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MEMANTINE DR REDDYS 10 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Memantine hydrochloride 10 mg Film-Coated Tablets
Memantine hydrochloride 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. What Memantine hydrochloride is and what it is
used for
2. What you need to know before you take
Memantine hydrochloride
3. How to take Memantine hydrochloride
4. Possible side effects
5. How to store Memantine hydrochloride
6. Contents of the pack and other information

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.

1. What Memantine hydrochloride is and
what it is used for

Children and adolescents

How does Memantine hydrochloride work
Memantine hydrochloride 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. Memantine
hydrochloride belongs to a group of medicines called
NMDA-receptor antagonists. Memantine hydrochloride
acts on these NMDA-receptors improving the
transmission of nerve signals and the memory.

What is Memantine hydrochloride used for
Memantine hydrochloride is used for the treatment of
patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you
take Memantine hydrochloride
Do not take Memantine hydrochloride


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 hydrochloride
 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
hydrochloride 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 hydrochloride
doses accordingly.
The use of medicines 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.

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

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

Memantine hydrochloride with food and drink
Food does not influence the effect of Memantine
hydrochloride.

Pregnancy and breast-feeding
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 memantine hydrochloride in pregnant women
is not recommended.
Women taking Memantine hydrochloride 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
hydrochloride may change your reactivity, making driving
or operating machinery inappropriate.

Common (may affect up to 1 in 10 people):
 Headache, sleepiness, constipation, elevated liver
function tests, dizziness, balance disorder, shortness
Always take this medicine exactly as your doctor has told
of breath, high blood pressure and drug
you. You should check with your doctor or pharmacist if
hypersensitivity
you are not sure.

3. How to take Memantine hydrochloride

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:
Week 1 (day 1-7):
Take half a 10 mg tablet once a day (pale yellow to
yellow, oval shaped) for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (pale yellow to yellow,
oval shaped) for 7 days or
half a 20 mg tablet once a day (pale red to grey red, oval
shaped) for 7 days.
Week 3 (day 15-21):
Take one and a half 10 mg tablets once a day (pale
yellow to yellow, oval shaped) for 7 days.

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 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) and psychotic reactions
Alzheimer’s disease has been associated with
depression, suicidal ideation and suicide. These events
have been reported in patients treated with Memantine
hydrochloride.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in
Week 4 (day 22-28):
Take one 20 mg tablet per day (pale red to grey red, oval this leaflet.
shaped) for 7 days or
5. How to store Memantine hydrochloride
two 10 mg tablets per day (pale yellow to yellow, oval
shaped) for 7 days.
Keep this medicine out of the sight and reach of children.

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

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.
This medicinal product does not require any special
storage conditions.

Do not throw away any medicines via wastewater or
If you have impaired kidney function, your doctor will
household waste. Ask your pharmacist how to throw
decide upon a dose that suits your condition. In this case, away medicines you no longer use. These measures will
monitoring of your kidney function should be performed
help protect the environment.
by your doctor at specified intervals.

Administration
Memantine hydrochloride 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.

6. Contents of the pack and other
information
What this medicine contains

The active substance is memantine hydrochloride.
Memantine hydrochloride 10 mg film-coated tablets
contain 10 mg memantine hydrochloride equivalent to
8.31 mg memantine.
Duration of treatment
Memantine hydrochloride 20 mg film-coated tablets
Continue to take Memantine hydrochloride as long as it is
contain 20 mg memantine hydrochloride equivalent to
of benefit to you. Your doctor should assess your
16.62 mg memantine.
treatment on a regular basis.
The other ingredients are microcrystalline cellulose,
If you take more Memantine hydrochloride than croscarmellose sodium, colloidal anhydrous silica and
magnesium stearate, povidone (K-30), all in the tablet
you should
core; and hypromellose, macrogol 400, titanium dioxide
 In general, taking too much Memantine
(E171) and iron oxide yellow (E172) and red iron oxide
hydrochloride should not result in any harm to you.
(only in 20 mg film-coated tablet), all in the tablet coating.
You may experience increased symptoms as
described in section 4. “Possible side effects”.
What Memantine hydrochloride tablets look like
 If you take a large overdose of Memantine
and contents of the pack
hydrochloride, contact your doctor or get medical
Memantine hydrochloride 10 mg film-coated tablets are
advice, as you may need medical attention.
pale yellow to yellow, oval shaped film-coated tablets

If you forget to take Memantine hydrochloride



If you find you have forgotten to take your dose of
Memantine hydrochloride, 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.
In general, the observed side effects are mild to
moderate.

with breaking line and engravings “1 0” on one side and
“R R” on the other side.
The tablet can be divided into equal doses.
Memantine hydrochloride 20 mg film-coated tablets are
pale red to grey red, oval shaped film-coated tablets with
breaking line and engravings “2 0” on one side and “R R”
on the other side.
The tablet can be divided into equal doses.
Memantine hydrochloride film-coated tablets are
available in blister packs of 7, 28, 42, 56, 98 and
112 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 04/2013

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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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