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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 because it contains important
information for you.
– 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 only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. (See section 4).
What is in this leaflet
1. What Riamet is and what it is used for
2. What you need to know before you take Riamet
3. How to take Riamet
4. Possible side effects
5. How to store Riamet
6. Contents of the pack and other information

1. What Riamet is and what it is used for
Riamet contains two substances called artemether and

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. What you need to know before you take
Riamet
Do not take Riamet
– if you are allergic (hypersensitive) to artemether,
lumefantrine, or any of the other ingredients of this
medicine (listed in section 6).
– 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.

1618628.

– 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 “Other medicines and
Riamet”).
– if you are taking certain medicines (see also “Other
medicines and Riamet”).
If any of the above apply to you, tell your doctor without
taking Riamet.
Warnings and precautions
Talk to 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.
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.
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).

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
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.
If you are pregnant or breast-feeding, 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 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 Riamet

pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Taking 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.
Use in children
– 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.
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.

Always take this medicine exactly as your doctor or
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lumefantrine. They belong to a group of medicines called
anti-malarials.

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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 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.

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

4. Possible side effects
Like all medicines, this medicine 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.
Some side effects could be serious and need
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 in swallowing or breathing, tell your
doctor straight away. These are signs of an allergic
reaction.
Other side effects are:
Very common (may affect more than 1 in 10 people)
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 (may affect up to 1 in 10 people)
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.
Uncommon (may affect up to 1 in 100 patients)
inability to coordinate movements), decreased skin
sensitivity), sleepiness, itching rash.

) These side effects have been reported in adults and
adolescents above 12 years of age.

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 this medicine out of the sight and reach of children.
Do not use Riamet after the expiry date which is stated 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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Riamet contains
– 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 and Manufacturer
Novartis Pharmaceuticals UK Limited
Frimley Business Park, Frimley
Camberley, Surrey
GU16 7SR
United Kingdom
This leaflet was last revised in - June 2017

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