IBUPROFEN Pädia 75 mg suppositories, 10 pcs

Instructions for use for IBUPROFEN Pädia 75 mg suppositories, 10 pcs

Detailed instructions for IBUPROFEN Pädia 75 mg suppositories, 10 pcs

Field of use

• This is an anti-inflammatory and analgesic drug (Non-Steroidal Anti-Inflammatory Drug/Anti-Inflammatory Drug, NSAR)
• The preparation is used for the short-term symptomatic treatment of
  • slight to moderate pain
  • Fever
• If you or your child do not feel better or worse after 3 days, contact your doctor.

Active substances / ingredients / ingredients

75 mg ibuprofen
Hard fat excipient (+)

Contraindications

• The medicine must not be used
  • if you or your child are allergic to ibuprofen or any of the other ingredients of this medicine
  • if you or your child have had bronchospasm, asthma attacks, nasal congestion, skin reactions or sudden swelling after taking acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs in the past
  • in unexplained blood disorders
  • if you have a history of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory drug therapy
  • if you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding
  • if you have or have had a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two separate episodes of proven ulcers or bleeding)
  • if you have severe liver or kidney dysfunction
  • if you have severe heart failure (heart failure)
  • in case of severe dehydration (caused e.g. B. by vomiting, diarrhea or insufficient fluid intake)
  • in the last trimester of pregnancy
  • in children under 8 months (7.5 kg body weight), as this dosage strength is not suitable due to the higher active substance content

dosage

• Unless otherwise prescribed by the doctor, the following dosage guidelines apply:
  • Always use this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • Unless otherwise prescribed by the doctor, the usual dose is:
    • Body weight (age): 7.5 - 9 kg (8 - 12 months)
      • Single dose (equivalent ibuprofen dose): 1 suppository (equivalent to 75 mg ibuprofen)
      • max. daily dose (24 hours) (corresponding ibuprofen dose): 3 suppositories (corresponding to 225 mg ibuprofen)
    • Body weight (age): 10 - 12 kg (12 months - 2 years)
      • Single dose (equivalent ibuprofen dose): 1 suppository (equivalent to 75 mg ibuprofen)
      • max. daily dose (24 hours) (corresponding ibuprofen dose): 4 suppositories (corresponding to 300 mg ibuprofen)
    • If you or your child have used the maximum single dose, wait at least 6 hours before the next dose.
  • Dosage in the elderly:
    • No special dose adjustment is required.

• Duration of use
  • The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen.
  • Medical advice should be sought if children 8 months or older require the use of this medicine for more than 3 days or if symptoms worsen.

• Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you use more than you should
  • You or your child should use ibuprofen as directed by your doctor or as directed in the package leaflet. If you feel that you are not feeling enough pain relief, do not increase the dose yourself, but consult your doctor.
  • If you have used more ibuprofen than you should, or if children have accidentally taken the medicine, always contact your doctor or nearest hospital to get an assessment of the risk and advice on further treatment.
  • Symptoms can include nausea, stomach and abdominal pain, vomiting (possibly with blood), headache, ringing in the ears, confusion and eye tremors. Bleeding in the gastrointestinal tract is also possible. At high doses, drowsiness, drowsiness, chest pain, heart palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems, liver and kidney dysfunction, drop in blood pressure, decreased breathing (respiratory depression) and purple red have been reported Discoloration of skin and mucous membranes (cyanosis) has been reported.
  • There is no specific antidote.
  • If you suspect an overdose with ibuprofen - even if the symptoms subside temporarily - notify your doctor. Depending on the severity of the poisoning, the doctor can decide on the measures that may be required.

• If you forgot the application
  • Do not apply twice if you forget the previous application.

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

Revenue

• Suppositories for insertion into the anus.
• The suppositories are inserted deep into the anus after defecation if possible.
• To improve the lubricity, warm the suppository in your hand or briefly dip it in warm water.

Patient notes

• Warnings and Precautions
  • Talk to your doctor, pharmacist or nurse before using this medicine and/or if you have an infection - see below under 'Infections".
  • Side effects can be minimized by using the lowest effective dose needed to control symptoms for the shortest possible time.
  • Safety in the gastrointestinal tract:
    • Concomitant use of this medicine with other non-steroidal anti-inflammatory drugs, including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors) should be avoided.
    • Elderly patients:
      • In older patients, side effects occur more frequently after the use of NSAR (non-steroidal anti-inflammatory drug/anti-rheumatic drug), in particular bleeding and perforation in the stomach and intestines, which can be life-threatening under certain circumstances. Therefore, particularly careful medical supervision is required in elderly patients.
    • Gastrointestinal bleeding, ulcers and perforations:
      • Gastrointestinal bleeding, ulcers and perforation, including fatal outcomes, have been reported during treatment with all NSAR (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs). They occurred with or without prior warning symptoms or a history of serious gastrointestinal events at any time during therapy.
      • The risk of occurrence of gastrointestinal bleeding, ulceration and perforation is higher with increasing NSAR(non-steroidal anti-inflammatory drug/anti-inflammatory drug) dose, in patients with a history of ulcers, particularly those with complications of bleeding or perforation, and in elderly patients. These patients should start treatment on the lowest dose available.
      • Combination therapy with drugs that protect the gastric mucosa (e.g. misoprostol or proton pump inhibitors) should be considered.
      • If you have a history of gastrointestinal adverse reactions, particularly if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of therapy.
      • Caution is advised if you or your child are also taking medicines that may increase the risk of ulcers or bleeding, such as B. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, which u. are used to treat depressive moods, or platelet aggregation inhibitors such as acetylsalicylic acid (ASA).
      • If you or your child develops gastrointestinal bleeding or ulcers during treatment with the product, the treatment should be discontinued.
      • NSAR (non-steroidal anti-inflammatory drugs) should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may worsen.
  • Effects on the cardiovascular system:
    • Anti-inflammatories/painkillers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
    • You should discuss your treatment with your doctor or pharmacist before using the medicine if you
      • have heart disease, including heart failure (heart failure) and angina (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any type of stroke (including mini had a stroke or transient ischemic attack ("TIA").
      • Have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.
  • Skin reactions:
    • Serious skin reactions have been reported in connection with treatment with this preparation. If you develop a skin rash, lesions on the mucous membranes, blisters or any other sign of allergy, you should stop using the medicine and seek medical attention immediately, as these can be the first signs of a very serious skin reaction.
    • During a chickenpox infection (varicella infection), use of the preparation should be avoided.
  • Infections
    • The medicine can mask signs of infection such as fever and pain. As such, it is possible that this may delay appropriate treatment of the infection, which may lead to an increased risk of complications. This has been seen in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and your infection symptoms persist or worsen, consult a doctor immediately.
  • Other notes:
    • The medicinal product should only be used after careful consideration of the risk-benefit ratio:
      • in certain congenital blood disorders (e.g. acute intermittent porphyria)
      • in certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis)
    • Particularly careful medical supervision is required:
      • if you have impaired kidney or liver function
      • in case of dehydration
      • immediately after major surgical interventions
      • in the case of allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic swelling of the nasal mucosa or chronic respiratory diseases that narrow the airways
    • In these cases, use the medicine only after consulting your doctor.
    • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. Therapy must be discontinued at the first sign of a severe hypersensitivity reaction after administration of the medicinal product. Medically necessary measures corresponding to the symptoms must be initiated by competent persons.
    • Ibuprofen, the active substance in this preparation, can temporarily inhibit the function of platelets (platelet aggregation). Patients with bleeding disorders should therefore be carefully monitored.
    • If this drug is used for a longer period of time, regular monitoring of the liver values, kidney function and blood count is required.
    • If the preparation is used before surgical interventions, the doctor or dentist must be consulted or informed.
    • Prolonged use of any type of pain reliever for a headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued. A diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) their regular use of headache drugs.
    • In general, the habitual use of painkillers, especially when several painkillers are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
  • Children and young people
    • There is a risk of renal dysfunction in dehydrated children and adolescents.
    • Please note the information in the "Contraindications" category".

• Ability to drive and use machines
  • Since central nervous side effects such as tiredness and dizziness can occur when using the drug in higher doses, the ability to react can be changed in individual cases and the ability to actively participate in road traffic and to operate machines can be impaired. This applies to a greater extent in combination with alcohol. You can then no longer react quickly and specifically enough to unexpected and sudden events. In this case, do not drive a car or other vehicles! Do not operate any tools or machines! Do not work without a safe grip!

Pregnancy

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• Pregnancy
  • If pregnancy is detected while using the drug, the doctor must be informed. You may only use ibuprofen in the first and second trimester of pregnancy after consulting your doctor. The preparation must not be used in the last trimester of pregnancy due to an increased risk of complications for mother and child.
• Lactation
  • Only small amounts of the active ingredient ibuprofen and its breakdown products pass into breast milk. Since adverse consequences for the infant have not yet become known, it is not usually necessary to interrupt breastfeeding in the case of short-term use.
• Fertility
  • This preparation belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

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