Memantin neuropharma

Package leaflet: Information for the user

Memantin NeuroPharma, 10 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 consult 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 reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Memantin NeuroPharma is and what it is 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 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 anti-dementia drugs.
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 functions. 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 this 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 arterial hypertension (high blood pressure).

In the above situations, treatment with Memantin NeuroPharma should be carried out under
strict supervision of the attending physician, who should regularly assess the effects of ongoing therapy.
During administration of memantine to patients with renal impairment (kidney problems),
the attending 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 (a substance usually used as an anaesthetic), dextromethorphan
(commonly used to treat cough), as well as other medicines belonging to the group of NMDA antagonists.
Children and adolescents
Memantin NeuroPharma is not recommended for use in children and adolescents under 18
years of age.
Memantin NeuroPharma and other medicines
You must tell 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 take.
In particular, treatment with Memantin NeuroPharma may affect the action of,
and may necessitate dosage adjustments by the attending physician, 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 in the treatment of movement disorders or intestinal spasms);
• anticonvulsants (substances used to prevent and stop seizures);
• barbiturates (substances mainly used as hypnotics);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used in the treatment of psychiatric disorders);
• oral anticoagulants.

If admitted to hospital, inform the doctor that the patient is taking Memantin
NeuroPharma.
Taking Memantin NeuroPharma with food and drink
You should inform the attending 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 levels of acidic substances in the blood caused by kidney dysfunction (impaired kidney function)) or severe urinary tract infections (structures through which urine flows). In the above cases,
the attending physician may need to modify 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 is not recommended for use in pregnant women.
Breastfeeding
Women taking Memantin NeuroPharma should not breastfeed.
Driving and operating machinery
The attending physician should inform the patient whether their condition allows them to safely
drive vehicles and operate machinery. Memantin NeuroPharma may additionally affect
reaction speed, as a result of which driving vehicles or operating machinery may be contraindicated.
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 taken exactly as directed by the doctor. If in 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 reactions, this dose should be reached gradually according to
the following treatment 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 be achieved by the beginning of week 4 of treatment.
Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage must be determined by the
attending physician.
In such cases, regular monitoring of kidney function at intervals specified by the attending physician
is necessary.
Method of administration
Memantin NeuroPharma should be taken orally once daily. For effective treatment, 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 attending physician
should regularly evaluate the course of treatment.
Taking more than the recommended dose of Memantin NeuroPharma
In general, taking an excessive dose of Memantin NeuroPharma does not usually pose a serious
health risk. In such cases, intensified symptoms described in section 4, "Possible adverse
reactions," may occur.
In the event of a significant overdose of Memantin NeuroPharma, contact the attending physician
or another doctor, as appropriate management may become necessary.
Missed dose of Memantin NeuroPharma
If a patient forgets to take the medicine, 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 (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 for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows further information on the safety of the medicine to be collected.
Adverse reactions can also be reported to the responsible entity.

5. How to store the medicine Memantin NeuroPharma

Keep the 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 specified month.
No special precautions for storage of the 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 package and other information

What Memantin NeuroPharma contains
The active substance is memantine hydrochloride.
Each coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
The other ingredients are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, anhydrous colloidal silicon dioxide, hypromellose, polyethylene glycol 4000, titanium dioxide (E 171).

What Memantin NeuroPharma looks like and contents of the pack
Memantin NeuroPharma 10 mg tablets are white or almost white, round, biconvex coated tablets with a division line on one side. The tablet length is 9 mm. The tablet can be divided into two equal doses.
Memantin NeuroPharma coated tablets 10 mg
Memantin NeuroPharma coated tablets are packed in blisters. Memantin NeuroPharma is available in pack sizes containing 7, 25, 28, 30, 42, 50, 56, 98 or 100 coated tablets.
Hospital pack: 420 coated tablets (collective pack).
Not all pack sizes may be marketed.

Marketing Authorisation 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

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]