Package Insert: Information for the Patient

Memantina Kern Pharma 10 mg/ml Oral Solution EFG

Memantine Hydrochloride

Read this entire package insert carefully before starting to take this medication because 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 for you 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.Seesection4.

How Memantina Kern Pharma works

Memantina Kern Pharma belongs to a group of medicationsdenominatedanti-dementia medications.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains the so-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.

What is Memantina Kern Pharma used for

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

Do not take Memantina Kern Pharma

• if you are allergic to the active ingredienthydrochloride of memantine or to any of the other components ofthismedication(including those listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Kern Pharma.

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

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

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

Memantine should be avoided when used 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.

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

Taking Memantina Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

In particular, the administration ofmemantine may 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.

Taking Memantina Kern Pharma 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 acidosis tubular renal (ATR, excess of 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 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 for use in pregnant women.

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.

Furthermore,memantine may alter your reaction time, so driving or operating machinery may be inappropriate.

Memantina Kern Pharma contains sorbitol

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

Follow exactly the administration instructions of this medication indicated by your doctor.Incaseofdoubt,consult your doctor or pharmacist.

Dosage

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

The recommended dose ofmemantine in adult patients andpatientswithadvancedageis 2 ml, equivalent to 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule:

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

Dosage for patients withrenalinsufficiency

Ifyou 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

Memantine should be administered 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.

Duration of treatment

Continue takingmemantine as long as it is beneficial foryou. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina Kern Pharma than you should

Incaseofoverdoseoraccidentalingestion,consult your doctororpharmacist 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 should not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.
• If you take a Memantina overdose, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to take Memantina Kern Pharma

• If you realize you have forgotten to take your dose ofmemantine, 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Memantina Kern Pharma may produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

Frequent (mayaffectbetween 1 and 10 of every 100 patients):

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

Possibly Frequent (mayaffectbetween 1 and 10 of every 100 patients):

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

Rare (mayaffectless than 1 of every 10,000 patients):

• Seizures.

Unknown Frequency (the frequency cannot be estimated from 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 been reports of these events in patients treated withmemantina.

Reporting Adverse Effects

Ifyouexperienceanytypeofadverseeffect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use,website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Do not use this medication after the expiration date that appears on the carton packaging and on the bottle label 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 2 months.

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 collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Memantina Kern Pharma

• The active ingredient is hydrochloride of memantine. Each ml of solution contains 10 mg of hydrochloride of memantine, equivalent to 8.31 mg of memantine.
• The other components are liquid non-crystallizable sorbitol (E420), potassium sorbate (E202) and purified water.

Appearance of the product and contents of the packaging

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

Memantina Kern Pharma oral solution is presented in a plastic bottle containing 100 ml of oral solution accompanied by a graduated dosing syringe of 2 ml.

Other presentations

Memantina Kern Pharma 10 mg tablets

Memantina Kern Pharma 20 mg tablets

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Colón II Industrial Estate, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet:May2013

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