IBUHEXAL akut 400 film-coated tablets, 50 pcs

Instructions for use for IBUHEXAL akut 400 film-coated tablets, 50 pcs

Detailed instructions for IBUHEXAL akut 400 film-coated tablets, 50 pcs

Field of use

IbuHexal acute 400mg (pack size: 50 pc) is an anti-inflammatory and pain relieving medicine (non-steroidal anti-inflammatory/analgesic).

The medicine is used at

• easy to moderately severe pain such as headache, toothache, menstrual pain, back joke;
• Fever.

IbuHexal acute 400mg (pack size: 50 pc) is also suitable for joint pain and thus in osteoarthritis and arthritis to counteract pain and inflammation. In addition, IbuHexal acute 400mg (pack size: 50 pcs) In the event of a flu infection, also as a pain reliever to relieve the fatigue and head, ear, ear or body pain.

Mode of action

IbuHexal acute 400mg (pack size: 50 pc) contains the active ingredient ibuprofen. This is able to prevent the body's production of prostaglandins and thus relieves pain and inflammatory reactions. Ibuprofen therefore has an anti -inflammatory, decongestant and analgesic effect. Ibuprofen can also have a fever -reducing effect on the temperature control center in the brain.

Active ingredients / ingredients / ingredients

IbuHexal acute 400mg (pack size: 50 pc) contains:

Active ingredient:
Ibuprofen
1 tablet contains 400 mg ibuprofen


Other ingredients:
Microcrystalline cellulose, croscarmellosis sodium, hypromellosis, macrogol 400, magnesium stearate (ph.eur.), High-disperses silicon dioxide, talcum, titanium dioxide (E 171)

Contradictions

IbuHexal acute 400mg (pack size: 50 pcs) must not be taken/applied

• in the case of known hypersensitivity to the active ingredient ibuprofen or one of the other components of the drug;
• if you have in the past with asthma attacks, Crohn's disease, nasal mucus swelling or skin reactions after taking Acetylsalicylic acid or other non-steroidal inflammatory inhibitors have reacted;
• 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 / anti-inflammatory drugs (NSAID);
• 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

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

Unless otherwise prescribed by the doctor, the following dosage guidelines apply

Always take the medicine exactly according to the instruction. Please ask your doctor or pharmacist if you are not quite sure.

Do not take the medicine without a medical or dental advice for more than 4 days.

Unless otherwise prescribed by the doctor, the usual dose is:

• 20 kg - 29 kg, 6 - 9 years: 1/2 film -coated tablet (corresponding to 200 mg ibuprofen)
  • max. Daily dose in number of tablets: up to 1 1/2 film -coated tablets (corresponding to 600 mg ibuprofen)
• 30 kg - 39 kg, 10 - 12 years: 1/2 film -coated tablet (corresponding to 200 mg ibuprofen)
  • max. Daily dose in number of tablets: 2 film -coated tablets (corresponding to 800 mg ibuprofen)
• > 40 kg children and adolescents from 12 years and adults: 1/2 - 1 film -coated tablet (corresponding to 200 - 400 mg ibuprofen)
  • max. Daily dose in number of tablets: 3 film -coated tablets (corresponding to 1200 mg ibuprofen)

If you have taken/applied the maximum single dose, wait at least 6 hours until the next intake/application.

Dosage in older people:

• No special dose adjustment is required.

Please speak to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you have taken/applied a larger amount than you should:
  • Use/apply the medicine according to the instructions of the doctor or according to the specified dosage instructions. If you have the feeling that you do not feel sufficient pain relief, then do not increase the dosage independently, but ask your doctor.
  • 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 have forgotten the intake/application of Aktren Forte:
  • If you have forgotten the intake/application, take/use the usual recommended quantity.

Taking

Please take the film -coated tablets unscrewed with plenty of liquid (e.g. a glass of water). This promotes the occurrence of action. The film -coated tablets can be taken regardless of meals. For patients who have a sensitive stomach, it is advisable to take the medicine during meals.

Patient information

• Warnings and Precautions
  • Bitte speak to your pharmacist before taking this medicine.
  • 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 use of this drug 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 NSAID, especially bio-tongues and fractures 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 the medicine, the treatment is to be stopped.
      • In patients with a gastrointestinal disease in the prehistory (Colitis Ulzerosa, 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 this medicine
        • 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 skin clipgen, mucosal defects or other signs of a hypersensitivity reaction should Aktren Forte and the doctor should be consulted immediately.
      • Use of this medicine should be avoided during a chickenpox infection (varicella infection).
    • Other information
      • This 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), 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 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 Aktren Forte, the therapy must be canceled. The symptoms corresponding, medically required measures must be initiated by expert persons.
      • Ibuprofen, the active ingredient of this drug, 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 this medicinal product is permanently, regular control of the liver values, the kidney function and the blood count is required.
      • When taking this drug before surgical interventions, the doctor or dentist must be asked 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 those that 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 under category "Contraindications".

 

• Wateriness and ability to operate 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 go to unexpected and sudden events no longer react quickly and specifically. 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

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before taking all drugs. If pregnancy is determined during a longer application of the drug, the doctor must be notified. In the first and second third of pregnancy, the medicine should only be used after consultation with the doctor. In the past three months, the medicine must not be used at birth due to an increased risk of complications for mother and child.

Still -time:
The active ingredient ibuprofen and its dismantling products pass into breast milk in small quantities. Since adverse consequences for infants have not yet become known, an interruption of breastfeeding will not be necessary for short -term use of the recommended dose with slight to moderate pain or fever.

Hints

Do not take IbuHexal acute 400 without medical or dental advice for more than 4 days.

For children and adolescents under the age of 14, the drug is not suitable due to the excessive substance content.

Keep out of reach of children.

Store with room repair and dry.

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.

In the event of severe pain in the upper abdomen, blood in the stool or in the event of vomiting blood, the medicine must be removed immediately and a doctor must be consulted.

A doctor must be informed immediately for visual disturbances, and the medicine must no longer be taken.

If signs of an infection appear or worsen during the use of the drug, a doctor should be appealed immediately.

Since side effects such as fatigue and dizziness can occur when using the drug in higher dosage, the ability to drive a motor vehicle or to use machines can be restricted in individual cases. This applies to an increased extent with the simultaneous alcohol consumption.

Therapy monitoring - If the intake is longer, regular control of the liver values, the kidney function and the blood count is required. Severe general hypersensitivity reactions can occur. You can manifest yourself as a facial swelling, swelling of the tongue, inner swelling of the larynx with narrowing of the airways, shortness of breath, hunting heart, drop in blood pressure up to the threatening shock. If one of these phenomena appears that can already occur in the event of an initial application, immediate medical help is required.

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

Miscellaneous

Terms:
Rheumaanemia

Manufacturer:  Hexal AG, Industriestraße 25, 83607 Holzkirchen