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MEMANTINE SYNTHON 10 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet
1.3.1

page 1/9

Package Leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Memantine Synthon 10 mg film-coated tablets
Memantine Synthon 20 mg film-coated tablets
Memantine Synthon Treatment Initiation Pack
5 mg + 10 mg + 15 mg + 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.

What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

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

What Memantine Synthon is and what it is used for
How does Memantine Synthon work
Memantine Synthon 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.

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

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Memantine Synthon belongs to a group of medicines called NMDA-receptor
antagonists. Memantine Synthon acts on these NMDA-receptors improving
the transmission of nerve signals and the memory.
What is Memantine Synthon used for
Memantine Synthon is used for the treatment of patients with moderate to
severe Alzheimer’s disease.
2.

What you need to know before you take Memantine Synthon
Do not take Memantine Synthon
if you are allergic to memantine hydrochloride 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 Synthon
Take special care with Memantine Synthon:
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 Synthon 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
Synthon 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 NMDAantagonists at the same time should be avoided.
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.

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

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Children and adolescents
Memantine Synthon is not recommended for children and adolescents under
the age of 18 years.
Other medicines and Memantine Synthon
Memantine Synthon 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
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any of the medicines listed above or any other medicines.
If you go into hospital, let your doctor know that you are taking Memantine
Synthon.
Memantine Synthon with food and drink
Food does not influence the effect of Memantine Synthon.
Pregnancy and breast-feeding
The use of Memantine Synthon in pregnant women is not recommended.
Women taking Memantine Synthon should not breast-feed.
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.

Driving and using machines

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

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

3.

How to take Memantine Synthon
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Dosage
Memantine Synthon 10 mg film-coated tablets
The recommended dose of Memantine Synthon 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
week 2
week 3
week 4 and beyond

half a 10 mg tablet
one 10 mg tablet
one and a half 10 mg tablet
two 10 mg tablets once a day

The recommended dose can also be achieved by using a treatment initiation
pack.
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 1 and a half tablet once a day in the third week. From the fourth
week on, the usual dose is 2 tablets once a day (1x 20 mg).
Memantine Synthon 20 mg film-coated tablets
The recommended dose of Memantine Synthon 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. For up-titration other tablet strengths
are available.
At the beginning of treatment you will start by using 5 mg
film-coated tablets once a day. This dose will be increased weekly by 5 mg
until the recommended (maintenance) dose is reached. The recommended

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

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maintenance dose is 20 mg once a day, which is reached at the beginning of
the 4th week.
Memantine Synthon Treatment Initiation Pack
5 mg + 10 mg + 15 mg + 20 mg film-coated tablets
The recommended treatment dose of 20 mg per day is achieved by a gradual
increase of the Memantine Synthon dose during the first 3 weeks of
treatment. The treatment scheme is also indicated on the treatment initiation
pack. Take one tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day (yellow, oval, biconvex) for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (white, round, biconvex) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (orange-brown, round, biconvex) for 7
days.
Week 4 (day 22-28):
Take one 20 mg tablet per day (pink, oval, biconvex) for 7 days.
week 1
week 2
week 3
week 4 and beyond

5 mg tablet
10 mg tablet
15 mg tablet
20 mg tablets once a day

Maintenance dose
The recommended daily dose is 20 mg once a day.
For continuation of the treatment, other tablet strengths are available. 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.
Memantine Synthon 10 mg film-coated tablets
Breaking the tablet
Place the tablet with the round side on a hard surface, the score line should
face upwards. Press with the forefinger and thumb of the same hand on either
side of the score line and push down until the tablet breaks as shown in the

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

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illustration.

Memantine Synthon 20 mg film-coated tablets
Breaking the tablet
Place the tablet with the round side on a hard surface, the score line should
face upwards. Press with the forefinger and thumb of the same hand on either
side of the score line and push down until the tablet breaks as shown in the
illustration.

Administration
Memantine Synthon 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 Synthon as long as instructed by your doctor. He
will assess your treatment on a regular basis.
If you take more Memantine Synthon than you should
In general, taking too much Memantine Synthon 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 Synthon, contact your doctor or
get medical advice, as you may need medical attention.

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

page 7/9

If you forget to take Memantine Synthon
If you have forgotten to take your dose of Memantine Synthon, wait and take
your next dose at the usual time.
Do not take a double dose to make up for the 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 (may affect up to 1 in 10 people)
Headache • sleepiness • constipation • elevated liver function tests • dizziness
• balance disorders • high blood pressure • shortness of breath • drug
hypersensitivity
Uncommon (may affect up to 1 in 100 people)
Tiredness • fungal infections • confusion • hallucinations • vomiting •
abnormal
gait

heart
failure

venous
blood
clotting
(thrombosis/thromboembolism)
Very rare (may affect up to 1 in 10,000 people)
Seizures
Not known (frequency cannot be estimated from the available data)
Inflammation of the pancreas • inflammation of the liver (hepatitis) •
Psychotic reactions
Alzheimer's disease has been associated with depression, suicidal thoughts
and suicide. These events have been reported in patients treated with
Memantine Synthon.
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 .
By reporting side effects you can help provide more information on the safety
of this medicine.

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

5.

page 8/9

How to store Memantine Synthon
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 blister
and carton after ‘EXP’. The first two digits indicate the month and the last
four digits indicate the year. The expiry date refers to the last day of that
month.
This medicinal product does not require any special storage conditions.
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 Synthon contains
The active substance is memantine hydrochloride. Each tablet contains 10
20 5/10/15/20 mg of memantine hydrochloride equivalent to 8.31 16.62
4.15/8.31/12.46/16.62 mg memantine.
The other ingredients are lactose monohydrate, microcrystalline cellulose,
colloidal anhydrous silica, talc and magnesium stearate, all in the tablet
core; and lactose monohydrate, hypromellose, titanium dioxide (E171),
iron oxide yellow (E172), iron oxide red (E172) and macrogol 4000 and
additional for Memantine Synthon 5 mg, 15 mg and 20 mg tablets iron
oxide yellow (E172) and for the Memantine Synthon 15 mg and 20 mg
tablets iron oxide red (E172), all in the tablet coating.
What Memantine Synthon looks like and contents of the pack
Memantine Synthon 10 mg film-coated tablets
Memantine 10 mg tablets are presented as white, round, biconvex tablets (8
mm) with a score line on one side and debossed with ‘M9MN’ and ‘10’ on
the other side. The tablet can be divided into equal halves.
Memantine tablets are available in blister packs of:
blisters containing 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100, 112 or 120
tablets and a Unit dose blister containing 30x1 tablet
Not all pack sizes may be marketed.

Common Technical Document
Memantine HCl
Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet

page 9/9

Memantine Synthon 20 mg film-coated tablets
Memantine 20 mg tablets are presented as pink, oval, biconvex tablets (13.5
x 6.6 mm) with a score line on one side and debossed with ‘M9MN 20’ on
the other side. The tablet can be divided into equal halves.
Memantine tablets are available in blister packs of:
blisters containing 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100, 112 or 120
tablets and a Unit dose blister containing 30x1 tablet
Not all pack sizes may be marketed.
Memantine Synthon Treatment Initiation Pack
5 mg + 10 mg + 15 mg + 20 mg film-coated tablets
Memantine 5 mg tablets are presented as yellow oval biconvex tablets (8 x
4.5 mm), debossed with ‘M9MN 5’ on one side.
Memantine 10 mg tablets are presented as white, round, biconvex tablets (8
mm) with a.score line on one side and debossed with ‘M9MN’ and ‘10’ on
the other side. The tablet can be divided into equal halves.
Memantine 15 mg tablets are presented orange-brown round biconvex tablets
(9.3 mm) with a score line on one side and debossed with ‘M9MN 15’ on the
other side. The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Memantine 20 mg tablets are presented as pink oval biconvex tablets (13.5 x
6.6 mm), with a score line on one side and debossed with ‘M9MN 20’ on the
other side. The tablet can be divided into equal halves.
Each pack contains 28 tablets in 4 blisters with 7 tablets of 5 mg, 7 tablets of
10 mg, 7 tablets of 15 mg and 7 tablets of 20 mg.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synthon BV,
Microweg 22,
6545 CM Nijmegen,
The Netherlands

Manufacturer(s):
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands
Synthon Hispania, S.L., C/Castelló, 1 - Polígono Las Salinas,
08830 Sant Boi de Llobregat, Barcelona, Spain
This leaflet was last revised in 09/2013

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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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