Package Insert: Information for the Patient

Memantina Kern Pharma 20 mg Tablets 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 refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you, 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 package insert. See section 4.

How Memantina Kern Pharma works

Memantina Kern Pharma belongs 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 receptors called N-methyl-D-aspartate (NMDA) 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.

What Memantina Kern Pharma is 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 ingredient hydrochloride of 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 Kern Pharma:

• if you have a history of epileptic seizures,
• if you have recently had 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 should regularly reevaluate the clinical benefit of memantine.

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

Memantine should be avoided when used 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.

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, have recently used or may need to use any other medication.

Specifically, the administration of memantine 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 Kern Pharma.

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 kidney 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 dose.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be 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, making driving or operating machinery unsuitable.

Memantina Kern Pharma contains lactose

If your doctor has indicated that you have a intolerance to certain sugars, consult with him 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

The recommended dose of memantine in adult patients and elderly patients is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below:

The normal starting dose is half a tablet once a day (5 mg) in the first week. It is increased to one tablet a day (10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week onwards, the normal dose is 20 mg administered once a day (20 mg).

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 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 tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment duration

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

If you take more Memantina Kern Pharma 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”.
• If you take a memantine 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 memantine dose, wait and take the next dose at the usual time.
• Do not take a double dose to compensate for the missed doses.

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.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect between 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.

Rare (may affect between 1 and 10 of every 1,000 patients):

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

Very rare (may affect fewer than 1 of every 10,000 patients):

• Seizures.

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

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

Alzheimer's disease has been linked to depression, suicidal ideation, and suicide. There have been reports of these events in patients treated with memantina.

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 Medications for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about 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 packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Memantina Kern Pharma 20 mg tablets

• The active ingredient is hydrochloride of memantina. Each tablet contains 20 mg of hydrochloride of memantina which are equivalent to 16.62 mg of memantina.
• The other components are pregelatinized cornstarch, microcrystalline cellulose, lactose monohydrate, sodium glycolate starch (type A) (potato starch), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

Memantina Kern Pharma 20 mg tablets are white, round, biconvex tablets, 11 mm in diameter, with a groove on one face. The tablet can be divided into two equal halves.

Memantina Kern Pharma 20 mg tablets are presented in packs of 56 tablets and in a clinical pack of 490 tablets.

Only some pack sizes may be commercially available.

Other presentations

Memantina Kern Pharma 10 mg tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Last review date of this prospectus: April 2013.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http:// www.aemps.gob.es /