KROMAFINA Tablet

by | Jun 14, 2021

KROMAFINA 4 mg and 8 mg Film Coated Tablet

Ondansetron (as hydrochloride dihydrate)

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, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Kromafina is and what it is used for.

2. Before you use Kromafina.

3. How to use Kromafina.

4. Possible side effects.

5 How to store Kromafina.

6. Further information.

1. What Kromafina is and what it is used for.

Kromafina contain a medicine called ondansetron. This belongs to a group of medicines called anti-emetics.

Kromafina is used for:

· preventing nausea and vomiting caused by chemotherapy (in adults and children) or

   radiotherapy for cancer (adults only).

· 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. What you need to know before you use Kromafina

Do not use Kromafina:

  • If you are allergic (hypersensitive) to ondansetron or any of the other ingredients of this medicine (listed in section 6).
  •  you are taking apomorphine (used to treat Parkinson’s disease).

If you are not sure, talk to your doctor, nurse or pharmacist before taking Kromafina.

Warnings and precautions

Check with your doctor, nurse or pharmacist before taking Kromafina if:

  • you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles).
  • you have an uneven heart beat (arrhythmias).
  • you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron.
  • you have liver problems.
  • you have a blockage in your gut.
  • you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before taking Kromafina.  

Other medicines and Kromafina

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Kromafina can affect the way some medicines work. Also some other medicines can affect the way Kromafina 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.
  • 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.
  • tramadol, a pain killer.
  • 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 Kromafina.

Pregnancy, breast feeding

Do not use during the first trimester of pregnancy after discuss with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Kromafina can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Kromafina. If you are a woman of childbearing potential, you may be advised to use effective contraception.

Do not breast-feed if you are taking Kromafina. This is because small amounts pass into the mother’s milk. Ask your doctor or midwife for advice.

Important information about some of the ingredients of Kromafina

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking this medicine.

3. How to use Kromafina

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose you have been prescribed will depend on the treatment you are having.

To prevent nausea and vomiting from chemotherapy or radiotherapy

On the day of chemotherapy or radiotherapy

  • the usual adult dose is 8 mg taken one to two hours before treatment and another 8 mg twelve hours after.

On the following days.

  • the usual adult dose is 8mg 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.

  • the usual dose for a child is up to one 4mg 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 16mg 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.

Kromafina 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 Kromafina than the label says.

If you continue to feel sick, tell your doctor or nurse.

If you take more Kromafina than you should

If you or your child take more Kromafina than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Kromafina

If you miss a dose and feel sick or vomit:

  • take Kromafina as soon as possible, then
  • take your next dose at the usual time (as shown on the label)
  • do not take a double dose to make up for a forgotten dose.

If you miss a dose but do not feel sick

  • take the next dose as shown on the label
  • do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Kromafina can cause 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 (may affect more than 1 in 10 people)

  • headache.

Common (may affect up to 1 in 10 people)

  • a feeling of warmth or flushing
  • constipation
  • changes to liver function test results (if you take Kromafina with a medicine called cisplatin, otherwise this side effect is uncommon).

Uncommon (may affect up to 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 (may affect up to 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 (may affect up to 1 in 10,000 people)

  • poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

5. How to store Kromafina

  • 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 bottle after ‘EXP’. The expiry date refers to the last day of that month.
  • Store below 30°C.
  • Do not refrigerate. Keep the bottle upright.
  • 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. Further information

        What Kromafina contains:  

  • The active ingredient is ondansetron. Each Zofran tablet contains ondansetron 4 mg or 8 mg.
  • The other ingredients are:

lactose, microcrystalline cellulose, pre-gelatinised maize starch, magnesium stearate, colloidal silicon dioxide, purified water and coated by yellow Opadry.        

What Kromafina film Coated Tablet looks like and contents of the pack:

  • Kromafina tablets are yellow, oblong, film coated tablets and come in two strengths.
  • The 4 mg tablets contain 4 mg of the active ingredient ondansetron and are marked with “JS13” on one face and plain on the other.
  • The 8 mg tablets contain 8 mg of the active ingredient ondansetron and are marked with “JS18” on one face and plain on the other.
  • Kromafina tablets come in:

blister packs of 10 tablets for each strength.

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