Kidofen

Leaflet attached to the packaging: patient information

Kidofen, 125 mg, suppositories

Ibuprofen

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

This medicine should always be used 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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult 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 pack 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 nonsteroidal anti-inflammatory drugs (NSAIDs). The active substance is ibuprofen.

Indications for use

Treatment of mild to moderate pain, such as:

• teething pain and toothache,
• headache,
• ear pain,
• throat pain,
• post-operative pain,
• pain due to soft tissue, joint, and bone damage,
• pain and fever in colds and flu.

Kidofen is used when oral administration of the medicine is not recommended, e.g., when vomiting occurs. If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Kidofen

When not to take Kidofen

• if you are allergic to ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if you have experienced shortness of breath, asthma, runny nose, or hives after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, as Kidofen may cause similar side effects in these patients;
• if you have ever had or currently have gastrointestinal bleeding;
• if you have ever had or currently have perforation of the stomach or intestine wall associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs);
• if you have or have had stomach or duodenal ulcers or gastrointestinal bleeding;
• if you have severe liver or kidney impairment;
• if you have severe heart failure;
• if you have bleeding disorders (blood clotting disorders);
• in children with a body weight below 12.5 kilograms;
• in the last three months of pregnancy.

Warnings and precautions

During treatment with ibuprofen, allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If you notice any of these symptoms, stop taking Kidofen immediately and seek medical attention.

Before taking Kidofen, consult a doctor or pharmacist.

• If you have stomach or intestinal diseases (such as chronic enteritis, duodenal ulcer, Crohn's disease, characterized by, among other things, chronic diarrhea), diseases of the rectum and anus, as the risk of gastrointestinal bleeding increases;
• if you have certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if you have high blood pressure and/or heart failure due to fluid retention;
• if you have kidney or liver dysfunction;
• if you have blood clotting disorders (ibuprofen may prolong bleeding time);
• if you have recently undergone major surgery;
• if you have asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies (current or past), as taking the medicine may cause bronchospasm;
• if you have severe dehydration caused by diarrhea, special caution should be exercised in children;
• if you have heart, kidney, or liver failure, are taking diuretics, or have lost a lot of fluid due to, for example, major surgery - your doctor will monitor your kidney function regularly;
• if you are 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. You should inform your doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), especially during the initial treatment period;
• if you have had ulcers and/or gastrointestinal bleeding and are over 65 years old, Kidofen may be used after consulting a doctor;
• if you have chickenpox - it is not recommended to take the medicine;
• if you experience headaches during long-term use of high doses of painkillers, do not alleviate them by increasing the dose of the painkiller;
• if Kidofen is used for a long time, your doctor will prescribe regular monitoring of kidney and liver function, as well as blood tests;
• if you experience vision disturbances, you should consult an ophthalmologist;
• Kidofen may adversely affect female fertility. This effect is temporary and reverses after stopping the medicine;

Infections
Kidofen may mask the symptoms of an infection, such as fever and pain. Therefore, Kidofen may delay the use of appropriate infection treatment and lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should immediately consult a doctor.
Do not take Kidofen if you are taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib).
Skin reactions
Severe skin reactions have occurred with 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 you experience any symptoms associated with these severe skin reactions described in section 4, stop taking Kidofen and seek medical attention immediately.

Kidofen and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines with Kidofen. Kidofen may affect the action of other medicines, and vice versa. You should inform your doctor if you 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 nonsteroidal anti-inflammatory drugs (NSAIDs);
• glucocorticosteroids (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);
• cyclosporin (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, as there is an increased risk of kidney dysfunction, such as high potassium levels in the blood (hyperkalemia). If such a disorder occurs, you should drink plenty of fluids.

Pregnancy and breastfeeding

This medicine is intended for children. Other medicines containing ibuprofen as an active substance are available for adults.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Kidofen if you are 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 also increase the risk of bleeding in you and your child and prolong or delay labor. During the first six months of pregnancy, do not take Kidofen unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Kidofen may cause the unborn child to have a narrowed blood vessel (ductus arteriosus) 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, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. Since there are no reports of harmful effects on infants, breastfeeding does not need to be discontinued during short-term use of ibuprofen in doses used to treat pain and fever.
Fertility
Kidofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is temporary and reverses after stopping the medicine.

Driving and using machines

Short-term use of Kidofen does not affect the ability to drive or operate machinery.

3. How to take Kidofen

Always take this medicine exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult a doctor or pharmacist.
Do not take Kidofen for more than 3 days without consulting a doctor.
Method of administration
The medicine is for rectal use.
Remove the suppository from the blister pack and insert it into the rectum, preferably after the child has had a bowel movement. To make the suppository more moist, you can warm it in your hand or briefly soak it in warm water.
Do not exceed the maximum daily dose of 20-30 mg of ibuprofen per kilogram of body weight, divided into 3-4 single doses.

• Children with a body weight from 12.5 kg to 17 kg (aged 2-4 years): the initial dose is 1 suppository. Then, if necessary, 1 suppository every 6-8 hours. Do not take more than 3 suppositories (375 mg of ibuprofen) in 24 hours.
• Children with a body weight from 17 kg to 20.5 kg: the initial dose is 1 suppository. Then, if necessary, 1 suppository every 6 hours. Do not take more than 4 suppositories (500 mg of ibuprofen) in 24 hours.

Do not give the medicine to children with a body weight below 12.5 kg. For these children, medicines containing smaller amounts of ibuprofen are recommended.
Patients with kidney or liver dysfunction should consult a doctor before taking the medicine.
Use the smallest effective dose for the shortest possible time. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Taking a higher dose of Kidofen than recommended

If you have taken a higher dose of Kidofen than recommended or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Overdose symptoms may include:nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, and disorientation. You may also experience agitation, drowsiness, disorientation, or coma. Rarely, patients experience seizures. After taking high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred. Additionally, you may experience prolonged prothrombin time/INR, probably due to disruption 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, you may experience low blood pressure and difficulty breathing.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missing a dose of Kidofen

Continue taking the medicine, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Seek medical attention immediately if you experience:

• rash, severe swelling of the face, lips, or throat, which may cause difficulty breathing, talking, or swallowing, 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 sign of a potentially serious allergic reaction called Kounis syndrome;
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell);
• red, scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis).

Other side effects may occur

Common(may affect up to 1 in 10 people):

• indigestion (feeling of bloating in the stomach, bloating, belching, heartburn, constipation), abdominal pain, and nausea.

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

• diarrhea, bloating, constipation, and vomiting;
• stomach or duodenal ulcers;
• gastrointestinal bleeding (due to perforation of the stomach or intestine wall); sometimes fatal, especially in the elderly;
• ulcerative stomatitis;
• worsening of symptoms of ulcerative colitis and Crohn's disease;
• gastritis;
• local irritation of the rectum;
• headache, dizziness, insomnia, tinnitus, and fatigue;
• hypersensitivity reactions with urticaria and itching.

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

• edema;
• hypertension;
• heart failure;
• reduced urea excretion;
• interstitial nephritis;
• nephrotic syndrome;
• acute kidney failure;
• renal papillary necrosis;
• increased blood urea levels;
• liver dysfunction;
• liver damage;
• acute hepatitis;
• significant reduction in blood cell count (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral ulcers, flu-like symptoms, significant exhaustion, nosebleeds, or subcutaneous hemorrhages;
• severe skin and soft tissue infections as a complication of chickenpox;
• stiffness of the neck, headache, nausea, vomiting, fever, disorientation (these are symptoms of aseptic meningitis, which may occur in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease);
• severe hypersensitivity reactions: facial swelling, tongue and throat swelling, which may cause difficulty breathing, talking, or swallowing, 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):

• 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 you experience any of the above symptoms, stop taking the medicine and consult a doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kidofen

Keep the medicine out of the sight and reach of children.
Store in the original packaging at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month.
Lot: Batch number.
EXP: Expiry date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Kidofen contains

• The active substance is ibuprofen. One suppository contains 125 mg of ibuprofen.
• The other ingredients are: solid fat (A), solid fat (B).

What Kidofen looks like and contents of the pack

Kidofen is a white to light yellow suppository in the shape of a one-sided pointed torpedo.
The packaging of the medicine is: 10 suppositories packed in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: +48 42 22-53-100
E-mail: [email protected]

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: