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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as yours, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Memantina Kern Pharma is and what it is 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. How to store Memantina Kern Pharma
6. Contents of the pack and other information

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

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

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains receptors known as N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Kern Pharma belongs to a group of medicines called NMDA receptor antagonists. It acts on these receptors, improving nerve signal transmission 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 starting to take Memantina Kern Pharma

Do not take Memantina Kern Pharma

• if you are allergic to memantine or to 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 have congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment must be carefully supervised, and your doctor should regularly re-evaluate the clinical benefit of memantine.

If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dosage of memantine.

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

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

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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Specifically, the administration of memantine may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• amantadine, ketamine, dextromethorphan,
• dantrolene, baclofen,
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
• hydrochlorothiazide (or any combination containing hydrochlorothiazide),
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and stop 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 admitted to hospital, 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 intend to substantially change your diet (for example, 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 are planning 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 advise you whether your condition allows you to drive and operate machinery safely.

In addition, memantine may affect your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Kern Pharma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Memantina Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Memantina Kern Pharma

The pack containing the memantina starting treatment should only be used at the beginning of memantina therapy.

Always follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 20 mg daily, reached by gradual increases in the dose of memantina during the first 3 weeks of treatment. The dosing schedule is also indicated on the starting treatment pack. Take one tablet once daily.

Week 1 (day 1-7)

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

Week 2 (day 8-14)

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

Week 3 (day 15-21)

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

Week 4 (day 22-28)

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

Maintenance dose

The recommended daily dose is 20 mg once daily.

To continue treatment, consult your doctor.

Dosage for patients with renal impairment

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

Administration

This medicine should be taken orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.

Duration of treatment

Continue taking memantine for as long as it benefits you. Your doctor should periodically review your treatment.

If you take more Memantina Kern Pharma than you should

In general, 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 require medical attention.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Memantina Kern Pharma

If you realize you have missed a dose of memantine, wait and take the next dose at the usual time.

Do not take a double dose to make up for the missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

Common (affects between 1 and 10 out of every 100 patients):

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

Uncommon (affects between 1 and 10 out of every 1,000 patients):

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

Very rare (affects less than 1 in every 10,000 patients):

Seizures.

Frequency not known (frequency cannot be estimated from available data):

Inflammation of the pancreas, inflammation of the liver (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 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of Memantine Kern Pharma

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Memantina Kern Pharma

The active substance is memantine hydrochloride.

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

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

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

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

The other components are pregelatinized corn starch, microcrystalline cellulose, monohydrate lactose, sodium carboxymethyl starch type A (from potato), colloidal anhydrous 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 each side.

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: 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 most recent review of this leaflet: February 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es