Eurartesim 320 mg/40 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Eurartesim 320 mg/40 mg film-coated tablets

Piperaquine tetraphosphate/artemether

Please read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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 tetrafluorophosphate piperaquine and artenimol and is used to treat uncomplicated malaria when oral administration of the medicine is appropriate.

Malaria is caused by infection with a parasite called Plasmodium, 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 weighing 5 kg or more.

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

Do not take Eurartesim if you or your child:

• are allergic to the active substances piperaquine tetraphosphate or artenimol, or to any of the other components of this medicine (listed in section 6);

• have a severe type of malaria infection that has affected parts of the body such as the brain, lungs, or kidneys;

• have a heart condition, such as changes in the rhythm or rate of the heartbeat, or any other heart disease;

• know that a family member (parents, grandparents, siblings) died suddenly due to a heart problem or was born with heart problems;

• suffer from changes in the levels of salts in the body (electrolyte imbalances);

• 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, sulpiride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;

• medicines used to treat infections. These include certain 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 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 cancers), bepridil (used to treat angina pectoris), difemethiazine (used to treat stomach problems), levomethadyl and methadone (used to treat drug addiction), and probucol (used to treat high cholesterol levels in the blood).

• have recently (e.g., within the last month) received treatment for malaria with certain medicines or have taken certain medicines to prevent malaria. These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine, or quinine.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine 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 recently taken any other medicine for the treatment of 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 experience vomiting;
• are taking certain medicines that could cause metabolic interactions. Examples are listed in the section “Other medicines and Eurartesim”.
• if malaria recurs or does not resolve after treatment with Eurartesim, your doctor may prescribe another medicine.

If you have any doubts about any of the points above, ask your doctor or pharmacist.

Inform your doctor if, after treatment, symptoms of serious adverse effects appear: paleness, general weakness, headache, difficulty breathing, rapid heartbeat (especially during exercise), confusion, dizziness, or dark-colored urine (for more information, see section 4).

Children

Do not give this medicine to infants under 6 months of age or weighing less than 5 kg.

Other medicines and Eurartesim

Tell your doctor or pharmacist if you or your child are using, have recently used, or might need to use any other medicine. Some medicines may affect how Eurartesim works, and your doctor may decide that Eurartesim is not suitable or that you or your child need additional monitoring while taking medicines that could cause possible interactions. Some examples are listed below (although there are others):

• some medicines used to treat high cholesterol levels in the blood (such as atorvastatin, lovastatin, simvastatin);
• medicines used to treat high blood pressure and heart conditions (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);
• some 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);
• some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
• medicines used to help you sleep: 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 cyclosporine, tacrolimus);
• sex hormones, including those contained in hormonal contraceptives (such as gestodene, progesterone, estradiol, testosterone);
• glucocorticosteroids (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 for general anesthesia.

Taking Eurartesim with food and drink

You should 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, think you might be pregnant, become pregnant, or are breastfeeding. Animal studies suggest that Eurartesim may harm the fetus when used during the first trimester of pregnancy. Therefore, Eurartesim should not be used during the first trimester of pregnancy if your doctor can prescribe an alternative medicine. If you find out you are pregnant within one month of taking Eurartesim, inform your doctor. Exposure of pregnant women during the second or third trimester has not been associated with fetal harm. If Eurartesim is considered more appropriate than other artemisinin-based combination treatments with more extensive use experience (or sulfadoxine–pyrimethamine), Eurartesim may be used during the second and third trimesters of pregnancy.

You must not breastfeed while taking this medicine, as it may pass into your breast milk.

If you are taking folic acid supplements to help prevent possible neural tube defects, you may continue taking these supplements while using Eurartesim.

Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.

Driving and using machines

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

3. How to take Eurartesim

Follow exactly the administration instructions for Eurartesim given by your doctor. If in doubt, consult your doctor or pharmacist again.

You or your child should take this medicine on an empty stomach. You or your child should take each dose at least 3 hours after the last food intake, and should not eat anything during the 3 hours following each dose of Eurartesim. You or your child may drink water at any time.

If it is difficult to swallow the tablets, they may be crushed and mixed with water. The mixture should be taken immediately.

A cycle of Eurartesim lasts three consecutive days. Take one dose each day. Try to take the dose at approximately the same time each of the three days.

The daily dose depends on the body weight of the patient. Your doctor will have prescribed a dose appropriate for your body weight or that of your child, according to the following table:

Vomiting after taking this medicine

If vomiting occurs within:

• 30 minutes after taking Eurartesim, the full dose should be taken again.
• 31–60 minutes after taking Eurartesim, half of the dose should be taken again.

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

Taking this medicine if malaria infection returns

• 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 in one year. If this occurs, inform your doctor. You or your child must not take a second course of Eurartesim until at least 2 months have passed since the first course.
• If you or your child has more than two malaria infections 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. Your doctor may recommend special monitoring for you or your child, as doses higher than those recommended may have a serious unwanted 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 correct 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 correct 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, ask 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 exactly as instructed and must complete the full 3-day treatment course. If you or your child cannot do this, consult your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Most of the adverse effects are not serious and usually disappear within a few days or weeks after treatment.

Cardiac problems

A heart problem called QT prolongation may occur when taking Eurartesim and for several days after the last dose. This may lead to a heart rhythm disorder that could be life-threatening. In adults and children, other disturbances in heart rhythm have been observed, with symptoms such as rapid heartbeat (tachycardia) and strong heartbeat that may be fast or irregular (palpitations). The frequency of these adverse effects is common (may affect up to 1 in 10 people).

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

If you notice any change in your or your child’s heart rhythm or experience symptoms (such as palpitations or irregular heartbeat), you must contact your doctor as soon as possible and before taking the next dose.

Your doctor may perform an electrocardiogram (ECG) while you or your child are receiving treatment and after the last dose has been administered. Your doctor will inform you when these ECGs will be carried out.

Problems with red blood cells

Sometimes, after receiving treatment for malaria, a problem with red blood cells called haemolytic anaemia may occur. This condition may appear late and present 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 periodic blood tests. If a lack of red blood cells due to your immune system is suspected (autoimmune haemolytic anaemia), these tests may include a direct antiglobulin test to determine whether treatment, for example with corticosteroids, is needed. The frequency of these adverse effects is unknown (cannot be estimated from the available data). Contact your doctor immediately if you or your child experiences one or more of the following symptoms after treatment with Eurartesim: paleness, general weakness, headache, difficulty breathing, rapid heartbeat (especially during exercise), confusion, dizziness, or dark-colored urine.

Other adverse effects in adults

Common (may affect up to 1 in 10 people)

Anaemia, headache, fever, general weakness.

Uncommon (may affect up to 1 in 100 people)

Influenza, respiratory infection, loss of appetite, dizziness, seizures (epileptic fits), cough, vomiting, abdominal pain, diarrhoea, nausea, liver inflammation or enlargement, liver cell injury, abnormal liver function tests, itching, muscle or joint pain.

Other adverse effects in children

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

Influenza, cough, fever.

Common (may affect up to 1 in 10 people)

Respiratory infection, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), loss of appetite, eye infection, abdominal pain, vomiting, diarrhoea, skin inflammation, rash, general weakness.

Uncommon (may affect up to 1 in 100 people)

Abnormalities in red blood cells, increased platelet count, enlargement of certain organs (such as the liver or spleen), lymph node swelling, seizures (epileptic fits), headache, abnormal heart sounds (detected by the doctor using a stethoscope), nosebleeds, nasal mucus, nausea, mouth inflammation, liver inflammation or enlargement, jaundice, abnormal liver function blood test results, itching and skin inflammation, joint pain.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from light and moisture.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Eurartesim

The active substances are piperaquine tetraphosphate and artefenomel.

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

The other components are:

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

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

Appearance of Eurartesim and pack contents

Eurartesim are white film-coated tablets, marked and with a central groove.

The 320 mg/40 mg tablets have two 'σ' symbols on one side and are available 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

Telephone: +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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien,

Luxembourg/Luxemburg

Alfasigma Belgium BV

Tel: 00800 78781345

[email protected]

France

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

Greece

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

Italy

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

Cyprus

ISANGEN PHARMA CYPRUS LTD
Tel: 24-638833
[email protected]

Belgium, Czech Republic, Denmark, Estonia, Croatia, Ireland, Iceland, Latvia, Lithuania, Hungary, Malta, Norway, Austria, Poland, Romania, Slovenia, Slovakia, Finland, Sweden.

Alfasigma S.p.A.
Italy

Tel/Tlf/Sími/Puh:
+39 051 6489602
[email protected]

Date of the most recent review of this leaflet: MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.