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DELOZ 10 MG/ML ORAL SOLUTION

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Package leaflet: Information for the user
Deloz 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. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Deloz is and what it is used for
2. What you need to know before you take Deloz
3. How to take Deloz
4. Possible side effects
5. How to store Deloz
6. Contents of the pack and other information
1.

What Deloz is and what it is used for

How does Deloz work
Deloz 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. Deloz belongs to a group of medicines called NMDAreceptor antagonists. Deloz acts on these NMDA-receptors improving the transmission of nerve
signals and the memory.
What is Deloz used for
Deloz is used for the treatment of patients with moderate to severeAlzheimer's disease
2. What you need to know before you take Deloz
Do not take Deloz
- 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 before taking Deloz:
- 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 Deloz
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 doses accordingly.
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.
Children and adolescents
Deloz is not recommended for children and adolescents under the age of 18 years.
Other medicines and Deloz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
In particular, Deloz 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 Deloz.
Deloz with food and drink
Inform your doctor if you have recently changed or intend to change your diet substantially (for
example 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
Ask your doctor or pharmacist for advice before taking any medicine.
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 in pregnant women is not recommended.
Women taking Deloz 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, Deloz may change your reactivity, making driving or operating machinery inappropriate.
Deloz contains sorbitol and potassium
This medicinal product contains sorbitol. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product. Your doctor will
advise you. Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, that is,
essentially potassium-free.
3.

How to take Deloz

Always take Deloz exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
Dosage
One pump actuation contains 5 mg memantine hydrochloride.
The recommended dose of Deloz 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
week 2
week 3
week 4 and beyond

one pump actuation
two pump actuations
three pump actuations
four pump actuations

The usual starting dose is one pump actuation once daily (1 x 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 (1 x 20 mg).
Dosage in patients with impaired kidney function
If you have problems with the way your kidneys work (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
Deloz 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 solution should be taken with a little water. The
solution can be taken with or without food.
For detailed instructions on the preparation and handling of the product see end of this leaflet
(“Instruction for proper use of the pump”).
Duration of treatment
Continue to take Deloz as long as it is of benefit to you. Your doctor will assess your treatment on a
regular basis.
If you take more Deloz than you should
- In general, taking too much Deloz 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 Deloz, contact your doctor or get medical advice, as you may
need medical attention.
If you forget to take Deloz
- If you find you have forgotten to take your dose of Deloz, 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 medicine, 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 1 to 10 users in 100):
· Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
shortness of breath, high blood pressure and medicine hypersensitivity
Uncommon (may affect 1 to 10 users in 1,000):
· Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and
venous blood clotting (thrombosis/thromboembolism)
Very rare (may affect less than 1 user in 10,000):
· 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 thoughts and suicide. These events
have been reported in patients treated with memantine.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.
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 Deloz
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 bottle label after
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Once opened, the contents of the bottle should be used within 3 months.
The bottle with the mounted pump must be kept and transported in an upright position only.
Do not throw away 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 Deloz contains
·
·

The active substance is memantine hydrochloride. Each pump actuation delivers 0.5 ml of
solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg
Memantine.
The other ingredients are potassium sorbate, sorbitol, hydrochloric acid for pH adjustment and
purified water.

What Deloz looks like and contents of the pack
Deloz oral solution is presented as a clear, colourless to light yellowish solution. Deloz oral solution is
available in bottles of 50 ml, 100 ml or 10 x 50 ml.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder
PHARMANELCOMMERCIALPHARMACEUTICALS.A.
106, MarathonosAve., 153 44
Gerakas,Attikis, Greece
Tel: +30 210 6048560
Fax: +30 210 6613013
E-mail: info@pharmanel.gr
Manufacturer
ONE PHARMAS.A.
60th km N.N.R.Athinon-Lamias
Sximatari Voiotias, 32009
Greece
This leaflet was last revised in 02/2014
Instruction for proper use of the pump
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.
1. Take the screw cap off the bottle:
The cap must be turned anticlockwise,
unscrewed completely and removed (figure 1).
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. Carefully slide the
plastic dip tube 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 it should
never be unscrewed.
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 can 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 1

Figure 2

Figure 3

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 a row
(figure 5). Any solution dispensed during this step
should be 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 5

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).
The dosing pump head can then be released and is
ready for the next pump actuation.

Figure 7

The dosing pump must only be used with the Deloz
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 Deloz.

Figure 8

Figure 6

Expand Transcript

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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