IBUPROFEN AbZ 40 mg/ml syrup, 100 ml

Instructions for use for IBUPROFEN AbZ 40 mg/ml syrup, 100 ml

Detailed instructions for IBUPROFEN AbZ 40 mg/ml syrup, 100 ml

Field of use

• The preparation is an anti-inflammatory, antipyretic and painkiller (non-steroidal anti-inflammatory drug/anti-inflammatory drug, NSAR).
• Application areas:
• The medicine is used for short-term symptomatic treatment
  • slight to moderate pain
  • Fever

Active ingredients / ingredients / ingredients

200 mg ibuprofen
Citric acid 1-water excipient (+)
450 mg glucose excipient (+)
Polysorbate 80 excipient (+)
Saccharin, sodium salt excipient (+)
1 g sucrose excipient (+)
Water, purified excipient (+)
Xanthan gum excipient (+)
Potassium sorbate excipient (+)
115 mg total sodium ion excipient (+)
Total Sodium Ion Excipient (+)
Strawberry flavor excipient (+)
Flavoring substances, natural and nature-identical excipient (+)
9.2 mg propylene glycol excipient (+)
Cream Flavor Excipient (+)
Flavoring substances, natural and nature-identical excipient (+)
Propylene glycol excipient (+)
Triacetin excipient (+)
0.4 mg benzyl alcohol excipient (+)

Contraindications

• Ibuprofen must not be taken,
  • if you or your child are allergic to ibuprofen or any of the other ingredients of this medicine;
  • if you or your child have had a history of bronchospasm, asthma attacks, nasal swelling, skin reactions or sudden swelling after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
  • for unexplained blood formation disorders;
  • if you already have or have had repeated stomach/duodenal ulcers (peptic ulcers) or bleeding in the past (at least two different episodes of proven ulcers or bleeding);
  • if you have a history of gastrointestinal bleeding or perforation in connection with previous therapy with non-steroidal anti-inflammatory drugs/anti-inflammatory drugs (NSAR);
  • if there is bleeding in the brain (cerebrovascular hemorrhage) or other active bleeding;
  • if you have severe liver or kidney dysfunction;
  • with severe heart failure (heart failure);
  • in severe dehydration (caused, for example, by vomiting, diarrhea or insufficient fluid intake);
  • in the last trimester of pregnancy.
  • for children under 10 kg (1 year), as this dose strength is not suitable due to the higher active ingredient content.

dosage

• Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
• For adults:
  • In adults, if it is necessary to take this medicine for more than 3 days for fever or for more than 4 days for pain, or if symptoms worsen, medical advice should be sought.
• For children and young people:
  • In children and adolescents, if it is necessary to take this medicine for more than 3 days or if symptoms worsen, medical advice should be sought.
• Recommended dose is:
  • 10 - 15 kg (children: 1 - 3 years)
    • Single dose: 2.5 ml (equivalent to 100 mg ibuprofen)
    • max. daily dose: 7.5 ml (equivalent to up to 300 mg ibuprofen)
  • 16 - 19 kg (children: 4 - 6 years)
    • Single dose: 3.75 ml (equivalent to 150 mg ibuprofen)
    • max. daily dose: 11.25 ml (equivalent to up to 450 mg ibuprofen)
  • 20 - 29 kg (children: 7 - 9 years)
    • Single dose: 5 ml (equivalent to up to 200 mg ibuprofen)
    • max. daily dose: 15 ml (equivalent to up to 600 mg ibuprofen)
  • 30 - 39 kg (children: 10 - 11 years)
    • Single dose: 7.5 ml (equivalent to 300 mg ibuprofen)
    • max. daily dose: 22.5 ml (equivalent to up to 900 mg ibuprofen)
  • >/= 40 kg (young people aged 12 and over)
    • Single dose: 5 - 10 ml (equivalent to 200-400 mg ibuprofen)
    • max. daily dose: 30 ml (equivalent to up to 1200 mg ibuprofen)
  • Dosage in the elderly
    • No special dose adjustment is required.
• If you have taken the maximum single dose, wait at least 6 hours before taking your next dose.

 

• Duration of application
  • The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen.

 

• If you have taken more ibuprofen than you should, or if children have accidentally taken the medicine, always contact a doctor or local hospital for an assessment of the risk and advice on further treatment.
  • Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, ringing in the ears, confusion, and tremors in the eyes. Bleeding in the gastrointestinal tract is also possible. At high doses there have been reports of drowsiness, dizziness, chest pain, heart palpitations, fainting, cramps (especially in children), weakness and dizziness, blood in the urine, dysfunction of the liver and kidneys, reduced breathing (respiratory depression), drop in blood pressure, blue-red coloring of the skin and Mucous membranes (cyanosis), freezing and breathing problems have been reported.
  • There is no specific antidote.

 

• If you forget to take:
  • Do not take a double dose if you forget to take the previous dose.

 

• If you have any further questions about using this medicine, talk to your doctor or pharmacist.

Intake

• Take ibuprofen according to your doctor's instructions or according to the dosage instructions given in the package leaflet. If you feel that you are not getting sufficient pain relief, do not increase the dose yourself, but ask your doctor.
• For patients who have a sensitive stomach, it is recommended to take the medication during meals.

Patient information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before you or your child takes the product.
  • Side effects can be minimized if the lowest effective dose needed to control symptoms is used for the shortest possible period of time.
  • Safety in the gastrointestinal tract
    • Simultaneous use of the preparation with other non-steroidal anti-inflammatory drugs, including so-called COX-2 inhibitors (cyclooxygenase 2 inhibitors), should be avoided.
  • Elderly patients
    • Older patients are more likely to experience side effects after using NSAR , especially bleeding and perforations in the stomach and intestines, which can be life-threatening under certain circumstances. Therefore, particularly careful medical monitoring is required in older patients.
  • Bleeding of the gastrointestinal tract, ulcers and breakthroughs (perforations)
    • Gastrointestinal bleeding, ulcers and perforations, including fatal outcomes, have been reported during treatment with all NSAR . They occurred with or without previous warning symptoms or a history of serious gastrointestinal events at any time during therapy.
      • The risk of occurrence of gastrointestinal bleeding, ulcers and perforations is higher with increasing NSARdose, in patients with a history of ulcers, especially with the complications of bleeding or perforations (the section can be found in the "Contraindication" category "), and in older patients. These patients should begin treatment at the lowest available dose. For these patients, as well as for patients who require concomitant therapy with low-dose acetylsalicylic acid (ASS) or other drugs that may increase the risk of gastrointestinal diseases, combination therapy with drugs that protect the gastric mucosa (e.g . Misoprostol or proton pump inhibitors) should be considered.
      • If patients have a history of gastrointestinal adverse reactions, particularly in older age, any unusual abdominal symptoms (especially gastrointestinal bleeding) should be reported, particularly at the start of therapy.
      • Caution is advised if patients are also receiving medicines that may increase the risk of ulcers or bleeding, such as: B. oral corticosteroids, anticoagulant medications such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, to treat depressive moods, or platelet aggregation inhibitors such as ASS (you can find the section in the “Interactions” category).
      • If gastrointestinal bleeding or ulcers occur during treatment with ibuprofen, treatment should be discontinued.
      • NSAR should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as their condition may worsen (see the section under “Side effects”).
  • Effects on the cardiovascular system
    • Anti-inflammatories/pain relievers such as ibuprofen may be associated with a slightly increased risk of a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment (3 days in children and adolescents or for fever and 4 days for the treatment of pain in adults).
    • You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if you:
      • have heart disease, including heart failure and angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (problems with blood flow in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including mini-stroke or transient ischemic attack (TIA).
      • Have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.
  • Skin reactions
    • Serious skin reactions have been reported in association with treatment with ibuprofen. If you develop a skin rash, mucous membrane lesions, blisters or other signs of allergy, you should stop treatment with the product and seek medical attention immediately, as these may be the first signs of a very serious skin reaction (see "Side effects" category).
    • The medicine should be avoided during a chickenpox infection (varicella infection).
  • Infections
    • the medicine may mask signs of infection such as fever and pain. It is therefore possible that the medicine may delay adequate treatment of the infection, which may lead to an increased risk of complications. This has been seen in bacterial pneumonia and bacterial skin infections associated with chickenpox.
    • If you take this medicine during an infection and your infection symptoms persist or worsen, consult a doctor immediately.
  • Other information
    • The preparation should only be used after careful consideration of the benefit-risk ratio:
      • in certain congenital blood formation disorders (e.g. acute intermittent porphyria);
      • in certain autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).
  • Particularly careful medical supervision is required:
    • with impaired kidney or liver function;
    • in case of dehydration;
    • immediately after major surgical procedures;
    • in case of allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic swelling of the nasal mucosa or chronic respiratory diseases that narrow the airways.
  • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed. At the first signs of a severe hypersensitivity reaction after taking ibuprofen, therapy must be discontinued. Medically necessary measures appropriate to the symptoms must be initiated by specialists.
  • Ibuprofen can temporarily inhibit platelet function (platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored.
  • If the drug is used for a long time, regular monitoring of liver values, kidney function and blood counts is necessary.
  • If you take ibuprofen before surgical procedures, you should consult or inform your doctor or dentist.
  • Prolonged use of any type of painkiller for headaches can make them worse. If this is the case or suspected, medical advice should be sought and treatment discontinued. The diagnosis of Medication Overuse Headache (MOH) should be suspected in patients who suffer from frequent or daily headaches despite (or precisely because) they regularly take medication for headaches.
  • In general, the habitual use of painkillers, especially when several painkillers are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
  • Children and young people
    • There is a risk of kidney dysfunction in dehydrated children and adolescents.

 

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

Pregnancy

• Pregnancy, breastfeeding and fertility
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Pregnancy:
  • If pregnancy is discovered while using ibuprofen, the doctor should be notified. You may only take the medication in the first and second trimesters of pregnancy after consulting your doctor. Ibuprofen must not be taken in the last trimester of pregnancy due to an increased risk of complications for mother and child.
• Lactation
  • The active ingredient ibuprofen and its breakdown products only pass into breast milk in small quantities. Since adverse consequences for the infant have not yet been reported, interruption of breastfeeding will generally not be necessary if the recommended dose is used for a short period of time.
• Reproductive ability
  • the preparation belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect women's fertility. This effect is after discontinuation of the
    Drug reversible (reversible).

Hints

If you have pain or fever, do not use it for longer than stated in the package leaflet without medical advice!

Manufacturer:  AbZ Pharma GmbH, Graf-Arco-Straße 3