Product Information for the Patient

Memantina Flas Stadafarma 10 mg Bucodispersable Tablets EFG

Memantina Flas Stadafarma 20 mg Bucodispersable Tablets EFG

Hydrochloride of Memantine

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

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they 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 product information. See section 4.

1. What is Memantina Flas Stadafarma and for what it is used

2. What you need to know before starting to take Memantina Flas Stadafarma

3. How to take Memantina Flas Stadafarma

4. Possible adverse effects

5. Storage of Memantina Flas Stadafarma

6. Contents of the package and additional information

How Memantina Flas Stadafarma works

Memantina Flas Stadafarma contains the active ingredient hydrochloride of memantine.

Memantine belongs to a group of medications known as antidementia medications. Memory loss 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. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nervous signals and memory.

What is Memantina Flas Stadafarma used for

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

Do not take Memantina Flas Stadafarma:

- if you are allergic to hydrochloride of 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 memantine:

- if you have a history of epileptic seizures

- 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 must reevaluate the clinical benefit of memantine regularly.

If you have kidney problems, your doctor must closely monitor your renal function and, if necessary, adjust the dose of memantine.

If you have renal tubular acidosis (ATR, excess of acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, your doctor may need to adjust the dose of the medication.

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

Children and adolescents

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

Other medications and Memantina Flas Stadafarma

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

In particular, the administration of memantine 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 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 memantine.

Taking Memantina Flas Stadafarma 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), as your doctor may need to adjust the dose of the medication.

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:

Memantine is not recommended for use in pregnant women.

Breastfeeding:

Women taking memantine should not breastfeed.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and operate machinery safely. Additionally, memantine may alter your reaction time, making driving or operating machinery inappropriate.

Memantina Flas Stadafarma contains aspartame, lactose and sodium

The 10 mg dose contains 2.5 mg of aspartame in each tablet and the 20 mg dose contains 5 mg in each tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

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

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

Dosage

The recommended dose of memantine 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:

Memantine tablets cannot be split.For doses not available, you should use another medication containing memantine whose dose is available.

Maintenance dose

The recommended daily dose is 20 mg once a day.

Consult your doctor for continuation of treatment.

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 form

Memantine must be administered orally once a day. To get the most out of your medication, you must take it every day and at the same time. The tablets should be placed on the tongue and allowed to dissolve before swallowing with or without water, as preferred by the patient. The tablets can be taken with or without food.

Treatment duration

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

Usage instructions

Memantine buccal tablets are easily broken, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

- Hold the blister by the ends and separate one of the cells from the rest, breaking it gently through the perforations that surround it.

- Remove the back part of the cell gently.

Deposit the tablet on your tongue. It will dissolve directly in the mouth, so it can be swallowed without water.

If you take more Memantina Flas Stadafarma than you should

Generally, taking memantine in excess should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

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

If you forgot to take Memantina Flas Stadafarma

- 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 doubts 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 classified as mild to moderate.

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

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

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait alteration, 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, and psychotic reactions.

Alzheimer's disease has been linked to 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 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 carton packaging and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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. 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 Flas Stadafarma

- The active ingredient is hydrochloride of memantine. Each buccal dispersible tablet of 10 mg contains 10 mg of hydrochloride of memantine, equivalent to 8.31 mg of memantine. Each buccal dispersible tablet of 20 mg contains 20 mg of hydrochloride of memantine, equivalent to 16.62 mg of memantine.

- The other components are carboxymethylcellulose, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, mannitol (E421), sodium croscarmellose, aspartame (E951), anhydrous colloidal silica, iron oxide red (E172), peppermint flavor [composed of cornstarch (corn), modified cornstarch (corn), peppermint oil (Mentha arvensis)] and magnesium stearate.

Appearance of the product and contents of the packaging

The buccal dispersible tablets of Memantina Flas Stadafarma 10 mg are pale pink, rounded, flat, speckled, with beveled edges, with a diameter of 9 mm, and engraved with a “10” on one of the faces.

The buccal dispersible tablets of Memantina Flas Stadafarma 20 mg are pale pink, rounded, flat, speckled, with beveled edges, with a diameter of 12 mm, and engraved with a “20” on one of the faces.

The packaging is available in sizes of 112 tablets for the 10 mg dose and 56 tablets for the 20 mg dose.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

or

Rontis Hellas Medical And Pharmaceutical Products S.A.

Industrial Area of Larissa, P.O. Box 3012,

GR41004 Larissa

Greece

or

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice

Poland

Last review date of this leaflet:March 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)