20 mg / 120 mg tablets
artemeter and lumefantrine
What Riamet is and what it is used for
Riamet is used only for the treatment of acute, uncomplicated malaria infection caused by the parasite “Plasmodium falciparum”. This parasite is a small organism that consists of a single cell and is found inside the red blood cells.
Riamet is used to treat adults, children, and infants weighing at least 5 kg.
Riamet is not used to prevent malaria or to treat severe malaria (when the brain, lungs, or kidneys are affected).
Riamet contains two substances, artemether, and lumefantrine. They belong to a group of drugs called malaria drugs.
What you need to know before taking Riamet
Do not take Riamet
- if you are allergic (hypersensitive) to artemether and lumefantrine or any of the other ingredients of this medicine (listed in section 6)
- if you have a severe form of malaria infection affecting the brain, lungs, or kidneys
- if you have heart problems, such as heart rhythm disorders, slow heartbeat, or severe heart disease
- if a close relative (parents, siblings, grandparents) died suddenly due to heart problems or congenital heart defects
- if your doctor has found that you have low levels of salts in your blood, such as potassium or magnesium
- if you are taking the following medicines: flecainide, metoprolol, imipramine, amitriptyline, clomipramine, certain antibiotics ( macrolides, fluoroquinolones, imidazole), certain antifungal medicines (triazole derivatives), terfenadine, astemizole, cisapride (see also “Other medicines” and Riam) ).
- if you are taking certain medicines (see also “Other medicines and Riamet”).
If any of the above applies to you, talk to a doctor and do not take Riamet.
Warnings and cautions
Talk to your doctor or pharmacist before taking Riamet:
- if you have severe liver or kidney disease
- if you have heart problems such as QT prolongation (abnormal ECG )
- if you are infected with both the parasite Plasmodium falciparum and Plasmodium vivax
- if you have taken any other medicine to treat malaria. Some of these medicines should not be used at the same time as Riamet.
- if you are pregnant in the first 3 months of pregnancy or intend to become pregnant. Your doctor will give you another medicine as your first option.
- if you feel worse or if you can not eat or drink.
If any of the above apply to you, talk to your doctor before taking Riamet.
Other medicines and Riamet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Do not take Riamet and talk to a doctor if you are taking any of the following medicines:
- drugs for the treatment of heart rhythm disorders such as flecainide or metoprolol
- drugs for the treatment of depression such as imipramine, amitriptyline, or clomipramine
- drugs for the treatment of infections:
- rifampin is an antibiotic used to treat leprosy and tuberculosis.
- certain antibiotics: macrolides, fluoroquinolones and imidazole
- triazole derivatives, antifungal agents
- medicines to treat allergies or inflammation called ‘non-sedating antihistamines’ such as terfenadine and astemizole
- cisapride, a medicine for stomach upset.
- certain drugs for the treatment of epilepsy (such as carbamazepine, and phenytoin ).
- St. John’s wort ( Hypericum perforatum ) is a medicinal plant or extract of this medicinal plant that is used to treat, for example, depression.
Tell your doctor if you are taking:
- any other drug for the treatment of malaria
- medicines to treat HIV infection or AIDS
- a hormonal contraceptive (in this case, you should use another method of contraception).
Riamet with food and drink
Riamet should be taken with food or drink containing fats such as milk. Be careful with grapefruit juice. Consult a doctor about suitable food or drink to take with Riamet.
Pregnancy and breastfeeding
Riamet is not recommended during the first three months of pregnancy and if possible, your doctor will prescribe another medicine in the first instance. In the latter part of your pregnancy, you should use Riamet if your doctor thinks it is appropriate for you.
Your doctor will explain the possible risks of taking Riamet during pregnancy. If you are taking hormonal contraceptives, you should also use another method of contraception for about a month.
You should not breastfeed while taking Riamet. After completing the Riamet treatment, you should wait a week before starting breastfeeding again.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Riamet can make you feel sleepy, dizzy, or generally weak. If this applies to you, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Riamet contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Riamet
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How to take Riamet
- take the tablets with food or drink containing fat such as milk. Consult a doctor about suitable food or drink to take with Riamet.
- if you feel unwell or are too ill to eat and drink consult a doctor.
- if you vomit within an hour of taking the tablets, you should take a new dose. If you are not sure, talk to a doctor.
Use for children
- when dosing small children or infants, the tablets may be crushed.
When treating children, you will receive a pack of 24 tablets. Follow your doctor’s instructions carefully and use only the amount of tablets needed. Return the remaining tablets to the pharmacy.
Dosage of Riamet
- Six doses should be taken over 3 days.
- The first dose should be taken as soon as possible and the subsequent five doses should be taken 8, 24, 36, 48, and 60 hours after the first dose as described in the section below.
- When you or your child has taken the first dose, calculate the times for the subsequent doses and write them down.
- All doses must be taken at the right time for the full effect of the medicine to be achieved.
Adults and children weighing 35 kg or more
Take four tablets at each dose.
You take as follows:
- 4 tablets as soon as possible, thereafter
- 4 tablets 8 hours later, thereafter
- 4 tablets 24 hours after the first dose one, thereafter
- 4 tablets 36 hours after the first dose one, thereafter
- 4 tablets 48 hours after the first dose one and
- finally 4 tablets 60 hours after the first dose.
This means that you take a total of 24 tablets.
No special precautions or dose adjustments are required for the treatment of the elderly.
Infants and children weighing between 5 and 35 kg
The number of tablets you need to give your child depends on the weight of the child:
- For children weighing between 5 and 15 kg: give 1 tablet according to the above times. This means that your child takes a total of 6 tablets.
- For children weighing between 15 and 25 kg: give 2 tablets according to the above times. This means that your child takes a total of 12 tablets.
- For children weighing between 25 and 35 kg: give 3 tablets according to the above times. This means that your child takes a total of 18 tablets.
If the malaria infection returns
The second course of treatment with Riamet may be necessary if the malaria infection returns or if you become infected with “Plasmodium falciparum” again after recovering. If this happens, consult a doctor.
If you take more Riamet than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. You may need medical attention. Remember to take the medicine with you and show it to the healthcare staff. If the tablets run out, bring the empty pack.
If you forget to take Riamet
Try to avoid forgetting any dose. If you still forget to take a dose of Riamet, take it as soon as you remember if it is not time for the next dose. In this case, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Ask your doctor for advice if you are unsure.
If you stop taking Riamet
Do not stop treatment unless your doctor tells you to. Always follow your doctor’s instructions carefully and complete the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate and usually, go away after a few days to a few weeks after stopping treatment. Some side effects have been reported more frequently in children while others have been reported more often in adults. In cases where this differs, a side effect has been reported with the most frequent frequency.
Some side effects can be serious and require immediate medical attention.
Rare (may affect up to 1 in 1,000 people)
If you get a rash, swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing, contact a doctor immediately. This is a sign of an allergic reaction.
Other side effects:
Very common (may affect more than 1 in 10 people)
Rapid heart rate, headache, dizziness, cough, vomiting, abdominal pain, nausea, muscle, and joint pain, decreased appetite, general weakness/fatigue, and difficulty sleeping.
Common (may affect up to 1 in 10 people)
Involuntary muscle contractions (sometimes as rapid spasms ), cardiac arrhythmias (called prolonged QT interval ), unexplained and persistent symptoms such as nausea, stomach upset, decreased appetite or unusual tiredness or weakness (signs of liver effects), diarrhea, abnormal gait *, tingling or tingling in hands and feet *, rash or itching, insomnia.
Uncommon (may affect up to 1 in 100 people)
Difficulty coordinating movements *decreased sensitivity of the skin *, drowsiness, itchy rash.
Has been reported (occurs in an unknown number of users)
Anemia is due to red blood cell degradation, which has been reported up to a few weeks after stopping treatment (delayed hemolytic anemia ).
*) These side effects have been reported in adults and adolescents over 12 years of age.
How to store the Riamet
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Do not use this medicine if the package is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
- The active substances in Riamet are artemether and lumefantrine.
- The other ingredients are polysorbate 80, hypromellose, microcrystalline cellulose, colloidal silica, croscarmellose sodium, and magnesium stearate.
What the medicine looks like and the contents of the pack
Riamet tablets are light yellow, round, and imprinted with “NC” on one side and “CG” on the other.
Riamet is supplied in blister packs containing 24 tablets.
Marketing Authorization Holder and Manufacturer
Novartis Sverige AB
164 28 Kista