Patient leaflet - Eurartesim

B. PACKAGE LEAFLET

Package leaflet: information for the user

Eurartesim 160 mg/20 mg film-coated tablets

Piperaquine tetraphosphate/artenimol

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 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 Eurartesim is and what it is used for
2. What you need to know before you or your child takes 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 to treat uncomplicated malaria when use of a medicine given by mouth is appropriate.

Malaria is caused by infection with a parasite called Plasmodium , spread by the bite of an infected mosquito.There are different types of Plasmodium parasite. Eurartesim kills the Plasmodium falciparum parasite.

The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more.

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

Do not take Eurartesim if you or your child:

is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the

other ingredients of this medicine (listed in section 6);

has a severe type of malaria infection which has affected parts of the body such as the brain,

lungs or kidneys;

has a heart condition, such as changes to the rhythm or rate of heart beat, or heart disease;
knows that any member of your family (parents, grandparents, brothers or sisters) died suddenly

due to a heart problem or was born with heart problems;

suffers from changes to the levels of salts in the body (electrolyte imbalances);
is taking other medicines that can have an effect on 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 problems such as phenothiazines, sertindole,

sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;

– medicines used to treat infections. These include some of the types of medicines used to

treat bacterial infections (macrolides [such as erythromycin or clarithromycin] and fluoroquinolones [such as moxifloxacin and sparfloxacin]) or fungal infections (including fluconazole and imidazole) as well as pentamidine (used to treat a specific type of pneumonia) and saquinavir (for 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

cancers), bepridil (used to treat angina), diphemanil (used to treat stomach disturbances), levomethadyl and methadone (used to treat drug addiction), and probucol (used to treat high blood cholesterol levels).

has recently (for example within about one month) been treated for malaria with certain

medicines or has taken certain medicines to prevent malaria. These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine

If any of the above applies to you or your child or if you are unsure, tell your doctor or pharmacist before taking or giving Eurartesim.

Warnings and precautions

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

has liver or kidney problems;
has a malaria infection caused by a parasite other than Plasmodium falciparum;
is taking or has taken any other medicines for the treatment of malaria (other than those

mentioned above);

is in the 1st trimester of pregnancy or breastfeeding (see below);
is female, elderly (over 65 years) or vomiting;
is taking certain other medicines which could cause possible metabolic interactions. Examples

are listed in the section “Other medicines and Eurartesim”;

if after treatment with Eurartesim malaria infection occurs again repeatedly or is not cured, your

doctor may prescribe another medicine.

If you are not sure about any of the above, please ask your doctor or pharmacist.

Children

Do not give this medicine to infants under 6 months or below 5 kg in weight.

Other medicines and Eurartesim

Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines. Some medicines can affect the way Eurartesim works and your doctor may decide that Eurartesim is not suitable or that extra checks are needed while you or your child is taking the medicines which could cause possible interactions. Examples are listed below (but there are several others):

– some medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin,

simvastatin);

– medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine,

nitrendipine, verapamil, felodipine, amlodipine);

– some 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);

– some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
– medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,

diazepam, alprazolam), zaleplon, zolpidem;

– medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital),

carbamazepine or phenytoin;

– medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin,

tacrolimus);

– sex hormones, including those contained in hormonal contraceptives (such as gestodene,

progesterone, estradiol), testosterone;

– glucocorticoids (hydrocortisone, dexamethasone);
– omeprazole (used to treat diseases related to gastric acid production);
– paracetamol (used to treat pain and fever);
– theophylline (used to improve bronchial air flow);
– nefazodone (used to treat depression);
– aprepitant (used to treat nausea);
– some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.

Eurartesim with food and drink

You should take the Eurartesim tablets with water only.

You should not take Eurartesim with grapefruit juice due to possible interactions.

Pregnancy and breast-feeding

Tell your doctor if you are in the 1st trimester of pregnancy, think you may be pregnant or become pregnant, or if you are breast-feeding. Based on animal data Eurartesim is suspected to harm the unborn child when used during the first three months of pregnancy. Therefore Eurartesim must not be used in the 1st trimester of pregnancy if your doctor can give you an alternative medicine. If you find out that you are pregnant within one month from taking Eurartesim, please inform your doctor. The exposure of pregnant women during the 2nd and 3rd trimester was not associated with any harm of the unborn child. If Eurartesim is more suitable for a pregnant woman than other artemisinin-based combination therapies with a higher range of experience (or sulfadoxine-pyrimethamine), Eurartesim may be used in the 2nd and 3rd trimester.

You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.

If you are taking folate supplements to prevent possible neural tube birth defects, you can continue taking them at the same time as Eurartesim.

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

Driving and using machines

You can drive or use machines after taking Eurartesim once you have recovered from your illness.

3. How to take Eurartesim

Always take Eurartesim exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

You or your child should take this medicine on an empty stomach. You or your child should take each dose no less than 3 hours after the last food intake, and no food should be taken within 3 hours after each dose of Eurartesim. You or your child can drink water at any time.

If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.

A course of Eurartesim lasts 3 consecutive days. Take one dose on each day. You should try to take the dose at about the same time on each of the three days.

The daily dose depends on the patient’s body weight. Your doctor should have prescribed a dose that is appropriate for your weight or your child’s weight as follows:

Body weight (kg)	Daily dose (mg)	Total number of tablets for treatment
5 to less than 7	Half 160 mg/20 mg tablet a day	1.5 tablet
7 to less than 13	One 160 mg/20 mg tablet a day	3 tablets
13 to less than 24	One 320 mg/40 mg tablet a day	3 tablets
24 to less than 36	Two 320 mg/40 mg tablets a day	6 tablets
36 to less than 75	Three 320 mg/40 mg tablets a day	9 tablets
>75	Four 320 mg/40 mg tablets a day	12 tablets

Vomiting when taking this medicine

If this happens within:

30 minutes of taking Eurartesim, the whole dose must be taken again.
31–60 minutes, half the dose must be taken again.

If you or your child vomit also the second dose, do not take or give your child another dose. Contact your doctor urgently to obtain an alternative treatment for malaria.

Taking this medicine, if the malaria infection returns

If you or your child gets another attack of malaria, you may take a second course of Eurartesim

within one year if your doctor thinks this is a suitable treatment. You or your child must not take more than two courses within one year. If this happens, talk to your doctor. You or your child should not take a second course of Eurartesim within 2 months of the first course.

If you or your child is infected more than twice in a 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, tell your doctor. Your doctor may suggest special monitoring for you or your child because doses higher than those recommended may have an unwanted, severe 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 right time, take it as soon as you remember. Then take the third (last) dose approximately 24 hours after the second dose.

If you or your child forgets to take the third (last) dose at the right 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.

Check with your doctor or pharmacist if you are not sure.

If you or your child stops taking Eurartesim

For the medicine to work effectively, you or your child should take the tablets as instructed and should complete the 3 days course of treatment. If you or your child is not able to do this, talk to your doctor or pharmacist.

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 not severe and normally disappear within a few days or weeks after treatment.

If you or your child gets a rash, swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing, these may be signs of an allergic reaction. Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital, taking this leaflet with you.

A heart problem, called QT prolongation, can occur while taking Eurartesim and for some days after taking the last dose. This can cause a life-threatening abnormality of the heart rhythm.

Your doctor may take electrical recordings of the heart (electrocardiogram, ECG) while you or your child is being treated and after the last dose is given. Your doctor will advise you when these readings will be taken.

If you notice anything different about your or your child’s heart rhythm or have symptoms (such as palpitations or irregular heart beat) you should contact your doctor as soon as possible and before the next dose is due.

Sometimes a problem with your red blood cells, called haemolytic anaemia can occur after receiving malaria treatment. Contact your doctor immediately if you or your child develops one or more of the following symptoms after treatment with Eurartesim: pale skin, general weakness, headache, shortness of breath and rapid heartbeat; particularly with exercise, confusion, dizziness, or dark-coloured urine.

Side effects in adults

Common (may affect up to 1 in 10people)

Anaemia, headache, heart rhythm disturbances (ECG changes or noticing unusually fast heart beats or palpitations), fever, general weakness.

Uncommon (may affect up to 1 in 100 people)

Influenza, respiratory infections, poor appetite or loss of appetite, dizziness, convulsions (fits), irregular or slow heart rate, cough, vomiting, abdominal pain, diarrhoea, nausea, inflammation or enlargement of the liver, abnormal liver function tests, itching, pain in the muscles or joints.

Side effects in children

Very common (may affect more than 1 in 10people)

Influenza, cough, fever.

Common (may affect up to 1 in 10 people)

Respiratory infections, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), poor appetite or loss of appetite, eye infection, heart rhythm disturbances (change as in adults, ECG changes), abdominal pain, vomiting, diarrhoea, skin inflammation, rash, general weakness.

Uncommon (may affect up to 1 in 100 people)

Abnormalities in red blood cells, excessive numbers of platelets, enlargement of some organs (such as liver or spleen), swollen lymph glands, convulsions (fits), headache, abnormal heart sounds (heard by your doctor with a stethoscope), nose bleeds, runny nose, nausea, inflammation of the mouth, inflammation or enlargement of the liver, jaundice, abnormal liver function blood tests, skin itching and inflammation, pain in the joints.

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 national reporting system listed in 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 take this medicine after the expiry date which is stated on the package after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from light and moisture.

Do not use this medicine if you notice the blister is open.

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 Eurartesim contains

The active substances are piperaquine tetraphosphate and artenimol.

Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate) and 20 mg artenimol.

The other ingredients are:

Tablet core: pre-gelatinised starch, dextrin, hypromellose (E464), croscarmellose sodium, magnesium stearate (E572).

Film coating: hypromellose, titanium dioxide (E171), macrogol 400.

What Eurartesim looks like and contents of the pack

Eurartesim are white film-coated tablets, embossed and with a break line along the middle.

The 160 mg/20 mg tablets have the letters ‘S’ and ‘T’ on one side and come in blisters containing 3 tablets.

Marketing Authorisation Holder

Alfasigma S.p.A.

Via Ragazzi del ’99, n. 5

40133 Bologna

Italy

Tel: +39 051 6489602

Fax: +39 051 388689

Email:

Manufacturer

Alfasigma S.p.A.

Via Pontina km. 30.400

00071 Pomezia (Rome)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg

Alfasigma Belgium sprl/bvba

Tel: +32 (0)2 420 93 16

Nederland	Deutschland
Alfasigma Nederland BV	Pharmore GmbH
Tel: +31 30 6702020	Tel: +49 (0) 5451 9690–0

España	Portugal
Alfasigma España, S.L.	Alfasigma Portugal, Lda
Tel: +34 93 415 48 22	Tel: + 351 217 226 110

France

Alfasigma France

Tél: +33 1 45 21 02 69

EXXáóa

A VIPharma International A.E.

Tql: +30 210–6194170

Italy

Alfasigma S.p.A.

Tel: +39 051 6489602

Kúnpog

ISANGEN PHARMA CYPRUS LTD

Tql: +357 24–638833

Et^rapun, Česká republika, Danmark, Eesti, Hrvatska, Ireland, Ísland, Latvija, Lietuva, Magyarország, Malta, Norge, Österreich, Polska, Romania, Slovenija, Slovenská republika, Suomi/Finland, Sverige, United Kingdom (Northern Ireland).

Alfasigma S.p.A.

Hmaaua, Olaszország, Itálie, Italja, Italien, Italia, Itaalia, Wlochy, Italija, Ítalía, taliansko, Itälija

Tea/Tel/Tlf/Sími/Puh: +39 051 6489602

This leaflet was last revised in month YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: information for the user

Eurartesim 320 mg/40 mg film-coated tablets

Piperaquine tetraphosphate/artenimol

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 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 Eurartesim is and what it is used for
2. What you need to know before you or your child takes 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 to treat uncomplicated malaria when use of a medicine given by mouth is appropriate.

The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more.

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

Do not take Eurartesim if you or your child:

is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the

other ingredients of this medicine (listed in section 6);

has a severe type of malaria infection which has affected parts of the body such as the brain,

lungs or kidneys;

has a heart condition, such as changes to the rhythm or rate of heart beat, or heart disease;
knows that any member of your family (parents, grandparents, brothers or sisters) died suddenly

due to a heart problem or was born with heart problems;

suffers from changes to the levels of salts in the body (electrolyte imbalances);
is taking other medicines that can have an effect on 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 problems such as phenothiazines, sertindole,

sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;

– medicines used to treat infections. These include some of the types of medicines used to

– 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

has recently (for example within about one month) been treated for malaria with certain

medicines or has taken certain medicines to prevent malaria. These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine

If any of the above applies to you or your child or if you are unsure, tell your doctor or pharmacist before taking or giving Eurartesim.

Warnings and precautions

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

has liver or kidney problems;
has a malaria infection caused by a parasite other than Plasmodium falciparum;
is taking or has taken any other medicines for the treatment of malaria (other than those

mentioned above);

is in the 1st trimester of pregnancy or breastfeeding (see below);
is female, elderly (over 65 years) or vomiting;
is taking certain other medicines which could cause possible metabolic interactions. Examples

are listed in the section “Other medicines and Eurartesim”;

if after treatment with Eurartesim malaria infection occurs again repeatedly or is not cured, your

doctor may prescribe another medicine.

If you are not sure about any of the above, please ask your doctor or pharmacist.

Children

Do not give this medicine to infants under 6 months or below 5 kg in weight.

Other medicines and Eurartesim

– some medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin,

simvastatin);

– medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine,

nitrendipine, verapamil, felodipine, amlodipine);

– some 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);

– some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
– medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,

diazepam, alprazolam), zaleplon, zolpidem;

– medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital),

carbamazepine or phenytoin;

– medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin,

tacrolimus);

– sex hormones, including those contained in hormonal contraceptives (such as gestodene,

progesterone, estradiol), testosterone;

– glucocorticoids (hydrocortisone, dexamethasone);
– omeprazole (used to treat diseases related to gastric acid production);
– paracetamol (used to treat pain and fever);
– theophylline (used to improve bronchial air flow);
– nefazodone (used to treat depression);
– aprepitant (used to treat nausea);
– some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.

Eurartesim with food and drink

You should take the Eurartesim tablets with water only.

You should not take Eurartesim with grapefruit juice due to possible interactions.

Pregnancy and breast-feeding

You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.

If you are taking folate supplements to prevent possible neural tube birth defects, you can continue taking them at the same time as Eurartesim.

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

Driving and using machines

You can drive or use machines after taking Eurartesim once you have recovered from your illness.

3. How to take Eurartesim

Always take Eurartesimexactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.

A course of Eurartesim lasts 3 consecutive days. Take one dose on each day. You should try to take the dose at about the same time on each of the three days.

The daily dose depends on the patient’s body weight. Your doctor should have prescribed a dose that is appropriate for your weight or your child’s weight as follows:

Body weight (kg)	Daily dose (mg)	Total number of tablets for treatment
5 to less than 7	Half 160 mg/20 mg tablet a day	1.5 tablet
7 to less than 13	One 160 mg/20 mg tablet a day	3 tablets
13 to less than 24	One 320 mg/40 mg tablet a day	3 tablets
24 to less than 36	Two 320 mg/40 mg tablets a day	6 tablets
36 to less than 75	Three 320 mg/40 mg tablets a day	9 tablets
>75	Four 320 mg/40 mg tablets a day	12 tablets

Vomiting when taking this medicine

If this happens within:

30 minutes of taking Eurartesim, the whole dose must be taken again.
31–60 minutes, half the dose must be taken again.

If you or your child vomit also the second dose, do not take or give your child another dose. Contact your doctor urgently to obtain an alternative treatment for malaria.

Taking this medicine, if the malaria infection returns

If you or your child gets another attack of malaria you may take a second course of Eurartesim

If you or your child is infected more than twice in a year, your doctor will prescribe an

4. Possible side effects

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

A heart problem, called QT prolongation, can occur while taking Eurartesim and for some days after taking the last dose. This can cause a life-threatening abnormality of the heart rhythm.

Side effects in adults

Common (may affect up to 1 in 10 people)

Anaemia, headache, heart rhythm disturbances (ECG changes or noticing unusually fast heart beats or palpitations), fever, general weakness.

Uncommon (may affect up to 1 in 100 people)

Side effects in children

Very common (may affect more than 1 in 10 people)

Influenza, cough, fever.

Common (may affect up to 1 in 10people)

Uncommon (may affect up to 1 in 100people)

Reporting of side effects

How to store Eurartesim

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the package after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from light and moisture.

Do not use this medicine if you notice the blister is open.

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 Eurartesim contains

The active substances are piperaquine tetraphosphate and artenimol.

Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate) and 40 mg artenimol.

The other ingredients are:

Tablet core: pre-gelatinised starch, dextrin, hypromellose (E464), croscarmellose sodium, magnesium stearate (E572).

Film coating: hypromellose, titanium dioxide (E171), macrogol 400.

What Eurartesim looks like and contents of the pack

Eurartesim are white film-coated tablets, embossed and with a break line along the middle.

The 160 mg/20 mg tablets have the letters ‘S’ and ‘T’ on one side and come in blisters containing 3 tablets.

Marketing Authorisation Holder

Alfasigma S.p.A.

Via Ragazzi del ’99, n. 5

40133 Bologna

Italy

Tel: +39 051 6489602

Fax: +39 051 388689

Email:

Manufacturer

Alfasigma S.p.A.

Via Pontina km. 30.400

00071 Pomezia (Rome)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg

Alfasigma Belgium sprl/bvba

Tel: +32 (0)2 420 93 16

Nederland	Deutschland
Alfasigma Nederland BV	Pharmore GmbH
Tel: +31 30 6702020	Tel: +49 (0) 5451 9690–0

España	Portugal
Alfasigma España, S.L.	Alfasigma Portugal, Lda
Tel: +34 93 415 48 22	Tel: + 351 217 226 110

France

Alfasigma France

Tél: +33 1 45 21 02 69

EXXáóa

A VIPharma International A.E.

Tql: +30 210–6194170

Italy

Alfasigma S.p.A.

Tel: +39 051 6489602

Kúnpog

ISANGEN PHARMA CYPRUS LTD

Tql: +357 24–638833

Alfasigma S.p.A.

Hmaaua, Olaszország, Itálie, Italja, Italien, Italia, Itaalia, Wlochy, Italija, Ítalía, taliansko, Itälija

Tea/Tel/Tlf/Sími/Puh: +39 051 6489602

This leaflet was last revised in month YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: information for the user

Eurartesim 320 mg/40 mg film-coated tablets

Piperaquine tetraphosphate/artenimol

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 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 Eurartesim is and what it is used for
2. What you need to know before you or your child takes 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 to treat uncomplicated malaria when use of a medicine given by mouth is appropriate.

The medicine can be taken by adults, adolescents, children and infants over 6 months old who weigh 5 kilograms or more.

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

Do not take Eurartesim if you or your child:

is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the

other ingredients of this medicine (listed in section 6);

has a severe type of malaria infection which has affected parts of the body such as the brain,

lungs or kidneys;

has a heart condition, such as changes to the rhythm or rate of heart beat, or heart disease;
knows that any member of your family (parents, grandparents, brothers or sisters) died suddenly

due to a heart problem or was born with heart problems;

suffers from changes to the levels of salts in the body (electrolyte imbalances);
is taking other medicines that can have an effect on 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 problems such as phenothiazines, sertindole,

sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;

– medicines used to treat infections. These include some of the types of medicines used to

– 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

has recently (for example within about one month) been treated for malaria with certain

medicines or has taken certain medicines to prevent malaria. These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine

If any of the above applies to you or your child or if you are unsure, tell your doctor or pharmacist before taking or giving Eurartesim.

Warnings and precautions

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

has liver or kidney problems;
has a malaria infection caused by a parasite other than Plasmodium falciparum;
is taking or has taken any other medicines for the treatment of malaria (other than those

mentioned above);

is in the 1st trimester of pregnancy or breastfeeding (see below);
is female, elderly (over 65 years) or vomiting;
is taking certain other medicines which could cause possible metabolic interactions. Examples

are listed in the section “Other medicines and Eurartesim”;

if after treatment with Eurartesim malaria infection occurs again repeatedly or is not cured, your

doctor may prescribe another medicine.

If you are not sure about any of the above, please ask your doctor or pharmacist.

Children

Do not give this medicine to infants under 6 months or below 5 kg in weight.

Other medicines and Eurartesim

– some medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin,

simvastatin);

– medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine,

nitrendipine, verapamil, felodipine, amlodipine);

– some 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);

– some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
– medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,

diazepam, alprazolam), zaleplon, zolpidem;

– medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital),

carbamazepine or phenytoin;

– medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin,

tacrolimus);

– sex hormones, including those contained in hormonal contraceptives (such as gestodene,

progesterone, estradiol), testosterone;

– glucocorticoids (hydrocortisone, dexamethasone);
– omeprazole (used to treat diseases related to gastric acid production);
– paracetamol (used to treat pain and fever);
– theophylline (used to improve bronchial air flow);
– nefazodone (used to treat depression);
– aprepitant (used to treat nausea);
– some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.

Eurartesim with food and drink

You should take the Eurartesim tablets with water only.

You should not take Eurartesim with grapefruit juice due to possible interactions.

Pregnancy and breast-feeding

You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.

If you are taking folate supplements to prevent possible neural tube birth defects, you can continue taking them at the same time as Eurartesim.

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

Driving and using machines

You can drive or use machines after taking Eurartesim once you have recovered from your illness.

3. How to take Eurartesim

Always take Eurartesimexactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.

A course of Eurartesim lasts 3 consecutive days. Take one dose on each day. You should try to take the dose at about the same time on each of the three days.

The daily dose depends on the patient’s body weight. Your doctor should have prescribed a dose that is appropriate for your weight or your child’s weight as follows:

Body weight (kg)	Daily dose (mg)	Total number of tablets for treatment
5 to less than 7	Half 160 mg/20 mg tablet a day	1.5 tablet
7 to less than 13	One 160 mg/20 mg tablet a day	3 tablets
13 to less than 24	One 320 mg/40 mg tablet a day	3 tablets
24 to less than 36	Two 320 mg/40 mg tablets a day	6 tablets
36 to less than 75	Three 320 mg/40 mg tablets a day	9 tablets
>75	Four 320 mg/40 mg tablets a day	12 tablets

Vomiting when taking this medicine

If this happens within:

30 minutes of taking Eurartesim, the whole dose must be taken again.
31–60 minutes, half the dose must be taken again.

If you or your child vomit also the second dose, do not take or give your child another dose. Contact your doctor urgently to obtain an alternative treatment for malaria.

Taking this medicine, if the malaria infection returns

If you or your child gets another attack of malaria you may take a second course of Eurartesim

If you or your child is infected more than twice in a year, your doctor will prescribe an

Eurartesim - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Eurartesim

1. What Eurartesim is and what it is used for

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

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

3. How to take Eurartesim

4. Possible side effects

6. Contents of the pack and other information

– 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.

1. What Eurartesim is and what it is used for

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

3. How to take Eurartesim