Kidofen

Leaflet attached to the packaging: patient information

Kidofen 100 mg/5 ml, oral suspension

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Kidofen and what is it used for
• 2. Important information before taking Kidofen
• 3. How to take Kidofen
• 4. Possible side effects
• 5. How to store Kidofen
• 6. Contents of the packaging and other information

1. What is Kidofen and what is it used for

Kidofen is a pain-relieving, antipyretic, and anti-inflammatory medicine. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine contains the active substance ibuprofen.

Indications for use

Fever of various origins (also in the course of viral infections, in the course of post-vaccination reactions).
Pains of various origins of mild to moderate severity:

• headaches, throat and muscle pains, e.g. in the course of viral infections;
• muscle, joint, and bone pains, as a result of injuries to the musculoskeletal system (sprains, strains);
• pains due to injuries to soft tissues, post-operative pains;
• toothaches, pains after dental procedures, pains due to teething;
• headaches;
• ear pains occurring in middle ear inflammatory conditions.

Kidofen is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, the patient should consult a doctor.

2. Important information before taking Kidofen

When not to take Kidofen

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has experienced shortness of breath, asthma, rhinitis, or hives after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,

because Kidofen may cause similar side effects in these patients;

• if the patient has or has had stomach or duodenal ulcers or bleeding ulcers;
• if the patient has ever had bleeding from the gastrointestinal tract;
• if the patient has ever had perforation of the stomach or intestine wall associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has severe liver or kidney failure;
• if the patient has severe heart failure;
• if the patient is taking other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors such as celecoxib or etoricoxib;
• if the patient is in the third trimester of pregnancy;
• if the patient has a bleeding disorder (blood clotting disorders).

Warnings and precautions

During the use of ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling in the face and neck area (angioedema), chest pain.
In case of any of these symptoms, the patient should immediately stop taking Kidofen
and contact a doctor or emergency medical services immediately.
Before starting to take Kidofen, the patient should discuss it with their doctor or pharmacist:

• if the patient has certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease);
• if the patient has stomach and/or intestinal diseases (such as chronic enteritis, ulcerative colitis, Crohn's disease, characterized by, among other things, chronic diarrhea), rectal and anal diseases, as the risk of gastrointestinal bleeding increases;
• if the patient has hypertension and/or heart function disorders due to fluid retention;
• if the patient has liver and/or kidney function disorders;
• if the patient has blood clotting disorders (ibuprofen may prolong bleeding time);
• if the patient has asthma or allergies (current or past), as taking the medicine may cause bronchospasm;
• if the patient is taking other medicines that may increase the risk of stomach and intestinal disorders or bleeding, such as corticosteroids or anticoagulant medicines like acenocoumarol or antiplatelet agents like acetylsalicylic acid, diuretics, or cardiac glycosides;
• if the patient is over 65 years old, as the risk of adverse reactions to the medicine increases, especially gastrointestinal bleeding and perforation of the stomach or duodenal wall, which can be fatal. The patient should inform their doctor about any unusual symptoms related to the gastrointestinal tract (especially bleeding, pain), especially during the initial treatment period;
• if the patient has chickenpox or another infection - see below, "Infections" section.

Infections
Kidofen may mask the symptoms of an infection, such as fever and pain. As a result, Kidofen may
delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.
Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, they should immediately stop taking Kidofen and seek medical attention.
During the use of Kidofen, the patient should follow the warnings below:

• if the patient experiences headaches during long-term use of high doses of painkillers - they should not be relieved by increasing the dose of the painkiller;
• if the patient experiences a rash, mucosal damage, or other skin reactions, they should immediately consult a doctor (see section 4);
• if the patient experiences vision disturbances, they should consult an ophthalmologist.

If the patient has heart disease, has had a stroke, or is at risk of these conditions (e.g. has high blood pressure, diabetes, high cholesterol, smokes), they should consult a doctor before taking this medicine.
In elderly patients, the dose of the medicine can be reduced, using the smallest possible therapeutic dose for the shortest possible period, in order to reduce the risk of adverse reactions.

Children

The medicine should not be used in children under 6 months of age without consulting a doctor.

Kidofen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take the following medicines at the same time as Kidofen. Kidofen may affect the action of other medicines and vice versa. The patient should inform their doctor if they are taking any of the following medicines.

Medicines that may increase the risk of gastrointestinal bleeding:

• acetylsalicylic acid (used to relieve pain and reduce fever);
• other non-steroidal anti-inflammatory drugs (NSAIDs);
• corticosteroids (steroid medicines used to treat, among other things, asthma);
• antiplatelet agents (medicines that reduce the risk of blood clots);
• selective serotonin reuptake inhibitors (medicines used to treat depression);
• selective cyclooxygenase-2 inhibitors (medicines used to treat rheumatic diseases).

Medicines that may cause kidney damage:

• tacrolimus (a medicine used to treat, among other things, atopic dermatitis);
• cyclosporine (a medicine used in patients after organ transplantation).

Kidofen may enhance the effect of:

• anticoagulant medicines (medicines that prevent blood clotting, such as warfarin);
• lithium (a medicine used to treat depression);
• methotrexate (a medicine used to treat certain cancers and rheumatoid arthritis).

Kidofen may reduce the effectiveness of:

• blood pressure-lowering medicines;
• diuretics (medicines that increase urine production), as there is an increased risk of kidney function disorders, such as high potassium levels in the blood (hyperkalemia). If such a disorder occurs, the patient should drink plenty of fluids;
• mifepristone (a medicine with abortifacient action).

Do not take Kidofen at the same time as:

• zidovudine (a medicine used to treat HIV infection), as it may prolong bleeding time;
• cardiac glycosides: NSAIDs may increase the symptoms of heart failure and increase the level of cardiac glycosides in the blood;
• quinolone antibiotics: as it increases the risk of seizures;
• probenecid and sulfinpyrazone (medicines used to treat gout), as they may delay the excretion of ibuprofen;
• sulfonylurea derivatives (medicines used to treat diabetes).

If the patient is unsure whether they are taking any of the above medicines, they should consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Kidofen should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and their child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Kidofen should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From

• the 20th week of pregnancy, Kidofen may cause the unborn child to have a narrowing of the arterial duct in the heart or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for a longer period than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. No harmful effects on the baby have been reported, so breastfeeding can be continued during short-term use of ibuprofen for pain and fever relief.
Fertility
Kidofen may make it more difficult to become pregnant. If the patient plans to become pregnant or has had difficulty becoming pregnant, they should inform their doctor.

Driving and using machines

Kidofen has no or negligible influence on the ability to drive and use machines. If the patient experiences drowsiness, dizziness, or vision disturbances, they should not drive or operate machinery.

Kidofen contains sucrose, sodium benzoate, sodium, and orange yellow (E 110)

Sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Sodium benzoate

The medicine contains 10 mg of sodium benzoate per 5 ml of suspension.

Sodium

The medicine contains a maximum of 42.49 mg of sodium (the main component of table salt) per 45 ml of suspension.
This corresponds to 2.12% of the maximum recommended daily intake of sodium in the diet for adults.

Orange yellow (E 110)

The medicine may cause allergic reactions.

3. How to take Kidofen

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.
The patient should use the smallest effective dose for the shortest possible period necessary to relieve the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).
Do not take Kidofen for more than 3 days without consulting a doctor.
The medicine is for oral use.

Shake before use.

Recommended dose

To dose the medicine, the measuring cup provided with the packaging should be used. This allows for accurate dosing.

Children under 6 months of age should only be given Kidofen in consultation with a doctor.
Do not exceed the recommended dose.
The medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur, the patient should consult a doctor.

Taking a higher dose of Kidofen than recommended

If the patient has taken a higher dose of Kidofen than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.
Symptoms of overdose may include: nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and convulsions. It may also cause agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in the urine, low potassium levels in the blood, and difficulty breathing. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of the action of circulating clotting factors in the blood. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and difficulty breathing may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missing a dose of Kidofen

The patient should continue taking the medicine, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Kidofen can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• rash, swelling of the face, lips, or throat that makes breathing, talking, or swallowing difficult, low blood pressure, slow or fast heart rate, pallor, anxiety, sweating, dizziness, loss of consciousness, and respiratory or cardiac arrest;
• gastrointestinal bleeding (vomiting blood or coffee grounds-like material, black stools, or blood in the stool);
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• red, non-raised, patchy, or circular spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell);
• red, peeling, widespread rash with bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Uncommon (may affect up to 1 in 100 people):

• indigestion (feeling of bloating in the stomach, bloating, belching, heartburn, constipation), abdominal pain, and nausea;
• headache;
• blurred vision, double vision, color vision disturbances;
• hives and itching.

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

• diarrhea, bloating, constipation, vomiting;
• gastritis;
• dizziness, insomnia, agitation, irritability, and fatigue;
• edema.

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

• stomach and/or duodenal ulcers;
• gastrointestinal bleeding (due to perforation of the stomach or intestinal wall),

sometimes with a fatal outcome, especially in elderly patients;

• ulcerative stomatitis;
• worsening of symptoms of ulcerative colitis and Crohn's disease;
• disorders of consciousness;
• depression, emotional disorders;
• tinnitus, hearing disorders;
• reduced uric acid excretion;
• hematuria;
• reduced creatinine clearance;
• kidney failure, renal papillary necrosis;
• reduced urine output;
• polyuria;
• increased sodium levels in the blood (causing edema);
• hypertension;
• heart failure;
• liver function disorders, especially during long-term use of the medicine;
• significant reduction in the number of blood cells (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers of the mucous membranes, flu-like symptoms, fatigue, nosebleeds, or subcutaneous bleeding (e.g. bruises, petechiae, purpura);
• severe skin and soft tissue infections as a complication of chickenpox;
• stiffness of the neck, headaches, nausea, vomiting, fever, disorientation (these are symptoms of aseptic meningitis, which may occur in patients with systemic lupus erythematosus and mixed connective tissue disease);
• severe hypersensitivity reactions: swelling of the face, tongue, and larynx that makes breathing, talking, or swallowing difficult, shortness of breath, rapid heart rate, low blood pressure, or severe shock;
• worsening of asthma symptoms.

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

• the skin becomes sensitive to light.

Taking medicines like Kidofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If the patient experiences any of the above symptoms, they should stop taking Kidofen and consult a doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should consult a doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Kidofen

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Kidofen contains

• The active substance of the medicine is ibuprofen. 5 ml of suspension contains 100 mg of ibuprofen.
• The other ingredients are: polysorbate 80, sodium benzoate, citric acid, sodium citrate, xanthan gum, sodium saccharin, orange flavor 72 VP, vanilla flavor AR 0345, orange yellow (E 110), sucrose, glycerol, sodium carboxymethylcellulose (type C), purified water.

What Kidofen looks like and what the pack contains

Kidofen is an oral suspension.
The packaging of the medicine is a brown glass bottle containing 100 ml, with an aluminum cap and a measuring cup, in a cardboard box.

Marketing authorization holder and manufacturer:

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. +48 42 22-53-100

Date of last revision of the leaflet: