ratioDolor Ibuprofen 300 mg

The analgesic, anti-inflammatory and antipyretic effect of ratioDolor Ibuprofen 300 mg painkillers is essentially due to the inhibition of the production of certain tissue hormones (prostaglandins).
This inhibits the development of inflammation and pain.
Ibuprofen as a lysine salt is characterized by good water solubility (20%). The even distribution of the dissolved substance on the mucous membrane causes rapid absorption of the active substance ibuprofen into the blood in the area of ​​the digestive tract.
Almost all of the amount of ibuprofen taken reaches its destination. Blood levels and freedom from pain are directly related to one another.
The highest effective levels of ibuprofen in the blood are reached about 30-45 minutes after ingestion. Protein binding in the blood is 99%.
Ibuprofen is broken down in the liver; excretion takes place within 24 hours, mainly via the kidneys, but also via the bile.

ratioDolor Ibuprofen 300 mg painkillers are used

• for painful conditions such as headaches, toothaches, muscle pains, joint pains, menstrual problems as well as pain and fever for colds and flu-like infections.
• For the treatment of the acute headache phase in migraines with and without aura and for the treatment of tension headaches.

ratioDolor Ibuprofen is used in adults, adolescents and children from 6 years of age.

If you do not feel better or if you feel worse after 3 to 4 days, contact your doctor.

Contraindications

ratioDolor Ibuprofen 300 mg painkillers must not be taken

• if you are allergic to ibuprofen, acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
• if you have known reactions of shortness of breath (due to spasm of the bronchial muscles), asthma, runny nose or nettle rash (urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past;
• if you have a history of gastrointestinal bleeding or perforation of a gastrointestinal ulcer caused by previous treatment with anti-inflammatory painkillers;
• if you have an existing gastrointestinal ulcer or bleeding or recurring gastrointestinal ulcers or bleeding (when ulcers or bleeding have been diagnosed twice or more);
• if you have a cerebral hemorrhage or other active bleeding;
• with a tendency to bleeding, certain blood diseases (hemolytic anemia, porphyria);
• in case of severe cardiac insufficiency;
• if you suffer from severe dehydration (caused by vomiting, diarrhea or not drinking enough fluids);
• in severe liver dysfunction;
• in severe renal dysfunction;
• by children under 6 years of age;
• in the last trimester of pregnancy.

interactions

ratioDolor Ibuprofen 300 mg Painkillers may affect or be affected by other medicines. For example:

• Taking ratioDolor Ibuprofen 300 mg painkillers at the same time as digoxin (a medicine to strengthen the heart), phenytoin (a medicine to treat seizures) or lithium (a medicine to treat depression) can increase the concentration of these medicines in the blood. Monitoring of serum lithium levels is necessary. Monitoring of serum digoxin and serum phenytoin levels is recommended.
• ratioDolor Ibuprofen 300 mg painkillers can reduce the effect of draining and blood pressure-lowering drugs (diuretics and antihypertensives).
• ratioDolor Ibuprofen 300 mg painkillers can reduce the effect of ACE inhibitors (medicines used to treat heart failure and high blood pressure). With concomitant use, the risk of developing renal dysfunction may also be increased.
• The simultaneous administration of ratioDolor Ibuprofen 300 mg painkillers and potassium-sparing diuretics (certain diuretics) can lead to an increase in the level of potassium in the blood.
• Taking ratioDolor Ibuprofen 300 mg painkillers at the same time as other anti-inflammatory and pain-relieving drugs from the group of non-steroidal anti-inflammatory drugs or with glucocorticoids (adrenal cortex hormones) increases the risk of gastrointestinal ulcers or bleeding.
• Medicines used to prevent blood clots such as acetylsalicylic acid and certain medicines used to treat depression (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Medicines that have an anticoagulant effect (ie thin the blood/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan).
• Administration of ratioDolor Ibuprofen 300 mg painkillers within 24 hours before or after administration of methotrexate (medicine to suppress cell proliferation and immune defence) can lead to an increased concentration of methotrexate and an increase in its undesirable effects.
• The risk of kidney-damaging effects from ciclosporin (medicine to suppress the immune system) is increased by the simultaneous administration of certain anti-inflammatory painkillers. This effect cannot be ruled out for a combination of ciclosporin with ibuprofen either.
• Medicines containing probenecid or sulfinpyrazone (medicines used to treat gout) may delay the elimination of ibuprofen. This can lead to an accumulation of ibuprofen in the body with an increase in its undesirable effects.
• Anti-inflammatory painkillers such as ibuprofen can increase the effects of anticoagulant medicines such as warfarin, phenprocoumon and heparin (see “Warning and precautions”).
• Clinical research has shown interactions between anti-inflammatory painkillers and sulfonylureas (hypoglycaemic drugs). Although interactions between ibuprofen and sulfonylureas have not yet been described, it is recommended to check blood sugar levels as a precaution if they are taken at the same time.
• Tacrolimus (a medicine used to prevent transplant rejection and to treat atopic dermatitis): The risk of kidney damage is increased when both medicines are given at the same time.
• Zidovudine (medicine against AIDS): There is evidence of an increased risk of bleeding into joints (haemarthrosis) and hematomas in HIV-positive haemophilia patients (bleeders) who use zidovudine and ibuprofen at the same time.
• Quinolone antibiotics: There may be an increased risk of seizures.

Some other medicines can also affect or be affected by treatment with ratioDolor Ibuprofen 300 mg Painkillers. You should therefore always seek the advice of your doctor or pharmacist before using ratioDolor Ibuprofen 300 mg Painkillers together with other medicines.

Taking ratioDolor Ibuprofen 300 mg painkillers together with alcohol
If possible, you should not drink alcohol while using ratioDolor Ibuprofen 300 mg painkillers, as side effects caused by the active ingredient, especially those affecting the gastrointestinal tract or the central nervous system, can be increased.

Pregnancy, breast-feeding 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 detected while using ratioDolor Ibuprofen 300 mg Painkillers, the doctor must be informed. You may only use ibuprofen in the first and second trimester of pregnancy after consulting your doctor. ratioDolor Ibuprofen 300 mg painkillers should not be used in the last third of pregnancy because of an increased risk of complications for mother and child.

Breast-feeding
The active ingredient ibuprofen and its breakdown products only pass into breast milk in small amounts. Since adverse consequences for the infant have not yet become known, interruption of breast-feeding will generally not be necessary with short-term use of ratioDolor Ibuprofen 300 mg painkillers. However, if prolonged intake of higher doses is prescribed, early weaning should be considered.

Fertility
Like other medicines that inhibit prostaglandin synthesis, ratioDolor Ibuprofen 300 mg Painkillers can make it difficult for you to become pregnant. You should tell your doctor if you plan to become pregnant or if you are having trouble conceiving.

application

The following dosage is recommended:
In adults and adolescents from 12 years of age, a maximum daily dose of 4 ratioDolor Ibuprofen 300 mg painkillers should not be exceeded. The daily dose should be divided into 3 or more single doses.

For children aged 6 to 11 years, the maximum recommended daily dose is 2 ratioDolor Ibuprofen 300 mg painkillers. If necessary, ratioDolor Ibuprofen 300 mg painkillers can be divided (e.g. 1⁄2 tablet up to 4 times a day).
May be given to children under 12 only with a doctor's prescription.

If the use of this medicine in children and adolescents is required for more than 3 days or if the symptoms worsen, a doctor should be consulted.

Special populations
Elderly
No specific dose adjustment is required.
Due to the possible side effect profile (see section 4 "Possible side effects"), elderly people should be monitored particularly carefully.

Renal
impairment No dose reduction is necessary in patients with mild to moderate renal impairment (for patients with severe renal impairment see “Do not take ratioDolor Ibuprofen 300 mg Painkillers”).

Hepatic
impairment No dose reduction is necessary in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment see “Do not take ratioDolor Ibuprofen 300 mg Painkillers”).

Duration of use
ratioDolor Ibuprofen 300 mg painkillers should not be taken for more than 3 - 4 days in a row without medical advice.

Method of
administration For oral use.
Take ratioDolor Ibuprofen 300 mg painkillers whole with plenty of liquid with or after meals.
If you have a sensitive stomach, it is advisable to take ratioDolor Ibuprofen 300 mg painkillers during meals.

side effects

If you experience the following symptoms/signs, you must stop using ratioDolor Ibuprofen 300 mg Painkillers and inform the doctor immediately.

• increased upper abdominal pain, vomiting blood, blood in your stools and/or blackening of your stools
• Decreased urination, accumulation of water in the body (oedema) and generally feeling unwell; this can be an expression of kidney disease up to and including kidney failure.

With regard to the following adverse drug reactions, it must be taken into account that they are predominantly dose-dependent and vary from patient to patient.

The most frequently observed side effects involve the digestive tract.

Stomach/duodenal ulcers (peptic ulcers), perforation (breakthrough) or bleeding, sometimes fatal, can occur, particularly in elderly patients (see “Warning and precautions”). Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, inflammation of the mouth with ulceration (ulcerative stomatitis), worsening of inflammatory bowel disease (ulcerative colitis and Crohn's disease, see section "Warnings and precautions") have been reported after use . Inflammation of the gastric mucosa was observed less frequently. In particular, the risk of gastrointestinal bleeding depends on the dose range and the duration of use.

Fluid accumulation in the tissues (oedema), high blood pressure and heart failure have been reported in association with treatment with anti-inflammatory painkillers.

Medicines like ratioDolor Ibuprofen 300mg Painkillers may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Very common side effects: may affect more than 1 in 10 people

• Gastrointestinal complaints such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and minor gastrointestinal blood loss, which in exceptional cases can cause anemia.

Common side effects: may affect up to 1 in 10 people

• central nervous disorders such as headaches, dizziness, insomnia, excitation, irritability or tiredness
• Stomach/duodenal ulcers (peptic ulcers), possibly with bleeding and perforation. Inflammation of the mouth with ulceration (ulcerative stomatitis), worsening of ulcerative colitis or Crohn's disease (inflammatory bowel disease)

Uncommon side effects: may affect up to 1 in 100 people

• Hypersensitivity reactions with skin rashes and itching as well as asthma attacks (possibly with a drop in blood pressure). In this case, the doctor must be informed immediately and ratioDolor Ibuprofen 300 mg painkillers must no longer be taken.
• visual disturbances If this applies to you, please stop taking ratioDolor Ibuprofen 300 mg painkillers and see a doctor immediately.
• gastric mucosal inflammation
• reduced urinary excretion and increased water retention in the tissue with the formation
  of edema, especially in patients with high blood pressure or impaired kidney function; nephrotic syndrome (water retention in the body [oedema] and excessive protein excretion in the urine); inflammatory kidney disease (interstitial nephritis) which may be associated with acute renal dysfunction.

Very rare side effects: may affect up to 1 in 10,000 people

• Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) has been described in temporal connection with the use of certain anti-inflammatory painkillers (NSAIDs; these also include ratioDolor Ibuprofen 300 mg painkillers). If signs of an infection (e.g. reddening, swelling, overheating, pain, fever) appear or worsen while using ratioDolor Ibuprofen 300 mg painkillers, you should consult your doctor immediately.
• Symptoms of meningitis (aseptic meningitis) such as severe headaches, nausea, vomiting, fever, stiff neck or clouding of consciousness have been observed with the use of ibuprofen. There seems to be an increased risk for patients who already suffer from certain diseases of the immune system (systemic lupus erythematosus, mixed collagen diseases).
• Disorders of blood formation (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs can be: fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In these cases, the drug should be discontinued immediately and a doctor consulted. Any self-treatment with pain or fever-reducing drugs should be avoided.
  In long-term therapy, the blood count should be checked regularly.
• severe general hypersensitivity reactions. They can express themselves as: swelling
  of the face, tongue and inner larynx with constriction of the airways, shortness of breath, tachycardia, drop in blood pressure and even threatening shock. If one of these symptoms occurs, which can occur even on first use, immediate medical attention is required and you must no longer take ratioDolor Ibuprofen 300 mg painkillers.
• psychotic reactions, depression
• Ringing in the ears (tinnitus), hearing problems
• Palpitations, edema (accumulation of fluid in the tissues), heart failure, heart attack
• high blood pressure
• Inflammation of the esophagus and pancreas, formation of membrane-like constrictions in the small and large intestine (intestinal, diaphragm-like strictures)
• Liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute liver inflammation (hepatitis) Liver values ​​should be checked regularly after long-term administration. Please follow your doctor's instructions.
• severe skin reactions such as rash with reddening and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss. In exceptional cases, severe skin infections and soft tissue complications can occur during chickenpox (varicella infection) (see also "Infections and infestations").
• Kidney tissue damage (papillary necrosis), increased uric acid concentrations in the blood

Unknown side effects: frequency cannot be estimated from the available data

• aseptic meningitis (non-bacterial meningitis)
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include a rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).

composition

What ratioDolor Ibuprofen 300 mg painkillers contain

• The active substance is: ibuprofen

1 film-coated tablet contains 500 mg ibuprofen lysine salt (equivalent to 292.6 mg ibuprofen).

• The other ingredients are: microcrystalline cellulose, croscarmellose sodium, talc, magnesium stearate, colloidal anhydrous silica, methylhydroxypropylcellulose, macrogol, glycerol.

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