Skip to Content

UK Edition. Click here for US version.

MEMANTINE DAWA 10 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Memantine Dawa 10 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 Dawa is and what it is
used for
2. What you need to know before you take
Memantine Dawa
3. How to take Memantine Dawa
4. Possible side effects
5. How to store Memantine Dawa
6. Contents of the pack and other information
1. What Memantine Dawa is and what it is
used for
Memantine Dawa 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 Dawa belongs to a
group of medicines called NMDA receptor
antagonists. Memantine Dawa acts on these
NMDA-receptors improving the transmission of
nerve signals and the memory.
Memantine Dawa is used for the treatment of
patients with moderate to severe Alzheimer’s
disease.

2. What you need to know before you take
Memantine Dawa
Do not take Memantine Dawa:
 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 Dawa:
 if you have a history of epileptic seizures
 if you have recently experienced
amyocardial 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 Dawa reassessed by your doctor on
a regular basis.
If you have renal impairment (kidney problems),
your doctor should closely monitor your kidney
function and if necessary adapt the memantine
hydrochloride doses accordingly.
The use of medicinal products called
amantadine (used in 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.
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), as your doctor may need to
monitor you.
Children and adolescents
Memantine Dawa are not recommended for
children and adolescents under the age of 18
years.
Other medicines and Memantine Dawa
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

In particular, Memantine Dawa may change the
effects of the 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 Dawa.
Memantine Dawa 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 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 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.
Tell your doctor if you are pregnant or planning
to become pregnant. The use of memantine in
pregnant women is not recommended.
Women taking Memantine Dawa 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 Dawa may change your
reactivity, making driving or operating
machinery inappropriate.
3. How to take Memantine Dawa
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 Memantine Dawa 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

half a 10 mg tablet
one 10 mg tablet
one and a half 10 mg tablets

week 4 and
beyond

two 10 mg tablets once a
day

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 tablets once
a day (1x 15 mg) in the third week. From the
fourth week on, the usual dose is 2 tablets once
a day (1x 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.
Administration
Memantine Dawa 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 Dawa as long as it
is of benefit to you. Your doctor should assess
your treatment on a regular basis.
If you take more Memantine Dawa than you
should
In general, taking too much Memantine Dawa
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
Dawa, contact your doctor or get medical
advice, as you may need medical attention.

If you forget to take Memantine Dawa
If you have forgotten to take your dose of
Memantine Dawa, 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.
Common (may affect more than 1 in 10 people):
-

headache
sleepiness
constipation
elevated liver function tests
dizziness
balance disorders
shortness of breath
high blood pressure
drug hypersensitivity

Uncommon (may affect up to 1 to 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 ideation and suicide. These
events have been reported in patients treated
with Memantine Dawa.
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; website: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 Memantine Dawa
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 carton and the
blister/bottle after EXP. The expiry date refers
to the last day of that month.
This medicinal product does not require any
special storage conditions.
HDPE bottle: Do not use for more than 75 days
after you first open it.

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 Dawa contains
The active substance is memantine
hydrochloride. Each film-coated tablet contains
10 mg memantine hydrochloride equivalent to
8.31 mg memantine.
The other ingredients are:
Tablet core: Cellulose microcrystalline, silica,
colloidal anhydrous, croscarmellose sodium,
hydromellose, talc and magnesium stearate.
Tablet coat: Hypromellose, Macrogol 400,
Titanium dioxide (E171).

This medicinal product is authorised in the
Member States of the EEA under the
following names:
Bulgaria: Memantine Sopharma 10 mg
филмирана таблетка
France: Memantine Pharmascope 10 mg
Comprimé pelliculé sécable
Germany: Memantin Pharmascope 10 mg
Filmtabletten
Netherlands: Memantine Pharmascope 10 mg
Filmomhulde tablet
Romania: Memantine Pharmascope 10 mg
Comprimat filmat
Sweden: Memantine Pharmascope 10 mg
Filmdragerad tablett
United Kingdom: Memantine DAWA 10 mg
Film-coated Tablets
This leaflet was last revised in 12/2014

What Memantine Dawa looks like and
contents of the pack
Memantine Dawa are presented as white to offwhite, caplet shaped, biconvex film-coated
tablets with break line on both sides. The tablet
can be divided into equal halves.
Memantine Dawa is available in blisters pack
sizes of 28, 42, 56 and 98 tablets.
Bottles are available in pack sizes of 30, 100
and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Dawa Ltd
5 Sandridge Close
Harrow, Middlesex
HA1 1XD
Manufacturer
Drugsrus Ltd
5 Sandridge Close
Harrow, Middlesex
HA1 1XD

Expand view ⇕

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.

Hide