NEMDATINE 20 mg Film-Coated Tablets

2. What you need to know before you take Nemdatine

Do not take Nemdatine

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Nemdatine

• if you have a history of epileptic seizures
• if you have recently suffered 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 re-evaluate 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 medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anesthetic), dextromethorphan (generally used to treat coughs), and other NMDA antagonists should be avoided at the same time.

Children and adolescents

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

Taking Nemdatine with other medicines

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

In particular, Nemdatine may affect the action of the following medicines, so your doctor may need to adjust their 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 reduce seizures)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists (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 medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 whether your illness allows you to drive and use machines safely. Additionally, Nemdatine may alter your reaction ability, so driving or operating machinery may be inadequate.

Nemdatine contains lactose monohydrate

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

3. How to take Nemdatine

Follow exactly the administration instructions of this medicine given 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. To adjust the dose, there are tablets with different doses.

At the start of treatment, you will begin taking Nemdatine 5 mg film-coated tablets once daily. This dose will be increased weekly by 5 mg until the recommended dose (maintenance dose) is reached. The recommended maintenance dose is 20 mg once daily, which is reached at the beginning of the fourth week.

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 periodically monitor your kidney function.

Administration

Nemdatine should be taken orally once daily. To get the most out of your medicine, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Generally, the side effects observed are mild to moderate.

Frequent (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

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

Rare (affects less than 1 user in 10,000)

• 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nemdatine

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

Do not use this medicine after the expiry date which is stated on the carton, blister, and label of the bottle after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C.

<[Only for HDPE bottle:]>

Use within 100 days of first opening the container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nemdatine

• The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

• The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc, and magnesium stearate. Tablet coating (Opadry II Rosa 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, and iron oxide red and yellow (E172).

Appearance of the product and pack size

Nemdatine 20 mg film-coated tablets are dark pink, oval, biconvex, 12.6 mm x 7 mm in size, with "M20" engraved on one side.

Package sizes

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

Not all pack sizes may be marketed.

Marketing authorisation 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 medicine from the representative of the marketing authorisation holder:

Date of last revision of this leaflet{MM/YYYY}

Other sources of information

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