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 you.

• You should 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 pack and other information

1. What is Polmatine and what is it used for

What is Polmatine

Polmatine belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain.
The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of nerve signals that are important for learning and memory. Polmatine belongs to a group of medicines known as NMDA receptor antagonists. Polmatine, by acting on NMDA receptors, improves the transmission of nerve signals and memory.

What is Polmatine used for

Polmatine is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. Important information before taking Polmatine

When not to take Polmatine:

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

Warnings and precautions

Before taking Polmatine, you should discuss this with your doctor:

• if you have ever had seizures
• if you have recently experienced a heart attack, have congestive heart failure, or have uncontrolled high blood pressure.

In these situations, treatment with Polmatine should be carried out under close medical supervision, and your doctor should regularly assess the effects of the treatment.
When memantine is given to patients with kidney problems, your doctor should closely monitor kidney function and, if necessary, adjust the dose of the medicine.
You should avoid taking other medicines such as amantadine (for 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 the age of 18.

Polmatine with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
In particular, the use of Polmatine may cause changes in the effects of, and require dose adjustments by your doctor, for 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 treat seizures)
• barbiturates (mainly used as sedatives)
• dopaminergic agonists (such as L-dopa, bromocriptine)
• neuroleptics (used to treat mental disorders)
• oral anticoagulants.

If you are admitted to the hospital, inform your doctor that you are taking Polmatine.

Polmatine with food and drink

Tell your doctor if you have recently changed your diet (e.g., switched from a normal diet to a strict vegetarian diet) or have been diagnosed with renal tubular acidosis (RTA, excessive blood acidity due to kidney problems or severe urinary tract infections). In these situations, your doctor may adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women who are pregnant or planning to become pregnant before starting treatment should inform their doctor. Memantine is not recommended during pregnancy.
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 use machines.

Polmatine contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Polmatine

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
The recommended dose of Polmatine for adults and elderly patients is 20 mg once a day.
In order to reduce the risk of side effects, the dose of the medicine should be increased gradually, according to the following scheme. Different tablet strengths are available to increase the dose gradually.
Treatment starts with a dose of 5 mg once a day. The dose is increased by 5 mg every week to reach the recommended maintenance dose (20 mg once a day), which is achieved at the beginning of the 4th week of treatment.

Dosing in patients with renal impairment

In patients with impaired kidney function, the doctor will determine the appropriate dose of the medicine.
In such cases, regular monitoring of kidney function should be carried out at specified intervals, according to the doctor's instructions.

Method of administration

Polmatine should be taken orally, once a day. To ensure effective treatment, the medicine should be taken regularly, at the same time every day. 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 effective. Your doctor will regularly assess the effectiveness of the treatment.

Overdose of Polmatine

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

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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common (affecting 1 to 10 in 100 patients):

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

Uncommon (affecting 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 (affecting 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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Drug 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polmatine

Keep this 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 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 Polmatine contains

• The active substance is memantine hydrochloride. Each coated tablet contains 10 mg or 20 mg of memantine hydrochloride, corresponding to 8.31 mg or 16.62 mg of memantine.
• The 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 pack

Polmatine 10 mg are white or almost white, oblong, biconvex, coated tablets with dimensions of 9.5 x 4.5 mm, with a score line; after breaking, 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 of 12.5 x 5.6 mm, with a narrowing and score line on both sides; after breaking, the tablet core is white or almost white. The tablet can be divided into equal doses.
One pack 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

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

Date of last revision of the leaflet: