Memantina Viatris 5 mg/actuation, oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantina Viatris 5 mg/spray, oral solution EFG

Memantine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Memantina Viatris is and what it is used for
2. What you need to know before taking Memantina Viatris
3. How to take Memantina Viatris
4. Possible adverse effects
5. How to store Memantina Viatris
6. Contents of the pack and other information

1. What Memantina Viatris is and what it is used for

Memantina Viatris contains memantine hydrochloride as the active substance. It belongs to a group of medicines known as antidementia drugs.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Viatris belongs to a group of medicines called NMDA receptor antagonists. Memantina Viatris acts on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina Viatris

Do not take Memantina Viatris

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Memantina Viatris

• If you have a history of epileptic seizures.
• If you have recently had a myocardial infarction (heart attack), if you have congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).

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

If you have renal impairment (kidney problem), your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.

The use of memantine together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), 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 medicines and Memantina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, taking memantine may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• Amantadine, ketamine, dextromethorphan.
• Dantrolene, baclofen.
• Cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine.
• Hydrochlorothiazide (or any combination containing hydrochlorothiazide).
• Anticholinergics (substances generally used to treat movement disorders or intestinal spasms).
• Anticonvulsants (substances used to prevent and stop 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 admitted to hospital, inform your doctor that you are taking Memantina Viatris.

Taking Memantina Viatris with food and drink

You should inform your doctor if you have recently changed or intend to make substantial changes to your diet (for example, switching 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 (kidney problem)) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of memantine during pregnancy is not recommended.

Breastfeeding

Women taking memantine should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely.

Furthermore, memantine may affect your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Viatris contains sorbitol

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

3. How to take Memantina Viatris

Follow exactly the administration instructions for Memantina Viatris given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage

Please follow the instructions below when using the dispenser. Pictograms are attached with the necessary instructions for correct use of the dispenser.

One press delivers 5 mg of memantine hydrochloride.

The recommended dose of Memantina Viatris in adult patients and elderly patients is four presses of the dispenser, equivalent to 20 mg administered once daily. In order to reduce the risk of adverse effects, this dose should be reached gradually according to the following daily treatment schedule:

The usual starting dose is one spray (5 mg) once daily during the first week. This dose is increased in the second week to two sprays once daily (10 mg) and in the third week to three sprays once daily (15 mg). From the fourth week onwards, the recommended dose is four sprays once daily (20 mg).

Dosage for patients with renal impairment

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

Administration

Memantina Viatris should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day and at the same time each day. The solution should be taken with a small amount of water. The solution may be taken with or without food.

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

Duration of treatment

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

If you take more Memantina Viatris than you should

• In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
• In general, taking an excessive amount of Memantina Viatris should not cause you any harm. You may experience an increase in the symptoms described in section 4, “Possible side effects”.

If you forget to take Memantina Viatris

If you realize you have forgotten to take your dose of Memantina Viatris, 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

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

• Headache, drowsiness, constipation, increased liver function tests, dizziness, loss of balance, difficult breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (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 thrombosis/venous thromboembolism).

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

• Seizures.

Frequency not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, inflammation of the liver (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 of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Viatris

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

Do not use this medicine after the expiry date stated on the carton and on the label of the bottle after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After opening, the contents of the bottle should be used within 12 weeks.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Memantina Viatris

The active substance is memantine hydrochloride.

Each pump actuation delivers 0.5 ml of solution containing 5 mg of memantine hydrochloride, equivalent to 4.16 mg of memantine.

Each ml of solution contains 10 mg of memantine hydrochloride.

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

Appearance of the product and contents of the container

Memantina Viatris oral solution is a clear, colourless to slightly yellowish solution.

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

A dosing device is included.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Chanelle Medical Unlimited Company
Dublin Road, Loughrea, Co. Galway
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Memantinhydrochlorid beta 10 mg/ml Lösung zum Einnehmen
Italy MEMANTINA DOC
Spain Memantina Viatris 5 mg/actuation, oral solution EFG
Netherlands Memantine 10 mg/ml drink
United Kingdom Memantine Hydrochloride 10 mg/ml oral solution
Slovak Republic Memantin Chanelle 10 mg/ml perorálny roztok

Date of latest revision of this leaflet: May 2021

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

Instructions for correct use of the dosing device

The solution must not be poured or dispensed directly into the mouth from the bottle or dosing device. The dose should be measured into a spoon or a glass of water using the dosing device.

Remove the screw cap from the bottle:
The cap must be turned counterclockwise, completely unscrewed and removed (Fig. 1).

Assembling the dosing device onto the bottle:
Remove the dosing device from the plastic bag (Fig. 2) and place it on top of the bottle. Carefully insert the plastic tube down into the bottle. Hold the dosing device on the neck of the bottle and turn it clockwise until firmly secured (Fig. 3). The dosing device should be screwed on only once at the beginning of use and must never be unscrewed.

How the dosing device works:
The dosing device head has two positions and turns easily:

• counterclockwise direction to open, and
• clockwise direction to close.

The dosing device head must not be pressed down while in the closed position. The solution can only be dispensed when in the open position. To open, turn the dosing device head in the direction of the arrow until it stops (approximately one-eighth of a turn, Fig. 4). The dosing device is then ready for use.

Preparing the dosing device:
When used for the first time, the dosing device does not deliver the correct amount of oral solution. Therefore, it must be primed by fully depressing the dosing device head completely five consecutive times (Fig. 5).

The solution dispensed during priming must be discarded. The next time the dosing device head is fully depressed (equivalent to one actuation), it will deliver the correct dose (Fig. 6).

Correct use of the dosing device:
Place the bottle on a flat, horizontal surface, for example on a table, and use it only in an upright position. Place a glass with a small amount of water or a spoon under the nozzle. Press the dosing device head down firmly, steadily and not too slowly (Fig. 7 and Fig. 8).

Then release the dosing device head; it will be ready for the next actuation.

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