Skip to Content

UK Edition. Click here for US version.

MEMANTINE SANDOZ 10 MG/ML ORAL SOLUTION

Active substance(s): MEMANTINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
SZ00000LT000

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantine 10 mg/ml Oral Solution
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 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

1

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.

What Memantine Oral Solution is and what
it is used for

How does Memantine Oral Solution work
Memantine Oral Solution 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 Oral Solution belongs to a group of medicines
called NMDA-receptor antagonists. Memantine Oral Solution
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 Oral Solution in pregnant women is not
recommended.

Women taking Memantine Oral Solution should not
breast-feed.

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

2

Driving and using machines
Your doctor will tell you whether your illness allows you to
drive and to use machines safely. Also, Memantine Oral
Solution may change your reactivity, making driving or
operating machinery inappropriate.

What you need to know before you take
Memantine Oral Solution

Memantine Oral Solution contains sorbitol (E420).
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.

Do not take Memantine Oral Solution
• if you are allergic to memantine hydrochloride or any of the
other ingredients of this medicine (listed in section 6).

3

Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine
Oral Solution:
• 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 Oral Solution

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

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

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:

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

Period of intake

Dosage once daily

week 2

1 ml

week 1

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 3

week 4 and beyond

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

0.5 ml
1.5 ml
2 ml

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.

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

Administration

In particular, Memantine Oral Solution 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 Oral Solution 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.

Instructions for use
Read these instructions carefully so that you know how to use
this medicine.

The medicine-kit consists of three parts:
• a bottle containing solution
• a plastic adapter, connected to
• a 2 ml oral syringe, with 0.5 ml graduations

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

Memantine Oral Solution 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

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

Before the first use
Hold the open bottle upright on a table. Remove the plastic
adapter from the oral syringe and push it firmly into the neck
of the bottle, as far as you can. The adapter must be kept in
the bottle until the last dose is withdrawn. To dispense a dose,
please follow all instructions in "Preparing a dose" up to
"Cleaning".

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

HH

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

Preparing a dose
Turn the cap to open the bottle. Check the plunger is fully
down inside the barrel of the oral syringe.
Keep the bottle upright and insert the oral syringe firmly into
the plastic adapter, as shown in the picture.

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

Withdrawing the dose
Hold the oral syringe in place and carefully turn the bottle
upside down. Slowly pull the plunger of the syringe down fully
so that the oral syringe fills with solution. Push the plunger
back up completely to expel any large air bubbles that may be
trapped inside the oral syringe.

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 carton and the bottle label after “EXP”. The expiry date
refers to the last day of that month.
Once opened, the contents of the bottle should be used within
6 months.

Slowly pull the plunger down until the barrel ring reaches the
mark corresponding to the number of milliliters or milligrams
you need to take (0.5 ml = 5 mg, 1 ml = 10 mg,
1.5 ml = 15 mg, 2 ml = 20 mg).

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

Carefully turn the bottle the right way up. Disconnect the oral
syringe by gently twisting it out of the plastic adapter.

Contents of the pack and other information

What Memantine Oral Solution contains
The active substance is memantine.
Each ml of memantine oral solution contains 10 mg
memantine hydrochloride which is equivalent to 8.31 mg
memantine.

Administering the dose
The solution can be swallowed directly from the oral syringe.
The patient must be sitting upright and the plunger must be
pushed slowly to allow the patient to swallow.

The other ingredients are potassium sorbate, sorbitol liquid
(non crystallising) (E420), sodium hydroxide (for pH
adjustment), hydrochloride acid (for pH adjustment) and
purified water.

Alternatively, the dose can be mixed in a small glass of water
just prior to administration. Stir and drink the entire mixture
right away.

What Memantine Oral Solution looks like and contents of
the pack
Memantine 10 mg/ml Oral Solution is a colourless and clear
solution.

This medicine is available in amber glass bottles type III
containing 20 ml, 50 ml or 100 ml of oral solution. The bottles
are closed with HDPE screw cap with tamper-evident ring and
packed in a carton box together with an oral syringe (LDPE
and PS) connected to a press-in bottle adapter (LDPE). The
oral syringe has a main graduation in steps of 0.5 ml and 5 mg
(0.5, 1, 1.5 2 ml respectively 5, 10, 15, 20 mg) and a fine
graduation in steps of 0.1 ml (= 1 mg).

The oral solution can be taken with or without food.
Replace the cap after use, leaving the adapter in place.

Cleaning
After use, wipe the outside of the oral syringe with a dry, clean
tissue.

Not all pack sizes may be marketed.

Duration of treatment

Marketing Authorisation Holder and Manufacturer

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

If you take more Memantine Oral Solution than you
should
• In general, taking too much Memantine Oral Solution 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 Oral Solution,
contact your doctor or get medical advice, as you may need
medical attention.
If you forget to take Memantine Oral Solution
• If you find you have forgotten to take your dose of
Memantine Oral Solution, wait and take your next dose at
the usual time.
• Do not take a double dose to make up for a forgotten dose.

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

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

or

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

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

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

4

How to store Memantine Oral Solution

or

Possible side effects

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

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

or

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

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

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

This leaflet was last revised in 05/2013.

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

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