Polmatine

Patient Information Leaflet

Polmatine, 10 mg, film-coated tablets
Polmatine, 20 mg, film-coated tablets
Memantini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Polmatine is and what it is used for
2. What you need to know 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 Polmatine is and what it is used for

What Polmatine is
Polmatine belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses that carry information within the brain. In the brain there are receptors known as N-methyl-D-aspartate (NMDA) receptors, which are involved in transmitting nerve signals important for learning processes and memory. Polmatine belongs to a group of medicines called NMDA receptor antagonists. By acting on NMDA receptors, Polmatine improves the transmission of nerve impulses and memory function.

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

2. Important information before using Polmatine

When not to use 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, discuss the following with your doctor:

• if the patient has had seizures in the past
• if the patient has recently suffered a myocardial infarction, has congestive heart failure, or has uncontrolled hypertension (high blood pressure).

In the above situations, treatment with Polmatine should be carried out under strict supervision of the treating physician, who should regularly assess the effects of the ongoing therapy.
When administering memantine to patients with renal impairment (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
Polmatine is not recommended for use in children and adolescents under 18 years of age.
Polmatine with 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 use.
In particular, treatment with Polmatine may affect the action 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 medicines containing hydrochlorothiazide)
• anticholinergic agents (usually used to treat movement disorders or intestinal spasms)
• anticonvulsants (used to prevent and stop seizures)
• barbiturates (mainly used as hypnotics)
• dopaminergic agonists (such as L-dopa, bromocriptine)
• neuroleptics (used to treat psychiatric disorders)
• oral anticoagulants.

If hospitalization occurs, inform the doctor that the patient is taking Polmatine.
Polmatine with food and drink
Inform the treating physician if the patient has recently made or plans to make significant changes in diet (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 concentration of acidic substances in the blood caused by kidney dysfunction or severe urinary tract infections). In the above situations, the doctor may change the dose of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Women who are pregnant or planning to become pregnant should inform their treating physician before starting treatment. Use of memantine in pregnant women is not recommended.
Women taking Polmatine should not breastfeed.
Driving and operating machinery
The treating physician should inform the patient whether the disease allows him or her to safely drive vehicles and operate machinery.
Polmatine may additionally affect reaction speed, thus driving vehicles or operating machinery may be contraindicated.
Polmatine contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to use Polmatine

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Recommended dose
The recommended dose of Polmatine for adults and elderly patients is 20 mg once daily.
To reduce the risk of adverse effects, the dosage should be increased gradually according to the following scheme. Tablets of different strengths are available to allow gradual dose escalation.

Treatment starts with the administration of the drug at a dose of 5 mg once daily. The dose should be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose is 20 mg once daily, 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 appropriate dosage of the drug should be determined by the treating physician. In such cases, regular monitoring of kidney function at specified intervals, according to the treating physician's recommendations, is necessary.

Method of administration
Polmatine should be taken orally once daily. For effective treatment, the medication should be taken regularly every day at the same time. Tablets should be swallowed with water. This formulation may be taken with food or independently of meals.

Duration of treatment
Treatment should be continued as long as beneficial effects are observed. The treating physician should regularly assess the course of therapy.

Use of a higher than recommended dose of Polmatine

• Generally, taking an excessive dose of Polmatine does not pose a health hazard. In such cases, intensified symptoms described in section 4, "Possible adverse reactions," may occur.
• In case of significant overdose of Polmatine, contact the treating physician or another doctor, as appropriate management measures may become necessary.

Missed dose of Polmatine

• If a patient forgets to take the medication, 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 doubts regarding the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Generally observed adverse reactions are mild to moderate in severity.

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

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

Uncommon (occur in 1 to 10 out of 1,000 patients):

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

Rare (occur in less than 1 out of 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 adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Polmatine

Keep this medicine out of sight and reach of children.
There are no special storage temperature requirements for this medicinal product.
Store 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 specified month.
The label on the packaging shows EXP followed by the expiry date, and Lot/LOT followed by the batch number.
Medicines must 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, equivalent to 8.31 mg or 16.62 mg of memantine, respectively.
• 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, elongated, biconvex, film-coated tablets, 9.5 x 4.5 mm in size, with a division line; the tablet core is white or almost white when divided.
The tablet can be divided into equal doses.
Polmatine 20 mg are pink, biconvex, film-coated tablets, 12.5 x 5.6 mm in size, with a constriction and a division line on both sides; the tablet core is white or almost white when divided.
The tablet can be divided into equal doses.
Pack contents:
Polmatine 10 mg: 14, 28, 56, 84, 112 film-coated tablets.
Polmatine 20 mg: 14, 28, 56, 84, 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01