Zenmem

Package Leaflet: Information for the Patient

Zenmem, 10 mg, Oral Disintegrating Tablets

Zenmem, 20 mg, Oral Disintegrating Tablets

Memantine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Another Person, Even if Their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including those Not Mentioned in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Zenmem and What is it Used for
• 2. Important Information Before Taking Zenmem
• 3. How to Take Zenmem
• 4. Possible Undesirable Effects
• 5. How to Store Zenmem
• 6. Package Contents and Other Information

1. What is Zenmem and What is it Used for

How Zenmem Works

Zenmem belongs to a Group of Medications Known as Anti-Dementia Medications. Memory Loss in Alzheimer's Disease is Caused by Disruptions 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 that are Involved in the Transmission of Nerve Signals Important for the Learning and Memory Process. Zenmem belongs to a Group of Medications Referred to as NMDA Receptor Antagonists. Zenmem, by Affecting NMDA Receptors, Improves the Transmission of Nerve Impulses and Memory.

What Zenmem is Used for

Zenmem is Used to Treat 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 Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Take Zenmem, Discuss it with a Doctor, Pharmacist, or Nurse:

• If the Patient has had Seizures in the Past;
• If the Patient has Recently had a Heart Attack (Myocardial Infarction), has Congestive Heart Failure, or Uncontrolled High Blood Pressure.

In these Situations, Treatment should be Carried out under Close Medical Supervision, which will Regularly Assess the Clinical Effects of Zenmem Therapy. During the Administration of Memantine to Patients with Renal Impairment (Kidney Problems), the Treating Doctor should Closely Monitor Kidney Function and, if Necessary, Adjust the Memantine Dosage Accordingly. It is Recommended to Avoid Concomitant Use of Medications such as: Amantadine (Used to Treat Parkinson's Disease), Ketamine (Usually Used as an Anesthetic), Dextromethorphan (Usually Used to Treat Cough), as well as Other Medications from the NMDA Antagonist Group.

Children and Adolescents

Zenmem is Not Recommended for Children and Adolescents Under 18 Years of Age.

Zenmem and Other Medications

Inform a Doctor or Pharmacist about all Medications Currently Being Taken or Recently Taken, as well as Medications Planned to be Taken. In Particular, the Use of Zenmem may Affect the Action (which may Result in the Need to Adjust the Dosage by the Treating Doctor) of the Following Medications:

• Amantadine, Ketamine, Dextromethorphan;
• Dantrolene, Baclofen;
• Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Nicotine;
• Hydrochlorothiazide (and all Combination Medications Containing Hydrochlorothiazide);
• Anticholinergic Medications (Substances Usually Used to Treat Movement Disorders or Intestinal Spasms);
• Antiepileptic Medications (Substances Used to Prevent and Interrupt Seizures);
• Barbiturates (Substances Mainly Used as Sleep Aids);
• Dopaminergic Agonists (Substances such as L-Dopa, Bromocriptine);
• Neuroleptics (Substances Used to Treat Mental Disorders);
• Oral Anticoagulants.

In the Event of Hospitalization, Inform a Doctor that you are Taking Zenmem.

Taking Zenmem with Food and Drink

Inform a Treating Doctor if you have Recently Made or Plan to Make Significant Changes to your Diet (e.g., Switching from a Normal Diet to a Strict Vegetarian Diet) or if you have been Diagnosed with Renal Tubular Acidosis (Excessive Concentration of Acidic Substances in the Blood due to Kidney Dysfunction) or Severe Urinary Tract Infections. In these Cases, it may be Necessary to Adjust the Dosage of Zenmem by the Treating Doctor.

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or are Planning to have a Child, Consult a Doctor or Pharmacist Before Taking this Medication. The Use of Memantine During Pregnancy is Not Recommended. Women Taking Zenmem should Not Breastfeed.

Driving and Operating Machinery

A Doctor should Inform you whether your Condition Allows you to Drive and Operate Machinery Safely. This Medication may Also Affect your Reaction Speed, Resulting in a Contraindication to Drive or Operate Machinery.

Zenmem Contains Aspartame, Lactose, and Sodium

Aspartame is a Source of Phenylalanine. It may be Harmful to Patients with Phenylketonuria. If you have been Diagnosed with an Intolerance to some Sugars, Consult a Doctor Before Taking this Medication. The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, i.e., it is Considered "Sodium-Free".

3. How to Take Zenmem

Always Take this Medication Exactly as Prescribed by a Doctor or Pharmacist. In Case of Doubts, Consult a Doctor or Pharmacist. The Recommended Daily Dose for Adults and Elderly Patients is 20 mg. To Reduce the Risk of Undesirable Effects, this Dose is Achieved Gradually, According to the Following Scheme: Achieving Doses of 5 mg and 15 mg is Not Possible with Zenmem; if these Doses are Needed, other Available Medications Containing 5 or 15 mg of Memantine should be Used. Maintenance DoseThe Recommended Maintenance Dose is 20 mg per Day. In Case of Continued Treatment, Consult a Doctor.

Dosage in Patients with Renal Impairment

In Patients with Renal Impairment, the Appropriate Dosage of Zenmem is Determined by the Treating Doctor Based on the Patient's Health Status. In this Case, Regular Monitoring of Kidney Function is Necessary at Specified Time Intervals, According to the Treating Doctor's Recommendations.

Method of Administration

Zenmem should be Taken Orally, Once a Day. To Ensure Effective Treatment, the Medication should be Taken Regularly, Every Day at the Same Time. The Tablets can be Taken with or Without Food.

Duration of Treatment

Treatment should be Continued as Long as it Remains Beneficial. The Treating Doctor should Regularly Assess the Course of Treatment.

Instructions for Use

Zenmem Oral Disintegrating Tablets are Easily Broken, so they should be Handled Carefully. Do Not Touch the Tablets with Wet Hands, as they may Break.

• Holding the Blister Pack by the Edges, Separate one Tablet from the Rest by Gently Peeling Along the Perforation.
• Carefully Remove the Foil.
• Place the Tablet on the Tongue. The Tablet will Quickly Dissolve and can be Swallowed Without Water.

Taking a Higher Dose of Zenmem than Recommended

• Generally, Taking Too Much Zenmem does Not Pose a Risk to the Patient's Health. In this Case, Enhanced Symptoms Described in Section 4 "Possible Undesirable Effects" may Occur.
• In Case of Significant Overdose of Zenmem, Contact a Treating Doctor or Another Doctor, as Medical Intervention may be Necessary.

Missing a Dose of Zenmem

• If you Missed a Dose of Zenmem, Take the Next Dose at the Usual Time.
• Do Not Take a Double Dose to Make up for the Missed Dose.

In Case of Further Doubts Regarding the Use of this Medication, Consult a Doctor, Pharmacist, or Nurse.

4. Possible Undesirable Effects

Like all Medications, Zenmem can Cause Undesirable Effects, although Not Everybody Gets them. Generally, the Observed Undesirable Effects are Mild to Moderate. Common (may Affect up to 1 in 10 People):

• Headache, Drowsiness, Constipation, Increased Activity of Liver Enzymes Shown in Laboratory Tests, Dizziness, Balance Disorders, Shallow Breathing, High Blood Pressure, and Hypersensitivity to the Medication.

Uncommon (may Affect up to 1 in 100 People):

• Fatigue, Fungal Infections, Confusion, Hallucinations, Vomiting, Abnormal Gait, Heart Failure, and Venous Thrombosis/Thromboembolism.

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 Undesirable Effects

If you Experience any Undesirable Effects, Including those Not Mentioned in this Package Leaflet, Inform a Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Medicinal Product Monitoring 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, e-mail: ndl@urpl.gov.pl. Undesirable Effects can also be Reported to the Marketing Authorization Holder. By Reporting Undesirable Effects, you can Help Provide More Information on the Safety of this Medication.

5. How to Store Zenmem

Store the Medication in a Place Invisible and Inaccessible to Children. Do Not Use this Medication After the Expiration Date Stated on the Package and Blister after "Expiration Date (EXP)". The Expiration Date Refers to the Last Day of the Specified Month. This Medication does Not Require Special Storage Conditions. Medications should Not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Medications that are No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Zenmem Contains

The Active Substance of Zenmem is Memantine Hydrochloride. Zenmem, 10 mg: Each Oral Disintegrating Tablet Contains 10 mg of Memantine Hydrochloride, which Corresponds to 8.31 mg of Memantine. Zenmem, 20 mg: Each Oral Disintegrating Tablet Contains 20 mg of Memantine Hydrochloride, which Corresponds to 16.62 mg of Memantine. The Other Ingredients are: Polyacrylate, Sodium Hydroxide (to Adjust pH), Lactose Monohydrate Spray-Dried, Microcrystalline Cellulose, Mannitol Spray-Dried, Sodium Croscarmellose, Aspartame (E951), Silicon Dioxide, Red Iron Oxide (E172), Peppermint Flavor [Containing Maltodextrin (Corn), Modified Starch E1450 (Corn), Peppermint Oil (Field Mint)], Magnesium Stearate.

What Zenmem Looks Like and What the Package Contains

Zenmem, 10 mg, Oral Disintegrating Tablets: Light Pink, Round, Flat, Speckled Tablets with Cut Edges, 9 mm in Diameter, with the Number "10" Embossed on one Side. Zenmem, 20 mg, Oral Disintegrating Tablets: Light Pink, Round, Flat, Speckled Tablets with Cut Edges, 12 mm in Diameter, with the Number "20" Embossed on one Side. The Following Package Sizes of Zenmem are Available: 10 mg: 28, 30, 56, 60, or 90 Oral Disintegrating Tablets. 20 mg: 28, 30, 56, 60, or 90 Oral Disintegrating Tablets. Not all Package Sizes may be Marketed.

Marketing Authorization 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 More Detailed Information on the Medication and its Names in the Member States of the European Economic Area, Contact:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, Tel: +48 22 375 92 00

Date of Last Update of the Package Leaflet: