Package Leaflet: Information for the User

Memantina Aristo 20 mg Coated Tabletswithfilm EFG

Memantine hydrochloride

Read this leaflet carefully before you start totake this medicine, because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only, do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctoror pharmacist, even if they are not listed in this leaflet. See section 4.

How Memantina Aristo works

Memantina Aristo contains the active ingredient memantine hydrochloride. This belongs to a group of medicines known as dementia medicines.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Memantinabelongs to the group of medicines called NMDA receptor antagonists. Memantina acts on these receptors by improving the transmission of nerve signals and memory.

When is Memantina Aristo used:

Memantina Aristo is used in the treatment of patients with moderate to severe Alzheimer's disease.

Do not take Memantina Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Aristo,

• if you have a history of epileptic seizures (convulsions).
• if you have recently had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be closely monitored and your doctor should regularly reevaluate the clinical benefit of Memantina Aristo.

If you have renal insufficiency (kidney problems), your doctor should closely monitor your renal function and, if necessary, adjust the memantine dosage.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used to induce anesthesia), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents.

Memantina Aristo is not recommended for use in children and adolescents under 18 years old.

Use of Memantina Aristowith other medications

Inform your doctor or pharmacistif you are taking, have taken recently or mayneed to take any other medication.

Specifically, the administration of memantinemay produce changes in the effects of the following medications, so your doctor may need to adjust the dosages:

• amantadine, ketamine, dextromethorphan.
• dantrolene, baclofen.
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine.
• hydrochlorothiazide (or any combination with hydrochlorothiazide).
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms).
• anticonvulsants (substances used to prevent and eliminate seizures).
• barbiturates (substances generally used to induce sleep).
• dopamine agonists (substances such as L-dopa, bromocriptine).
• neuroleptics (substances used in the treatment of mental illnesses).
• oral anticoagulants.

If you are admitted to a hospital, inform your doctor that you are taking Memantina Aristo.

Taking Memantina Aristowith food and drinks

You should inform your doctor if you have recently changed or intend to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (ATR, excess of acid-producing substances in the blood due to renal dysfunction(kidney problem)) or severe urinary tract infections (urine conduit), as your doctor may need to adjust the medication dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy
Memantina is not recommended for use in pregnant women.

BreastfeedingWomen taking Memantina Aristoshould discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Your condition may affect your ability to drive or use machinery and you should not engage in these activities unless your doctor indicates it is safe to do so.

Memantina Aristomay cause dizziness and somnolence, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Furthermore, Memantina Aristomay alter your reaction time, making driving or operating machinery inappropriate.

Memantina Aristocontains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Memantina Aristo in adult patients and elderly patients is 20 mg administered once a day.

To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule:

The treatment is initiated with a dose of 5 mg once a day. This dose is increased weekly by 5 mg per week until the recommended dose (maintenance dose) is reached. The recommended maintenance dose is 20 mg once a day and will be achieved at the beginning of the fourth week following the mentioned schedule.

There are tablets with different doses available to adjust the dosage.

Dosage for patients with reduced renal function

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor must monitor your renal function periodically.

Administration

Memantina Aristo must be taken orally once a day. To get the most out of your medication, you should take it every day at the same time. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment duration

Continue taking Memantina Aristo as long as it benefits you. Your doctor should evaluate your treatment periodically.

If you take more Memantina Aristo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

Generally, taking an excessive amount of Memantina Aristo should not cause any harm. You may experience an increase in the symptoms described in section 4 "Possible adverse effects".

If you forgot to take Memantina Aristo

• If you realize you have forgotten to take your dose of Memantina Aristo, wait and take the next dose at the usual time.
• Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication.

Less frequent (may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and formation of blood clots in the venous system (venous thromboembolism).

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

• Seizures.

Unknown frequency (frequency cannot be estimated from available data):

• Pancreatitis, hepatitis (liver inflammation), and psychotic reactions.

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

• Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Memantine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system:National System for Pharmacovigilance of Medicines for Human Use:Website:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and in the blister pack after CAD.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Memantina Aristo

The active ingredient is Memantine hydrochloride.

Each coated tablet of 20 mg contains 20 mg ofMemantine hydrochloridewhich is equivalent to 16.62 mg of memantine.

The other components are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, anhydrous colloidal silica, hypromellose, Macrogol 4000, titanium dioxide (E 171).

Appearance of the product and contents of the package

Memantina Aristo 20 mg coated tablets are presented in the form of oval-shaped tablets with a white or almost white color. Each tablet has three breaking lines on both sides by which it can be divided into four equal parts.

Memantina Aristo 20 mg coated tablets:

Memantina Aristo coated tablets are presented in blisters containing the tablets. Memantina Aristo coated tablets are available in packaging of 7, 28, 30, 42, 50, 56, 98 and 100.

Clinical packaging of 420 coated tablets with a film.

Only some package sizes may be commercially marketed.

Marketing Authorization Holder

Aristo Pharma Iberia S.L.

C/ Solana 26

28850 – Torrejón de Ardoz, Madrid

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)
C/ Solana 26

28850 – Torrejón de Ardoz, Madrid

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

13435 Berlin, Germany

NEURAXPHARM ARZNEIMITTEL GMBH U CO.KG

Elisabethselbert Strasse, 23

Langenfeld – 40764, Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Memantin Aristo 20 mg Filmtabletten

Poland:Memantin NeuroPharma 20 mg

Portugal:Memantina Aristo / 20 mg coated tablets

Spain:Memantina Aristo 20 mg coated tablets with film EFG

Last review date of this leaflet: September 2017

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices: http://www.aemps.gob.es/