Package Insert: Information for the Patient

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

1.What is Memantina TecniGen and how is it used

2.What you need to know before starting to take Memantina TecniGen

3.How to take Memantina TecniGen

4.Possible adverse effects

5Storage of Memantina TecniGen

6.Contents of the package and additional information

How Memantina TecniGen works

Memantina TecniGen 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 receptors called N-methyl-D-aspartate (NMDA) that participate in the transmission of important nervous signals in learning and memory. Memantina TecniGen belongs to the group of medications called NMDA receptor antagonists. Memantina TecniGen acts on these receptors by improving the transmission of nervous signals and memory.

What Memantina TecniGen is used for

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

Do not take Memantina TecniGen

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 TecniGen:

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

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

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

Memantine use should be avoided 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.

Memantine use is not recommended in children and adolescents under 18 years old.

Taking Memantina TecniGen with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, even those purchased without a prescription.

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

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 TecniGen.

Taking Memantina TecniGen with food, drinks, and alcohol

You should inform your doctor if you have recently changed or plan to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, 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 dose.

Pregnancy, breastfeeding, and fertility

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

Memantine use is not recommended in pregnant women.

Women taking Memantina TecniGen should discontinue breastfeeding.

Driving and operating machinery

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

Furthermore, Memantina TecniGen may alter your reaction time, making driving or operating machinery unsuitable.

Memantina TecniGen contains sodium

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 as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dosage

The recommended dose of Memantina TecniGen 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 below:

The 10 mg tablet can be divided into two equal halves.

There are tablets with different doses available for adjusting the dose.

The usual starting dose is half a tablet once a day (5 mg) in the first week. It is increased to one tablet a day (10 mg) in the second week and to one and a half tablets a day in the third week. From the fourth week onwards, the usual dose is two tablets 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 should monitor your renal function periodically.

Administration

Memantina TecniGen 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.

Treatment duration

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

If you take more Memantina TecniGen than you should

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

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

If you take an overdose of Memantina TecniGen, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to take Memantina TecniGen

If you realize you have forgotten to take your memantina dose, wait and take the next dose at the usual time.

Do not take a double dose to make up for the missed dose.

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

Like all medications, Memantina TecniGen may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect between 1 and 10 of every 100 patients):

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

Rare (may affect between 1 and 10 of every 1,000 patients):

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

Very rare (may affect fewer than 1 of every 10,000 patients):

• 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. There have been reports of these events in patients treated with memantina.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effects not mentioned in this prospectus, inform your doctor or pharmacist.

If you experience adverse effects, consult your doctor or pharmacist,even if they are adverse effects not listed in this prospectus.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Memantina TecniGen

The active ingredient is hydrochloride of memantine. Each film-coated tablet contains 10 mg of hydrochloride of memantine, which are equivalent to 8.31 mg of memantine.

The other components are microcrystalline cellulose, povidone K-25, sodium croscarmellose and magnesium stearate, in the tablet core; and hydroxypropyl cellulose and talc, in the tablet coating.

Appearance of the product and content of the packaging

Memantina TecniGen is presented in the form of film-coated tablets of white color, oblong biconvex shape, scored on one face. The tablet can be divided into two equal doses.

Memantina TecniGen tablets are presented in packaging of 28, 56 and 112 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor.

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

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

Portugal: Memantina TecniGen

Italy: Memantina Tecnimede

Spain: Memantina TecniGen 10 mg film-coated tablets EFG

Revision date of this leaflet:July 2023

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