Memantin neuropharma

Package leaflet: Information for the user

Memantin NeuroPharma, 20 mg, film-coated tablets
Memantine hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

How Memantin NeuroPharma works
Memantin NeuroPharma contains the active substance memantine hydrochloride. It belongs to
a group of medicines known as antidementia agents.
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 transmitting nerve signals important for learning processes and memory. Memantin NeuroPharma belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, Memantin NeuroPharma improves the transmission of nerve impulses and memory.

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

2. Important information before using Memantin NeuroPharma

When not to use Memantin NeuroPharma

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

Warnings and precautions
Before starting treatment with Memantin NeuroPharma, discuss the following with your doctor or
pharmacist:

• in patients who have previously experienced epileptic seizures;
• in patients who have recently suffered a myocardial infarction (heart attack), or who suffer from congestive heart failure or uncontrolled hypertension (high blood pressure).

In the above situations, treatment with Memantin NeuroPharma should be carried out under
close medical supervision, and the treating physician should regularly assess the effects of ongoing therapy.
When administering memantine to patients with renal impairment (kidney problems),
the treating physician should carefully monitor kidney function and, if necessary, adjust the dosage accordingly.
Concomitant use of the following drugs should be avoided: amantadine (used to treat Parkinson's disease), ketamine (a substance usually used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.

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

Memantin NeuroPharma and 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 Memantin NeuroPharma may alter the effects of, and may require dose adjustments by the treating physician for the following medicines:

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

If hospitalization is required, inform the doctor that the patient is taking Memantin NeuroPharma.

Taking Memantin NeuroPharma 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 blood due to kidney dysfunction) or severe urinary tract infections (structures through which urine flows). In these cases, the treating physician may need to adjust the dosage of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Memantine should not be given to pregnant women.

Breastfeeding
Women taking Memantin NeuroPharma should not breastfeed.

Driving and operating machinery
The treating physician should advise the patient whether their condition allows them to drive safely
and operate machinery. Memantin NeuroPharma may additionally affect reaction speed, making driving or operating machinery potentially inadvisable.

Memantin NeuroPharma contains lactose
If the patient suffers from intolerance to certain sugars, they should consult their doctor before using this medicine.

3. How to use Memantin NeuroPharma

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantin NeuroPharma for adult and elderly patients is 20 mg once daily.
To reduce the risk of adverse effects, this dose should be reached gradually, according to the following titration schedule:
Treatment should be initiated at a dose of 5 mg once daily. The dose should be increased by 5 mg weekly until the recommended maintenance dose of 20 mg once daily is reached, which should occur at the beginning of the 4th week of treatment.
Dosage in patients with renal impairment
In patients with impaired renal function, the appropriate dosage must be determined by the treating physician. Regular monitoring of renal function at intervals specified by the treating physician is required in such cases.
Method of administration
Memantin NeuroPharma should be taken orally once daily. For optimal effectiveness, the medicine should be taken regularly every day at the same time. Tablets should be swallowed with water. This formulation may be taken with or without food.
Duration of treatment
Treatment should be continued as long as it provides beneficial effects. The treating physician should regularly assess the course of therapy.
Use of a higher than recommended dose of Memantin NeuroPharma
Generally, taking an excessive dose of Memantin NeuroPharma does not pose a serious health risk. In such cases, the symptoms described in section 4, "Possible side effects," may become more pronounced.
In the event of significant overdose of Memantin NeuroPharma, contact the treating physician or another doctor, as appropriate management may become necessary.
Missed dose of Memantin NeuroPharma
If a patient forgets to take a dose, they should take the next dose 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Generally observed adverse reactions are mild to moderate in severity.
Common (may affect up to 1 in 10 people):

• Headache, somnolence, constipation, increased 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 thromboembolism (venous thrombosis/embolism).

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

• 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 Memantin NeuroPharma.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Reporting adverse reactions helps provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Memantin NeuroPharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the indicated month.
No special precautions for storage of this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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, colloidal anhydrous silica, hypromellose, macrogol 4000, titanium dioxide (E 171).

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

Marketing Authorisation Holder
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturer
Laboratorios Lesvi, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí (Barcelona)
Spain

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warszawa
[email protected]