What Artesun-Plus contains
Artesunate (INN) 25.00mg; Amodiaquine (INN) 67.50mg (in the form of amodiaquine hydrochloride 88.16mg
Artesunate (INN) 50.00mg; Amodiaquine (INN) 135.00mg (in the form of amodiaquine hydrochloride 176.32mg)
Artesunate (INN) 100.00mg; Amodiaquine (INN) 270.00mg (in the form of amodiaquine hydrochloride 352.64mg)
What Artesun-Plus looks like and contents of the pack
Artesun-Plus is a round bilayer tablet: one layer is yellow coloured, the other one is white to slightly yellow.
Artesun-Plus 25mg/67.5mg is engraved on the white side with “25”
Artesun-Plus 50mg/135mg is engraved on the white side with “50”
Artesun-Plus 100mg/270mg is engraved on the white side with “100”
Artesun-Plus 25mg/67.5mg and Artesun-PIus 50mg/135mg are presented in blister pack of 3 tablets.
Artesun-Plus 100mg/270mg is presented in blister pack of 3 and 6 tablets.
WHAT Artesun-Plus IS AND WHAT IT IS USED FOR
Artesun-PIus belongs to a group of antimalarials, are used for the treatment of malaria infections in adults and children, especially used in the treatment of malaria caused by resistant strain of plasmodium falciparum against other anti-malarial drug. Patients with uncomplicated malaria who can still swallow their medicines.
Artesun-Plus reduces the number of malaria parasites in your body. Your doctor has, therefore, prescribed Artesun-Plus to treat this malaria infection. It is important that you complete the prescribed dose as advised by your doctor or pharmacist.
Before you take Artesun-Plus
Do not take Artesun-Plus:
• Patients with known hypersensitivity to artesunate, amodiaquine and related derivatives or to any of the excipients.
• Patients with history of hepatic and/or haematological impairment during treatment with amodiaquine.
• Patients with retinopathy (in case of frequent treatment).
If you are not sure, ask your doctor.
Take special care with Artesun-Plus
This medicine may cause liver and/or blood impairment sometimes fatal. In case of marked weakness and gastrointestinal disturbances, nausea, vomiting, abdominal pain, in case of jaundice (dark urine, pale bowel motions); in case of sore throat or mouth ulcers, stop the treatment and consult a doctor immediately, your doctor maybe need to take 1 blood sample.
Because caution should be exercised in some patients, it is important to inform your doctor if you have, or have ever had, any of the following:
– a problem with your heart rhythm or any other heart problem
– a family history of heart rhythm problem or sudden death
– low levels of potassium or magnesium in your blood
– problems with your liver or kidneys
If in doubt, do not hesitate to ask the advice of your doctor or pharmacist.
Pregnancy and breast feeding
Artesun-Plus should not be used during pregnancy unless clearly necessary. Artesun-Plus should not be used in breast-feeding women.
Generally, during pregnancy and breastfeeding, you should always ask the advice of your doctor or pharmacist before using any drug.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Patients receiving Artesun-Plus should be warned that undesirable effects such as dizziness and visual disorders may occur in which case they should not drive or use machines.
Taking other medicines
Antacids containing products, e.g. magnesium trisilicate and kaolin are known to decrease the gastrointestinal absorption of amodiaquine when administered simultaneously.
The incidence of hepatic and haematological events is higher, when amodiaquine is combined with other drugs with potential for liver and/or haematological toxicity.
How to take Artesun-Plus
Always take Artesun-Plus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dosage should be adjusted in accordance with the patient’s weight, i.e. 2 to 10mg of artesunate per kg of body weight and 7.5 to 15 mg of amodiaquine per kg of body weight once daily for 3 days. The dosage should be adjusted in accordance with the patient’s age as listed in the following table:
|Weight range (approximately age range)||Product||1st day of treatment||2nd day of treatment||3rd day of treatment|
|≥ 4.5kg to <9kg (2 to 11 months)||Artesun-PIus 25mg/67.5mg Blisters of 3 tablets||1 tablet||1 tablet||1 tablet|
|≥ 9kg to < 18kg (1 to 5 years)||Artesun-PIus 50mg/135mg Blisters of 3 tablets||1 tablet||1 tablet||1 tablet|
|≥ 18 kg to < 36kg (8 to 13 years)||Artesun-Plus 100mg/270mg Blisters of 3 tablets||1 tablet||1 tablet||1 tablet|
|≥ 36kg (14years and above)||Artesun-Plus 100mg/270mg Blisters of 6 tablets||2 tablets||2 tablets||2 tablets|
Method and route of administration
The tablets should be swallowed with water and taken after a meal. For very young children, the tablets should be crushed and given with water.
If you vomit within a half-hour of taking tablets, take another tablet as soon as you can. Then, contact your doctor for a prescription for more tablets. Tell your doctor if you keep vomiting
Frequency and time of administration
One intake daily.
If you take more Artesun-Plus than you should
• The usual symptoms of an overdose are headache,, vertigo and vomiting; the more severe manifestations including cardiac arrhythmias, convulsion and coma, after prolonged use (not recommended, see above) of high doses and retinopathy may occur.
Tell your doctor immediately or go to your nearest casualty department. Remember to take your medicine with you, even if it is empty, and show it to your doctor or the staff in the casualty department.
If you forget to take Artesun-Plus
Take your tablets as soon as you remember. Then go on as before; i.e. take the next dose after the recommended time interval. Do not take a double dose to make up for forgotten individual doses.
Possible side effects
Like all medicines, Artesun-Plus can cause side effects, although not everybody gets them.
Undesirable effects may be linked to amodiaquine: potentially severe disturbances of liver function -abnormal blood count (decrease of white blood cells) – itching, rashes, slate-grey pigmentation, especially of the fingers and mucous membranes – gastrointestinal disturbances – eye disorders – rarely neuromyopathy (nervous system and muscles impairment).
Undesirable effects may be linked to artesunate: headache, dizziness, nausea, vomiting, abdominal pain, diarrhea, changes in laboratory tests (usually without clinical manifestation): neutropenia (decrease of a particular type of white blood cells), anemia and reticulocytes decrease (decrease of red blood cells), and transaminases increase (liver enzymes).
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Storing your medicine
• Do not use Artesun-Plus after the expiry date which is stated on the blister and the outer packaging.
• Keep your tablets in their original packaging and do not store above 30oC.
• Keep out of reach and sight of children.
This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same symptoms as you.
The information in this leaflet applies only to Artesun-Plus. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Who makes your medicine
Guilin Pharmaceutical Co Ltd.
No. 43 Qilidian Road, Guilin 541004, Guangxi, China.
Date of last revision: August 2012.