Memantina Accord

Package leaflet: Information for the user

Memantina Accord 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 others, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Memantina Accord is and what it is used for

How Memantina Accord works
Memantina Accord contains the active substance memantina cloridrato.
Memantina Accord belongs to a group of medicines known as anti-dementia drugs. Memory loss in Alzheimer's disease is due to a disruption in message transmission 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. Memantina Accord belongs to a group of medicines called NMDA receptor antagonists. Memantina Accord acts on these NMDA receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina Accord

Do not take Memantina Accord

• 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 Memantina Accord

• 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 cases, treatment must be closely monitored and the clinical benefits of Memantina Accord must be regularly evaluated by your doctor.
If you have impaired renal function (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the memantine dosage 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
Memantina Accord is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina Accord
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 Memantina Accord, 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 (such as L-dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants.
If you are admitted to hospital, inform the doctor that you are taking Memantina Accord.
Memantina Accord 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 kidney dysfunction (insufficient 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, are planning a pregnancy, or 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 Memantina Accord 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 condition.
Furthermore, Memantina Accord may affect your reaction speed, making it inadvisable to drive vehicles or operate machinery.
Memantina Accord contains lactose
This medicine contains lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Memantina Accord

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantina Accord for adult 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:

The usual starting dose is half a tablet once daily (1 x 5 mg) for the first week. The dose is increased to one tablet once daily (1 x 10 mg) during the second week and to one and a half tablets once daily (1 x 15 mg) in the third week. From the fourth week onwards, the usual dose is two 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 dosing regimen suitable for your condition. In such cases, regular monitoring of kidney function must be performed by your doctor.

Administration
Memantina Accord 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 tablets may be taken with or without food.

Duration of treatment
Continue taking Memantina Accord for as long as you benefit from it. Your doctor will review your treatment at regular intervals.

If you take more Memantina Accord than you should

• In general, overdose with Memantina Accord is not harmful. A higher number of symptoms described in section 4 "Possible side effects" may occur.
• In case of a significant overdose with Memantina Accord, contact your doctor as medical intervention may be required.

If you forget to take Memantina Accord

• If you forget to take a dose of Memantina Accord, wait and take the next dose at the scheduled 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, increased liver function tests, dizziness, balance disorders, feeling of breathlessness, 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 blood coagulation (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, 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.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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 provide more information on the safety of this medicine.

5. How to store Memantina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that 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 Memantina Accord 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 components are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal siliconic acid,
crospovidone and magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, and titanium dioxide (E 171), all in the tablet coating.
Description of the appearance of Memantina Accord and package contents
Memantina Accord film-coated tablets are white, oblong, film-coated tablets with a breakline. "MT" is imprinted on one side and "10" on the other side, both divided by the breakline. The tablet can be divided into two equal doses.
Memantina Accord film-coated tablets are available in blister packs (PVC/PE/PVDC-aluminium blisters) containing 14, 28, 30, 42, 50, 56, 98, 100 and 112 tablets. Memantina Accord
film-coated tablets are also available in calendar blisters with single-dose separable packs in pack sizes of 14x1, 28x1, 56x1 or 98x1 tablet.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Delorbis Pharmaceuticals Ltd
17, Athinon Street
Ergates Industrial Area, 2643 Nicosia
Cyprus
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
This leaflet was last updated on
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

Patient Information Leaflet: Information for the User

Memantina Accord 20 mg film-coated tablets

memantine hydrochloride
Please read this entire 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Memantina Accord is and what it is used for

How Memantina Accord works
Memantina Accord contains the active substance memantina hydrochloride.
Memantina Accord 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.
Memantina Accord belongs to a group of medicines called NMDA receptor antagonists.
Memantina Accord acts on these NMDA receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina Accord

Do not take Memantina Accord

• 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 Memantina Accord

• 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 Memantina Accord should be regularly evaluated by your doctor.
If you have impaired renal function (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the dosage 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), destromethorphan (commonly used to treat cough), and other NMDA antagonists.

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

Other medicines and Memantina Accord
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 Memantina Accord, 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 the doctor that you are taking Memantina Accord.

Memantina Accord 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 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 to become pregnant, 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 Memantina Accord 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 condition.
Moreover, Memantina Accord may affect your reaction speed, making it advisable not to drive or operate machinery.

Memantina Accord contains lactose
This medicine contains lactose. If you have been diagnosed by your doctor as having an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Memantina Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantina Accord for adult and elderly patients is 20 mg once daily.
To reduce the risk of unwanted side effects, this dose should be reached gradually according to the following daily dosing schedule. Tablets with different strengths are available for dose titration.
At the beginning of treatment, you will start with Memantina Accord 5 mg film-coated tablets once daily. This dose will be increased weekly by 5 mg until the recommended dose (maintenance dose) is reached. The recommended maintenance dose of 20 mg once daily is reached at the beginning of the fourth week.

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 this case, your doctor should monitor your kidney function at regular intervals.

Administration
Memantina Accord should be taken 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 tablets may be taken with or without food.

Duration of treatment
Continue taking Memantina Accord for as long as you benefit from it. Your doctor will review your treatment at regular intervals.

If you take more Memantina Accord than you should

• In general, overdose with Memantina Accord is not harmful. However, a greater number of symptoms described in section 4 “Possible side effects” may occur.
• In case of a significant overdose with Memantina Accord, contact your doctor as medical intervention may be required.

If you forget to take Memantina Accord

• If you forget to take a dose of Memantina Accord, wait and 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 how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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, sensation of breathlessness, 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 blood coagulation (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, 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.

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 Memantina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
EXP. The expiry date refers to the last day of that 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. Pack contents and other information

What Memantina Accord contains
The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of
memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other components are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide,
crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80,
macrogol 400, titanium dioxide (E 171), red iron oxide (E 172) and yellow iron oxide (E 172),
all in the tablet coating.

Description of the appearance of Memantina Accord and pack contents
Memantina Accord 20 mg film-coated tablets are film-coated, scored tablets, light red in colour, tending to grey-red, oblong in shape, with "MT" imprinted divided by the score line on one side and "20" divided by the score line on the other side. The tablet can be divided into two equal doses.
Memantina Accord film-coated tablets are available in blister packs (PVC/PE/PVDC-aluminium blisters) containing 14, 28, 42, 56, or 98 tablets. Memantina Accord film-coated tablets are also available in calendar blisters with single-dose compartments in packs of 14x1, 28x1, 56x1 or 98x1 tablet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Delorbis Pharmaceuticals Ltd
17, Athinon Street
Ergates Industrial Area, 2643 Nicosia
Cyprus
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

This leaflet was last updated on
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Package leaflet: information for the user

Memantina Accord 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Memantina Accord is and what it is used for

How Memantina Accord works
Memantina Accord contains the active substance memantina cloridrato.
Memantine Accord 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.
Memantina Accord belongs to a group of medicines called NMDA receptor antagonists.
Memantina Accord acts on these NMDA receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before taking Memantina Accord

Do not take Memantina Accord

• 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 Memantina Accord

• 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 Memantina Accord must be evaluated regularly by your doctor.
If you have impaired renal function (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the memantine dosage 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
Memantina Accord is not recommended for children and adolescents under 18 years of age.

Other medicines and Memantina Accord
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 Memantina Accord, 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 the doctor that you are taking Memantina Accord.

Memantina Accord with food and drink
Talk to your doctor if you have recently changed or plan to substantially change your diet (for example, 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 transporting 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 to become pregnant, 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 Memantina Accord must not breastfeed.

Driving and using machines
Your doctor will advise you whether it is safe for you to drive or operate machinery given your condition.
Furthermore, Memantina Accord may affect your reaction time, making it advisable not to drive or operate machinery.

Memantina Accord contains lactose
This medicine contains lactose. If you have been diagnosed by your doctor as having an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Memantina Accord

The Memantina Accord starter pack must be used only at the beginning
of treatment with Memantina Accord.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Dosage
The recommended maintenance dose of 20 mg daily is reached by a gradual increase of
Memantina Accord dosage 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 (white in colour) once daily for 7 days.
Second week (day 8-14):
Take one 10 mg film-coated tablet (white in colour, with break line) once daily for 7 days.
Third week (day 15-21):
Take one 15 mg film-coated tablet (orange to grey-orange in colour) once daily for 7 days.
Fourth week (day 22-28):
Take one 20 mg film-coated tablet (pale red to grey-red in colour) once daily for 7 days.

Maintenance dose
The recommended maintenance dose is 20 mg daily.
For continuation of therapy, consult your doctor.

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 must be performed by the doctor.

Administration
Memantina Accord 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 tablets may be taken with or without food.

Duration of treatment
Continue taking Memantina Accord for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.

If you take more Memantina Accord than you should

• In general, overdose with Memantina Accord is not harmful. A higher number of symptoms described in section 4 "Possible side effects" may occur.
• In case of a significant overdose with Memantina Accord, contact your doctor, as medical intervention may be required.

If you forget to take Memantina Accord

• If you forget to take a dose of Memantina Accord, wait and take the next dose at the scheduled time.
• Do not take a double dose to make up for the missed dose.

If you have any doubts about the use of this medicinal product, 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 (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorders, breathlessness, 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 blood coagulation (thrombosis/thromboembolism).

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

• Seizures.

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

• Pancreatitis, hepatitis and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. 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 or pharmacist. 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 Memantina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that 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 Memantina Accord contains
The active substance is memantine hydrochloride. Each film-coated tablet contains 5/10/15/20 mg of
memantine hydrochloride, equivalent to 4.15/8.31/12.46/16.62 mg of memantine.
The other components are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide,
crospovidone and magnesium stearate, all in the tablet core; hypromellose, polysorbate 80,
macrogol 400, titanium dioxide (E 171), and additional components for Memantina Accord 15 mg and
Memantina Accord 20 mg film-coated tablets: yellow and red iron oxide (E 172), all in the
tablet coating.

Description of the appearance of Memantina Accord and contents of the pack
Memantina Accord 5 mg film-coated tablets are film-coated, white, oval-shaped tablets, with “MT” printed on one side and “5” on the other.
Memantina Accord 10 mg film-coated tablets are film-coated, white, oval-shaped tablets with a breakline, with “MT” divided by the breakline on one side and “10” divided by the breakline on the other. The tablet can be divided into two equal doses.
Memantina Accord 15 mg film-coated tablets are film-coated, orange to greyish-orange, oval-shaped tablets, with “MT” printed on one side and “15” on the other.
Memantina Accord 20 mg film-coated tablets are film-coated, light red to greyish-red, oval-shaped tablets with a breakline, with “MT” divided by the breakline on one side and “20” divided by the breakline on the other. The tablet can be divided into two equal doses.

An initial treatment pack contains 28 tablets in 4 blisters: 7 tablets of Memantina Accord 5 mg, 7 tablets of Memantina Accord 10 mg, 7 tablets of Memantina Accord 15 mg, and 7 tablets of Memantina Accord 20 mg.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Delorbis Pharmaceuticals Ltd
17, Athinon Street
Ergates Industrial Area, 2643 Nicosia
Cyprus
Accord Healthcare Polska Sp. z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

This leaflet was last updated on
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu