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RIAMET 20MG/120MG TABLETS

Active substance(s): ARTEMETHER / LUMEFANTRINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Riamet 20 mg / 120 mg tablets
®

artemether and lumefantrine

Read all of this leaflet carefully before you start
taking this medicine.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor
or pharmacist.
–– This medicine has been prescribed for you or your
child. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
–– If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Riamet is and what it is used for
2. Before you take or give Riamet to your child
3. How to take or give Riamet to your child
4. Possible side effects
5. How to store Riamet
6. Further information

1. WHAT RIAMET IS AND WHAT IT IS USED FOR
Riamet contains two substances called artemether
and lumefantrine. They belong to a group of medicines
called anti‑malarials.
Riamet is only used for the treatment of acute
uncomplicated malaria infections caused by a parasite
called “Plasmodium falciparum”. This parasite is a
tiny organism made up of one cell that is found inside
red blood cells.
Riamet is used to treat adults, children and infants of
5 kg body weight and above.
Riamet is not used to prevent malaria or to treat
severe malaria (where it has affected the brain,
lungs or kidneys).
2. BEFORE YOU TAKE OR GIVE RIAMET TO
YOUR CHILD
Do not take Riamet
–– if you are allergic (hypersensitive) to artemether,
lumefantrine, or any of the other ingredients of
Riamet listed at the end of this leaflet.
–– if you have a severe type of malaria infection where
it has affected parts of your body such as the
brain, lungs or kidneys.
–– if you have a heart condition, such as changes in
the rhythm or rate of the heart beat, a slow heart
beat, or severe heart disease.
–– if any member of your family (parents, grandparents,
brothers or sisters) has died suddenly due to a
heart problem or was born with heart problems.

–– if your doctor has told you that you have low levels
of electrolytes such as potassium or magnesium
in your blood.
–– if you are taking the following medicines: flecainide,
metoprolol, imipramine, amitriptyline, clomipramine,
certain antibiotics (macrolides, fluoroquinolones,
imidazole), triazole antifungal agents, terfenadine,
astemizole, cisapride (see also “Taking other
medicines”).
–– if you are taking certain medicines (see also
“Taking other medicines”).
If any of the above apply to you, tell your doctor
without taking Riamet.
Take special care with Riamet
Check with your doctor or pharmacist before taking
Riamet:
–– if you have severe liver or kidney problems.
–– if you have a heart disorder, such as an abnormal
electrical signal called “prolongation of
the QT interval”.
–– if you are infected with both the “Plasmodium
falciparum” and “Plasmodium vivax” parasites.
–– if you are taking or have taken any other medicines
for the treatment of malaria. Some of these
medicines must not be given together with Riamet.
–– if you are in the first 3 months of pregnancy or
intend to become pregnant. Your doctor will try to
give you an alternative medicine first.
–– if you feel worse, or if you feel too unwell to eat
and drink.

If any of these apply to you, talk to your doctor before
you take Riamet.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
In particular, do not take this medicine and tell your
doctor if you are taking any of the following:
–– medicines used to treat heart rhythm problems
such as flecainide or metoprolol.
–– medicines used to treat depression such as
imipramine, amitriptyline or clomipramine.
–– medicines used to treat infections called:
–– rifampin, an antibiotic to treat leprosy or
tuberculosis
–– antibiotics, including the following types:
macrolides, fluoroquinolones or imidazole,
–– triazole antifungal agents.
–– medicines used to treat allergies or inflammation
called “non‑sedating antihistamics” such as
terfenadine or astemizole.
–– cisapride ‑ a medicine used to treat stomach
problems.
–– certain medicines used to treat epilepsy (such as
carbamazepine, phenytoin)
–– St John’s wort (Hypericum perforatum) a medicinal
plant or extract of this medicinal plant used to
treat for example depressed mood.
If you are taking any of the above medicines, do not
take Riamet.

Please tell your doctor if you are taking:
–– any other medicines to treat malaria.
–– medicines to treat HIV infections or AIDS
–– an hormonal birth control medicine (in this
case you should follow an additional method
of birth control).
Taking Riamet with food and drink
Riamet should be taken with food or drinks rich in
fat such as milk . Grapefruit juice should be used
cautiously. Please ask your doctor for advice on the
best food or drinks to take Riamet with.
Pregnancy and breast‑feeding
Tell your doctor if you are pregnant, think you may
be pregnant or become pregnant while taking
Riamet.
Riamet must not be used during the first 3 months
of pregnancy if it is possible for the doctor to give
an alternative medicine first. In the later stages of
pregnancy, you should take Riamet only if clearly
necessary.
Your doctor will discuss with you the potential risk
of taking Riamet during pregnancy. If you are taking
hormonal birth control medicine, you should also
use an additional method of birth control for about
one month.
You should not breast‑feed while you are taking
Riamet. Once you have stopped taking Riamet,
you should wait at least 1 week before starting
to breast‑feed again.

Ask your doctor or pharmacist for advice before
taking any medicine during pregnancy or while you
are breast‑feeding.
Driving and using machines
Riamet may make you feel sleepy, dizzy or generally
weak. If this happens to you, do not drive or use any
tools or machines.

3. HOW TO TAKE OR GIVE RIAMET TO YOUR
CHILD
Always take or give Riamet exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Taking or giving Riamet
–– the tablets should be taken with food or drinks
rich in fat such as milk. Please ask your doctor for
advice on the best food or drinks to take Riamet
with.
–– if you feel worse or are too unwell to eat or drink,
please talk to your doctor.
–– if you are sick (vomit) within 1 hour of taking the
tablets take another dose. If in doubt, talk to your
doctor.
–– when given to small children or infants, the tablets
may be crushed.
When treating your child, a 24‑tablet pack will be
provided. Follow your doctor´s instructions carefully
and use only the number of tablets needed. Return
the remaining tablets to your pharmacist.
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How much to take or give
–– six doses are taken over 3 days.
–– the first dose should be taken as soon as possible
and should be followed by five further doses at 8,
24, 36, 48 and 60 hours after the first dose, as
described in the next section.
–– when you take your first dose, work out the times
you will need to take the rest of the doses at and
write them down.
–– all doses must be taken and at the right times,
to gain the full benefits of this medicine.
Adults and children weighing 35 kg and above
Take four tablets at each time interval.
So you take or give:
–– 4 tablets as soon as possible, then
–– 4 tablets 8 hours later, then
–– 4 tablets 24 hours after the first dose, then
–– 4 tablets 36 hours after the first dose, then
–– 4 tablets 48 hours after the first dose and then
–– the final 4 tablets 60 hours after the first dose.
This will mean you take or give a total of 24 tablets.
No special precautions or dosage adjustments are
considered to be necessary in elderly patients.
Infants and children weighing 5 kg to less than
35 kg
The number of tablets you need to give to your child
depends on their weight:
–– children 5 kg to less than 15 kg bodyweight: give
1 tablet at each of the time intervals outlined above.
This means your child will take a total of 6 tablets.

–– children 15 kg to less than 25 kg bodyweight:
give 2 tablets at each of the time intervals outlined
above. This means your child will take a total of
12 tablets.
–– children 25 kg to less than 35 kg bodyweight:
give 3 tablets at each of the time intervals outlined
above. This means your child will take a total of
18 tablets.

If you stop taking Riamet
Do not stop taking your medicine unless your doctor
tells you to. Always follow your doctor´s instructions
carefully, and complete the course of medication.

If the malaria infection returns
A second course of Riamet may be necessary if the
malaria infection returns, or if you are re‑infected
with the parasite “Plasmodium falciparum” after
having been cured. If this happens to you please
talk to your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Riamet can cause side effects,
although not everybody gets them.
Most of the side effects are mild to moderate and
generally disappear after a few days to a few weeks
after treatment. Some side effects are more commonly
reported in children and others are more commonly
reported in adults. In cases where there is a difference,
the frequency listed below is the more common one.

If you take more Riamet than you should
If you have accidentally taken too many tablets, talk
to your doctor straight away, or go to your nearest
emergency unit. You may require medical attention.
Remember to take your medicine with you, and show
it to your doctor or the staff of the emergency unit.
If you have run out of tablets, take the empty
packaging along with you.
If you forget to take Riamet
Try to make sure that you do not miss any doses.
However, if you do forget a dose of Riamet, take the
missed dose as soon as you remember unless it is
almost time for your next dose. Then take your next
dose at the usual time. Ask your doctor for advice.
Do not take a double dose to make up for a forgotten
dose.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Some side effects could be serious and need
immediate medical attention.
Rare (affecting less than 1 in 1,000 patients)
If you get a rash, swelling of the face, lips, tongue or
throat with difficulty in swallowing or breathing, tell
your doctor straight away. These are signs of an
allergic reaction.
Other side effects are:
Very common (affecting more than 1 in 10 patients)
Fast heart beat, headache, dizziness, cough, being
sick (vomiting), stomach pain, feeling sick (nausea),
joints or muscles aching, loss of appetite, general
weakness, tiredness, trouble with sleeping.

Common (affecting less than 1 in 10 patients)
Involuntary muscle contractions (sometimes in rapid
spasms), heart rhythm disturbances (called QTc
prolongation), Symptoms such as unexplained
persistent nausea, stomach problems, loss of
appetite or unusual tiredness or weakness (signs
of liver problems),diarrhoea, abnormal walking«),
tingling or numbness of the hands and feet«), a rash
or itching on the skin, insomnia.

on the carton. The expiry date refers to the last day of
that month.
Do not store above 30°C.
Do not use Riamet if you notice that the pack 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.

Uncommon (affecting less than 1 in 100 patients)
inability to coordinate movements«), decreased skin
sensitivity«), sleepiness, itching rash.

6. FURTHER INFORMATION
What Riamet contains

«) These

side effects have been reported in adults
and adolescents above 12 years of age.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE RIAMET
Keep out of the reach and sight of children.
Do not use Riamet after the expiry date which is stated

Manufacturer
Novartis Pharmaceuticals UK Limited
Frimley Business Park, Frimley
Camberley, Surrey
GU16 7SR
United Kingdom
This leaflet was last revised in May 2015

–– The active substances of Riamet are artemether
and lumefantrine.
–– The other ingredients are polysorbate 80,
hypromellose, microcrystalline cellulose, colloidal
anhydrous silica, croscarmellose sodium, and
magnesium stearate.
What Riamet looks like and contents of the pack
Riamet tablets are light yellow, round with the imprint
“NC” on one side and “CG” on the other side.
Riamet tablets are available in blister packs
containing 24 tablets.
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited
Frimley Business Park, Frimley
Camberley, Surrey
GU16 7SR
England
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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