The active ingredient is artesunate. GARSUN is used for the treatment of severe malaria infections caused by a parasite called “Plasmodium falciparum” in adults and children.
1. What GARSUN is and what it is used for
2. What you need to know before the use of GARSUN
You should not be given GARSUN:
If you are allergic (hypersensitive) to artesunate or any of the other ingredients of GARSUN (listed in section 6).
Your doctor or healthcare professional will check and confirm whether:
- you are infected with “Plasmodium falciparum” before giving the injection.
GARSUN has not been tested in the treatment of malaria caused by other malarial parasites.
Warnings and precautions
Special care should be taken with GARSUN:
- after intravenous or intramuscular treatment of the critical phase of the falciparum malaria infection, you will need to take oral medication to complete the treatment and avoid relapse
- your doctor should choose the correct antimalarial regimen in order to prevent resistance
- a reduction of red blood cells within the first month after therapy with GARSUN has been reported, particularly in small children and travellers. The healthcare provider may therefore monitor your blood count in the first weeks after malaria therapy.
Other medicines and GARSUN
Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines).
Pregnancy and breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving GARSUN. Severe malaria is especially hazardous during pregnancy, therefore full dose parenteral GARSUN treatment should be administered at any stage of pregnancy without delay. If you want to breastfeed talk to your doctor first. GARSUN is present in your breast milk. The medicine levels are not expected to cause any adverse effects in breastfed infants. The amount of medicine present in breast milk does not protect the infant from malaria.
3. How to use GARSUN
Do not share medicines prescribed for you with any other person. GARSUN will be given to you by a person who is qualified to do so. Your doctor will prescribe the dose that you should take. GARSUN is injected in a vein or intramuscularly (into a muscle). You will receive three injections within 24 hours, then once daily if necessary. As soon as you are able to swallow medication, your doctor will stop the GARSUN injection and prescribe another antimalarial treatment course.
If you have the impression that the effect of GARSUN is too strong or too weak, talk to your doctor.
If you receive more GARSUN than you should
Since a healthcare professional will administer GARSUN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.
If you missed a dose of GARSUN
Since a healthcare professional will administer GARSUN, he/she will control the frequency with which you receive the injections. If you missed a dose of GARSUN, tell your doctor immediately.
4. Possible side effects
GARSUN can have side effects. Not all side effects reported for GARSUN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GARSUN, please consult your healthcare provider for advice.
If any of the following happens, stop using GARSUN and tell your doctor immediately or go to the casualty department at your nearest hospital:
- rash or hives,
- difficulty breathing,
- chest tightness,
- swelling of the face, lips, tongue or throat.
These are all very serious side effects. If you have them, you may have had a serious reaction to GARSUN. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following:
Frequent side effects:
- anaemia (low red blood cells) may occur within one month after treatment. It has been reported especially in young children and in travellers. If you feel excessively tired, weak or short of breath up to 4 weeks after treatment, inform your doctor or healthcare provider
- dizziness
- light-headedness
- headache
- trouble with sleeping
- ringing in ears
- convulsions
- cough
- nasal symptoms
- rash
- taste alteration (metallic/bitter taste)
- nausea and vomiting
- abdominal pain or cramps
- diarrhoea
- anorexia
- hair loss
- muscle pain, joint pain
- pain at the injection site
- feeling weak or tired
- fever
Less frequent side effects:
- neutropenia (low white blood cell count), reduction in platelets (which are important for blood clotting)
- an abnormal decrease of new, immature red blood cells, decrease of red blood cells in a complete blood count
- hypersensitivity
- pins and needles feeling in hands and feet
- heart rhythm problems (slow or irregular heartbeat)
- blockage in arteries
- retinal vascular damage caused by hypertension
- inflammation of the pancreas (pancreatitis)
- increased liver enzymes
- inflammation of the liver (hepatitis, with yellowing of eyes and skin)
- blockage by a gallstone or by a substance known as biliary sludge of the main opening to the gallbladder, called the cystic duct
- loss of balance or coordination
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. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of GARSUN.
5. How to store GARSUN
Storage conditions for GARSUN prior to reconstitution: Store all medicines out of reach of children. Store GARSUN at or below 30 °C. Keep the vial and the ampoules in the outer carton until required for use. Do not use GARSUN after the expiry date printed on the vial or outer carton.
Storage conditions for GARSUN after reconstitution: After reconstitution, the injection should preferably be used immediately. However, the doctor may store the reconstituted solution at room temperature up to 30 °C for 1 hour. If the doctor has not used GARSUN within 1 hour after reconstitution, the solution must be thrown away.
Disposal
GARSUN should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of GARSUN no longer required. These measures will help to protect the environment.