Auromemo

AuroMemo, 10 mg, film-coated tablets
AuroMemo, 20 mg, film-coated tablets
Memantini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What AuroMemo is and what it is 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 AuroMemo is and what it is used for

What AuroMemo is
AuroMemo contains memantine hydrochloride. It belongs to a group of medicines known as anti-dementia drugs.
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, which play a role in transmitting nerve signals important for learning and memory processes. AuroMemo belongs to a group of medicines known as NMDA receptor antagonists. By acting on NMDA receptors, AuroMemo improves nerve impulse transmission and memory.
AuroMemo is used in the treatment of patients with moderate to severe Alzheimer's disease.

2. Important information before using AuroMemo

When not to use AuroMemo

• if the patient is 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 this with your doctor or pharmacist:

• in patients who have previously experienced epileptic seizures;
• in patients who have recently suffered a myocardial infarction (heart attack), or who suffer from congestive heart failure or uncontrolled hypertension (high blood pressure). In the above situations, treatment with AuroMemo should be conducted under strict supervision of the attending physician, who should regularly assess the effects of ongoing therapy.

During administration of memantine to patients with renal impairment (kidney problems),
the attending physician should closely monitor kidney function and, if necessary, appropriately
adjust the dosage of the medicine.
Concomitant use of the following drugs should be avoided: amantadine (used in the treatment of Parkinson's disease), ketamine (a substance usually used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.

Children and adolescents
AuroMemo should not be given to children or adolescents under 18 years of age.

AuroMemo and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, the use of AuroMemo may affect the action of, and may require dose adjustments by the attending physician for the following medicines:

• amantadine, ketamine, dextromethorphan;
• dantrolene, baclofen;
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
• hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
• anticholinergic drugs (substances usually used in the treatment of movement disorders or intestinal spasms);
• anticonvulsant drugs (substances used to prevent or stop seizures);
• barbiturates (substances mainly used as sedatives);
• dopaminergic agonists (such as L-dopa, bromocriptine);
• neuroleptics (substances used in the treatment of psychiatric disorders);
• oral anticoagulants.

If hospitalised, inform the doctor that the patient is taking AuroMemo.

Taking AuroMemo with food, drink and alcohol
Inform your attending physician if the patient has recently made or plans to make significant changes in diet (e.g. switching from a normal diet to a strict vegetarian diet), or if the patient has been diagnosed with renal tubular acidosis (RTA, excessive levels of acidic substances in the blood caused by kidney dysfunction), or severe urinary tract infections (structures through which urine flows). In the above cases, the attending physician may need to modify the dosage of the medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Memantine is not recommended for use in pregnant women.

Breastfeeding
Women taking AuroMemo should not breastfeed.

Driving and operating machinery
The attending physician should advise the patient whether their condition allows them to drive or operate machinery safely.
AuroMemo may additionally affect reaction speed, thus driving vehicles or operating machinery may be contraindicated.

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use AuroMemo

This medicine should always be used according to the instructions of the treating physician. In case of doubts,
please consult your doctor or pharmacist.
Dosage
The recommended therapeutic dose of AuroMemo for adults and elderly patients is 20 mg per
day. To reduce the risk of adverse effects, this dose should be reached gradually,
using the following daily treatment schedule:

The usual starting dose is 5 mg or half a 10 mg tablet once daily (5 mg) for the first week. In the second week, the dose is increased to one 10 mg tablet daily (10 mg), and in the third week to one and a half 10 mg tablets or 15 mg once daily. From the fourth week onwards, the usual dose is two 10 mg tablets or one 20 mg tablet once daily (20 mg).
Dosage in patients with renal impairment
In patients with impaired renal function, the appropriate dosage of the medicinal product should be determined by the treating physician. In such cases, renal function must be continuously monitored at regular intervals, as recommended by the treating physician.
Method of administration
AuroMemo should be administered orally, once daily. To ensure effective treatment, the medicinal product should be taken regularly every day at the same time. Tablets should be swallowed with water. This medicinal product may be taken with food or independently of meals.
Duration of treatment
Treatment should be continued as long as it produces beneficial effects. The treating physician should regularly assess the course of treatment.
Use of a higher than recommended dose of AuroMemo

• Generally, taking an excessive dose of AuroMemo does not pose a health risk. In such a case, enhanced adverse reactions described in section 4, "Possible adverse effects," may occur.
• In case of significant overdose with AuroMemo, contact the treating physician or another doctor, as appropriate management measures may become necessary.

Missed dose of AuroMemo

• If a patient forgets to take the medicinal product, the next dose should be taken at the usual time.
• A double dose should not be taken to make up for the missed dose.

If you have any further questions concerning the use of this medicinal product, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Generally observed adverse effects are mild to moderate in severity.
Common (may occur in up to 1 in 10 people):

• Headache, drowsiness, constipation, increased liver enzyme levels, dizziness,
  imbalance, shallow breathing, high blood pressure, and hypersensitivity to the medicine

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

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

Very rare (may occur in up to 1 in 10,000 people):

• Seizures

Frequency not known (frequency cannot be estimated from 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 of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store AuroMemo

Keep this medicine out of 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 stated month.
No special storage instructions apply to this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

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

• 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.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, colloidal anhydrous silica, microcrystalline cellulose silicified, sodium carboxymethyl starch (type A), talc, sodium stearyl fumarate.

Tablet 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
Film-coated tablet.
AuroMemo 10 mg film-coated tablets
White or almost white, centrally bevelled, elongated, biconvex film-coated tablets with a single score line on both sides and engraved with "ME" and "10" on either side of the breakline 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 film-coated tablets
Light red to grey-red, oval, elongated, film-coated tablets, engraved with "ME" on one side and "20" on the other side. Size: 14.2 mm x 8.1 mm.
AuroMemo is available in blister packs and HDPE bottles, packed in cardboard boxes.
Pack sizes:
Blister packs: 14, 28, 30, 42, 50, 56, 60, 90, 98 and 112 film-coated tablets.
HDPE bottle: 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
Poland
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
This medicinal product is authorised in the European Economic Area countries 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, filmomhulde tabletten
Poland: AuroMemo
Spain: Memantina Aurobindo Pharma 10 mg/20 mg comprimidos recubiertos con película EFG