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MEMANTINE SANDOZ 20 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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SZ00000LT000

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantine 10 mg Film-coated Tablets
Memantine 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 is and what it is used for
2. What you need to know before you take Memantine
3. How to take Memantine
4. Possible side effects
5. How to store Memantine
6. Contents of the pack and other information

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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.

What Memantine is and what it is used for

How does Memantine work
Memantine belongs to a group of medicines known as
anti-dementia medicines.
Memory loss in Alzheimerʼs 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 belongs to a group of medicines called
NMDA-receptor antagonists. Memantine acts on these
NMDA-receptors improving the transmission of nerve signals
and the memory.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.

The use of Memantine in pregnant women is not
recommended.

Women taking Memantine 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 may
change your reactivity, making driving or operating machinery
inappropriate.

What is Memantine used for
Memantine is used for the treatment of patients with moderate
to severe Alzheimerʼs disease.

2

Memantine 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.

What you need to know before you take
Memantine

3

Do not take Memantine
• 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:
• 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)

How to take Memantine

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

Dosage

The recommended dose 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:

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

Period of intake

Dosage once daily

week 2

10 mg

week 1

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

week 3

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.

week 4 and beyond

5 mg

15 mg
20 mg

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.

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

Administration

Other medicines and Memantine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Memantine 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.

In particular, Memantine 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

Memantine 10 mg film-coated Tablets
The tablet can be divided into 2 equal doses, as seen in the
picture. If required, take the tablet in your hands and press the
thumbs downwards, over the index fingers.

If you go into hospital, let your doctor know that you are taking
Memantine.
Memantine 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

Continued on the next page >>

Artwork Proof Box
Ref: Licence application
Proof no.
001.0

Date prepared:
24/05/2013

Colours:
Black
Dimensions: 180 x 420 mm

Font size:
8pt
Fonts:
Helvetica

Memantine 20 mg film-coated Tablets
The tablet can be divided into 4 equal doses, as seen in the
picture. If required, place the tablet on a flat surface with the
score lines facing upward; using your thumb, apply pressure
to the tablet.

Tablet coating: hypromellose (E464), lactose monohydrate,
macrogol, triacetin and titanium dioxide (E171).

Memantine 20 mg Film-coated Tablets
Tablet core: lactose monohydrate, sodium starch glycolate
(type A), microcrystalline cellulose, colloidal anhydrous silica,
magnesium stearate.
Tablet coating: Polyvinyl alcohol, macrogol, titanium dioxide
(E171), talc, iron oxide red (E172) and iron oxide yellow
(E172).
What Memantine looks like and contents of the pack
Memantine 10 mg Film-coated Tablets are white film-coated
tablets of oval shape (6.1 x 11.6 mm) with a breaking line on
both sides. The tablet can be divided into equal doses.

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

Memantine 20 mg Film-coated Tablets are light red
film-coated tablets of round shape (diameter 11.1 mm) with
two crossed breaking lines on one side. The tablet can be
divided into equal doses.

If you take more Memantine than you should
• In general, taking too much Memantine 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, contact your
doctor or get medical advice, as you may need medical
attention.

This medicine is available in transparent
PVC-Aclar/Aluminium and/or transparent
PVC-PVDC/Aluminium blister packs containing 7, 10, 14, 18,
20, 22, 28, 30, 40, 42, 45, 48, 49, 49x1, 50, 56, 56x1, 60, 70,
84, 90, 96, 98, 98x1, 100, 100x1, 112, 980(10x98) or
1000(20x50) film-coated tablets.
This medicine is available in HPDE bottles with PP screw cap
with tamper-evident ring and desiccant containing 28, 30, 56,
98, 100 or 112 film-coated tablets.

If you forget to take Memantine
• If you find you have forgotten to take your dose of
Memantine, wait and take your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

4

Marketing authorization holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom,

Possible side effects

Manufacturer:
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia

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

In general, the observed side effects are mild to moderate.

or

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

LEK S.A.,
ul. Domaniewska 50 C,
02-672 Warszawa, Poland

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)

or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany

Very Rare, may affect up to 1 in 10,000 people:
• seizures

or

Not known, frequency cannot be estimated from the available
data:
• inflammation of the pancreas, inflammation of the liver
(hepatitis) and psychotic reactions

S.C. Sandoz, S.R.L.,
Str. Livezeni nr. 7A,
RO-540472 Targu-Mures,
Romania

Alzheimer's disease has been associated with depression,
suicidal ideation and suicide. These events have been
reported in patients treated with this medicine.

or

Weimer Pharma GmbH,
Im Steingerüst 30, 76437 Rastatt,
Germany.

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 Yellow Card
Scheme (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.

5

This leaflet was last revised in 05/2013.

How to store Memantine

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

This medicinal product does not require any special storage
conditions.

Do not use this medicine after the expiry date which is stated
on the blister or bottle label and carton after “EXP”. The expiry
date refers to the last day of that month.
HPDE bottle: Once opened, the contents of the bottle should
be used within 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 contains
The active substance is memantine.

Memantine 10 mg Film-coated Tablets:
Each film-coated tablet contains 10 mg memantine
hydrochloride which is equivalent to 8.31 mg of memantine.

Memantine 20 mg Film-coated Tablets:
Each film-coated tablet contains 20 mg memantine
hydrochloride which is equivalent to 16.62 mg of memantine.
The other ingredients are:
Memantine 10 mg Film-coated Tablets
Tablet core: lactose monohydrate, microcrystalline cellulose,
colloidal anhydrous silica, magnesium stearate.

SZ00000LT000

Artwork Proof Box
Ref: Licence application
Proof no.
001.0

Date prepared:
24/05/2013

Colours:
Black
Dimensions: 180 x 420 mm

Font size:
8pt
Fonts:
Helvetica

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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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