General

Together we can change “illness” into “wellness.”

Anti Nausea Medication

5-HT3 Receptor Antagonists

EmistopLogo-RGB

SCHEDULING STATUS: S4

PROPRIETARY NAME AND DOSAGE FORM
EMISTOP 4 mg (solution for injection)
EMISTOP 8 mg (solution for injection)

Please read this patient information leaflet carefully before EMISTOP is administered to you.

  • Keep this information. You may need to read it again.
  • If you have any questions, please ask your doctor or pharmacist.
  • EMISTOP has been prescribed for you and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

WHAT EMISTOP CONTAINS

EMISTOP injection is a clear solution containing the active ingredient ondansetron (as ondansetron hydrochloride dihydrate).

Emistop 4 mg:  Each 2 ml ampoule contains ondansetron hydrochloride dihydrate equivalent to 4 mg ondansetron (2 mg/ml).

Emistop 8 mg:  Each 4 ml ampoule contains ondansetron hydrochloride dihydrate equivalent to 8 mg ondansetron (2 mg/ml).

The inactive ingredients are:  Citric acid monohydrate, nitrogen, sodium citrate, sodium chloride, water for injection.

WHAT EMISTOP IS USED FOR

EMISTOP injection is used to prevent and treat nausea and vomiting caused by chemotherapy or radiotherapy and for the prevention and treatment of nausea and vomiting after surgery.

BEFORE YOU RECEIVE EMISTOP

You should not receive EMISTOP if:

  • You are allergic to ondansetron or any of the ingredients.
  • If you have congenital long QT syndrome.
  • EMISTOP contains sodium.  If you are on a sodium controlled diet, speak to your doctor before being given this medicine.

Take special care with EMISTOP injection if:

  • You have signs of intestinal obstruction (blockage) – you will need to be monitored.
  • You have dysrhythmias or cardiac conduction disorders (heartbeat disorders) or are being treated with antidysrhythmic (for irregular heartbeat).

Pregnancy and breast-feeding:

Pregnancy:
Please tell your doctor if you are pregnant or planning to be pregnant.

Breast-feeding:
Ondansetron passes into breast milk, therefore nursing mothers should not breastfeed.

If you are pregnant or breast-feeding your baby consult your doctor, pharmacist or other healthcare professional before using EMISTOP.

Driving and using machines:
EMISTOP has no effect on your ability to drive or use machines.

Important information about some of the ingredients of EMISTOP:
EMISTOP contains sodium. This should be taken into consideration if you are on a strictly controlled salt diet.

Taking other medicines:
Please tell your healthcare professional if you are taking any other medicines. (This includes complementary or traditional medicines)

The following medicines may interact with your EMISTOP injection:

  • Phenytoin, carbamazepine (treatments for epilepsy).
  • Rifampicin (an antibiotic for treatment of tuberculosis (TB)).
  • Tramadol (painkiller).
  • Beta-blockers (medicines that slow heart rate).
  • Apomorphine (used to treat Parkinson’s disease).

HOW EMISTOP WILL BE ADMINISTERED

EMISTOP injection is for intravenous (into a vein) and intramuscular (into the muscle) use.

You will not be expected to give yourself EMISTOP. It will be given to you by a person who is qualified to do so.

Your doctor will decide on the correct dose for you based on your condition.

If you receive more EMISTOP than you should:

Since a healthcare professional will administer EMISTOP, he/she will control the dosage.  However, in the event of overdosage your doctor will manage the overdosage

POSSIBLE SIDE EFFECTS

EMISTOP can have side effects.  Serious allergic reactions may occur.  Should your general health worsen while receiving EMISTOP, please consult your doctor, pharmacist or other health care professional for advice.

Treatment with EMISTOP should be stopped immediately, should any of the following side effects occur:

  • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty breathing.
  • Serious allergic reactions including skin reactions, fever, low blood pressure (dizziness), allergic pneumonitis (cough or other lung symptoms), shock (cold, clammy skin, irregular breathing, weakness, anxiety).

These are all very serious side effects.  If you have them, you may have had a serious allergic reaction to EMISTOP.  You may need urgent medical attention.

Frequent:
Constipation, sensation of warmth or flushing, headache.

Less frequent:
Allergic reaction around the injection site, rash, itching, hiccups.

Movement disorders, dizziness, heartbeat disturbances, low blood pressure, slow heartbeat, blurred vision, severe allergic reaction.

Temporary changes in heartbeat.

Not all side effects reported for EMISTOP are included in this leaflet.  If you notice any side effect not listed, please tell your doctor or pharmacist.

STORING AND DISPOSING OF EMISTOP

Your doctor or pharmacist knows how to store EMISTOP.  Store at or below 30 °C in a dry place.  Do not refrigerate or freeze.  Store all medicines out of reach of children.

Keep ampoules in the outer carton, in order to protect from light. Do not use EMISTOP injection after the expiry date shown on the carton.  Only clear solutions, free from particles, should be used.  Do not use if ampoule is damaged.  Medicines should not be disposed of via wastewater or household waste.  Return the expired medicine to you pharmacist for safe disposal.

PRESENTATION OF EMISTOP

EMISTOP 4 mg is packed into a 2 ml clear and colourless type I glass ampoule with a blue dot.  Each ampoule contains 2 ml solution for injection.  5 ampoules are packed into an outer carton.

EMISTOP 8 mg is packed into a 5 ml clear and colourless type I glass ampoule with a blue dot.  Each ampoule contains 4 ml solution for injection.  5 ampoules are packed into an outer carton.

IDENTIFICATION OF EMISTOP

Emistop 4 mg is a clear and colourless solution, free from visible particles.

Emistop 8 mg is a clear and colourless solution, free from visible particles.

REGISTRATION NUMBERS

EMISTOP 4 mg: 45/5.10/0386

EMISTOP 8 mg: 45/5.10/0387

NAME AND ADDRESS OF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Silverwood Close,
Westlake, 7945
Cape Town, South Africa

DATE OF PUBLICATION

32 July 2014
Version: PD9026A

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