Nemedan

Package leaflet: Information for the user

Nemedan, 20 mg, coated tablets
Memantini hydrochloridum
Please read all of 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 them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Nemedan is and what it is used for

What Nemedan is
Nemedan contains the active substance memantine and belongs to a group of medicines called 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 and memory processes. Nemedan belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, Nemedan improves the transmission of nerve impulses and memory.

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

2. Important information before using Nemedan

When not to use Nemedan

• if the patient has a known allergy (hypersensitivity) to memantine hydrochloride or any of the other ingredients of Nemedan (see section 6).

Warnings and precautions
When to exercise special caution when using Nemedan
Inform the doctor if:

• the patient has previously experienced epileptic seizures;
• the patient has recently suffered a myocardial infarction, has congestive heart failure, or has uncontrolled arterial hypertension (high blood pressure).

In the above situations, treatment with Nemedan should be carried out under strict medical supervision, with the doctor regularly assessing the therapeutic effects.
When administering memantine to patients with renal function impairment (kidney problems), the treating physician should closely monitor kidney function and, if necessary, appropriately adjust the dosage of the drug.
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 drugs belonging to the NMDA antagonist class.
Children and adolescents
Nemedan is not recommended for use in children and adolescents under 18 years of age.
Nemedan and other medicines
Inform your treating doctor or pharmacist about all medicines currently taken or recently taken, including those available without a prescription.
In particular, the use of Nemedan may alter the effects 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 products containing hydrochlorothiazide);
• anticholinergic drugs (usually used in the treatment of movement disorders or intestinal spasms);
• anticonvulsants (used to prevent and stop convulsive seizures);
• barbiturates (mainly used as sedatives);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (used in the treatment of psychiatric disorders);
• oral anticoagulants.

If hospitalization occurs, inform the doctor that the patient is taking Nemedan.
Nemedan 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 (impaired kidney function)) or severe urinary tract infections (structures through which urine flows). In the above cases, the treating physician may need to modify the dosage of the drug.
Pregnancy, breastfeeding, and effects on fertility
Women who are pregnant, breastfeeding, or planning to become pregnant should inform their treating physician before starting treatment.
Pregnancy
Memantine is not recommended for use in pregnant women.
Breastfeeding
Women taking Nemedan should not breastfeed.
Driving and operating machinery
The treating physician should inform the patient whether their condition allows them to safely drive vehicles or operate machinery.
Nemedan may additionally affect reaction speed, making driving vehicles or operating machinery inadvisable.

3. How to use Nemedan

Nemedan must always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Dosage
The recommended dose of Nemedan for adults and elderly patients is 20 mg once daily.
To minimize the risk of adverse effects, the dose should be increased gradually according to the following schedule. Tablets of different strengths may be used for this purpose.
At the beginning of treatment, Nemedan coated tablets 5 mg should be taken once daily. The dose should be increased by 5 mg every week until the recommended maintenance dose is reached.
The recommended maintenance dose is 20 mg once daily, which is achieved at the beginning of the fourth week.
Dosage in patients with renal impairment
In patients with impaired renal function, the appropriate dosage must be determined by the physician. Such patients require regular monitoring of renal function at intervals specified by the physician.
Method of administration
Nemedan 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 medicinal product 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 evaluate the course of treatment.
Use of a higher than recommended dose of Nemedan

• In general, ingestion of an excessive dose of Nemedan does not pose a health hazard. In such cases, enhanced symptoms described in section 4. "Possible adverse reactions" may occur.
• In the event of significant overdose of Nemedan, contact the treating physician or another doctor, as appropriate management may be necessary.

Missed dose of Nemedan

• If a patient forgets to take the medicine, the next dose should be taken at the usual time.
• A double dose should not be taken to make up for the missed dose.

If in doubt about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Nemedan can cause adverse reactions, although not everyone will experience them.
Generally observed adverse reactions are mild to moderate in severity.
Common (may occur in 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 occur in up to 1 in 100 people):

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

Very rare (may occur in up to 1 in 1000 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 Nemedan.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicinal product Nemedan

Keep the medicine out of the sight and reach of children.
Do not use Nemedan after the expiry date stated on the carton and blister after the words "Expiry date". The expiry date refers to the last day of the specified month.
No special precautions for storage of the medicinal product are required.
Tablets may be stored outside the blister for up to 7 days (e.g. in a pill box).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Nemedan 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:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, talc,
magnesium stearate; and
Coating of the tablet No: 28 Opadry Pink 20A34056: hypromellose 2910, hydroxypropylcellulose, talc,
titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172).

What Nemedan looks like and contents of the pack
Nemedan coated tablets are reddish, oval-shaped coated tablets with the imprint ‘20’ on one side.
Nemedan coated tablets are available in blisters containing 30 tablets.

Marketing Authorisation Holder and Manufacturer/Importer
G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria

For further information and details regarding the medicinal product's name in other EEA countries, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]