Memantina Mylan: detailed information

Package leaflet: Information for the patient

Memantina Mylan 10 mg film-coated tablets

memantine hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you take 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Memantina Mylan contains the active substance memantine. It belongs to a group of medicines known as anti-dementia medicines.
Memory loss in Alzheimer's disease is due to a disturbance in message transmission 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. Memantina Mylan belongs to a group of medicines called NMDA receptor antagonists. Memantina Mylan acts on these NMDA receptors, improving nerve signal transmission and memory.
Memantina Mylan is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you should know before taking Memantina Mylan

Do not take Memantina Mylan:

if you are allergic to memantine 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 Mylan:

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 Mylan 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 memantine accordingly.
Avoid concomitant use of medicines 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 Mylan is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina Mylan
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 Mylan, and your doctor may need to adjust their dosage:

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 medical staff that you are taking Memantina Mylan.
Memantina Mylan with food and drinks
Consult 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 transports urine), as your doctor may need to adjust the dose 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 Mylan should 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 Mylan may affect your reaction time, making it inadvisable to drive vehicles or operate machinery.
Memantina Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Memantina Mylan

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 Mylan for adult and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually, following this daily dosing schedule:

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

The usual starting dose is half a 10 mg tablet once daily (5 mg) for the first week.
This dose is increased to one 10 mg tablet once daily (10 mg) during the second week, and to one and a half 10 mg tablets once daily in the third week. From the fourth week onwards, the usual dose is two 10 mg tablets once daily (20 mg).
Dosage in patients with reduced renal function
In case of reduced renal function, the doctor may decide on a dosage regimen suitable for your condition. In such cases, regular monitoring of renal function should be requested by the doctor.
Administration
Memantina Mylan should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. Take the tablets with some water. The tablets may be divided into two equal doses and may be taken with or without food.
Duration of treatment
Continue taking Memantina Mylan for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.
If you take more Memantina Mylan than you should

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

If you forget to take Memantina Mylan

If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
In general, the side effects observed are mild to moderate.
Common (may affect up to 1 in 10 people):
Headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorders,
shortness of breath, hypertension and drug hypersensitivity.
Uncommon (may affect up to 1 in 100 people):

Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure and 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. During post-marketing experience, these events have been reported in patients treated with memantine hydrochloride.
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 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 Mylan

Keep out of the sight and reach of children.
Do not use Memantina Mylan after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product requires no 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. Package contents and other information

What Memantina Mylan contains

The active substance is memantine. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 “Memantina Mylan contains sodium”), magnesium stearate, talc, anhydrous colloidal silica, all in the tablet core; polydextrose (E1200), titanium dioxide (E 171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), yellow iron oxide (E 172), macrogol 400 (E1521), macrogol 8000, indigo carmine aluminium lake (E132), red iron oxide (E172), all in the tablet coating.

Description of the appearance of Memantina Mylan and package contents
Dark yellow, elongated, tapered, biconvex film-coated tablets, with “ME” printed to the left of the break line and “10” to the right of the break line on one side of the tablet, and a break line on the other side.
The tablet can be divided into two equal doses.
Memantina Mylan film-coated tablets are available in blisters – in packs of 7, 10, 14, 28, 28x1, 30, 42, 50, 56, 56x1, 60, 70, 84, 98, 98x1, 100, 100x1 or 112 film-coated tablets.
The packs of 28x1, 56x1, 98x1 and 100x1 film-coated tablets are provided in perforated unit-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer responsible for batch release:
McDermott Laboratories Ltd. T/A Gerard Laboratories
Unit 35 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca. 1
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Mylan bvba/sprl Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Mylan bvba/sprl
Teл.: +359 2 44 55 400 Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Mylan Healthcare CZ s.r.o. Mylan EPD Kft
Tel: +420 222 004 400 Tel: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Mylan Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
BGP Products Switzerland GmbH Eesti Mylan Healthcare Norge AS
filiaal Tel: +47 66 75 33 00
Tel: +372 6363 052

Ελλάδα Österreich
Generics Pharma Hellas ΕΠΕ Arcana Arzneimittel GmbH
Τηλ: +30 210 993 6410 Tel: +43 1 416 2418

España Polska
Mylan Pharmaceuticals, S.L Mylan Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00

France Portugal
Mylan S.A.S Mylan, Lda.
Tel: +33 4 37 25 75 00 Tel: + 351 21 412 72 56

Hrvatska România
Mylan Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Mylan Healthcare d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Mylan s.r.o.
Símí: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Mylan Italia S.r.l. Mylan Finland OY
Tel: + 39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
Varnavas Hadjipanayis Ltd. Mylan AB
Τηλ: +357 2220 7700 Tel: + 46 855 522 750

Latvija United Kingdom (Northern Ireland)
Mylan Healthcare SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

This patient information leaflet was last approved on

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/

Package leaflet: information for the patient

Memantina Mylan 20 mg film-coated tablets

memantine hydrochloride
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. See section 4.

Contents of this leaflet:

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

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

Memantina Mylan contains the active substance memantine. It belongs to a group of medicines known as anti-dementia medications.
Memory loss in Alzheimer's disease is due to impaired signal 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 Mylan belongs to a group of medicines known as NMDA receptor antagonists. Memantina Mylan acts on these NMDA receptors, improving nerve signal transmission and memory.
Memantina Mylan is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Memantina Mylan

Do not take Memantina Mylan:

if you are allergic to memantine 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 Mylan:

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 Mylan reassessed regularly by your physician.
If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the memantine dose accordingly.
Avoid concomitant use of medicines 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 Mylan is not recommended for children and adolescents under 18 years of age.

Other medicines and Memantina Mylan
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines.
In particular, the effects of the following medicines may be altered by Memantina Mylan, and your doctor may need to adjust their dosage:

amantadine, ketamine, dextromethorphan
dantrolene, baclofen
cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
hydrochlorothiazide (or combinations containing hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to prevent and treat epileptic seizures)
barbiturates (substances generally used to induce sleep)
dopaminergic agonists (substances such as L-dopa, bromocriptine)
neuroleptics (substances used in the treatment of mental disorders)
oral anticoagulants.

If you are admitted to hospital, inform medical staff that you are taking Memantina Mylan.

Memantina Mylan with food and drink
Consult 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 dose of the medicine accordingly.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan 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 Mylan should 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. In addition, Memantina Mylan may affect your reaction speed, making it inadvisable to drive vehicles or operate machinery.

Memantina Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Memantina Mylan

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantina Mylan for adult and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually, following this daily dosing schedule:

Week 1	half a 10 mg tablet
Week 2	one 10 mg tablet
Week 3	one and a half 10 mg tablets
Week 4 and onwards	one 20 mg tablet once daily

Dosage in patients with reduced renal function
In case of reduced renal function, the doctor may decide on a dosage regimen suitable for your condition. In such cases, regular monitoring of renal function must be requested by the doctor.

Administration
Memantina Mylan 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 Mylan for as long as you benefit from it. Your doctor will review the treatment at regular intervals.

If you take more Memantina Mylan than you should

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

If you forget to take Memantina Mylan

If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the side effects observed are mild to moderate.

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

Headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorders, shortness of breath, hypertension, and drug hypersensitivity.

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

Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous 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. During post-marketing experience, these events have been reported in patients treated with memantine hydrochloride.

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 detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memantina Mylan

Keep out of the sight and reach of children.
Do not use Memantina Mylan after the expiry date stated on the packaging 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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Memantina Mylan contains

The active substance is memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2 “Memantina Mylan contains sodium”), magnesium stearate, talc, anhydrous colloidal silica, all in the tablet core; polydextrose (E1200), titanium dioxide (E 171), hypromellose 3cP (E464), hypromellose 6cP (E464), hypromellose 50cP (E464), iron oxide red (E 172), macrogol 400 (E1521), macrogol 8000, all in the tablet coating.

Description of the appearance of Memantina Mylan and contents of the pack
Film-coated red oval tablets with bevelled edges, marked “ME” on one side and “20” on the other side.
Memantina Mylan film-coated tablets are available in blisters in pack sizes of 7, 10, 14, 28, 28x1,
30, 42, 50, 56, 56x1, 60, 70, 84, 98, 98x1, 100, 100x1 or 112 film-coated tablets.
The packs of 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are supplied in single-dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Responsible for Batch Release:
McDermott Laboratories Ltd. T/A Gerard Laboratories
Unit 35 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca. 1
Hungary

For further information about this medicine, please contact the local representative of the marketing authorisation holder: