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DEMOREM 4MG/5ML ORAL SOLUTION

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Patient Information Leaflet

Demorem 4mg/5ml Oral Solution
Ondansetron
Code 3145/5
This leaflet contains important information about Demorem Oral
Solution. Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your
pharmacist.
• This medicine has been prescribed for you personally and you should
not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Demorem Oral Solution is and what it is used for
2. Before you take Demorem Oral Solution
3. How to take Demorem Oral Solution
4. Possible side effects
5. How to store Demorem Oral Solution
6. Further information
1.

What Demorem Oral Solution is and what it is used for
Demorem Oral Solution contains a medicine called ondansetron. This belongs to a
group of medicines called anti-emetics.

Demorem Oral Solution is used for:
o preventing nausea and vomiting caused by chemotherapy (in adults
and children) or radiotherapy for cancer (adults only)
o preventing nausea and vomiting after surgery (adults only).
Ask your doctor, nurse or pharmacist if you would like any further explanation about
these uses.

2.

Before you take Demorem Oral Solution
♦ Do not take Demorem Oral Solution if:


you are taking apomorphine (used to treat Parkinson’s disease)



you know you are allergic (hypersensitive) to ondansetron, or to any of the other
ingredients (these are listed in section 6). Signs of an allergic reaction include: a

rash, swallowing or breathing problems, swelling of your lips, face, throat or
tongue.
♦ Take special care with Demorem Oral Solution
Check with your doctor or pharmacist before taking Demorem Oral Solution if:
o you have ever had heart problems (e.g. congestive heart failure which causes
shortness of breath and swollen ankles)
o you have an uneven heart beat (arrhythmias)
o you are allergic to medicines similar to ondansetron, such as granisetron or
palonosetron
o you have liver problems
o you have a blockage in your gut
o you have problems with the levels of salts in your blood, such as potassium,
sodium and magnesium.

Taking other medicines:
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines that you buy without a prescription and
herbal medicines. This is because Demorem Oral Solution can affect the way some
medicines work. Also some other medicines can affect the way Demorem Oral
Solution works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the
following medicines:


carbamazepine or phenytoin used to treat epilepsy



rifampicin used to treat infections such as tuberculosis (TB)



antibiotics such as erythromycin or ketoconazole



tramadol, a pain killer



anti-arrhythmic medicines used to treat an uneven heart beat



beta-blocker medicines used to treat certain heart or eye problems, anxiety or
prevent migraines



medicines that affect the heart (such as haloperidol or methadone)



cancer medicines (especially anthracyclines and trastuzumab)



SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or
anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram,
escitalopram



SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression
and/or anxiety including venlafaxine, duloxetine.

If you are not sure if any of the above applies to you, talk to your doctor, nurse or
pharmacist before having Demorem Oral Solution.
♦ Pregnancy and breast-feeding
o If you are pregnant, think may be pregnant or are trying for a baby you should
tell your doctor before you take this medicine
o if you are breast feeding or about to start breast feeding tell your doctor know
before you start taking this medicine. Demorem passes into mother’s milk and
should not be taken during breast feeding.
♦ Driving and using machinery
Demorem Oral Solution should not affect your ability to drive or operate machinery,
but if you feel faint or dizzy do not drive or operate machinery until you feel better.

3.

How to take Demorem Oral Solution
Always take Demorem Oral Solution exactly as your doctor has told you. You should
check with your doctor, nurse or pharmacist if you are not sure.

The dose you have been prescribed will depend on the treatment you are having.

Do not mix Demorem Oral Solution with anything (not even water) before
swallowing it.

To prevent nausea and vomiting from chemotherapy or radiotherapy
On the day of chemotherapy or radiotherapy


the usual adult dose is two 5ml spoonfuls taken one or two hours before
treatment and another two 5ml spoonfuls twelve hours after.

On the following days


the usual adult dose is two 5 ml spoonfuls twice a day



this may be given for up to 5 days.

Children aged over 6 months and adolescents
The doctor will decide the dose depending on the child’s size (body surface area) or
weight. Look at the label for more information.


the usual dose for a child is up to one 5 ml spoonful twice a day



this can be given for up to 5 days.

To prevent nausea and vomiting after an operation
The usual adult dose is four 5 ml spoonfuls before your operation.

Children aged over 1 month and adolescents
It is recommended that Ondansetron is given as an injection.

Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg (two 5 ml spoonfuls).
Demorem Oral Solution should start to work within one or two hours of taking a dose.

If you are sick (vomit) within one hour of taking a dose


take the same dose again



otherwise, do not take more Demorem Oral Solution than the label says.

If you continue to feel sick, tell your doctor or nurse.
♦ If you take more Demorem Oral Solution than you should
If you accidentally take an overdose of your medicine, either call your doctor straight
away, or go to your nearest hospital casualty department. Always take any remaining
medicine, the container and the label with you, so that the medicine can be identified.
♦ If you forget to take a dose of Demorem Oral Solution
If you forget to take a dose of Demorem Oral Solution and feel sick or vomit, take
another dose as soon as possible and then carry on as before. If you miss a dose but do
not feel sick take the next dose as on the label.

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, Demorem Oral Solution can have side effects although not
everybody gets them.

Allergic reactions
If you have an allergic reaction, stop taking it and see a doctor straight away. The
signs may include:
• sudden wheezing and chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue
• skin rash - red spots or lumps under your skin (hives) anywhere on your body
• collapse

Other side effects include:
Very common (affects more than 1 in 10 people)
• headache

Common (affects less than 1 in 10 people)
• a feeling of warmth or flushing
• constipation
• changes to liver function test results (if you take Demorem Oral Solution with
a medicine called cisplatin, otherwise this side effect is uncommon)

Uncommon (affects less than 1 in 100 people)
• hiccups
• low blood pressure, which can make you feel faint or dizzy
• uneven heart beat
• chest pain
• fits

• unusual body movements or shaking

Rare (affects less than 1 in 1,000 people)
• feeling dizzy or light headed
• blurred vision
• disturbance in heart rhythm (sometimes causing a sudden loss of
consciousness)

Very rare (affects less than 1 in 10,000 people)
• poor vision or temporary loss of eyesight, which usually comes back within 20
minutes.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: 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 Demorem Oral Solution


Keep out of the sight and reach of children.



Store in the original bottle.



Do not use Demorem Oral Solution after 4 weeks of first opening the bottle.



Do not use Demorem Oral Solution after the expiry date which is stated on the
bottle after Exp: The expiry date refers to the last day of that month.



Medicines should not be disposed via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required.

These

measures will help to protect the environment.

6.

Further Information
Demorem 4mg/5ml Oral Solution is a clear colourless solution with a smell of
strawberries.

Each 5 ml of Demorem Oral Solution contains Ondansetron Hydrochloride Dihydrate
equivalent to 4 mg of Ondansetron as active ingredient.

It also contains the following inactive ingredients: glycerol, citric acid monohydrate,
sodium citrate, sodium benzoate, strawberry flavour and purified water.

Each bottle contains 50ml of oral solution. A double ended 5ml and 2.5ml
polypropylene spoon is also included to help measure the dose.

The Marketing Authorisation for Demorem Oral Solution is held by:
Percuro Medica Limited, Cunard Road, Park Royal, London NW10 6PN.

It is manufactured by Percuro Medica Limited, Cunard Road, Park Royal, London
NW10 6PN.

Contact us at the above address for information in large print, audio or
Braille.
This leaflet was updated in March 2015
Code 3145/5

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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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