Polmatine

Package Leaflet: Information for the Patient

Polmatine, 10 mg, coated tablets

Polmatine, 20 mg, coated tablets

Memantine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package 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 known as NMDA receptor antagonists. Polmatine, by affecting
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:

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

Warnings and precautions

Before starting treatment with Polmatine, the patient should discuss it with their doctor:

• if the patient has had seizures in the past
• if the patient has recently had a heart attack, has congestive heart failure, or has uncontrolled high blood pressure.

In these situations, treatment with Polmatine 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.
It is recommended to 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

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, taking Polmatine may affect the action of, and require dosage adjustments by the doctor, 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, the patient should inform their doctor that they are taking Polmatine.

Polmatine with food and drink

The patient should inform their doctor if they have recently changed their diet (e.g., switched from a normal diet to a strict vegetarian diet) or have been diagnosed with renal tubular acidosis (RTA, excessive acid in the blood due to kidney problems or severe urinary tract infections).
In these situations, the doctor may change the dosage of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Women who are pregnant or plan to become pregnant before starting treatment should inform their doctor.
Memantine is not recommended for pregnant women. Women taking Polmatine should not breastfeed.

Driving and using machines

The doctor should inform the patient whether their condition allows them to drive or use machines safely.
Polmatine may also affect reaction speed, making it inadvisable to drive or use machines.

Polmatine contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Polmatine

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.
Recommended dose
The recommended dose of Polmatine for adults and the elderly is 20 mg once a day.
In order to reduce the risk of side effects, the dosage of the medicine should be increased gradually, according to the following scheme. Different tablet strengths are available for gradual dose increase.
Treatment starts with a dose of 5 mg once a day. The dose is increased by 5 mg every week until the recommended maintenance dose is reached (20 mg once a day), which is achieved at the beginning of the 4th week of treatment.

Dosage in patients with renal impairment

In patients with impaired kidney function, the doctor will determine the appropriate dosage of the medicine.
In such cases, regular monitoring of kidney function is necessary, at intervals specified by the doctor.

Method of administration

Polmatine 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 with water. The medicine can be taken with or without food.

Duration of treatment

Treatment should be continued as long as it is beneficial. The doctor should regularly assess the course of treatment.

Taking a higher dose of Polmatine than recommended

• Generally, taking too much Polmatine does not pose a risk to health. In such cases, the patient may experience increased side effects described in section 4 "Possible side effects".
• In case of significant overdose of Polmatine, the patient should contact their doctor or another doctor, as appropriate action may be necessary.

Missing a dose of Polmatine

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

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Common (affect 1 to 10 in 100 patients):

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

Uncommon (affect 1 to 10 in 1,000 patients):

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

Rare (affect less than 1 in 10,000 patients):

• Seizures.

Unknown (frequency cannot be estimated from the 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 side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Polmatine

Keep the medicine out of the sight and reach of children.
No special precautions for storage temperature are necessary. Store the blisters in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Polmatine contains

• The active substance of the medicine is memantine hydrochloride. Each coated tablet contains 10 mg or 20 mg of memantine hydrochloride, which corresponds to 8.31 mg or 16.62 mg of memantine.
• Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone type B, colloidal anhydrous silica, magnesium stearate; Tablet coating: hypromellose 6cP, titanium dioxide (E171), iron oxide red (E172) (only 20 mg coated tablets), macrogol 400.

What Polmatine looks like and contents of the package

Polmatine, 10 mg are white or almost white, elongated, biconvex, coated tablets with dimensions 9.5 x 4.5 mm, with a dividing line; after division, the tablet core is white or almost white.
The tablet can be divided into equal doses.
Polmatine, 20 mg are pink, biconvex, coated tablets with dimensions 12.5 x 5.6 mm, with a narrowing and a dividing line on both sides; after division, the tablet core is white or almost white. The tablet can be divided into equal doses.
One package contains:
Polmatine 10 mg: 14, 28, 56, 84, 112 coated tablets.
Polmatine 20 mg: 14, 28, 56, 84, 112 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the package leaflet: