Product Information for the User

Memantina Aristo 10 mg/ml Oral Solution EFG

Memantine Hydrochloride

Read this entire product information carefully before starting totake this medication, as it contains important information for you.

- Keep this product information, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed to you alone, and you should not give it to others who 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 product information. See section 4.

How Memantina Aristo works

Memantina Aristo contains the active substance memantine hydrochloride. This belongs to a group of medicines known as dementia medicines.

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. Memantine belongs to the group of medicines called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nerve signals and memory.

When is Memantina Aristo used

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

Do not take Memantina Aristo

• if you are allergic to Memantina hydrochloride or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Aristo,

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

In the above situations, treatment must be closely monitored and your doctor must regularly reevaluate the clinical benefit of Memantina Aristo.

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

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

Children and adolescents.

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

Use of Memantina Aristo with other medications

Inform your doctor or pharmacistif you are taking, have taken recently or may have to take 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 dosages:

• 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 Aristo.

Memantina Aristo with food and drink

You must inform your doctor if you have recently changed or intend to change your diet substantially (for example from a normal diet to a strict vegetarian diet) or if you have renal 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 think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Memantina is not recommended for use in pregnant women.

Breastfeeding

Women taking Memantina Aristo should discontinue breastfeeding.

Driving and operating machinery

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

Additionally, Memantina Aristomay alter your reaction time, so driving or operating machinery may be inappropriate.

Memantina Aristo contains sorbitol (E 420)

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

0.5 ml of oral solution contains 5 mg of memantine hydrochloride.

The recommended dose of Memantina Aristo in adult patients and elderly patients is 2 ml, equivalent to 20 mg, once a day.

To reduce the risk of adverse effects, this dose is achieved gradually by following the daily treatment schedule below:

The initial starting dose is 0.5 ml (equivalent to 5 mg) taken once a day, during the first week. This dose is increased to 1 ml (equivalent to 10 mg), taken once a day, during the second week, and to 1.5 ml (equivalent to 15 mg), taken once a day, during the third week. From the fourth week, the recommended dose is 2 ml (equivalent to 20 mg), taken once a day.

Dosage for patients with reduced renal function

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

The solution should not be poured or dispensed directly into the mouth from the bottle or syringe. Measure the dose using the syringe and pour it into a spoon or into a glass of water.

Instructions for use

• Open the bottle: Press the cap and turn it counterclockwise.
• Insert the adapter of the dosing syringe into the neck of the bottle (Figure 1). Make sure the adapter is securely tightened.
• Insert the syringe into the adapter (Figure 1).
• 
  Turn the bottle upside down, placing the mouth of the bottle downwards (Figure 2).

• Fill the dosing syringe with a small amount of solution by pulling the plunger gently (Figure 3A). Then, push the plunger upwards, emptying the contents to remove any air bubbles that may have formed (Figure 3B). Next, slide the plunger to the mark in milliliters (ml) corresponding to the dose prescribed by your doctor (Figure 3C).

• Place the bottle on its base. Remove the syringe from the adapter.
• Empty the contents of the syringe into a spoon or a glass of water by pushing the plunger and emptying the contents of the syringe (Figure 4).
• Take the entire contents of the spoon or glass of water.
• Wash the syringe with water only (Figure 5).

• Close the bottle with the screw cap.

Treatment duration

Continue taking Memantina Aristo as long as it benefits you. Your doctor should evaluate your treatment periodically.

If you take more Memantina Aristo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

Generally, taking an excessive amount of Memantina Aristo 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 Aristo

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect up to1 in10 patients):

• Headache, drowsiness, constipation, elevated liver function levels, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication.

Poorly frequent (may affectup to 1 in100 patients):

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

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

• Seizures.

Unknown frequency (frequency cannot be estimated from available data):

• Pancreatitis, hepatitis (liver inflammation), and psychotic reactions.

Alzheimer's disease has been linked to depression, suicidal ideation, and suicide. These events have been reported 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 a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system:

Spanish System for Pharmacovigilance of Medications for Human UseWebsite: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 use this medication after the expiration date that appears on the box and on the label of the bottle after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Once opened, the contents of the bottle must be used within the next 6 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Memantina Aristo

?The active ingredient is Memantine hydrochloride

?1ml of solution contains 10 mg of Memantine hydrochloride which is equivalent to 8.31 mg of memantine

• 0.5 ml of solution contains 5 mg of Memantine hydrochloride which is equivalent to 4.15 mg of memantine.
• The other components are: potassium sorbate, liquid sorbitol 70% (non-crystallized) (E420), purified water

Appearance of the product and content of the container

Memantina Aristo oral solution is a transparent, colorless to yellowish solution.

Amber glass vial with a graduated syringe (marks of graduation of 0.5 ml) and an adapter for the syringe. It is presented in vials of 30 ml, 50 ml or 100 ml of solution.

Clinical packaging: 500 ml.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Aristo Pharma Iberia S.L.

C/ Solana 26

28850 – Torrejón de Ardoz, Madrid

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)
C/ Solana 26

28850 – Torrejón de Ardoz, Madrid

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

13435 Berlin, Germany

NEURAXPHARM ARZNEIMITTEL GMBH U CO.KG

Elisabethselbert Strasse, 23

Langenfeld – 40764, Germany

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

Germany:Memantin Aristo10 mg/ml Lösung zum Einnehmen

Poland:Memantin NeuroPharma 10 mg/ml Roztwór doustny

Portugal:Memantina Aristo 10 mg/ml solução oral

Spain:Memantina Aristo 10 mg/ml solución oral EFG

Last review date of this leaflet:September 2017

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices: http://www.aemps.gob.es/