Ezemantis

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

EZEMANTIS 10 mg film-coated tablets

Generic medicine
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.

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

1. What Ezemantis is and what it is used for

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

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

2. What you need to know before taking Ezemantis

Do not take Ezemantis

• 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 Ezemantis.
Exercise particular caution:

• if you have a history of epileptic seizures;
• if you have recently had a myocardial infarction (heart attack) or suffer from congestive heart failure or uncontrolled high blood pressure. In these situations, treatment must be carefully monitored and the clinical benefits of Ezemantis should be regularly reassessed by your doctor. In case of renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the dose of Ezemantis 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.

Contact your doctor if you have recently changed or plan to substantially change your
dietary regimen (e.g. from a normal diet to a strictly vegetarian diet), or if you suffer from
renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to renal
dysfunction (insufficient kidney function)) or severe urinary tract infections (the structures that transport urine),
as your doctor may need to adjust the dose of the medicine accordingly.
Children and adolescents
Ezemantis is not recommended for children and adolescents under 18 years of age.
Other medicines and Ezemantis
Ezemantis may alter the effects of the following medicines, and the dose may need to be adjusted by
your doctor:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination 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. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

If you are admitted to hospital, inform medical staff that you are taking Ezemantis.
Ezemantis with food and drink
Food does not affect the effect of Ezemantis.
Pregnancy and breastfeeding
The use of Ezemantis is not recommended during pregnancy.
Women taking Ezemantis must not breastfeed.
If you are already pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or operate machinery given your condition.
Additionally, Ezemantis may affect your reaction speed, making it inadvisable to drive vehicles or
operate machinery.
Ezemantis contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before
taking this medicine.

3. How to take Ezemantis

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Ezemantis for adults and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be gradually reached according to the following
daily schedule:
First week: half a tablet (10 mg) daily
Second week: one tablet (10 mg) daily
Third week: one and a half tablets (15 mg) daily
From the fourth week onwards: two tablets (20 mg) daily
Dosage in patients with impaired renal function
If you have impaired renal function, your doctor will decide the appropriate dosage regimen based on your
condition. In such cases, regular monitoring of renal function should be arranged by the doctor.
Tablet splitting
Place the tablet with the rounded side on a hard surface, with the break line facing upwards. Apply pressure with the thumb and index finger of the same hand on both sides of the score line and push until the tablet breaks, as illustrated in the figure.

Administration method
Ezemantis should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. The tablets should be swallowed with a glass of water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Ezemantis for the length of time prescribed by your doctor; he or she will review your treatment at regular intervals.
If you take more Ezemantis than you should
In general, overdose with Ezemantis is not harmful. A greater number of the symptoms described in section 4, "Possible side effects", may occur.
In case of a significant overdose of Ezemantis, contact your doctor, as medical intervention may be required.
If you forget to take Ezemantis
If you forget to take a dose, wait and 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezemantis 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 - drowsiness - constipation - increased liver function tests - dizziness - balance disorders - shortness of breath - hypertension - hypersensitivity to the medicine.

Uncommon (may affect up to 1 in 100 people)

• Fatigue - fungal infections - confusion - hallucinations - vomiting - gait disorders - heart failure - venous blood clotting (thrombosis/thromboembolism).

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

• Seizures

Not known (frequency cannot be determined from the available data)

• Inflammation of the pancreas - inflammation of the liver (hepatitis) - psychotic reactions

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Ezemantis.

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 http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ezemantis

Keep out of the reach and sight of children.
Do not use Ezemantis after the expiry date stated on the blister and outer packaging after EXP.
The first two digits indicate the month, the last four the year. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

5. Contents of the pack and other information

What Ezemantis contains
The active substance is memantine hydrochloride. Each tablet contains 10 mg of memantine hydrochloride,
equivalent to 8.31 mg of memantine.
The other components are: in the tablet core: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, talc and magnesium stearate; in the tablet coating: monohydrate lactose, hypromellose, titanium dioxide (E171), macrogol 4000.
Description of the appearance of Ezemantis and pack contents
Ezemantis 10 mg tablets are white, round, biconvex (8 mm) with a score line on one side and embossed with "M9MN" and "10" on the other side. The tablets can be divided into two equal parts.
PVC/AL blister packs containing:
56 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Fb Health Spa
Via dei Sabini, 28
63100 Ascoli Piceno
Italy
Manufacturers responsible for batch release
Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands
Synthon Hispania SL C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain

PACKAGE LEAFLET: INFORMATION FOR THE USER

EZEMANTIS 20 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet
7 What Ezemantis is and what it is used for
8 What you need to know before taking Ezemantis
9 How to take Ezemantis
10 Possible side effects
11 How to store Ezemantis
12 Contents of the pack and other information

1. What Ezemantis is and what it is used for

How Ezemantis works
Ezemantis belongs to a group of medicines known as anti-dementia drugs. Memory loss in Alzheimer's disease is due to a disruption in the transmission of signals 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. Ezemantis belongs to a group of medicines called NMDA receptor antagonists. Ezemantis acts on these NMDA receptors, improving the transmission of nerve signals and memory.
What Ezemantis is used for
Ezemantis is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Ezemantis

Do not take Ezemantis

• 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 Ezemantis.
Exercise particular caution:

• if you have a history of epileptic seizures;
• if you have recently had a myocardial infarction (heart attack) or suffer from congestive heart failure or uncontrolled high blood pressure. In these cases, treatment must be closely monitored and the clinical benefits of Ezemantis reassessed regularly by your treating physician. If you have renal impairment (kidney problems), your doctor must carefully monitor kidney function and, if necessary, adjust the dose of Ezemantis 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.

Talk to your treating physician if you have recently changed or intend to substantially change your
dietary regimen (e.g. from a normal diet to a strictly vegetarian diet), or if you suffer from
renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction
(insufficient kidney function)) or severe urinary tract infections (the structure that carries urine),
as your doctor may need to adjust the dose of the medicine accordingly.
Children and adolescents
Ezemantis is not recommended for children and adolescents under 18 years of age.
Other medicines and Ezemantis
Ezemantis may alter the effects of the following medicines, and the dose may need to be adjusted by
your doctor:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination 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.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines, including those not requiring a prescription.
If hospitalised, inform medical staff that you are taking Ezemantis.
Ezemantis with food and drink
Food does not affect the action of Ezemantis.
Pregnancy and breastfeeding
The use of Ezemantis is not recommended during pregnancy.
Women taking Ezemantis must not breastfeed.
If you are already pregnant or breastfeeding, think you may be pregnant, or plan to have a baby,
consult your doctor or pharmacist before starting to take this medicine.
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, Ezemantis may affect your reaction time, making it inadvisable to drive vehicles or
operate machinery.
Ezemantis contains lactose
If your doctor has informed you that you are intolerant to certain sugars, contact your doctor before
taking this medicine.

3. How to take Ezemantis

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Ezemantis for adults and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose is gradually reached according to the treatment schedule
described below. For this titration phase, tablets with different concentrations of memantine are available.
At the beginning of treatment, you will start by taking 5 mg of memantine once daily. This dose should be
increased weekly by 5 mg until the recommended maintenance dose is reached.
The recommended maintenance dose of 20 mg daily is achieved at the beginning of the fourth week of
treatment.
Dosage in patients with impaired renal function
If you have impaired renal function, your doctor will decide the appropriate dosage regimen based on your
condition. In such cases, your doctor should regularly monitor your renal function.
Tablet splitting
Place the tablet with the rounded side on a hard surface, with the break line facing upwards. Apply pressure
with the thumb and index finger of the same hand on both sides of the break line and push until the tablet
breaks, as illustrated in the figure.

Method of administration
Ezemantis must 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 Ezemantis for as long as prescribed by your doctor; he or she will evaluate your treatment at
regular intervals.
If you take more Ezemantis than you should
In general, overdose with Ezemantis is not harmful. A greater number of symptoms described in section 4
''Possible side effects'' may occur.
In case of a significant overdose of Ezemantis, contact your doctor, as medical intervention may be
required.
If you forget to take Ezemantis
If you forget to take a dose, 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezemantis 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 - shortness of breath - hypertension - drug hypersensitivity.

Uncommon (may affect up to 1 in 100 people)
Fatigue - fungal infections - confusion - hallucinations - vomiting - gait disturbances - heart failure - venous blood clotting (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) - psychotic reactions

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. These events have
been reported in patients treated with Ezemantis.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly via the website
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Ezemantis

Keep out of the sight and reach of children.
Do not use Ezemantis after the expiry date stated on the blister and outer packaging following EXP.
The first two digits indicate the month, the last four digits the year. The expiry date refers to the last day of that month.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

5. Contents of the pack and other information

What Ezemantis contains
The active substance is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride,
equivalent to 16.62 mg of memantine.
The other components are: in the tablet core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silicon dioxide, talc and magnesium stearate; in the tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Ezemantis and contents of the pack
Ezemantis 20 mg tablets are pink, oval and biconvex (13.5 x 6.6 mm), with a break line engraved on one side and embossed with 'M9MN 20' on the other side. The tablets can be divided into two equal parts.
PVC/AL blister packs containing:
28 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Fb Health Spa
Via dei Sabini, 28
63100 Ascoli Piceno
Italy

Manufacturers responsible for batch release
Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands
Synthon Hispania SL C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain