Package Insert: Information for the User

Memantine Aurovitas 10 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 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.

6. Contents of the pack and additional information

Memantina Aurovitas contains the active ingredient memantine hydrochloride. It 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 nervous signals in learning and memory. Memantina Aurovitas belongs to the group of medicines called NMDA receptor antagonists. Memantina Aurovitas acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Memantina Aurovitas:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Aurovitas:

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

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

If you have 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 as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

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

Use of Memantina Aurovitas with other medications

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

Specifically, the administration of Memantina Aurovitas may produce changes in the effects of the following medications, so your doctor may need to adjust the dosage:

• 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 Aurovitas.

Use of Memantina Aurovitas with food, drinks, and alcohol

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 acidosis tubular renal (ATR, excess of 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, 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 Memantina Aurovitas should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely. Additionally, Memantina Aurovitas may alter your reaction time, making driving or operating machinery unsuitable.

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

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

The recommended dose of Memantina Aurovitas 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:

The normal starting dose is half a tablet of 10 mg once a day (5 mg) in the first week. It is increased to one tablet of 10 mg a day (10 mg) in the second week and to 1 tablet and a half of 10 mg once a day in the third week. From the fourth week onwards, the normal dose is 2 tablets of 10 mg or 1 tablet of 20 mg administered once a day (20 mg).

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 must monitor your renal function periodically.

Administration

Memantina Aurovitas must be taken orally once a day. To get the most out of your medication, you should take it every day and 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 Aurovitas as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina Aurovitas than you should

• Generally, taking an excessive amount of Memantina Aurovitas should not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.
• If you take a Memantina Aurovitas overdose, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to take Memantina Aurovitas

• If you realize you have forgotten to take your Memantina Aurovitas 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 thismedication, ask your doctor or pharmacist.

Like all medications, Memantina Aurovitas may produce adverse effects, although not everyone will experience them.

Adverse effects are generally classified as mild to moderate.

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

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

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

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

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

• Seizures.

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

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

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

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 Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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 label, box, bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Memantina Aurovitas

• The active ingredient is hydrochloride of memantine.

Each film-coated tablet contains 10 mg of hydrochloride of memantine equivalent to 8.31 mg of memantine.

• The other components (excipients) are:

Core of the tablet:microcrystalline cellulose, silica gel, anhydrous colloidal silica, sodium glycolate (type A) starch, talc, and sodium stearate fumarate.

Covering:hydroxypropyl cellulose, titanium dioxide (E171), macrogol (6000)andtalc.

Appearance of the product and contents of the package

Film-coated tablets.

Memantina Aurovitas 10 mg film-coated tablets[Size: approximately 12.7 mm x 5.7 mm]

Film-coated tablets, white or off-white, oval, biconvex, with a single line of breakage on both sides and engraved with ‘ME’ and ‘10’ on each side of the breakage line of one of the faces and smooth on the other face.

The tablet can be divided into equal doses.

Memantina Aurovitas film-coated tablets are presented in transparent PVC/PE/PVdC/Aluminum blisters and HDPE bottles.

Blister:

For 10 mg tablets:14, 28, 42, 56, 98, 100, and 112 film-coated tablets.

For 20 mg tablets:28, 42, 56, and 98 film-coated tablets.

Bottle:60 and 1,000 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

France:MEMANTINE ARROW LAB 10 mg, film-coated tablet

Germany:Memantin Aurobindo 10 mg Filmtabletten

Malta:Memantine Aurobindo 10 mg film-coated tablets

Portugal:Memantina Aurobindo

Romania:Memantina Aurobindo 10 mg film-coated tablets

Spain:Memantina Aurovitas 10 mg film-coated tablets EFG

Last review date of this leaflet:December 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/