Memantin Neuropharma

Leaflet attached to the packaging: information for the user

Memantin NeuroPharma, 20 mg, coated tablets

Memantine hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Memantin NeuroPharma and what is it used for

How Memantin NeuroPharma works

Memantin NeuroPharma contains the active substance memantine hydrochloride. It belongs to the group of anti-dementia medicines. 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 that participate in the transmission of nerve signals important for the learning process and memory. Memantin NeuroPharma belongs to a group of medicines called NMDA receptor antagonists. Memantin NeuroPharma, by affecting NMDA receptors, improves the transmission of nerve impulses and memory.

What Memantin NeuroPharma is used for

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

2. Important information before taking Memantin NeuroPharma

When not to take Memantin NeuroPharma

Warnings and precautions

Before starting treatment with Memantin NeuroPharma, the patient should discuss it with their doctor or pharmacist:

• in the case of patients who have had seizures in the past;
• in the case of patients who have recently had a heart attack (myocardial infarction) or suffer from congestive heart failure or uncontrolled hypertension (high blood pressure).

In these situations, treatment with Memantin NeuroPharma should be carried out under close medical supervision, and the doctor should regularly assess the effects of the treatment. During the administration of memantine to patients with kidney function disorders (kidney problems), the doctor should carefully monitor kidney function and, if necessary, adjust the dosage of the medicine. The patient should avoid taking medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a substance usually used as an anesthetic), dextromethorphan (usually used to treat cough), and other medicines from the group of NMDA receptor antagonists.

Children and adolescents

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

Memantin NeuroPharma and other medicines

The patient should tell 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 Memantin NeuroPharma may cause changes in the action and require modification of the dosage by the doctor of the following medicines:

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

In the event of hospitalization, the patient should inform their doctor that they are taking Memantin NeuroPharma.

Taking Memantin NeuroPharma with food and drink

The patient should inform their doctor if they have recently made or plan to make significant changes to their diet (e.g., switching from a normal diet to a strict vegetarian diet) or if they 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 (structures through which urine flows). In these cases, the doctor may need to adjust 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. Pregnancy Memantine should not be used during pregnancy. Breastfeeding Women taking Memantin NeuroPharma should not breastfeed.

Driving and using machines

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

Memantin NeuroPharma contains lactose

If the patient has an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Memantin NeuroPharma

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Dosage

The recommended dose of Memantin NeuroPharma for adults and the elderly is 20 mg per day. To minimize the risk of side effects, this dose is achieved gradually, according to the following treatment schedule. Initially, the patient starts treatment with a dose of 5 mg once a day. This dose is increased by 5 mg every week until the recommended maintenance dose of 20 mg once a day is reached, which should be achieved at the beginning of the 4th week of treatment.

Dosage in patients with kidney function disorders

In patients with impaired kidney function, the doctor determines the appropriate dosage of the medicine. In such cases, regular monitoring of kidney function is necessary at specified time intervals, according to the doctor's instructions.

Method of administration

Memantin NeuroPharma 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. This medicine can be taken with or without food.

Duration of treatment

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

Taking a higher dose of Memantin NeuroPharma than recommended

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

Missing a dose of Memantin NeuroPharma

If the patient forgets to take a dose, they should take the next dose of Memantin NeuroPharma at the usual time. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Memantin NeuroPharma can cause side effects, although not everybody gets them. The observed side effects are usually mild to moderate.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 10,000 people):

• 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 Memantin NeuroPharma.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Memantin NeuroPharma

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and blister after "(EXP)". The expiry date refers to the last day of the specified month. There are no special precautions for storing the medicinal product. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Memantin NeuroPharma contains

The active substance is memantine hydrochloride. Each coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine. The other ingredients are lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, silicon dioxide, hypromellose, macrogol 4000, titanium dioxide (E 171).

What Memantin NeuroPharma looks like and contents of the pack

Memantin NeuroPharma 20 mg coated tablets are white or almost white, round, biconvex coated tablets with a cross-shaped break line on one side. The length of the tablet is 12 mm. The tablet can be divided into four equal doses. Memantin NeuroPharma coated tablets are packaged in blisters. Memantin NeuroPharma is available in packs containing 7, 28, 30, 42, 50, 56, 98, or 100 coated tablets. Hospital pack: 420 coated tablets (bulk pack). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany

Manufacturer

Laboratorios Lesvi, S.L., Avda. Barcelona 69, 08970 Sant Joan Despí (Barcelona), Spain To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:Neuraxpharm Polska sp. z o.o., ul. Domaniewska 37, 02-672 Warsaw, info-poland@neuraxpharm.com

Date of the last revision of the leaflet: