Package Insert: Information for the User

Memantine Aurovitas Spain 5 mg/beat, Oral Solution EFG

Hydrochloride of Memantine

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, 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 package insert.See section 4.

6. Contents of the Container and Additional Information

Memantina Aurovitas Spain 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 nerve 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 nerve signals and memory.

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

Do not take Memantina Aurovitas Spain

• If you are allergic to hydrochloride 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 Memantina Aurovitas Spain:

• 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 of Memantina Aurovitas Spain regularly.

If you have kidney problems, 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 Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Aurovitas Spain 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 of Memantina Aurovitas Spain may 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 like 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 Aurovitas Spain.

Taking Memantina Aurovitas Spain 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 kidney tubular acidosis (ATR, excess of 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, breastfeeding and fertility

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

Memantina Aurovitas Spain is not recommended for use in pregnant women.

Women taking Memantina Aurovitas Spain should discontinue breastfeeding.

Driving and operating machinery

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

Furthermore, Memantina Aurovitas Spain may alter your reaction time, making driving or operating machinery unsuitable.

Memantina Aurovitas Spain contains sorbitol

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

Follow exactly the administration instructions of this medication as indicated by your doctor. 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, 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 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 the dosifier. Measure the dose in a spoon or in a glass of water using the dosifier.

Removing 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 clockwise until it is securely attached (fig.3). The dosifier should only be screwed on once at the start of 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 must 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 the bottle on a flat, horizontal surface, for example on a table, and it should only be used 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 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 Memantina Aurovitas Spain 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 Aurovitas Spain.

Dosage for patients with kidney problems

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

Memantina Aurovitas Spain should 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.

Treatment duration

Continue taking Memantina Aurovitas Spain as long as it benefits you. Your doctor should evaluate your treatment regularly.

Sif you take more Memantina Aurovitas Spain 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 Memantina Aurovitas Spain should not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

If you forget to take Memantina Aurovitas Spain

If you realize you have forgotten to take your dose of Memantina Aurovitas Spain, wait and take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

Ifyou interrupt the treatment with Memantina Aurovitas Spain

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 medicationcan 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 patients):

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

Infrequent (may affect up to 1 in100 patients):

• 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 in10,000 patients):

• Seizures.

Unknown 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 Memantina Aurovitas Spain.

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 medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging and on the label of the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does notrequire special storage conditions.

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

The bottle with the dosifier mounted must be stored and transported only in a vertical position.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines that you no longer need at the SIGRE pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Memantina Aurovitas Spain

• The active principle is hydrochloride of memantine.

Each pump dose (one pump) releases 0.5 ml of solution containing 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 E202, liquid sorbitol (non-crystallizing) E420, and purified water.

Appearance of the product and content of the container

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

Memantina Aurovitas Spain, oral solution is presented in 100 ml bottles. A dosifier is included.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Chanelle Medical Unlimited Company

Dublin Road

Loughrea, Co. Galway

Ireland

Last review date of this leaflet: May 2018

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