PATIENT INFORMATION LEAFLET

Memantina Stada5mg/tablet, oral solution EFG

Memantine hydrochloride

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have similar symptoms to yours, 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.

Memantina Stada contains memantina as the active principle.

What is Memantina Stada used for

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

How Memantina Stada works

Memantina belongs to a group of medications known as dementia medications.

The 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.

Memantina belongs to the group of medications called NMDA receptor antagonists. Memantina acts on these receptors by improving the transmission of nervous signals and memory.

Do not take Memantina Stada

• if you are allergic (hypersensitive) to hydrochloride of memantine or to any of the other components of this medication(see section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Stada.

• if you have a history of epileptic seizures.
• if you 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 ofmemantineregularly.

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

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 as an anesthetic), 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.

Taking Memantina Stada with other medications

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

In particular, the administration ofmemantinemay 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 Memantina Stada.

Taking Memantina Stada with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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.

Memantine is not recommended during pregnancy.

Women taking memantine should discontinue breastfeeding.

Driving and operating machinery

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

Memantina Stada contains sorbitol

This medication contains 100 mg of sorbitol in each ml of oral solution.

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

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 of memantine in adult patients and elderly patients is four pulses of the dosifier, which is equivalent to 20 mg once a day. In order to reduce the risk of adverse effects, this dose is achieved gradually following the daily treatment schedule:

The starting dose is one pulse once a day (5 mg) 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).

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.

Remove the cap from the bottle:

The cap must be turned in the opposite direction to the clock hands, unscrewed completely 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. Insert the plastic tube carefully into the bottle. Keep the dosifier on the bottle neck and turn in the direction of the clock hands until it is firmly attached (fig.3). The dosifier should only be screwed 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 hands to open
• in the direction of the clock hands 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 should be discarded. The next time the dosifier head is pressed down completely (equivalent to one pulse), it already dispenses the correct dose (fig.6).

Correct use of the dosifier:

Place a glass with a little water or a spoon under the nozzle. Press the dosifier head down firmly but calmly and sustainably, not too slowly (fig.7, fig.8).

The head can then be released and is ready for the next pulse.

The dosifier should only be used with memantine 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 memantine.

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 regularly.

Administration

Memantine Stada should be taken orally once a day. To get the most out of your medication, you should take it every day at the same time. The solution should be taken with a little water. The solution can be taken with or without food.

Treatment duration

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

Should you take more Memantina Stada than 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 of memantine should not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

Should you forget to take Memantina Stada

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 dose.

Should you interrupt treatmentwithMemantina Stada

If you want to stop treatment before completing the treatment course, talk to your doctor or pharmacist.

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 will experience them.

Generally, the adverse effects observed are mild to moderate.

Frequent (affects between1 and 10 of every 100 patients):

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

Less frequent (affects between1 and 10 of every 1,000 patients):

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

Very rare (affectsless than 1 of every 10,000 patients):

Seizures.

Unknown frequency (the frequency cannot be estimated from the 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 beenreportsof the occurrence of these events 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 an adverse effect not listed in this prospectus. You can also report them directly through thenationalsystemofnotificationincludedintheSpanish System of 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 usethis medicationafter the expiration date that appears on the packaging and on the bottle after CAD. 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 a maximum of 12 weeks.

The bottle with the dosifier attachedmustbe storedandtransported only in a vertical position.

Medications should not be thrown away through drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition ofMemantina Stada

The active ingredient is hydrochloride of memantine.

Eachdosageofthedosifier(onedosage)releases0.5mlofsolutioncontaining5mgofhydrochlorideofmemantine,equivalentto4.16mgofmemantine. Each ml of solution contains 10 mg of hydrochloride of memantine.

The other components are potassium sorbate (E202), liquid non-crystallizable sorbitol (E420) and purified water.

Appearance of the product and contents of the package

Memantina Stada oral solution is presented in the form of a transparent, colorless yellowish solution.

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

A dosifier is included.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

Chanelle Medical

Loughrea, Co. Galway

Ireland

or

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel,

Germany

or

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

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

Ireland:Memantine Clonmel 10 mg/ml Oral Solution

Netherlands:Memantine CF 10 mg/ml, drank
Portugal:Memantina Ciclum

Spain:Memantina Stada 5 mg/dosage, oral solution EFG

MaltaMemantine Clonmel 10 mg/ml oral solution

Date of the last review of this leaflet: April 2021

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