PAIDOFEN CHILDREN 100 MG/5 ML ORAL SUSPENSION STRAWBERRY FLAVOUR SUGAR FREE 1 BOTTLE OF 150 ML WITH DOSING SYRINGE

Name
PAIDOFEN Children 100mg/5ml oral suspension strawberry flavour sugar free
PAIDOFEN Children 100mg/5ml oral suspension orange flavour sugar free
Ibuprofen


What it is and what it is used for
PAIDOFEN contains ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) whose action allows to reduce pain, fever and inflammation.

This medicine is indicated for the treatment of symptoms of fever and mild to moderate pain in children aged 3 months to 12 years.


What you need to know before taking the medicine
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen.
Stop Paidofen immediately and contact your doctor or medical emergency immediately if you notice any of these signs.

Do not take/give your child PAIDOFEN:
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
- if the child is less than 3 months old or weighs less than 5.6 kg (See the section "How to use PAIDOFEN");
- if you are allergic to medicines such as acetylsalicylic acid or to other similar medicines (analgesics, antipyretics, non-steroidal anti-inflammatory drugs), especially if you have had nose problems such as nasal polyps and asthma (See section "Warnings and precautions");
- if you suffer from stomach ulcer (active peptic ulcer);
- if you suffer from severe kidney or liver disease (renal or hepatic failure);
- if you suffer from severe heart disease (heart failure);
- if you have suffered in the past from blood loss (haemorrhage), perforation of the stomach or intestine or if you have suffered recurrent stomach bleeding or ulcers (two or more distinct episodes of proven ulceration or bleeding);
- if you are being treated with other anti-inflammatory medicines (NSAIDs, including specific COX-2 inhibitors) (See the sections "Warnings and precautions" and "Other medicines and PAIDOFEN");
- If you have any disease that increases the risk of bleeding;
- In case of unclear blood disorders;
- If you are severely dehydrated, for example if you have had severe vomiting, diarrhoea or if you drink very little.

Pregnancy, breastfeeding and fertility
• Do not take Paidofen during the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery:
- It can cause kidney and heart problems in the unborn baby.
- May affect the bleeding tendency of mother and baby
- and cause labor to be delayed or take longer than expected.

You should not take Paidofen during the first 6 months of pregnancy unless strictly necessary and advised by your doctor. If treatment is necessary during this period or while trying to become pregnant, the lowest possible dose should be used for the shortest possible time.

If taken for more than a few days from 20 weeks of pregnancy onwards, Paidofen may cause kidney problems in the unborn baby which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.


Warnings and precautions
Talk to your doctor or pharmacist before taking or administering PAIDOFEN to your child if:

• you suffer or have suffered from allergy to medicines used to treat fever, pain and inflammation (non-steroidal anti-inflammatory drugs) and if you suffer from difficulty breathing (asthma), polyps in the nose or angioedema)
• are taking other medicines used to treat pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see section "Other medicines and PAIDOFEN");
• have suffered from stomach and intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation as an increase in gastrointestinal bleeding and perforation may occur. In these cases, your doctor will advise you to start treatment with the lowest available dose and possibly the concomitant use of medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if you are taking low dose aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section "Other medicines and PAIDOFEN"). Bleeding, ulceration and perforation of the stomach or intestine, which can be fatal, may occur at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. Therefore, tell your doctor about any uncommon gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with PAIDOFEN and contact your doctor;
• suffer or have suffered from an inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these diseases may worsen (see section "Possible side effects");
• if you are taking medicines that may increase the risk of ulcers or bleeding, such as medicines used to treat inflammation and certain immune system diseases (oral corticosteroids), anticoagulants such as warfarin, medicines that may have an antiplatelet effect such as aspirin, medicines to treat depression (selective serotonin reuptake inhibitors) (see section "Other medicines and PAIDOFEN");
• have heart disease (uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease) or have had reduced blood flow to the brain (stroke), or if you think your child may be at risk of these conditions (for example, if you have high blood pressure, high levels of sugar (diabetes) or fat in the blood, or if you smoke). Medicines like PAIDOFEN may be associated with a small increased risk of heart attack or reduced blood flow to the brain: the risk is more likely at high doses. Do not exceed the recommended dose or duration of treatment;
• suffer or have suffered from high blood pressure and/or severe heart disease (heart failure) since fluid retention, high blood pressure and swelling (oedema) have been reported in association with NSAID therapy;
• have an infection – see section “Infections below”.

Infections
Paidofen may hide the symptoms of infections such as fever and pain. It is therefore possible that Paidofen may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.

Skin reactions
Serious skin reactions have been reported in association with Paidofen treatment. Stop taking Paidofen and contact a doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy as these may be the first signs of a very serious skin reaction. See section 4. Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with Ibuprofen treatment. Stop using Paidofen and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration of treatment necessary to control symptoms. Use PAIDOFEN with caution and tell your doctor if you or your child:
- have had stomach or intestinal problems in the past such as ulcers, perforations or bleeding. If your child is being treated with other medicines that can cause stomach and intestinal problems, your doctor may prescribe medicines that protect the stomach (misoprostol or proton pump inhibitors) (See the section "Other medicines and PAIDOFEN");
- suffer from asthma. PAIDOFEN may cause breathing problems in this case;
- has problems with blood clotting;
- suffer from kidney disease, heart disease, high blood pressure or are being treated with medicines called diuretics. In these cases, serious kidney problems may occur (critical reduction of kidney function, nephrotoxicity or fluid retention);
- suffers from liver disease;
- is dehydrated (for example due to fever, vomiting or diarrhoea). In this case, your child will need to be rehydrated before starting and during treatment.

In case of prolonged treatments with PAIDOFEN you must pay particular attention and inform your doctor immediately if the following appear:
- signs or symptoms of ulcers or bleeding in your stomach or intestines; - signs or symptoms of liver problems;
- signs or symptoms of kidney damage;
- vision disturbances (blurred or reduced vision, areas of complete or partial blindness, alterations in color perception);
- signs or symptoms of meningitis, a serious inflammation of the meninges. Symptoms may include fever, neck tension, headache, vomiting and disorientation. Ibuprofen can rarely cause aseptic meningitis; this inflammation is more common in people with systemic lupus erythematosus or other collagen diseases (See the section "Possible side effects").

Elderly people
This medicine is intended for children, however it may be used in the elderly.
If you are elderly, you may be more likely to experience some side effects such as bleeding and perforation of the stomach or intestine, even serious ones, following treatment with medicines such as PAIDOFEN.
These effects may occur especially at high doses of PAIDOFEN or if you have suffered in the past from ulcers, haemorrhages and perforations of the stomach or intestine (See the section "Possible side effects").
If you are elderly, take the lowest possible dose of this medicine. In elderly people, the use of medicines that protect the stomach (misoprostol or proton pump inhibitors) is recommended.
Tell your doctor if you have stomach or intestinal problems, especially if you have had ulcers, bleeding or perforation of the stomach or intestine in the past.

Children and adolescents
In dehydrated children and adolescents there is a risk of impaired renal function.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your child experiences any of the following side effects STOP treatment with PAIDOFEN and contact your doctor:
- non-raised, target-shaped or circular reddish patches on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- Widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome).
- A widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis)
- allergic reactions, including serious ones, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnoea), abnormal heart beat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock and worsening of asthma;
- aseptic meningitis with symptoms such as disorientation, headache, nausea, vomiting, stiff neck and fever (more common if the child suffers from systemic lupus erythematosus or other collagen diseases).

The following additional side effects may occur:

Uncommon (may affect up to 1 in 100 people):
• headache, dizziness, drowsiness and convulsions;
• stomach pain, nausea and difficulty in digesting (dyspepsia);
• skin rashes;
• vision disorders.

Rare (may affect up to 1 in 1,000 people):
• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood swings, hearing problems;
• cerebrovascular hemorrhage;
• dry eyes;
• perception of one's heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• the skin becomes sensitive to light;
• severe kidney disease including tubular necrosis, glomerular nephritis, blood in the urine and increased urine output;
• decrease in hematocrit levels.

Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of blood cells (anemia, leukopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, nosebleeds and hemorrhages;
• signs or symptoms of ulceration or bleeding of the stomach and intestines, black and foul-smelling stools, vomiting blood;
• lesions with bleeding from the mouth, heartburn (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (liver necrosis), liver disease (liver failure, liver dysfunction, hepatitis, jaundice);
• severe kidney disease (acute renal failure, papillary necrosis) particularly following long-term treatment, associated with an increase in the concentration of urea in the blood and swelling (edema);
• decrease in hemoglobin levels in the blood;
• heart attack (myocardial infarction);
• serious skin infections and soft tissue complications during chickenpox infection;
• worsening of infection-related inflammation (e.g. necrotising fasciitis) associated with the use of some non-steroidal anti-inflammatory drugs (NSAIDs). If signs of an infection appear or worsen, you should contact your doctor immediately to assess whether anti-infective/antibiotic therapy is necessary.

Not known (frequency cannot be estimated from the available data):
• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as buzzing, ringing or rustling (tinnitus);
• severe heart disease (heart failure) and swelling (edema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, obstruction of the larynx, shortness of breath (bronchospasm), temporary cessation of breathing (apnoea) and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease);
• inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis);
• inflammation of the esophagus (esophagitis);
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell);
• a widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).
Stop using Paidofen if you develop these symptoms and contact your doctor immediately. See also section 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of side effects
If you get 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 via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.