IBUDEX 200 mg film -coated tablets, 10 pcs

Instructions for use for IBUDEX 200 mg film -coated tablets, 10 pcs

Detailed instructions for IBUDEX 200 mg film -coated tablets, 10 pcs

Field of use

• The preparation is an anti-inflammatory and pain relieving drug (non-steroidal anti-inflammatory/analgesic). It contains the active ingredient ibuprofen.
• The medicine is used at
  • easy to moderately severe pain such as headache, toothache, regulation pain;
  • Fever.

Active ingredients / ingredients / ingredients

200 mg ibuprofen
ACID Blue 9 Hedge Terms (+)
Carmellosis, sodium salt auxiliary material (+)
Carnaubawachs auxiliary substance (+)
Cellulose, microcrystalline auxiliary material (+)
Chinoling elbing auxiliary substance (+)
Crooscarmellosis, sodium salt auxiliary material (+)
Erythrosine auxiliary substance (+)
Hypromellic auxiliary substance (+)
Macrogol 400 auxiliary material (+)
Magnesium stair auxiliary material (+)
Corn starch auxiliary substance (+)
Silicium dioxide, high disperser auxiliary substance (+)
Stearic acid auxiliary material (+)
Talcum auxiliary material (+)
Titan dioxide HILDBOFT (+)

Contradictions

• The medicine must not be used/applied
  • if you are allergic to ibuprofen or one of the other components of this drug;
  • if you have reacted in the past with asthma attacks, nasal mucus swelling or skin reactions after taking acetylsalicylic acid or other non-steroidal inflammatory inhibitors;
  • in the case of unexplained blood formation disorders;
  • in the event of existing or repeated stomach/duodenum ulcers (peptic ulcers) or bleeding (at least 2 different episodes of proven ulcers or bleeding);
  • in the case of gastrointestinal bleeding or breakthrough (perforation) in the history in connection with previous therapy with non-steroidal anti-rheumatics/antiphlogistika (NSAR);
  • for brain bleeding (cerebrovascular bleeding) or other active bleeding;
  • in severe liver or kidney dysfunction;
  • with severe heart failure (heart failure);
  • in the last third of the pregnancy;
  • in children under 20 kg (6 years), since this dose strength is usually not suitable due to the active ingredient content.

dosage

• Always take the preparation precisely according to instructions or exactly according to the agreement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.
  • The recommended dose is:
    • Body weight (age): 20 kg - 29 kg (6 - 9 years)
      • Single dose in number of tablets: 1 excessive tablet
      • max. Daily dose in the number of tablets: 3 covered tablets
    • Body weight (age): 30 kg - 39 kg (10 - 12 years)
      • Single dose in number of tablets: 1 excessive tablet
      • max. Daily dose in the number of tablets: 4 covered tablets
    • Body weight (age): > 40 kg (children and adolescents from 12 years and adults)
      • Single dose in number of tablets: 1 - 2 excessive tablets
      • max. Daily dose in the number of tablets: 6 excessive tablets
  • If you have taken the maximum single dose, wait at least 6 hours until the next income.
  • Adult
    • If this medicine is taken for more than 3 days in the case of fever and longer than 4 days in the case of pain or if the symptoms worsen, medical advice should be obtained.
  • Children and adolescents
    • If this medicine is required for more than 3 days in children and adolescents or if the symptoms worsen, medical advice should be obtained.
• Please speak to your doctor or pharmacist if you have the impression that the effect of the drug is too strong or too weak.

• If you have taken a larger amount than you should:
  • Take the medicine according to the doctor's instructions or according to the specified dosage instructions.
  • Central nervous disorders such as headaches, dizziness, dunging and unconsciousness (in children also seizures) as well as abdominal pain, nausea and vomiting can occur as symptoms of overdose. Furthermore, bleeding in the gastrointestinal tract and functional disorders of the liver and kidneys are possible. Furthermore, blood pressure drop, reduced breathing (respiratory depression) and the blue -red color of the skin and mucous membranes (cyanosis) can occur.
  • There is no specific antidote (antidot).
  • If you suspect an overdose, please notify your doctor. According to the severity of poisoning, this can decide on the measures necessary.

• If you forgot to take it:
  • Do not take the double amount if you have forgotten the prior intake.

• If you have any further questions about taking this medicine, please contact your doctor or pharmacist.

Taking

• Please take the covered tablets 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 tablets during meals.
• Side effects can be minimized by using the lowest effective effective dose required for symptom control over the shortest possible period.

Patient information

• Warnings and Precautions
  • Please speak to your pharmacist before taking the preparation.
  • Side effects can be minimized by using the lowest effective dose required for symptom control over the shortest period.
  • Security in the gastrointestinal tract
    • A simultaneous application with other non-steroidal withdrawalinhibitors, including so-called COX-2 inhibitors (cyclooxygenase-2-inhibitors), should be avoided.
    • 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 of therapy.
      • 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 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 gastrointestinal bleeding or ulcers during treatment with this preparation, the treatment must be discontinued.
      • 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
    • Anti -inflammatory agents/painkillers such as ibuprofen can go hand in hand with a slightly increased risk of heart attack or stroke, especially when using in high doses. Do not exceed the recommended dose or duration of treatment.
    • You should discuss your treatment with your doctor or pharmacist before taking the preparation
      • having heart disease, including heart failure (heart failure) and angina pectoris (chest pain), or a heart attack, a bypass surgery, peripheral arterial disease (circulatory disorders in the legs or feet due to narrowed or closed arteries) or any kind of stroke (including mini -Stroke or transitory ischemic attack, "tia").
      • Heavy prints, diabetes or high cholesterol levels or heart diseases or strokes occur in their family history or when they are smokers.
  • 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.
    • An application should be avoided during a chickenpox infection (varicella infection).
  • Other information
    • The medicine should only be under strict weighing up the benefiten-risk ratio are used:
      • for certain innate blood formation disorders (e.g. acute intermittent porphyria);
      • for certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis), since these patients have an increased risk of aseptic meningitis.
    • A particularly careful medical monitoring is required:
      • with restricted kidney function, since it can continue to deteriorate;
      • for liver dysfunction; Liver dysfunction increase the risk of the occurrence of kidney harmfulness and damage, as well as for severe, possibly fatal liver reactions;
      • directly after larger surgical interventions;
      • in allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic nasal mucosal swelling or chronic, respiratory respiratory diseases.
    • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed. At the first sign of a severe hypersensitivity reaction after taking the drug, the therapy must be canceled. The symptoms corresponding, medically required measures must be initiated by expert persons.
    • Ibuprofen, the active ingredient of the 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 medicinal products at the same time, 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 preparation is permanently increasing, 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.
    • The longer use of all kinds of painkillers against headaches can make them worse. If this is the case or if this is suspected, medical advice should be obtained and the treatment can be canceled. The diagnosis of headache in the use of medication (Medication Overuse Headache, MOH) should be assumed in patients who suffer from frequent or daily headaches, although (or precisely because) they regularly take medicines for headaches.
    • 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).
    • When using NSAIDs, the simultaneous enjoyment of alcohol, active ingredient side effects, in particular Soche, which affect the gastrointestinal tract or the central nervous system, can be reinforced.
  • Children and adolescents
    • There is a risk of kidney dysfunction in dehydrated children and adolescents.
    • Please note the information in category "contraindications".

• Wateriness and operating machines
  • Since when using the drug in higher dosage, 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

• If you are pregnant or breastfeed, or if you suspect that you are pregnant or intend to become pregnant, ask yourn doctor or pharmacist for advice.
• Pregnancy
  • If pregnancy is determined during an application of the drug, 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 preparation 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.

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