you whether your illness allows you to drive or use machines safely. Mirvedol may also affect your reaction speed, making it inadvisable to drive or use machines.

Mirvedol contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Mirvedol

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Dosage
The recommended dose of Mirvedol for adults and the elderly is 20 mg once a day. To reduce the risk of side effects, the dose of the medicine should be increased gradually, according to the following scheme:

• 1. first week: half a 10 mg tablet
• 2. second week: one 10 mg tablet
• 3. third week: one and a half 10 mg tablets
• 4. fourth week and subsequent weeks: two 10 mg tablets once a day

Usually, the dosage starts withhalf a tablet once a day (1 x 5 mg) for the first week of treatment. In the second week, the dose is increased to one tablet once a day (1 x 10 mg) and to one and a half tablets once a day in the third week of treatment. From the fourth week onwards, usually2 tablets are given once a day (1 x 20 mg).
Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage of the medicine is determined by the doctor.
In such cases, it is necessary to constantly monitor kidney function at regular intervals, as recommended by the doctor.

Method of administration

The tablet can be divided into equal doses.
Mirvedol should be taken orally, once a day. To ensure the treatment is effective, the medicine should be taken regularly, every day at the same time. The tablets should be swallowed, washed down with water.
The tablets can be taken with or without food.
Use in children and adolescents
Mirvedol is not recommended for children and adolescents under 18 years of age.
Duration of treatment
Treatment should be continued for as long as it is beneficial. The doctor should regularly assess the course of treatment.

Taking a higher dose of Mirvedol than recommended

• Generally, taking too much Mirvedol does not pose a risk to health. In such cases, the symptoms described in section 4 "Possible side effects" may be intensified.
• In the event of significant overdose of Mirvedol, you should contact your doctor or another doctor, as it may be necessary to take appropriate action.

Missing a dose of Mirvedol

If you forget to take a dose, you should take the next dose of Mirvedol at the usual time.
You should not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Mirvedol can cause side effects, although not everybody gets them.
Usually, the observed side effects are mild to moderate.
Common (may affect up to 1 in 10 people):

• headache, drowsiness, constipation, elevated liver enzymes, dizziness, balance disorders, shallow breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (may affect up to 1 in 100 people):

• fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, and blood clots (thrombosis/embolism).

Rare (may affect up to 1 in 10,000 people):

• seizures.

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

• pancreatitis, liver inflammation, and psychotic reactions.

Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such cases have been reported in patients treated with memantine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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
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 Mirvedol

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Mirvedol contains

The active substance of the medicine is memantine hydrochloride.
Each coated tablet contains 10 mg of memantine hydrochloride, which corresponds to 8.31 mg of memantine.
The other ingredients of the medicine are:
Core: microcrystalline cellulose (Type 102 and Type 101), sodium croscarmellose, anhydrous colloidal silica (E 551), magnesium stearate (E470b).
Coating Opadry White 03B28796: hypromellose 6cP, titanium dioxide (E 171), macrogol 400

What Mirvedol looks like and contents of the pack

White, oval, biconvex coated tablets with a length of about 10 mm and a width of about 5.5 mm, with a dividing line on one side and the inscription "N93" embossed on the other side.
Mirvedol 10 mg coated tablets are packaged in white Aluminum/PVC/PE/PVDC blisters. The blisters are placed in cardboard boxes.
Cardboard boxes contain 28, 30, 56, or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

For more information, please contact:

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]
Fax: +48 (22) 755 96 24

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

Poland: Mirvedol
Romania: Mirvedol 10 mg film-coated tablets
Hungary: Mirvedol 10 mg film tablet

Date of last revision of the leaflet: October 2020