Memantine Glenmark

Package Leaflet: Information for the User

Memantine Glenmark, 10 mg, Film-Coated Tablets

Memantine Glenmark, 20 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 Another Person, Even if their Symptoms are the Same.
• If the Patient Experiences any Side Effects, Including those not Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist.

Package Leaflet Contents

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

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

Memantine Glenmark belongs to a Group of Medications Called Anti-Dementia Medications.
Memory Loss in Alzheimer's Disease is Caused by Disrupted Transmission of Nerve Impulses
that Carry Information in the Brain. The Brain has so-called N-Methyl-D-Aspartate (NMDA) Receptors,
which are Involved in Transmitting Nerve Signals Important for Learning and Memory. Memantine Glenmark
belongs to a Group of Medications Known as NMDA Receptor Antagonists. Memantine Glenmark, by Acting on
NMDA Receptors, Improves the Transmission of Nerve Impulses and Memory.

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

2. Important Information Before Taking Memantine Glenmark

When Not to Take Memantine Glenmark:

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

If the Patient is Uncertain whether this Information Applies to them, they Should Discuss it with their Doctor or Pharmacist Before Taking Memantine Glenmark.

Warnings and Precautions

Before Taking Memantine Glenmark, the Patient Should Discuss it with their Doctor or Pharmacist.

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

In these Situations, Treatment with Memantine Glenmark Should be Carried out Under Close Medical Supervision, and the Doctor Should Regularly Assess the Effects of the Treatment.
If the Patient has Kidney Problems, the Treating Doctor Should Closely Monitor Kidney Function During Treatment with Memantine Glenmark and, if Necessary, Adjust the Dosage.
If the Patient has Renal Tubular Acidosis (a Condition where the Kidneys do not Function Properly, Leading to an Excess of Acidic Substances in the Blood) or Severe Urinary Tract Infections (Infections of the Structures Through which Urine Flows), the Doctor may Need to Adjust the Dosage of Memantine Glenmark.
The Patient Should Avoid Taking Memantine Glenmark with Medications such as Amantadine (a Medication Used to Treat Parkinson's Disease), Ketamine (a Medication Commonly Used as an Anesthetic), Dextromethorphan (a Medication Commonly Used to Treat Cough), and other NMDA Receptor Antagonists.

Children and Adolescents

Memantine Glenmark is not Recommended for Children and Adolescents Under 18 Years of Age.

Memantine Glenmark and Other Medications

The Patient Should Inform their Doctor or Pharmacist about all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take.
In Particular, Taking Memantine Glenmark may Affect the Action of and Require Dosage Adjustment by the Doctor of the Following Medications:

• Amantadine, Ketamine, Dextromethorphan
• Dantrolene, Baclofen
• Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Nicotine
• Hydrochlorothiazide (or any Combination Medication Containing Hydrochlorothiazide)
• Anticholinergic Medications (Medications Commonly Used to Treat Movement Disorders or Intestinal Cramps)
• Antiepileptic Medications (Medications Used to Prevent and Treat Seizures)
• Barbiturates (Medications Mainly Used as Sedatives)
• Dopaminergic Agonists (Medications such as L-Dopa, Bromocriptine)
• Neuroleptics (Medications Used to Treat Psychiatric Disorders)
• Oral Anticoagulants

If the Patient is Admitted to Hospital, they Should Inform their Doctor about Taking Memantine Glenmark.

Memantine Glenmark with Food and Drink

The Patient Should Inform their Doctor if they have Recently Changed their Diet Significantly (e.g., from a Normal Diet to a Strict Vegetarian Diet) or Plan to do so.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or is Planning to have a Child, they Should Consult their Doctor or Pharmacist Before Taking this Medication.
Memantine Glenmark is not Recommended for Use in Pregnant Women.
Women Taking Memantine Glenmark Should not Breastfeed.

Driving and Using Machines

The Doctor Should Inform the Patient whether their Condition Allows them to Drive or Use Machines Safely.
Memantine Glenmark may Also Affect Reaction Speed, Making Driving or Operating Machines Inadvisable.

3. How to Take Memantine Glenmark

This Medication Should Always be Taken Exactly as Prescribed by the Doctor. If the Patient is Uncertain, they Should Consult their Doctor or Pharmacist.

Dosage

The Recommended Dose of Memantine Glenmark for Adult and Elderly Patients is 20 mg Once a Day. To Reduce the Risk of Side Effects, the Dose Should be Increased Gradually, According to the Following Schedule:

Typically, the Dosage Starts with Half a Tablet Once a Day (1 x 5 mg) for the First Week of Treatment. In the Second Week, the Dose is Increased to One Tablet Once a Day (1 x 10 mg) and to One and a Half Tablets Once a Day in the Third Week of Treatment.
From the Fourth Week Onwards, the Usual Dose is Two 10 mg Tablets Once a Day (1 x 20 mg) or One 20 mg Tablet Once a Day (1 x 20 mg).
When Increasing the Dose, it Should be Taken into Account that Different Tablet Strengths are Available.

Dosage in Patients with Renal Impairment

In Patients with Renal Impairment, the Treating Doctor will Determine the Dose of Memantine Glenmark Based on the Severity of the Kidney Disease. In this Case, the Doctor will Monitor Kidney Function at Regular Intervals.

Method of Administration

Memantine Glenmark Should be Taken Orally, Once a Day. To Ensure the Treatment is Effective, the Medication Should be Taken Regularly Every Day at the Same Time. The Tablets Should be Swallowed with Water. The Tablets can be Taken with or Without Food.
The 10 mg and 20 mg Tablets can be Divided into Equal Doses.

Duration of Treatment

Memantine Glenmark Should be Taken for as Long as the Treatment is Effective for the Patient. The Treating Doctor Should Regularly Assess the Progress of the Treatment.

Taking More than the Recommended Dose of Memantine Glenmark

• Generally, Taking Too Much Memantine Glenmark does not Pose a Risk to Health. However, the Side Effects Described in Section 4 "Possible Side Effects" may be More Pronounced.
• In Case of Significant Overdose of Memantine Glenmark, the Patient Should Contact their Doctor or Another Doctor, as Medical Attention may be Necessary.

Missing a Dose of Memantine Glenmark

• If the Patient Misses a Dose of Memantine Glenmark, they Should Take the Next Dose at the Usual Time.
• The Patient Should not Take a Double Dose to Make up for the Missed Dose.

If the Patient has any Further Questions about Taking this Medication, they Should Consult their Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Memantine Glenmark can Cause Side Effects, although not Everybody gets them.

If the Patient Experiences Side Effects such as Seizures, Suicidal Thoughts, they Should Immediately Discuss this with their Doctor or Pharmacist.

Commonly Observed Side Effects are Usually Mild to Moderate.
Common Side Effects (in Less than 1 in 10 Patients):

• Headache, Drowsiness, Constipation, Elevated Liver Enzymes, Dizziness, Balance Disorders, Shortness of Breath, High Blood Pressure, and Hypersensitivity to the Medication

Uncommon Side Effects (in Less than 1 in 100 Patients):

• Fatigue, Fungal Infections, Disorientation, Hallucinations, Vomiting, Abnormal Gait, Heart Failure, and Blood Clots in the Veins (Thrombosis/Thromboembolism)

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

• Seizures

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

• Pancreatitis, Hepatitis, and Psychotic Reactions

Alzheimer's Disease is Associated with Depression, Suicidal Thoughts, and Suicide. Such Events have been Reported in Patients Treated with Memantine.

Reporting Side Effects

If the Patient Experiences any Side Effects, Including those not Listed in this Package Leaflet, they Should Inform their Doctor, Pharmacist, or Nurse. 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, e-mail: ndl@urpl.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 Glenmark

The Medication Should be Stored Out of Sight and Reach of Children.
Do not Use this Medication After the Expiry Date Stated on the Carton After "EXP" or on the Blister After "EXP". The Expiry Date Refers to the Last Day of the Month.
There are no Special Precautions for Storage.
Medications Should not be Disposed of via Wastewater or Household Waste. The Patient Should Ask their Pharmacist how to Dispose of Medications they no Longer Use. This will Help Protect the Environment.

6. Package Contents and Other Information

What Memantine Glenmark Contains

The Active Substance is Memantine Hydrochloride.
Each 10 mg Film-Coated Tablet of Memantine Glenmark Contains 10 mg of Memantine Hydrochloride, which Corresponds to 8.31 mg of Memantine.
Each 20 mg Film-Coated Tablet of Memantine Glenmark Contains 20 mg of Memantine Hydrochloride, which Corresponds to 16.62 mg of Memantine.
The Other Ingredients are:
Memantine Glenmark, 10 mg:
Silicified Microcrystalline Cellulose
Microcrystalline Cellulose 98%
Colloidal Silicon Dioxide 2%
Cros Carmellose Sodium
Talc
Magnesium Stearate
Coating Opadry White (03B28796)
Containing:
Hypromellose 6cP
Titanium Dioxide (E171)
Macrogol 400
Memantine Glenmark, 20 mg:
Silicified Microcrystalline Cellulose
Microcrystalline Cellulose 98%
Colloidal Silicon Dioxide 2%
Cros Carmellose Sodium
Talc
Magnesium Stearate
Coating Opadry 03B84713 Pink
Containing:
Hypromellose 6cP
Titanium Dioxide (E171)
Macrogol 400
Iron Oxide Red (E172)

What Memantine Glenmark Looks Like and Contents of the Package

Memantine Glenmark, 10 mg are White or Almost White, Oval, Film-Coated Tablets with Dimensions of Approximately 11 mm x 6 mm, with the Number "10" Engraved on one Side and a Score Line on the Other Side.
The Tablet can be Divided into Equal Doses.
Memantine Glenmark, 20 mg are Brown-Pink, Oval, Film-Coated Tablets with Dimensions of Approximately 14 mm x 7 mm, with the Number "20" Engraved on one Side and a Score Line on the Other Side.
The Tablet can be Divided into Equal Doses.
Memantine Glenmark, 10 mg and Memantine Glenmark, 20 mg are Packaged in Blisters of 28, 56, or 120 Film-Coated Tablets in a Carton. One Blister Contains 14 Tablets.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

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

Glenmark Pharmaceuticals Sp. z o. o.
ul. Osmańska 14
02-823 Warsaw

Date of Last Revision of the Package Leaflet: