IBU-LYSIN-ratiopharm 293 mg film-coated tablets, 10 pcs

Instructions for use for IBU-LYSIN-ratiopharm 293 mg film-coated tablets, 10 pcs

Application Notes

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

1 Tablet

1-4 times a 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
- Active bleeding, such as:
- Cerebral hemorrhage
- Bleeding in the gastrointestinal tract, including in the past
- 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:
- Mixed collagenosis (inflammatory rheumatic collagenosis)
- Lupus erythematosus
- Porphyria (metabolic disease)
- Major surgery that took place shortly before
- Chickenpox

What age group do you need to consider?
- Children under 12 years of age: The medicine must not be used.
- 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 oral mucosa
- Inflammation of the gastric mucosa
- Ulcers in the digestive tract, which very rarely can rupture
- 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 IBU-LYSIN-ratiopharm 293 mg film-coated tablets, 10 pcs

Field of use

Ibu-lysine ratiopharm 293 mg film-coated tablets (pack size: 10 pieces) is an analgesic, antipyretic and anti-inflammatory drug and is used for:

• slight to moderate pain
• Fever
• Migraines with and without aura

Mode of action

Ibu-lysine ratiopharm 293 mg film-coated tablets (pack size: 10 pieces) contains the proven active ingredient ibuprofen. This belongs to a group of substances that act both against pain and inflammation and reduce fever. Ibu-lysine ratiopharm 293 mg film-coated tablets (pack size: 10 pieces) inhibits the production of the body's own messenger substances prostaglandins. These have a decisive effect on inflammatory reactions and pain mediation.

Active substances / ingredients / ingredients

1 Tablet of Ibu-lysin-ratiopharm 293 mg film-coated tablets (pack size: 10 pieces) contains:

• 500 mg ibuprofenDLlysine (equivalent to 292.6 mg ibuprofen

Other ingredients of Ibu-lysin-ratiopharm 293 mg film-coated tablets (pack size: 10 pieces):

Microcrystalline Cellulose, Hypromellose, Croscarmellose Sodium, Glycerol, Magnesium Stearate (Ph.Eur), Macrogol 6000, Talc, Colloidal Anhydrous Silicon Dioxide

Contraindications

If you have a history of hypersensitivity to any of the above ingredients, if you have had an asthma attack, swelling of the nasal mucosa or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past, if you have or have ever had stomach or intestinal ulcers, stomach or intestinal bleeding, severe liver or Kidney dysfunction, severe, uncontrolled heart problems, in the last 3 months of pregnancy and in children under 40 kg (12 years) this product must not be used.

dosage

Recommended use of Ibu-lysine ratiopharm 293 mg film-coated tablets (pack size: 10 pieces):

• Adolescents from the age of 15 and adults take 1 tablet with a maximum total daily dose of 4 tablets of Ibu-lysin-ratiopharm 293 mg film-coated tablets (pack size: 10 pieces).
• Adolescents over 12 years of age with a body weight of 40 kg or more take 1 tablet at a maximum total daily dose of 2-3 tablets of Ibu-lysin-ratiopharm 293 mg film-coated tablets (pack size: 10 pieces).

Take Ibu-lysin-ratiopharm 293 mg film-coated tablets (pack size: 10 pieces) whole and preferably during or after a meal with sufficient liquid.

Revenue

Please swallow the film-coated tablets whole with plenty of liquid (e.g. a glass of water) during or after a meal. If you have a sensitive stomach, it is advisable to take the medicine with meals. Take the medicine as instructed by your doctor or according to the dosage instructions provided. If you feel that you are not feeling enough pain relief, then do not increase the dosage yourself, but consult your doctor.

Patient notes

Particular caution is required when taking the drugThe following describes when you may only use the drug with particular caution under certain conditions (i.e. at longer intervals or in a reduced dose and under medical supervision). Please ask your doctor about this. This also applies if this information applied to you in the past. Safety in the gastrointestinal tract Concomitant use with other non-steroidal anti-inflammatory drugs, including so-called COX-Inhibitors) should be avoided. Side effects can be reduced by using the lowest effective dose for the shortest amount of time needed to control symptoms. Elderly patients Elderly patients are more likely to experience side effects after using non-steroidal anti-inflammatory drugs, in particular bleeding and perforation in the stomach and intestines, which can be life-threatening under certain circumstances. Therefore, particularly careful medical supervision is required in elderly patients. Gastrointestinal haemorrhage, ulcers and perforations (perforations): Gastrointestinal haemorrhages, ulcers and perforations, including fatal outcomes, have been reported during treatment with all NSAR . They have occurred with or without prior warning symptoms or a history of serious gastrointestinal events at any time during therapy. The risk of gastrointestinal bleeding, ulceration and perforation is higher with increasing NSAR- Dose, in patients with a history of ulcers, particularly if complicated with bleeding or perforation, and in elderly patients. These patients should start treatment on the lowest available dose. For these patients, as well as for patients who require concomitant therapy with low-dose acetylsalicylic acid (ASA) or other drugs that may increase the risk of gastrointestinal disorders 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 side effects, particularly if you are elderly, you should report any unusual abdominal symptoms ( especially gastrointestinal bleeding), particularly at the beginning of therapy. Caution is advised if you are also receiving medicines that may increase the risk of ulcers or bleeding 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 ASS.If you experience gastrointestinal bleeding or ulcers during treatment with the drug , 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. Cardiovascular effects Drugs such as this drug may be associated with a small increased risk of Heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (maximum 4 days)! If you have heart problems or a previous stroke, or think you may have a You may be at risk for these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol, or are a smoker) you should discuss your treatment with your doctor or pharmacist Skin reactions Serious skin reactions with NSARtherapy have been reported very rarely Redness and blistering, some with fatal outcome, have been reported (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome). 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, the drug should be discontinued and the doctor consulted immediately. Other information The drug 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) Particularly careful medical supervision is required: - 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 - with impaired kidney or liver function severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. Therapy must be discontinued at the first sign of a hypersensitivity reaction after taking the drug. Medically necessary measures corresponding to the symptoms must be initiated by competent persons. Ibuprofen, the active principle of the drug, can temporarily inhibit the blood platelet function (thrombocyte aggregation). Patients with blood clotting disorders should therefore be carefully monitored. Concomitant use of ibuprofen-containing medicines may impair the anticoagulant effect of low-dose acetylsalicylic acid (preventing the formation of blood clots). You should therefore not use ibuprofen-containing medicines without your doctor's express instructions. If you are also taking medicines to inhibit blood clotting or to lower blood sugar, you should have your blood coagulation or blood sugar levels checked as a precaution Liver values, kidney function and blood count must be checked. If the drug is taken before surgery, the doctor or dentist must be consulted or informed. With prolonged use of painkillers, headaches may occur, which should not be treated with increased doses of the drug. Ask your doctor for advice if you often suffer from headaches despite taking the drug! 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). The 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.
Ability to drive and use machinesSince central nervous side effects such as tiredness and dizziness can occur when using the drug 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. 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 secure footing! Storage Keep medicines out of the reach of children. Disposal: Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This measure helps to protect the environment.

Pregnancy

Pregnancy If pregnancy is detected while using the drug, the doctor must be informed. You may only use ibuprofen in the first and second trimester of pregnancy after consulting your doctor. In the last third of pregnancy, the drug must not be used because of an increased risk of complications for mother and child. 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 prolonged intake of higher doses is prescribed, early weaning should be considered.

Hints

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

Miscellaneous

- In the event of severe pain in the upper abdomen, vomiting blood, blood in the stool or blackening of the stool, the drug should be discontinued and the doctor informed immediately.- Side effects can be reduced if the smallest effective amount is always taken for the shortest possible time.- long-term use, have the liver values, kidney function and blood count checked regularly - Long-term, high-dose, improper use of painkillers can cause headaches that must not be treated with increased amounts of the drug. - In general, the habitual use of painkillers, especially in Combination of several analgesic active ingredients, lead to permanent kidney damage with the risk of kidney failure.

Manufacturer: ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm