Kidofen

Package leaflet: Information for the patient

Kidofen 100 mg/5 ml, oral suspension
Ibuprofenum
Please read carefully the entire leaflet before using 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
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Table of contents

1. What Kidofen is and what it is 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 pack and other information

1. What Kidofen is and what it is used for

Kidofen is an analgesic, antipyretic and anti-inflammatory medicine. It belongs to a group of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The medicine contains the active
substance ibuprofen.
Indications
Fever of various origins (including viral infections and post-vaccination reactions).
Mild to moderate pain of various causes:

• headaches, sore throat and muscle pain, e.g. during viral infections;
• muscle, joint and bone pain due to musculoskeletal injuries (strains, sprains);
• soft tissue injury pain, postoperative pain;
• toothache, pain following dental procedures, teething pain;
• headache;
• ear pain occurring in inflammatory conditions of the middle ear.

Kidofen is intended for short-term use. If symptoms persist or worsen, or if new symptoms occur,
consult your 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 asthma, rhinitis, or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,

because Kidofen may cause similar adverse reactions in these patients;

• if the patient currently has or has ever had peptic ulcer disease of the stomach and/or duodenum or peptic ulcer bleeding;
• if the patient has ever had or currently has gastrointestinal bleeding;
• if the patient has ever experienced perforation (a hole) in the wall of the stomach or intestine related to 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 simultaneously, 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 tendency (coagulation disorders).

Warnings and precautions
Allergic reactions to ibuprofen, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain, have occurred during treatment.
If any of these symptoms occur, Kidofen should be discontinued immediately and the patient should contact a doctor or emergency medical services without delay.
Before starting Kidofen, discuss the following with a 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 disorders (e.g., chronic inflammatory bowel disease, ulcerative colitis, Crohn's disease presenting with chronic diarrhea), or diseases of the anus and rectum, as this increases the risk of gastrointestinal bleeding;
• if the patient has hypertension and/or heart disorders due to fluid retention;
• if the patient has impaired kidney or liver function;
• if the patient has blood coagulation disorders (ibuprofen may prolong bleeding time);
• if the patient has bronchial asthma or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if the patient is taking other medicines that may increase the risk of gastrointestinal disorders or bleeding, such as corticosteroids, anticoagulants like acenocoumarol, antiplatelet agents like acetylsalicylic acid, diuretics, or cardiac medications;
• if the patient is aged 65 years or older, as the risk of adverse effects of the drug increases, especially gastrointestinal bleeding and perforation of the stomach or duodenal wall, which may be fatal. The patient should inform the doctor of any unusual gastrointestinal symptoms (especially bleeding, pain), particularly during the initial treatment period;
• if the patient has chickenpox or any other infection – see below, section "Infections".

Infections
Kidofen may mask symptoms of infection such as fever and pain. Therefore, Kidofen may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, medical advice should be sought immediately.

Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, 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). If the patient develops any symptoms related to these severe skin reactions described in section 4, Kidofen should be discontinued immediately and medical help should be sought.

While taking Kidofen, the following warnings should be observed:

• if headaches occur during prolonged use of high doses of painkillers, they should not be treated by increasing the dose of the painkiller;
• if a rash, mucosal damage, or other skin reactions occur, the patient should consult a doctor immediately (see section 4);
• if visual disturbances occur, the patient 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, or smokes), the patient should consult a doctor before using this medicine.
In elderly patients, the dose of the medicine may be reduced, using the lowest possible therapeutic dose for the shortest possible duration to minimize the risk of adverse effects.

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

Kidofen and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take Kidofen simultaneously with the following medicines. Kidofen may affect the action of other medicines and vice versa. The patient should inform the doctor if taking any of the following medicines.

Medicines that may increase gastrointestinal bleeding:

• acetylsalicylic acid (used for pain relief and fever reduction);
• other non-steroidal anti-inflammatory drugs (NSAIDs);
• corticosteroids (steroid medicines used, among others, in the treatment of bronchial asthma);
• antiplatelet agents (medicines that reduce the risk of blood clots);
• selective serotonin reuptake inhibitors (medicines used to treat depression);
• selective cyclooxygenase-2 (COX-2) inhibitors (medicines used to treat rheumatic disease).

Medicines that may cause kidney damage:

• tacrolimus (a medicine used, among others, in the treatment of atopic dermatitis);
• cyclosporine (a medicine used in organ transplant patients).

Kidofen may enhance the effect of:

• anticoagulants (medicines preventing 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:

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

Do not take Kidofen simultaneously with:

• zidovudine (a medicine used to treat HIV infection), as it may prolong bleeding time;
• cardiac glycosides: NSAIDs may worsen symptoms of heart failure and increase serum levels of cardiac glycosides;
• quinolone antibiotics: as this may increase the risk of seizures;
• probenecid and sulfinpyrazone (medicines used to treat gout), as they may delay the elimination 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 effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Kidofen if the patient is in the last three 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 tendency to bleeding in both the mother and the child and may delay or prolong labor. During the first six months of pregnancy, Kidofen should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible duration should be used. From the 20th week of pregnancy, Kidofen may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for more than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. No harmful effects on infants have been reported; therefore, discontinuation of breastfeeding is not necessary during short-term use of ibuprofen at doses used for pain and fever relief.

Fertility
Kidofen may impair fertility. If the patient is planning to become pregnant or has had difficulty conceiving, she should inform her doctor.

Driving and operating machinery
Kidofen has no effect or has a negligible effect on the ability to drive vehicles or operate machinery. However, if drowsiness, dizziness, or visual disturbances occur, the patient should not drive or operate machinery.

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

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

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

Sodium
The medicine contains up to 42.49 mg of sodium (a 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.

Sunset 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If, during the course of an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
Do not use Kidofen for longer than 3 days without consulting a doctor.
This medicine is for oral use.
Shake well before use.
Recommended dose
The dosing device provided with the packaging should be used to measure the dose. This ensures accurate dosing.

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

Overdose of Kidofen medicine
If a patient has taken a higher than recommended dose of Kidofen, or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to obtain advice regarding possible health risks and guidance on actions to take in such a case.

Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures have been reported occasionally in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in urine, low blood potassium levels, feeling cold, and breathing difficulties. Additionally, prothrombin time/INR may be prolonged, probably due to interference with circulating blood coagulation factors. Acute renal failure and liver damage may also occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and breathing difficulties may occur.

There is no specific antidote. The doctor will administer symptomatic and supportive treatment.

Missed dose of Kidofen medicine
Continue taking the medicine as prescribed, without increasing the next dose.
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
You should immediately contact a doctor or go to the nearest hospital if any of the following occur:

• rash, swelling of the face, lips or throat causing difficulty in breathing, speaking or swallowing, low blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest or cardiac arrest;
• gastrointestinal bleeding (vomiting blood or coffee-ground-like material, black stools or blood in stool);
• chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome;
• red, flat, round or target-like skin lesions on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs or 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. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cells);
• red, widespread, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Not common (may affect up to 1 in 100 people):

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

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

• diarrhoea, bloating, constipation, vomiting;
• gastritis;
• dizziness, insomnia, restlessness, irritability and fatigue;
• oedema.

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

• peptic ulcer of the stomach and/or duodenum;
• gastrointestinal bleeding due to perforation of the stomach or intestinal wall,

sometimes with fatal outcome, especially in elderly patients;

• erosive stomatitis;
• exacerbation of symptoms of colitis and Crohn's disease;
• disturbances of consciousness;
• depression, emotional disturbances;
• tinnitus, hearing disturbances;
• decreased urea excretion;
• haematuria;
• decreased creatinine clearance;
• renal failure, renal papillary necrosis;
• reduced urine output;
• polyuria;
• increased blood sodium concentration (causing oedema);
• hypertension;
• heart failure;
• liver function disorders, particularly during long-term treatment;
• marked decrease in blood cell counts (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, nosebleeds or subcutaneous haemorrhages (e.g. bruises, purpura, petechiae);
• severe skin and soft tissue infections as a complication of chickenpox;
• neck stiffness, headache, nausea, vomiting, fever, disorientation (symptoms of aseptic meningitis, which may occur in patients with systemic lupus erythematosus or mixed connective tissue disease);
• severe hypersensitivity reactions: swelling of the face, tongue and larynx causing difficulty in breathing, speaking or swallowing, dyspnoea, tachycardia, decreased arterial blood pressure or severe shock;
• worsening of asthma symptoms.

Frequency unknown (frequency cannot be estimated from available data):

• skin becomes sensitive to light.

Taking medicines such as Kidofen may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke.
If any of the above symptoms occur, the medicine should be discontinued
and medical advice should be sought immediately.
Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, consult a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring
of Adverse Drug Reactions at the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Kidofen

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kidofen contains

• The active substance 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, natural orange flavouring substance 72 VP, vanilla flavouring substance AR 0345, sunset yellow (E 110), sucrose, glycerol, sodium carboxymethyl starch (type C), purified water.

What Kidofen looks like and contents of the pack
Kidofen is an oral suspension.
The pack consists of a brown glass bottle containing 100 ml, with an aluminium screw cap and a dosing syringe, in a cardboard carton.
Marketing Authorisation Holder and Manufacturer:
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. + 48 42 22-53-100