Zenmem

Package leaflet: information for the patient

Zenmem, 10 mg, orodispersible tablets
Zenmem, 20 mg, orodispersible tablets
Memantini hydrochloridum
Please read carefully this entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, 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.

Table of contents

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

1. What Zenmem is and what it is used for

How Zenmem works
Zenmem 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 and memory processes. Zenmem belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, Zenmem improves the transmission of nerve impulses and memory.

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

2. Important information before taking Zenmem

When not to take Zenmem

• 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 Zenmem, discuss this with your doctor, pharmacist or
nurse:

• if the patient has had seizures in the past;
• if the patient has recently suffered a myocardial infarction (heart attack), has congestive heart failure or uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be carried out under strict supervision of the attending physician,
who will regularly assess the clinical effects of therapy with Zenmem.
When administering memantine to patients with renal impairment (kidney problems), the attending physician
should closely monitor kidney function and, if necessary, appropriately
adjust the memantine dosage.
Concomitant use of the following drugs should be avoided: amantadine (used in the treatment of Parkinson's disease), ketamine (usually used as an anaesthetic), dextromethorphan (usually used in the treatment of cough), as well as other drugs belonging to the group of NMDA antagonists.
Children and adolescents
Zenmem is not recommended for children and adolescents under 18 years of age.
Zenmem and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines the patient plans to take.
In particular, treatment with Zenmem may affect the action of the following
medicines (which may consequently require dosage adjustment by the attending physician):

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination medicines containing hydrochlorothiazide);
• anticholinergic drugs (substances usually used in the treatment of 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 in the treatment of psychiatric disorders);
• oral anticoagulants.

If hospitalised, inform the doctor that the patient is taking Zenmem.
Taking Zenmem with food and drink
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 [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, dosage adjustment by the attending physician
may be necessary.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor or pharmacist before taking this medicine.
The use of memantine during pregnancy is not recommended.
Women taking Zenmem should not breastfeed.
Driving and operating machinery
The doctor should inform the patient whether the disease allows him to safely drive
and operate machinery. This medicine may additionally affect reaction speed, making
driving or operating machinery inadvisable.
Zenmem contains aspartame, lactose and sodium
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact
the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Zenmem

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended daily dose for adults and elderly patients is 20 mg.
To reduce the risk of adverse effects, this dose should be reached gradually,
according to the following scheme:

Obtaining doses of 5 mg and 15 mg is not possible by using Zenmem medication; if these doses are required, other available medications containing 5 mg or 15 mg of memantine should be used.

Maintenance dose
The recommended maintenance dose is 20 mg once daily.
If continuing treatment, consult your physician.

Dosage in patients with renal impairment
In patients with impaired kidney function, the appropriate dosage must be determined by the treating physician based on the patient's health status. In such cases, regular monitoring of kidney function at intervals specified by the treating physician is necessary.

Method of administration
Zenmem tablets should be taken orally once daily. For effective treatment, the medication should be taken regularly every day at the same time. Tablets may be taken with or without food.

Duration of treatment
Treatment should be continued as long as beneficial effects are observed. The treating physician should regularly assess the course of therapy.

Instructions for use
Zenmem orodispersible tablets are fragile and should be handled carefully. Do not touch the tablets with wet hands, as they may disintegrate.

• Holding the blister pack at the edges, carefully separate one tablet portion from the rest along the perforated line.
• Gently peel back the foil.
• Place the tablet on the tongue. The tablet dissolves rapidly and can be swallowed without water.

Overdose of Zenmem

• Generally, taking an excessive dose of Zenmem does not pose a serious health risk. In such cases, symptoms described in section 4, "Possible adverse reactions," may be intensified.
• In the event of a significant overdose, contact your treating physician or another doctor, as appropriate medical management may be required.

Missed dose of Zenmem

• If a patient forgets to take Zenmem, they should take the next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

If you have any further questions regarding the use of this medication, consult your physician, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally observed side effects are mild to moderate in severity.
Common (may affect up to 1 in 10 people):

• headache, drowsiness, constipation, increased liver enzyme activity shown in laboratory tests, dizziness, loss of balance, 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 (blood clots in veins).

Very 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 memantine.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Zenmem

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: "Expiry
date (EXP)". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zenmem contains
The active substance in Zenmem is memantine hydrochloride.
Zenmem 10 mg: each orally disintegrating tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
Zenmem 20 mg: each orally disintegrating tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other ingredients are: polyacrylic acid, sodium hydroxide (for pH adjustment), spray-dried lactose monohydrate, microcrystalline cellulose, spray-dried mannitol, sodium croscarmellose, aspartame (E951), colloidal anhydrous silica, iron oxide red (E172), peppermint flavour [containing maltodextrin (from maize), modified starch E1450 (from maize), peppermint oil (field mint)], magnesium stearate.

What Zenmem looks like and contents of the pack
Zenmem 10 mg, orally disintegrating tablets: light pink, round, flat, speckled tablets with bevelled edges, 9 mm in diameter, imprinted with the number “10” on one side.
Zenmem 20 mg, orally disintegrating tablets: light pink, round, flat, speckled tablets with bevelled edges, 12 mm in diameter, imprinted with the number “20” on one side.
The following pack sizes of Zenmem are available:
10 mg: 28, 30, 56, 60 or 90 orally disintegrating tablets.
20 mg: 28, 30, 56, 60 or 90 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer
Genepharm S.A., 18 km Marathon Avenue, 15351 Pallini Attikis, Greece
Rontis Hellas S.A., Larisa Industrial Area, P.O. Box 3012, GR41004 Larisa, Greece

For further information about this medicinal product and its brand names in the European Economic Area countries, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: +48 22 375 92 00