Prospect: information for the user

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

Memantine hydrochloride

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, 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 prospect. See section 4.

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

2.What you need to know before starting to take Memantina Kern Pharma

3.How to take Memantina Kern Pharma

4.Possible adverse effects

5.Storage of Memantina Kern Pharma

6.Contents of the package and additional information

Memantina Kern Pharma contains the active ingredient hydrochloride of memantine. It belongs to a group of medications known as anti-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. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine Kern Pharma acts on these receptors, improving the transmission of nervous signals and memory.

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 memantine or any of the other ingredients in this medication(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 failure or if you have uncontrolled high blood pressure.

In these 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 dose of memantine.

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

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

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

Other medications and Memantina Kern Pharma

Inform your doctor or pharmacist if you are using or have recently usedor 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),

- dopamine agonists (substances like 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 memantine.

Taking Memantina Kern Pharma with food and drinks

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), as your doctor may need to adjust the dose of the medication.

Pregnancy and breastfeeding

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

Pregnancy:Memantine is not recommended for use in pregnant women.

Breastfeeding:Women taking memantine should not breastfeed.

Driving and operating machinery

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

Additionally, memantine may alter your reaction time, making driving or operating machinery inappropriate.

Memantina Kern Pharma contains lactose

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

Memantina Kern Pharma contains sodium

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

The packaging with the initial treatment of memantine should only be used at the beginning of memantine treatment.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended daily dose is 20 mg, which is achieved through gradual increases in the memantine dose during the first 3 weeks of treatment. The treatment schedule is also indicated on the initial treatment packaging. Take one tablet once a day.

Week 1 (days 1-7)

Take one 5 mg tablet once a day (convex 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 groove on both sides) for 7 days.

Week 3 (days 15-21)

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

Week 4 (days 22-28)

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

Maintenance dose

The recommended daily dose is 20 mg once a day.

Consult your doctor to continue treatment.

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

This medication should be taken orally once a day. To get the most out of your medication, you should take it every day 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 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 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.

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

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 dose.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (affecting between 1 and 10 of every 100 patients):

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

Infrequent (affecting between 1 and 10 of every 1,000 patients):

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

Very rare (affecting 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 associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with memantine.

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 Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute toproviding more information about the safety of this medication.

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 and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Memantina Kern Pharma

The active ingredient is hydrochloride of memantine.

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

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

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

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

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

Appearance of the product and content of the container

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

Memantina Kern Pharma 10 mg tablets are white, round, flat, 8 mm in diameter, with a groove on each face.

The tablet can be divided into equal doses.

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

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

Each starter treatment package 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.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II,

08228 Terrassa – Barcelona

Spain

Last review date of this prospectus:February 2024

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