Ibuprofen Doc Generici

Patient Information Leaflet

IBUPROFENE DOCgen Children 100mg/5ml oral suspension, strawberry sugar-free, orange 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 IBUPROFENE DOCgen is and what it is used for
2. What you need to know before taking IBUPROFENE DOCgen
3. How to take IBUPROFENE DOCgen
4. Possible side effects
5. How to store IBUPROFENE DOCgen
6. Contents of the pack and other information

1. What IBUPROFENE DOCgen is and what it is used for

IBUPROFENE DOCgen contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), whose action helps reduce pain, fever, and inflammation.
IBUPROFENE DOCgen 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 need to know before taking IBUPROFENE DOCgen

Do not use IBUPROFENE DOCgen if the child

• is allergic to ibuprofen or to any of the other ingredients of this medicine listed in section 6;
• has had or is currently experiencing allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips, or throat (angioedema), or hives, particularly if associated with nasal polyps and asthma, after taking other painkillers, 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 had or is currently experiencing gastrointestinal bleeding and/or perforation following previous treatment with NSAIDs;
• has had 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 IBUPROFENE DOCgen”);
• has any illness 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 trimester of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using IBUPROFENE DOCgen if the child:

• has had or currently suffers from an 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 IBUPROFENE DOCgen”);
• has had stomach or intestinal problems (history of ulcers), 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 IBUPROFENE DOCgen”). During treatment with any NSAID, gastrointestinal bleeding, ulceration, and perforation may occur at any time, with or without warning symptoms or previous history of serious gastrointestinal events, and may be fatal. Therefore, inform the doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, discontinue treatment with IBUPROFENE DOCgen and contact the doctor immediately;
• has had or currently suffers from inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section “Possible side effects”);
• is taking medicines that may increase the risk of ulcer or bleeding, such as oral corticosteroids (used to treat inflammation and some immune system disorders), anticoagulants such as warfarin, medicines with antiplatelet effects such as aspirin, or antidepressants (selective serotonin reuptake inhibitors) (see section “Other medicines and IBUPROFENE DOCgen”);
• has heart disease (uncontrolled hypertension, congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease) or has had reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g., high blood pressure, high blood sugar (diabetes), high blood lipid levels, or smoking). Medicines such as IBUPROFENE DOCgen may be associated with a slight increase in the risk of heart attack or stroke: the risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• has high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported with NSAID therapy;
• has chickenpox, as use of IBUPROFENE DOCgen should be avoided in this case;
• has an infection – see section “Infections” below.

Infections
IBUPROFENE DOCgen may mask symptoms of infections such as fever and pain. Therefore,
IBUPROFENE DOCgen 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, consult your doctor immediately.
Severe skin reactions have been reported in association with treatment with IBUPROFENE
DOCgen. Discontinue use of IBUPROFENE DOCgen and consult your doctor immediately if
rash, mucosal lesions, blisters, or other signs of allergy appear, as these may be early signs of a
serious skin reaction. See section 4.
The use of IBUPROFENE DOCgen requires adequate precautions, especially if the child:

• has asthma, as breathing difficulties may worsen;
• has blood clotting disorders;
• has kidney, heart, or liver disease, is taking diuretics (medicines that increase urine production), or has undergone major surgery resulting in fluid loss, as the doctor may recommend periodic blood and urine tests;
• has undergone major surgery;
• has 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 IBUPROFENE DOCgen, 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, 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 color 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 vascular diseases).

Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Other medicines and IBUPROFENE DOCgen
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicine.
IBUPROFENE DOCgen 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). These combinations should be avoided as they increase the risk of adverse effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• antibiotics known as quinolones, used to treat bacterial infections;
• anticoagulant medicines (i.e., substances that thin the blood and prevent clotting, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• antidepressants such as selective serotonin reuptake inhibitors (SSRIs);
• phenytoin, a medicine used to treat seizures;
• antidiabetic medicines for high blood sugar (sulfonylureas);
• antiviral medicines for HIV (ritonavir and zidovudine);
• immunomodulatory medicines (cyclosporine and tacrolimus);
• methotrexate, a medicine used to treat cancer and rheumatism;
• lithium, a medicine used for mental disorders;
• mifepristone, a medicine used for medical abortion: do not take NSAIDs within 8–12 days after taking mifepristone;
• probenecid and sulfinpyrazone, medicines used to treat gout;
• medicines for high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor 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 the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen;
• medicines used to treat heart conditions (cardiac glycosides such as digoxin).

IBUPROFENE DOCgen with food and drinks
The medicine can be taken 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, planning to become pregnant, or 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 beyond normal.
You should not take IBUPROFENE DOCgen 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 time should be used. From week 20 of pregnancy, IBUPROFENE DOCgen may cause kidney problems in the fetus if taken for more than a few days, reducing the level of amniotic fluid surrounding the baby (oligohydramnios), or causing constriction 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.
IBUPROFENE DOCgen contains:
Maltitol liquid: if your doctor has diagnosed you with an 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 daily dietary intake recommended for an adult.
Sodium benzoate: this medicine contains 2.5 mg of sodium benzoate per 2.5 ml dose, equivalent to 15 mg for the 15 ml dose.
IBUPROFENE DOCgen Children 100mg/5ml orange-flavoured sugar-free oral suspension also contains orange flavour, which in turn contains linalool and citrale, which may cause allergic reactions.

3. How to take IBUPROFENE DOCgen

Take 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 weighing more than 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 supplied with the product.

The daily dose of 20–30 mg/kg body weight, divided into three doses daily at intervals of 6–8 hours, can 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 the child suffers from stomach problems, administer IBUPROFENE DOCgen preferably during meals.
In 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.
IBUPROFENE DOCgen should be administered for short-term treatment only.
Adverse 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 observe any improvement or if you notice 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 it downwards and turning it to the left.
2. Insert the tip of the syringe fully into the hole of 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 completely and store it out of sight and reach of children.

If you take more IBUPROFENE DOCgen than you should
If you have taken more IBUPROFENE DOCgen than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice regarding potential risks and necessary actions.
Symptoms may include nausea, stomach ache, 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. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, it may cause: uncontrolled eye movements (nystagmus), increased levels of acid in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney-related effects, bleeding in the stomach and intestines, deep loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur.
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 will experience them.
If the child experiences any of the following side effects, STOP treatment with IBUPROFENE DOCgen and consult a doctor immediately:

• severe skin and mucous membrane disorders characterized by rashes, redness, itching, and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
• allergic reactions, even severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth, and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness, and fever (more frequent if the child has systemic lupus erythematosus or other collagenopathies).

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

• headache, dizziness, drowsiness, and seizures
• stomach pain, nausea, and indigestion (dyspepsia)
• skin rashes
• visual disturbances

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

• cystitis, rhinitis
• depression, insomnia, difficulty concentrating, mood instability, hearing disturbances
• 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 haematocrit levels

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 include: 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, stomach burning (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 after long-term treatment, associated with increased blood urea concentration and swelling (oedema)
• decreased haemoglobin levels in blood
• heart attack (myocardial infarction)
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of infections-related inflammation (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, consult a doctor immediately to assess whether anti-infective/antibiotic therapy is needed.

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

• irritability
• fluid retention and loss of appetite
• abnormal perception of noises such as buzzing, ringing, or hissing (tinnitus)
• severe heart disease (heart failure) and swelling (oedema)
• 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 formation of pustules under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular exanthema). Stop using IBUPROFENE DOCgen if these symptoms develop 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).
• The skin becomes sensitive to light.

The 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 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store IBUPROFENE DOCgen

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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What IBUPROFENE DOCgen contains

IBUPROFENE DOCgen Children 100 mg/5 ml oral suspension, strawberry flavour, 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, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavour, maltitol syrup, glycerin, purified water.

IBUPROFENE DOCgen Children 100 mg/5 ml oral suspension, orange flavour, 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, acesulfame potassium, xanthan gum, sodium benzoate, orange flavour, maltitol syrup, glycerin, purified water.

Description of the appearance of IBUPROFENE DOCgen and contents of the pack
The pack contains one 150 ml bottle of white or almost white suspension and a dosing syringe.
Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (FR)