Auromemo

Patient Information Leaflet: User Information

AuroMemo, 10 mg, coated tablets

AuroMemo, 20 mg, coated tablets

Memantine hydrochloride

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

1. What is AuroMemo and what is it used for

What is AuroMemo

AuroMemo contains memantine hydrochloride. It belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is caused by disturbances in the transmission of nerve impulses
carrying information in the brain. In the brain, there are so-called N-methyl-D-aspartate (NMDA) receptors,
which are involved in the transmission of nerve signals important for learning and memory processes.
AuroMemo belongs to a group of medicines called NMDA receptor antagonists. AuroMemo, by acting on NMDA receptors, improves the transmission of nerve impulses and memory.
AuroMemo is used to treat patients with moderate to severe Alzheimer's disease.

2. Important information before taking AuroMemo

When not to take AuroMemo

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

Warnings and precautions

Before starting treatment with AuroMemo, discuss it with your doctor or pharmacist

• in patients who have had seizures in the past;
• in patients who have recently had a heart attack (myocardial infarction), or who suffer from congestive heart failure or uncontrolled hypertension (high blood pressure). In these situations, treatment with AuroMemo 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 (kidney problems),
the doctor should closely monitor kidney function and, if necessary, adjust the dosage of the medicine.
It is recommended to avoid concomitant use of such medicines as amantadine (used in the treatment of Parkinson's disease), ketamine (a substance usually used as an anesthetic), dextromethorphan
(usually used to treat cough), as well as other NMDA receptor antagonist medicines.

Children and adolescents

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

AuroMemo and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
In particular, the use of AuroMemo may cause changes in the action and require modification of the dosage by the doctor of the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination medicines containing hydrochlorothiazide);
• anticholinergic medicines (substances usually used to treat movement disorders or intestinal cramps);
• antiepileptic medicines (substances used to prevent and stop epileptic seizures);
• barbiturates (substances mainly used as sleeping pills);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used to treat mental disorders);
• oral anticoagulants.

In case of hospitalization, inform your doctor that you are taking AuroMemo.

Taking AuroMemo with food, drink, and alcohol

Inform your doctor if you have recently changed your diet (e.g., switched from a normal diet to a strict vegetarian diet) or if you have been diagnosed with renal tubular acidosis (RTA, excessive concentration of acidic substances in the blood due to kidney dysfunction) or severe urinary tract infections (structures through which urine flows). In these cases, it may be necessary for your doctor to adjust the dosage of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking AuroMemo should not breastfeed.

Driving and using machines

Your doctor should inform you whether your illness allows you to drive and use machines safely.
AuroMemo may also affect your reaction speed, making it inadvisable to drive or operate machinery.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take AuroMemo

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

Dosage

The recommended dose of AuroMemo for adults and the elderly is 20 mg per day. To minimize the risk of side effects, this dose is achieved gradually, using the following daily treatment schedule:
Usually, the initial dose is 5 mg or half a 10 mg tablet once a day (5 mg) for the first week. In the second week, the dose is increased to one 10 mg tablet per day (10 mg), and in the third week to one and a half 10 mg tablets or 15 mg once a day. From the fourth week, the usual dose is two 10 mg tablets or one 20 mg tablet once a day (20 mg).

Dosage in patients with renal impairment

In patients with impaired kidney function, the doctor will determine the appropriate dosage of the medicine. In such cases, it is necessary to constantly monitor kidney function at specified intervals, according to the doctor's instructions.

Method of administration

AuroMemo should be taken orally, once a day. To ensure the treatment is effective, the medicine should be taken regularly every day at the same time. The tablets should be swallowed with water. The medicine can be taken with or without food.

Duration of treatment

Treatment should be continued for as long as it is effective. The doctor should regularly assess the course of treatment.

Taking a higher dose of AuroMemo than recommended

• Generally, taking too much AuroMemo does not pose a risk to health. In such cases, enhanced side effects described in section 4 "Possible side effects" may occur.
• In case of significant overdose of AuroMemo, contact your doctor or another doctor, as it may be necessary to implement appropriate procedures.

Missing a dose of AuroMemo

• If you forget to take a dose, take the next dose of AuroMemo at the usual time.
• Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, AuroMemo 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, elevated liver enzyme levels, dizziness

dizziness, balance disorders, shallow breathing, high blood pressure, and hypersensitivity to the medicine
Uncommon(may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, and venous thrombosis (thrombosis/embolism)

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

• Seizures

Frequency not known(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 AuroMemo.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AuroMemo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister after the words "Expiry date". The expiry date refers to the last day of the 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. This will help protect the environment.

6. Contents of the pack and other information What AuroMemo contains

• The active substance is memantine hydrochloride. Each tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients are: Core:microcrystalline cellulose, anhydrous colloidal silica, siliconized microcrystalline cellulose, sodium carboxymethylcellulose (type A), talc, sodium stearyl fumarate.

Coating:hydroxypropylcellulose, titanium dioxide (E 171), macrogol 6000, talc, yellow iron oxide (E 172) (for 20 mg), red iron oxide (E 172) (for 20 mg).

What AuroMemo looks like and contents of the pack

Coated tablet.
AuroMemo 10 mg coated tablets
White or almost white, tapered, oblong, biconvex coated tablets with a single score line on both sides and embossed with "ME" and "10" on both sides of the score line on one side and smooth on the other side. The tablet can be divided into equal doses.
Size: 12.7 mm x 5.7 mm.
AuroMemo 20 mg coated tablets
Light red to reddish-brown, oval, oblong, coated tablets with embossed "ME" on one side and "20" on the other side. Size: 14.2 mm x 8.1 mm.
AuroMemo is available in blisters and HDPE bottles, packaged in cardboard boxes.
Pack sizes:
Blisters: 14, 28, 30, 42, 50, 56, 60, 90, 98, and 112 coated tablets.
HDPE bottle: 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
BBG 3000 Birzebbugia
Malta
Generis Farmacêutica S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

Date of last revision of the leaflet: 05/2021

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

Czech Republic:
AuroMemo
Germany:
Memantin PUREN 5 mg/15 mg Filmtabletten
Netherlands:
Memantine Aurobindo 5 mg/10 mg/15 mg/20 mg, film-coated tablets
Poland:
AuroMemo
Spain:
Memantina Aurobindo Pharma 10 mg/20 mg comprimidos recubiertos con película EFG