IBUBETA 400 acute film tablets, 30 pcs

Instructions for use for IBUBETA 400 acute film tablets, 30 pcs

Application Notes

Children from 6-9 years (with 20-29 kg body weight)	1/2 Tablet	1-3 times a day	6 hours apart, with the meal
Children from 10-12 years (with 30-39 kg body weight)	1/2 Tablet	1-4 times a day	6 hours apart, with the meal
Adolescents from 12 years and adults (over 40 kg body weight)	1/2-1 Tablet	1-4 times a day&<;BR&> (max. 3 tablets per day)	6 hours apart, with the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient belongs to a group of substances that act both against pain and inflammation and can reduce fever. All three effects are primarily based on the inhibition of an endogenous substance called prostaglandin. This substance must be present as a messenger substance so that pain can be felt, inflammatory reactions can be started or the body temperature can be raised.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Hematopoietic disorders
- Ulcers in the digestive tract, even in history
- Bleeding in the gastrointestinal tract, including in the past
- Active bleeding, such as:
- Cerebral hemorrhage
- Severely impaired liver function
- Severely impaired renal function
- Severe heart failure
- Severe dehydration

Under certain circumstances - talk to your doctor or pharmacist about this:
- Gastrointestinal complaints
- Inflammatory bowel diseases, including in history, such as:
- Crohn's disease
- Ulcerative colitis
- Blood clotting disorder
- High blood pressure
- Coronary heart disease (circulatory disorders of the heart muscle)
- Possible risk of vasoconstriction in the heart, as with:
- Increased fat concentration in the blood
- Diabetes mellitus (diabetes)
- Smoking
- Peripheral circulatory disorders (e.g. arms, legs)
- Circulatory disorders of the cerebral vessels
- Collagenosis (changes in the connective tissue area), such as:
- Lupus erythematosus
- Mixed collagenosis (inflammatory rheumatic collagenosis)
- Porphyria (metabolic disease)
- Major surgery that took place shortly before
- Chickenpox

What age group do you need to consider?
- Children under 6 years of age: The medicine should not normally be used in this group. There are preparations that are more suitable in terms of the strength of the active ingredient and/or dosage form.
- Elderly patients from 65 years of age: The treatment should be well coordinated with your doctor and carefully monitored, e.g. by close controls. The desired effects and undesired side effects of the drug can be stronger or weaker in this group.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

- Gastrointestinal problems such as:
- Nausea
- Vomiting
- Heartburn
- Bloating
- Diarrhea
- Constipation
- Stomach pain
- Bleeding in the gastrointestinal tract
- Tarry stools, please consult a doctor immediately if this occurs
- Inflammation of the gastric mucosa
- Ulcers in the digestive tract, which very rarely can rupture
- Inflammation of the oral mucosa
- Headache
- Dizziness
- Fatigue
- Insomnia
- Irritability
- Excitement
- Skin hypersensitivity reactions such as:
- Skin rash
- Itching
- Attacks of shortness of breath
- Visual disturbances, please consult a doctor immediately if they occur

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- The ability to react can also be impaired when used as intended, especially in higher doses or in combination with alcohol. Be particularly careful when driving or using machines (including household ones) that could injure you.
- In case of pain or fever, do not use longer than specified in the leaflet without medical advice!
- With long-term use of painkillers, headaches caused by the painkiller can occur. Talk to your doctor to prevent your headache from becoming chronic.
- The habitual use of painkillers can lead to permanent kidney damage. If several painkillers are combined, or if one painkiller contains several active ingredients, the risk increases.
- Caution: Patients with nasal polyps, chronic respiratory infections, asthma or who are prone to allergic reactions such as hay fever: the medicine can trigger an asthma attack or a severe allergic skin reaction. Therefor consult your doctor before usage.
- Be careful if you are allergic to painkillers!
- Be careful if you are allergic to binding agents (e.g. carboxymethyl cellulose with the E number E 466)!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.
- Consumption of alcohol should be avoided as far as possible during long-term treatment . Occasional alcohol consumption in small amounts is allowed, but not with the drug.

Detailed instructions for IBUBETA 400 acute film tablets, 30 pcs

Field of use

• The drug is an anti-inflammatory and analgesic drug (non-steroidal anti-inflammatory drug/analgesic). It contains the active ingredient ibuprofen.
• The drug is used in
  • mild to moderate pain such as headache, toothache, menstrual pain;
  • Fever.

Active substances / ingredients / ingredients

400 mg ibuprofen
Cellulose, microcrystalline excipient (+)
Croscarmellose sodium salt excipient (+)
Hypromellose excipient (+)
Macrogol 400 excipient (+)
Magnesium stearate (Ph. Eur.) [pflanzlich] excipient (+)
Corn starch excipient (+)
Silicon dioxide, highly dispersed excipient (+)
Stearic acid excipient (+)
Talc excipient (+)
Titanium dioxide excipient (+)
23 mg total sodium ion excipient (+)
Total Sodium Ion Excipient (+)

Contraindications

• The medicine must not be taken
  • if you are allergic to ibuprofen or any of the other ingredients of this medicine;
  • if you have had asthma attacks, nasal congestion or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past;
  • in unexplained blood formation disorders;
  • if you have or have had a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 distinct episodes of proven ulcers or bleeding);
  • if you have a history of gastrointestinal bleeding or perforation (perforation) in connection with previous therapy with non-steroidal anti-inflammatory drugs/anti-inflammatory drugs (NSAR);
  • if you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding;
  • if you have severe liver or kidney dysfunction;
  • if you have severe heart failure (heart failure);
  • in the last trimester of pregnancy;
  • in children under 20 kg (6 years), since this dosage strength is usually not suitable due to the active substance content.

dosage

• Always take the medicine exactly as described or as your doctor or pharmacist has told you. Check with 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: 1/2 film-coated tablet
      • maximum daily dose in the number of tablets: up to 1 1/2 film-coated tablets
    • Body weight (age): 30 kg - 39 kg (10 - 12 years)
      • Single dose in number of tablets: 1/2 film-coated tablet
      • maximum daily dose in the number of tablets: 2 film-coated tablets
    • Body weight (age): > 40 kg (children and adolescents from 12 years and adults)
      • Single dose in number of tablets: 1/2 - 1 film-coated tablet
      • maximum daily dose in the number of tablets: 3 film-coated tablets
  • If you have taken the maximum single dose, wait at least 6 hours before taking the next dose.

• Duration of use
  • Adult
    • In adults, if taking this medicine is required for more than 3 days in case of fever and more than 4 days in case of pain, or if the symptoms worsen, medical advice should be sought.
  • Children and young people
    • If children and adolescents need to take this medicine for more than 3 days or if symptoms worsen, medical advice should be sought.
    • The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen.
  • Side effects can be minimized by using the lowest effective dose needed to control symptoms for the shortest possible time.
• Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

• If you take more than you should
  • Take this medicine as directed by your doctor or as directed here.
  • If you have taken more tablets than you should, or if children have accidentally taken the medicine, always contact your doctor or nearest hospital for an assessment of the risk and advice on further treatment.
  • Symptoms can include nausea, stomach pain, abdominal pain, vomiting (possibly with blood), headache, ringing in the ears, confusion, and eye tremors. At high doses, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems have been reported.
  • Bleeding in the gastrointestinal tract and functional disorders of the liver and kidneys are also possible. It can also lead to a drop in blood pressure, reduced breathing (respiratory depression) and a bluish red coloring of the skin and mucous membranes (cyanosis).
  • There is no specific antidote.

• If you forget to take a dose
  • Do not take a double dose to make up for a forgotten dose.

• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Revenue

• Please swallow the film-coated tablets whole with plenty of liquid (e.g. a glass of water) during or after a meal.
• For patients who have a sensitive stomach, it is recommended to take this medicine with meals.

Patient notes

• Warnings and Precautions
  • Please talk to your pharmacist before taking this medicine.
  • Side effects can be minimized by using the lowest effective dose needed to control symptoms for the shortest period of time.
  • Safety in the gastrointestinal tract
    • Concomitant use of this medicine with other non-steroidal anti-inflammatory drugs, including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors) should be avoided.
    • Elderly patients:
      • Side effects occur more frequently in older patients after the use of NSAR , in particular bleeding and perforations in the stomach and intestines, which can be life-threatening under certain circumstances. Therefore, particularly careful medical supervision is required in elderly patients.
    • Gastrointestinal bleeding, ulcers and perforations:
      • Gastrointestinal bleeding, ulcers and perforations, including fatal outcomes, have been reported during treatment with all NSAR . They occurred with or without prior warning symptoms or a history of serious gastrointestinal events at any time during therapy.
      • The risk of occurrence of gastrointestinal bleeding, ulcers and perforation is higher with increasing NSARdose, in patients with a history of ulcers, especially those complicated with bleeding or perforation, and in elderly patients. These patients should start treatment on the lowest dose available.
      • Combination therapy with drugs that protect the gastric mucosa (e.g. misoprostol or proton pump inhibitors) should be considered.
      • If you have a history of gastrointestinal adverse reactions, particularly if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of therapy.
      • Caution is advised if you are also receiving medicines that may increase the risk of ulcers or bleeding, such as B. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, to treat depressive moods, or platelet aggregation inhibitors such as ASA.
      • If you develop gastrointestinal bleeding or ulcers during treatment with the medicine, the 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.
    • Effects on the cardiovascular system
      • Anti-inflammatories/painkillers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used 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 if you
        • have heart disease, including heart failure (heart failure) and angina pectoris (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any type of stroke (including mini - had a 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 with reddening and blistering, some with fatal outcome, have been reported very rarely (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome) with NSARtherapy. The risk of such reactions appears to be highest at the start of therapy, since the majority of these reactions occurred within the first month of treatment. At the first sign of skin rashes, mucosal defects or other signs of a hypersensitivity reaction, Aktren Forte should be discontinued and the doctor consulted immediately.
      • Avoid using this medicine if you have chickenpox (varicella) infection.
    • Other Notes
      • This medicinal product should only be used after careful consideration of the risk/benefit ratio:
        • in certain congenital blood disorders (e.g. acute intermittent porphyria);
        • in certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis), as these patients are at increased risk of aseptic meningitis.
      • Particularly careful medical supervision is required:
        • if you have impaired kidney function, as this can continue to deteriorate;
        • in liver dysfunction; Hepatic dysfunction increases the risk of developing kidney toxicity and damage, as well as severe, potentially fatal liver reactions;
        • immediately after major surgical interventions;
        • in the 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 observed very rarely. Therapy must be discontinued at the first sign of a severe hypersensitivity reaction after taking Aktren Forte. Medically necessary measures corresponding to the symptoms must be initiated by competent persons.
      • Ibuprofen, the active ingredient in this medicine, can temporarily inhibit the function of platelets (platelet aggregation). Patients with bleeding disorders should therefore be carefully monitored.
      • If medicines containing ibuprofen are used at the same time, the anticoagulant effect of low-dose acetylsalicylic acid (preventing the formation of blood clots) may be impaired. In this case, you should therefore not use ibuprofen-containing medicines without your doctor's express instructions.
      • If you are taking medicines to inhibit blood clotting or to lower blood sugar at the same time, you should have your blood clotting or blood sugar levels checked as a precaution.
      • If this drug is administered for a longer period of time, regular monitoring of the liver values, kidney function and blood count is required.
      • The doctor or dentist should be consulted or informed if this medicine is taken before surgery.
      • Prolonged use of any type of pain reliever for a headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued. A diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) their regular use of headache drugs.
      • 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).
      • When using NSAR , drug-related side effects, especially those affecting the gastrointestinal tract or the central nervous system, can be increased through the simultaneous consumption of alcohol.
• Children and young people
  • There is a risk of renal dysfunction in dehydrated children and adolescents.
  • Please note the information under the "Contraindications" category".

• Ability to drive and use machines
  • Since central nervous side effects such as tiredness and dizziness can occur when using the drug in higher doses, the ability to react can be altered in individual cases 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

• 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 this medicine, the doctor should be informed. You may only use ibuprofen in the first and second trimester of pregnancy after consulting your doctor. This medicine must not be used in the last trimester of pregnancy because of an increased risk of complications for mother and child.
• Lactation
  • Only small amounts of the active ingredient ibuprofen and its breakdown products pass into breast milk. Since adverse consequences for the infant have not yet become known, it is not usually necessary to interrupt breastfeeding if the product is used for a short period of time. However, if longer use or higher doses are prescribed, early weaning should be considered.
• Fertility
  • This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

Hints

In case of pain or fever, do not use longer than specified in the leaflet without medical advice!

Manufacturer: betapharm Arzneimittel GmbH, Kobelweg 95, 86156 Augsburg