Nemdatine 10 mg film-coated tablets

Introduction

Package Leaflet: Information for the Patient

Nemdatine 10 mg Film-Coated Tablets EFG

Memantine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as 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 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 Nemdatine and what is it used for
2. What you need to know before taking Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. Storage of Nemdatine
6. Package Contents and Additional Information

1. What is Nemdatine and what is it used for

How Nemdatine Works

Nemdatine contains the active ingredient memantine hydrochloride. Nemdatine belongs to a group of medications known as 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. Nemdatine belongs to the group of medications called NMDA receptor antagonists. Nemdatine acts on these NMDA receptors, improving the transmission of nerve signals and memory.

What Nemdatine is Used For

Nemdatine is used in the treatment of adult patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Nemdatine

Do Not Take Nemdatine

• if you are allergic to memantine hydrochloride or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Nemdatine

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

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

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

The use of medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anesthetic), dextromethorphan (generally used to treat cough), and other NMDA antagonists should be avoided at the same time.

Children and Adolescents

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

Taking Nemdatine with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

In particular, Nemdatine may affect the action of the following medications, so your doctor may need to adjust their doses:

• 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 reduce 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 Nemdatine.

Taking Nemdatine with Food and Drinks

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, an 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 your medication.

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 medication.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking Nemdatine should not breastfeed.

Driving and Using Machines

Your doctor will inform you if your condition allows you to drive and use machines safely. Additionally, Nemdatine may affect your reaction ability, so driving or operating machines may be inadequate.

Nemdatine Contains Lactose Monohydrate

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

3. How to Take Nemdatine

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 Nemdatine in adult and elderly patients is 20 mg once daily. To reduce the risk of side effects, this dose is gradually achieved by following the daily treatment scheme:

The usual starting dose is half a tablet once daily (1x 5 mg) during the first week. This is increased to one tablet once daily (1x 10 mg) in the second week and to one and a half tablets once daily (1x 15 mg) in the third week. From the fourth week onwards, the usual dose is two tablets once daily (1x 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 regularly monitor your kidney function.

Administration

Nemdatine should be taken 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 Nemdatine as long as it is beneficial for you. Your doctor should regularly evaluate your treatment.

If You Take More Nemdatine Than You Should

• Generally, taking an excessive amount of Nemdatine should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible Side Effects".
• If you take a large overdose of Nemdatine, contact your doctor or seek medical advice, as you may need medical attention.

If You Forget to Take Nemdatine

• If you realize you have forgotten to take your dose of Nemdatine, wait and take the next dose at the usual time.
• Do not take a double dose to make up for 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, this medication can cause side effects, although not everyone gets them.

Generally, the side effects observed are mild to moderate.

Frequent (affects 1 to 10 in every 100 patients)

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

Uncommon (affects 1 to 10 in every 1,000 patients)

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous blood clot formation (thrombosis/thromboembolism).

Rare (affects less than 1 in every 10,000 patients)

• Seizures.

Frequency Not Known (frequency cannot be estimated from 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 Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nemdatine

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

Do not use this medication after the expiration date stated on the carton, blister, and label of the bottle after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

<[Only for HDPE bottle:]>

Use within 100 days of first opening the package.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Nemdatine

• The active ingredient is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

• The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc, and magnesium stearate. Tablet coating (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, and triacetin.

Appearance of the Product and Package Contents

Nemdatine 10 mg film-coated tablets are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, scored, and marked with "M 10" on the scored side.

Package Sizes

Blister packs: 28, 30, 42, 50, 56, 60, 98, and 112 film-coated tablets. Bottle: 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

You can obtain further information on this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Package Leaflet{MM/YYYY}

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.