Demorem 4mg/5ml Oral Solution
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