Memantina Merz: detailed information

Package leaflet: Information for the user

Memantine Merz 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

How Memantine Merz works
Memantine Merz contains the active substance 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 called NMDA receptor antagonists.
Memantine Merz acts on these NMDA receptors, improving nerve signal transmission 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 epileptic 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 must be closely monitored and the clinical benefits of Memantine Merz should be regularly reassessed by your treating physician.
If you have impaired renal function (kidney problems), your treating doctor must carefully monitor your kidney function and, if necessary, adjust the dosage of memantine accordingly.
Avoid concomitant intake of medicinal products such as amantadine (used to treat Parkinson's disease), ketamine (a substance generally used as an anesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.
Children and adolescents
Memantine Merz is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantine Merz
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 Memantine Merz, and dosage 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 Memantine Merz.
Memantine Merz with food and drink
Talk to your treating 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 kidney dysfunction (impaired renal function)) or severe urinary tract infections (the structure transporting urine), as your doctor may need to adjust the dosage of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of memantine during pregnancy is not recommended.
Breastfeeding
Women taking Memantine Merz must not breastfeed.
Driving and using machines
Your treating doctor will advise you whether your condition allows you to drive or operate machinery safely.
Moreover, Memantine Merz may affect your reaction speed, making it advisable to avoid driving vehicles or operating 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 exactly as directed by your doctor. If you have any doubts, consult 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, this dose should be reached gradually according to the following daily dosing schedule:

Week 1	half a 10 mg tablet
Week 2	one 10 mg tablet
Week 3	one and a half 10 mg tablets
Week 4 and onwards	two 10 mg tablets once daily

The usual starting dose is half a tablet once daily (1 x 5 mg) for the first week. The dosage 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. 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 you have reduced kidney function, your doctor may decide on a dosage regimen suitable for your condition. In such cases, your doctor should request regular monitoring of kidney function.
Administration
Memantine Merz should be taken orally once daily. To obtain benefit, you must take the medication regularly every day at the same time. Swallow the tablets with some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Memantine Merz for as long as you benefit from it. Your doctor will review the treatment at regular intervals.
If you take more Memantine Merz than you should

In general, overdose of Memantine Merz is not harmful. A greater number of symptoms described in section 4 “Possible side effects” may occur.
In case of a significant overdose of Memantine Merz, contact your doctor, as medical intervention may be required. If you forget to take Memantine Merz
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 will experience them.
In general, the side effects observed are mild to moderate.

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

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

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):

Seizures

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

5. How to store Memantine Merz

Keep this medicine out of sight and reach of children.
Do not use Memantine Merz after the expiry date stated on the packaging 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 medicines 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 Memantine Merz 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 excipients are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal siliconic acid, and
magnesium stearate in the tablet core; in the tablet coating: hypromellose, macrogol 400, titanium dioxide (E 171), and yellow and red iron oxide (E 172).
Description of the appearance of Memantine Merz and contents of the pack
Memantine Merz film-coated tablets are yellow to pale yellow, oval-shaped, film-coated tablets, with "1-0" engraved on one side along the break line and "M M" on the other side.
Memantine Merz film-coated tablets are available in blister packs containing 14, 28, 30, 42, 50, 56, 98, 100, 112 tablets, 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 Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Abbe Pharma GmbH
Tél/Tel: +32 2 340 2828 Tel.: +370 52 711710
България Luxembourg/Luxemburg
Merz Pharmaceuticals GmbH HANFF Global Health Solutions s.à r.l.
Tel.: +49 (0)69 1503 – 0 Tél: +352 45 07 07-1
Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungaria Kft.
Tel: +420 225 275 600 Tel: +36 1 4369980
Danmark Malta
Lundbeck Pharma A/S Clinipharm Co. Ltd
Tlf: +45 4371 4270 Tel: +356 21 43 74 15
Deutschland Nederland
Merz Pharmaceuticals GmbH Lundbeck B.V.
Tel: +49 (0)69 1503 - 0 Tel: +31 20 697 1901
Eesti Norge
H. Abbe Pharma GmbH H. Lundbeck AS
Tel.: +372 6 460980 Tlf: +47 91 300 800
Ελλάδα Österreich
Lundbeck Hellas S.A. Merz Pharma Austria GmbH
Τηλ: +30 210 610 5036 Tel.: +43 1 865 88 95
España Polska
Merz Pharma España S.L. Centrala Farmaceutyczna CEFARM SA
Tel: +34 91 657 47 84 Tel: +48 22 634 02 22
France Portugal
Lundbeck SAS Merz Pharma España S.L.
Tél: +33 1 79 41 29 00 Tel: +34 91 657 47
Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Export A/S
Tel.: +385 1 3649 210 Tel: +40 21319 88 26
Ireland Slovenija
Lundbeck (Ireland) Limited Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500
Ísland Slovenská republika
Lundbeck Export A/S, útibú á Íslandi Lundbeck Slovensko s.r.o.
Sími.: +354 414 7070 Tel: +421 2 5341 42 18
Italia Suomi/Finland
Lundbeck Italia S.p.A. Oy H. Lundbeck Ab
Tel: +39 02 677 4171 Puh/Tel: +358 2 276 5000
Κύπρος Sverige
Lundbeck Hellas A.E H. Lundbeck AB
Τηλ.: +357 22490305 Tel: +46 4225 4300
Latvija United Kingdom
H. Abbe Pharma GmbH Lundbeck Limited
Tel.: +371 67 103203 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.

Package leaflet: information for the user

Memantine Merz 5 mg/dose oral solution
Memantine hydrochloride
Please read all of 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

How Memantine Merz works
Memantine Merz contains the active substance 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, which are involved in the transmission of nerve signals important for learning and memory.
Memantine Merz belongs to a group of medicines called 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 should know before taking 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 epileptic 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 cases, treatment must be closely monitored and the clinical benefits of Memantine Merz should be regularly reassessed by your treating physician.
If you have impaired renal function (kidney problems), your treating physician must carefully monitor kidney function and, if necessary, adjust the memantine dosage 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), destromethorphan (commonly used for the treatment of cough), and other NMDA antagonists.
Children and adolescents
Memantine Merz is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantine Merz
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 Memantine Merz, and dosage adjustment may be necessary:

amantadine, ketamine, destromethorphan
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 Memantine Merz.
Memantine Merz with food and drinks
Talk to your treating physician if you intend to make significant changes to your diet (for example, switching 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 system that transports urine), as your doctor may need to adjust the dosage 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 or pharmacist 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 treating physician will advise you whether your condition allows you to drive or operate machinery safely.
In addition, Memantine Merz may affect your reaction speed, making it inadvisable to drive or operate machinery.
Memantine Merz contains sorbitol
This medicine contains 100 mg of sorbitol per gram, equivalent to 200 mg/4 pump actuations. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
One press of the pump downwards delivers 5 mg of memantine hydrochloride. The recommended dose of Memantine Merz for adult and elderly patients is four downward presses of the dosing pump, equivalent to 20 mg once daily.
To reduce the risk of undesirable effects, reach this dose gradually according to the following daily dosing schedule:

Week 1	one downward press of the dosing pump
Week 2	two downward presses of the dosing pump
Week 3	three downward presses of the dosing pump
Week 4 and onwards	four downward presses of the dosing pump

The usual initial dose is one downward press of the pump dispenser (1 x 5 mg) once daily during the first week. This dosage is increased to two downward presses of the pump dispenser once daily (1 x 10 mg) in the second week, and to three downward presses of the pump dispenser (1 x 15 mg) once daily in the third week. From the fourth week onwards, the recommended dose is four downward presses of the pump dispenser once daily (1 x 20 mg).
Dosage in patients with reduced renal function
If you have reduced renal function, your doctor may decide on a dosage regimen appropriate for your condition. In such cases, regular monitoring of renal function must be requested by the doctor.
Administration
Memantine Merz should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Take the solution with some water. The solution may 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 taking Memantine Merz for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.
If you take more Memantine Merz than you should

In general, overdose of Memantine Merz is not harmful. A higher number of symptoms described in section 4 “Possible side effects” may occur.
In case of a significant overdose of Memantine Merz, contact your doctor, as medical intervention may be required. If you forget to take Memantine Merz
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 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 side effects observed 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 drug hypersensitivity

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

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

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

seizures
Not known (frequency cannot be estimated from the available data):
inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. During post-marketing experience, these events have been reported in patients treated with Memantine Merz.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help 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 carton and on the label of the bottle after EXP. The expiry date refers to the last day of the month.
Store below 30°C.
After first opening, use the contents of the bottle within 3 months.
The bottle with the dosing pump screwed on must be kept and transported in an upright position only.
Do not dispose of medicines 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 Memantine Merz contains
The active substance is memantine hydrochloride.
Each pump activation (one downward press) 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 is a clear, colourless to slightly yellow solution.
Memantine Merz oral solution is available in 50 ml, 100 ml or 500 ml bottles (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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Lundbeck S.A./N.V. H. Abbe Pharma GmbH
Tél/Tel: +32 2 340 2828 Tel.: +370 52 711710

България Luxembourg/Luxemburg
Merz Pharmaceuticals GmbH HANFF Global Health Solutions s.à r.l.
Tel.: +49 (0)69 1503 – 0 Tél: +352 45 07 07-1

Česká republika Magyarország
Lundbeck Česká republika s.r.o. Lundbeck Hungaria Kft.
Tel: +420 225 275 600 Tel: +36 1 4369980

Danmark Malta
Lundbeck Pharma A/S Clinipharm Co. Ltd
Tlf: +45 4371 4270 Tel: +356 21 43 74 15

Deutschland Nederland
Merz Pharmaceuticals GmbH Lundbeck B.V.
Tel: +49 (0)69 1503 - 0 Tel: +31 20 697 1901

Eesti Norge
H. Abbe Pharma GmbH H. Lundbeck AS
Tel.: +372 6 460980 Tlf: +47 91 300 800

Ελλάδα Österreich
Lundbeck Hellas S.A. Merz Pharma Austria GmbH
Τηλ: +30 210 610 5036 Tel.: +43 1 865 88 95

España Polska
Merz Pharma España S.L. Centrala Farmaceutyczna CEFARM SA
Tel: +34 91 657 47 84 Tel: +48 22 634 02 22

France Portugal
Lundbeck SAS Merz Pharma España S.L.
Tél: +33 1 79 41 29 00 Tel: +34 91 657 47 84

Hrvatska România
Lundbeck Croatia d.o.o. Lundbeck Export A/S
Tel.: +385 1 3649 210 Tel: +40 21319 88 26

Ireland Slovenija
Lundbeck (Ireland) Limited Lundbeck Pharma d.o.o.
Tel: +353 1 468 9800 Tel.: +386 2 229 4500

Ísland Slovenská republika
Lundbeck Export A/S, útibú á Íslandi Lundbeck Slovensko s.r.o.
Sími.: +354 414 7070 Tel: +421 2 5341 42 18

Italia Suomi/Finland
Lundbeck Italia S.p.A. Oy H. Lundbeck Ab
Tel: +39 02 677 4171 Puh/Tel: +358 2 276 5000

Κύπρος Sverige
Lundbeck Hellas A.E H. Lundbeck AB
Τηλ.: +357 22490305 Tel: +46 4225 4300

Latvija United Kingdom
H. Abbe Pharma GmbH Lundbeck Limited
Tel.: +371 67 103203 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/.

Instructions for correct use of the pump dispenser

The solution must not be poured or pumped directly into the mouth from the bottle or pump.
Measure the dose into a spoon or glass of water using the pump.
Remove the screw cap from the bottle:
Turn the cap counterclockwise, unscrew it completely and remove it (fig. 1).

Technical blue drawing showing two steps: a hand unscrewing a cap and a hand rotating a device over a medical vial

Assembling the dosing pump onto the bottle:
Remove the dosing pump from the plastic pouch (fig. 2) and place it on top of the bottle. Carefully slide the plastic dip tube into the bottle. Hold the dosing pump over the bottle neck and screw it on clockwise until it locks securely (fig. 3). The dosing pump should be screwed on only once when first used and must never be unscrewed.

Blue line drawing of two hands opening a single-dose medication package, with a curved arrow indicating the opening movement

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

counterclockwise for the open position, and
clockwise for the locked position.

The pump head must not be pressed down when 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 turn (approximately one-eighth of a turn, fig. 4). The dosing pump is then ready for use.

Blue line drawing showing two hands rotating the top part of a medical device to the left, indicated by a curved arrow

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

The solution dispensed during this process must be discarded. Each subsequent full downward press of the pump head will deliver the correct dose (fig. 6).

Blue line drawing showing a hand pressing the dispenser of a vial five times repeatedly, with a downward-pointing arrow

Blue drawing showing a hand pressing the pump

Correct use of the dosing pump:
Place the bottle on a flat, horizontal surface, such as a table, and use it only in an upright position. Hold a glass containing a small amount of water or a spoon under the nozzle. Press the pump head down firmly, but steadily and evenly—do not press too slowly (fig. 7, fig. 8).

Blue technical drawing showing a hand pressing the dispenser of a vial over a glass

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

Package leaflet: Information for the user

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 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 they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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 epileptic 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 must be closely monitored and the clinical benefits of Memantine Merz should be regularly reassessed by your treating physician.
If you have impaired renal function (kidney problems), your treating physician must carefully monitor kidney function and, if necessary, adjust the dosage 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
Memantine Merz is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantine Merz
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 Memantine Merz, and dosage 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 Memantine Merz.
Memantine Merz with food and drinks
Talk to your treating doctor if you intend to make significant changes to your diet (e.g. switching 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 (impaired kidney function)) or severe urinary tract infections (the structure that transports urine), as your doctor may need to adjust the dosage of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of memantine during pregnancy is not recommended.
Breastfeeding
Women taking Memantine Merz must not breastfeed.
Driving and using machines
Your treating doctor will advise you whether your condition allows you to drive or operate machinery safely.
Moreover, Memantine Merz may affect your reaction speed, making it advisable to avoid driving vehicles or operating 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

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

Dosage

The recommended dose of Memantine Merz of 20 mg daily is reached by a gradual increase in dose during the first 3 weeks of treatment. The dosing schedule is also indicated for the starter pack. Take one tablet once daily.

First week (day 1–7):
Take one 5 mg film-coated tablet once daily (white to off-white, oval-elongated) for 7 days.

Second week (day 8–14):
Take one 10 mg film-coated tablet once daily (yellow to pale yellow, oval) for 7 days.

Third week (day 15–21):
Take one 15 mg film-coated tablet once daily (orange-grey, oval-elongated) for 7 days.

Fourth week (day 22–28):
Take one 20 mg film-coated tablet once daily (red-grey, oval-elongated) for 7 days.

Week 1	5 mg tablet
Week 2	10 mg tablet
Week 3	15 mg tablet
Week 4 and onwards	20 mg tablets once daily

Maintenance dose
The recommended maintenance dose is 20 mg daily.
For continuation of therapy, please consult your doctor.
Dosage in patients with reduced renal function
In case of reduced renal function, your treating physician may decide on a dosage regimen suitable
for your condition. In such cases, regular monitoring of renal function must be requested by the physician.
Administration
Memantine Merz should be administered orally once daily. To obtain benefit, you must take the medicine
regularly every day at the same time. Swallow the tablets with some water. The oral drops may be taken
with or without food.
Duration of treatment
Continue taking Memantine Merz for as long as you benefit from it. Your doctor will evaluate the treatment
at regular intervals.
If you take more Memantine Merz than you should

In general, overdose of Memantine Merz is not harmful. A higher number of symptoms described in section 4 “Possible side effects” may occur.
In case of a significant overdose of Memantine Merz, contact your doctor, as medical intervention may be required. If you forget to take Memantine Merz
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 a 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 everyone gets them.
In general, the side effects observed are mild to moderate.

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

Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, hypertension, and drug hypersensitivity

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):

Seizures

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the carton and label of the bottle after EXP. The expiry date refers to the last day of the month.
Store below 30°C.
After first opening, use the contents of the bottle within 3 months.
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 Memantine Merz contains
The active substance 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, anhydrous colloidal silicic acid and magnesium stearate in the tablet core; in the
tablet coating are hypromellose, macrogol 400 and titanium dioxide (E 171). The additional excipient in
Memantine Merz 10 mg film-coated tablets is yellow iron oxide (E 172), and the additional excipients in
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, tending to off-white, oval-oblong tablets, with “5”
imprinted on one side and “MEM” on the other side.
Memantine Merz 10 mg film-coated tablets are yellow to pale yellow, oval-shaped tablets with “1-0”
imprinted on the score line on one side and “M M” on the other side. The tablet can be divided into two
equal parts.
Memantine Merz 15 mg film-coated tablets are orange, tending to grey-orange, oval-oblong tablets, 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 tablets, with
“20” imprinted on one side and “MEM” on the other side.
A starter pack contains 28 tablets in 4 blisters: 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 Authorization 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 about this medicinal product, please contact the local representative of the
Marketing Authorization Holder.