Eurartesim

Package leaflet: Information for the user

Eurartesim 160 mg/20 mg film-coated tablets

Piperaquine tetraphosphate/artemether
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Eurartesim is and what it is used for
2. What you need to know before you or your child take Eurartesim
3. How to take Eurartesim
4. Possible side effects
5. How to store Eurartesim
6. Contents of the pack and other information

1. What Eurartesim is and what it is used for

Eurartesim contains the active substances piperaquine tetraphosphate and artenimol. It is used for the treatment of uncomplicated malaria when oral therapy is appropriate.
Malaria is caused by infection with a parasite called Plasmodium and is transmitted through the bite of an infected mosquito. There are several types of Plasmodium parasites. Eurartesim kills the Plasmodium falciparum parasite.
This medicine can be taken by adults, adolescents, children and infants over 6 months of age and weighing at least 5 kilograms.

2. What you need to know before you or your child takes Eurartesim

Do not take Eurartesim if you or your child:

• are allergic to the active substances, piperaquine tetraphosphate or artesunate, or to any of the other ingredients of this medicine (listed in section 6);
• have a severe form of malaria affecting vital organs such as the brain, lungs, or kidneys;
• have a heart disorder, such as an abnormal heart rhythm or heart rate, or any other heart disease;
• know that any member of your family (parents, grandparents, siblings) died suddenly from a heart problem or was born with congenital heart defects;
• suffer from disturbances in the levels of salts in the body (electrolyte imbalance);
• are taking other medicines that may affect heart rhythm, such as:
  • quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine, or sotalol;
  • medicines used to treat depression, such as amitriptiline, fluoxetine, or sertraline;
• medicines used to treat mental health conditions, such as phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;
• medicines used to treat infections. These include certain types of antibacterial agents (macrolides [such as erythromycin or clarithromycin] and fluoroquinolones [such as moxifloxacin and sparfloxacin]), antifungal agents (including fluconazole and imidazoles), as well as pentamidine (used to treat a specific type of pneumonia) and saquinavir (used to treat HIV);
• antihistamines used to treat allergies or inflammation, such as terfenadine, astemizole, or mizolastine;
• certain medicines used to treat gastrointestinal disorders, such as cisapride, domperidone, or droperidol;
• other medicines, such as vinca alkaloids and arsenic trioxide (used to treat certain types of cancer), bepridil (used to treat angina), difemethane (used to treat stomach disorders), levometadyl and methadone (used to treat drug addiction), and probucol (used to treat high cholesterol levels in the blood).
  • have recently been treated (e.g., within the last month) for malaria with certain medicines or have taken medicines to prevent malaria. These include: mefloquine, halofantrine, lumefantrine, chloroquine, or quinine.

If you or your child fall into any of the above categories, or if you are unsure, inform your doctor or pharmacist before taking or administering Eurartesim.

Warnings and precautions

Talk to your doctor or pharmacist before taking Eurartesim if you or your child:

• have liver or kidney problems;
• have malaria caused by a parasite other than Plasmodium falciparum;
• are taking or have taken other medicines to treat malaria (other than those mentioned above);
• are in the first trimester of pregnancy or are breastfeeding (see below);
• are female, elderly (over 65 years), or experiencing vomiting;
• are taking other medicines that may cause metabolic interactions. Examples are listed in section “Other medicines and Eurartesim”;
• if, after treatment with Eurartesim, malaria infection recurs repeatedly or is not cured, your doctor may prescribe another medicine. If you have any doubts about the above points, consult your doctor or pharmacist.

Contact your doctor if, after treatment, you experience specific symptoms of serious adverse effects: pale skin, general weakness, headache, shortness of breath, rapid heartbeat—especially during physical exertion—confusion, dizziness, or dark-colored urine (for details, see section 4).

Children

This medicine must not be given to infants under 6 months of age or weighing less than 5 kg.

Other medicines and Eurartesim

Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines. Some medicines may affect the action of Eurartesim, and your doctor may decide that Eurartesim is unsuitable or that additional monitoring is required during treatment. Examples include (but are not limited to):

• certain medicines used to treat high blood cholesterol (such as atorvastatin, lovastatin, simvastatin);
• medicines used to treat high blood pressure and heart conditions (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);
• certain medicines used to treat HIV (antiretrovirals): HIV protease inhibitors (such as atazanavir, darunavir, indinavir, lopinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);
• certain medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
• medicines used to aid sleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;
• medicines used to prevent or treat epileptic seizures: barbiturates (such as phenobarbital), carbamazepine, or phenytoin;
• medicines used after organ transplantation or in autoimmune diseases (such as cyclosporine, tacrolimus);
• sex hormones, including those contained in hormonal contraceptives (such as gestodene, progesterone, estradiol), testosterone;
• glucocorticoids (hydrocortisone, dexamethasone);
• omeprazole (used to treat acid-related stomach disorders);
• paracetamol (used to treat pain and fever);
• theophylline (used to improve bronchial airflow);
• nefazodone (used to treat depression);
• aprepitant (used to treat nausea);
• certain anesthetic gases (such as enflurane, halothane, and isoflurane) used in general anesthesia.

Eurartesim with food and drink

Take Eurartesim tablets with water only. Eurartesim must not be taken with grapefruit juice due to possible interactions.

Pregnancy and breastfeeding

Inform your doctor if you are in the first trimester of pregnancy, suspect you are pregnant, are planning a pregnancy, or are breastfeeding. Based on animal data, Eurartesim is suspected to cause harm to the unborn child when administered during the first three months of pregnancy. Therefore, Eurartesim should not be used during the first trimester of pregnancy unless your doctor cannot prescribe an alternative medicine. If you discover you are pregnant within one month of taking Eurartesim, inform your doctor immediately.

Exposure to Eurartesim during the second and third trimesters of pregnancy has not been associated with harm to the unborn child. Eurartesim may be used during the second and third trimesters of pregnancy if it is considered more appropriate than other artemisinin-based combination therapies with more extensive use experience (or sulfadoxine-pyrimethamine).

You must not breastfeed while being treated with this medicine, as it may pass into breast milk and harm the baby.

If you are taking folic acid supplements to prevent possible neural tube defects, you may continue taking them during treatment with Eurartesim.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.

Driving and using machines

You may drive or operate machinery after taking Eurartesim, once you have recovered from the illness.

3. How to take Eurartesim

Always take Eurartesim exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
You or your child must take this medicine on an empty stomach. You or your child must take each dose at least 3 hours after the last intake of food, and must not eat anything else within 3 hours after each dose of Eurartesim. You or your child may drink water at any time.
If the tablets are difficult to swallow, you may crush them and mix them with water: drink the mixture immediately.
A course of Eurartesim lasts for three consecutive days. Take one dose each day. You should try to take the dose at approximately the same time each day.
The daily dose depends on the patient's body weight. Your doctor should have prescribed a dose appropriate for your weight or the weight of your child, according to the following scheme:

Vomiting during treatment with Eurartesim
If vomiting occurs within:

• 30 minutes after taking Eurartesim, the full dose should be administered again.
• 31–60 minutes, half the dose should be administered again. If you or your child vomit the second dose as well, do not take or give another dose. Contact your doctor urgently to request an alternative treatment for malaria.

Taking Eurartesim if malaria infection recurs

• If you or your child has another episode of malaria, a second course of Eurartesim may be taken within one year, if your doctor considers it appropriate. You or your child must not take more than two courses of treatment within one year. If this occurs, consult your doctor. You or your child must not take a second course of Eurartesim within 2 months following the first course.
• If you or your child is infected more than twice within one year, your doctor will prescribe an alternative treatment.

If you or your child takes more Eurartesim tablets than you should
If you or your child takes more than the recommended dose, inform your doctor. The doctor may
suggest that you or your child be closely monitored, as doses higher than recommended may have a
serious undesirable effect on the heart (see also section 4).
If you or your child forgets to take Eurartesim
If you or your child forgets to take the second dose of Eurartesim at the scheduled time, take it as soon
as you remember. Then take the third (final) dose approximately 24 hours after the second dose. If you
or your child forgets to take the third (final) dose at the scheduled time, take it as soon as you remember.
Never take more than one dose in the same day to make up for a missed dose.
If you have any doubts, consult your doctor or pharmacist.
If you or your child stops treatment with Eurartesim
For the medicine to work effectively, you or your child must take the tablets as instructed and complete the 3-day treatment course. If you or your child is unable to do so, consult your doctor or pharmacist.
If you have any questions about using 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 side effects are not serious and usually disappear within a few days or weeks after treatment.

Heart problems
During treatment with Eurartesim, and for several days after taking the last dose, a heart problem called QT prolongation may occur. This can cause a life-threatening abnormal heart rhythm. In adults and children, other heart rhythm disorders have been reported, with symptoms such as rapid heartbeat (tachycardia) and strong heartbeat that may be rapid or irregular (palpitations). The frequency of these side effects is common (may occur in up to 1 in 10 people).

In addition, in adults, irregular heart rate (sinus arrhythmia) or slow heart rate (bradycardia) have been observed. The frequency of these side effects is uncommon (may occur in up to 1 in 100 people).

If you notice any change in your heart rhythm or your child’s heart rhythm, or if symptoms such as palpitations or irregular heartbeat occur, you must contact your doctor as soon as possible and in any case before taking or administering the next dose.
Your doctor may perform a recording of the heart's electrical activity (electrocardiogram [ECG]) during treatment for you or your child and after the last dose has been administered. Your doctor will inform you about when these recordings will be performed.

Problems with red blood cells
Occasionally, after treatment for malaria, haemolytic anaemia may occur, a condition affecting blood cells called red blood cells. This condition may be delayed and may occur up to one month after using Eurartesim (delayed haemolytic anaemia). In most cases, anaemia resolves without specific treatment, but sometimes, in severe cases, blood transfusion may be necessary. Your doctor will perform regular blood tests. If autoimmune haemolytic anaemia (anaemia caused by your immune system) is suspected, these tests may include a direct antiglobulin test to determine whether treatment, for example with corticosteroids, is needed. The frequency of these side effects is not known (cannot be estimated from the available data). Contact your doctor immediately if you or your child develop one or more of the following symptoms after treatment with Eurartesim: pale skin, generalised weakness, headache, shortness of breath, rapid heartbeat—especially during physical exertion—confusion, dizziness, or dark-coloured urine.

Other side effects in adults
Common (may occur in up to 1 in 10 people)
Anaemia, headache, fever, generalised weakness.

Uncommon (may occur in up to 1 in 100 people)
Influenza, respiratory infections, decreased appetite or loss of appetite, dizziness, seizures (fits), cough, vomiting, abdominal pain, diarrhoea, nausea, inflammation or enlargement of the liver, liver cell damage, abnormal liver function tests, itching, muscle or joint pain.

Other side effects in children
Very common (may occur in more than 1 in 10 people)
Influenza, cough, fever.

Common (may occur in up to 1 in 10 people)
Respiratory infections, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), decreased appetite or loss of appetite, eye infection, abdominal pain, vomiting, diarrhoea, skin inflammation, skin rash, generalised weakness.

Uncommon (may occur in up to 1 in 100 people)
Abnormalities of red blood cells, excessive number of platelets, enlargement of certain organs (such as liver or spleen), swollen lymph glands, seizures (fits), headache, abnormal heart sounds (detected by the doctor using a stethoscope), nosebleeds, runny nose, nausea, mouth inflammation, inflammation or enlargement of the liver, jaundice, abnormal blood liver function tests, itching and skin inflammation, joint pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eurartesim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if you notice that the blister is open.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eurartesim contains
The active substances are piperaquine tetraphosphate and artenimol.
Each film-coated tablet contains 160 mg of piperaquine tetraphosphate (as tetrahydrate) and
20 mg of artenimol.
The other components are:
Tablet core: pregelatinized starch, dextrin, hypromellose (E464), sodium croscarmellose,
magnesium stearate (E572).
Film coating: hypromellose, titanium dioxide (E171), macrogol 400.
Description of the appearance of Eurartesim and pack contents
Eurartesim are white, film-coated tablets, marked and with a score line in the centre.
The 160 mg/20 mg tablets have the letters “S” and “T” on one side and are supplied in blisters
containing 3 tablets.
Marketing Authorization Holder
Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5
40133 Bologna
Italy
Tel: +39 051 6489602
Fax: +39 051 388689
E-mail: [email protected]
Manufacturer
Alfasigma S.p.A.
Via Pontina km. 30,400
00071 Pomezia (Roma)
Italy
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien
Luxembourg/Luxemburg
Alfasigma Belgium BV
Tel: 00800 78781345
[email protected]
Nederland Deutschland
Alfasigma Nederland BV Pharmore GmbH
Tel: +31 30 6702020 Tel: +49 (0) 5451 9690-0
[email protected] [email protected]
España Portugal
Alfasigma España, S.L. Alfasigma Portugal, Lda
Tel: +34 93 415 48 22 Tel: +351 217 226 110
[email protected] [email protected]
France
Alfasigma France
Tél: +33 1 45 21 0269
[email protected]
Ελλάδα
A VIPharma International A.E.
Τηλ: +30 210-6194170
[email protected]
Italy
Alfasigma S.p.A.
Tel: +39 051 6489602
[email protected]
Κύπρος
ISANGEN PHARMA CYPRUS LTD
Τηλ: +357 24-638833
[email protected]
България, Česká republika, Danmark, Eesti, Hrvatska, Ireland, Ísland, Latvija, Lietuva,
Magyarország, Malta, Norge, Österreich, Polska, România, Slovenija, Slovenská republika,
Suomi/Finland, Sverige.
Alfasigma S.p.A.
Italy, Italy, Itálie, Itàlia, Italien, Italia, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija
Tel/Tel/Tlf/Sími/Puh: +39 051 6489602
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

Package leaflet: Information for the user

Eurartesim 320 mg/40 mg film-coated tablets

Piperaquine tetraphosphate/artemether
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Eurartesim is and what it is used for
2. What you need to know before you or your child take Eurartesim
3. How to take Eurartesim
4. Possible side effects
5. How to store Eurartesim
6. Contents of the pack and other information

1. What Eurartesim is and what it is used for

Eurartesim contains the active substances piperazine tetraphosphate and artenimol. It is used to treat uncomplicated malaria, when oral therapy is appropriate.
Malaria is caused by infection with a parasite called Plasmodium, which is transmitted through the bite of an infected mosquito. There are several types of Plasmodium parasites. Eurartesim kills the parasite Plasmodium falciparum.
This medicine can be taken by adults, adolescents, children and infants aged over 6 months and weighing at least 5 kilograms.

2. What you should know before you or your child takes Eurartesim

Do not take Eurartesim if you or your child

• are allergic to the active substances, tetraflumethionate piperazine or artenimol, or to any of the other ingredients of this medicine (listed in section 6);
• have a severe form of malaria infection affecting parts of the body such as the brain, lungs, or kidneys;
• have a heart disorder, such as an abnormal heart rhythm or heart rate, or any heart disease;
• know that any member of your family (parents, grandparents, siblings) has died suddenly from a heart problem or was born with heart defects;
• suffer from disturbances in the levels of salts in the body (electrolyte imbalance);
• are taking other medicines that may affect heart rhythm, such as:
  • quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine, or sotalol;
  • medicines used to treat depression, such as amitriptyline, fluoxetine, or sertraline;
• medicines used to treat mental health conditions, such as phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;
• medicines used to treat infections. These include certain types of antibacterial agents (macrolides [such as erythromycin or clarithromycin] and fluoroquinolones [such as moxifloxacin and sparfloxacin]), antifungal agents (including fluconazole and imidazoles), as well as pentamidine (used to treat a specific type of pneumonia) and saquinavir (for the treatment of HIV);
• antihistamines used to treat allergies or inflammation, such as terfenadine, astemizole, or mizolastine;
• certain medicines used to treat stomach problems, such as cisapride, domperidone, or droperidol;
• other medicines, such as vinca alkaloids and arsenic trioxide (used to treat certain types of cancer), bepridil (used to treat angina), difemanil (used to treat stomach disorders), levomethadyl and methadone (used to treat drug addiction), and probucol (used to treat high blood cholesterol levels).
  • have recently (e.g. within the last month) been treated for malaria with certain medicines or have taken medicines to prevent malaria. These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine, or quinine.

If you or your child falls into any of the above categories or if you are unsure, inform your doctor or pharmacist before taking or administering Eurartesim.

Warnings and precautions

Talk to your doctor or pharmacist before taking Eurartesim if you or your child:

• have liver or kidney problems;
• have a malaria infection caused by a parasite other than Plasmodium falciparum;
• are taking or have taken other medicines to treat malaria (other than those mentioned above);
• are in the first trimester of pregnancy or are breastfeeding (see below);
• are female, elderly (over 65 years of age), or experiencing vomiting;
• are taking certain other medicines that may cause metabolic interactions. Examples are listed in section “Other medicines and Eurartesim”;
• if, after treatment with Eurartesim, the malaria infection recurs repeatedly or is not cured, your doctor may prescribe a different medicine. If you have any doubts about any of the points above, consult your doctor or pharmacist.

Contact your doctor if, after treatment, you experience specific symptoms of serious side effects: pale skin, generalized weakness, headache, shortness of breath, rapid heartbeat—especially during physical exertion—confusion, dizziness, or dark-colored urine (for details, see section 4).

Children

This medicine must not be given to infants under 6 months of age or weighing less than 5 kg.

Other medicines and Eurartesim

Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines. Some medicines may affect the action of Eurartesim, and your doctor may decide that Eurartesim is unsuitable or that additional monitoring is required during treatment with medicines that could cause interactions. Examples are listed below (but there are many others):

• certain medicines used to treat high blood cholesterol (such as atorvastatin, lovastatin, simvastatin);
• medicines used to treat high blood pressure and heart conditions (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);
• certain medicines used to treat HIV (antiretroviral medicines): HIV protease inhibitors (such as atazanavir, darunavir, indinavir, lopinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);
• certain medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
• medicines used to promote sleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;
• medicines used to prevent or treat epileptic seizures: barbiturates (such as phenobarbital), carbamazepine, or phenytoin;
• medicines used after organ transplantation and in autoimmune diseases (such as ciclosporin, tacrolimus);
• sex hormones, including those contained in hormonal contraceptives (such as gestodene, progesterone, estradiol), testosterone;
• glucocorticoids (hydrocortisone, dexamethasone);
• omeprazole (used to treat conditions related to gastric acid production);
• paracetamol (used to treat pain and fever);
• theophylline (used to improve bronchial airflow);
• nefazodone (used to treat depression);
• aprepitant (used to treat nausea);
• certain gases (such as enflurane, halothane, and isoflurane) used in general anesthesia.

Eurartesim with food and drink

Take Eurartesim tablets with water only. Eurartesim must not be taken with grapefruit juice due to possible interactions.

Pregnancy and breastfeeding

Inform your doctor if you are in the first trimester of pregnancy, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding. Based on animal data, Eurartesim is suspected to cause harm to the unborn child when administered during the first three months of pregnancy. Therefore, Eurartesim should not be used during the first trimester of pregnancy unless your doctor can prescribe an alternative medicine. If you discover you are pregnant within one month of taking Eurartesim, inform your doctor. Exposure to Eurartesim during the second and third trimesters of pregnancy has not been associated with harm to the unborn child. If Eurartesim is considered more appropriate for a pregnant woman than other artemisinin-based combination therapies with more extensive use experience (or sulfadoxine-pyrimethamine), Eurartesim may be used during the second and third trimesters.

You must not breastfeed during treatment with this medicine, as the medicine may pass into breast milk and affect the infant.

If you are taking folic acid supplements to prevent possible neural tube defects, you may continue taking them together with Eurartesim.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.

Driving and using machines

You may drive or operate machinery after taking Eurartesim, once you have recovered from the illness.

3. How to take Eurartesim

Always take Eurartesim exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
You or your child must take this medicine on an empty stomach. You or your child must take each dose
no less than 3 hours after the last intake of food, and must not eat any food within 3 hours after each
dose of Eurartesim. You or your child may drink water at any time.
If the tablets are difficult to swallow, you may crush them and mix them with water: drink the mixture
immediately.
A course of Eurartesim lasts three consecutive days. Take one dose each day. You should try to take
the dose at approximately the same time each day for the three days.
The daily dose depends on the patient's body weight. Your doctor should have prescribed a dose
appropriate for your weight or the weight of your child, according to the following scheme:

Vomiting during treatment with Eurartesim
If vomiting occurs within:

• 30 minutes after taking Eurartesim, the full dose should be administered again.
• 31–60 minutes, half the dose should be administered again. If you or your child vomits the second dose as well, do not take or give another dose. Contact your doctor urgently to request an alternative treatment for malaria.

Taking Eurartesim if malaria infection recurs

• If you or your child has another malaria attack, a second course of Eurartesim may be taken within one year, if your doctor considers it appropriate. You or your child must not take more than two treatment courses within one year. If this occurs, consult your doctor. You or your child must not take a second course of Eurartesim within 2 months following the first course.
• If you or your child is infected more than twice in one year, your doctor will prescribe an alternative treatment.

If you or your child takes more Eurartesim tablets than you should
If you or your child takes a higher dose than recommended, inform your doctor. The doctor may
suggest that you or your child be closely monitored, as doses higher than recommended may cause
serious unwanted effects on the heart (see also section 4).
If you or your child forgets to take Eurartesim
If you or your child forgets to take the second dose of Eurartesim at the scheduled time, take it as soon
as you remember. Then take the third (final) dose approximately 24 hours after the second dose. If you
or your child forgets to take the third (final) dose at the scheduled time, take it as soon as you remember.
Never take more than one dose on the same day to make up for a missed dose.
If you have any doubts, consult your doctor or pharmacist.
If you or your child stops treatment with Eurartesim
For the medicine to work effectively, you or your child must take the tablets as instructed and complete
the 3-day treatment course. If you or your child is unable to do so, consult your doctor or pharmacist.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are not serious and usually disappear within a few days or weeks after treatment.

Heart problems
During treatment with Eurartesim, and for several days after taking the last dose, a heart problem called QT prolongation may occur. This can lead to a potentially life-threatening abnormal heart rhythm. In adults and children, other disturbances in heart rhythm have been reported, with symptoms such as rapid heartbeat (tachycardia) and strong heartbeat that may be rapid or irregular (palpitations). The frequency of these side effects is common (may occur in up to 1 in 10 people).

Additionally, in adults, irregular heart rate (sinus arrhythmia) or slow heart rate (bradycardia) have been observed. The frequency of these side effects is uncommon (may occur in up to 1 in 100 people).

If you notice any change in your heartbeat or your child's heartbeat, or if you experience symptoms such as palpitations or irregular heartbeat, you must contact your doctor as soon as possible and before taking or administering the next dose.
Your doctor may perform an electrocardiogram (ECG) to monitor the electrical activity of the heart during treatment for you or your child and after the last dose has been administered. Your doctor will inform you when these recordings will be performed.

Problems with red blood cells
Occasionally, after treatment for malaria, haemolytic anaemia may occur, a condition affecting blood cells known as red blood cells. This condition may be delayed and may appear up to one month after using Eurartesim (delayed haemolytic anaemia). In most cases, the anaemia resolves without specific treatment, but sometimes, in severe cases, a blood transfusion may be required. Your doctor will perform regular blood tests. If autoimmune haemolytic anaemia (anaemia caused by your immune system) is suspected, these tests may include a direct antiglobulin test to determine whether treatment, for example with corticosteroids, is needed. The frequency of these side effects is unknown (cannot be estimated from the available data). Contact your doctor immediately if you or your child develop one or more of the following symptoms after treatment with Eurartesim: pale skin, generalised weakness, headache, shortness of breath, and rapid heartbeat, especially during physical exertion, confusion, dizziness, or dark-coloured urine.

Other side effects in adults
Common (may occur in up to 1 in 10 people)
Anaemia, headache, fever, generalised weakness.

Uncommon (may occur in up to 1 in 100 people)
Influenza, respiratory infections, decreased appetite or loss of appetite, dizziness, seizures (fits), cough, vomiting, abdominal pain, diarrhoea, nausea, inflammation or enlargement of the liver, liver cell damage, abnormal liver function tests, itching sensation, muscle or joint pain.

Other side effects in children
Very common (may occur in more than 1 in 10 people)
Influenza, cough, fever.

Common (may occur in up to 1 in 10 people)
Respiratory infections, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), decreased appetite or loss of appetite, eye infection, abdominal pain, vomiting, diarrhoea, skin inflammation, rash, generalised weakness.

Uncommon (may occur in up to 1 in 100 people)
Abnormalities of red blood cells, excessive number of platelets, enlargement of certain organs (such as liver or spleen), swollen lymph glands, seizures (fits), headache, abnormal heart sounds (detected by the doctor using a stethoscope), nosebleeds, runny nose, nausea, inflammation of the mouth, inflammation or enlargement of the liver, jaundice, abnormal liver function blood tests, itching, skin inflammation, joint pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eurartesim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if you notice that the blister is open.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Eurartesim Contains
The active substances are piperaquine tetraphosphate and artenimol.
Each film-coated tablet contains 320 mg of piperaquine tetraphosphate (as tetrahydrate) and 40 mg of artenimol.
The other components are:
Tablet core: pregelatinized starch, dextrin, hypromellose (E464), sodium croscarmellose, magnesium stearate (E572).
Film coating: hypromellose, titanium dioxide (E171), macrogol 400.

Description of the Appearance of Eurartesim and Contents of the Package
Eurartesim are film-coated tablets, white in colour, marked with engravings and a central breakline.
The 320 mg/40 mg tablets have two letters “σ” on one side and are supplied in blisters containing 3, 6, 9, 12, 270 or 300 tablets.

Marketing Authorization Holder
Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5
40133 Bologna
Italy
Tel: +39 051 6489602
Fax: +39 051 388689
E-mail: [email protected]

Manufacturer
Alfasigma S.p.A.
Via Pontina km. 30,400
00071 Pomezia (Rome)
Italy

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Alfasigma Belgium BV
Tel: 00800 78781345
[email protected]

Nederland
Alfasigma Nederland BV
Tel: +31 30 6702020
[email protected]

Deutschland
Pharmore GmbH
Tel: +49 (0) 5451 9690-0
[email protected]

España
Alfasigma España, S.L.
Tel: +34 93 415 48 22
[email protected]

Portugal
Alfasigma Portugal, Lda
Tel: +351 217 226 110
[email protected]

France
Alfasigma France
Tél: +33 1 45 21 0269
[email protected]

Ελλάδα
A VIPharma International A.E.
Τηλ: +30 210-6194170
[email protected]

Italy
Alfasigma S.p.A.
Tel: +39 051 6489602
[email protected]

Κύπρος
ISANGEN PHARMA CYPRUS LTD
Τηλ: +357 24-638833
[email protected]

България, Česká republika, Danmark, Eesti, Hrvatska, Ireland, Ísland, Latvija, Lietuva,
Magyarország, Malta, Norge, Österreich, Polska, România, Slovenija, Slovenská republika,
Suomi/Finland, Sverige
Alfasigma S.p.A.
Italy, Italia, Itälia, Itálie, Italien, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija
Teл/Tel/Tlf/Sími/Puh: +39 051 6489602
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.