Memantine Vipharm

Package Leaflet: Information for the Patient

Memantine Vipharm, 10 mg, Film-Coated Tablets

Memantine Vipharm, 20 mg, Film-Coated Tablets

Memantine Hydrochloride
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Memantine Vipharm and what is it used for

How Memantine Vipharm works
Memantine Vipharm contains the active substance memantine hydrochloride (Memantini hydrochloridum). It belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to 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 transmitting nerve signals important for the learning and memory process. Memantine Vipharm belongs to a group of medicines called NMDA receptor antagonists. Memantine Vipharm, by acting on NMDA receptors, improves the transmission of nerve impulses and memory.
What Memantine Vipharm is used for
Memantine Vipharm is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking Memantine Vipharm

When not to take Memantine Vipharm

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

Warnings and precautions

Before starting treatment with Memantine Vipharm, discuss with your doctor or pharmacist:

• if you have ever had seizures;
• 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 Memantine Vipharm should be carried out under close medical supervision, and the doctor should regularly assess the benefits of the treatment.
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 dose of the medicine.
It is recommended to avoid concomitant use of such medicines as amantadine (in the treatment of Parkinson's disease), ketamine (a substance usually used as an anesthetic), dextromethorphan (usually used in the treatment of cough), other NMDA receptor antagonists.
The treating doctor should be informed if the patient has recently made or plans to make significant changes in their 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 due to kidney dysfunction) or severe urinary tract infection (structures through which urine flows). In these cases, it may be necessary to modify the dosing of the medicine by the doctor.

Children and adolescents

Memantine Vipharm is not recommended for children and adolescents under 18 years of age.

Memantine Vipharm with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Memantine Vipharm may change the effect and require dose modification by the doctor of the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic agents (substances usually used in the treatment of movement disorders or intestinal cramps);
• antiepileptic drugs (substances used in the prevention and interruption of epileptic seizures);
• barbiturates (substances mainly used as sedatives);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used in the treatment of mental disorders);
• oral anticoagulants.

In the event of hospitalization, inform your doctor that you are taking Memantine Vipharm.

Memantine Vipharm with food and drink

Inform your treating doctor if you have recently made or plan to make significant changes in 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 infection (structures through which urine flows). In these cases, it may be necessary to modify the dosing of the medicine by the doctor.

Pregnancy and breastfeeding

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

Driving and using machines

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

Memantine Vipharm contains lactose

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

3. How to take Memantine Vipharm

Take this medicine always as directed by your doctor. If you are not sure, ask your doctor or pharmacist.
Recommended dose

10 mg

The recommended dose of Memantine Vipharm for adults and elderly patients is 20 mg once a day.
In order to reduce the risk of side effects, the dose of the medicine should be increased gradually, according to the following scheme:
Usually, treatment 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, usually two tablets are given once a day (1 x 20 mg).

20 mg

The recommended dose of Memantine Vipharm for adults and elderly patients is 20 mg once a day.
In order to reduce the risk of side effects, the dosing of the medicine should be increased gradually, according to the treatment scheme. Other tablet strengths are available for gradual dose increase.
Treatment starts with 5 mg of memantine once a day (half a 10 mg tablet). This dose is increased by 5 mg every week to achieve the recommended maintenance dose. The recommended maintenance dose is 20 mg once a day and is achieved at the beginning of the 4th week.

Dosing in patients with renal impairment

In patients with impaired renal function, the appropriate dosing of the medicine is determined by the treating doctor.
In such cases, it is necessary to constantly monitor kidney function at specified time intervals, in accordance with the doctor's recommendations.

10 mg and 20 mg Breaking the tablet

Place the round tablet on a hard surface, with the dividing line facing upwards. Press with your thumb and index finger on both sides of the dividing line and press down until the tablet breaks, as shown in the picture.

Method of administration

Memantine Vipharm should be taken orally, once a day. To make the treatment effective, the medicine should be taken regularly every day at the same time. The tablets should be swallowed, washed down with water. The tablets can be taken with food or independently of food.

Duration of treatment

Treatment with Memantine Vipharm should be continued for as long as it is beneficial. The treating doctor should regularly assess the course of treatment.

Taking a higher dose of Memantine Vipharm than recommended

Generally, taking too much Memantine Vipharm does not pose a threat to health.
In such a case, enhanced symptoms described in section 4 "Possible side effects" may occur.
In the event of significant overdose of Memantine Vipharm, contact your treating doctor or another doctor, as there may be a need to implement appropriate procedures.

Missing a dose of Memantine Vipharm

If you miss a dose, wait and take the next dose of Memantine Vipharm at the usual time.
Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, the observed side effects are mild to moderate.

• headache, drowsiness, constipation, elevated liver enzyme levels, dizziness, balance disorders, high blood pressure, shallow breathing, hypersensitivity to the medicine.

Uncommon(may affect up to 1 in 100 people):

• fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, venous thrombosis (thrombophlebitis).

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

• seizures.

Frequency not known(cannot be estimated from the available data):

• pancreatitis, hepatitis, psychotic reactions.

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 leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
e-mail: [email protected].
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 medicine.

5. How to store Memantine Vipharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Memantine Vipharm contains

• The active substance of the medicine is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, which corresponds to 8.31 mg of memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride, which corresponds to 16.62 mg of memantine.
• The other ingredients are: Tablet coreLactose monohydrate, microcrystalline cellulose, talc, colloidal anhydrous silica, magnesium stearate.

Coating

10 mg

Lactose monohydrate, hypromellose 15 cps, titanium dioxide (E 171), macrogol 4000.

20 mg

Lactose monohydrate, hypromellose 15 cps, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

What Memantine Vipharm looks like and contents of the pack

10 mg

Memantine Vipharm 10 mg film-coated tablets are white, round (8 mm), biconvex tablets with a dividing line on one side and with the inscription "M9MN" and "10" on the other side. The tablet can be divided into equal doses.
Memantine Vipharm is available in blister packs of 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100, 112 or 120 film-coated tablets and a blister containing a single dose of 30x1 tablet.
Not all pack sizes may be marketed.

20 mg

Memantine Vipharm 20 mg film-coated tablets are pink, oval (13.5 x 6.6 mm), biconvex tablets with a dividing line on one side and with the inscription "M9MN 20" on the other side. The tablet can be divided into equal doses.
Memantine Vipharm is available in blister packs of 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100, 112 or 120 film-coated tablets and a blister containing a single dose of 30x1 tablet.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel: (+48 22) 679-51-35
fax: (+48 22) 678-92-87
e-mail: [email protected]
Poland

Manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland
Synthon BV
Microweg 22
6545 CM, Nijmegen
Netherlands
Synthon Hispania SL
C/ Castelló 1, Polígono Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
A-8054 Graz
Austria
Industria Química y Farmacéutica Vir, S.A
C/ Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Memantin Genericon 10 mg Filmtabletten
Memantin Genericon 20 mg Filmtabletten
Czech Republic
Memantine Vipharm 10 mg coated tablets
Memantine Vipharm 20 mg coated tablets
Finland
Adaxor 10 mg
Adaxor 20 mg
Greece
Memantine Synthon Ariti 10 mg
Memantine Synthon Ariti 20 mg
Iceland
ZALATINE 10 mg film-coated tablet
ZALATINE 20 mg film-coated tablet
Netherlands
Memantine Synthon 10 mg, tablets
Memantine Synthon 20 mg, tablets
Poland
Memantine Vipharm
Portugal
Memantina Synthon
Slovakia
Memantine Vipharm 10 mg film-coated tablets
Memantine Vipharm 20 mg film-coated tablets
Spain
Memantina Vir 10 mg film-coated tablets EFG
Memantina Vir 20 mg film-coated tablets EFG
Hungary
Memantine Vipharm 10 mg film tablet
Memantine Vipharm 20 mg film tablet
United Kingdom
Memantine Synthon 10 mg film-coated tablets
Memantine Synthon 20 mg film-coated tablets

Date of last revision of the leaflet: 29/09/2018