EUDORLIN Migraine film -coated tablets, 10 pcs

Instructions for use for EUDORLIN Migraine film -coated tablets, 10 pcs

Detailed instructions for EUDORLIN Migraine film -coated tablets, 10 pcs

Field of use

• The medicine is an anti -inflammatory and pain relieving drug (non -steroidal anti -inflammatory/anti -inflammatory agent, nsar).
• It is used for symptomatic treatment
  • the acute headache phase for migraines with and without aura
  • from tension headache

Active ingredients / ingredients / ingredients

400 mg ibuprofen
Carboxymethylar, sodium salt type a auxiliary substance (+)
Hypromellic auxiliary substance (+)
Macrogol 4000 auxiliary substances (+)
Magnesium stair (Ph. EUR.) [pflanzlich] Hedge substance (+)
Corn starch auxiliary substance (+)
Povidon K30 auxiliary material (+)
Silicium dioxide, high disperser auxiliary substance (+)
Titan dioxide HILDBOFT (+)

Contradictions

• The medicine must not be taken
  • if you are allergic to ibuprofen or one of the other components of this drug
  • in allergic reactions after taking acetylsalicylic acid or other non -steroidal inflammatory inhibitors in the past, such as
    • Breath of breathing by narrowing the airways (bronchospasm)
    • Asthma attacks
    • Swelling of the nasal mucosa
    • Skin reaction (e.g. reddening, whispering or. Ä.)
  • 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 of previous therapy with non-steroidal anti-inflammatory drugs / anti-inflammatory drugs (NSAID)
  • for brain bleeding (cerebrovascular bleeding) or other active bleeding
  • in the case of severe liver or kidney dysfunction
  • in the case of severe heart failure (heart failure)
  • in the last months of pregnancy
  • of children under 20 kg (under 6 years), since this dose strength is usually not suitable due to the active ingredient content

dosage

• Always take this medicine exactly as described in this package insert or follow the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.
• Dosage
  • Unless otherwise prescribed by the doctor, the recommended dose is:
    • 20 - 29 kg body weight (children: 6 - 9 years):
      • Single dose: 1/2 film -coated tablet (corresponding to 200 mg ibuprofen)
      • max. Daily dose: 1.5 film -coated tablets (corresponding to 600 mg ibuprofen)
    • 30 - 39 kg body weight (children: 10 - 12 years):
      • Single dose: 1/2 film -coated tablet (corresponding to 200 mg ibuprofen)
      • max. Daily dose: 2 film -coated tablets (corresponding to 800 mg ibuprofen)
    • from 40 kg body weight (children and adolescents from the age of 12 and adults)
      • Single dose: 1/2 - 1 film -coated tablet (corresponding to 200 - 400 mg ibuprofen)
      • max. Daily dose: 3 film -coated tablets (corresponding to 1200 mg ibuprofen)
    • After taking the maximum single dose, a distance of at least 6 hours until the next income must be observed.
  • Older people and patients with an earlier stomach or duodenum ulcer
    • These patients should start with the lowest dosage and be monitored by a doctor.
  • Limited kidney or liver function
    • If the kidney or liver function is slightly restricted, no dose reduction is required.
  • Application in children and adolescents
    • If this drug is required for children and adolescents for more than 3 days or if the symptoms worsen, medical advice should be givenbe fetched.

• Duration of the application
  • Do not apply this medicine to children and adolescents without a medical advice for more than 3 days and no longer than 4 days in adults.
  • Please speak to your doctor or pharmacist if you have the impression that the medicine is too strong or too weak.

• If you have taken a larger amount of the drug than you should
  • Take the medicine according to the doctor's instructions or according to the dosage instructions given here. If you have the feeling that you do not feel sufficient pain relief, then do not increase the dosage independently, but ask your doctor.
  • Possible symptoms of the overdose are:
    • central nervous disorders, such as headaches, dizziness, drowsiness and lack of consciousness (also seizures in children)
    • Gastrointestinal complaints such as abdominal pain, nausea and vomiting, bleeding in the gastrointestinal tract
    • Functional disorders of liver and/or kidneys
    • Blood pressure drop
    • reduced breathing (respiratory depression)
    • blaurot coloring of skin and mucous membranes (cyanosis)
  • There is no specific counterplicit (antidot).
  • If you suspect an overdose, please notify a doctor immediately. According to the severity of poisoning, this can decide on the measures necessary.

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

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

Taking

• Please take the film -coated tablets with sufficient liquid (e.g. a glass of water) during or after a meal.

Patient information

• Warnings and Precautions
  • Side effects can be reduced by using the lowest effective dose via the shortest period required for symptom control.
  • 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.
  • 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 breakthroughs (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 prehistory of side effects on the gastrointestinal tract, especially at older age, you should report any unusual symptoms in the abdomen (especially magema 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, blood clottingslitting medication, such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, to treat depressive moods, or platelet aggregation inhibitors, such as ASS.
    • If you have gastrointestinal bleeding or ulcers during treatment, the treatment must be discontinued immediately and contact with a doctor.
    • In patients with a gastrointestinal disease, NSAR should be used with caution (Colitis Ulcerosa, Crohn's disease) because their condition can deteriorate.
  • Effects on the cardiovascular system
    • Medicines like this 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. Do not exceed the recommended dose or treatment duration (see the maximum duration "dosage")!
    • 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 are smokers), you should be with your doctor or Pharmacists speak.
  • 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 a doctor should be consulted immediately.
  • Other information
    • Please speak to your doctor or pharmacist before taking this medicine.
    • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed.
    • Patients with blood clotting disorders should therefore be carefully monitored
    • in this case, you should therefore not use ibuprofen-containing medicines without the express instruction of your doctor
    • 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
    • in general, the habitual present cancausing pain relievers, especially when combining several pain relieving active ingredients, leading to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
    • Use of this drug should be avoided during a chickenpox infection (varicella infection).
• Children and adolescents
  • Please note the information under category "contraindication".
  • There is a risk of kidney dysfunction in dehydrated children and adolescents.

• Wateriness and operating machines:
  • Since when using this 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 used. This applies to an increased degree in interaction 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 your doctor or pharmacist for advice before taking this drug.
• Pregnancy:
  • You may only apply the medicine 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.
• Fertile/childhood ability
  • This preparation belongs to a group of drugs (non -steroidal anti -inflammatory drugs/anti -inflammatory drugs, NSAID) that can affect the fertility of women. This effect is reversible after stopping the drug (reversible).
• Still -time:
  • The active ingredient ibuprofen and its dismantling products only pass into breast milk in small quantities.

Hints

Miscellaneous.

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)


- It must be checked whether the indication for anti -infectious/antibiotic treatment is available.
- Since nervous side effects such as fatigue and dizziness can occur when using ibuprofen in higher dosage, the ability to drive a motor vehicle or.this applies even more in combination with alcohol.

- If one of these phenomena appears that can already occur in the event of an initial application.
- Immediate medical help is required.