Kidofen

Leaflet accompanying the packaging: patient information

Kidofen, 60 mg, suppositories

Ibuprofen

Read the leaflet carefully before using 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

• 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 packaging and other information

1. What Kidofen is and what it is 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 and toothache,
• headache,
• earache,
• sore throat,
• post-operative pain,
• pain due to soft tissue, joint, and bone injuries,
• pain and fever associated with colds and flu.

Kidofen is used when oral administration is not recommended, such as when vomiting occurs. If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.

2. Important information before taking Kidofen

When not to take Kidofen

• if the patient is allergic to ibuprofen or other NSAIDs or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced shortness of breath, asthma, runny nose, or hives after taking acetylsalicylic acid or other NSAIDs, as Kidofen may cause similar side effects in these patients;
• if the patient has ever had or currently has gastrointestinal bleeding;
• if the patient has ever had or currently has a perforation of the stomach or intestine wall associated with NSAID use;
• if the patient has or has had stomach or duodenal ulcers or gastrointestinal bleeding;
• if the patient has severe liver or kidney impairment;
• if the patient has severe heart failure;
• if the patient has a bleeding disorder (coagulation disorder);
• in infants weighing less than 6 kilograms;
• in the last three months of pregnancy.

Warnings and precautions

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

Before starting Kidofen treatment, the patient should discuss it with their doctor or pharmacist.

• if the patient has stomach or intestinal diseases (such as chronic inflammatory bowel disease, ulcerative colitis, or Crohn's disease), rectal or anal diseases, as the risk of gastrointestinal bleeding increases;
• if the patient has certain skin diseases (systemic lupus erythematosus or mixed connective tissue disease);
• if the patient has high blood pressure and/or heart failure due to fluid retention;
• if the patient has kidney or liver function disorders;
• if the patient has bleeding disorders (ibuprofen may prolong bleeding time);
• if the patient has recently undergone major surgery;
• if the patient has asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies (current or past), as ibuprofen may cause bronchospasm;
• if the patient has severe dehydration caused by diarrhea, especially in children;
• if the patient has heart, kidney, or liver failure, is taking diuretics, or has lost a lot of fluid due to major surgery - the doctor will monitor kidney function regularly;
• if the patient is over 65 years old, as the risk of adverse reactions, especially gastrointestinal bleeding and perforation, increases. The patient should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding or pain), especially during the initial treatment period;
• if the patient has had ulcers or gastrointestinal bleeding and is over 65 years old, Kidofen may be used after consulting a doctor;
• if the patient has chickenpox - it is not recommended to use the medicine;
• if the patient experiences headaches during long-term use of high doses of painkillers, they should not increase the dose of the painkiller;
• if Kidofen is used long-term, the doctor will regularly monitor kidney and liver function and perform blood tests;
• if the patient experiences vision disturbances, they should consult an eye doctor;
• Kidofen may affect fertility in women. This effect is temporary and reverses after stopping the medicine;
• if the patient has an infection - see the section below titled "Infections".

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 the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.
Do not take Kidofen with 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 the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Kidofen and seek medical attention immediately.

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.
Do not take the following medicines with Kidofen, as they may increase the risk of side effects:

• acetylsalicylic acid (used for pain relief and fever reduction);
• other NSAIDs;
• corticosteroids (steroid medicines used for asthma, etc.);
• antiplatelet agents (medicines that reduce blood clot risk);
• selective serotonin reuptake inhibitors (medicines used for depression);
• selective cyclooxygenase-2 inhibitors (medicines used for rheumatic diseases).

Medicines that may cause kidney damage:

• tacrolimus (a medicine used for atopic dermatitis, etc.);
• cyclosporin (a medicine used in organ transplant patients).

Kidofen may enhance the effects of:

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

Kidofen may reduce the effectiveness of:

• blood pressure-lowering medicines;
• diuretics, 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.

Pregnancy and breastfeeding

This medicine is intended for children. Other ibuprofen-containing medicines are available for adults.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Kidofen should not be taken during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first six months of pregnancy, Kidofen should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Kidofen may cause the unborn baby's heart to have a narrowed blood vessel (ductus arteriosus) or kidney problems, leading to low amniotic fluid levels. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. As there are no reports of harmful effects on babies, breastfeeding can continue during short-term use of ibuprofen for pain and fever relief.
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

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Do not use Kidofen for more than 3 days without consulting a doctor.
Method of administration
The medicine is for rectal use.
The suppository should be removed from the blister pack and inserted into the rectum, preferably after the child has had a bowel movement. To make the suppository more moist, it can be warmed in the hand or briefly dipped 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.

• Infants weighing 6-8 kilograms: the initial dose is 1 suppository. If necessary, 1 suppository can be given after 6-8 hours. Do not take more than 3 suppositories in 24 hours.
• Children weighing 8-12.5 kilograms: the initial dose is 1 suppository. If necessary, 1 suppository can be given after 6 hours. Do not take more than 4 suppositories in 24 hours.

Kidofen should be used in infants over 3 months old and weighing 6 kilograms or more. Patients with kidney or liver function disorders should consult their doctor before taking the medicine.
Use the lowest effective dose for the shortest possible time. If the infection symptoms (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).

Overdose of Kidofen

If the patient has taken more than the recommended dose of Kidofen or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital for advice on the possible risk to their health and the actions to be taken.
Overdose symptoms may include:nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, disorientation, and dizziness. The patient may also experience agitation, drowsiness, disorientation, or coma. Seizures have occurred rarely in patients. 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, feeling cold, and breathing difficulties. Additionally, the prothrombin time/INR may be prolonged, probably due to the disruption of circulating coagulation factors in the blood. Acute kidney failure and liver damage may occur. In patients with asthma, asthma symptoms may worsen. Additionally, low blood pressure and breathing difficulties may occur.
There is no specific antidote. The doctor will provide symptomatic and supportive treatment.

Missed dose of Kidofen

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

4. Possible side effects

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

The patient should contact their doctor immediately if they experience:

• rash, severe swelling of the face, lips, tongue, or throat, which may cause difficulty breathing, speaking, or swallowing, low blood pressure, slow or fast heart rate, pale skin, 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, peeling skin, 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 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;
• increased urea levels;
• interstitial nephritis;
• nephrotic syndrome;
• acute kidney failure;
• renal papillary necrosis;
• increased serum urea levels;
• liver function disorders;
• liver damage;
• acute hepatitis;
• significant decrease in blood cell count (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe exhaustion, nosebleeds, or subcutaneous bleeding;
• 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 and mixed connective tissue disease);
• severe hypersensitivity reactions: facial, tongue, or throat swelling that may cause difficulty breathing, speaking, 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 the patient experiences any of the above symptoms, they should stop taking the medicine and consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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,
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, 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 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. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Kidofen contains

• The active substance is ibuprofen. One suppository contains 60 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 is: 10 suppositories 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: