MEMANTINA 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Memantina TecniGen 10 mg film-coated tablets
   1. WHAT IS MEMANTINA TECNIGEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINA TECNIGEN
   3. HOW TO TAKE MEMANTINA TECNIGEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CELECOXIB TECNIGEN
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. Memantina TecniGen 20 mg film-coated tablets
   1. WHAT IS MEMANTINA TECNIGEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINA TECNIGEN
   3. HOW TO TAKE MEMANTINA TECNIGEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CELECOXIB TECNIGEN
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. Memantina TecniGen (5 mg)+(10 mg)+(15 mg)+(20 mg) film-coated tablets
   1. WHAT IS MEMANTINA TECNIGEN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINA TECNIGEN
   3. HOW TO TAKE MEMANTINA TECNIGEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MEMANTINA TECNIGEN
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Memantina TecniGen 10 mg film-coated tablets

Generic medicine
Read this leaflet carefully before you start taking this medicinebecause it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse.

Contents of this leaflet:

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

1. WHAT IS MEMANTINA TECNIGEN AND WHAT IT IS USED FOR

How Memantina TecniGen works
Memantina TecniGen 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 TecniGen belongs to a group of drugs defined as NMDA receptor antagonists.
Memantina TecniGen acts on these NMDA receptors, improving the transmission of nerve
signals and memory.

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINA TECNIGEN

Donottake Memantina TecniGen

• if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6.1).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Memantina TecniGen:

• 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 hypertension (high blood pressure).

In these situations, treatment must be carefully monitored and the clinical benefits of
Memantina TecniGen re-evaluated by the doctor at regular intervals.
If you have kidney impairment (kidney problems), your doctor must carefully monitor
kidney function and, if necessary, adjust the dose of memantine accordingly.
You should avoid the 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.
The use of Memantina TecniGen is not recommended in children and adolescents under the age of
18 years.

Other medicines and Memantina TecniGen
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 TecniGen and
it may be necessary to adjust their 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 admitted to hospital, tell the doctor that you are taking Memantina TecniGen.

Taking Memantina TecniGen with food, drinks and alcohol
You should inform your doctor if you have recently changed or 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 (insufficient kidney function) or severe infections of the urinary tract (the structure that
transports urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantina TecniGen should not breastfeed.

Driving and using machines
Your doctor will tell you if your condition allows you to drive vehicles or use machines without risk.
In addition, Memantina TecniGen may alter your reactivity, making driving
vehicles or using machines inappropriate.

3. HOW TO TAKE MEMANTINA TECNIGEN

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

Dosage
The recommended dose of Memantina TecniGen for adult and elderly patients is 20 mg once a
day. To reduce the risk of undesirable effects, you must gradually reach this dose
following this daily dosage schedule. Tablets with other dosages are available for increasing the titration.
The 10 mg tablet can be divided into two equal doses.
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week.
The dose is increased to one tablet once a day (1x 10 mg) in the second week and to 1
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 (1x 20 mg).

Dosage in patients with impaired renal function
In case of impaired renal function, the doctor may establish a dose suitable for your
condition. In this case, regular monitoring of renal function must be requested from the doctor at
regular intervals.

Administration
Memantina TecniGen is to be taken orally once a day. To benefit from it, you must take
the medicine regularly every day at the same time. You must take the tablets with a little
water.
The tablets can be taken with or without meals.

Duration of treatment
Continue to take Memantina TecniGen as long as you benefit from it. The doctor must evaluate the
treatment at regular intervals.

If you take more Memantina TecniGen than you should

• in general, an overdose of Memantina TecniGen is not harmful. An increase in the symptoms described in section 4 “Possible side effects” may occur;
• in case of a significant overdose of Memantina TecniGen, contact your doctor as medical care may be necessary.

If you forget to take Memantina TecniGen

• 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 missed dose.

If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

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 (affects 1 to 10 people in 100):

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

Uncommon (affects 1 to 10 people in 1000):

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

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

• 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. These events
have been reported in patients treated with Memantina TecniGen.
If you get any side effects, even those not listed in this leaflet, please
tell your doctor, pharmacist or nurse.

5. HOW TO STORE CELECOXIB TECNIGEN

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 blister and the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 Memantina TecniGen 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 other ingredients are microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate (tablet core); hydroxypropylcellulose, talc (tablet coating).

Description of the appearance of Memantina TecniGen and package contents
Memantina TecniGen 10 mg film-coated tablets are oblong,
biconvex, white film-coated tablets with an indentation on one side.
Memantina TecniGen 10 mg film-coated tablets are a maintenance pack and are
available in blisters of 56 and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande 2, Abrunheira
2710-089 Sintra (Portugal)

Manufacturers responsible for batch release
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Portugal: Memantina Tecnigen
Italy: Memantina TecniGen 10 mg film-coated tablets
Spain: Memantina TecniGen 10 mg comprimidos recubiertos con película EFG

Memantina TecniGen 20 mg film-coated tablets

Generic medicine
Read this leaflet carefully before you start taking this medicineas it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse.

Contents of this leaflet:

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

1. WHAT IS MEMANTINA TECNIGEN AND WHAT IT IS USED FOR

How Memantina TecniGen works
Memantina TecniGen 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 TecniGen belongs to a group of drugs defined as NMDA receptor antagonists.
Memantina TecniGen acts on these NMDA receptors, improving the transmission of nerve
signals and memory.

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINA TECNIGEN

Donottake Memantina TecniGen

• if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6.1).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Memantina TecniGen:

• 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 hypertension (high blood pressure).

In these situations, treatment must be carefully monitored and the clinical benefits of
Memantina TecniGen reassessed by the doctor at regular intervals.
If you have kidney impairment (kidney problems), your doctor must carefully monitor
kidney function and, if necessary, adjust the dose of memantine accordingly.
You should avoid the 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.
The use of Memantina TecniGen is not recommended in children and adolescents under the age of
18 years.

Other medicines and Memantina TecniGen
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 TecniGen and
it may be necessary to adjust their 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, tell your doctor that you are taking Memantina TecniGen.

Taking Memantina TecniGen with food, drinks and alcohol
You should inform your doctor if you have recently changed or 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 (insufficient kidney function) or severe urinary tract infections (the structure that
transports urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy, breastfeeding and fertility
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.
The use of memantine in pregnant women is not recommended.
Women taking Memantina TecniGen should not breastfeed.

Driving and using machines
Your doctor will tell you if your condition allows you to drive vehicles or use machines without risk.
In addition, Memantina TecniGen may alter your reactivity, making driving
vehicles or using machines inappropriate.

Memantina TecniGen contains Sunset Yellow FCF aluminium lake (E110)
Sunset Yellow FCF aluminium lake (E110) may cause allergic reactions.

3. HOW TO TAKE MEMANTINA TECNIGEN

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

Dosage
The recommended dose of Memantina TecniGen for adult and elderly patients is 20 mg once a
day.
To reduce the risk of side effects, you must gradually reach this dose following the
following daily dosage schedule. Tablets with other dosages are available for increasing the titration.
At the beginning of treatment, you will start taking Memantina TecniGen 5 mg film-coated tablets
once a day. This dose will be increased weekly by 5 mg until the
recommended (maintenance) dose is reached. The recommended maintenance dose is 20 mg once a
day and is reached at the beginning of the fourth week.

Dosage in patients with impaired renal function
In case of impaired renal function, your doctor may establish a dose suitable for your
condition. In this case, monitoring of renal function must be requested by the doctor at
regular intervals

Administration
Memantina TecniGen should be taken orally once a day. To benefit from it, you must take
the medicine regularly every day at the same time. You should take the tablets with a little
water.
The tablets can be taken with or without food.

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

If you take more Memantina TecniGen than you should

• in general, an overdose of Memantina TecniGen is not harmful. An increase in the symptoms described in section 4 “Possible side effects” may occur;
• in case of a significant overdose of Memantina TecniGen, contact your doctor as medical care may be necessary.

If you forget to take Memantina TecniGen

• 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 missed dose.

If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

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 (affects 1 to 10 people in 100):

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

Uncommon (affects 1 to 10 people in 1000):

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

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

• Convulsions

Not known (frequency cannot be estimated based on available data)

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

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. These events
have been reported in patients treated with Memantina TecniGen.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist
or nurse.

5. HOW TO STORE CELECOXIB TECNIGEN

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 blister and the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Memantina TecniGen 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 other components are microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate (tablet core); hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), yellow sunset FCF aluminium lake (E110) (tablet coating).

Description of the appearance of Memantina TecniGen and package contents
Memantina TecniGen 20 mg film-coated tablets are elliptical,
biconvex, pink-orange film-coated tablets.
Memantina TecniGen 20 mg film-coated tablets are a maintenance pack and are
available in blisters of 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande 2, Abrunheira
2710-089 Sintra (Portugal)

Manufacturers responsible for batch release
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Portugal: Memantina Tecnigen
Italy: Memantina TecniGen 20 mg film-coated tablets
Spain: Memantina TecniGen 20 mg film-coated tablets EFG

Memantina TecniGen (5 mg)+(10 mg)+(15 mg)+(20 mg) film-coated tablets

Generic medicine
Read this leaflet carefully before taking this medicineas it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse.

Contents of this leaflet:

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

1. WHAT IS MEMANTINA TECNIGEN AND WHAT IT IS USED FOR

How Memantina TecniGen works
Memantina TecniGen 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 TecniGen belongs to a group of drugs defined as NMDA receptor antagonists.
Memantina TecniGen acts on these NMDA receptors improving the transmission of nerve
signals and memory.

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINA TECNIGEN

Donottake Memantina TecniGen

• if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6.1).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Memantina TecniGen:

• 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 hypertension (high blood pressure).

In these situations, treatment must be carefully monitored and the clinical benefits of
Memantina TecniGen re-evaluated by the doctor at regular intervals.
If you have impaired renal function (kidney problems), your doctor must carefully monitor
renal function and, if necessary, adjust the dose of memantine accordingly.
You should avoid the 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.
The use of Memantina TecniGen is not recommended in children and adolescents under the age of
18 years.

Other medicines and Memantina TecniGen
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 Memantina TecniGen and
it may be necessary to adjust their 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, tell the doctor that you are taking Memantina TecniGen.

Taking Memantina TecniGen with food, drinks and alcohol
You should inform your doctor if you have recently changed or 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
renal dysfunction (insufficient kidney function) or severe urinary tract infections (the structure that
transports urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy, breastfeeding and fertility
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.
The use of memantine in pregnant women is not recommended.
Women taking Memantina TecniGen should not breastfeed.

Driving and using machines
Your doctor will tell you if your illness allows you to drive vehicles or use machines without risk.
In addition, Memantina TecniGen may alter your reactivity, making driving
vehicles or using machines inappropriate.

Memantina TecniGen 20 mg contains sunset yellow FCF aluminium lake (E110).
Each 20 mg tablet contains sunset yellow FCF aluminium lake (E110) which may cause
allergic reactions.

3. HOW TO TAKE MEMANTINA TECNIGEN

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

Dosage
The recommended treatment dose of 20 mg per day is reached through a gradual increase
in the dose of Memantina TecniGen 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 tablet once a day (film-coated elliptical, biconvex, white tablets) for 7 days.
Second week (day 8-14):
Take one 10 mg tablet once a day (film-coated oblong, biconvex, white tablets) for 7 days.
Third week (day 15-21):
Take one 15 mg tablet once a day (film-coated elliptical, biconvex, yellow tablets) for 7 days.
Fourth week (day 22-28):
Take one 20 mg tablet once a day (film-coated elliptical, biconvex, pink-orange tablets) 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 impaired renal function
In case of impaired renal function, your doctor may establish a dose suitable for your
condition. In this case, your doctor must perform regular monitoring of renal function.

Administration
Memantina TecniGen should be taken orally once a day. To benefit from it, you must take
the medicine regularly every day at the same time. You should take the tablets with a little
water.
The tablets can be taken with or without food.

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

If you take more Memantina TecniGen than you should

• in general, an overdose of Memantina TecniGen is not harmful. An increase in the symptoms described in section 4 “Possible undesirable effects” may occur;
• in case of a significant overdose of Memantina TecniGen, contact your doctor as medical care may be necessary.

If you forget to take Memantina TecniGen

• 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, pharmacist or
nurse.

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 (affects 1 to 10 people in 100):

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

Uncommon (affects 1 to 10 people in 1000):

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

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

• 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. These events
have been reported in patients treated with Memantina TecniGen.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or
nurse.

5. HOW TO STORE MEMANTINA TECNIGEN

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 blister and the package after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Memantina TecniGen 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 other components of Memantina TecniGen 5/10/15/20 mg are microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate (tablet core); hydroxypropylcellulose, talc for Memantina TecniGen 5/10 mg, hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) for Memantina TecniGen 15 mg, hydroxypropylcellulose, hypromellose, talc, titanium dioxide

(E171), yellow iron oxide (E172), red iron oxide (E172), aluminium lake yellow
sunset FCF (E110) for Memantina TecniGen 20 mg (tablet coating).

Description of the appearance of Memantina TecniGen and package contents
Starter pack:
Memantina TecniGen 5 mg film-coated tablets are elliptical,
biconvex, white film-coated tablets.
Memantina TecniGen 10 mg film-coated tablets are oblong,
biconvex, white film-coated tablets, with a score line on one side. The tablet can be divided into two equal doses
.
Memantina TecniGen 15 mg film-coated tablets are elliptical,
biconvex, yellow film-coated tablets.
Memantina TecniGen 20 mg film-coated tablets are elliptical,
biconvex, pink-orange film-coated tablets.
A starter pack contains 28 tablets in 4 blisters with 7 tablets of
Memantina TecniGen 5 mg, 7 tablets of Memantina TecniGen 10 mg, 7 tablets of Memantina
TecniGen 15 mg and 7 tablets of Memantina TecniGen 20 mg. Each 7-tablet blister
is contained in a single cardboard pack.

Marketing Authorisation Holder:
TECNIMEDE Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande 2, Abrunheira
2710-089 Sintra (Portugal)

Manufacturers responsible for batch release
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Portugal: Memantina Tecnigen
Italy: Memantina TecniGen (5mg)+(10mg)+(15mg)+(20mg) film-coated tablets
Spain: Memantina TecniGen (5mg)+(10mg)+(15mg)+(20mg) comprimidos recubiertos con
película EFG