InfoCons Consumer Protection informs you – Pedea – Package Leaflet

Before anything else

Read all of this leaflet carefully before this medicine is administered to your baby because it contains important information .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for your baby. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your baby’s.
• If your baby get any side effects, talk to your doctor or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Pedea is and what it is used for

While a baby is inside its mother’s womb it does not need to use its lungs. An unborn baby has a blood vessel called the ductus arteriosus near the heart which allows the baby’s blood to bypass the lungs and circulate to the rest of the body.

When the baby is born and starts using its lungs the ductus arteriosus normally closes. However, in some cases this does not happen. The medical term for this condition is ‘patent ductus arteriosus’ , i.e. an open ductus arteriosus . This can cause heart problems in your baby. This condition is much more frequent in premature newborn than in full -term newborn infants.

Pedea, when given to your baby, can help to close the ductus arteriosus .

The active substance in Pedea is ibuprofen. Pedea closes the ductus arteriosus by inhibiting the production of prostaglandin, a naturally occurring chemical in the body which keeps the ductus arteriosus open.

⚠️ 2. What you need to know before P edea is administered to your baby

Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care professional s.

Do not use Pedea

• if your baby is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) ;
• if your baby has a life -threatening infection which has not been treated;
• if your baby is bleeding, especially if the bleeding is inside the skull or in the intestines;
• if your baby has a decrease of blood cells called platelets (thrombocytopenia) or other problems with their blood clotting;
• if your baby has kidney problems;
• if your baby has other problems with their heart which require the ductus arteriosus to remain open so that adequate circulation of the blood is maintained;
• if your baby has or is suspected to have certain problems with their intestines (a condition called necrotising enterocolitis);

18 Warnings and precautions

• Before treatment with Pedea, your baby’s heart will be examined to confirm that the ductus arteriosus is open.
• Pedea should not be given in the first 6 hours of life.
• If your baby is suspected of having liver disease, signs and symptoms of which include yellowing of the skin and eyes.
• If your baby is already suffering from an infection that is being treated, the doctor will treat your baby with Pedea only after careful consideration of your baby’s condition.
• Pedea should be carefully administered to your baby by the healthcare professional, to avoid damage to the skin and surrounding tissues.
• Ibuprofen may reduce the ability of your baby’s blood to clot. Your baby should therefore be watched for signs of prolonged bleeding.
• Your baby may develop some bleeding from the intestines and the kidneys. To detect this, your baby’s stools and urine may be tested to determine if there is any blood present in them.
• Pedea may reduce the amount of urine your baby passes. If this is significant, your baby’s treatment may be stopped until the volume of urine returns to normal.
• Pedea may be less effective in very premature babies less than 27 weeks of gestational age .
• Serious skin reactions have been reported in association with Pedea treatment. Your doctor should discontinue Pedea immediately, if any of the following side effects occur: skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome ) has been identified as a potential risk associated with ibuprofen. Your doctor should discontinue Pedea immediately, if any of the following side effects occur : skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Other medicines and Pedea

Tell your doctor or pharmacist if your baby is taking or has recently taken any other medicines, including medicines obtained without a prescription.

Certain medicines, if given together with Pedea, may cause side effects. These are detailed below:

• your baby may have problems passing urine and may have been prescribed diuretics. Ibuprofen may reduce the effect of these medicines.
• your baby may be given anticoagulants (medicine preventing blood clotting). Ibuprofen may increase the anti -clotting effect of this product.
• your baby may be given nitric oxide to improve blood oxygenation. Ibuprofen may increase the risk of bleeding.
• your baby may be given corticosteroids to prevent inflammation. Ibuprofen may increase the risk of bleeding in the stomach and intestines.
• your baby may be given aminosides (one family of antibiotics) to treat infection. Ibuprofen may increase blood concentrations and thus increase the risk of toxicity on kidney and ear Important information about some of the ingredients of Pedea This medicinal product contains less than 1 mmol sodium ( 15 mg) per 2 ml, i.e. essentially ‘sodium – free’.

💊 3. How to use pedea

Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.

19 A course of therapy is defined as three intravenous injections of Pedea given at 24 hour intervals. The dose to be administered will be calculated from the weight of your baby. It is 10 mg/kg for the first administration and 5 mg/kg for the second and the third administrations.

This calculated amount will be given by infusion in a vein over a period of 15 minutes.

If after this first course of treatment, the ductus arteriosus is not closed or re -opens, your baby’s doctor may decide to give a second course of treatment.

If after the second course of treatment, the ductus arteriosus is still not closed, a surgery may then be proposed.

If your baby is administered more Pedea than they should:

If your baby is administered more Pedea than they should, speak to your baby’s doctor about the risks and any action that need to be taken. The symptoms of overdose can include drowsiness, loss of consciousness, coma, convulsions, gastrointestinal problems, slow heart rate, low blood pressure, breathing problems or stopped breathing, blood in the urine, inability of kidneys to work properly, excess acid in the blood, and low levels of potassium in the blood.

❗ 4. Possible side effects

Like all medicines, Pedea can cause side effects, although not everybody gets them. However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data)

Very common

• Decrease in the number of platelets in the blood (thrombocytopenia),
• Decrease in white blood cells called neutrophils (neutropenia),
• Increase in creatinine level in the blood,
• Decrease in sodium level in the blood,
• Breathing problems (bronchopulmonary dysplasia),

Common

• Bleeding inside the skull (intraventricular haemorrhage) and brain injury (periventricular leukomalacia),
• Bleeding in the lung,
• Perforation of the intestine and injury of intestinal tissue (necrotizing enterocolitis),
• Reduced volume of urine passed, blood in the urine, fluid retention

Uncommon

• Acute failure of the kidney’s functions
• Bleeding in the intestine
• Below normal oxygen content in the arterial blood (hypoxemia)

Not known

• Perforation of the stomach
• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute 20 generalised exanthematous pustulosis). Stop using Pedea if you develop these symptoms and seek medical attention immediately. See also section 2.
• Drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS syndrome include skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your baby’s doctor or your pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or your 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 Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. H ow to store P edea

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

After opening, Pedea should be administered immediately.

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. C ontents of the pack and other information

What Pedea contains

• The active substance is ibuprofen. Each ml contains 5 mg ibuprofen. Each 2 ml ampoule contains 10 mg ibuprofen.
• The other ingredients are trometamol, sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid 25% (for pH adjustment) and water for injections.

What Pedea looks like and contents of the pack

Pedea 5mg/ml solution for injection is a clear, colourless to slightly yellow solution.

Pedea 5mg/ml solution for injection is supplied in cartons of four 2 ml ampoules.

Marketing Authorisation Holder

Recordati Rare Diseases Tour Hekla 52, avenue du Général de Gaulle F- 92800 Puteaux France

Manufacturer

Recordati Rare Diseases Tour Hekla 52, avenue du Général de Gaulle F-92800 Puteaux France or Recordati Rare Diseases Eco River Parc 30, rue des Peupliers F-92000 Nanterre France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder :

Belgique/België/Belgien Recordati Tél/Tel: +32 2 46101 36 Lietuva Recordati AB.

Tel: + 46 8 545 80 230 Švedija България Recordati Rare Diseases Tel: + 33 (0)1 47 73 64 58 Франция Luxembourg/Luxemburg Recordati Tél/Tel: +32 2 46101 36 Belgique/Belgien Česká republika Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francie Magyarország Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Franciaország Danmark Recordati AB.

Tlf.: +46 8 545 80 230 Sverige Malta Recordati Rare Diseases Tel: +33 1 47 73 64 58 Franza Deutschland Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Nederland Recordati Tel: +32 2 46101 36 België Eesti Recordati AB.

Tel: + 46 8 545 80 230 Rootsi Norge Recordati AB.

Tlf : +46 8 545 80 230 Sverige Ελλάδα Recordati Rare Diseases Tηλ: +33 (0)1 47 73 64 58 Γαλλία Österreich Recordati Rare Diseases Germany GmbH Tel: +49 731 140 554 0 Deutschland España Recordati Rare Diseases Spain S.L. U.

Tel: + 34 91 659 28 90 Polska Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 Francja France Portugal 22 Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Recordati Rare Diseases SARL Tel: +351 21 432 95 00 Hrvatska Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francuska România Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Franţa Ireland Recordati Rare Diseases Tel: +33 (0)1 47 73 64 58 France Slovenija Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francija Ísland Recordati AB.

Simi:+46 8 545 80 230 Svíþjóð Slovenská republika Recordati Rare Diseases Tél: +33 (0)1 47 73 64 58 Francúzsko Italia Recordati Rare Diseases Italy Srl Tel: +39 02 487 87 173 Suomi/Finland Recordati AB.

Puh/Tel : +46 8 545 80 230 Sverige Κύπρος Recordati Rare Diseases Τηλ : +33 1 47 73 64 58 Γαλλία Sverige Recordati AB.

Tel : +46 8 545 80 230 Latvija Recordati AB.

Tel: + 46 8 545 80 230 Zviedrija

This leaflet was last revised in

Detailed info rmation on this medicine is available on the European medicines Agency website: https://ema.europa.eu The following information is intended for medical or healthcare professionals only:

As for all parenteral products, ampoules of Pedea should be visually inspected for particulate matter and the integrity of the container prior to use. Ampoules are intended for single use only, any unused portions must be discarded.

Posology and method of administration (see also section 3) For intravenous use only. Treatment with Pedea can only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.

A course of therapy is defined as three intravenous doses of Pedea given at 24- hour intervals.

The ibuprofen dose is adjusted to the body weight as follows:

23 – 1st injection: 10 mg/kg,

• 2nd and 3rd injections: 5 mg/kg.

If the ductus arteriosus does not close 48 hours after the last injection or if it re -opens, a second course of 3 doses, as above, may be given.

If the condition is unchanged after the second course of therapy, surgery of the PDA may then be necessary.

If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels.

Method of administration:

Pedea should be administered as a short infusion over 15 minutes, preferably undiluted. To facilitate the administration an infusion pump may be used.

If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. Any unused portion of the solution should be discarded.

The total volume of solution injected to preterm infants should take into account the total daily fluid volume administered. A maximal volume of 80 ml/kg/day on the first day of life should usually be respected; this should be progressively increased in the following 1- 2 weeks (about 20 ml/kg birthweight/day) up to a maximal volume of 180 ml/kg birthweight/day.

Incompatibilities Chlorhexidine must not be used to disinfect the neck of the ampoule as it is not compatible with the Pedea solution. Therefore, for asepsis of the ampoule before use, ethanol 60% or isopropyl alcohol 70% is recommended.

When disinfecting the neck of the ampoule with an antiseptic, to avoid any interaction with the Pedea solution, the ampoule must be completely dry before it is opened.

This medicinal product must not be mixed with other medicinal products except sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.

In order to avoid any substantial variation of pH due to the presence of acidic medicinal products that could remain in the infusion line, the latter must be rinsed before and after administration of Pedea with 1.5 to 2 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Pedea (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/04/284).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.