Memantina viatris 5 mg/pulsaciÓn, soluciÓn oral efg

PATIENT INFORMATION LEAFLET

Memantina Viatris 5 mg/beat, oral solution EFG

Hydrochloride of memantine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMemantina Viatrisand for what it is used

2. What you need to know before starting to takeMemantina Viatris

3. How to takeMemantina Viatris

4. Possible side effects

5. Storage ofMemantina Viatris

6. Contents of the package and additional information

Memantina Viatris contains memantine hydrochloride as the active ingredient.Pertains 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 Viatrisbelongs to the group of medications called NMDA receptor antagonists.Memantina Viatrisacts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Memantina Viatris

- If you are allergic to hydrochloride memantine or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeMemantina Viatris

• 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 memantinaregularly.

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

The use of memantine should be avoided 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

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

Other medications and Memantina Viatris

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

Specifically, the administration of memantinamay 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 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 takingMemantina Viatris.

Taking Memantina Viatris with food and drinks

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 kidney tubular acidosis (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 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

The use of memantine is not recommended during pregnancy.

Breastfeeding

Women taking memantinashould discontinue breastfeeding.

Driving and operating machinery

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

Additionally, memantinamay alter your reaction time, making driving or operating machinery inappropriate.

Memantina Viatris contains sorbitol

This medication contains 36 mg of sorbitol in each 0.5 ml, which is equivalent to 72 mg/ml.

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Follow exactly the administration instructions forMemantina Viatrisprescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Dosage

Please follow the following instructions when using the dosifier. Pictograms are attached with the necessary indications for the correct use of the dosifier.

One pulse contains 5 mg of hydrochloride memantine.

The recommended dose ofMemantina Viatrisin adult patients and elderly patients is four pulses of the dosifier, equivalent to 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily treatment schedule:

The starting dose is one pulse (5 mg) once a day in the first week. This dose is increased in the second week to two pulses once a day (10 mg) and in the third week to three pulses once a day (15 mg). From the fourth week, the recommended dose is four pulses 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 Viatrismust 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 solution should be taken with a little water. The solution can be taken with or without food.

For detailed instructions on the preparation and handling of the product, see the end of this prospectus.

Treatment duration

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

If you take more Memantina Viatristhan 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 ofMemantina Viatrisshould notcause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

If you forgot to take Memantina Viatris

If you realize you have forgotten to take your dose ofMemantina Viatris, wait and take the next dose at the usual time. Do not take a double dose to compensate for the missed dose.

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 may 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.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, 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 associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated withmemantina.

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 about 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 box and on the bottle label after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once opened, the contents of the bottle must be used within 12 weeks.

The bottle with the dosing device attached must be stored and transported only in an upright position.

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

Composition ofMemantina Viatris

The active ingredient is hydrochloride of memantine.

Each pump of the dosifier releases 0.5 ml of solution, which contains 5 mg of hydrochloride of memantine equivalent to 4.16 mg of memantine.

Each ml of solution contains 10 mg of hydrochloride of memantine.

The other components are: potassium sorbate E-202, liquid sorbitol (non-crystallized) (E-420) and purified water.

Appearance of the product and contents of the package

Memantina Viatris oral solution is a transparent, colorless to slightly yellowish solution.

Memantina Viatris oral solution is presented in 50 ml, 100 ml or 10 x 50 ml bottles.

A dosifier is included.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, Co. Galway,

Ireland

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyMemantinhydrochlorid beta 10 mg/ml Lösung zum Einnehmen

ItalyMEMANTINA DOC

SpainMemantina Viatris 5 mg/pulsación, solución oral EFG

NetherlandsMemantine 10 mg/ml drank

United KingdomMemantine Hydrochloride 10 mg/ml oral solution

Slovak RepublicMemantin Chanelle 10 mg/ml perorálny roztok

Last review date of this leaflet:May2021

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

Instructions for the correct use of the dosifier

The solution must not be poured or dispensed directly into the mouth from the bottle or dosifier. Measure the dose in a spoon or in a glass of water using the dosifier.

Removing the rosca cap from the bottle:

The cap must be turned in the opposite direction to the clock, completely unscrewed and removed (fig. 1).

Mounting the dosifier on the bottle:

Remove the dosifier from the plastic bag (fig. 2) and place it on top of the bottle. Carefully insert the plastic tube into the bottle. Keep the dosifier on the bottle neck and turn it clockwise until it is securely attached (fig. 3). The dosifier should only be screwed on once when starting use and should never be unscrewed.

How the dosifier works:

The dosifier head has two positions and turns easily:

- in the opposite direction to the clock to open and

- in the direction of the clock to close.

The dosifier head should not be pressed down while it is in the closed position. The solution can only be dispensed in the open position. To open, turn the dosifier head in the direction indicated by the arrow until it cannot be turned any further (about one-eighth of a turn, fig. 4). The dosifier is then ready for use.

Preparing the dosifier:

When used for the first time, the dosifier does not dispense the correct amount of oral solution. Therefore, it must be prepared (primed) by pressing the dosifier head down completely five times in a row (fig. 5).

The solution dispensed in this way must be discarded. The next time the dosifier head is pressed down completely (equivalent to one press), it already dispenses the correct dose (fig. 6).

Correct use of the dosifier:

Place the bottle on a flat, horizontal surface, such as a table, and use it only in a vertical position.Place a glass with a little water or a spoon under the nozzle. Press the dosifier head down firmly, but calmly, steadily and not too slowly (fig. 7 and fig. 8).

Subsequently, the dosifier head can be released and will be ready for the next press.

The dosifier should only be used with the Memantina Viatris solution in the bottle provided, not for other products or containers. If the dosifier does not work correctly, consult your doctor or pharmacist. Close the dosifier after using Memantina Viatris.