MEMANTINA 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Memantine hydrochloride
   1. What is Memantine Merz and what is it used for
   2. What you need to know before taking Memantine Merz
   3. How to take Memantine Merz
   4. Possible side effects
   5. How to store Memantine Merz
   6. Contents of the pack and other information
2. Memantine hydrochloride
   1. What is Memantine Merz and what is it used for
   2. What you need to know before you take Memantine Merz
   3. How to take Memantine Merz
   4. Possible side effects
   5. How to store Memantine Merz
   6. Package contents and other information
3. Memantine hydrochloride
   1. What is Memantine Merz and what is it used for
   2. What you need to know before taking Memantine Merz
   3. How to take Memantine Merz
   4. Possible side effects
   5. How to store Memantine Merz
   6. Contents of the pack and other information
4. Memantine hydrochloride
   1. What is Memantine Merz and what is it used for
   2. What you need to know before taking Memantine Merz
   3. How to take Memantine Merz
   4. Possible side effects
   5. How to store Memantine Merz
   6. Package Contents and Other Information

Memantine Merz 10 mg film-coated tablets

Memantine hydrochloride

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Memantine Merz is and what it is used for
• 2. What you need to know before you take Memantine Merz
• 3. How to take Memantine Merz
• 4. Possible side effects
• 5. How to store Memantine Merz
• 6. Contents of the pack and other information

1. What is Memantine Merz and what is it used for

How Memantine Merz works
Memantine Merz contains the active ingredient memantine hydrochloride.
Memantine Merz belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disturbance in the transmission of
messages in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)
receptors involved in the transmission of nerve signals important for learning and memory.
Memantine Merz belongs to a group of drugs defined as NMDA receptor antagonists.
Memantine Merz acts on these NMDA receptors improving the transmission of nerve signals and
memory.

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

2. What you need to know before taking Memantine Merz

Do not take Memantine Merz

• if you are allergic (hypersensitive) 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 Memantine Merz

• 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 high blood pressure.

In these situations the treatment should be carefully monitored and the clinical benefits of Memantine Merz
re-evaluated by your doctor at regular intervals.
If you have impaired kidney function (kidney problems), your doctor must carefully monitor
kidney function and, if necessary, adjust the memantine dosage accordingly.
Avoid concomitant use of medicinal products 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.

Children and adolescents
Memantine Merz is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine Merz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, the effects of the following medicines may be altered by Memantine Merz and
the dosage may need to be adjusted:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations with hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat 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 the medical staff that you are taking Memantine Merz.

Memantine Merz with food and drink
Talk to your doctor if you intend to substantially change your diet (for example
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 kidney dysfunction (impaired kidney
function) or severe urinary tract infections (the structure that carries urine), as
your doctor may need to adjust the drug dosage accordingly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of memantine during pregnancy is not recommended.

Breastfeeding
Women taking Memantine Merz should not breastfeed .
Driving and using machines
Your doctor will tell you if your condition allows you to drive or use machines
without risk.
In addition, Memantine Merz may alter your responsiveness, making it inadvisable to drive
vehicles or use machines.

Memantine Merzcontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Memantine Merz

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.

Dosage
The recommended dose of Memantine Merz for adult and elderly patients is 20 mg once daily. To
reduce the risk of undesirable effects, reach this dosage gradually following this
daily dosage schedule:
The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week. The
dosage is increased to one tablet once a day (1 x 10 mg) in the second week and to
one and a half tablets once a day in the third week. From the fourth week onwards, the usual dose
is equal to 2 tablets once a day (1 x 20 mg).

Dosage in patients with reduced kidney function
In case of reduced kidney function, the treating doctor may decide on a dosage regimen suitable
for your condition. In this case, regular monitoring of kidney function must be
requested by the doctor.

Administration
Memantine Merz is to be administered orally once daily. To benefit, you must
take the medicine regularly every day at the same time. Take the tablets with a little
water. The tablets can be taken with or without food.

Duration of treatment
Continue to take Memantine Merz as long as you benefit from it. The doctor will evaluate the treatment at
regular intervals.

If you take more Memantine Merz than you should

• In general, an overdose of Memantine Merz is not harmful. You may experience a greater number of symptoms described in section 4 “Possible side effects”.
• In case of a considerable overdose of Memantine Merz, contact your treating doctor as his/her intervention may be required. If you forget to take Memantine Merz
• If you forget to take a dose, take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose. If you have any 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.

In general, the observed side effects are mild to moderate.

Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension and hypersensitivity to the drug Uncommon (may affect up to 1 in 100 people):
• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure and venous thrombosis (thromboembolism)

Very rare (may affect up to 1 in 10,000 people):

• Convulsions

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

• Pancreatitis, liver inflammation (hepatitis) and 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 Merz.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Memantine Merz

Keep this medicine out of the sight and reach of children.
Do not use Memantine Merz after the expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Memantine Merz contains
The active ingredient is memantine hydrochloride. Each film-coated tablet contains 10 mg of
memantine hydrochloride equivalent to 8.31 mg of memantine.
The excipients are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silicon dioxide and
magnesium stearate, in the tablet core; in the tablet coating are hypromellose,
macrogol 400, and titanium dioxide (E 171) and yellow and red iron oxide (E 172).

Description of the appearance of Memantine Merz and contents of the pack
The film-coated tablets of Memantine Merz are presented as film-coated tablets,
of colour from yellow to pale yellow, oval in shape, with “1-0” imprinted on the break line on one side and
“M M” on the other side.
The film-coated tablets of Memantine Merz are available in blister packs of 14, 28,
30, 42, 50, 56, 98, 100, 112 and multiple packs of 840 (20 packs of 42), 980 (10 packs of

• 98) or 1000 (20 packs of 50) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany

Manufacturer
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 340 2828

Lietuva

• H. Abbe Pharma GmbH Tel.: +370 52 711710

България
Merz Pharmaceuticals GmbH
Tel.: +49 (0)69 1503 – 0

Luxembourg/Luxemburg
HANFF Global Health Solutions s.à r.l.
Tél: +352 45 07 07-1

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Lundbeck Pharma A/S
Tlf: +45 4371 4270

Malta
Clinipharm Co. Ltd
Tel: +356 21 43 74 15

Deutschland
Merz Pharmaceuticals GmbH
Tel: +49 (0)69 1503 - 0

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Abbe Pharma GmbH Tel.: +372 6 460980 Norge
• H. Lundbeck AS Tlf: +47 91 300 800 ΕλλάδαLundbeck Hellas S.A. Τηλ: +30 210 610 5036 ÖsterreichMerz Pharma Austria GmbH Tel.: +43 1 865 88 95

España
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Polska
Centrala Farmaceutyczna CEFARM SA
Tel: +48 22 634 02 22

France
Lundbeck SAS
Tél: + 33 1 79 41 29 00

Portugal
Merz Pharma España S.L.
Tel: +34 91 657 47

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: + 385 1 3649 210

România
Lundbeck Export A/S
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Ísland
Lundbeck Export A/S, útibú á Íslandi
Sími.: +354 414 7070

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Lundbeck Italia S.p.A.
Tel: +39 02 677 4171

Suomi/Finland
Oy H. Lundbeck Ab
Puh/Tel: +358 2 276 5000

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige

• H. Lundbeck AB Tel: +46 4225 4300

Latvija

• H. Abbe Pharma GmbH Tel.: +371 67 103203 United KingdomLundbeck Limited Tel: +44 1908 64 9966

More detailed information on this medicine is available on the website of the European Medicines
Agency (EMA): http://www.ema.europa.eu.

Memantine Merz 5 mg/delivery oral solution

Memantine hydrochloride

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Memantine Merz is and what it is used for
• 2. What you need to know before you take Memantine Merz
• 3. How to take Memantine Merz
• 5. Possible side effects
• 5. How to store Memantine Merz
• 6. Contents of the pack and other information

1. What is Memantine Merz and what is it used for

How Memantine Merz works
Memantine Merz contains the active ingredient memantine hydrochloride.
Memantine Merz belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disturbance in the transmission of
messages in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors
involved in the transmission of nerve signals important for learning and memory.
Memantine Merz belongs to a group of medicines defined as NMDA receptor antagonists.
Memantine Merz acts on NMDA receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before you take Memantine Merz

Do not take Memantine Merz

• if you are allergic (hypersensitive) to memantine hydrochloride or to any of the excipients of Memantine Merz solution (see section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine Merz

• 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 high blood pressure.

In these situations, treatment should be carefully monitored and the clinical benefits of Memantine Merz
re-evaluated by your doctor at regular intervals.
If you have impaired kidney function (kidney problems), your doctor must carefully monitor
kidney function and, if necessary, adjust the dose of memantine accordingly.
Avoid concomitant use of medicinal products 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.

Children and adolescents
Memantine Merz is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine Merz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, the effects of the following medicines may be altered by Memantine Merz and
the dosage may need to be adjusted:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations with hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat 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 the medical staff that you are taking Memantine Merz.

Memantine Merz with food and drink
Talk to your doctor if you intend to make substantial changes to 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 kidney dysfunction
(impaired kidney function)) or severe urinary tract infections (the structure that carries urine),
as your doctor may need to adjust the dosage of the medicine accordingly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of memantine during pregnancy is not recommended.
Breastfeeding
Women taking Memantine Merz should not breastfeed.

Driving and using machines
Your doctor will tell you if your condition allows you to drive or operate machinery
without risk.
In addition, Memantine Merz may alter your responsiveness, making it inadvisable to drive
vehicles or operate machinery.

Memantine Merz contains sorbitol
This medicine contains 100 mg of sorbitol per gram equivalent to 200 mg/4 presses of the
metering pump. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to
certain sugars, or if you have a diagnosis of hereditary fructose intolerance (HFI), a rare genetic
disease in which patients cannot metabolize fructose, talk to your doctor before you
take this medicine.
In addition, this medicine contains potassium, less than 1 mmol (39 mg) per dose, therefore essentially
potassium-free.

3. How to take Memantine Merz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Dosage
One pump action downwards contains 5 mg of memantine hydrochloride. The recommended dose
of Memantine Merz for adult and elderly patients is four pump actions downwards, equivalent to 20 mg once daily.
To reduce the risk of undesirable effects, reach this dosage gradually following this
daily dosage schedule:
The usual starting dose is one pump action downwards (1 x 5 mg) once
daily for the first week. This dosage is increased to two pump actions downwards of the
pump applicator once daily (1 x 10 mg) in the second week and to three pump actions downwards
of the pump applicator (1 x 15 mg) once daily in the third week. From the fourth week onwards, the
recommended dose is four pump actions downwards of the pump applicator once daily (1 x
20 mg).

Dosage in patients with reduced kidney function
In case of reduced kidney function, the treating physician may decide on a dosage regimen suitable
for your condition. In this case, regular monitoring of kidney function must be
requested by the doctor.

Administration
Memantine Merz is to be administered orally once daily. To benefit, you must
take the medicine regularly every day at the same time. Take the solution with a little water.
The solution can be taken with or without food. For detailed instructions on preparation
and handling of the product, see the end of this leaflet.

Duration of treatment
Continue to take Memantine Merz as long as you benefit from it. The doctor will evaluate the treatment at
regular intervals.

If you take more Memantine Merz than you should

• in general, an overdose of Memantine Merz is not harmful. You may experience a greater number of symptoms described in section 4 “Possible undesirable effects”.
• in case of a significant overdose of Memantine Merz, contact your treating physician as their intervention may be required. If you forget to take Memantine Merz
• if you forget to take a dose, take the next dose at the scheduled time.

• do not take a double dose to make up for a missed dose. If you have any 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.
In general, the observed side effects are mild to moderate.

Common (may affect up to 1 in 10 people):

• headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension and hypersensitivity to the drug

Uncommon (may affect up to 1 in 100 people):

• fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure and venous thrombosis (thromboembolism)

Very rare (may affect up to 1 in 10,000 people):

• convulsions Not known (frequency cannot be estimated from available data):
• pancreatitis, liver inflammation (hepatitis) and 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 Merz.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Memantine Merz

Keep this medicine out of the sight and reach of children.
Do not use Memantine Merz after the expiry date which is stated on the pack and on the
bottle label after EXP. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 30°C.
Once opened, use the contents of the bottle within 3 months.
The bottle with the attached dosing pump must be kept and transported only in an
upright position.
Do not dispose of any medicine in waste water 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 Memantine Merz contains
The active ingredient is memantine hydrochloride.
Each pump activation (one press down) delivers 0.5 ml of solution containing 5 mg
of memantine hydrochloride, equivalent to 4.16 mg of memantine.
The excipients are potassium sorbate, sorbitol (E 420), purified water.

Description of the appearance of Memantine Merz and contents of the pack
Memantine Merz oral solution appears as a transparent, colorless to pale yellow
solution.
Memantine Merz oral solution is available in bottles of 50 ml, 100 ml or 500 ml (10 x 50 ml).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany

Manufacturer
Merz Pharma GmbH & Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder.

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 340 2828

Lietuva

• H. Abbe Pharma GmbH Tel.: +370 52 711710 БългарияMerz Pharmaceuticals GmbH Tel.: +49 (0)69 1503 – 0 Luxembourg/LuxemburgHANFF Global Health Solutions s.à r.l. Tél: +352 45 07 07-1

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Lundbeck Pharma A/S
Tlf: +45 4371 4270

Malta
Clinipharm Co. Ltd
Tel: +356 21 43 74 15

Deutschland
Merz Pharmaceuticals GmbH
Tel: +49 (0)69 1503 - 0

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Abbe Pharma GmbH Tel.: +372 6 460980 Norge
• H. Lundbeck AS Tlf: +47 91 300 800 ΕλλάδαLundbeck Hellas S.A. Τηλ: +30 210 610 5036 ÖsterreichMerz Pharma Austria GmbH Tel.: +43 1 865 88 95

España
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Polska
Centrala Farmaceutyczna CEFARM SA
Tel: +48 22 634 02 22

France
Lundbeck SAS
Tél: + 33 1 79 41 29 00

Portugal
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: + 385 1 3649 210

România
Lundbeck Export A/S
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Ísland
Lundbeck Export A/S, útibú á Íslandi
Sími.: +354 414 7070

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Lundbeck Italia S.p.A.
Tel: +39 02 677 4171

Suomi/Finland
Oy H. Lundbeck Ab
Puh/Tel: +358 2 276 5000

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige

• H. Lundbeck AB Tel: +46 4225 4300 Latvija
• H. Abbe Pharma GmbH Tel.: +371 67 103203 United KingdomLundbeck Limited Tel: +44 1908 64 9966

More detailed information on this medicine is available on the website of the European
Medicines Agency (EMA): http://www.ema.europa.eu/.

Instructions for the correct use of the pump
The solution must not be poured or pumped directly into the mouth from the bottle or pump.
Measure the dose in a spoon or a glass of water, using the pump.
Remove the screw cap from the bottle:
The cap must be turned counterclockwise, completely unscrewed and removed (fig. 1).

Assembling the dosing pump onto the bottle:
Remove the dosing pump from the plastic bag (fig. 2) and place it over the bottle. Carefully slide the plastic suction tube into the bottle. Hold the dosing pump over the
neck of the bottle and screw it clockwise until it clicks firmly into place (fig. 3). The dosing
pump must be screwed on only once when you start using it and must never be
unscrewed.

How the dosing pump works:
The head of the dosing pump has two positions and is easy to turn:

• counterclockwise for the open position and
• clockwise for the locked position. The head of the dosing pump must not be pressed down when it is in the locked position. The solution can only be dispensed in the unlocked position. To unlock, turn the pump head in the direction of the arrow until it can no longer be turned (about an eighth of a turn, fig. 4). The dosing pump is then ready for use.

Preparing the dosing pump:
When used for the first time, the dosing pump does not dispense the correct amount of oral solution.
Therefore, the pump must be primed (activated) by pressing the pump head
down completely five times in sequence (fig. 5).

The solution thus dispensed must be discarded. The next time the pump
head is pressed down completely, it will dispense the correct dose (fig. 6).

Correct use of the dosing pump:
Place the bottle on a flat, horizontal surface, such as a table top, and use it
only in an upright position. Hold a glass with a little water or a spoon under the nozzle. Press
down on the pump head firmly but calmly and steadily – not too slowly
(fig. 7, fig. 8).

The pump head can then be released and is ready for the next press
down.
The dosing pump must be used exclusively with the Memantine Merz solution in the
supplied bottle, not with other substances or containers. If the pump does not work
correctly, consult your doctor or pharmacist. Lock the dosing pump after using
Memantine Merz.

Memantine Merz 5 mg film-coated tablets
Memantine Merz 10 mg film-coated tablets
Memantine Merz 15 mg film-coated tablets
Memantine Merz 20 mg film-coated tablets

Memantine hydrochloride

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
• 1. What Memantine Merz is and what it is used for
• 2. What you need to know before you take Memantine Merz
• 3. How to take Memantine Merz
• 6. Possible side effects
• 5. How to store Memantine Merz
• 6. Contents of the pack and other information

1. What is Memantine Merz and what is it used for

How Memantine Merz works
Memantine Merz contains the active ingredient memantine hydrochloride.
Memantine Merz belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disturbance in the transmission of
messages in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors
involved in the transmission of nerve signals important for learning and memory.
Memantine Merz belongs to a group of drugs defined as NMDA receptor antagonists.
Memantine Merz acts on these NMDA receptors, improving the transmission of nerve signals and
memory.

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

2. What you need to know before taking Memantine Merz

Do not take Memantine Merz

• if you are allergic (hypersensitive) 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 Memantine Merz

• 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 high blood pressure.

In these situations the treatment should be carefully monitored and the clinical benefits of Memantine Merz
re-evaluated by your doctor at regular intervals.
If you have impaired kidney function (kidney problems), your doctor must carefully monitor
kidney function and, if necessary, adjust the dose of memantine accordingly.
Avoid concomitant use of medicinal products 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.

Children and adolescents
Memantine Merz is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine Merz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, the effects of the following medicines may be altered by Memantine Merz and
it may be necessary to adjust the dosage:

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

If you are hospitalized, inform the medical staff that you are taking Memantine Merz.

Memantine Merz with food and drink
Talk to your doctor if you intend 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 substances that form
acid in the blood due to kidney dysfunction
(impaired kidney function)) or severe urinary tract infections (the structure that carries urine),
as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of memantine during pregnancy is not recommended.

Breastfeeding
Women taking Memantine Merz should not breastfeed.

Driving and using machines
Your doctor will tell you if your condition allows you to drive or operate machinery
without risk.
In addition, Memantine Merz may alter your responsiveness, making it inadvisable to drive
vehicles or operate machinery.

Memantine Merz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Memantine Merz

Memantine Merz starter pack must be used only at the beginning of treatment with Memantine Merz. Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor or pharmacist.

Dosage
The recommended dose of Memantine Merz 20 mg per day is reached through a gradual increase of the dose of Memantine Merz during the first 3 weeks of treatment. The treatment schedule is also indicated on the starter pack. Take one tablet once a day.
First week (day 1-7):
Take one 5 mg film-coated tablet once a day (white to off-white, oval-oblong) for 7 days.
Second week (day 8-14):
Take one 10 mg film-coated tablet once a day (yellow to pale yellow, oval) for 7 days.
Third week (day 15-21):
Take one 15 mg film-coated tablet once a day (grey-orange, oval-oblong) for 7 days.
Fourth week (day 22-28):
Take one 20 mg film-coated tablet per day (grey-red, oval-oblong) for 7 days.
Maintenance dose
The recommended maintenance dose is 20 mg per day.
For continuation of therapy, consult your doctor.

Dosage in patients with reduced renal function
In case of reduced renal function, the treating physician may decide on a dosage regimen suitable for your condition. In this case, regular monitoring of renal function should be requested by the doctor.

Administration
Memantine Merz is to be administered orally once a day. To benefit, you must take the medicine regularly every day at the same time. Take the tablets with a little water. The drops can be taken with or without meals.

Duration of treatment
Continue to take Memantine Merz as long as you benefit from it. The doctor will evaluate the treatment at regular intervals.

If you take more Memantine Merz than you should

• In general, an overdose of Memantine Merz is not harmful. You may experience a greater number of symptoms described in section 4 “Possible undesirable effects”.
• In case of a significant overdose of Memantine Merz, contact your doctor as his/her intervention may be required. If you forget to take Memantine Merz
• If you forget to take a dose, take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

If you have any doubts 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.
In general, the observed side effects are from mild to moderate.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure and venous thrombosis (thromboembolism) Very rare (may affect up to 1 in 10,000):
• Convulsions

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

• Pancreatitis, inflammation of the liver (hepatitis) and 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 Merz.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system as detailed in Annex V.

5. How to store Memantine Merz

Keep this medicine out of the sight and reach of children.
Do not use Memantine Merz after the expiry date which is stated on the package and on the
bottle label after EXP. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 30°C.
Once opened, use the contents of the bottle within 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Memantine Merz contains
The active ingredient is memantine hydrochloride. Each tablet contains 5/10/15/20 mg of memantine
hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg of memantine.
The excipients of Memantine Merz 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose,
sodium croscarmellose, colloidal anhydrous silicon dioxide and magnesium stearate, in the core
of the tablet; in the coating of the tablet are hydroxypropyl methylcellulose, macrogol 400 and
titanium dioxide (E 171), the additional excipient for Memantine Merz 10 mg film-coated tablets
is yellow iron oxide (E 172) and the additional excipients for Memantine Merz 15 mg and
Memantine Merz 20 mg film-coated tablets are yellow and red iron oxide (E 172).

Description of the appearance of Memantine Merz and contents of the pack
Memantine Merz 5 mg film-coated tablets are white to off-white, oval-oblong in shape with “5” imprinted
on one side and “MEM” on the other side.
Memantine Merz 10 mg film-coated tablets are yellow to pale yellow in colour, oval in shape,
with “1-0” imprinted on the breaking line on one side and “M M” on the other side. The tablet can
be divided into two equal halves.
Memantine Merz 15 mg film-coated tablets are orange, tending to grey-orange, oval-oblong in shape with “15” imprinted
on one side and “MEM” on the other side.
Memantine Merz 20 mg film-coated tablets are light red, tending to grey-red, oval-oblong in shape with “20” imprinted
on one side and “MEM” on the other side.
A starter pack contains 28 tablets in 4 blisters with 7 tablets of
Memantine Merz 5 mg, 7 tablets of Memantine Merz 10 mg, 7 tablets of Memantine Merz 15
mg and 7 tablets of Memantine Merz 20 mg.

Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany

Manufacturer
Merz Pharma GmbH + Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 340 2828

Lietuva

• H. Abbe Pharma GmbH Tel.: +370 52 711710 БългарияMerz Pharmaceuticals GmbH Tel.: +49 (0)69 1503 – 0 Luxembourg/LuxemburgHANFF Global Health Solutions s.à r.l.. Tél: +352 45 07 07-1

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Lundbeck Pharma A/S
Tlf: +45 4371 4270

Malta
Clinipharm Co. Ltd
Tel: +356 21 43 74 15

Deutschland
Merz Pharmaceuticals GmbH
Tel: +49 (0)69 1503 - 0

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Abbe Pharma GmbH Tel.: +372 6 460980 Norge
• H. Lundbeck AS Tlf: +47 91 300 800 ΕλλάδαLundbeck Hellas S.A. Τηλ: +30 210 610 5036 ÖsterreichMerz Pharma Austria GmbH Tel.: +43 1 865 88 95

España
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Polska
Centrala Farmaceutyczna CEFARM SA
Tel: +48 22 634 02 22

France
Lundbeck SAS
Tél: + 33 1 79 41 29 00

Portugal
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: + 385 1 3649 210

România
Lundbeck Export A/S
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Ísland
Lundbeck Export A/S, útibú á Íslandi
Sími.: +354 414 7070

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Lundbeck Italia S.p.A.
Tel: +39 02 677 4171

Suomi/Finland
Oy H. Lundbeck Ab
Puh/Tel: +358 2 276 5000

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige

• H. Lundbeck AB Tel: +46 4225 4300

Latvija

• H. Abbe Pharma GmbH Tel.: +371 67 103203 United KingdomLundbeck Limited Tel: +44 1908 64 9966

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

Memantine Merz 20 mg film-coated tablets

Memantine hydrochloride

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Memantine Merz is and what it is used for
• 2. What you need to know before you take Memantine Merz
• 3. How to take Memantine Merz
• 4. Possible side effects
• 5. How to store Memantine Merz
• 6. Contents of the pack and other information

1. What is Memantine Merz and what is it used for

How Memantine Merz works
Memantine Merz contains the active ingredient memantine hydrochloride.
Memantine Merz belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disturbance in the transmission of
messages in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors
involved in the transmission of nerve signals important for learning and memory.
Memantine Merz belongs to a group of medicines defined as NMDA receptor antagonists.
Memantine Merz acts on these NMDA receptors, improving the transmission of nerve signals and
memory.

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

2. What you need to know before taking Memantine Merz

Do not take Memantine Merz

• if you are allergic (hypersensitive) 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 Memantine Merz

• 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 high blood pressure. In these situations, treatment should be carefully monitored and the clinical benefits of Memantine Merz re-evaluated by your doctor at regular intervals.

In case of impaired renal function (kidney problems), your doctor must carefully monitor
renal function and, if necessary, adjust the dosage of memantine accordingly.
Avoid concomitant use of medicinal products such as amantadine (for the treatment of
Parkinson's disease), ketamine (a substance generally used as an anesthetic),
dextromethorphan (generally used for cough treatment) and other NMDA antagonists.

Children and adolescents
Memantine Merz is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine Merz
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines.
In particular, the effects of the following medicines may be altered by Memantine Merz and
it may be necessary to adjust the dosage:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations with hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat 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 the medical staff that you are taking Memantine Merz.

Memantine Merz with food and drink
Talk to your doctor if you intend 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 impaired renal function
(impaired kidney function)) or severe urinary tract infections (structure that transports urine), as your doctor may need to adjust the dosage of the medicine accordingly.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of memantine during pregnancy is not recommended.

Breastfeeding
Women taking Memantine Merz should not breastfeed.

Driving and using machines
Your doctor will tell you if your condition allows you to drive or operate machinery
without risk.
In addition, Memantine Merz may alter your responsiveness, making it inadvisable to drive
vehicles or operate machinery.

Memantine Merz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Memantine Merz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Dosage
The recommended dose of Memantine Merz for adult and elderly patients is 20 mg once daily. To
reduce the risk of undesirable effects, reach this dosage gradually following this
daily dosage schedule. Tablets with other
strengths are available for titration increases.
At the beginning of treatment, you will start using Memantine Merz 5 mg film-coated tablets
once daily. This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached.
The recommended maintenance dose is 20 mg once daily,
which is reached at the beginning of the fourth week.

Dosage in patients with reduced kidney function
In case of reduced kidney function, the treating physician may decide on a dosage regimen suitable
for your condition. In this case, regular monitoring of kidney function must be
requested by the doctor.

Administration
Memantine Merz is to be administered orally once daily. To benefit, you must
take the medicine regularly every day at the same time. Take the tablets with a little
water. The tablets can be taken with or without meals.

Duration of treatment
Continue to take Memantine Merz as long as you benefit from it. The doctor will evaluate the treatment at
regular intervals.

If you take more Memantine Merz than you should

• In general, an overdose of Memantine Merz is not harmful. You may experience a greater number of symptoms described in paragraph 4 “Possible side effects”.
• In case of a considerable overdose of Memantine Merz, contact your treating physician as his/her intervention may be required.

If you forget to take Memantine Merz

• If you forget to take a dose, take the next dose at the scheduled time.
• Do not take a double dose to make up for a forgotten dose. If you have any doubts about using 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.
In general, the observed side effects are from mild to moderate.

Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension and hypersensitivity to the drug Uncommon (may affect up to 1 in 100 people):
• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure and venous thrombosis (thromboembolism)

Very rare (may affect up to 1 in 10,000 people):

• Convulsions

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

• Pancreatitis, liver inflammation (hepatitis) and 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 Merz.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V. By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store Memantine Merz

Keep this medicine out of the sight and reach of children.
Do not use Memantine Merz after the expiry date which is stated on the package and on the
bottle label after EXP. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 30°C.
Once opened, use the contents of the bottle within 3 months.
Do not dispose of any medicine in 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 Memantine Merz contains
The active ingredient is memantine hydrochloride. Each film-coated tablet contains 20 mg of
memantine hydrochloride equivalent to 16.62 mg of memantine.
The excipients are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silicon dioxide,
magnesium stearate, in the tablet core; and hydroxypropyl methylcellulose, macrogol 400, titanium dioxide (E 171), red and yellow iron oxide (E 172), in the tablet coating.

Description of the appearance of Memantine Merz and package contents
Memantine Merz 20 mg film-coated tablets are light red in color, tending towards greyish-
red, oval-oblong shaped with “20” imprinted on one side and “MEM” on the other side.
Memantine Merz tablets are available in blister packs of 14, 28, 42, 56, 98 and multiple packs of 840 (20 packs of 42) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany

Manufacturer
Merz Pharma GmbH + Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany
For further information on this medicinal product, contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 340 2828

Lietuva

• H. Abbe Pharma GmbH Tel.: +370 52 711710 БългарияMerz Pharmaceuticals GmbH Tel.: +49 (0)69 1503 – 0 Luxembourg/LuxemburgHANFF Global Health Solutions s.à r.l. Tél: +352 45 07 07-1 Česká republikaLundbeck Česká republika s.r.o. Tel: +420 225 275 600 MagyarországLundbeck Hungaria Kft. Tel: +36 1 4369980

Danmark
Lundbeck Pharma A/S
Tlf: +45 4371 4270

Malta
Clinipharm Co. Ltd
Tel: +356 21 43 74 15

Deutschland
Merz Pharmaceuticals GmbH
Tel: +49 (0)69 1503 - 0

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Abbe Pharma GmbH Tel.: +372 6 460980 Norge
• H. Lundbeck AS Tlf: +47 91 300 800 ΕλλάδαLundbeck Hellas S.A. Τηλ: +30 210 610 5036 ÖsterreichMerz Pharma Austria GmbH Tel.: +43 1 865 88 95

España
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Polska
Centrala Farmaceutyczna CEFARM SA
Tel: +48 22 634 02 22

France
Lundbeck SAS
Tél: + 33 1 79 41 29 00

Portugal
Merz Pharma España S.L.
Tel: +34 91 657 47 84

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: + 385 1 3649 210

România
Lundbeck Export A/S
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Ísland
Lundbeck Export A/S, útibú á Íslandi
Sími.: +354 414 7070

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Lundbeck Italia S.p.A.
Tel: +39 02 677 4171

Suomi/Finland
Oy H. Lundbeck Ab
Puh/Tel: +358 2 276 5000

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige

• H. Lundbeck AB Tel: +46 4225 4300 Latvija
• H. Abbe Pharma GmbH Tel.: +371 67 103203 United KingdomLundbeck Limited Tel: +44 1908 64 9966

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