ROKIFEN [Ibuprofen] 600 mg Film-coated tablets

ROKIFEN

instructions for medical use of the medicinal product

Tradename

Rokifen, Рокифен

International non-proprietary name

Ibuprofen, Ибупрофен

Composition

Each film-coated tablet contains:

active substance: ibuprofen BP 600 mg

excipients: dextrin, sodium carboxymethyl starch, hydroxypropyl cellulose, povidone K30.

Dosage form

Tablets.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs ( NSAIDs) .

Pharmacological properties

Rokifen is a non-steroidal anti-inflammatory drug with anti-inflammatory, antipyretic and analgesic effects. The active ingredient is ibuprofen.

Pharmacodynamics

Ibuprofen suppresses anti-inflammatory factors, reduces platelet aggregation. It inhibits cyclooxygenase types 1 and 2, disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins both in healthy tissues and in the focus of inflammation, and suppresses the exudative and proliferative phases of inflammation. Reduces pain sensitivity in the focus of inflammation. Causes a weakening or disappearance of the pain syndrome, incl. for pain in the joints at rest and during movement, a decrease in morning stiffness and swelling of the joints, helps to increase the range of motion.
The antipyretic effect is due to a decrease in the excitability of the thermoregulatory centers of the diencephalon.

Pharmacokinetics

Ibuprofen is rapidly and almost completely absorbed from the gastrointestinal tract, its _Cmax in plasma is reached 1-2 hours after ingestion, in the synovial fluid - after 3 hours, binds to plasma proteins by 99%.

It slowly penetrates into the joint cavity, lingers in the synovial tissue, creating higher concentrations in it than in plasma.

Metabolism of ibuprofen occurs mainly in the liver. T _{1 / 2} from plasma is 2-3 hours. It is excreted by the kidneys in the form of metabolites (no more than 1% is excreted unchanged), to a lesser extent - with bile. Ibuprofen is completely eliminated within 24 hours.

Indications for use

Symptomatic treatment:

·   joint, muscle pain;

·   pain in the back, lower back, sciatica;

·   pain due to ligament injury;

·   tension headache and migraine;

·   toothache;

·   painful menstruation;

·   febrile conditions with colds, flu;

·   rheumatoid arthritis, osteoarthritis.

Contraindications

• hypersensitivity to iboprofen;

·   erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;

·   inflammatory bowel disease in the acute phase, incl. ulcerative colitis;

·   anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug (complete or incomplete syndrome of acetylsalicylic acid intolerance - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

·   liver failure or active liver disease;

·   renal failure (CC less than 30 ml / min), progressive kidney disease;

·   confirmed hyperkalemia;

·   hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

·   in the period after coronary artery bypass grafting;

·   pregnancy (III trimester);

·   children's age up to 12 years.

Dosage and administration

For oral administration. Patients with a sensitive stomach are advised to take the drug with food. The tablets should be swallowed whole, without chewing, with plenty of liquid.

In order to minimize the risks of developing adverse reactions, the drug should be taken at the minimum effective dose and for the shortest period necessary to achieve a clinical effect.

Adults and children over 12 years of age: The recommended dose of ibuprofen is 1200-1800 mg daily in divided doses. For some patients, 600-1200 mg per day may be sufficient. In severe and acute cases, it is possible to increase the dose until the end of the acute phase of the disease. In this case, the maximum daily dose should not exceed 2400 mg, divided into several doses.

Elderly: Elderly people are at an increased risk of serious adverse reactions. Undesirable effects can be minimized by using the lowest effective dose for the shortest period of time.
It is necessary to monitor gastrointestinal bleeding. In case of impaired liver or kidney function, the dose of the drug should be selected individually.
Special instructions and precautions

Treatment with the drug should be carried out in the minimum effective dose, the minimum possible short course. During treatment, it is necessary to control the functional state of the liver and kidneys. Prescribe with caution: old age, congestive heart failure, cerebrovascular disease, arterial hypertension, coronary heart disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, nephrotic syndrome (CC less than 30-60 ml / min), hyperbilirubinemia, gastric ulcer and duodenal ulcer (history), the presence of Helicobacter pylori infections, gastritis, enteritis, colitis, long-term use of NSAIDs, blood diseases of unknown etiology (leukopenia and anemia), pregnancy (I-II) trimester, lactation period, children under 12 years of age.

During the period of treatment should refrain from drinking alcohol.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, one should refrain from activities that require increased concentration of attention and speed of psychomotor reactions.

Use during pregnancy and during breastfeeding

The drug is contraindicated for use in the third trimester of pregnancy. In the I and II trimesters should be administered with caution. If you need to take the drug during lactation, then breastfeeding should be stopped.

Interaction with other drugs

Caution should be exercised when co-administered with the following drugs due to possible drug interactions in some patients.

Antihypertensive drugs, β-blockers and diuretics. NSAIDs may reduce the effect of antihypertensive drugs such as ACE inhibitors, angiotensin II receptor antagonists, β-blockers and diuretics. Diuretics may also increase the risk of NSAID nephrotoxicity.

cardiac glycosides. NSAIDs can exacerbate heart failure, decrease glomerular filtration rate, and increase plasma levels of cardiac glycosides.

Lithium. NSAIDs may reduce lithium excretion.
Methotrexate. NSAIDs can suppress tubular secretion of methotrexate and reduce the clearance of methotrexate.
Cyclosporine. NSAIDs increase the risk of nephrotoxicity.

COX-2 inhibitors and other NSAIDs. Co-administration with other NSAIDs, including selective COX-2 inhibitors, should be avoided due to the risk of additional effects.

Corticosteroids. Increased risk of gastrointestinal ulcers or bleeding when administered with NSAIDs.

Anticoagulants. NSAIDs may enhance the effects of anticoagulants such as warfarin.

Antiplatelet drugs and selective serotonin reuptake inhibitors. NSAIDs increase the risk of gastrointestinal bleeding.

Aminoglycosides. NSAIDs may reduce the excretion of aminoglycosides.

The simultaneous use of acetylsalicylic acid and ibuprofen is not recommended due to the risk of increasing adverse reactions.

Side effect

From the gastrointestinal tract: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, irritation or dryness of the oral mucosa, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis, peptic ulcer, perforation walls of the gastrointestinal tract, pancreatitis.

From the side of the cardiovascular system:   heart failure, tachycardia, increased blood pressure.

From the respiratory system: shortness of breath, bronchospasm.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

From the side of the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

From the side of the hepatobiliary system:   liver dysfunction, liver failure, hepatitis and jaundice.

From the senses : hearing impairment: hearing loss, ringing or noise in the ears; visual disturbances: toxic damage to the optic nerve, blurred vision or double vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis).

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome) , eosinophilia, allergic rhinitis.

From the blood and lymphatic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia.

General disorders: malaise, fatigue.

The risk of ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision disorders, scotoma, amblyopia) increases with prolonged use in large doses.

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, tinnitus, chills, acute renal failure, low blood pressure, bradycardia, tachycardia, breathing problems.

Treatment: gastric lavage (only within an hour after ingestion), activated charcoal, alkaline drink, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure).

Storage conditions

Store in a dry place, at a temperature not exceeding 30º C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the package. &a