Dolibloc

Patient Information Leaflet

DOLIBLOC Children 100 mg/5 ml oral suspension, strawberry flavour, sugar-free, Children 100 mg/5 ml oral suspension, orange flavour, sugar-free

Ibuprofen
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after:
  • 24 hours in infants aged 3 to 5 months
  • 3 days in infants and children over 6 months of age and in adolescents.

Contents of this leaflet:

1. What DOLIBLOC is and what it is used for
2. What you need to know before taking DOLIBLOC
3. How to take DOLIBLOC
4. Possible side effects
5. How to store DOLIBLOC
6. Contents of the pack and other information

1. What DOLIBLOC is and what it is used for

Dolibloc contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This class of medicines helps reduce pain, fever, and inflammation.
DOLIBLOC is indicated in children from 3 months to 12 years of age for the treatment of symptoms of fever and mild to moderate pain.

2. What you should know before taking DOLIBLOC

Do not use DOLIBLOC if the child

• is allergic to ibuprofen or to any of the other ingredients of this medicine listed in section 6;
• has had or currently experiences allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips, and throat (angioedema), or urticaria, particularly if associated with nasal polyps and asthma, after taking other analgesics, antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• suffers from severe kidney or liver disease (renal or hepatic insufficiency);
• suffers from severe heart disease (heart failure);
• has suffered or currently suffers from stomach and/or intestinal bleeding (gastrointestinal haemorrhage) or perforation following previous treatment with NSAIDs;
• has suffered or currently suffers from gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
• is currently taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section “Other medicines and Dolibloc”);
• has any condition that increases the risk of bleeding;
• has unexplained blood disorders;
• is in a state of severe dehydration, for example, after severe episodes of vomiting, diarrhoea, or very low fluid intake;
• is under 3 months of age or weighs less than 5.6 kg;
• is in the last three months of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using DOLIBLOC if the child:

• has a history of allergy to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), or suffers from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, severe respiratory or chest problems such as chronic obstructive pulmonary disease, or swelling of the face, lips, and throat (angioedema);
• is taking other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors) (see section “Other medicines and Dolibloc”);
• has had stomach or intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation, as this may increase the risk of gastrointestinal bleeding and perforation. In such cases, the doctor may advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if the child is taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal disorders (see section “Other medicines and Dolibloc”). During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration, and perforation of the stomach or intestine may occur, which can be fatal. Therefore, inform the doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Dolibloc and contact the doctor immediately;
• suffers or has suffered from inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section “Possible side effects”);
• is taking medicines that could increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants like warfarin, medicines with antiplatelet effects such as aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and Dolibloc”);
• has heart disease (uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease) or has suffered from reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g., if the child has high blood pressure, high blood sugar levels (diabetes), high blood lipid levels, or smokes). Medicines like Dolibloc may be associated with a slight increase in the risk of heart attack or stroke: the risk is higher at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• suffers or has suffered from high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (oedema) have been reported with NSAID therapy;
• has chickenpox, as use of Dolibloc should be avoided in this case;
• has an infection – see section “Infections” below.

Infections
Dolibloc may mask symptoms of infections such as fever and pain. Therefore, Dolibloc may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Signs of an allergic reaction to this medicine, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop taking Dolibloc immediately and contact your doctor or emergency medical services if you notice any of these signs.

Take special care with Dolibloc:
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Dolibloc and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Serious skin reactions have been reported with Dolibloc treatment. Stop taking Dolibloc and consult your doctor immediately if a rash, mucosal lesions, blisters, or other signs of allergy appear, as these may be early signs of a severe skin reaction. See section 4. The use of Dolibloc requires adequate precautions, especially if the child:

• suffers or has suffered from asthma, as breathing difficulties may worsen;
• has coagulation disorders;
• has kidney, heart, or liver disease, is taking medicines that increase urine production (diuretics), or has undergone major surgery resulting in fluid loss, as in these cases the doctor may recommend periodic blood and urine tests;
• has undergone major surgery;
• suffers from certain congenital disorders affecting blood formation (e.g., acute intermittent porphyria);
• is dehydrated (e.g., due to fever, vomiting, or diarrhoea); in this case, rehydrate the child before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatment with Dolibloc, pay particular attention and inform the doctor immediately if any of the following occur:

• signs or symptoms of stomach or intestinal ulceration or bleeding (e.g., black, tarry, foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g., hepatitis, jaundice);
• signs or symptoms of kidney damage (e.g., increased urine production, blood in urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, altered colour perception);
• symptoms such as frequent or daily headaches despite regular use of headache medicines, which may be caused by excessive use of these medicines;
• symptoms such as headache, disorientation, nausea, vomiting, neck stiffness, and fever, as these may indicate aseptic meningitis (more common if the child has systemic lupus erythematosus or other collagen diseases).

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

Other medicines and DOLIBLOC
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.
Dolibloc may interact with or be affected by other medicines. In particular, inform your doctor or pharmacist if the child is taking:

• other medicines used to treat pain, reduce fever, and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid). Such combinations should be avoided, as they increase the risk of adverse effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• medicines used to treat bacterial infections (quinolone antibiotics);
• medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine used to treat seizures (phenytoin);
• antidiabetic medicines to treat high blood sugar levels (sulfonylureas);
• medicines used to treat viral infections (HIV) (ritonavir and zidovudine);
• medicines that modulate the immune response (cyclosporine and tacrolimus);
• a medicine used to treat cancer and rheumatic diseases (methotrexate);
• a medicine used for mental disorders (lithium);
• a medicine used to terminate pregnancy (mifepristone): do not take NSAIDs within 8–12 days after taking mifepristone;
• medicines used to treat gout (probenecid and sulfinpyrazone);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan) and diuretics;
• potassium-sparing diuretics;
• CYP2C9 inhibitors (e.g., voriconazole, fluconazole), as concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen;
• medicines used to treat heart conditions (cardiac glycosides such as digoxin).

Dolibloc with food and drinks
The medicine can be administered with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the medicine with food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
It is unlikely that girls under 12 years of age will be pregnant or breastfeeding. In such a case, do not take this medicine during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your or your baby’s tendency to bleed and may delay or prolong labour.
DOLIBLOC should not be used during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From week 20 of pregnancy, DOLIBLOC may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
This medicine passes into breast milk in small amounts. It may be taken during breastfeeding if used at the recommended doses and for short periods.

Fertility
This medicine belongs to a group of drugs (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the drug.

DOLIBLOC contains:

• Maltitol liquid: If your doctor has diagnosed you with intolerance to certain sugars, consult him before taking this medicine.
• Sodium: This medicine contains 4.51 mg of sodium (a main component of table salt) per 2.5 ml dose. This corresponds to 0.23% of the maximum recommended daily dietary intake for an adult.
• Sodium benzoate: This medicine contains 2.5 mg of sodium benzoate per 2.5 ml dose, equivalent to 15 mg in the 15 ml dose.

DOLIBLOC Bambini 100mg/5ml orange-flavoured sugar-free oral suspension also contains orange flavouring, which in turn contains linalool and citral, substances that may cause allergic reactions.

3. How to take DOLIBLOC

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

• In children aged between 3 and 6 months, limit administration to those with a body weight above 5.6 kg.
• The daily oral dose for infants and children aged between 3 months and 12 years can be administered using the dosing syringe provided with the product.

The daily dose of 20–30 mg/kg body weight, divided into three doses daily at intervals of 6–8 hours, may be administered according to the following schedule (calculate the dose to be administered based on the weight shown in the table and the child's age).

The graduated scale on the syringe clearly shows markings for different dosages; in particular, the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of ibuprofen.
If your child suffers from stomach problems, administer Dolibloc preferably during meals.
In the case of post-vaccination fever, refer to the dosage indicated above, administering a single dose (2.5 ml), followed, if necessary, by another dose after 6 hours. Do not administer more than two doses within 24 hours. Consult your doctor if fever does not decrease.
Dolibloc should be administered for short-term treatment only.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Contact your doctor if you do not notice improvement or if you observe worsening of symptoms after:

• 24 hours in infants aged between 3 and 5 months
• 3 days in infants and children over 6 months of age and in adolescents

Instructions for using the dosing syringe (see figure below):

1. Unscrew the cap by pushing downwards and turning to the left.
2. Insert the tip of the syringe fully into the hole in the inner cap.
3. Shake well.
4. Invert the bottle, then, holding the syringe firmly, gently pull the plunger downwards to draw the suspension into the syringe up to the mark corresponding to the desired dose.
5. Return the bottle to an upright position and remove the syringe by gently rotating it.
6. Insert the tip of the syringe into the child's mouth, and gently press the plunger to dispense the suspension.
7. After use, screw the cap back on to close the bottle and wash the syringe with warm water. Allow the syringe to dry, and store it out of sight and reach of children.

If you take more DOLIBLOC than you should
If you have taken more DOLIBLOC than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the potential risk and guidance on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), deep drowsiness with reduced response to normal stimuli (lethargy), headache, ringing in the ears, confusion, and uncontrolled eye movements (nystagmus). At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, decreased blood potassium levels (hypokalaemia), feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Other possible symptoms include: increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney-related effects, bleeding in the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhoea, reduced activity of the nervous system and respiratory function, disorientation, excitability, fainting, low blood pressure (hypotension), and decreased or increased heart rate (bradycardia or tachycardia).
Additionally, reduced blood coagulation (prolonged prothrombin time) may occur.
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur.
In patients with asthma, the condition may worsen.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using ibuprofen and consult your doctor immediately if you notice that the child experiences any of
the following symptoms:

• flat, red, target-shaped or circular spots on the trunk, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (bullous dermatitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis);
• allergic reactions, even severe, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, stiff neck and fever (more frequent if the child has systemic lupus erythematosus or other collagen diseases).

Other side effects include:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness and convulsions
• stomach pain, nausea and difficulty digesting (dyspepsia)
• skin rashes
• visual disturbances

Rare (may affect up to 1 in 1,000 people):

• cystitis, rhinitis
• depression, insomnia, difficulty concentrating, mood instability, hearing disorders
• cerebral haemorrhage
• dry eyes
• awareness of heartbeat (palpitations)
• diarrhoea, flatulence, dry mouth, constipation and vomiting
• hair loss (alopecia), skin reaction caused by exposure to sunlight (photosensitivity dermatitis)
• severe kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine and increased urine production
• decreased levels of haematocrit

Very rare (may affect up to 1 in 10,000 people):

• reduction in the number of blood cells (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood
• bleeding lesions in the mouth, heartburn (gastritis)
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, hepatic dysfunction, hepatitis, jaundice)
• severe kidney diseases (acute renal failure, papillary necrosis), particularly following long-term treatment, associated with increased blood urea concentration and swelling (oedema)
• decreased levels of haemoglobin in the blood
• heart attack (myocardial infarction)
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of inflammation related to infections (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, consult your doctor immediately to determine whether anti-infective/antibiotic therapy is needed.

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

• irritability
• fluid retention and decreased appetite
• abnormal perception of noises such as ringing, buzzing or hissing sounds (tinnitus)
• severe heart disease (heart failure) and swelling (oedema), chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• increased blood pressure (hypertension) and reduced blood flow to the body (shock)
• respiratory tract disorders including asthma, laryngeal obstruction, laboured breathing (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 oesophagus (oesophagitis)
• a widespread, red, scaly rash with pustule formation under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using Dolibloc if you develop these symptoms and contact your doctor immediately. See also section 2.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells).
• Skin becomes sensitive to light.

The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a modest increase in the
risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOLIBLOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening the bottle, store for a maximum of: 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DOLIBLOC contains
Dolibloc Bambini 100 mg/5 ml oral suspension, strawberry-flavoured, sugar-free

• The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components are citric acid monohydrate, sodium citrate, potassium acesulfame, xanthan gum, sodium benzoate, strawberry flavour, maltitol syrup, glycerin, purified water.

Dolibloc Bambini 100 mg/5 ml oral suspension, orange-flavoured, sugar-free

• The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components are citric acid monohydrate, sodium citrate, potassium acesulfame, xanthan gum, sodium benzoate, orange flavour, maltitol syrup, glycerin, purified water.

Description of the appearance of DOLIBLOC and contents of the pack
The pack contains one 150 ml bottle of white or almost white suspension and an oral dosing syringe.
Marketing Authorization Holder
Epifarma S.r.l. - Via S. Rocco, 6 - 85033 Episcopia (PZ)
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)