IBULYSIN ADGC 400 mg film-coated tablets, 50 pcs

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

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

Field of use

Ibulysin ADGC 400 mg film -coated tablets (pack size: 50 pc) is used for a short -term symptomatic treatment of headache and migraine pain. The active ingredient is ibuprofen, combined with the salt lysine, and belongs to the drug group of non -steroidal anti -inflammatory drugs (NSAID). Ibulysin ADGC® can be used in adults and adolescents from the age of 12 with a body weight from 40 kg.

Active ingredients / ingredients / ingredients

Active ingredients of Ibulysin ADGC 400 mg film -coated tablets (pack size: 50 pc):

The active ingredient is ibuprofen.
Each film-coated tablet contains 400 mg ibuprofen (as an ibuprofen DL-lysine (1: 1)).

The other ingredients are: tablet core: microcrystalline cellulose, silicon dioxide-coated, copovidone, carboxymethylar stake sodium (type a) (ph.eur.), Magnesium[pflanzlich] stearate (ph. E171), Talkum, Macrogol 4000, Methacrylic ethylacrylate copolymer (1: 1) (Ph.EUR.), Sodium hydrogen carbonate.

Contradictions

In the case of known hypersensitivity to one of the above -mentioned ingredients, this product should not be used.

dosage

Application recommendation of Ibulysin ADGC 400 mg film -coated tablets (pack size: 50 pcs):

Adults and adolescents from 40 kg body weight (12 years andd older):
Take 1 tablet with water up to three times a day.
The distance between the income should be at least six hours.
Do not take more than three tablets (1200 mg ibuprofen) within 24 hours.

Taking

• The medicine is to take
• The film -coated tablets have a breaker on one side. The broken base only serves to share the tablet if you have difficulty swallowing them as a whole.

Patient information

• Warnings and Precautions
  • Please speak to your doctor or pharmacist before taking the medicine:
    • if you have or had asthma or allergic diseases because shortness of breath can occur.
    • if you suffer from hay fever, nasal polyps or chronic respiratory diseases that are narrowing, as there is an increased risk of the occurrence of allergic reactions. These can express themselves as asthma attacks (so-called analgesics asthma), quincke-edema or hives (urticaria).
    • if you have kidney, heart, liver or intestinal problems.
    • if you have a gastrointestinal disease (such as Ulcerosa Colitis or Crohn's disease).
    • if you have certain congenital blood formation disorders (e.g. an acute intermittent porphyria).
    • if you have a systemic lupus erythematos (SLE) or a so -called mixed collagenosis - these are diseases of the immune system that cause joint pain, skin changes and other organ disorders.
    • if you have chickenpox (varicella) - in this case it is advisable not to take this preparation because your condition could deteriorate.
    • if you have an infection - see below under "Infections".
    • if you have just had a larger operation.
    • if you suffer from lack of fluid.
    • if you take other NSAIDs. The application together with other NSAR (including the so-called selective COX-2 inhibitors) should be avoided.
    • if you are pregnancy in the first six months.
  • Other warnings
    • 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 medicine
      • have a heart disease including heart failure (heart failure) and angina (chest pain), or a heart attack, a bypass operation, a 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
      • Serious skin reactions were reported in connection with treatment with NSAIDs. The risk of such reactions is highest for patients in the first month of treatment. If the rash occurs, lesions of the mucous membranes, bubbles or other signs of an allergy should be set to treatment with the medicine and immediately go into medical treatment, as this can be the first signs of a very serious skin reaction.
    • Side effects can be minimized if the lowest effective dose is used for the shortest possible period. The risk of side effects is increased in older patients.
    • Ibuprofen can temporarily affect the platelet function (thrombocyte aggregation). Patients with blood clotting disorders should therefore be monitored closely.
    • The doctor or dentist must be asked or informed if the medicine is used before an surgical intervention.
    • The habitual intake of different types of painkillers can become a permanent Kidney damage leads to the risk of kidney failure. This risk may be increased with salt loss and lack of fluid due to physical stress. The habitual intake of painkillers is therefore to be avoided.
    • 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 treatment can be broken off. The diagnosis of headache in medication overuse (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.
    • If Ibuprofen is used for a long time, regular control of your liver values, kidney function and blood count is required.
    • NSAR can mask symptoms of infection and fever.
    • Infections
      • The medicine can cover signs of infections such as fever and pain. Therefore, it is possible that the preparation will delay adequate treatment of the infection, which can lead to an increased risk of complications. This was observed in bacterial pneumonia and bacterial skin infections in connection with chickenpox. If you take this medicine during an infection and stop or worsen your symptoms of infection or worsen, consult a doctor immediately.
  • Children and adolescents
    • The medicine must not be applied to children under the age of 12 or adolescents below 40 kg body weight.
    • There is a risk of kidney dysfunction in dehydrated young people.

Pregnancy

• If you are pregnant or breastfeed, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this drug.
• Pregnancy
  • Do not take this medicine in pregnancy in the last three months. Avoid using this drug in the first six pregnancy months, unless the doctor recommends anything else.
• Breastfeeding
  • Ibuprofen and its dismantling products only pass into breast milk in small quantities. The drug can therefore be taken during breastfeeding if it is used in the recommended dosage and over the shortest possible period.
• Fertility
  • This preparation belongs to a group of drugs that can affect the fertility of women. This effect is reversible after stopping the drug (reversible).

Hints

Ibulysin ADGC 400 mg film-coated tablets: ibuprofen (as an ibuprofen DL-lysine (1: 1)). Areas of application: short -term symptomatic treatment of headaches and migraines in adults and adolescents from the age of 12 with a body weight from 40 kg. If the application of this medicine is needed for more than three days or if the symptoms worsen, the patient should obtain medical advice. Warning: In the event of pain or fever without medical advice, no longer use than specified in the package insert! Pharmacy.
Read the package supplement and ask your doctor or pharmacist for risks and side effects.
Zentiva Pharma GmbH, 65927 Frankfurt am Main
As of: December 2021

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

Manufacturer:  Zentiva Pharma GmbH, Linkstrasse 2, 10785 Berlin