Memantina Ratiopharm: detailed information

Package leaflet: Information for the patient

Memantina ratiopharm 10 mg film-coated tablets

memantine hydrochloride
Please 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 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

How Memantina ratiopharm works
Memantina ratiopharm contains the active substance memantine hydrochloride. It 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 ratiopharm belongs to a group of medicines called NMDA receptor antagonists.
Memantina ratiopharm acts on these NMDA receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina ratiopharm

Do not take Memantina ratiopharm

if you are allergic to memantine hydrochloride, peanuts, 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 Memantina ratiopharm

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 high blood pressure. In these situations, treatment must be closely monitored and the clinical benefits of Memantina ratiopharm must be reassessed regularly by your doctor.

If you have renal impairment (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the dosage of memantine accordingly.
Avoid concomitant use of medicinal products such as:

amantadine (used to treat Parkinson's disease),
ketamine (a substance generally used as an anaesthetic),
dextromethorphan (commonly used to treat cough), and
other NMDA antagonists.

Children and adolescents
Memantina ratiopharm is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina ratiopharm
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 ratiopharm, 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 medical staff that you are taking Memantina ratiopharm.
Memantina ratiopharm 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 suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections (the structure that transports urine), as your doctor may need to adjust the dosage of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of memantine during pregnancy is not recommended.
Women taking Memantina ratiopharm must 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.
Furthermore, Memantina ratiopharm may affect your reaction time, making it advisable not to drive or operate machinery.
Memantina ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains soya lecithin. If you are allergic to peanuts or soya, do not take this medicine.

3. How to take Memantina ratiopharm

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose of Memantina ratiopharm for adult and elderly patients is 20 mg once daily. To reduce the risk of undesirable effects, this dose should be reached gradually according to the following 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 initial dose is half a tablet once daily (1x 5 mg) for the first week. The dosage 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).
The tablet may be divided into equal parts.

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

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

If you take more Memantina ratiopharm than you should

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

If you forget to take Memantina ratiopharm

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

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

4. Possible side effects

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

Headache, drowsiness, constipation, increased 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 disorders, heart failure, and venous blood clotting (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), 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.
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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memantina 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 on the blister after
Exp. The expiry date refers to the last day of that month.
Blister packs
Do not store above 25 °C.
HDPE bottles
This medicine does not require any special storage conditions.
Usable period after first opening of the container: 6 months
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Memantina ratiopharm 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 components are:
Tablet core
Microcrystalline cellulose (E 460), pregelatinized starch (E 1404), lactose, anhydrous colloidal silicon dioxide (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).

Description of the appearance of Memantina ratiopharm and contents of the pack
White to off-white, capsule-shaped, biconvex film-coated tablets, with a break line on one side and "10" engraved on the other side.
Memantina ratiopharm is available in packs containing 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film-coated tablets.
Not all pack sizes may be marketed.

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

България
Тева Фарма ЕАД
Тел: +359 24899585

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

España
Teva Pharma, S.L.U.
Tel: +34 913873280

France
Teva Santé
Tél: +33 155917800

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Ísland
Alvogen ehf.
Sími: +354 5222900

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Lietuva
UAB Teva Baltics
Tel: +370 52660203

Luxembourg/Luxemburg
ratiopharm GmbH
Allemagne/Deutschland
Tél/Tel: +49 73140202

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Norge
Teva Norway AS
Tlf: +47 66775590

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

Portugal
ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Tel: +351 214767550

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

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

Patient information leaflet

Memantina ratiopharm 20 mg film-coated tablets

memantine hydrochloride
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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

How Memantina ratiopharm works
Memantina ratiopharm contains the active substance memantina cloridrato. It belongs to a group
of medicines known as anti-dementia drugs.
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 involved in the transmission of nerve signals important for learning and memory.
Memantina ratiopharm belongs to a group of medicines called NMDA receptor antagonists.
Memantina ratiopharm acts on these NMDA receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina ratiopharm

Do not take Memantina ratiopharm

if you are allergic to memantine hydrochloride, peanuts, 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 Memantina ratiopharm

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 high blood pressure. In these situations, treatment must be closely monitored and the clinical benefits of Memantina ratiopharm reassessed regularly by your doctor.

If you have impaired kidney function (kidney problems), your doctor must carefully monitor
renal function and, if necessary, adjust the memantine dosage 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 ratiopharm is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, the effects of the following medicines may be altered by Memantina ratiopharm, 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 medical staff that you are taking Memantina
ratiopharm.
Memantina ratiopharm 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 (infection of the structures transporting urine), as your doctor may need to adjust the dosage of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of memantine during pregnancy is not recommended.
Women taking Memantina ratiopharm must 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.
Furthermore, Memantina ratiopharm may affect your reaction time, making it advisable to avoid
driving vehicles or operating machinery.
Memantina ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If you have been diagnosed by your doctor with an intolerance to certain
sugars, contact your doctor before taking this medicine.
This medicine contains soya lecithin. If you are allergic to peanuts or soya, do not take this
medicine.

3. How to take Memantina ratiopharm

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Memantina ratiopharm for adult and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually according to the following daily dosing schedule. Tablets with other strengths are available for dose titration.
At the beginning of treatment, you will start with 5 mg 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.
The tablet may be divided into equal parts.
Dosage in patients with reduced renal function
If you have reduced kidney function, your doctor may decide on a dosage regimen appropriate for your condition. In such cases, regular monitoring of kidney function should be performed by your doctor.
Administration
Memantina ratiopharm should be taken 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 taken with or without food.
Duration of treatment
Continue taking Memantina ratiopharm for as long as you benefit from it. Your doctor will review your treatment at regular intervals.
If you take more Memantina ratiopharm than you should

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

If you forget to take Memantina ratiopharm

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the side effects observed are mild to moderate.
Common (may affect from 1 to 10 people in 100):

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

Uncommon (may affect from 1 to 10 people in 1,000):

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

Very rare (may affect 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), 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.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through 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 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 on the blister after
Exp. The expiry date refers to the last day of that month.
Blister packs
Do not store above 25 °C.
HDPE bottles
This medicine does not require any special storage conditions.
Period of validity after first opening of the container: 6 months
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 ratiopharm 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:
Tablet core
Microcrystalline cellulose (E 460), pregelatinized starch (E 1404), lactose, anhydrous colloidal silicon dioxide (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).

Description of the appearance of Memantina ratiopharm and contents of the pack
Film-coated tablets, white to off-white in colour, capsule-shaped, biconvex, with a break line on one side and "20" imprinted on the other.
Memantina 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 Authorization Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé ratiopharm - Comércio e Indústria de Produtos
Tél: +33 155917800 Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Alvogen ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5222900 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

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

Patient Information Leaflet

Memantina ratiopharm 5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

memantine hydrochloride
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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

How Memantina ratiopharm works
Memantina ratiopharm contains the active substance memantine hydrochloride. It belongs to a group
of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disruption in message 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 ratiopharm belongs to a group of medicines called NMDA receptor antagonists.
Memantina ratiopharm acts on these NMDA receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Memantina ratiopharm

Do not take Memantina ratiopharm

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Memantina ratiopharm

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 high blood pressure.

In these situations, treatment must be carefully monitored and the clinical benefits of Memantina ratiopharm should be reassessed regularly by your treating physician.
If you have renal impairment (kidney problems), your treating physician must closely monitor kidney function and, if necessary, adjust the memantine dosage accordingly.
Avoid concomitant use of medicines such as:

amantadine (used to treat Parkinson's disease),
ketamine (a substance generally used as an anesthetic),
dextromethorphan (commonly used to treat cough),
and other NMDA antagonists.

Children and adolescents
Memantina ratiopharm is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina ratiopharm
Inform your doctor or pharmacist if you are taking or using, have recently taken or used, or might take or use any other medicines.
In particular, the effects of the following medicines may be altered by Memantina ratiopharm, 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 medical staff that you are taking Memantina ratiopharm.
Memantina ratiopharm with food and drink
Talk to your treating physician 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 suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections (the structure that transports urine), as your doctor may need to adjust the dosage of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of memantine during pregnancy is not recommended.
Women taking Memantina ratiopharm must not breastfeed.
Driving and using machines
Your treating physician will advise you on whether it is safe for you to drive or operate machinery given your condition.
Moreover, Memantina ratiopharm may affect your reaction time, making it inadvisable to drive vehicles or operate machinery.
Memantina ratiopharm contains lactose and soy lecithin
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Memantina ratiopharm

The starter pack of Memantina ratiopharm must be used only
at the beginning of treatment with Memantina ratiopharm.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
The recommended dose of 20 mg daily is reached by a gradual increase in the dose of
Memantina ratiopharm over the first 3 weeks of treatment. Take one tablet once daily.
First week (day 1-7):
Take one 5 mg tablet once daily (white to off-white in colour, capsule-shaped, biconvex, flat on one side and marked with “5” on the other side) for 7 days.
Second week (day 8-14):
Take one 10 mg tablet once daily (white to off-white in colour, capsule-shaped, biconvex, with a breakline on one side and marked with “10” on the other side) for 7 days.
Third week (day 15-21):
Take one 15 mg tablet once daily (white to off-white in colour, capsule-shaped, biconvex, flat on one side and marked with “15” on the other side) for 7 days.
Fourth week (day 22-28):
Take one 20 mg tablet once daily (white to off-white in colour, capsule-shaped, biconvex, with a breakline on one side and marked 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 onwards	20 mg tablets once daily

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

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

Administration
Memantina ratiopharm 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 taken with or without food.

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

If you take more Memantina ratiopharm than you should

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

If you forget to take Memantina ratiopharm

If you forget to take a dose of Memantina ratiopharm, take the next dose at your usual scheduled 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 everyone gets them.
In general, the side effects observed are mild to moderate.
Common (may affect from 1 to 10 people in 100):

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

Uncommon (may affect from 1 to 10 people in 1,000):

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

Very rare (may affect 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), 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.
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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memantina ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Memantina ratiopharm contains
The active substance is memantine hydrochloride.
Each film-coated tablet contains 5 mg of memantine hydrochloride, equivalent to 4.15 mg
of memantine.
Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to
8.31 mg of memantine.
Each film-coated tablet contains 15 mg of memantine hydrochloride, equivalent to
12.46 mg of memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to
16.62 mg of memantine.
The other components are:
Tablet core
Microcrystalline cellulose (E 460), pregelatinized starch (E 1404), lactose, anhydrous colloidal silica
(E 551), magnesium stearate (E 470b).
Coating
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b),
soybean lecithin (E 322), xanthan gum (E 415).

Description of the appearance of Memantina ratiopharm and package contents
The 5 mg film-coated tablets are white to off-white, capsule-shaped, biconvex, flat on one side and marked with "5" on the other side.
The 10 mg film-coated tablets are white to off-white, capsule-shaped, biconvex, with a break line on one side and marked with "10" on the other side.
The 15 mg film-coated tablets are white to off-white, capsule-shaped, biconvex, flat on one side and marked with "15" on the other side.
The 20 mg film-coated tablets are white to off-white, capsule-shaped, biconvex, with a break line on one side and marked with "20" on the other side.
Memantina ratiopharm is available in packages containing 28 (7+7+7+7) film-coated tablets.

Marketing Authorization Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 Ireland
Tel: +44 2075407117