ratioDolor Ibuprofen 400 mg film-coated tablets

ratioDolor Ibuprofen 400 mg is an analgesic and antipyretic drug (non-steroidal anti-inflammatory drug, also known as non-steroidal anti-inflammatory drug [NSAID]).

ratioDolor Ibuprofen 400 mg is used for the short-term symptomatic treatment of:

• mild to moderate pain such as headache, toothache, menstrual pain and fever and pain when you have a cold
• acute migraine headaches with or without aura

ratioDolor Ibuprofen 400 mg is used in children weighing 20 kg or more (6 years and older), adolescents and adults.

Contraindications

ratioDolor Ibuprofen 400 mg must not be taken

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have had shortness of breath, asthma, runny nose, swelling (angioedema) or hives after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past
• if you have unexplained blood disorders
• if you have or have had in the past ulcers (peptic ulcers) or bleeding in your stomach or small intestine (at least two separate episodes of proven ulceration or bleeding)
• if you have a history of bleeding or perforation in the gastrointestinal tract related to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
• if you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding
• if you suffer from severe liver or kidney problems
• in the last 3 months of pregnancy
• if you suffer from severe heart muscle weakness (heart failure).
• if you suffer from severe dehydration (caused by vomiting, diarrhea or not drinking enough fluids)
• in children under 20 kg body weight or under 6 years of age, as this dose strength is not suitable due to the higher amount of active substance

interactions

ratioDolor Ibuprofen 400 mg may affect or be affected by other medicines. For example:

• Medicines that have an anticoagulant effect (ie thin the blood/prevent clotting, eg aspirin/acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that reduce high blood flow (ACE inhibitors such as captopril, beta-blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan).

Some other medicines can also affect or be affected by treatment with ratioDolor Ibuprofen 400 mg. You should therefore always seek the advice of your doctor or pharmacist before using ratioDolor Ibuprofen 400 mg with other medicines.

Enhancement of the effect and/or side effects:

• Digoxin (active substance used to treat heart failure and cardiac arrhythmia), phenytoin (active substance used to treat epilepsy or neuropathic pain), lithium (active substance used to treat certain mental disorders): possibly increased blood levels of these active substances. A control of the blood level is usually not necessary when used as intended (maximum over 3 days in the case of migraine headaches or fever in children and adolescents and over 4 days in adults for the treatment of pain).
• Anticoagulants such as warfarin.
• Methotrexate (medicine used to treat cancer and certain rheumatic diseases): Increased side effects.
• Acetylsalicylic acid and other anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs) and glucocorticoids (medicines containing cortisone or cortisone-like substances): There is an increased risk of ulcers and bleeding in the gastrointestinal tract.
• Platelet aggregation inhibitors and selective serotonin reuptake inhibitors (medicines used to treat depression): There is an increased risk of bleeding in the gastrointestinal tract.

Weakening of the effect:

• Medicines that drain water (diuretics) and medicines to lower blood pressure (antihypertensives). There may also be an increased risk for the kidneys.
• ACE inhibitors (medicines used to treat heart failure and high blood pressure). In addition, the risk of developing renal dysfunction is increased.
• Low-dose acetylsalicylic acid: When used concomitantly with ibuprofen, the anticoagulant (antithrombotic) effect of low-dose acetylsalicylic acid may be impaired.

Other possible interactions:

• Zidovudine (medicine used to treat HIV infection/AIDS): Increased risk of bleeding into joints and bruising in HIV-positive hemophiliacs.
• Ciclosporin (medicine to suppress the immune reaction): There is evidence of kidney damage.
• Tacrolimus: Kidney toxicity/overdose can occur when both drugs are administered at the same time.
• Sulfonylureas (antidiabetics): Although interactions between ibuprofen and sulfonylureas, unlike other NSAIDs, have not been described to date, it is recommended to check blood sugar levels as a precaution if they are taken at the same time.
• Probenecid and sulfinpyrazone (medicines used to treat gout): May delay elimination of ibuprofen.
• Potassium-sparing water pills (diuretics): Can lead to hyperkalemia (too much potassium in the blood).
• Quinolone antibiotics: There may be an increased risk of seizures.
• CYP2C9 inhibitors: Concomitant use of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitor) an 80 to 100% increased exposure to S(+) - ibuprofen was found. Consideration should be given to reducing the ibuprofen dose when co-administering potent CYP2C9 inhibitors, particularly when high doses of ibuprofen are co-administered with either voriconazole or fluconazole.

Taking ratioDolor Ibuprofen 400 mg with alcohol
If possible, you should not drink alcohol during treatment with ratioDolor Ibuprofen 400 mg. Concomitant intake of alcohol can increase some side effects affecting the gastrointestinal tract or the central nervous system.

Pregnancy, lactation 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 you become pregnant while using ratioDolor Ibuprofen 400 mg, you should notify your doctor. In the first 6 months of pregnancy, you may only take ibuprofen after consulting your doctor. ratioDolor Ibuprofen 400 mg must not be taken in the last 3 months 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, it is usually not necessary to interrupt breastfeeding if the recommended dose is used for a short time.

Fertility
ratioDolor Ibuprofen 400 mg belongs to a group of medicines (NSAIDs) that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

application

The usual dose is:

adult

Starting dose: Take 200 mg or 400 mg ibuprofen (1⁄2 or 1 tablet ratioDolor Ibuprofen 400 mg).
If necessary, take an additional 200 mg or 400 mg ibuprofen (1⁄2 or 1 tablet), but do not exceed the total dose of 1200 mg ibuprofen (3 tablets) in any
24 hour period. The interval between each dose should not be less than 6 hours.

Children weighing 20 kg or more (6 years and older) and adolescents
ratioDolor Ibuprofen 400 mg should only be used in children weighing at least 20 kg. The maximum total daily dose of ibuprofen is 30 mg per kg body weight divided into 3 to 4 divided doses. The interval between each dose should not be less than 6 hours. Do not exceed the recommended maximum daily dose.

The following dosing guidelines apply to ratioDolor Ibuprofen 400 mg in children and adolescents:

Body weight / single dose mg ibuprofen (tablets) Maximum / daily dose mg ibuprofen (tablets)

20-29 kg / 200 mg (1⁄2 tablet) / 600 mg (1 1⁄2 tablets)

30-39 kg / 200 mg (1⁄2 tablet) / 800 mg (2 tablets)

40 kg and more / 200-400 mg (1⁄2-1 tablet) / 1200 mg (3 tablets)

May be given to children under 12 only with a doctor's prescription.

Please talk to your doctor or pharmacist if you have the impression that the effect of ratioDolor Ibuprofen 400 mg is too strong or too weak.

Method of
administration For oral use. Swallow the film-coated tablets with water.
For patients with a sensitive stomach, it is recommended to take ratioDolor Ibuprofen 400 mg during meals.
The tablet can be divided into equal doses.

Duration of use
For short-term use only.
The smallest effective amount should be used for the shortest time needed to control symptoms.
If adults have to take ratioDolor Ibuprofen 400 mg for more than 3 days to treat migraine headaches or fever, or for more than 4 days to treat pain, or if the symptoms worsen, a doctor should be consulted.
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.

side effects

The following list of undesirable effects includes all side effects that have become known in connection with ibuprofen treatment, including those associated with high-dose long-term treatment in rheumatism patients. The frequency information, which goes beyond very rare reports, relates to the short-term use of daily doses of a maximum of 1200 mg ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.

Possible side effects
With the following side effects, it must be taken into account that they are predominantly dose-dependent and vary between individuals.

The most frequently observed side effects concern the gastrointestinal tract. Ulcerations of the stomach and small intestine (peptic ulcers), perforation or bleeding in the gastrointestinal tract, sometimes fatal, especially in elderly patients, can occur (see section 2 “Warnings and precautions”). Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, ulcerative stomatitis (inflammation of the lining of the mouth with ulceration), worsening of the intestinal diseases ulcerative colitis and Crohn's disease (see section 2. "Warning and precautions") are after administration been reported. Inflammation of the lining of the stomach (gastritis) has been observed less frequently.

Medicines like ratioDolor Ibuprofen 400 mg may be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke.

Common (may affect up to 1 in 10 people)

• Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and light gastrointestinal bleeding, which in exceptional cases can lead to anemia.

Uncommon (may affect up to 1 in 100 people)

• Central nervous disorders such as headaches, dizziness, insomnia, excitement, irritability or tiredness.
• Hypersensitivity reactions with skin rash and itching and asthma attacks (possibly with drop in blood pressure).
• visual disturbances
• Ulcers in the gastrointestinal tract, in some cases with bleeding and perforation.
• Ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, inflammation of the lining of the stomach (gastritis).
• Various rashes.

Rare (may affect up to 1 in 100 people)

• ringing in the ears (tinnitus)
• Kidney tissue damage (papillary necrosis), especially in long-term treatment.
• Increased uric acid concentration in the blood.

Very rare (may affect up to 1 in 10,000 people)
Decreased urination and accumulation of water in the body (oedema). These can be signs of kidney disease, sometimes including kidney failure.

• Nephrotic syndrome (accumulation of fluid in the body [oedema] and excessive protein excretion in the urine), inflammatory kidney disease (interstitial nephritis) which may be accompanied by acute renal dysfunction.
• Liver dysfunction, liver damage, especially with long-term treatment, liver failure, acute inflammation of the liver (hepatitis).
• Blood disorders, agranulocytosis (an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local signs of infection such as sore throat/pharynx/mouth or urinary tract problems).
• Severe skin reactions such as rash with reddening and blistering (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).
• In isolated cases, severe skin infections with soft tissue complications can occur during chickenpox infection.
• Signs of meningitis (aseptic meningitis) such as severe headache, nausea, vomiting, fever, stiff neck or decreased consciousness. There seems to be an increased risk for patients who already suffer from certain diseases of the immune system (systemic lupus erythematosus and mixed collagen diseases).
• Severe hypersensitivity reactions
• Worsening of infection-related inflammation.
• Psychotic reactions, depression.
• Palpitations, weakness of the heart muscle (heart failure), heart attack.
• High blood pressure
• Inflammation of the esophagus and pancreas.
• Formation of membrane-like constrictions in the intestine.

Not known (cannot be estimated from the available data)

• 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).

countermeasures

If you have the following side effects, you must stop taking ratioDolor Ibuprofen 400 mg and inform your doctor immediately:

• rash and itching.
• asthma attack
• Severe hypersensitivity reactions. These can be characterized by swelling of the face, tongue and larynx with constriction of the airways, shortness of breath, palpitations and drop in blood pressure up to life-threatening shock.
• haematopoietic disorders. The first signs can be: fever, sore throat, superficial wounds in the mouth, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. Refrain from any self-treatment with painkillers or fever-reducing drugs.
• Worsening of infection-related inflammation: If signs of an infection appear or worsen while taking ratioDolor Ibuprofen 400 mg.
• visual disturbances
• Relatively severe pain in the upper abdomen, vomiting blood, blood in the stool or black stool (tarry stool).
• Decreased urination and retention of water in the body (oedema).

composition

What ratioDolor Ibuprofen 400 mg contains

• The active substance is ibuprofen-DL-lysine.
  Each film-coated tablet contains 684 mg ibuprofen-DL-lysine, equivalent to 400 mg ibuprofen.
• The other ingredients are:
  tablet core microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica; magnesium stearate. Film coating Hypromellose, Macrogol 6000, Glycerol 85%.

Usually ships out within 3-4 days