Memantina Tecnigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantina TecniGen 10 mg film-coated tablets

Generic medicine
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, pharmacist or nurse.
• 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 effect, including those not listed in this leaflet, inform 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 taking 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 MEMANTINE TECNIGEN IS AND WHAT IT IS USED FOR

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

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING MEMANTINE TECNIGEN

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

Other medicines and Memantina TecniGen
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 TecniGen, 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 TecniGen.

Taking Memantina TecniGen with food, drinks and alcohol
You should inform 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 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 carries urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of memantine in pregnant women is not recommended.
Women taking Memantina TecniGen must not breastfeed.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely.
Furthermore, Memantina TecniGen may affect your reaction ability, making it inappropriate to drive or operate machinery.

3. HOW TO TAKE MEMANTINA TECNIGEN

Take this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantina TecniGen for adult 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 titration schedule. Tablets with other dosage strengths are available for dose titration.

The 10 mg tablet may be divided into two equal doses.
The usual starting dose is half a tablet once daily (1x 5 mg) during the first week.
The dose is increased to one tablet once daily (1x 10 mg) during the second week and to one and a half tablets once daily during the third week. From the fourth week onwards, the usual dose is two tablets once daily (1x 20 mg).
Dosage in patients with impaired renal function
In case of impaired renal function, your doctor may determine a dose appropriate for your condition. In such cases, regular monitoring of renal function should be requested by your doctor.
Administration
Memantina TecniGen should be taken orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. You should take the tablets with some water.
The tablets may be taken with or without food.
Duration of treatment
Continue taking Memantina TecniGen for 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, overdose of Memantina TecniGen is not harmful. An increase in symptoms described in section 4 “Possible side effects” may occur;
• in case of a significant overdose of Memantina TecniGen, contact your doctor as medical treatment may be necessary.

If you forget to take Memantina TecniGen

• if you forget to take a dose, wait and take the next dose at your usual time;
• do not take a double dose to make up for the forgotten dose.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In general, the adverse reactions observed are mild to moderate.
Common (affects 1 to 10 people in 100):

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorders, sensation of breathlessness, hypertension, and hypersensitivity to the medicine.

Uncommon (affects 1 to 10 people in 1,000):

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

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

• Seizures.

Not known (frequency cannot be estimated from 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. These events have been reported in patients treated with Memantina TecniGen.
If you experience any adverse reaction, including those not listed in this leaflet, consult 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 stated on the blister and on the carton 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 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Memantina TecniGen 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 ingredients are microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate (tablet core); hypromellose, talc (tablet coating).

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

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

Responsible manufacturers 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 authorized in the Member States of the European Economic Area under the following names:
Portugal: Memantina Tecnigen
Italy: Memantina TecniGen 10 mg film-coated tablets
Spain: Memantina TecniGen 10 mg comprimidos recubiertos con película EFG

This patient information leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantina TecniGen 20 mg film-coated tablets

Generic 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 MEMANTINA TECNIGEN IS 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 medicines known as NMDA receptor antagonists. Memantina TecniGen acts on these NMDA receptors, improving nerve signal transmission 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 TAKING MEMANTINE TECNIGEN

Do not take 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 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 carefully monitored and the clinical benefits of Memantina TecniGen should be regularly reassessed by your doctor.
If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dose of memantine accordingly.
You should 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.
The use of Memantina TecniGen is not recommended in children and adolescents under 18 years of age.

Other medicines and Memantina TecniGen
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 TecniGen, 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 TecniGen.

Taking Memantina TecniGen with food, drinks and alcohol
You should inform 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 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 carries urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, 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 must not breastfeed.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely.
Furthermore, Memantina TecniGen may affect your reaction time, making it inappropriate to drive or operate machinery.

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

3. HOW TO TAKE MEMANTINE TECNIGEN

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 Memantina TecniGen for adult 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 dosage schedule. For dose titration, tablets with other strengths are available.
At the beginning of treatment, you will start taking Memantina TecniGen 5 mg film-coated tablets once daily. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose is 20 mg once daily, which is achieved at the beginning of the fourth week.
Dosage in patients with impaired renal function
If you have impaired renal function, your doctor may determine a dose appropriate for your condition. In such cases, regular monitoring of renal function should be arranged by your doctor at regular intervals.
Administration
Memantina TecniGen 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 TecniGen for as long as you benefit from it. Your doctor should review your treatment at regular intervals.
If you take more Memantina TecniGen than you should

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

If you forget to take Memantina TecniGen

• if you forget to take a dose, wait and take the next dose at your usual time;
• do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
In general, the adverse reactions observed are 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 drug hypersensitivity.

Uncommon (affects 1 to 10 people in 1,000):

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

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

• 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. These events have been reported in patients treated with Memantina TecniGen.
If you experience any adverse reaction, including those not listed in this leaflet, consult 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 stated on the blister and carton 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 no longer used. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Memantina TecniGen 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 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), sunset yellow FCF aluminium lake (E110) (tablet coating).

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

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

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 authorized in the Member States of the European Economic Area under the following names:
Portugal: Memantina Tecnigen
Italy: Memantina TecniGen 20 mg film-coated tablets
Spain: Memantina TecniGen 20 mg film-coated tablets EFG

This patient information leaflet was last approved on

INSTRUCTION LEAFLET: INFORMATION FOR THE USER

Memantina TecniGen (5 mg)+(10 mg)+(15 mg)+(20 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, pharmacist, or nurse.
• 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 effect, including those not listed in this leaflet, contact 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 taking 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 MEMANTINA TECNIGEN IS 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 impaired transmission of signals 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 medicines known as NMDA receptor antagonists. Memantina TecniGen acts on these NMDA receptors, improving nerve signal transmission 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 TAKING MEMANTINE TECNIGEN

Do not take 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 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 carefully monitored and the clinical benefits of Memantina TecniGen reassessed by your doctor at regular intervals.
If you have renal impairment (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the dose of memantine accordingly.
You should 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 for cough treatment), and other NMDA antagonists.
The use of Memantina TecniGen is not recommended in children and adolescents under 18 years of age.

Other medicines and Memantina TecniGen
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 TecniGen, 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 TecniGen.

Taking Memantina TecniGen with food, drinks and alcohol
You should inform 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 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 system that carries urine), as your doctor may need to adjust the dose of the medicine accordingly.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, 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 must not breastfeed.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely.
Furthermore, Memantina TecniGen may affect your reactivity, making driving or operating machinery inappropriate.

Memantina TecniGen 20 mg contains Sunset Yellow aluminium lake (E110).
Each 20 mg tablet contains Sunset Yellow aluminium lake (E110), which may cause allergic reactions.

3. HOW TO TAKE MEMANTINE TECNIGEN

Memantina TecniGen starter pack should only be used at the beginning
of treatment with Memantina TecniGen.
Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended maintenance dose of 20 mg daily is reached by a gradual increase in the dose of Memantina TecniGen over the first 3 weeks of treatment. The dosing schedule is also indicated on the starter pack packaging. Take one tablet once daily.
First week (day 1-7):
Take one 5 mg tablet once daily (oval, biconvex, film-coated white tablets) for 7 days.
Second week (day 8-14):
Take one 10 mg tablet once daily (oblong, biconvex, film-coated white tablets) for 7 days.
Third week (day 15-21):
Take one 15 mg tablet once daily (oval, biconvex, film-coated yellow tablets) for 7 days.
Fourth week (day 22-28):
Take one 20 mg tablet once daily (oval, biconvex, film-coated pink-orange tablets) for 7 days.

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

Dosage in patients with impaired renal function
In case of impaired renal function, your doctor may determine a dose appropriate for your condition. In such cases, your doctor must monitor renal function at regular intervals.

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

If you forget to take Memantina TecniGen

• if you forget to take a dose, wait and take the next dose at your 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, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In general, the adverse reactions observed are mild to moderate.
Common (affects 1 to 10 people in 100):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, sensation of breathlessness, hypertension, and drug hypersensitivity.

Uncommon (affects 1 to 10 people in 1,000):

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

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

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

5. HOW TO STORE MEMANTINE TECNIGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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

Starter pack:

Memantina TecniGen 5 mg film-coated tablets are film-coated, elliptical, biconvex, white tablets.

Memantina TecniGen 10 mg film-coated tablets are film-coated, oblong, biconvex, white 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 film-coated, elliptical, biconvex, yellow tablets.

Memantina TecniGen 20 mg film-coated tablets are film-coated, elliptical, biconvex, orange-pink tablets.

A starter pack contains 28 tablets in 4 blisters: 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 package.

Marketing Authorization Holder:

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

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 authorized in the Member States of the European Economic Area under the following names:

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

This patient information leaflet was last approved on