MEMANTINE KERN PHARMA 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Memantina Kern Pharma 20 mg Tablets EFG

Memantine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Memantina Kern Pharma and what is it used for
2. What you need to know before taking Memantina Kern Pharma
3. How to take Memantina Kern Pharma
4. Possible side effects
5. Storage of Memantina Kern Pharma
6. Package Contents and Additional Information

1. What is Memantina Kern Pharma and what is it used for

How Memantina Kern Pharma Works

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

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains so-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 medications called NMDA receptor antagonists. Memantine acts on these receptors, 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.

2. What you need to know before taking Memantina Kern Pharma

Do Not Take Memantina Kern Pharma

• if you are allergic to the active ingredient memantine hydrochloride or to 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 Kern Pharma:

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

In these situations, treatment should be carefully supervised, and your doctor should regularly reassess the clinical benefit of memantine.

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

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

The use of memantine is not recommended in children and adolescents under 18 years of age.

Taking Memantina Kern Pharma with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In particular, 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).
• dopaminergic agonists (substances such as L-dopa, bromocriptine).
• neuroleptics (substances used in the treatment of mental illnesses).
• oral anticoagulants.

If you are hospitalized, 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 substantially (e.g., from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (urinary tract), as your doctor may need to adjust the dose of the medication.

Pregnancy, Breastfeeding, and Fertility

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

The use of memantine is not recommended in pregnant women.

Women taking memantine should stop breastfeeding.

Driving and Using Machines

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

Also, Memantina may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina Kern Pharma Contains Lactose

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

3. How to Take Memantina Kern Pharma

Follow the administration instructions of this medication exactly 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 daily. To reduce the risk of side effects, this dose is gradually achieved following the daily scheme:

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

Dosage for Patients with Renal Impairment

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.

Administration

Memantine should be administered orally once daily. 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.

Duration of Treatment

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

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 Toxicology 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 side effects".
• If you take an overdose of memantine, contact your doctor or seek medical advice, as you may need medical attention.

If You Forget to Take Memantina Kern Pharma

• If you realize you have forgotten to take your dose of memantine, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Memantina Kern Pharma can cause side effects, although not everyone gets them.

Generally, side effects are classified as mild to moderate.

Frequent (may affect 1 to 10 in 100 patients):

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

Uncommon (may affect 1 to 10 in 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Rare (may affect less than 1 in 10,000 patients):

• Seizures.

Frequency Not Known (frequency cannot be estimated from the 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 memantine.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Memantina Kern Pharma

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

Do not use this medication after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Memantina Kern Pharma 20 mg Tablets

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

Appearance of the Product and Package Contents

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

Memantina Kern Pharma 20 mg tablets are available in packages of 56 tablets and in a clinical package of 490 tablets.

Not all package sizes may be marketed.

Other Presentations

Memantina Kern Pharma 10 mg Tablets EFG

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet: April 2013.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/