Mirvedol

Package leaflet: Information for the patient

Mirvedol, 10 mg, film-coated tablets
Memantine hydrochloride
Please read carefully the entire leaflet before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Mirvedol is and what it is 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 pack and other information

1. What Mirvedol is and what it is used for

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

2. Important information before using Mirvedol

When not to use Mirvedol

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

Warnings and precautions
Before starting treatment with Mirvedol, discuss with your doctor or pharmacist:

• if the patient has previously experienced epileptic seizures;
• if the patient has recently suffered a myocardial infarction (heart attack), or suffers from congestive heart failure or uncontrolled hypertension (high blood pressure).

In the above situations, treatment with Mirvedol should be carried out under close medical supervision, with the treating physician regularly assessing the effects of ongoing therapy.
When administering memantine to patients with impaired renal function (kidney problems), the treating physician should closely monitor kidney function and, if necessary, appropriately adjust the dosage of the medicine.
Concomitant use of the following medicines should be avoided: amantadine (used to treat Parkinson's disease), ketamine (usually used as an anaesthetic), dextromethorphan (usually used to treat cough), and other medicines belonging to the group of NMDA antagonists.

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

Mirvedol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, treatment with Mirvedol may alter the effects of, and may necessitate dosage adjustments by the treating physician for 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 in the treatment of movement disorders or intestinal spasms);
• anticonvulsants (substances used to prevent or stop seizures);
• barbiturates (substances mainly used as sedatives);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used in the treatment of psychiatric disorders);
• oral anticoagulants.

If hospital admission is required, inform the doctor that the patient is taking Mirvedol.

Mirvedol with food and drink
Inform the treating physician if the patient has recently changed or plans to change their diet significantly (e.g. switching from a normal diet to a strict vegetarian diet), or if the patient has been diagnosed with renal tubular acidosis (RTA, excessive levels of acidic substances in the blood due to impaired kidney function) or severe urinary tract infections (structures through which urine flows). In the above cases, dosage adjustment by the treating physician may be necessary.

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 her doctor or pharmacist before using this medicine.

Pregnancy
Memantine is not recommended for use in pregnant women.

Breastfeeding
Women taking Mirvedol should not breastfeed.

Driving and operating machinery
The doctor should advise the patient whether their condition allows them to drive safely and operate machinery. Mirvedol may additionally affect reaction speed, making driving or operating machinery potentially inadvisable.

Mirvedol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet; therefore, this medicine is considered "sodium-free".

3. How to use Mirvedol

This medicine should always be used exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist.

Dosage

The recommended dose of Mirvedol for adults and elderly patients is 20 mg once daily. To reduce the risk of side effects, the dose should be increased gradually according to the following schedule:

1. Week: half a tablet 10 mg
2. Week: one tablet 10 mg
3. Week: one and a half tablets 10 mg
4. Week: two tablets 10 mg once daily

Typically, treatment starts with half a tablet once daily (1x5 mg) during the first week. In the second week, the dose is increased to one tablet once daily (1x10 mg), and to one and a half tablets once daily in the third week. Starting from the fourth week, the usual dose is 2 tablets once daily (1x20 mg).

Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage of Mirvedol must be determined by the treating physician. In such cases, regular monitoring of kidney function at specified intervals, as directed by the physician, is necessary.

Method of administration
The tablet may be divided into equal doses.
Mirvedol should be taken orally, once daily. For effective treatment, the medicine must be taken regularly, at the same time each day. Tablets should be swallowed whole, with water.
The tablets may be taken with food or independently of meals.

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

Duration of treatment
Treatment should be continued as long as it provides beneficial effects. The treating physician should regularly assess the course of treatment.

Overdose of Mirvedol

• In general, taking an excessive dose of Mirvedol does not usually pose a health risk. In such cases, intensified symptoms described in section 4, "Possible side effects", may occur.
• In the event of a significant overdose of Mirvedol, contact your treating physician or another doctor, as appropriate management may be required.

Missed dose of Mirvedol
If a patient forgets to take a dose, they should take the next dose at the usual time. A double dose should not be taken to make up for the missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Generally observed adverse reactions are mild to moderate in severity.

Common (may affect more than 1 in 10 patients):

• Headache, drowsiness, constipation, increased levels of liver enzymes, dizziness, loss of balance, shallow breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (may affect more than 1 in 100 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, unsteady gait, heart failure, and venous thromboembolism (thrombosis/thromboembolism).

Very rare (may affect more than 1 in 10,000 patients):

• Seizures.

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

• Pancreatitis, hepatitis, 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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the 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 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions enables more information about the safety of the medicine to be collected.

5. How to store Mirvedol

Keep this medicine 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 stated month.
There are no special precautions for storage of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

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

What Mirvedol looks like and contents of the pack
White, oval, biconvex film-coated tablets approximately 10 mm in length and 5.5 mm in width, with a central break line on one side and the imprint "N93" on the other.
Mirvedol 10 mg film-coated tablets are packed in white aluminum/PVC/PE/PVDC blisters. The blisters are contained in cardboard boxes.
The cardboard boxes contain 28, 30, 56 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel. +48 (22) 755 96 48
[email protected]
Fax: +48 (22) 755 96 24

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Mirvedol
Romania: Mirvedol 10 mg comprimate filmate
Hungary: Mirvedol 10 mg filmtabletta