IBUARISTO acute 400 mg film-coated tablets, 20 pcs

Instructions for use for IBUARISTO acute 400 mg film-coated tablets, 20 pcs

Application Notes

Adolescents from 12 years and adults (over 40 kg body weight)

1/2-1 Tablet

1-4 times a day (max. 3 tablets a day)

6 hours apart, regardless of 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
- Severe heart failure
- Severely impaired liver function
- Severely impaired renal function
- Hematopoietic disorders
- Ulcers in the digestive tract, even in history
- Active bleeding, such as:
- Bleeding in the gastrointestinal tract, including in the past
- Cerebral hemorrhage
- 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
- High blood pressure
- 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

What age group do you need to consider?
- Children under 12 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
- Headache
- Dizziness
- Insomnia
- Fatigue
- 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)!
- Beware of intolerance to lactose. If you have to follow a diabetic diet, you should consider the sugar content.
- 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 IBUARISTO acute 400 mg film-coated tablets, 20 pcs

Field of use

Ibuaristo acute 400 mg film-coated tablets (pack size: 20 pieces) contains the active ingredient ibuprofen. Ibuprofen is a drug that reduces fever and relieves pain (nonsteroidal anti-inflammatory drug, NSAR). In adults and adolescents from 40 kg body weight (from 12 years), Ibuaristo acute 400 mg film-coated tablets (pack size: 20 pieces) is used for the short-term symptomatic treatment of mild to moderate pain and/or fever.

Active substances / ingredients / ingredients

Active ingredients of Ibuaristo acute 400 mg film-coated tablets (pack size: 20 pieces):

The active substance is: ibuprofen.

Each film-coated tablet contains 500 mg ibuprofen.

The other ingredients are: Tablet core: hypromellose, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, pregelatinised starch (maize), colloidal anhydrous silica, sodium laurilsulfate, magnesium stearate (Ph.Eur.) [pflanzlich ]Film-coating: hypromellose, titanium dioxide (E171), talc, propylene glycol

Contraindications

If you are known to be hypersensitive to any of the ingredients, the product should not be taken.

dosage

Recommended use of Ibuaristo acute 400 mg film-coated tablets (pack size: 20 pieces):

Always take this medicine exactly as described in the package leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:
Adults and adolescents from 40 kg body weight (from 12 years):
Half a tablet (200 mg) or a whole tablet (400 mg) as a single dose. If necessary, additional doses of half a tablet or a whole tablet can be taken.

The interval between the doses depends on the symptoms and the maximum recommended total daily dose.
It should not be less than 6 hours. Do not take more than 3 tablets (1200 mg ibuprofen) in any 24 hour period. IbuAristo acute 400 mg is not intended for use in children under the age of 12 or in adolescents weighing less than 40 kg.

Swallow the tablets with a glass of water.

The tablets should not be crushed, chewed or sucked to avoid irritation of the stomach or throat.

For patients who have a sensitive stomach, it is recommended to take IbuARISTO acutely during meals.

This medicine is for short-term use only.

Revenue

• The preparation is for oral use.
• Swallow the tablets with a glass of water.
• The tablets should not be crushed, chewed or sucked to avoid irritation of the stomach or throat.
• For patients who have a sensitive stomach, it is recommended to take the medicine during meals.

Patient notes

• Warnings and Precautions
  • Side effects can be minimized by using the lowest effective dose needed to control symptoms for the shortest possible time.
  • You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if you:
    • have systemic lupus erythematosus (SLE, sometimes known as lupus) or mixed collagen disease (an autoimmune disease affecting the connective tissues)
    • Have or have had gastrointestinal disease (ulcerative colitis, Crohn’s disease) as your condition may get worse
    • have certain congenital blood disorders (e.g. acute intermittent porphyria)
    • suffer from impaired liver or kidney function
    • have just undergone major surgery
    • are sensitive (allergic) to other substances
    • suffer from hay fever, nasal polyps or chronic obstructive pulmonary disease, as you are at increased risk of allergic reactions. The allergic reactions can manifest themselves as asthma attacks (so-called analgesic asthma), rapid swelling (Quincke's edema) or hives
    • suffer from dehydration d. H. have dried up
  • Effects on the gastrointestinal tract
    • Simultaneous use of ibuprofen with other non-steroidal anti-inflammatory drugs (NSAR) including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors) should be avoided.
    • Gastrointestinal bleeding, ulcers and perforation:
      • Gastrointestinal bleeding, ulcers and perforations, including fatal outcomes, have been reported in all NSAR . These 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. For these patients, as well as for patients who require concomitant treatment with low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, combination therapy with drugs that protect the gastric mucosa (e.g., with misoprostol or proton pump inhibitors) should be considered.
      • If you have a history of gastrointestinal side effects, particularly if you are elderly, you should see a doctor if you experience any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.
      • Caution is advised if you are also taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat mental health conditions including depression) or antiplatelet drugs such as aspirin.
      • If you develop gastrointestinal bleeding or ulcers during treatment with this preparation, you must stop treatment and seek medical advice.
  • Effects on the cardiovascular system
    • Anti-inflammatory drugs/painkillers such as ibuprofen, particularly when used in high doses, may be associated with a small increased risk of heart attack or stroke. Do not exceed the recommended dose or duration of treatment.
    • You should discuss your treatment with your doctor or pharmacist before taking it if you:
      • have heart disease, including heart failure (heart failure) and angina (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-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, lesions on the mucous membranes, blisters or any other sign of allergy, you should discontinue treatment and seek medical attention immediately, as these may be the first signs of a very serious skin reaction.
    • The use of ibuprofen should be avoided during chickenpox (varicella infection).
  • Other warnings
    • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first sign of a hypersensitivity reaction after taking the drug, treatment must be stopped and a doctor consulted. Medically necessary measures corresponding to the symptoms are to be initiated by the medical specialist.
    • Ibuprofen can temporarily inhibit blood platelet function (platelet aggregation). Patients with bleeding disorders should therefore be carefully monitored.
    • Long-term use of ibuprofen requires regular monitoring of the liver values, kidney function and blood count.
    • Prolonged use of painkillers can cause headaches that shouldn't be treated with more painkillers. Talk to your doctor if you think this applies to you.
    • In general, the habitual intake of painkillers, especially when combining several painkillers, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). This risk can be increased with physical exertion in connection with salt loss and dehydration. It should therefore be avoided.
    • Ibuprofen can mask symptoms of infection or fever.
    • The risk of kidney failure is increased in dehydrated (dry) patients, the elderly and those taking diuretics (water pills) and ACE-inhibitors.
    • If you experience visual disturbances, please contact your doctor.
  • Elderly patients
    • Elderly patients should know that they have an increased risk of side effects, particularly bleeding and perforation in the gastrointestinal tract, which can be fatal.
  • Teenagers
    • Dehydrated (drained) adolescents are at risk of kidney dysfunction.

• Ability to drive and use machines
  • Ibuprofen generally has no or negligible influence on the ability to drive and use machines. However, since central nervous side effects such as tiredness and dizziness can occur when used in higher doses, the ability to react 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.

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
  • Do not take this medicine in the last three months of pregnancy. Avoid using this medicine during the first six months of pregnancy unless your doctor advises otherwise.
• Lactation
  • Small amounts of ibuprofen pass into breast milk. However, as no adverse effects on the infant have been reported to date, discontinuation of breast-feeding is generally not necessary with short-term use of the recommended dose for fever and pain.
• Fertility
  • Ibuprofen belongs to a group of medicines (NSAR) that can impair fertility in women. This effect is reversible (reversible) after stopping the drug. You should speak to a doctor if you are planning to become pregnant or are having trouble conceiving.

Hints

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

Manufacturer: Aristo Pharma GmbH, Wallenroder Strasse 8-10, 13435 Berlin