Medicine guide
Pedea
·
- Prescription status not stated
- Heart, blood pressure and circulation
- Active substance
- Ibuprofen
- Made by
- Recordati Rare Diseases
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Certain medicines, if given together with Pedea, may cause side effects. These are detailed below:
- 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 Pedea is administered to your baby Pedea will only be given to your baby in a special neonatal intensive care unit by qualified health care professionals.
- 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);
- 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.
- - 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’.
From the package leaflet in EMA’s product information, p. 17–18 · 2025-11-25
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (ibuprofen). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities.
Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.
Half-life1.8–2.0 h
Mostly cleared after≈ 9.5 hfive half-lives — our arithmetic
How the body breaks it down
Ibuprofen is rapidly metabolized and eliminated in the urine.
With food
When ibuprofen is administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-02-17
How to take it
These directions are for this exact strength and form. Another one is different.
- Pedea will only be given to your baby in a special neonatal intensive care unit by qualified healthcare professional.
- 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.
From the package leaflet in EMA’s product information, p. 18–19.
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 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.
From the package leaflet in EMA’s product information, p. 19–20.
How to store it
- 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.
From the package leaflet in EMA’s product information, p. 20.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Recordati Rare Diseases |
|---|---|
| Active substance | Ibuprofen |
| Used in | Heart, blood pressure and circulation |
| Classification | C01EB16 · Heart, blood pressure and circulation |
| Authorised on | 2004-07-28 |
| Last updated by the regulator | 2025-11-25 |
| EMA product number | EMEA/H/C/000549 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.