Kidofen

Package leaflet: Information for the patient

Kidofen, 125 mg, suppositories
Ibuprofenum
Please read the entire 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
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• 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 you feel worse, contact your doctor.

Table of contents

1. What Kidofen is and what it is used for
2. What you need to know before using Kidofen
3. How to use 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 called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine contains the active substance ibuprofen.
Indications
Treatment of mild to moderate pain such as:

• teething pain and toothache,
• headache,
• earache,
• sore throat,
• postoperative pain,
• pain due to injury of soft tissues, joints and bones,
• pain and fever associated with colds and influenza.

Kidofen is used when oral administration is not appropriate, e.g. when vomiting occurs.
If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using Kidofen

When not to use Kidofen

• if the patient is allergic to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine listed in section 6;
• if the patient has experienced asthma, breathlessness, nasal congestion or urticaria after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as Kidofen may cause similar adverse reactions in such patients;
• if the patient has or has ever had gastrointestinal bleeding;
• if the patient has ever experienced or currently has perforation (a hole) in the stomach or intestinal wall related to the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient currently has or has ever had peptic ulcer disease of the stomach and/or duodenum or ulcer bleeding;
• if the patient has severe liver or kidney failure;
• if the patient has severe heart failure;
• if the patient has a bleeding disorder (coagulation disorders);
• in children weighing less than 12.5 kg;
• during the last three months of pregnancy.

Warnings and precautions
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment.
If any of these symptoms occur, Kidofen must be discontinued immediately and medical help must be sought without delay.
Before starting treatment with Kidofen, discuss this with your doctor or pharmacist.

• If the patient has gastrointestinal disorders (e.g., chronic inflammatory bowel disease, duodenal ulceration, Crohn's disease presenting with chronic diarrhoea), or disorders of the anus and rectum, as the risk of gastrointestinal bleeding may be increased;
• if the patient has certain skin disorders (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• 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 recently undergone major surgery;
• if the patient has bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, or allergies (current or past), as bronchospasm may occur after taking the medicine;
• if the patient has severe dehydration due to diarrhoea, particular caution should be taken in children;
• if the patient has heart, kidney or liver failure, is taking diuretics, or has lost a large amount of fluid (e.g., after major surgery), the doctor may recommend regular kidney function monitoring;
• if the patient is 65 years of age or older, as the risk of adverse effects of the medicine, especially gastrointestinal bleeding and perforation of the stomach or duodenal wall (which may be fatal), increases. The patient should inform the doctor of any unusual gastrointestinal symptoms (especially bleeding, pain), particularly during the initial treatment period;
• if the patient has had peptic ulceration and/or gastrointestinal bleeding and is 65 years of age or older, Kidofen may be used only after consultation with a doctor;
• if the patient has chickenpox – use of the medicine is not recommended;
• if headaches occur during long-term use of high doses of painkillers, do not attempt to relieve them by increasing the dose of the painkiller;
• if Kidofen is used long-term, the doctor will recommend regular monitoring of kidney and liver function and blood tests;
• if visual disturbances occur, the patient should consult an ophthalmologist;
• Kidofen may adversely affect fertility in women; this effect is reversible and resolves after discontinuation of treatment;
• if the patient has an infection – see below under the section titled "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 existing infection and symptoms persist or worsen, immediate medical advice should be sought.
Do not use Kidofen together with other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib).

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

Kidofen and other medicines
Inform your doctor or pharmacist about any medicines currently used, recently taken, or planned for use.
Do not take the following medicines together with Kidofen. 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);
• glucocorticosteroids (steroid medicines used, among others, in asthma treatment);
• antiplatelet medicines (medicines that reduce the risk of blood clots);
• selective serotonin reuptake inhibitors (medicines used in depression treatment);
• selective cyclooxygenase-2 (COX-2) inhibitors (medicines used in rheumatic disease treatment).

Medicines that may cause kidney damage:

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

Kidofen may enhance the effect of:

• anticoagulants (medicines preventing blood clotting, e.g., warfarin);
• lithium (a medicine used in depression treatment);
• methotrexate (a medicine used in the treatment of certain cancers and rheumatoid arthritis).

Kidofen may reduce the effectiveness of:

• antihypertensive medicines;
• diuretics, as there is an increased risk of kidney function disorders, such as increased blood potassium levels (hyperkalaemia). If such a disorder occurs, the patient should drink large amounts of fluids.

Pregnancy and breastfeeding

This medicine is intended for children. Other ibuprofen-containing medicines intended for adults have been authorised for marketing.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not use Kidofen if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. 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 labour. During the first 6 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 should be used for the shortest possible duration. From week 20 of pregnancy, Kidofen may cause narrowing of a blood vessel (ductus arteriosus) in the unborn child's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for longer 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 infants, interruption of breastfeeding is not necessary during short-term use of ibuprofen at doses used for pain and fever relief.

Fertility
Kidofen belongs to a group of medicines (NSAIDs) which may affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Short-term use of Kidofen has no influence on the ability to drive or operate machinery.

3. How to use 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, consult a doctor or pharmacist.
Do not use Kidofen for longer than 3 days without consulting a doctor.
Method of administration
This is a rectal medicine.
Remove the suppository from the blister and insert it into the rectum, preferably after the child has passed a bowel movement.
To facilitate insertion, the suppository may be warmed in the hand or briefly immersed in warm water.
Do not exceed the maximum daily dose of 20 mg to 30 mg of ibuprofen per kg of body weight, divided into 3 to 4 individual doses.

• Children weighing 12.5 kg to 17 kg (aged 2 to 4 years): initial dose is 1 suppository. Then, if needed, 1 suppository every 6 to 8 hours. Do not use more than 3 suppositories (375 mg of ibuprofen) within 24 hours.
• Children weighing 17 kg to 20.5 kg: initial dose is 1 suppository. Then, if needed, 1 suppository every 6 hours. Do not use more than 4 suppositories (500 mg of ibuprofen) within 24 hours.

This medicine should not be used in children weighing less than 12.5 kg. For these children, medicines containing a lower amount of ibuprofen are recommended.
Patients with impaired kidney or liver function should consult a doctor before using this medicine.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Use of a higher than recommended dose of Kidofen
If a patient has used more than the recommended dose of Kidofen, or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital for advice on possible health risks and actions to take.

Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion and nystagmus. Stimulation, drowsiness, confusion or coma may also occur. Seizures may occur occasionally. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. Additionally, prothrombin time/INR may be prolonged, probably due to interference with circulating blood clotting factors. Acute kidney 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 provide symptomatic and supportive treatment.

Missed dose of Kidofen
Continue using the medicine as scheduled, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if any of the following occur:

• rash, severe 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 material resembling coffee grounds, black stools or blood in the stool);
• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome;
• red, flat, target-like or circular skin lesions on the trunk, often with blisters in the centre, peeling skin, mouth, throat, nose, genital or eye ulcers. 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 cell);
• red scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis).

Other adverse reactions may occur
Common (may occur in up to 1 in 10 people):

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

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

• diarrhoea, bloating, constipation and vomiting;
• peptic ulcer of the stomach and/or duodenum;
• gastrointestinal bleeding (caused by perforation of the stomach or intestinal wall); sometimes fatal, especially in elderly people;
• ulcerative inflammation of the oral mucosa;
• exacerbation of symptoms of colitis and Crohn's disease;
• gastritis;
• local irritation of the anus;
• headache, dizziness, insomnia, tinnitus and fatigue;
• hypersensitivity reactions with urticaria and itching.

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

• oedema;
• hypertension;
• heart failure;
• reduced urea excretion;
• interstitial nephritis;
• nephrotic syndrome;
• acute renal failure;
• renal papillary necrosis;
• increased serum urea concentration;
• liver function disorders;
• liver damage;
• acute hepatitis;
• 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, severe exhaustion, nosebleeds or subcutaneous haemorrhages;
• 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, shortness of breath, rapid heartbeat, low blood pressure or severe shock, worsening of asthma symptoms.

Frequency not known (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 sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 and carton. The expiry date refers to the last day of the stated month.
Lot: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Kidofen contains

• The active substance is ibuprofen. Each suppository contains 125 mg of ibuprofen.
• Other ingredients are: hard fat (A), hard fat (B).

What Kidofen looks like and contents of the pack
Kidofen is white to slightly yellowish suppositories, torpedo-shaped with one end tapered.
Packaging: 10 suppositories packed in a cardboard box.
Marketing Authorisation 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