MEMANTINE STADAFARMA 20 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Memantina Flas Stadafarma

Do Not Take Memantina Flas Stadafarma:

• if you are allergic to memantine hydrochloride or 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 suffered a myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In these situations, treatment should be carefully monitored, and your doctor should regularly reassess the clinical benefit of memantine.

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

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

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

Children and Adolescents

The use of memantine is not recommended in children and adolescents under 18 years of age.

Other Medications and Memantina Flas Stadafarma

Tell 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)
• dopaminergic agonists (substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental illnesses)
• oral anticoagulants.

If you are hospitalized, 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 plan to change your diet substantially (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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

The use of memantine is not recommended in pregnant women.

Breastfeeding:

Women taking memantine should not breastfeed.

Driving and Using Machines

Your doctor will inform you if your condition allows you to drive and use machines safely. Also, memantine may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina Flas Stadafarma Contains Aspartame, Lactose, and Sodium

The 10 mg dose contains 2.5 mg of aspartame per tablet, and the 20 mg dose contains 5 mg per tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains lactose. If your doctor has told you 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".

3. How to Take Memantina Flas Stadafarma

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

Dosage

The recommended dose of memantine in adult and elderly patients is 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved following the following daily scheme:

Memantine tablets cannot be divided. For unavailable doses, you should use another medication that contains memantine with an available dose.

Maintenance Dose

The recommended daily dose is 20 mg once a day.

Consult your doctor for continuation of treatment.

Dosage for Patients with Renal Impairment

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

Method of Administration

Memantine should be administered 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 placed on the tongue and allowed to dissolve before swallowing them with or without water, as the patient prefers. The tablets can be taken with or without food.

Duration of Treatment

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

Instructions for Use

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

• Hold the blister pack by the ends and separate one of the cells from the rest, breaking it gently along the perforations that surround it.
• Gently remove the back of the cell.

Place 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

In general, taking an overdose of memantine should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible Side Effects".

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 ingested.

If You Forget to Take Memantina Flas Stadafarma

• If you realize you have forgotten to take your dose of memantina, wait and take the next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In general, side 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, difficult breathing, high blood pressure, and hypersensitivity to the medication.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

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

• Seizures.

Frequency Not Known (frequency cannot be estimated from 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 memantine.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Memantina Flas Stadafarma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister pack after "EXP". 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Memantina Flas Stadafarma

• The active ingredient is memantine hydrochloride. Each 10 mg orodispersible tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine. Each 20 mg orodispersible tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

• The other components are polacrilin, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, mannitol (E421), sodium croscarmellose, aspartame (E951), anhydrous colloidal silica, red iron oxide (E172), peppermint flavor [composed of maltodextrin (from corn), modified corn starch E1450, peppermint oil (Mentha arvensis)], and magnesium stearate.

Appearance of the Product and Package Contents

Memantina Flas Stadafarma 10 mg orodispersible tablets are pale pink, round, flat, speckled, with beveled edges, 9 mm in diameter, and engraved with a "10" on one side.

Memantina Flas Stadafarma 20 mg orodispersible tablets are pale pink, round, flat, speckled, with beveled edges, 12 mm in diameter, and engraved with a "20" on one side.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

or

Laboratori Fundació DAU

c/ C 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona

Spain

Date of the Last Revision of this Package Leaflet:March 2021

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