Package Insert: Information for the Patient

Memantine Sandoz 20 mg Film-Coated Tablets

memantine hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

How Memantina Sandoz works

Memantina belongs to a group of medications known as dementia medications.

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 nervous signals in learning and memory. Memantina belongs to the group of medications called NMDA receptor antagonists. Memantina acts on these receptors by improving the transmission of nervous signals and memory.

What Memantina Sandoz is used for

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

Do not take Memantina Sandoz

• 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 Sandoz:

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

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

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 for anesthesia), dextromethorphan (a medication for cough treatment), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Specifically, the administration of Memantina Sandoz may 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 like 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 Sandoz.

Taking Memantina Sandoz with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking memantine should discontinue breastfeeding.

Driving and operating machinery

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

Additionally, memantine may alter your reaction time, making driving or operating machinery unsuitable.

Memantina Sandoz contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; it is essentially "sodium-free".

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

Dosage

The recommended dose of memantine in adult 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 below:

Dosage for patients with renal insufficiency

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

Administration

Memantine should be administered 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.

The tablets can be divided into four equal doses, as described in the diagram. If necessary, place the tablet on a smooth surface with the score lines facing up, press the tablet with your thumb.

Treatment duration

Continue taking memantine as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Generally, taking an excessive amount of memantine 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 Sandoz

• If you realize you have forgotten to take your memantine dose, 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 medication, 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 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.

Poorly frequent,may affect up to 1 in 100 people:

• fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorder, heart failure, and formation of blood clots in the venous system (thrombosis/thromboembolism).

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

• seizures.

Unknown frequency,the frequency cannot be estimated from the available data:

• pancreatitis, hepatitis, and psychotic reactions.

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

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 theSpanish System for Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the blister or label and packaging after CAD. The expiration date is the last day of the month indicated.

After the first opening, use the contents of the bottle within 6 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Memantine Sandoz Composition

• The active ingredient is memantine. Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg of memantine.
• The other components are lactose monohydrate, carboxymethylstarch sodium (type A) from potato, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate in the core;

alcohol polyvinyl, macrogol, titanium dioxide (E 171), talc, red iron oxide (E 172), and yellow iron oxide (E 172) in the coating.

Appearance of the product and contents of the package

Coated tablets with a brownish-red film, round (11.1 mm in diameter) with two cross-shaped score lines on one side.

The tablet can be divided into equal doses.

Coated tablets are packaged in transparent PVC-Alu blisters or transparent PVC-PVDC-Alu blisters or in HDPE bottles with PP screw caps with a safety closure and desiccant inserted in a cardboard package.

Package sizes:

Blister: 7, 10, 14, 18, 20, 22, 28, 30, 40, 42, 45, 48, 49, 49x1, 50, 56, 56x1, 60, 70, 84, 90, 96, 98, 98x1, 100, 100x1, 112, 980 (10x98) or 1000 (20x50) coated tablets.

Bottle: 28, 30, 56, 98, 100, or 112 coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek S.A

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179

Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

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

Netherlands:Memantine Sandoz 20 mg, filmomhulde tabletten

Austria:Memantin Sandoz 20 mg – Filmtabletten

Belgium:MemantineSandoz 20 mg filmomhulde tabletten

Cyprus:MemantineSandoz20mgtabs

Czech Republic:MemantinSandoz20mg

Germany:Memantin HEXAL 20 mg Filmtabletten

Denmark:MemantineSandoz

Greece:Memantine/Sandoz

Finland:Memantine Sandoz 20 mg tabletti, kalvopäällysteinen

France:MemantineSandoz20mg,comprimé pelliculé sécable

Iceland:Memantine Sandoz

Luxembourg:MemantineSandoz 20 mg comprimés pelliculés

Malta:Memantine 20 mg Film-coated Tablets

Norway:Memantine Sandoz

Portugal:Memantina Sandoz

Sweden:Memantine Sandoz

United Kingdom:Memantine 20 mg Film- coated Tablets

Last review date of this leaflet: May 2020

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/