Kidofen

Package leaflet: Information for the patient

Kidofen, 60 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 the
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 of the leaflet

1. What Kidofen is and what it is used for
2. Important information 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 of the medicine is not recommended, e.g. when vomiting occurs.
If there is no improvement after 3 days or if your condition worsens, 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 previously experienced asthma, difficulty breathing, nasal congestion or hives after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as Kidofen may cause similar adverse reactions in these patients;
• if the patient currently has or has ever had gastrointestinal bleeding;
• if the patient has ever experienced or currently has a perforation (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-related 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 infants with body weight below 6 kilograms;
• during the last three months of pregnancy.

Warnings and precautions
Allergic reactions to ibuprofen, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain, have been reported 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 stomach and/or intestinal diseases (e.g. chronic bowel inflammation, duodenal ulceration, Crohn's disease presenting with chronic diarrhoea), or diseases of the anus and rectum, as the risk of gastrointestinal bleeding increases;
• if the patient has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease);
• if the patient has high blood pressure 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 administration of the medicine;
• if the patient is severely dehydrated due to diarrhoea; particular caution is required in children;
• if the patient has heart, kidney or liver failure, is taking diuretics, or has lost large amounts of fluid (e.g. after major surgery) – the doctor may recommend regular monitoring of kidney function;
• if the patient is aged 65 years or older, as the risk of adverse effects of the medicine increases, especially gastrointestinal bleeding and perforation of the stomach or duodenal wall, which may be fatal. The patient should inform the doctor about any unusual gastrointestinal symptoms (especially bleeding, pain), particularly during the initial treatment period;
• if the patient has had gastrointestinal ulcers and/or bleeding and is aged 65 years 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 analgesics – do not attempt to relieve them by increasing the analgesic dose;
• 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, section titled "Infections".

Infections
Kidofen may mask symptoms of infection such as fever and pain. Consequently, Kidofen may delay appropriate treatment of infection and thereby increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient uses this medicine during an existing infection and infection symptoms persist or worsen, immediate medical advice must be sought.
Do not use Kidofen together with other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib).

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 of the symptoms associated with these severe skin reactions described in section 4, Kidofen must be discontinued immediately and medical help must be sought.

Kidofen and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do 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 the doctor if taking any of the medicines listed below.

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 reducing the risk of blood clot formation);
• selective serotonin reuptake inhibitors (medicines used in depression treatment);
• selective cyclooxygenase-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:

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

Kidofen may reduce the effectiveness of:

• medicines that lower blood pressure;
• diuretics (medicines increasing urine production), as there is an increased risk of kidney function disorders, such as increased potassium levels in blood (hyperkalemia). 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 have been authorised for adult use.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a 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 complications during delivery. It may cause kidney and heart disorders in the unborn child. It may increase the risk of bleeding in both the mother and the child and may delay or prolong labour. 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 should be used for the shortest possible time. From week 20 of pregnancy, Kidofen may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart or kidney disorders, 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 after discontinuation of treatment.

Driving and operating machinery
Short-term use of Kidofen does not affect 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 medicine is for rectal use only.
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 to soften it.
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.

• Infants weighing 6 kg to 8 kg: initial dose is 1 suppository. Then, if necessary, 1 suppository every 6 to 8 hours. Do not use more than 3 suppositories within 24 hours.
• Children weighing 8 kg to 12.5 kg: initial dose is 1 suppository. Then, if necessary, 1 suppository every 6 hours. Do not use more than 4 suppositories within 24 hours.

Kidofen should be used in infants older than 3 months of age and weighing 6 kg or more.
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 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 ingested the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on what 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. Restlessness, drowsiness, confusion or coma may also occur. Seizures may occur rarely. After ingestion of 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 coagulation 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 prescribed, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further doubts 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 everybody will experience them.
You should contact a doctor immediately if 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 symptom of a potentially serious allergic reaction known as Kounis syndrome;
• red, flat, target-like or round skin lesions on the trunk, often with blisters in the centre, peeling skin, ulcers in the mouth, throat, nose, genital organs 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. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy and increased eosinophil count (a type of white blood cells);
• red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis).

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

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

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

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

Very rare (may affect 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 count (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, marked 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 and 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 should be sought immediately.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring
of 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 effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Kidofen

Keep this medicine 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 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 required. These measures help protect the environment.

6. Contents of the pack and other information

What Kidofen contains

• The active substance is ibuprofen. One suppository contains 60 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 yellow, torpedo-shaped suppositories, pointed at one end.
The medicine is packed as: 10 suppositories 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