IBUDEX 400 mg film -coated tablets, 50 pcs

Instructions for use for IBUDEX 400 mg film -coated tablets, 50 pcs

Detailed instructions for IBUDEX 400 mg film -coated tablets, 50 pcs

Field of use

IBUDEX 400mg (pack size: 50 pcs) are a pain relieving agent with slight to medium pain.

Mode of action

IBUDEX 400MG (pack size: 50 pc) Effectively relieves your pain with the active ingredient ibuprofen. This inhibits the body's own prostaglandin synthesis, a messenger material that is necessary for the secondary pipe. Furthermore, prostaglandins are also involved in the development of fever and inflammation. This means that IBUDEX 400mg (pack size: 50 pc) also has an anti -inflammatory and fever -lowering.

Active ingredients / ingredients / ingredients

1 Tablet of IBUDEX 400mg (pack size: 50 pc) contains:

400 mg ibuprofen

Other components of IBUDEX 400mg (pack size: 50 pc)

Cornstarch; Microcrystalline cellulose; Magnesium stearate (Ph.Eur.) [pflanzlich]; Stearic acid (Ph.Eur.) [pflanzlich]; Croinkellose sodium; Hypromellose; Macrogol 400; Carmellose sodium; High disperse silicon dioxide; Talc; Titandioxide (E171); Traces of Carnaubawachs

Contradictions

In the case of known hypersensitivity to one of the above -mentioned ingredients, this product should not be used.
In the case of a present pregnancy in the last third, a asthma, a diabetes mellitus, a blood formation disorder with an unclear cause, for gastrointestinal bleeding or perforations, for brain hemorrhage, with heart failure and brain hemorrhage must not be used.
This product is not suitable for children under the age of 12.

dosage

Application recommendation of IBUDEX 400mg (pack size: 50 pc):

From IBUDEX 400mg (pack size: 50 pc) you and children from 12 years (> 40 kg) can take a tablet with plenty of water if necessary. In order to avoid overdosing, the maximum daily dose should not exceed 3 tablets of IBUDEX 400mg (pack size: 50 pc) . There should be 6 hours between the income. With a sensitive stomach IBUDEX 400mg (pack size: 50 pc) can be taken in parallel to a meal.

Taking

• Please take the film -coated tablets unscrewed with plenty of liquid (e.g. a glass of water) during or after a meal.
• For patients who have a sensitive stomach, it is advisable to take the preparation during meals.

Patient information

• Particular caution is required when taking it
  • Security in the gastrointestinal tract
    • Simultaneous use with other non-steroidal inflammatory inhibitors, including so-called COX-2 inhibitors (cyclooxygenase-2-inhibitors), should be avoided.
    • Side effects can be reduced by using the lowest effective dose via the shortest period required for symptom control.
    • Older patients:
      • In older patients, side effects occur more frequently after using NSAR, in particular bleeding and breakthroughs in the stomach and intestinal area, which may be life-threatening. Therefore, particularly careful medical monitoring is required in older patients.
      • Bleeding of the gastrointestinal tract, ulcers and breakthroughs (perforations): Bleeding of the gastrointestinal tract, ulcers and perforations, also with a fatal outcome, were reported during treatment with all NSAIDs. They occurred with or without prior warning symptoms or serious events in the gastrointestinal tract in the prehistory at any time.
      • The risk of the occurrence of gastrointestinal bleeding, ulcers and breakthroughs is higher with increasing NSAR dose, in patients with ulcers in the history, especially with the complications bleeding or breakthrough, and in older patients. These patients should begin treatment with the lowest available dose.
      • For these patients as well as for patients who need accompanying therapy with low-dose acetylsalicylic acid (ASA) or other medicines that can increase the risk of gastrointestinal diseases, a combination therapy with gastric mucosa should protect drugs (e.g. misoprostol or Proton pump inhibitors).
      • If you have a history of side effects on the gastrointestinal tract, especially at older age, you should report any unusual symptoms in the abdomen (especially gastrointestinal bleeding), especially at the beginning of the therapy.
      • Caution is advisable if you get medicines that can increase the risk of ulcers or bleeding, such as: B. Oral corticosteroids, anti-blood clotting drugs such as warfarin, selective serotonin reuptake inhibitors that are used, among other things, to treat depressive moods, or thrombocyte aggregation inhibitors such as ASA.
      • If you have a gastrointestinal bleeding or ulcers during treatment with Aktren.
      • In patients with a gastrointestinal disease in the prehistory (ulcerative colitis, Crohn's disease), caution should be used because their condition can deteriorate.
  • Effects on the cardiovascular system
    • Medicines like this preparation may be associated with a slightly increased risk of heart attacks ("heart attack") or strokes. Any risk is more likely with high doses and longer treatment. You do not exceed the recommended dose or treatment time (maximum 4 days)!
    • If you have heart problems or a previous stroke or think that you could have a risk to these diseases (e.g. if you have high blood pressure, diabetes or high cholesterol or smokers), you should discuss your treatment with your doctor or pharmacist.
  • Skin reactions
    • Under NSAR therapy, serious skin reactions with redness and bladder formation, some with a fatal outcome, were reported (exfediative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/lyell syndrome).
    • The highest risk of such reactions seems to exist at the beginning of therapy, since these reactions occurred in the majority of cases in the first month of treatment. At the first sign of rashes, mucosal defects or other signs of a hypersensitivity reaction, the medicine should be discontinued and the doctor should be consulted immediately.
  • Other information
    • The medicine should only be used with the strict weighing of the benefit-risk ratio:
      • for certain innate blood formation disorders (e.g. acute intermittent porphyria);
      • for certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis).
    • A particularly careful medical monitoring is required:
      • with limited kidney or liver function;
      • directly after larger surgical interventions;
      • in allergies (e.g. skin reactions to other medicinal products, asthma, hay fever), chronic nasal mucosal swelling or chronic respiratory diseases narrowing.
      • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed. At the first sign of a severe hypersensitivity reaction after taking/administration, the therapy must be canceled.
      • The symptoms corresponding, medically required measures must be initiated by expert persons.
      • Ibuprofen, the active ingredient of this preparation, can temporarily inhibit the platelet function (thrombocyte aggregation). Patients with blood clotting disorders should therefore be carefully monitored.
      • When the use of ibuprofen-containing drugs, the anticoagulant effect of low-dose acetylsalicylic acid (prevention of the development of blood clots) can be impaired. In this case, you should therefore not use ibuprofen-containing medicines without the express instruction of your doctor.
      • If you are taking on medicinal products at the same time to inhibit blood clotting or to reduce the blood sugar, the blood clotting or blood sugar levels should take place as a precaution.
      • If the administration is permanently, regular control of the liver values, the kidney function and the blood count is required.
      • When taking surgical interventions, the doctor or dentist must be questioned or informed.
      • If painkillers are used for a long time, headaches can occur, which may not be treated by increased doses of the drug. Ask your doctor for advice if you often suffer from headache despite taking this preparation!
      • In general, the habitual intake of pain relievers, especially when combining several pain relieving active ingredients, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
      • The medicine belongs to a group of medicinal products (non-steroidal anti-rheumatics) that can affect the fertility of women. This effect is reversible after stopping the drug (reversible).
  • Children
    • Please note the information under category "contraindications".

 

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

Pregnancy

• Schwaner
  • If pregnancy is determined during an application, the doctor must be notified. You can only use ibuprofen in the first and second thirds of pregnancy after consultation with your doctor. In the last third of pregnancy, the medicine must not be used due to an increased risk of complications for mother and child.
• Breastfeeding
  • The active ingredient ibuprofen and its dismantling products only pass into breast milk in small quantities. Since disadvantageous consequences for the infant have not yet become known, breastfeeding will generally not be necessary for short -term use. If a longer use or intake of higher doses is prescribed, however, an early wing should be considered.

Hints

IBUDEX 400mg (pack size: 50 pc) should not be taken for more than 4 days without a medical opinion.

Do not apply longer for pain or fever without medical advice than specified in the package insert!

Manufacturer:  Dexcel Pharma GmbH, Carl-Zeiss-Straße 2, 63755 Alzenau