EURARTESIM 320 mg / 40 mg FILM-COATED TABLETS

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 artenimol or any of the other ingredients 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 disease, such as changes in the rhythm or frequency of the heartbeat, or a heart condition;
• know that a family member (parents, grandparents, brothers, or sisters) died suddenly from a heart problem or was born with heart problems;
• suffer from changes in the levels of salts in the body (hydroelectrolytic imbalances);
• take other medicines that may have an effect on the heartbeat 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 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 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), difemanil (used to treat stomach problems), levometadyl, and methadone (used to treat drug addiction) and probucol (used to treat high cholesterol levels in the blood).

• have recently (e.g., during 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 points apply to you or your child or if you are not sure, inform your doctor or pharmacist before taking or administering Eurartesim.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if you or your child:

• have liver or kidney problems;
• have a malaria infection caused by a parasite that is not Plasmodium falciparum;
• take or have taken any other medicine for the treatment of malaria (other than those mentioned above);
• are in the first trimester of pregnancy or breastfeeding (see below);
• are a woman, elderly (over 65 years), or have vomiting;
• take certain medicines that may produce metabolic interactions. Examples are listed in the section “Other medicines and Eurartesim”;
• if after treatment with Eurartesim the malaria infection recurs or does not heal, it is possible that your doctor will prescribe another medicine.

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

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

Children

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

Other medicines and Eurartesim

Inform your doctor or pharmacist if you or your child are using, have recently used, or could use any other medicine. Some medicines may affect the way Eurartesim works and your doctor may decide that Eurartesim is not suitable or that more monitoring is needed while you or your child are taking medicines that could produce possible interactions. The following are some examples (although there are more):

• certain medicines used to treat high cholesterol levels in the blood (such as atorvastatin, lovastatin, simvastatin);
• medicines used to treat high blood pressure and heart problems (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 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 diseases 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 drinks

You should take Eurartesim tablets only with water.

Eurartesim should 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 may be pregnant, or become pregnant or are breastfeeding. Animal studies suggest that Eurartesim may cause harm 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 medicine. If you discover that you are pregnant within a month of taking Eurartesim, inform your doctor. Exposure of pregnant women during the second or third trimester was not associated with harm to the fetus. If for a pregnant woman Eurartesim is more suitable than other artemisinin combination therapies with more experience of use (or sulfadoxine-pyrimethamine), Eurartesim can be used in the second and third trimesters of pregnancy.

You should not breastfeed while taking this medicine, as it may pass to your child through breast milk.

If you are taking folic acid supplements to prevent possible birth defects of the neural tube, you can continue using these supplements at the same time as Eurartesim.

Consult your doctor or pharmacist before using 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

Follow exactly the administration instructions of Eurartesim indicated by your doctor. In case of 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 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 desired.

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

A cycle 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 of the three days.

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

Vomiting when taking this medicine

If it occurs:

• within 30 minutes of taking Eurartesim, the full dose should be taken again.
• between 31-60 minutes, 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 alternative treatment for malaria.

Taking this medicine if the malaria infection recurs

• If you or your child has 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 happens, inform your doctor. You or your child should not take a second cycle of Eurartesim until at least 2 months have passed since the first cycle.
• If you or your child becomes infected more than twice in a year, your doctor will prescribe 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 of you and your child since doses higher than those recommended by the doctor 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 (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 make up for a forgotten dose.

In case of doubt, ask your doctor or pharmacist.

If you or your child stops taking Eurartesim

To make the medicine work effectively, you or your child must take the tablets as instructed and complete the 3-day treatment cycle. If you or your child cannot do this, consult your doctor or pharmacist.

If you have any other questions about 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 side effects are not serious and usually disappear within a few days or weeks after treatment.

Heart problems

A heart problem called QT prolongation can occur when taking Eurartesim and for a few days after the last dose. This can cause a heart rhythm abnormality that can be fatal. In adults and children, other heart rhythm abnormalities with symptoms such as rapid heartbeat (tachycardia) and strong or irregular heartbeat (palpitations) have been observed. The frequency of these side effects is common (may affect up to 1 in 10 people).

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

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

Your doctor may perform an electrical tracing of the heart (electrocardiogram, ECG) while you or your child are receiving treatment and after administration of the last dose. Your doctor will inform you when these tracings will be performed.

Problems with red blood cells

Sometimes, after receiving treatment for malaria, a problem with red blood cells called hemolytic anemia can appear. This condition can appear late and present up to a month after the use of Eurartesim (late hemolytic anemia). In most cases, the 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 needed, for example with corticosteroids. The frequency of these side effects is unknown (cannot be estimated from the available data). Contact your doctor immediately if you or your child presents one or more of the following symptoms after treatment with Eurartesim: paleness, general weakness, headache, difficulty breathing, and rapid heartbeat (especially when exercising), confusion, dizziness, or dark-colored urine.

Other side effects in adults

Common (may affect up to 1 in 10 people)

Anemia, headache, fever, general weakness.

Uncommon (may affect up to 1 in 100 people)

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

Other side effects in children

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

Flu, cough, fever.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

Abnormalities in red blood cells, excess platelets, enlargement of certain organs (such as the liver or spleen), lymph node inflammation, seizures (epileptic crises), headache, abnormal heart sounds (heard by the doctor with a stethoscope), nosebleeds, nasal discharge, nausea, mouth inflammation, liver inflammation or enlargement, jaundice, abnormal liver function test results, itching, and skin inflammation.

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side 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 that appears on the packaging after CAD. 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 that the blister is open.

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

6. Package contents and additional information

Composition of Eurartesim

The active ingredients are piperaquine tetraphosphate and artenimol.

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

The other ingredients are:

Core of the tablet: pregelatinized starch, dextrin, hypromellose (E464), sodium croscarmellose, magnesium stearate (E572).

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

Appearance of Eurartesim and package contents

Eurartesim is a white, film-coated tablet with inscription and a score line in the middle of the tablet.

The 320 mg/40 mg tablets have two letters 'σ' on one face 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

Phone: +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

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

België/Belgique/Belgien, Deutschland

Luxembourg/LuxemburgPharmore GmbH

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

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

[email protected]

България, 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.

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

Тел/Teл/Tel/Tlf/Sími/Puh: +39 051 6489602

[email protected]

Date of last revision of this prospectus:November 2024

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