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MEMANTINE GLENMARK 10MG/ML ORAL SOLUTION

Active substance(s): MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the user

Instructions for proper use of the pump

Memantine hydrochloride

The solution must not be poured or pumped directly into the mouth from the bottle or pump. Measure
the dose onto a spoon or into a glass of water, using the pump.

Memantine Glenmark 10 mg/ml oral solution
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.
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.
This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What Memantine oral solution is and what it
is used for
2. What you need to know before you take
Memantine oral solution
3. How to take Memantine oral solution
4. Possible side effects
5. How to store Memantine oral solution
6. Contents of the pack and other information

Dosage
One pump actuation contains 5 mg memantine
hydrochloride.
The recommended dose of Memantine oral
solution for adults and elderly patients is four
pump actuations, equivalent to 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

one pump actuation

week 3

three pump actuations

week 2
week 4 and beyond

1. Take the screw cap off the bottle:
The cap must be turned anticlockwise, unscrewed completely and removed (figure 1).
Figure 1

two pump actuations

Four pump actuations

The usual starting dose is one pump actuation
once daily (1x 5 mg) for the first week. This
dose is increased in the second week to two
pump actuations once daily (1 x 10 mg), and in
the third week to three pump actuations once
daily (1 x 15 mg). From the fourth week the
recommended dose is four pump actuations once
daily (1x 20 mg).
1. What Memantine oral solution is and
Dosage in patients with impaired kidney
what it is used for
function
If you have problems with the way your kidneys
How does Memantine oral solution work
work (impaired kidney function), your doctor
Memantine oral solution belongs to a group of
will decide upon a dose that suits your condition.
medicines known as anti-dementia medicines.
In this case, monitoring of your kidney function
Memory loss in Alzheimer’s disease is due to
should be performed by your doctor at specified
a disturbance of message signals in the brain.
intervals.
The brain contains so-called N-methyl-Daspartate (NMDA)-receptors that are involved in Administration
Memantine oral solution should be administered
transmitting nerve signals important in learning
orally once a day. To benefit from your medicine
and memory.
you should take it regularly every day at the same
Memantine oral solution belongs to a group of
time of the day. The solution should be taken
medicines called NMDA-receptor antagonists.
with a little water. The solution can be taken with
Memantine oral solution acts on these NMDAor without food.
receptors improving the transmission of nerve
For detailed instructions on the preparation and
signals and the memory.
handling of the product see end of this leaflet
What is Memantine oral solution used for
(“Instructions for proper use of the pump”)
Memantine oral solution is used for the treatment Duration of treatment
of patients with moderate to severe Alzheimer’s
Continue to take Memantine oral solution as
disease.
long as it is of benefit to you. Your doctor should
assess your treatment on a regular basis.
2. What you need to know before you
If you take more Memantine oral solution
take Memantine oral solution
than you should
- In general, taking too much Memantine oral
Do not take Memantine oral solution
solution should not result in any harm to you.
- if you are allergic to memantine hydrochloride
You may experience increased symptoms as
or any of the other ingredients of this
described in section 4. “Possible side effects”.
medicine (listed in section 6).

If you take a large overdose of Memantine
Warnings and precautions
oral solution, contact your doctor or get
Talk to your doctor before taking Memantine oral
medical advice, as you may need medical
solution
attention.
- if you have a history of epileptic seizures;
- if you have recently experienced a myocardial If you forget to take Memantine oral solution
- If you find you have forgotten to take your
infarction (heart attack), or if you are
dose of Memantine oral solution, wait and
suffering from congestive heart failure or
take your next dose at the usual time.
from an uncontrolled hypertension (high
- Do not take a double dose to make up for a
blood pressure).
forgotten dose.
In these situations the treatment should be
If
you
have any further questions on the use of
carefully supervised, and the clinical benefit
this medicine, ask your doctor or pharmacist.
of Memantine oral solution reassessed by your
doctor on a regular basis.
4. Possible side effects
If you suffer from renal impairment (kidney
Like all medicines, this medicine can cause side
problems), your doctor should closely monitor
effects, although not everybody gets them. In
your kidney function and if necessary adapt the
general, the observed side effects are mild to
Memantine doses accordingly.
The use of medicinal products called amantadine moderate.
Common (may affect 1 to 10 users in 100):
(for the treatment of Parkinson’s disease),
• Headache, sleepiness, constipation, elevated
ketamine (a substance generally used as an
liver function tests, dizziness, balance
anaesthetic), dextromethorphan (generally used
disorders, shortness of breath, high blood
to treat cough) and other NMDA-antagonists at
pressure and drug hypersensitivity
the same time should be avoided.
Uncommon (may affect 1 to 10 users in 1,000):
Children and adolescents
• Tiredness, fungal infections, confusion,
Memantine oral solution is not recommended
hallucinations, vomiting, abnormal gait, heart
for children and adolescents under the age of 18
failure and venous blood clotting (thrombosis/
years.
thromboembolism)
Other medicines and Memantine oral solution
Very
Rare (may affect less than 1 user in
Tell your doctor or pharmacist if you are taking
10,000):
or have recently taken or might take any other
medicines, including medicines obtained without • Seizures
Not known (frequency cannot be estimated
a prescription.
from the available data):
In particular, Memantine oral solution may
• Inflammation of the pancreas, inflammation of
change the effects of the following medicines
the liver (hepatitis) and psychotic reactions
and their dose may need to be adjusted by your
Alzheimer’s disease has been associated with
doctor:
depression, suicidal thoughts and suicide. These
- amantadine, ketamine, dextromethorphan;
events have been reported in patients treated with
- dantrolene, baclofen;
memantine.
- cimetidine, ranitidine, procainamide,
quinidine, quinine, nicotine;
If you get any side effects, talk to your doctor
- hydrochlorothiazide (or any combination with or pharmacist. This includes any possible side
effects not listed in this leaflet.
hydrochlorothiazide);
- anticholinergics (substances generally used to
Reporting of side effects
treat movement disorders or intestinal cramps); If you get any side effects, talk to your doctor
- anticonvulsants (substances used to prevent
or pharmacist. This includes any possible side
and relieve seizures);
effects not listed in this leaflet. You can also
- barbiturates (substances generally used to
report side effects directly via the Yellow Card
induce sleep);
Scheme, Website: www.mhra.gov.uk/yellowcard.
- dopaminergic agonists (substances such as
By reporting side effects you can help provide
L-dopa, bromocriptine);
more information on the safety of this medicine.
- neuroleptics (substances used in the treatment
of mental disorders);
5. How to store Memantine oral solution
- oral anticoagulants.
Keep this medicine out of the sight and reach of
If you go into hospital, let your doctor know that children.
you are taking Memantine oral solution
Do not use Memantine oral solution after the
Memantine oral solution with food and drink
expiry date which is stated on the carton and the
Inform your doctor if you have recently changed bottle label after EXP. The expiry date refers to
or intend to change your diet substantially (e.g.
the last day of that month.
from normal diet to strict vegetarian diet) or if
Do not store above 30 °C.
you are suffering from states of renal tubulary
Once opened, the contents of the bottle should be
acidosis (RTA, an excess of acid-forming
used within 3 months.
substances in the blood due to renal dysfunction
The bottle with the mounted pump must be kept
(poor kidney function) or severe infections of
and transported in an upright position only.
the urinary tract (structure that carries urine), as
Do not throw away medicines via wastewater or
your doctor may need to adjust the dose of your
household waste. Ask your pharmacist how to
medicine.
throw away medicines you no longer use. These
Pregnancy and breast-feeding
measures will help protect the environment.
Ask your doctor or pharmacist for advice before
taking any medicine.
6. Contents of the pack and other
If you are pregnant or breast-feeding, think you
information
may be pregnant or are planning to have a baby,
What Memantine oral solution contains
ask your doctor or pharmacist for advice before
• The active substance is memantine
taking any medicine.
hydrochloride. Each pump actuation delivers
The use of memantine in pregnant women is not
0.5 ml of solution which contains 5 mg of
recommended.
memantine hydrochloride which is equivalent
to 4.16 mg memantine.
Women taking Memantine oral solution should
• The other ingredients are potassium sorbate,
not breast-feed.
sorbitol, hydrochloric acid for pH adjustment
Driving and using machines
and purified water.
Your doctor will tell you whether your illness
What
Memantine oral solution looks like and
allows you to drive and to use machines safely.
contents of the pack
Also, Memantine oral solution may change your
Memantine oral solution is presented as a clear,
reactivity, making driving or operating machinery colourless to light yellowish solution. Memantine
inappropriate.
oral solution is available in bottles of 50 ml,
Memantine oral solution contains sorbitol and 100 ml or 10 x 50 ml.
potassium
Not all pack sizes may be marketed.
This medicinal product contains sorbitol. If you
Marketing Authorisation Holder
have been told by your doctor that you have an
Glenmark Pharmaceuticals Europe Limited
intolerance to some sugars, contact your doctor
Laxmi House, 2B Draycott Avenue
before taking this medicinal product. Your doctor
Kenton, Middlesex, HA3 0BU
will advise you. Furthermore, this medicine
United Kingdom
contains potassium, less than 1 mmol (39 mg) per
Manufacturer
dose, that is, essentially potassium-free.
ONE PHARMA S.A.
60th km. N.N.R Athinon-Lamias
3. How to take Memantine oral solution
Sximatari Voiotias, 32009
Always take Memantine oral solution exactly as
Greece
your doctor has told you. Check with your doctor
This leaflet was last revised in 06/2015
or pharmacist if you are not sure.

2. Mounting the dosing pump on the bottle:
Take the dosing pump out of the plastic bag (figure 2) and place it on top of the bottle. Slide the
plastic dip tube carefully into the bottle. Hold the dosing pump onto the neck of the bottle and screw
it clockwise until it fits firmly (figure 3). The dosing pump is only screwed on once when starting the
use, and should never be unscrewed.
Figure 2


Figure 3

3. How the dosing pump works:
The dosing pump head has two positions and is easy to turn:
- anticlockwise to unlock and
- clockwise to lock.
The dosing pump head should not be pushed down while in the locked position. The solution may only
be dispensed in the unlocked position. To unlock, turn the pump head in the direction of the arrow
until it cannot be turned any further (figure 4). The dosing pump is then ready for use.
Figure 4

4. Preparing the dosing pump:
When used for the first time, the dosing pump does not dispense the correct amount of oral solution.
Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely
six times in succession (figure 5).
Figure 5

The solution thus dispensed is discarded. The next time the dosing pump head is pushed downwards
completely (equivalent to one pump actuation), it dispenses the correct dose (figure 6).
Figure 6

5. Correct use of the dosing pump:
Hold the bottle in a slightly tilted position.
Hold a glass with a little water or a spoon below the nozzle. Push down the dosing pump head in a firm
but calm and steady manner - not too slowly (figure 7, figure 8).
Figure 7

Figure 8

The dosing pump head can then be released and is ready for the next pump actuation.
The dosing pump must only be used with the Memantine oral solution in the bottle provided, not
for other substances or containers. If the pump does not function properly, consult your doctor or a
pharmacist. Lock the dosing pump after using Memantine oral solution.

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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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