Package leaflet: Information for the user

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

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Nemedan is and what it is used for
What you need to know before you take Nemedan
How to take Nemedan
Possible side effects
How to store Nemedan
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. It 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 receptors known as 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 hypersensitivity (allergy) to memantine hydrochloride or to 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 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 NMDA antagonists.
Children and adolescents
Nemedan is not recommended for use in children and adolescents under 18 years of age.
Nemedan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription.
In particular, treatment with 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 is required, 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 levels of acidic substances in the blood due to kidney dysfunction (impaired kidney function)) or severe urinary tract infections (structures through which urine passes). In such cases, the treating physician may need to adjust the dosage of the medicine.
Pregnancy, breastfeeding and fertility
Women who are pregnant, breastfeeding, or planning to become pregnant should inform their doctor before starting treatment.
Pregnancy
Memantine is not recommended for use during pregnancy.
Breastfeeding
Women taking Nemedan should not breastfeed.
Driving and operating machinery
The treating physician should advise the patient whether their medical condition allows them to drive or operate machinery safely.
Nemedan may additionally affect reaction speed, making driving or operating machinery potentially inadvisable.
Nemedan contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use Nemedan

Nemedan must always be used according to the instructions of your physician. If in
doubt, consult your doctor or pharmacist.
Dosage
The recommended dose of Nemedan for adults and elderly patients is 20 mg once daily.
To reduce the risk of adverse effects, the dose should be increased gradually according
to the following scheme:

Week 1	half a tablet 10 mg
Week 2	one tablet 10 mg
Week 3	one and a half tablets 10 mg
Week 4 and onwards	two tablets 10 mg

The usual starting dose is half a tablet once daily (1 x 5 mg) for the first week.
The dose is increased to one tablet once daily (1 x 10 mg) in the second week, and to one and a half
tablets once daily in the third week. From the fourth week onwards, the usual dose is
2 tablets once daily (1 x 20 mg).
Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage of the medicinal product should be determined by the treating physician. In such patients, regular monitoring of kidney function at specified intervals, as recommended by the treating physician, is necessary.
Method of administration
Nemedan should be administered orally, once daily. To ensure effective treatment, the medicinal product should be taken regularly every day at the same time. Tablets should be swallowed with water. This medicinal product can 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 treatment.
Use of a higher than recommended dose of Nemedan

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

Missed dose of Nemedan

If a patient forgets to take the medicinal product, 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 in doubt regarding the use of this medicinal product, consult a physician 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, loss of balance, 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 (venous thrombosis/embolism).

Very rare (may occur in up to 1 in 1000 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 Nemedan.
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 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 marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety profile of the medicine.

5. How to store Nemedan

Keep this medicine out of 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 that month.
No special precautions for storage of the medicinal product are required.
Tablets divided in half or whole tablets, after removal from the blister, may be stored 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 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
Other components are:
Tablet core: microcrystalline cellulose, lactose DC (composition: monohydrate lactose, Povidone K 30), anhydrous colloidal silicon dioxide, talc, magnesium stearate; and
Coating of the tablet Opadry White Y-1-7000: hypromellose 5 cp, titanium dioxide (E 171), macrogol 400.

What Nemedan looks like and contents of the pack
Nemedan coated tablets are white or almost white, elongated, biconvex coated tablets with a division groove on both sides.
The tablet can be divided into equal doses.
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 product names 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]