MEMANTINE KERN PHARMA 5 mg + 10 mg + 15 mg + 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Kern Pharma 5 mg + 10 mg + 15 mg + 20 mg Tablets EFG

Memantine Hydrochloride

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, 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 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. Contents of the pack and further information

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

Memantina Kern Pharma contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti-dementia medicines.

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 medicines called NMDA receptor antagonists. Memantina Kern Pharma acts on these receptors, improving the transmission of nerve signals and memory.

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 memantine or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take memantine:

• if you have a history of epileptic seizures.
• 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 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.

If you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, your doctor may need to adjust the dose of the medicine.

The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a general anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.

Children and Adolescents

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

Other Medicines and Memantina Kern Pharma

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

In particular, the administration of memantine may affect the effects of the following medicines, 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 used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and eliminate seizures),
• barbiturates (substances 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 memantine.

Taking Memantina Kern Pharma with Food and Drinks

You should inform your doctor if you have recently changed or plan to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the dose of the medicine.

Pregnancy and Breastfeeding

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

Pregnancy:The use of memantine is not recommended in pregnant women.

Breastfeeding:Women taking memantine should not breastfeed.

Driving and Using Machines

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

Additionally, memantine may affect 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 medicine.

Memantina Kern Pharma contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to Take Memantina Kern Pharma

The starter pack with memantine should only be used at the beginning of treatment with memantine.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 20 mg per day, which is achieved by gradual increments of the memantine dose during the first 3 weeks of treatment. The treatment schedule is also indicated on the starter pack. Take one tablet once a day.

Week 1 (days 1-7)

Take one 5 mg tablet once a day (biconvex tablet marked with a "5") for 7 days.

Week 2 (days 8-14)

Take one 10 mg tablet once a day (flat tablet with a score line on both sides) for 7 days.

Week 3 (days 15-21)

Take one 15 mg tablet once a day (biconvex tablet marked with a "15") for 7 days.

Week 4 (days 22-28)

Take one 20 mg tablet once a day (biconvex tablet with a score line on one side) for 7 days.

Maintenance Dose

The recommended daily dose is 20 mg once a day.

For continued treatment, consult your doctor.

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 regularly monitor your kidney function.

Administration

This medicine 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 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 benefits you. Your doctor should evaluate your treatment periodically.

If you Take More Memantina Kern Pharma than you Should

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.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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 dose.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are usually classified as mild to moderate.

Common (affecting 1 to 10 in every 100 patients):

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

Uncommon (affecting 1 to 10 in every 1,000 patients):

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

Rare (affecting less than 1 in every 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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Memantina Kern Pharma

The active substance is memantine hydrochloride.

Each 5 mg tablet contains 5 mg of memantine hydrochloride, equivalent to 4.15 mg of memantine.

Each 10 mg tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

Each 15 mg tablet contains 15 mg of memantine hydrochloride, equivalent to 12.46 mg of memantine.

Each 20 mg tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

The other ingredients are pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, sodium carboxymethylcellulose type A (from potato), anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Contents of the Pack

Memantina Kern Pharma 5 mg tablets are white, round, biconvex tablets, 6 mm in diameter, marked with a "5" on one side.

Memantina Kern Pharma 10 mg tablets are white, round, flat tablets, 8 mm in diameter, with a score line on both sides.

The tablet can be divided into equal doses.

Memantina Kern Pharma 15 mg tablets are white, round, biconvex tablets, 9 mm in diameter, marked with a "15" on one side.

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

Each starter pack contains 28 tablets in 4 PVC-Alu blisters, with 7 tablets of 5 mg, 7 tablets of 10 mg, 7 tablets of 15 mg, and 7 tablets of 20 mg.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II,

08228 Terrassa – Barcelona

Spain

Date of the Last Revision of this Package Leaflet:February 2024

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