Riamet Dispersible Tablets contain the active ingredient Artemether and lumefantrine.
Riamet Dispersible Tablets are used to treat sudden, uncomplicated malaria caused
due to a parasite called Plasmodium falciparum. It is used in children and infants
weighing between 5kg and less than 35kg and aged between ≥ 3 months up to 12 years.
2. What should I know before I give Riamet Dispersible Tablets to my child?
Do not use if your child has ever had an allergic reaction to Riamet Dispersible Tablets
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if your child has any other medical conditions, takes any other
medicines, or is pregnant or breastfeeding.
3. What if my child is taking other medicines?
Some medicines may interfere with Riamet Dispersible Tablets and affect how it works.
4. How do I give Riamet Dispersible Tablets to my child?
Your doctor will advise your child of the appropriate dose.
Follow the instructions provided when Riamet Dispersible Tablets were prescribed,
including the number of days it should be taken.
5. What should I know while giving Riamet Dispersible Tablets?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that your child is using Riamet
Dispersible Tablets.
Tell your doctor immediately if you notice any signs of an allergic reaction in your
child.
|
Things you should not do
|
Do not stop giving this medicine suddenly to your child.
Do not exceed the dose advised by your doctor.
Do not let your child do anything that could be dangerous, as Riamet Dispersible Tablets
may cause dizziness or unusual weakness in some children.
|
Looking after the medicine
|
Store below 30°C.
Protect from moisture.
|
6. Are there any side effects?
Common side effects include headache, feeling sick, vomiting, dizziness, itching,
decreased appetite, tiredness, hives.
Active ingredients:
Artemether and lumefantrine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Riamet Dispersible Tablets.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Riamet Dispersible Tablets.
Where to find information in this leaflet:
1. Why am I giving Riamet Dispersible Tablets to my child?
Riamet Dispersible Tablets contain the active ingredients Artemether and lumefantrine. They are antimalarial medicines.
Riamet Dispersible Tablets are used to treat
sudden, uncomplicated malaria caused by a parasite called Plasmodium falciparum. It
is used
in children and infants weighing between 5kg and less than 35kg and between aged ≥
3 months up to 12 years. Malaria is an infectious disease which is spread by an infected
Anopheles mosquito. The infection is caused by a parasite, and the mosquito carries
the parasite and injects them into the bloodstream when it bites a person. Common
symptoms include fever, chills, headache, feeling sick. Riamet Dispersible Tablets
help to kill the Plasmodium falciparum parasite.
2. What should I know before I give Riamet Dispersible Tablets to my child?
Warnings
Do not use Riamet Dispersible Tablets:
If your child is allergic to Artemether and lumefantrine, or any of the ingredients
listed at the end of this leaflet. Always check the ingredients to make sure you can
use this medicine. Symptoms of an allergic reaction may include shortness of breath,
difficulty breathing, swelling of the face, lips, tongue or other parts of the body,
rash, hives.
If your child suffers from severe malaria (e.g. affecting your child's brain, kidneys,
or lungs) according to the World Health Organization definition (shown by both clinical
signs and blood tests).
If they have any heart diseases or any problems with heart function, heart rate problems.
If they have symptoms such as muscle weakness, constipation, extreme tiredness (may
indicate low potassium level) or weakness, cramps, or tremors (may indicate low level
of magnesium in blood).
Check with your doctor if your child:
has any other medical conditions, any liver or kidney problems.
takes any medicines for any other condition
has any heart problems, severe heart disease, heart rhythm problems, any family history
of heart problems.
suffers from liver or kidney problems.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if your child is pregnant.
Do not give Riamet Dispersible Tablets to your child if you think she is pregnant
or if she becomes pregnant while taking Riamet Dispersible Tablets.
Do not give Riamet Dispersible Tablets to your child during the first trimester of
pregnancy.
Do not give Riamet Dispersible Tablets to your child in the later stages of pregnancy
unless clearly indicated by your doctor. Your doctor will discuss with you the potential
risks and benefits of taking Riamet Dispersible Tablets during pregnancy.
If your daughter is taking hormonal birth control medicine, she should also use an
additional method of birth control while on treatment with Riamet Dispersible Tablets
Talk to your doctor if your child is breastfeeding.
Do not give your child Riamet Dispersible Tablets while breast-feeding. It is recommended
not to resume breastfeeding until at least four weeks after the last dose.
3. What if my child is taking other medicines?
Tell your doctor or pharmacist if your child is taking any other medicines, including
any medicines, vitamins or supplements bought without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with
Riamet Dispersible Tablets
and affect how it works.
Tell your doctor if your child takes any of the following medicines:
Any other antimalarial drugs e.g. mefloquine or quinine, halofantrine
Anti-retroviral medicines or protease inhibitors which are used to treat HIV infections
or AIDS
Do not give Riamet Dispersible Tablets to your child if they are taking any of the
following medicines:
medicines which are used to treat abnormal heartbeat problems (e.g. flecainide, metoprolol)
medicines used to treat depression or other mental illnesses (e.g. imipramine, amitriptyline,
clomipramine)
rifampicin, antibiotic used to treat leprosy or tuberculosis
medicines used to treat epilepsy (e.g carbamazepine, phenytoin)
St John's wort (Hypericum perforatum), a medicinal plant extract used to relieve some
temporary feelings of sadness or low mood.
triazole antifungal medicines (e.g. fluconazole, itraconazole)
antibiotics (e.g. macrolides, fluoroquinolones, and imidazole)
medicines used to treat stomach problems e.g. cisapride,
certain medicines used to treat swelling or allergies (e.g. non-sedating antihistaminics
such as terfenadine or astemizole)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Riamet Dispersible Tablets.
4. How do I give Riamet Dispersible Tablets to my child?
How much to give
Your doctor will advise you of the appropriate dose to give.
Follow the instructions provided when Riamet Dispersible Tablets were prescribed,
including the number of days it should be taken.
Dose for infants and children weighing 5 kg to < 35 kg, and aged ≥ 3 months up to
12 years:
The treatment consists of a total of six-doses given over a period of 60 hours (2.5
days).
The following are the recommended doses depending on your child's body weight:
5 kg to less than 15 kg: 1 tablet per dose
15 kg to less than 25 kg: 2 tablets per dose
25 kg to less than 35 kg: 3 tablets per dose.
The number of tablets per dose will be the same at each time interval.
Do not exceed the dose advised by your doctor.
Contact your doctor or pharmacist if you do not understand your dose.
When to give Riamet Dispersible Tablets
Your doctor will advise you regarding when to give Riamet Dispersible Tablets to your
child
Give your child a total of six doses (over 3 days) based on body weight as follows:
5 to < 15 kg bodyweight and ≥ 3 months:
Dose 1:
Give 1 dispersible tablet to your child as advised by your doctor as soon as possible,
after your doctor has diagnosed malaria.
Dose 2:
Give 1 tablet after 8 hours after the first dose.
Dose 3 to 6:
Give 1 tablet to your child twice daily (morning and evening) on each of the following
two days (total course comprises 6 tablets).
15 to < 25 kg bodyweight:
Dose 1:
Give 2 dispersible tablets to your child as advised by your doctor as soon as possible,
after your doctor has diagnosed malaria.
Dose 2:
Give 2 tablets again after 8 hours after the first dose.
Dose 3 to 6:
Give 2 tablets twice daily (morning and evening) on each of the following two days
(total course comprises 12 tablets).
25 to < 35 kg bodyweight & < 12 years:
Dose 1:
Give 3 dispersible tablets to your child as advised by your doctor as soon as possible,
after your doctor has diagnosed malaria.
Dose 2:
Give 3 tablets again after 8 hours after the first dose.
Dose 3 to 6:
Give 3 tablets twice daily (morning and evening) on each of the following two days
(total course comprises 18 tablets).
How to give Riamet Dispersible Tablets
Before giving Riamet Dispersible tablet(s), immediately place the tablet(s) in a drinking
glass or cup, containing a small amount of water (approximately 10 mL per tablet).
Allow the tablet(s) to disintegrate, stir it gently and give it to your child to drink.
Then, rinse the glass with an additional small amount of water (approximately 10 mL)
and give it to your child to drink completely.
The tablets should be immediately followed by food or drinks rich in fat (e.g. milk).
If your child is too unwell to eat or drink, you should still give him/her Riamet
Dispersible Tablet(s) as prescribed.
Contact your doctor or pharmacist immediately if your child vomits within one hour
of taking the dose.
If you forget to give Riamet Dispersible Tablets
Give Riamet Dispersible Tablets to your child as prescribed by your doctor. If your
child missed his/her dose at the usual time, give your child the missed dose as soon
as you remember, and then give the next dose at the usual time.
If it is almost time for the next dose, skip the dose your child has missed and give
the next dose when you are meant to.
Do not give a double dose to make up for the dose your child has missed.
If you give too many Riamet Dispersible Tablets
If you think that you have given too many Riamet Dispersible Tablets to your child,
your child may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while giving Riamet Dispersible Tablets?
Things you should do
Remember to give your child all six doses at the indicated time intervals.
Your daughter must not breast-feed whilst taking this medicine and for 4 weeks after
she has taken the last tablet.
Call your doctor straight away:
If you notice any signs of an allergic reaction in your child
If your child is too unwell to eat or drink or if the condition worsens.
If your child keeps vomiting.
Remind any doctor, dentist or pharmacist you visit that your child is using Riamet
Dispersible Tablets.
Things you should not do
Do not suddenly stop giving this medicine to your child.
Do not give Riamet Dispersible Tablets to anyone else, even if they seem to have the
same condition as your child.
Avoid giving grapefruit juice to your child during treatment.
Do not exceed the dose advised by your doctor.
Do not let your child do anything that could be dangerous, as Riamet Dispersible Tablets
may cause dizziness or unusual weakness in some children.
Laboratory tests:
Your doctor may advise you to take your child for a blood checkup e.g. monitoring
blood potassium level or suggest an ECG during treatment with Riamet Dispersible Tablets
Driving or using machines
Be careful before you drive or use any machines or tools until you know how
Riamet Dispersible Tablets affect you.
Looking after the medicine
Store below 30°C.
Protect from moisture
Follow the instructions in the carton on how to take care of your child's medicine
properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to give this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not give this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If your child does experience any side effects,
most of them are minor and temporary. However, some side effects may need medical
attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Serious side effects
|
What to do
|
Abnormal lab tests:
Stomach pain, itching, yellowing of your child's skin or eyes, light-colored stools,
feeling sick, vomiting
Fevers, chills, body aches, sore throat, coughing
Excessive bleeding or bruising
Weakness, pale skin, dizziness, shortness of breath
Heart problems:
Fast or irregular heart beats
Other Problems:
Involuntary muscle contractions, twisting or repetitive movements or abnormal postures.
Stomach problems:
Fever, fatigue, rash, weight loss, yellowing of your child's skin or eyes.
|
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if your child has any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything in your child that makes him/her
feel unwell.
Other side effects not listed here may occur in some children.
Reporting side effects
After your child has received medical advice for any side effects they experience,
you can report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
giving any of your child's medicine.
7. Product details
This medicine is only available with a doctor's prescription.
What Riamet Dispersible Tablets contain
Active ingredient
(main ingredient)
|
Artemether and lumefantrine
|
Other ingredients
(inactive ingredients)
|
Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose,
colloidal anhydrous silica and polysorbate 80, sodium saccharin and cherry flavour
|
Potential allergens
|
Sugars and latex (in trace amounts)
|
Do not give this medicine if your child is allergic to any of these ingredients.
What Riamet Dispersible Tablets look like
Riamet Dispersible Tablets (20 mg/120 mg) are flat, yellow, round, uncoated tablets
with bevelled edges; imprinted with “CD” on one side and “NVR” on the other side.
Blister packs containing 6*, 12*, 18, 180*, 360*, 540* dispersible tablets.
*Not all presentations may be available.
Australian Registration Number:
Riamet 20 mg/120 mg Dispersible tablets: AUST R 158523
Who distributes Riamet Dispersible Tablets
Riamet Dispersible tablets are supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1800 671 203
®= Registered Trademark
This leaflet was prepared in August 2025.
Internal document code:
riaDT240620c_V2 based on PI ria240620i