PACKAGE LEAFLET: INFORMATION FOR THE USER

YMANA	5 mg film-coated tablets
YMANA	10 mg film-coated tablets
YMANA	15 mg film-coated tablets
YMANA	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 Ymana is and what it is used for

2.    What you need to know before you take Ymana

3.    How to take Ymana

4.    Possible side effects

5.    How to store Ymana

6.    Contents of the pack and other information

1.    WHAT YMANA IS AND WHAT IT IS USED FOR

Ymana tablets belong to a group of medicines known as antidementia 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. Ymana tablets belong to a group of medicines called NMDA receptor antagonists. Ymana tablets acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

-    Ymana tablets are used for the treatment of patients with moderate to severe Alzheimer’s disease.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE YMANA

Do not take Ymana:

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

If you are not sure, talk to your doctor or pharmacist before taking Ymana tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ymana tablets if:

-    you have a history of epileptic seizures

-    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 Ymana tablets should be 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 Ymana 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

Ymana tablets are not recommended for children and adolescents under the age of 18 years.

Other medicines and Ymana

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular, Ymana tablets 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 Ymana tablets.

Ymana with food, drink and alcohol

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, breast-feeding and fertility

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 Ymana in pregnant women is not recommended. Women taking Ymana tablets 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, Ymana tablets may change your reactivity, making driving or operating machinery inappropriate.

3. HOW TO TAKE YMANA

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 Ymana tablets for adults and elderly 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 (day 1-7)	5 mg a day
week 2 (day 8-14)	10 mg a day
week 3 (day 15-21)	15 mg a day
week 4 and beyond	20 mg a day

The usual starting dose is 5 mg a day for the first week. This is increased to 10 mg a day in the second week and to 15 mg a day in the third week. From the fourth week on, the usual dose is 20 mg 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.

Method of administration

Ymana tablets 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. The 10 mg and 20 mg tablet can be divided into equal doses.

Duration of treatment

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

If you take more Ymana tablets than you should

If you take a large overdose of Ymana tablets, contact your doctor or get medical advice, as you may need medical attention. In general, taking too many Ymana tablets should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.

If you forget to take Ymana tablets

-    If you find you have forgotten to take your dose of Ymana tablets, 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 product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any effects such as seizures, suicidal ideation and suicidal thoughts, speak to your doctor or pharmacist immediately.

In general, the observed side effects are mild to moderate. Common (may affect up to 1 in 10 people):

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

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

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

Very rare (may affect less then 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) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with Ymana tablets.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in the leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE YMANA

Do not store above 25°C. Keep the blister in the outer carton in order to protect from light.

Keep 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 after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Ymana tablets contains

Active substance: memantine hydrochloride.

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

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

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

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

The other ingredients are:

Tablet core: silicified microcrystalline cellulose, croscarmellose sodium, talc, magnesium stearate.

Film-coating: hypromellose, macrogol 400 and titanium dioxide (E171).

Additional for the 15 mg tablets, Iron Oxide yellow (E172) in the tablet coating.

Additional for the 20 mg tablets, Red Iron Oxide (E172) in the tablet coating.

What Ymana tablets look like and contents of the pack

Ymana 5 mg are white to off white coloured, capsule shaped, biconvex, film-coated tablets, debossed with “5” on one side and plain on the other side. The dimensions of each tablet are approximately 10 x 4 mm.

Ymana 10 mg are white to off white coloured, oval shaped, film-coated tablets, debossed with “10” on one side and score line on the other side. The dimensions of each tablet are approximately 11 x 6 mm.

Ymana 15 mg are mustard yellow coloured, oval shaped, film-coated tablets, debossed with “15” on one side and plain on the other side. The dimensions of each tablet are approximately 14 x 7 mm.

Ymana 20mg are brownish pink coloured, oval shaped, film-coated tablets, debossed with “20” on one side and score line on the other side. The dimensions of each tablet are approximately

14    x 7 mm.

Ymana 10 mg and 20 mg tablets can be divided into equal halves. 5 mg Tablet packs: Al/PVC blister packs contain 7 tablets per blister strip. Pack size of 7 tablets is presented.

10 mg Tablet packs: Al/PVC blister packs containing either 7, 10 or 14 tablets per blister strip. Pack sizes of 7, 28 and 30 tablets are presented.

15    mg Tablet packs: Al/PVC blister packs contain 7 tablets per blister strip. Pack size of 7 tablets is presented.

20 mg Tablet packs: Al/PVC blister packs containing either 7, 10 or 14 tablets per blister strip. Pack sizes of 7, 28 and 30 tablets are presented.

Marketing Authorization Holder and Manufacturer

ALKALOID-INT d.o.o.,

Slandrova ulica 4,

1231 Ljubljana - Crnuce Slovenia

tel.: +386 1 300 42 90 fax: +386 1 300 42 91 e-mail: info@alkaloid.si

This medicine product is authorised in the Member states of the EEA under the following names:

Bulgaria: YMANA 5 mg; 10 mg; 15 mg; 20 mg film-coated tablets

Croatia: YMANA 5 mg; 10 mg; 15 mg; 20 mg filmom oblozene tablete

Slovenia: YMANA 5 mg; 10 mg; 15 mg; 20 mg filmsko oblozene tablete

UK:    YMANA 5 mg; 10 mg; 15 mg; 20 mg film-coated tablets

YMANA 5 mg film-coated tablets; PL 34088/0034 YMANA 10 mg film-coated tablets; PL 34088/0035 YMANA 15 mg film-coated tablets; PL 34088/0036 YMANA 20 mg film-coated tablets; PL 34088/0037

This leaflet was last revised in 08/2014

YMANA_tbl_UK_mock-up_180x310mm_LUPIN.indd 2 19/08/2014 13:20:06