Memigmin

Package Leaflet: Information for the Patient

Memigmin, 10 mg, 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 you. 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Memigmin and what is it used for
• 2. Important Information Before Taking Memigmin
• 3. How to Take Memigmin
• 4. Possible Side Effects
• 5. How to Store Memigmin
• 6. Contents of the Package and Other Information

1. What is Memigmin and What is it Used For

How Memigmin Works

Memigmin belongs to a group of anti-dementia medications.
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
that are involved in the transmission of nerve signals important for the learning process and for memory.
Memigmin belongs to a group of medications known as NMDA receptor antagonists. Memigmin, by its effect on NMDA receptors,
improves the transmission of nerve impulses and memory.

What Memigmin is Used For

Memigmin is used to treat patients with moderate to severe Alzheimer's disease.

2. Important Information Before Taking Memigmin

When Not to Take Memigmin

• If you are allergic to memantine hydrochloride or any of the other ingredients of this medication (listed in section 6) .

Warnings and Precautions

Before starting treatment with Memigmin, tell your doctor or pharmacist:

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

In these situations, treatment with Memigmin should be carried out under close medical supervision,
and the doctor should regularly assess the effects of the treatment.
If you have kidney problems, your doctor should closely monitor your kidney function and adjust the dosage of memantine if necessary.
You should avoid taking medications such as amantadine (for Parkinson's disease), ketamine (usually used as an anesthetic),
dextromethorphan (usually used to treat cough), and other NMDA receptor antagonists.
Tell your doctor if you have recently changed your diet (e.g., switched to a strict vegetarian diet) or if you have been diagnosed with renal tubular acidosis (RTA, excessive acidity in the blood due to kidney dysfunction)
or severe urinary tract infections. In these cases, your doctor may need to adjust the dosage of the medication.

Children and Adolescents

Memigmin is not recommended for use in children and adolescents under 18 years of age.

Other Medications and Memigmin

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken,
as well as any medications you plan to take.
In particular, taking Memigmin may affect the action of, and require dosage adjustments by your doctor, the following medications:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic medications (substances usually used to treat movement disorders or intestinal cramps);
• antiepileptic medications (substances used to prevent and stop seizures);
• barbiturates (substances mainly used as sleep aids);
• dopaminergic agonists (substances such as L-dopa, bromocriptine);
• neuroleptics (medications used to treat mental disorders);
• oral anticoagulants. If you are hospitalized, inform your doctor that you are taking Memigmin.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medication.
Memantine is not recommended during pregnancy.
Women taking Memigmin should not breastfeed.

Driving and Operating Machinery

Your doctor should inform you whether your condition allows you to drive or operate machinery safely.
Memigmin may also affect your reaction speed, making it inadvisable to drive or operate machinery.

Memigmin Contains Lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medication.

3. How to Take Memigmin

Always take this medication exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended dose of Memigmin for adults and elderly patients is 20 mg once a day.
To reduce the risk of side effects, the dosage of Memigmin should be increased gradually, according to the following scheme:

Dosage in Patients with Renal Impairment

In patients with impaired renal function, the doctor will determine the appropriate dosage of Memigmin.
In such cases, it is necessary to closely monitor kidney function and, if necessary, adjust the dosage of memantine.

Method of Administration

Memigmin 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.

Duration of Treatment

Treatment should be continued as long as it is effective. Your doctor will regularly assess the treatment.

Overdose of Memigmin

• Generally, taking too much Memigmin does not pose a risk to your health. In such cases, you may experience increased side effects as described in section 4, "Possible Side Effects".
• In case of significant overdose of Memigmin, contact your doctor or another doctor, as medical attention may be necessary.

Missed Dose of Memigmin

• If you forget to take a dose of Memigmin, wait and take the next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Memigmin can cause side effects, although not everybody gets them.
Generally, the observed side effects are mild to moderate.
Common(may affect up to 1 in 10 people)

• Headache, drowsiness, constipation, increased liver enzyme activity, dizziness

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 blood clots in the veins (thrombosis/embolism).

Rare(may affect up to 1 in 10,000 people)

• Seizures. Unknown(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 Memigmin.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Memigmin

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
There are no special precautions for storage of this medicinal product.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required.
These measures will help protect the environment.

6. Contents of the Package and Other Information

What Memigmin Contains

The active substance of Memigmin is memantine hydrochloride. Each coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
The other ingredients are: tablet core – microcrystalline cellulose, lactose DC (lactose monohydrate, povidone K30, colloidal anhydrous silica, talc, magnesium stearate), coating Opadry White Y-1-7000– hypromellose 5cp, titanium dioxide (E171), macrogol 400.

What Memigmin Looks Like and Contents of the Package

Memigmin coated tablets are white or almost white, elongated, biconvex, coated tablets with a dividing line on both sides. The tablet can be divided into equal doses.
Memigmin coated tablets are available in PVC/PE/PVDC/Aluminum blisters of 7, 14, 28, 30, 42, 49, 50, 56, 70, 84, 98, 100, and 112 coated tablets.
In Poland, only packages of 28 and 56 coated tablets are approved for marketing.

Marketing Authorization Holder

EGIS Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest,
Hungary

Manufacturer

EGIS Pharmaceuticals PLC
Bökényföldi út 118-120
H-1165 Budapest
Hungary
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia

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

Bulgaria
Memigmin
10 mg филмирани таблетки
Czech Republic
Memigmin
10 mg potahované tablety
Hungary
Memigmin
10 mg filmtabletta
Lithuania
Memigmin
10 mg plėvele dengtos tabletės
Latvia
Memigmin
10 mg apvalkotās tabletes
Poland
Memigmin,
10 mg, coated tablets
Romania
Memigmin
10 mg comprimate filmate
Slovakia
Memigmin
10 mg filmom obalené tablety
Date of Last Revision of the Leaflet:20.07.2017