Description

Product Overview

WHAT ARTEMETHER IS AND WHAT IT IS USED FOR

ARTEMETHER contains two substances called ARTEMETHERand LUMEFANTRINE. They belong to a group of medicinescalled anti-malarials.

ARTEMETHER is only used for the treatment of acute uncomplicated malaria infections caused by a parasitecalled “Plasmodium falciparum”. This parasite is a tiny organism made up of one cell that is found insidered blood cells.

ARTEMETHERis used to treat adults, children and infants of 5 kg body weight and above.

ARTEMETHERis not used to prevent malaria or to treat severe malaria (where it has affected the brain, lungs orkidneys).

BEFORE YOU TAKE OR GIVE ARTEMETHER TO YOUR CHILD

Do not take ARTEMETHER
• If you are allergic (hypersensitive) to ARTEMETHER, LUMEFANTRINE, or any of the other ingredients of
ARTEMETHER 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 heartbeat, 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 ARTEMETHER.

Take special care with ARTEMETHER
Check with your doctor or pharmacist before taking ARTEMETHER:

• 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 ARTEMETHER.
• 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 ARTEMETHER.

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 ARTEMETHER.
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 ARTEMETHER with food and drink
ARTEMETHER 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 ARTEMETHER with.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or become pregnant while taking
ARTEMETHER.

ARTEMETHERmust 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 ARTEMETHER only if clearly necessary.

Your doctor will discuss with you the potential risk of taking ARTEMETHER 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 ARTEMETHER. Once you have stopped taking ARTEMETHER, 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

ARTEMETHER may make you feel sleepy, dizzy or generally weak. If this happens to you, do not drive or use any tools or machines.

HOW TO TAKE OR GIVE ARTEMETHER TO YOUR CHILD

Always take or give ARTEMETHER exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking or giving ARTEMETHER
• 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 ARTEMETHERwith.
• 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.

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 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 andwrite 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 outlinedabove. 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 outlinedabove. This means your child will take a total of 18 tablets.

If the malaria infection returns
A second course of ARTEMETHER 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 ARTEMETHER 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 ARTEMETHER
Try to make sure that you do not miss any doses. However, if you do forget a dose of ARTEMETHER, 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 ARTEMETHER
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 product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, ARTEMETHER 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 (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 heartbeat, 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.

Uncommon (affecting less than 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.
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.

HOW TO STORE ARTEMETHER

Keep out of the reach and sight of children.

Do not use ARTEMETHER 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 ARTEMETHER 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.Artermether/Lumenfantrine – Taj Dearob Pharma | ARTEMETHER contains two substances called ARTEMETHERand LUMEFANTRINE. They belong to a group of medicinescalled anti-malarials. ARTEMETHER is only used for the treatment of acute uncomplicated malaria infections caused by a parasitecalled “Plasmodium falciparum”. This parasite is a tiny organism made up of one cell that is found insidered blood cells.
Artermether/Lumenfantrine – Taj Dearob Pharma | ARTEMETHER contains two substances called ARTEMETHERand LUMEFANTRINE. They belong to a group of medicinescalled anti-malarials. ARTEMETHER is only used for the treatment of acute uncomplicated malaria infections caused by a parasitecalled “Plasmodium falciparum”. This parasite is a tiny organism made up of one cell that is found insidered blood cells.