Memantine Grindeks

Package Leaflet: Information for the User

Memantine Grindeks, 10 mg, Film-Coated 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.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for a Specific Person. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same.
• If the Patient Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Memantine Grindeks and What is it Used for

Memantine Grindeks Contains the Active Substance Memantine Hydrochloride (Hereinafter Referred to as Memantine). It Belongs to a Group of Medications Called Anti-Dementia Medications. It Helps to Alleviate the Symptoms of Dementia in Alzheimer's Disease.

How Memantine Grindeks Works

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 Learning and Memory Processes. Memantine Belongs to a Group of Medications Known as NMDA Receptor Antagonists. It Acts on NMDA Receptors, Improving the Transmission of Nerve Signals and Memory.

What is Memantine Grindeks and What is it Used for

Memantine Grindeks is Used to Treat Patients with Moderate to Severe Alzheimer's Disease.

2. Important Information Before Taking Memantine Grindeks

When Not to Take Memantine Grindeks

• If the Patient is Allergic to Memantine or Any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Starting Treatment with Memantine Grindeks, Discuss it with Your Doctor

• If the Patient Has Had Seizures in the Past;
• If the Patient Has Recently Had a Heart Attack or Suffers from Congestive Heart Failure or Uncontrolled Hypertension (High Blood Pressure).

In These Situations, Treatment with Memantine Should be Carried out Under Close Medical Supervision, and the Doctor Should Regularly Assess the Effects of the Treatment.
When Administering Memantine to Patients with Renal Impairment, the Doctor Should Closely Monitor Renal Function and, if Necessary, Adjust the Dosage of the Medication.

Children and Adolescents

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

Memantine Grindeks and Other Medications

Tell Your Doctor or Pharmacist About All Medications the Patient is Currently Taking or Has Recently Taken, Including Those Planned to be Taken.
Do Not Take Memantine Grindeks with the Following Medications:

• Amantadine (Used to Treat Parkinson's Disease);
• Ketamine (Mainly Used as an Anesthetic);
• Dextromethorphan (Mainly Used to Treat Cough);
• Other NMDA Antagonists.

Memantine Grindeks May Affect the Action of, and Require Dose Adjustment by the Doctor, the Following Medications:

• Dantrolene, Baclofen;
• Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Nicotine;
• Hydrochlorothiazide (and All Combination Medications Containing Hydrochlorothiazide);
• Anticholinergic Agents (Medications Used to Treat Movement Disorders or Intestinal Spasms);
• Antiepileptic Medications (Substances Used to Prevent and Stop Seizures);
• Barbiturates (Substances Mainly Used as Sedatives);
• Dopaminergic Agonists (Substances Such as L-Dopa, Bromocriptine);
• Antipsychotic Medications (Used to Treat Mental Disorders);
• Oral Anticoagulants (Used to Prevent Blood Clotting).

In the Event of Hospitalization, Inform the Doctor that the Patient is Taking Memantine Grindeks.

Memantine Grindeks with Food and Drink

Inform the Doctor if the Patient Has Recently Made or Plans to Make Significant Changes to Their Diet (e.g., Switching from a Normal Diet to a Strict Vegetarian Diet) or if They Have Renal Tubular Acidosis (RTA), or Severe Urinary Tract Infections, as it May be Necessary to Adjust the Medication Dosage.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant or Plans to Have a Child, They Should Consult a Doctor or Pharmacist Before Taking this Medication. Memantine Should Not be Used During Pregnancy.
Women Taking Memantine Grindeks Should Not Breastfeed.

Driving and Operating Machinery

The Doctor Should Inform the Patient if Their Condition Allows Them to Drive and Operate Machinery Safely. Memantine Grindeks May Affect Reaction Speed, Resulting in Impaired Driving or Operating Machinery.

Memantine Grindeks Contains Lactose

If the Patient Has Been Diagnosed with Intolerance to Some Sugars, They Should Consult a Doctor Before Taking the Medication.

3. How to Take Memantine Grindeks

Always Take the Medication as Directed by the Doctor. If in Doubt, Consult the Doctor or Pharmacist.

Dosage for Adults and Elderly Patients (Over 65 Years of Age)

The Recommended Dosage is 20 mg Once a Day. To Reduce the Risk of Side Effects, the Medication Dosage Should be Gradually Increased According to the Following Scheme:
Typically, Treatment Starts with Half a Tablet Once a Day. This Dosage is Increased to One Tablet a Day in the Second Week and to One and a Half Tablets a Day in the Third Week. From the Fourth Week Onwards, the Usual Dosage is 2 Tablets a Day.

Dosage for Patients with Renal Impairment

In Patients with Renal Impairment, the Doctor Will Determine the Appropriate Dosage of the Medication.
In Such Cases, Regular Monitoring of Renal Function is Necessary, at Time Intervals Specified by the Doctor.

Method of Administration

Tablets Should be Taken Orally, Once a Day. For the Treatment to be Effective, the Medication Should be Taken Regularly, at the Same Time Every Day. The Tablets Should be Swallowed with Water. The Medication can be Taken with or Without Food.
The Tablet can be Divided into Equal Doses.

Duration of Treatment

Memantine Grindeks Should be Continued as Long as it Remains Effective. The Doctor Should Regularly Assess the Course of Treatment.

Taking More than the Recommended Dosage of Memantine Grindeks

Generally, Taking Too Much Memantine Grindeks Does Not Pose a Risk to Health. In Such Cases, Enhanced Side Effects Described in Section 4 May Occur.
In the Event of Significant Overdose of Memantine Grindeks, Consult a Doctor or Seek Medical Advice, as Appropriate Action May be Necessary.

Missing a Dose of Memantine Grindeks

If the Patient Forgets to Take a Dose of Memantine Grindeks, They Should Wait and 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 About Taking this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Memantine Grindeks can Cause Side Effects, Although Not Everybody Gets Them.

Generally, the Observed Side Effects are Mild to Moderate.
Common(Occurs in Less than 1 in 10 Patients):

• Hypersensitivity to the Medication
• Somnolence
• Dizziness
• Balance Disorders
• Hypertension
• Shallow Breathing
• Constipation
• Elevated Liver Enzyme Levels
• Headache

Uncommon(Occurs in Less than 1 in 100 Patients):

• Fungal Infections
• Confusion
• Hallucinations
• Abnormal Gait
• Heart Failure
• Venous Thromboembolism (Thrombosis/Thromboembolism)
• Vomiting
• Fatigue

Rare(Occurs in Less than 1 in 10,000 Patients):

• Seizures

Frequency Not Known(Cannot be Estimated from the Available Data):

• Psychotic Reactions
• Pancreatitis
• Hepatitis

Alzheimer's Disease is Associated with Depression, Suicidal Thoughts, and Suicide. Such Cases Have Been Reported in Patients Treated with Memantine.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, 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, Website: https://smz.ezdrowie.gov.pl.
Side Effects can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Memantine Grindeks

Store the Medication in a Place Out of Sight and Reach of Children.
No Special Precautions for Storing the Medication are Necessary.
Do Not Use this Medication After the Expiry Date Stated on the Carton After the Words "Expiry Date (EXP)". The Expiry Date Refers to the Last Day of the Month.
Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Memantine Grindeks Contains

• The Active Substance of the Medication is Memantine Hydrochloride. Each Film-Coated Tablet Contains 10 mg of Memantine Hydrochloride.
• Other Ingredients of the Medication: Tablet Core:Lactose Monohydrate, Microcrystalline Cellulose, Talc, Colloidal Silica, Anhydrous, Magnesium Stearate. Tablet Coating:Opadry II White 33G28707 (Hypromellose (E 464), Titanium Dioxide (E 171), Lactose Monohydrate, Macrogol 3000, Triacetin), Carnauba Wax.

What Memantine Grindeks Looks Like and What the Package Contains

White or Almost White, Biconvex, Prolonged, Film-Coated Tablets with Rounded Ends, Concave in the Middle, with a Score Line on Both Sides. Tablet Size: Length Approximately 12.7 mm, Height 3.7 mm.
PVC/PVDC/Aluminum Blister Packs Containing 7 or 10 Film-Coated Tablets, in a Cardboard Box.
Packaging: 28, 30, 56, or 60 Film-Coated Tablets.
Not All Pack Sizes May be Marketed.

Marketing Authorization Holder and Manufacturer:

AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Estonia
Memantine Grindeks
Austria
Memantin Grindeks 10 mg Filmtabletten
Croatia
Memantine Grindeks 10 mg Film-Coated Tablets
Czech Republic Memantine Grindeks
France
MEMANTINE GRINDEKS 10 mg, Comprimé Pelliculé Sécable
Greece
Memantine Grindeks 10 mg, Επικαλυμμένα με Λεπτό Υμένιο Δισκία
Hungary
Memantine Grindeks 10 mg Filmtabletta
Ireland
Memantine Grindeks 10 mg Film-Coated Tablets
Italy
Memantina Grindeks
Latvia
Memantine Grindeks 10 mg Apvalkotās Tabletes
Lithuania
Memantine Grindeks 10 mg Plėvele Dengtos Tabletės
Poland
Memantine Grindeks
Portugal
Memantină Grindeks 10mg Comprimidos Revestidos por Película
Romania
Memantină Grindeks 10mg Comprimate Filmate
Slovakia
Memantine Grindeks 10 mg Filmom Obalené Tablety

Date of Last Revision of the Package Leaflet:

07/2023