Instructions for Mazezik-Sanovel tablets 100 mg No. 30
Composition
active ingredient: flurbiprofen;
1 film-coated tablet contains 100 mg of flurbiprofen;
excipients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate; colloidal anhydrous silicon dioxide;
shell: Opadry II blue OY-L-20906 (lactose monohydrate; hydroxypropyl methylcellulose; titanium dioxide (E 171); polyethylene glycol 4000; FD&C blue dye No. 2 (indigo carmine) (E 132)).
Dosage form
Film-coated tablets.
Main physicochemical properties: oblong, biconvex tablets, film-coated, blue, with a break line on both sides.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs.
Propionic acid derivatives. Flurbiprofen. ATC code M01A E09.
Pharmacological properties
Pharmacodynamics
Flurbiprofen is a nonsteroidal anti-inflammatory drug with analgesic properties. The mechanism of action is associated with pronounced inhibition of prostaglandin synthesis by inhibiting the enzyme cyclooxygenase (COX 1 and 2), which leads to a decrease in inflammation, hyperemia, edema, and pain relief.
Pharmacokinetics
Absorption: After oral administration, flurbiprofen is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentrations are reached approximately 1.5 hours after a single dose. Food intake does not affect the bioavailability of the drug. The half-life is on average 6 hours.
Metabolism: plasma protein binding is more than 99%. Flurbiprofen is almost completely metabolized. The drug is excreted mainly in the urine in free and bound form (20%) and as hydroxylated metabolites (50%).
Indication
Acute musculoskeletal pain, signs and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gouty arthritis. Dysmenorrhea.
Contraindication
Increased individual sensitivity to flurbiprofen or any component of the drug. Hypersensitivity to flurbiprofen, ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, manifested by asthma, acute rhinitis, angioedema, urticaria or other allergic reactions. Peptic ulcer or gastrointestinal bleeding in history or in the acute phase (two or more clear episodes of exacerbation of ulcer disease or bleeding). Treatment of peri-operative pain in coronary artery bypass grafting (CABG). Cerebrovascular and other bleeding. Inflammatory bowel diseases. Simultaneous administration with other NSAIDs. Severe heart failure, renal failure, hepatic failure. Last trimester of pregnancy.
Interaction with other medicinal products and other types of interactions
The concomitant use of flurbiprofen with:
acetylsalicylic acid, if acetylsalicylic acid is taken in low doses (not higher than
75 mg per day) has not been prescribed by a doctor, as this may lead to a risk of adverse reactions;
other NSAIDs, including ibuprofen and selective cyclooxygenase-2 (COX-2) inhibitors, as this may increase the risk of side effects.
Flurbiprofen should be used with caution in combination with the following drugs:
Anticoagulants: NSAIDs may increase the therapeutic effect of anticoagulants such as warfarin. There is a risk of serious gastrointestinal bleeding when warfarin is combined with NSAIDs.
Beta-blockers: Flurbiprofen attenuates the hypotensive effect of propranolol, but not atenolol.
ACE inhibitors and diuretics. Nonsteroidal anti-inflammatory drugs may reduce the therapeutic effect of these drugs. There may be an increased risk of nephrotoxicity.
Corticosteroids may increase the risk of adverse reactions in the digestive tract.
Antiplatelet and selective serotonin reuptake inhibitors: The risk of gastrointestinal bleeding may be increased.
Methotrexate and lithium preparations. There is evidence of increased levels of these drugs in blood plasma.
Cyclosporines: There is some evidence of a possible drug interaction that may lead to an increased risk of nephrotoxicity.
Tacrolimus: Increased risk of nephrotoxicity.
Zidovudine: There is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients receiving concomitant treatment with zidovudine and ibuprofen.
Quinolone antibiotics may increase the risk of seizures.
Digoxin: NSAIDs may worsen heart failure, reduce GFR, and reduce plasma glycoside levels.
Cemetidine, ranitidine. Will not affect the pharmacokinetics of flurbiprofen, except for a small significant systemic effect.
Oral hypoglycemic agents: A slight decrease in plasma glucose concentration occurred, which did not cause signs or symptoms of hypoglycemia.
Antacids when used in the elderly: the rate of absorption of flurbiprofen is reduced, but there is no effect on the completeness of absorption.
Application features
Patients with a history of gastrointestinal ulceration, bleeding, or perforation are at increased risk of developing upper gastrointestinal complications.
The effect of the drug on the function of the cardiovascular system, hypertension and edema.
Due to the risk of edema and fluid retention, the drug should be used with caution in patients with heart failure, a history of hypertension, and patients with a history of edema from any cause. The use of nonsteroidal anti-inflammatory drugs may cause an increased risk of serious thrombotic complications, myocardial infarction, and stroke, which can be fatal.
Hemorrhagic complications (bleeding).
Flurbiprofen at a dose of 200 mg per day may prolong bleeding, so the drug should be prescribed with caution to patients at risk of bleeding.
The effect of the drug on kidney and liver function.
It should be used with caution in liver and kidney diseases. Patients who have been taking NSAIDs for a long time and have liver and kidney diseases should be carefully examined and they should also be provided with close medical supervision during drug therapy. If signs of liver failure and deviations from the norm of liver function indicators occur, the drug should be discontinued.
Elderly patients are at increased risk of adverse reactions to nonsteroidal anti-inflammatory drugs, especially gastrointestinal bleeding or perforation, which can be fatal.
Bronchospasm may occur in patients with bronchial asthma or allergic diseases currently, or who have a history of bronchospasm.
It is not recommended to use flurbiprofen in parallel with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Systemic lupus erythematosus and systemic connective tissue diseases – increased risk of aseptic meningitis.
Effects on the cardiovascular and cerebrovascular system: caution should be exercised (after consulting a doctor) when starting the use of drugs containing the active ingredient flurbiprofen in patients who have experienced elevated blood pressure and edema during treatment with nonsteroidal anti-inflammatory drugs.
There is epidemiological evidence that the use of NSAIDs in high doses (2400 mg daily) and long-term use may lead to a small increased risk of thrombotic complications (e.g. myocardial infarction or stroke).
Impairment of female reproductive function: The drug may inhibit cyclooxygenase/prostaglandin synthesis and lead to impairment of female fertility due to effects on ovulation. This phenomenon is reversible.
Gastrointestinal complications may be fatal during treatment with or without worsening symptoms or a history of serious cardiovascular events.
Increased doses of NSAIDs and a history of peptic ulcer disease are a risk of adverse reactions from the digestive tract. During treatment in such cases, it is recommended to use the minimum effective dose of the drug.
Patients with a history of gastrointestinal disease, particularly the elderly, should be informed of any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.
The drug should be used with caution in patients receiving concomitant therapy with drugs that may increase the risk of peptic ulcer or bleeding, including oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid.
Serious skin reactions, which can be fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred very rarely. The highest risk of these reactions occurs at the beginning of treatment, with the first manifestations appearing in most cases within the first month of treatment.
Patients should discontinue flurbiprofen treatment at the first appearance of rash, mucosal lesions, or other signs of hypersensitivity.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use during pregnancy or breastfeeding
Pregnancy category: 1st and 2nd trimester: C; 3rd trimester D
Reproductive studies in rats and rabbits have shown no evidence of developmental impairment. However, animal reproduction studies are not always predictive of human reproductive health. There are no adequate and well-controlled studies in pregnant women. MAJEZIK-SANOVEL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Due to the known effects of NSAIDs on the fetal cardiovascular system (closure of the ductus arteriosus), use in the last stages of pregnancy (from the 6th month) is contraindicated.
Animal studies are insufficient regarding the effects on pregnancy and postnatal development.
Flurbiprofen concentrations in breast milk and plasma, which can reach the child, are approximately 0.10 mg of flurbiprofen per day when a woman takes flurbiprofen at a dose of 200 mg/day. A decision should be made whether to discontinue nursing or to discontinue the prostaglandin-inhibiting drug, taking into account the importance of the drug to the mother.
Fertility
The use of NSAIDs may delay follicular release or prevent ovarian follicle rupture, which is associated with possible infertility. In women who have difficulty conceiving or who are undergoing infertility investigations, discontinuation of flurbiprofen should be considered.
Ability to influence reaction speed when driving vehicles or other mechanisms
Studies on the effect of the drug on the ability to drive and use machines have not been conducted. However, patients who experience dizziness or drowsiness after taking the drug should refrain from driving or operating potentially dangerous machinery.
Method of administration and doses
The drug should be taken orally at a dose of 50–100 mg 2–3 times a day.
The recommended dose is 150–200 mg per day.
If necessary, the recommended dose may be increased to 300 mg per day.
For dysmenorrhea: initially 100 mg followed by 50 mg or 100 mg every 4 or 6 hours. The maximum recommended dose should not exceed 300 mg per day.
It is recommended to take the tablets after meals.
The duration of treatment is determined by the doctor individually in each case.
Children
The drug should not be used in children.
Overdose
Overdose symptoms: diarrhea, tinnitus, headache and gastrointestinal bleeding may occur. In more severe poisoning, toxic lesions of the central nervous system may occur in the form of drowsiness, sometimes - agitation, as well as disorientation or coma. Sometimes patients experience muscle spasm. In severe poisoning, metabolic acidosis may occur and prothrombin time may be prolonged due to the effect on blood clotting factors. Acute renal failure and liver damage may occur. In patients with bronchial asthma, exacerbation of the disease may occur.
Treatment. Treatment may be symptomatic and supportive, and may include airway clearance and monitoring of cardiac and vital signs until stable. Oral administration of activated charcoal is recommended if the patient presents within 1 hour of ingestion of a potentially toxic amount. Frequent or prolonged muscle spasms should be treated with intravenous diazepam or lorazepam. Bronchodilators should be used in the presence of bronchial asthma.
Side effects
The following adverse reactions have been observed during short-term use of flurbiprofen. The frequency of adverse reactions is defined as follows: very common (> 1/10), common (> 1/100 to <1/10), uncommon (> 1/1,000 to <1/100), rare (> 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
When used in recommended doses, temporary mild side effects may develop.
From the gastrointestinal tract: often - dyspepsia, constipation, nausea, vomiting, diarrhea, gastropathy caused by nonsteroidal anti-inflammatory drugs, abdominal pain, liver dysfunction, with prolonged use - ulcerative stomatitis, bleeding. Exacerbation of ulcerative colitis and Crohn's disease; infrequently - bloody diarrhea, esophageal disorders, gastritis, hematemesis, peptic ulcer, stomatitis, gastrointestinal ulcers; rarely - the frequency of adverse reactions increases in elderly patients, especially gastrointestinal bleeding or perforation, which can be fatal.
Gastrointestinal complications may be fatal during treatment with or without worsening symptoms or a history of serious cardiovascular events.
Increased doses of NSAIDs and a history of peptic ulcer disease are a risk factor for adverse reactions from the digestive tract.
From the cardiovascular system: infrequently - heart failure; rarely - myocardial infarction, tachycardia;
From the side of the hematopoietic system: rarely - agranulocytosis, leukopenia, anemia, including hemolytic and aplastic, leukopenia, pancytopenia; infrequently - iron deficiency anemia. The first signs are high fever, sore throat, mouth ulcers, flu symptoms, severe exhaustion, unexplained bleeding and bruising, rash, purpura; frequency unknown - inhibition of platelet aggregation, thrombocytopenia, neutropenia.
Vascular disorders: infrequently - vasodilation, hypertension.
From the nervous system: often - headache, dizziness, drowsiness, asthenia, depression, amnesia, tremor; infrequently - ataxia, cerebrovascular ischemia, parasthesia, parosmia.
Mental disorders: often - nervousness, anxiety, insomnia; infrequently - confusion.
From the hepatobiliary system: infrequently - hepatitis, liver dysfunction.
Allergic reactions: very often - skin rash, often - itching, urticaria, bronchospasm, photosensitivity, Quincke's edema, anaphylactic shock, angioedema, eczema.
Bronchospasm may occur in patients with bronchial asthma or allergic diseases currently, or who have a history of bronchospasm.
Infections and infestations: common: rhinitis, urinary tract infections;
From the side of the chest, respiratory system and mediastinum: often - asthma, epistaxis, bronchospasm.
Reproductive system: Impairment of reproductive function in women. The drug may inhibit cyclooxygenase/prostaglandin synthesis and lead to impairment of female fertility due to effects on ovulation. This phenomenon is reversible upon discontinuation of treatment.
Skin: Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred very rarely. The highest risk of these reactions occurs at the beginning of treatment, with the first manifestations occurring in most cases within the first month of treatment.
Muscular system: often - convulsions.
On the part of the immune system: in patients with autoimmune disorders (namely, systemic lupus erythematosus, systemic connective tissue diseases) during treatment with NSAIDs, isolated cases of symptoms of aseptic meningitis, namely, neck stiffness, headache, nausea, vomiting, high fever or disorientation, were observed; frequency unknown - anaphylaxis.
On the part of the organs of vision: cases of visual disturbances, namely blurred and/or impaired vision, have been reported with the use of flurbiprofen or other non-steroidal anti-inflammatory drugs. Regular ophthalmological examinations should be performed while using the drug.
Metabolism and nutrition disorders: often - weight change; infrequently - hyperuricemia, fluid retention.
Other: hearing loss, vertigo, increased sweating, aseptic meningitis (isolated cases have been reported). Optic neuritis, oral paresthesias, depression, hallucinations, tinnitus, dizziness, malaise, fatigue and drowsiness, melena, feeling of warmth or tingling in the mouth when sucking the lollipop; hepatitis, cholestasis, interstitial nephritis, insomnia, nephrotic syndrome.
The use of nonsteroidal anti-inflammatory drugs (especially at high doses of 2400 mg daily), as well as long-term use, may lead to a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Laboratory indicators: increased liver enzymes, decreased hemoglobin and hematocrit. Since gastrointestinal disorders and bleeding can occur without any symptoms, regular examinations should be performed. Patients on long-term treatment should periodically check general indicators and blood chemistry.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
5 tablets in a blister; 1 or 2 or 6 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Sanovel Ilyach Sanai ve Tijaret A.Sh.
Address
Balaban Quarter, Cihaner Sokagi, No. 10, Istanbul, 34580, Silivri District, Turkey.
