Memantina Kern Pharma 10 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Memantina Kern Pharma 10 mg/ml oral solution EFG

Memantine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

How Memantina Kern Pharma works

Memantina Kern Pharma belongs to a group of medicines known as antidementia agents.

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

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

In the above situations, treatment must be carefully monitored, 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.

The use of memantine should be avoided concomitantly with other medicines such as amantadine (used to treat Parkinson’s disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a medicine used to treat cough), and other NMDA antagonists.

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

Taking Memantina Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Specifically, 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 control 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 Memantina.

Taking Memantina Kern Pharma with food, drinks, and alcohol

You should inform your doctor if you have recently changed or intend to make substantial changes to your diet (for example, switching from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to kidney dysfunction [kidney problem]) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine.

Pregnancy, breastfeeding, and fertility

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

The use of memantine is not recommended in pregnant women.

Women taking memantine should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely.

In addition, memantine may affect your reaction time; therefore, driving or operating machinery may be inappropriate.

Memantina Kern Pharma contains sorbitol

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

3. How to take Memantina Kern Pharma

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage

Each ml of solution contains 10 mg of memantine hydrochloride.

The recommended dose of memantine in adult and elderly patients is 2 ml, equivalent to 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

The usual starting dose is 0.5 ml (5 mg) once daily during the first week. This dose is increased in the second week to 1 ml once daily (1x 10 mg) and in the third week to 1.5 ml once daily (15 mg). From the fourth week onwards, the recommended dose is 2 ml once daily (20 mg).

Dosage for patients with renal impairment

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

Administration

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

Duration of treatment

Continue taking memantine for 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

• 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.

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 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, Memantina Kern Pharma can cause adverse effects, although not everyone experiences them.

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

Common (may affect between 1 and 10 out of 100 patients):

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

Uncommon (may affect between 1 and 10 out of 100 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 (may affect less than 1 out of 10,000 patients):

• Seizures.

Frequency not known (frequency cannot be estimated from the 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 an effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products, website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 cardboard package and on the label of the bottle after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

After opening, the contents of the bottle must be used within 2 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Kern Pharma

• The active substance is memantine hydrochloride. Each ml of solution contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other components are non-crystallizable liquid sorbitol (E420), potassium sorbate (E202), and purified water.

Appearance of the product and contents of the pack

Memantina Kern Pharma oral solution is a clear, colourless to slightly yellowish solution.

Memantina Kern Pharma oral solution is supplied in a plastic bottle containing 100 ml of oral solution, accompanied by a 2 ml graduated dosing syringe.

Other presentations

Memantina Kern Pharma 10 mg tablets

Memantina Kern Pharma 20 mg tablets

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Date of the most recent revision of this leaflet: May 2013

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es