Polmatine

Package Leaflet: Information for the Patient

Polmatine, 5 mg/dose, Oral Solution

Memantine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Polmatine and what is it used for

What is Polmatine

Polmatine belongs to a group of medicines used to treat dementia.
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 for memory.
Polmatine belongs to a group of medicines called NMDA receptor antagonists. Polmatine, by its effect on NMDA receptors,
improves the transmission of nerve impulses and memory.

What is Polmatine used for

Polmatine is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking Polmatine

When not to take Polmatine

Warnings and precautions

Before starting treatment with Polmatine, you should discuss this with your doctor:

In these situations, treatment with Polmatine should be carried out under close medical supervision,
who should regularly assess the effects of the therapy.
During the administration of memantine to patients with renal impairment (kidney problems),
the attending physician 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), and other NMDA receptor antagonists.

Children and adolescents

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

Polmatine and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about medicines you plan to take.
In particular, taking Polmatine may cause changes in the effect and require modification of the dosage by the attending physician of the following medicines:

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

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

Polmatine with food and drink

Inform your doctor if you have recently made or plan to make significant changes to your diet (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 kidney dysfunction or severe urinary tract infections).
In these situations, your doctor may change the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Women who are pregnant or plan to become pregnant should inform their doctor before starting treatment. Memantine is not recommended for pregnant women.
Women taking Polmatine should not breastfeed.

Driving and using machines

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

Polmatine contains sorbitol

The medicine contains 100 mg of sorbitol in each 1 ml of solution.

3. How to take Polmatine

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Recommended dose
One dose (one pump actuation) contains 5 mg of memantine hydrochloride.
The recommended dose of Polmatine for adults and the elderly is four pump actuations, which corresponds to 20 mg once daily.
In order to reduce the risk of side effects, the dosage of the medicine should be increased gradually, according to the following scheme:
Usually, dosing starts with one dose (one pump actuation) once daily (1 x 5 mg) for the first week of treatment.
In the second week, the dose is increased to two doses (two pump actuations) once daily (1 x 10 mg), and in the third week of treatment,
three doses (three pump actuations) are administered once daily (1 x 15 mg).
From the fourth week onwards, it is recommended to administer four doses (four pump actuations) once daily (1 x 20 mg).

Dosing in patients with renal impairment

In patients with impaired renal function, the appropriate dosing of the medicine is determined by the attending physician.
In such cases, it is necessary to continuously monitor kidney function at specified time intervals, according to the attending physician's instructions.

Method of administration

Polmatine should be taken orally, once daily. For the treatment to be effective, the medicine should be taken regularly every day at the same time.
The solution should be taken with a small amount of water. The solution can be taken with or without food.
Detailed instructions for preparing and taking the medicine - see the end of this leaflet.

Duration of treatment

Treatment should be continued for as long as it is beneficial. The attending physician should regularly assess the course of therapy.

Use of a higher than recommended dose of Polmatine

• Generally, taking too much Polmatine does not pose a risk to health. In such cases, enhanced side effects described in section 4 "Possible side effects" may occur.
• In case of significant overdose of Polmatine, you should contact your doctor or another doctor, as there may be a need to implement appropriate procedures.

Missed dose of Polmatine

• If you forget to take a dose, you should take the next dose of Polmatine at the usual time.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Polmatine can cause side effects, although not everybody gets them.
Usually, the observed side effects are mild to moderate.

Common (occurring in 1 to 10 out of 100 patients):

• Headache, drowsiness, constipation, elevated liver enzyme levels, dizziness, balance disorders, shallow breathing, and high blood pressure.

Uncommon (occurring in 1 to 10 out of 1000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, and blood clots in the veins (venous thrombosis / embolism)

Rare (occurring in less than 1 out of 10,000 patients):

• Seizures.

Unknown (frequency 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 side effects

If you experience any side effects, including those 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 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 Polmatine

Keep the medicine out of the sight and reach of children.
No special precautions for storage of the medicinal product are necessary.
The bottle with the pump should be stored and transported only in an upright position.
Do not use this medicine after the expiry date stated on the label and carton after: EXP.
The expiry date stated on the packaging after EXP means the last day of the given month.
The inscription on the packaging after Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
Such measures will help protect the environment.

6. Contents of the pack and other information

What Polmatine contains

• The active substance of the medicine is memantine hydrochloride. Each pump actuation (one pump press) delivers 0.5 ml of solution containing 5 mg of memantine hydrochloride, which corresponds to 4.16 mg of memantine.
• The other ingredients are: potassium sorbate (E202), non-crystallizing liquid sorbitol (E420), purified water.

What Polmatine looks like and contents of the pack

Polmatine, oral solution is a clear, colorless or slightly yellowish solution.
Polmatine, oral solution is available in bottles of 50 ml or 100 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet:

INSTRUCTIONS FOR PROPER USE OF THE PUMP

The solution must not be poured or pumped directly from the bottle or pump into the mouth.
Use the pump to measure the dose of the medicine into a spoon or glass of water.
Remove the cap from the bottle:
Turn the cap counterclockwise and remove it (fig. 1).

Placing the pump on the bottle:
Remove the pump from the plastic bag (fig. 2) and place it on the bottle, carefully inserting the plastic tube into the bottle.
Then hold the pump on the neck of the bottle and turn it clockwise until it stops (fig. 3).
The pump should be put on only once, before starting to use it; it should not be removed later.

Operating the pump:
The pump head has two settings and can be easily turned:
counterclockwise to open it, or clockwise to close it.
The pump should not be pressed when it is in the closed position. The pump dispenses the solution only when it is in the open position.
To open the pump, turn the head counterclockwise in the direction of the arrow until it stops (about one-eighth of a full turn, fig. 4).
The pump is then ready for use.

Preparing the pump:
When using the pump for the first time, it does not dispense the correct amount of oral solution.
Therefore, you need to prepare it by pressing the pump head to the stop five times (fig. 5).

Remove the solution that has leaked from the pump. At the next full pump actuation (which corresponds to one dose),
you will receive the correct dose of the medicine (fig. 6).

Proper use of the pump:
Place the bottle on a flat surface, such as a table, and use it only when it is in an upright position.
Place a glass or spoon with a small amount of water under the pump outlet, then press the pump head firmly but calmly (not too slowly)
until you feel resistance (fig. 7, fig. 8).

Then release the pump head. The pump is ready for the next actuation.
The pump can only be used with the Polmatine solution and the accompanying bottle.
The pump must not be used to dispense other substances or attached to other containers.
If the pump does not work properly, consult your doctor or pharmacist. After using Polmatine, close the pump.