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Memantine ratiopharm (memantine hydrochloride) – Package leaflet - N06DX01

Updated on site: 08-Oct-2017

Medication nameMemantine ratiopharm
ATC CodeN06DX01
Substancememantine hydrochloride
ManufacturerRatiopharm GmbH

Package leaflet: Information for the patient

Memantine ratiopharm 10 mg film-coated tablets

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Memantine ratiopharm is and what it is used for

2.What you need to know before you take Memantine ratiopharm

3.How to take Memantine ratiopharm

4.Possible side effects

5.How to store Memantine ratiopharm

6.Contents of the pack and other information

1.What Memantine ratiopharm is and what it is used for

How does Memantine ratiopharm work

Memantine ratiopharm belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Memantine ratiopharm used for

Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Memantine ratiopharm

Do not take Memantine ratiopharm:

if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Memantine ratiopharm:

if you have a history of epileptic seizures.

if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine ratiopharm reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called

● amantadine (for the treatment of Parkinson’s disease),

ketamine (a substance generally used as an anaesthetic),

dextromethorphan (generally used to treat cough) and

other NMDA-antagonists

at the same time should be avoided.

Children and adolescents

Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine ratiopharm

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamine, dextromethorphan

dantrolene, baclofen

cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

hydrochlorothiazide (or any combination with hydrochlorothiazide)

anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

anticonvulsants (substances used to prevent and relieve 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 go into hospital, let your doctor know that you are taking Memantine ratiopharm.

Memantine ratiopharm with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of memantine in pregnant women is not recommended.

Women taking Memantine ratiopharm should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Memantine ratiopharm may change your reactivity, making driving or operating machinery inappropriate.

Memantine ratiopharm contains lactose and soya lecithin

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.

3.How to take Memantine ratiopharm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

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 beyond

two 10 mg tablets once a day

 

 

The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week on, the usual dose is two tablets once a day (1x 20 mg).

The tablet can be divided into equal doses.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Memantine ratiopharm should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day.

The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment

Continue to take Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine ratiopharm than you should

In general, taking too much Memantine ratiopharm should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.

If you take a large overdose of Memantine ratiopharm, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine ratiopharm

If you find you have forgotten to take your dose of Memantine ratiopharm, wait and take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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 observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100):

Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

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

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user 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 memantine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Memantine ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

Blister packs

Do not store above 25°C.

HDPE bottles

This medicinal product does not require any special storage conditions.

Shelf life after first opening of the container: 6 months

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Memantine ratiopharm contains

-The active substance is memantine hydrochloride.

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

-The other ingredients are:

Tablet core

Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).

Coating

Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).

What Memantine ratiopharm looks like and contents of the pack

White to off-white, capsule shaped (12.5 x 5.6 mm), biconvex tablets with a break score on one side and embossed with “10” on the other side.

Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film- coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

HBM Pharma s.r.o.

Slabinská 30, 03680 Martin

Slovakia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB “Sicor Biotech”

Tél/Tel: +32 3 820 73 73

Tel: +370 5 266 0203

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

ratiopharm GmbH

Teл: +359 2 489 95 82

Allemagne/Deutschland

 

Tél/Tel: +49 731 402 02

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321 740

Deutschland

Nederland

ratiopharm GmbH

Teva Nederland B.V.

Tel: +49 731 402 02

Tel: +31 800 0228 400

Eesti

Norge

UAB “Sicor Biotech” Eesti filiaal

ratiopharm AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 007 0

España

Polska

ratiopharm España, S.A.

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +34 91 567 29 70

Tel.: +48 22 345 93 00

France

Portugal

Teva Santé

ratiopharm, Comércio e Indústria de

Tél: +33 1 55 91 78 00

Produtos Farmacêuticos, Lda

 

Tel: +351 21 476 75 50

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +40 21 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 51 321740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

Medical ehf.

TEVA Pharmaceuticals Slovakia s.r.o.

Sími: +354 534 3500

Tel: +421 2 57 26 79 11

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +39 02 89 17 98 1

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε., Ελλάδα

Teva Sweden AB

Τηλ: +30 210 72 79 099

Tel: +46 42 12 11 00

Latvija

United Kingdom

UAB “Sicor Biotech” filiāle Latvijā

Teva UK Limited

Tel: +371 673 23 666

Tel: +44 1977 628500

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the patient

Memantine ratiopharm 20 mg film-coated tablets

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Memantine ratiopharm is and what it is used for

2.What you need to know before you take Memantine ratiopharm

3.How to take Memantine ratiopharm

4.Possible side effects

5.How to store Memantine ratiopharm

6.Contents of the pack and other information

1. What Memantine ratiopharm is and what it is used for

How does Memantine ratiopharm work

Memantine ratiopharm belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Memantine ratiopharm used for

Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Memantine ratiopharm

Do not take Memantine ratiopharm:

if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Memantine ratiopharm:

if you have a history of epileptic seizures.

if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine ratiopharm reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called

● amantadine (for the treatment of Parkinson’s disease),

ketamine (a substance generally used as an anaesthetic),

dextromethorphan (generally used to treat cough) and

other NMDA-antagonists

at the same time should be avoided.

Children and adolescents

Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine ratiopharm

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamine, dextromethorphan

dantrolene, baclofen

cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

hydrochlorothiazide (or any combination with hydrochlorothiazide)

anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

anticonvulsants (substances used to prevent and relieve 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 go into hospital, let your doctor know that you are taking Memantine ratiopharm.

Memantine ratiopharm with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of memantine in pregnant women is not recommended.

Women taking Memantine ratiopharm should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Memantine ratiopharm may change your reactivity, making driving or operating machinery inappropriate.

Memantine ratiopharm contains lactose and soya lecithin

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.

3. How to take Memantine ratiopharm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme. For up-titration other tablet strengths are available.

At the beginning of treatment you will start by using 5 mg 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, which is reached at the beginning of the 4th week.

The tablet can be divided into equal doses.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Memantine ratiopharm should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day.

The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment

Continue to take Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine ratiopharm than you should

In general, taking too much Memantine ratiopharm should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.

If you take a large overdose of Memantine ratiopharm, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine ratiopharm

If you find you have forgotten to take your dose of Memantine ratiopharm, wait and take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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 observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100):

Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

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

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user 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 memantine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Memantine ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

Blister packs

Do not store above 25°C.

HDPE bottles

This medicinal product does not require any special storage conditions.

Shelf life after first opening of the container: 6 months

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Memantine ratiopharm contains

-The active substance is memantine hydrochloride.

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

-The other ingredients are:

Tablet core

Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).

Coating

Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).

What Memantine ratiopharm looks like and contents of the pack

White to off-white, capsule shaped (15.6 x 8.0 mm), biconvex tablets with a break score on one side and embossed with “20” on the other side.

Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

HBM Pharma s.r.o.

Slabinská 30, 03680 Martin

Slovakia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB “Sicor Biotech”

Tél/Tel: +32 3 820 73 73

Tel: +370 5 266 0203

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

ratiopharm GmbH

Teл: +359 2 489 95 82

Allemagne/Deutschland

 

Tél/Tel: +49 731 402 02

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321 740

Deutschland

Nederland

ratiopharm GmbH

Teva Nederland B.V.

Tel: +49 731 402 02

Tel: +31 800 0228 400

Eesti

Norge

UAB “Sicor Biotech” Eesti filiaal

ratiopharm AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 007 0

España

Polska

ratiopharm España, S.A.

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +34 91 567 29 70

Tel.: +48 22 345 93 00

France

Portugal

Teva Santé

ratiopharm, Comércio e Indústria de

Tél: +33 1 55 91 78 00

Produtos Farmacêuticos, Lda

 

Tel: +351 21 476 75 50

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +40 21 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 51 321740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

Medical ehf.

TEVA Pharmaceuticals Slovakia s.r.o.

Sími: +354 534 3500

Tel: +421 2 57 26 79 11

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +39 02 89 17 98 1

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε., Ελλάδα

Teva Sweden AB

Τηλ: +30 210 72 79 099

Tel: +46 42 12 11 00

Latvija

United Kingdom

UAB “Sicor Biotech” filiāle Latvijā

Teva UK Limited

Tel: +371 673 23 666

Tel: +44 1977 628500

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the patient

Memantine ratiopharm 5 mg film-coated tablets

Memantine ratiopharm 10 mg film-coated tablets

Memantine ratiopharm 15 mg film-coated tablets

Memantine ratiopharm 20 mg film-coated tablets

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Memantine ratiopharm is and what it is used for

2.What you need to know before you take Memantine ratiopharm

3.How to take Memantine ratiopharm

4.Possible side effects

5.How to store Memantine ratiopharm

6.Contents of the pack and other information

1. What Memantine ratiopharm is and what it is used for

How does Memantine ratiopharm work

Memantine ratiopharm belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Memantine ratiopharm used for

Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Memantine ratiopharm

Do not take Memantine ratiopharm:

if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Memantine ratiopharm:

if you have a history of epileptic seizures.

if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine ratiopharm reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called

amantadine (for the treatment of Parkinson’s disease),

ketamine (a substance generally used as an anaesthetic),

dextromethorphan (generally used to treat cough) and

other NMDA-antagonists

at the same time should be avoided.

Children and adolescents

Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine ratiopharm

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

In particular, Memantine ratiopharm may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

amantadine, ketamine, dextromethorphan

dantrolene, baclofen

cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

hydrochlorothiazide (or any combination with hydrochlorothiazide)

anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

anticonvulsants (substances used to prevent and relieve 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 go into hospital, let your doctor know that you are taking Memantine ratiopharm.

Memantine ratiopharm with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of memantine in pregnant women is not recommended.

Women taking Memantine ratiopharm should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Memantine ratiopharm may change your reactivity, making driving or operating machinery inappropriate.

Memantine ratiopharm contains lactose and soya lecithin

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.

3. How to take Memantine ratiopharm

The Memantine ratiopharm treatment initiation pack is only to be used for the beginning of the treatment with Memantine ratiopharm.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine ratiopharm dose during the first 3 weeks of treatment. Take one tablet once a day.

Week 1 (day 1-7):

Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and embossed with “5” on the other side) for 7 days.

Week 2 (day 8-14):

Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and embossed with “10” on the other side) for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and embossed with “15” on the other side) for 7 days.

Week 4 (day 22-28):

Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and embossed with “20” on the other side) for 7 days.

week 1

5 mg tablet

 

 

week 2

10 mg tablet

 

 

week 3

15 mg tablet

 

 

week 4 and beyond

20 mg tablets once a day

 

 

Maintenance dose

The recommended daily dose is 20 mg once a day. For continuation of the treatment please consult your doctor.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Memantine ratiopharm should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day.

The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment

Continue to take Memantine ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine ratiopharm than you should

In general, taking too much Memantine ratiopharm should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.

If you take a large overdose of Memantine ratiopharm, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine ratiopharm

If you find you have forgotten to take your dose of Memantine ratiopharm, wait and take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on 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 observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100):

Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

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

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

Very Rare (affects less than 1 user 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 memantine.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Memantine ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister pack after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Memantine ratiopharm contains

-The active substance is memantine hydrochloride.

Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

-The other ingredients are:

Tablet core

Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).

Coating

Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).

What Memantine ratiopharm looks like and contents of the pack

The 5 mg film-coated tablets are white to off-white, capsule shaped (9.6 x 4.54 mm), biconvex tablets plain on one side and embossed with “5” on the other side.

The 10 mg film-coated tablets are white to off-white, capsule shaped (12.5 x 5.6 mm), biconvex tablets with a break score on one side and embossed with “10” on the other side.

The 15 mg film-coated tablets are white to off-white, capsule shaped (14.0 x 6.0 mm), biconvex tablets plain on one side and embossed with “15” on the other side.

The 20 mg film-coated tablets are white to off-white, capsule shaped (15.6 x 8.0 mm), biconvex tablets with a break score on one side and embossed with “20” on the other side.

Memantine ratiopharm is available in packs with 28 (7 +7 +7 + 7) film-coated tablets.

Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

HBM Pharma s.r.o.

Slabinská 30, 03680 Martin

Slovakia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A./AG

UAB “Sicor Biotech”

Tél/Tel: +32 3 820 73 73

Tel: +370 5 266 0203

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

ratiopharm GmbH

Teл: +359 2 489 95 82

Allemagne/Deutschland

 

Tél/Tel: +49 731 402 02

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt.

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321 740

Deutschland

Nederland

ratiopharm GmbH

Teva Nederland B.V.

Tel: +49 731 402 02

Tel: +31 800 0228 400

Eesti

Norge

UAB “Sicor Biotech” Eesti filiaal

ratiopharm AS

Tel: +372 661 0801

Tlf: +47 66 77 55 90

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 007 0

España

Polska

ratiopharm España, S.A.

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +34 91 567 29 70

Tel.: +48 22 345 93 00

France

Portugal

Teva Santé

ratiopharm, Comércio e Indústria de

Tél: +33 1 55 91 78 00

Produtos Farmacêuticos, Lda

 

Tel: +351 21 476 75 50

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +40 21 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 51 321740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

Medical ehf.

TEVA Pharmaceuticals Slovakia s.r.o.

Sími: +354 534 3500

Tel: +421 2 57 26 79 11

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +39 02 89 17 98 1

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε., Ελλάδα

Teva Sweden AB

 

Τηλ: +30 210 72 79 099

Tel: +46

42 12 11 00

Latvija

United Kingdom

UAB “Sicor Biotech” filiāle Latvijā

Teva UK Limited

Tel: +371 673 23 666

Tel: +44

1977 628500

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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