Emistop 8 mg Solution

EMISTOP contains the active substance ondansetron, which belongs to a group of medicines called anti-emetics. 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.

EMISTOP should not be administered: Tell your doctor or healthcare professional before being given the injection if:

• if you are hypersensitive (allergic) to ondansetron or any of the other ingredients of EMISTOP (see section 6)
• if you are pregnant (see Pregnancy, breastfeeding and fertility)
• during the first 12 weeks of your pregnancy
• if you have congenital long QT syndrome, which is seen on an electrocardiogram (ECG), an electrical recording of the heart operated by your healthcare provider
• if you are taking medicine called apomorphine which is used for treatment of Parkinson's disease.

Warnings and precautions

Tell your doctor or healthcare professional before being given the injection:

• if you or your child has liver problems, as it may take longer for EMISTOP to be excreted, in this case, your doctor will give you the correct dose for your condition
• if you have had abnormal levels of electrolytes such as magnesium or potassium in your body, this may have symptoms such as, muscle weakness that can result in paralysis, respiratory failure, low blood pressure, muscle twitching, cramping during exercise and convulsions. EMISTOP may prolong your QT interval, which is seen on an electrocardiogram (ECG) performed by your healthcare provider, due to abnormalities in your heart rhythm. Your healthcare provider will take special precautions when giving you EMISTOP
• if you have signs of intestinal obstruction (blockage) – you will need to be monitored as EMISTOP is known to delay the time it takes for ingested food to travel through the human gut
• if you have dysrhythmias or cardiac conduction disorders (heartbeat disorders) or are being treated with antidysrhythmic (for irregular heartbeat)
• if you, after administration of EMISTOP, suddenly feel chest pain or tightness of the chest, shortness of breath, sweating and you have a rapid heartbeat
• if you are taking other serotogenic medicines (medicines that are used to treat altered mental status, involuntary nervous system and neuromuscular abnormalities) as they may affect your mental health
• if you had tonsil surgery, using EMISTOP to stop vomiting and nausea may cause invisible bleeding
• if you or your child have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
• if you or your child are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
• if you are within the first 12 weeks of pregnancy, as EMISTOP increases the risk of your baby developing oral cleft palate and/or lip (openings or splits in the upper lip, the roof of the mouth or both).

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.

To prevent nausea and vomiting from chemotherapy or radiotherapy

Adults: On the day of chemotherapy or radiotherapy the recommended adult dose is 8 mg given by a slow injection into your vein or muscle, just before your treatment, and another 8 mg twelve hours later. The usual adult intravenous dose does not exceed 8 mg. On the following days, if your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you or your child may be given more than the usual dose of EMISTOP. Your doctor will decide this.

Children and adolescents: The doctor will decide the dose based on the child’s weight or size (body surface area). On the day of chemotherapy, the first dose is given by a slow injection into the vein, just before your child’s treatment. On the following days oral dosing can commence twelve hours after the last intravenous dose and may be continued for up to 5 days.

To prevent and treat nausea and vomiting after an operation

Adults: The usual dose for adults is 4 mg given by a slow injection into your vein or an injection into your muscle. For prevention this will be given just before your operation.

Children: Your doctor will decide on the dose to be given. The maximum dose is 4 mg given as a slow injection into the vein. For prevention this will be given just before your operation.

Patients with moderate or severe liver problems: The total daily dose should not be more than 8 mg. Your doctor will tell you how long your treatment with EMISTOP will last. If you have the impression that the effect of EMISTOP is too strong or too weak, tell your doctor or pharmacist.

If you are administered 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 overdose.

If a dose of EMISTOP is missed: Since a healthcare professional will administer EMISTOP, it is unlikely that the dose will be missed.

EMISTOP can have side effects. Not all side effects reported for EMISTOP are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using EMISTOP, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using EMISTOP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

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 or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• seizures (fits or convulsions)
• disturbance in heart rhythm, abnormally rapid heartbeat (tachycardia), uneven heartbeat, slow heartbeat
• if you suddenly feel pain in your neck, jaw, shoulder or chest or tightness of the chest, shortness of breath, sweating fast heartbeat and fatigue (myocardial ischaemia).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache
• hot flushes
• constipation, diarrhoea, stomach pain or stomach cramps
• allergic reaction around the injection site, rash.

Less frequent side effects:

• movement disorders, dizziness
• blurred vision, poor vision or temporary loss of eyesight, which usually comes back within 20 minutes
• your eyes may become fixed upwards, involuntarily (oculogyric crisis)
• low blood pressure
• hiccups, spasm of the vocal cords
• changes to liver function test results.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of EMISTOP. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Your doctor or pharmacist knows how to store EMISTOP. For single use only. Discard any unused portion. Store at or below 30 °C keep well closed. Do not refrigerate or freeze. 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. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).