Brand name Nemdatine

Form tablets, film-coated

Active substance / Dosage

MEMANTINE HYDROCHLORIDE

Prescription type Restricted prescription – dispensable on hospital or specialist prescription

ATC code

N06DX01

Registration number 042783

Manufacturer ACTAVIS GROUP PTC EHF

Table of Contents

Package leaflet: Information for the patient
Nemdatine 5 mg film-coated tablets
1. What Nemdatine is and what it is used for
2. What you need to know before taking Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. How to store Nemdatine
6. Package contents and other information
Patient information leaflet
Nemdatine 10 mg film-coated tablets
1. What Nemdatine is and what it is used for
2. What you should know before taking Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. How to store Nemdatine
6. Package contents and other information
Patient information leaflet
Nemdatine 15 mg film-coated tablets
1. What Nemdatine is and what it is used for
2. What you need to know before taking Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. How to store Nemdatine
6. Package contents and other information
Package leaflet: information for the patient
Nemdatine 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets
1. What Nemdatine is and what it is used for
2. What you need to know before taking Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. How to store Nemdatine
6. Package contents and other information
Patient Information Leaflet
Nemdatine 20 mg film-coated tablets
1. What Nemdatine is and what it is used for
2. What you need to know before taking Nemdatine
3. How to take Nemdatine
4. Possible side effects
5. How to store Nemdatine
6. Package contents and other information

Package leaflet: Information for the patient

Nemdatine 5 mg film-coated tablets

memantine hydrochloride
Read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nemdatine is and what it is used for
What you need to know before taking Nemdatine
How to take Nemdatine
Possible side effects
How to store Nemdatine
Contents of the pack and other information

1. What Nemdatine is and what it is used for

How Nemdatine works
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of
medicines known as anti-dementia medicines.
Memory loss in Alzheimer's disease is due to impaired transmission of signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in nerve signal transmission important for learning and memory.
Nemdatine belongs to a group of medicines known as NMDA receptor antagonists. Nemdatine acts on these NMDA receptors, improving nerve signal transmission and memory.
What Nemdatine is used for
Nemdatine is used for the treatment of moderate to severe Alzheimer's disease in adults.

2. What you need to know before taking Nemdatine

Do not take Nemdatine

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Nemdatine:

if you have a history of epileptic 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 must be closely monitored and the clinical benefits of Nemdatine
must be regularly reassessed by your doctor.
If you have renal impairment (kidney problems), your doctor must carefully monitor
your kidney function and, if necessary, adjust the dose of memantine accordingly.
Avoid concomitant use of medicinal products such as amantadine (used for the treatment of
Parkinson’s disease), ketamine (a substance generally used as an anaesthetic),
dextromethorphan (commonly used to treat cough) and other NMDA antagonists.
Children and adolescents
Nemdatine is not recommended for children and adolescents under 18 years of age.
Other medicines and Nemdatine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, the effects of the following medicines may be altered by Nemdatine and
dose adjustment may be necessary:

amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or combinations containing hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and treat epileptic seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L-dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants. If hospitalised, inform medical staff that you are taking Nemdatine.

Nemdatine with food and drink
Talk to your doctor if you have recently changed or plan to substantially change
your diet (e.g. from a normal diet to a strictly vegetarian diet) or if
you suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to
renal dysfunction (insufficient kidney function)) or severe urinary tract infections (the system that
transports urine), as your doctor may need to adjust the dose of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before taking this medicine.
Pregnancy
The use of memantine is not recommended in pregnant women.
Breastfeeding
Women taking Nemdatine must not breastfeed.
Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or use machinery given
your underlying condition. In addition, Nemdatine may affect your reaction time, making it
inadvisable to drive or operate machinery.
Nemdatine contains lactose monohydrate
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before
taking this medicine.

3. How to take Nemdatine

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose of Nemdatine for adults and elderly patients is 20 mg once daily. To reduce the
risk of undesirable effects, reach this dose gradually according to the following daily dosing schedule:

Week 1	1 tablet of 5 mg
Week 2	2 tablets of 5 mg
Week 3	3 tablets of 5 mg
Week 4 and onwards	4 tablets of 5 mg once daily

The usual starting dose is one tablet once daily (1 x 5 mg) for the first week. The dosage is increased to two tablets once daily (1 x 10 mg) during the second week, and to three tablets once daily (1 x 15 mg) in the third week. From the fourth week onwards, the usual dose is four tablets once daily (1 x 20 mg).
Dosage in patients with reduced renal function
In case of reduced renal function, your doctor may decide on a dosage regimen suitable for your condition. In such cases, regular monitoring of renal function should be requested by the doctor.
Administration
Nemdatine should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Take the tablets with some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Nemdatine for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.
If you take more Nemdatine than you should

In general, overdose of Nemdatine is not harmful. A greater number of symptoms described in section 4 “Possible side effects” may occur.
If you take a significant overdose of Nemdatine, contact your doctor or seek medical advice, as you may require medical attention.

If you forget to take Nemdatine

If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the side effects observed are mild to moderate.
Common (affects 1 to 10 people in 100):

Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension, and hypersensitivity to the medicine.

Uncommon (affects 1 to 10 people in 1,000):

Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous blood coagulation (thrombosis/thromboembolism).

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

Seizures.

Not known (frequency cannot be estimated from the available data):

Inflammation of the pancreas, inflammation of the liver (hepatitis), psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. During
post-marketing experience, these events have been reported in patients treated with memantine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system referred to in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the 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 that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nemdatine contains

The active substance is memantine hydrochloride. Each film-coated tablet contains 5 mg of memantine hydrochloride, equivalent to 4.15 mg of memantine.
The other components 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.

Description of the appearance of Nemdatine and pack contents
Nemdatine 5 mg film-coated tablets (tablets) are white, oval-shaped, biconvex,
measuring 8 mm x 4.5 mm, with "M5" engraved on one side.
Pack sizes
Blister packs: 42 and 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
TEVA Gyógyszergyár Zrt.
Pallagi út 13
Debrecen 4042
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Accord Healthcare Ireland Ltd.
Tel: +371 67323666 Ireland
Tel: +353 214619040

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Patient information leaflet

Nemdatine 10 mg film-coated tablets

memantine hydrochloride
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nemdatine is and what it is used for
What you need to know before taking Nemdatine
How to take Nemdatine
Possible side effects
How to store Nemdatine
Contents of the pack and other information

1. What Nemdatine is and what it is used for

How Nemdatine works
Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of
medicines known as anti-dementia medicines.
Memory loss in Alzheimer's disease is due to a disruption in signal transmission in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in nerve signal transmission important for learning and memory.
Nemdatine belongs to a group of medicines called NMDA receptor antagonists. Nemdatine acts on these NMDA receptors, improving nerve signal transmission and memory.

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

2. What you should know before taking Nemdatine

Do not take Nemdatine

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Nemdatine:

if you have a history of epileptic 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 must be closely monitored and the clinical benefits of Nemdatine should be regularly reassessed by your doctor.
If you have renal impairment (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the dose of memantine accordingly.
Avoid concomitant use of medicinal products such as amantadine (used to treat Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.

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

Other medicines and Nemdatine
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, the effects of the following medicines may be altered by Nemdatine, and dose adjustment may be necessary:

amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or combinations containing hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and treat epileptic seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L-dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants.

If you are admitted to hospital, inform medical staff that you are taking Nemdatine.

Nemdatine with food and drink
Talk to your doctor if you have recently changed or plan to substantially change your diet (e.g. from a normal diet to a strictly vegetarian diet), or if you have renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections (the structure that carries urine), as your doctor may need to adjust your dose accordingly.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
The use of memantine is not recommended in pregnant women.

Breastfeeding
Women taking Nemdatine must not breastfeed.

Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or operate machinery given your underlying condition. In addition, Nemdatine may affect your reaction time, making it advisable not to drive or operate machinery.

Nemdatine contains lactose monohydrate
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Nemdatine

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose of Nemdatine for adults and elderly patients is 20 mg once daily. To reduce the
risk of undesirable effects, reach this dose gradually according to the following daily dosage schedule:

Week 1	Half tablet of 10 mg
Week 2	1 tablet of 10 mg
Week 3	1 and a half tablets of 10 mg
Week 4 and onwards	2 tablets of 10 mg once daily

The usual starting dose is half a tablet once daily (1 x 5 mg) during the first week. The dose is increased to one tablet once daily (1 x 10 mg) in the second week, and to one and a half tablets once daily in the third week (1 x 15 mg). From the fourth week onwards, the usual dose is 2 tablets once daily (1 x 20 mg).
Dosage in patients with reduced renal function
If renal function is impaired, the treating physician may decide on a dosage regimen appropriate for your condition. In such cases, regular monitoring of renal function should be requested by the physician.
Administration
Nemdatine should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Take the tablets with some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Nemdatine for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.
If you take more Nemdatine than you should

In general, overdose of Nemdatine is not harmful. A higher number of symptoms described in section 4 “Possible side effects” may occur.
If you take a significant overdose of Nemdatine, contact your doctor or seek medical advice, as you may require medical attention.

If you forget to take Nemdatine

If you forget to take a dose, 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 doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the side effects observed are mild to moderate.

Common (affects 1 to 10 people in 100):

Headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorders, shortness of breath, hypertension and drug hypersensitivity.

Uncommon (affects 1 to 10 people in 1,000):

Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure and venous blood coagulation (thrombosis/thromboembolism).

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

Seizures.

Not known (frequency cannot be estimated from the available data):

Inflammation of the pancreas, inflammation of the liver (hepatitis), psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. During post-marketing experience, these events have been reported in patients treated with memantine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
[For HDPE bottle only:]
Use within 100 days after opening.

6. Package contents and other information

What Nemdatine contains

The active substance 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 6 cP, titanium dioxide (E171), monohydrate lactose, macrogol 3350, and triacetin.

Description of the appearance of Nemdatine and package contents
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, measuring 9.8 mm x 4.9 mm, with "M 10" engraved on one side.
Pack sizes
Blister packs: 28, 30, 42, 50, 56, 60, 98, and 112 film-coated tablets
Bottles: 100, 130*, 250*, and 500* film-coated tablets
* Intended only for centres where dose dispensing takes place
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
TEVA Gyógyszergyár Zrt.
Pallagi út 13
Debrecen 4042
Hungary

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.