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YMANA 15MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

YMANA
YMANA
YMANA
YMANA

5 mg film-coated tablets
10 mg film-coated tablets
15 mg film-coated tablets
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.
YMANA_tbl_UK_mock-up_180x310mm_LUPIN.indd 1

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 hydrochloro­
thiazide)
- 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.

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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/yellowcard.
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.

YMANA_tbl_UK_mock-up_180x310mm_LUPIN.indd 2

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, filmcoated 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, filmcoated 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, filmcoated 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.,
Šlandrova ulica 4,
1231 Ljubljana – Črnuče
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 obložene
tablete
Slovenia: YMANA 5 mg; 10 mg; 15 mg; 20 mg filmsko obložene
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

19/08/2014 13:20:06

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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