Package Leaflet: Information for the User

Eurartesim 320 mg/40 mg Film-Coated Tablets

Piperaquine tetraphosphate/artenimol

Read this leaflet carefully before you start taking this medicine because 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Eurartesim 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. Storage of Eurartesim

6. Contents of the pack and additional information

Eurartesim contains the active principles piperaquine tetraphosphate and artemol and is used in the treatment of uncomplicated malaria when it is appropriate to administer the medication orally.

Malaria is caused by infection with a parasite calledPlasmodium, resulting from the bite of an infected mosquito. There are several types ofPlasmodiumparasites. Eurartesim kills thePlasmodium falciparumparasite.

The medication can be taken by adults, adolescents, children, and infants over 6 months of age who weigh 5 kg or more.

Do not take Eurartesim if you or your child:

• are allergic to the active ingredients piperaquine tetraphosphate or artemimol or to any of the other components of this medication (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 heart rhythm or frequency, or a heart disease;
• know that a family member (parents, grandparents, brothers, or sisters) died suddenly from a heart problem or was born with heart problems;
• have changes in the levels of salts in the body (electrolyte imbalances);
• are taking other medications that can affect heart rhythm, such as:

• quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine, or sotalol;
• medications used to treat depression, such as amitriptyline, fluoxetine, or sertraline;
• medications used to treat mental health problems, such as phenothiazines, sertindol, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;
• medications used to treat infections. These include some types of medications 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 (used to treat HIV);
• antihistamines used to treat allergies or inflammation, such as terfenadine, astemizole, or mizolastine;
• some medications used to treat stomach problems, such as cisapride, domperidone, or droperidol;
• other medications, such as vinca alkaloids and arsenic trioxide (used to treat certain cancers), bepridil (used to treat angina), difemanil (used to treat stomach problems), levometadilo, and metadona (used to treat drug addiction), and probucol (used to treat high cholesterol in the blood).

• have received treatment for malaria with certain medications or have taken medications to prevent malaria in the past month. These medications include mefloquine, halofantrine, lumefantrine, chloroquine, or quinine.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication 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 medication for malaria treatment (other than those mentioned above);
• is in the first trimester of pregnancy or breastfeeding (see below);
• is a woman, elderly (over 65 years), or has vomiting;
• is taking certain medications that could produce metabolic interactions. Examples are listed in the section “Other medications and Eurartesim”.
• if after treatment with Eurartesim the malaria infection returns or does not cure, your doctor may prescribe another medication.

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

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

Children

Do not give this medication to infants under 6 months or with a weight under 5 kg.

Other medications and Eurartesim

Inform your doctor or pharmacist if you or your child is taking, has taken recently, or may need to take any other medication. Some medications may affect how Eurartesim works, and your doctor may decide that Eurartesim is not suitable or that you need more monitoring while taking medications that may cause potential interactions. The following are some examples (although there are more):

• some medications used to treat high cholesterol in the blood (such as atorvastatin, lovastatin, simvastatin);
• medications used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);
• some medications used to treat HIV (antiretrovirals): HIV protease inhibitors (such as atazanavir, darunavir, indinavir, lopinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapina);
• some medications used to treat microbial infections (such as telitromycin, rifampicin, dapsone);
• medications used to help you sleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam, zaleplon, zolpidem);
• medications used to prevent/treat seizures: barbiturates (such as phenobarbital), carbamazepine, or phenytoin;
• medications used after organ transplantation and in autoimmune diseases (such as cyclosporine, tacrolimus);
• sex hormones, including those containing hormonal contraceptives (such as gestodene, progesterone, estradiol, testosterone);
• glucocorticosteroids (hydrocortisone, dexamethasone);
• omeprazole (used to treat diseases related to acid production in the stomach);
• paracetamol (used to treat pain and fever);
• theophylline (used to improve air flow in the bronchi);
• nefazodone (used to treat depression);
• aprepitant (used to treat nausea);
• some gases (such as enflurane, halothane, and isoflurane) used for general anesthesia.

Taking Eurartesim with food and drinks

You should take Eurartesim tablets only with water.

Eurartesim should not be taken with orange juice due to possible interactions.

Pregnancy and breastfeeding

Inform your doctor if you are in the first trimester of pregnancy, think you may be pregnant, become pregnant, or are breastfeeding. Animal studies suggest that Eurartesim may cause damage to 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 give you an alternative medication. If you discover you are pregnant within a month of taking Eurartesim, inform your doctor. Exposure of pregnant women to Eurartesim during the second or third trimester was not associated with fetal damage. If Eurartesim is more suitable for a pregnant woman than other combined artemisinin treatments with a greater experience of use (or sulfadoxine-pyrimethamine), Eurartesim may be used during the second and third trimesters of pregnancy.

Do not breastfeed while taking this medication, as it may pass to your baby through breast milk.

If you are taking folate supplements to prevent possible congenital neural tube defects, you may continue to use these supplements at the same time as Eurartesim.

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

Driving and using machines

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

Follow exactly the administration instructions for Eurartesim indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

You or your child should take this medication on an empty stomach. You or your child should take each dose when at least 3 hours have passed since the last food intake, and should not eat anything in the 3 hours following each dose of Eurartesim. You or your child can drink water whenever you want.

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

A Eurartesim cycle lasts for three consecutive days. Take a dose each day. It should be ensured that the dose is taken approximately at the same time each of the three days.

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

Vomiting after taking this medication

If it occurs within:

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

If you or your child also vomit 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 medication if malaria returns

• If you or your child presents another episode of malaria, you may take a second cycle of Eurartesim within a year if your doctor believes it is the appropriate treatment. You or your child should not take more than two cycles in a year. If this occurs, inform your doctor. You or your child should not take a second cycle of Eurartesim until two months have passed since the first cycle.
• If you or your child becomes 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 a dose greater than the recommended dose, inform your doctor. Your doctor may recommend special follow-up for you and your child since doses higher than those recommended by the doctor may have a severe, 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 correct 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 correct time, take it as soon as you remember. Never take more than one dose on the same day to compensate for a missed dose.

In case of doubt, ask your doctor or pharmacist.

If you or your child interrupts the treatment with Eurartesim

To ensure the medication works effectively, you or your child must take the tablets according to the instructions and complete the 3-day treatment cycle. If you or your child cannot do so, consult your doctor or pharmacist.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.The majority of side effects are not serious and usually disappear within a few days or weeks after treatment.

Cardiac problems

A cardiac problem, called QT prolongation, can occur when taking Eurartesim and for a few days after the last dose. This can cause an abnormal heart rhythm that can be fatal.In adults and children, other heart rhythm alterations with symptoms such as rapid heart rate (tachycardia) and strong heart rate that can be rapid or irregular (palpitations) have been observed. The frequency of these side effects is frequent (can affect up to1 in 10people).

Additionally, irregular (sinus arrhythmias) or slow (bradycardia) heart rate has been observed in adults. The frequency of these side effects is rare (can affect up to1 in 100people).

If you notice anything different in your heart rhythm or your child's heart rhythm or have symptoms (such as palpitations or irregular heart rate), you must contact your doctor as soon as possible and before taking the next dose.

Your doctor may perform an electrocardiogram (ECG) of the heart while you or your child receives treatment and after the last dose. Your doctor will inform you when these recordings will be made.

Problems with red blood cells

Sometimes, after receiving malaria treatment, a problem with red blood cells called hemolytic anemia can appear. This condition can appear late and present up to a month after using Eurartesim (late hemolytic anemia). In most cases, anemia resolves without specific treatment, but sometimes, in severe cases, blood transfusion may be necessary. Your doctor will perform periodic blood tests. If it is suspected that the lack of red blood cells is caused by your immune system (autoimmune hemolytic anemia), these tests may include a direct antiglobulin test to determine if treatment is necessary, for example, with corticosteroids. The frequency of these side effects is unknown (cannot be estimated from available data). Contact your doctor immediately if you or your child presents one or more of the following symptomsafterthe treatment withEurartesim:pale skin, general weakness, headache, difficulty breathing, and rapid heart rate (especially when exercising), confusion, dizziness, or dark-colored urine.

Other side effects in adults

Frequent(can affect up to 1 in 10people)

Anemia, headache, fever, general weakness.

Rare(can affect up to 1 in 100people)

Flu, respiratory infection, loss of appetite or decreased appetite, dizziness, seizures (epileptic crises), cough, vomiting, abdominal pain, diarrhea, nausea, liver inflammation or enlargement, liver cell damage, abnormal liver function tests, itching, muscle or joint pain.

Other side effects in children

Very frequent(can affect more than 1 in 10people)

Flu, cough, fever.

Frequent(can affect up to 1 in 10people)

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

Rare(can affect up to 1 in 100people)

Abnormalities in red blood cells, thrombocytosis, enlargement of some organs (such as the liver or spleen), lymph node inflammation, seizures (epileptic crises), headache, abnormal heart sounds (heard by the doctor with a stethoscope), nasal bleeding, nasal mucosities, nausea, mouth inflammation, liver inflammation or enlargement, jaundice, abnormal liver function test results, itching, skin inflammation, joint pain.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

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

Do not use this medication if you observe that the blister pack is open.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Eurartesim

The active principles are piperaquine tetraphosphate and artemol.

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

The other components are:

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

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

Appearance of Eurartesim and contents of the package

Eurartesim are white film-coated tablets with an inscription and a notch in the middle of the tablet.

The 320 mg/40 mg tablets have two letters ’σ’ on one side and come 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]

Responsible for manufacturing

Alfasigma S.p.A.

Via Pontina km. 30,400

00071 Pomezia (Roma)

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

België/Belgique/Belgien, Deutschland

Luxembourg/Luxemburg Pharmore GmbH

Alfasigma Belgium sprl/bvba Tel.: +49 (0) 5451 9690-0

Tel: +32 (0)2 420 93 16 [email protected]

[email protected]

??????, Ceská republika, Danmark, Eesti, Hrvatska, Ireland, Ísland, Latvija, Lietuva,

Magyarország, Malta, Norge, Österreich, Polska, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige.

Alfasigma S.p.A.

??????, Olaszország, Itàlie, Italja, Italien, Italia, Itaalia, Wlochy, Italija, Ítalía, taliansko, Italija

Te?/Tel/Tlf/Sími/Puh: +39 051 6489602

[email protected]

Last review date of this SmPC:November 2024

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.