Instructions for Olfen-50 Lactab enteric-coated tablets 50 mg No. 20
Composition
active substance: diclofenac sodium;
1 enteric tablet contains diclofenac sodium 50 mg;
auxiliary substances: sodium starch glycolate, microcrystalline cellulose, sodium stearyl fumarate, colloidal anhydrous silica, talc, hypromellose;
enteric coating: methacrylate copolymer dispersion, triethylcitrate, talc;
colored shell: hypromellose, titanium dioxide (E 171), talc, quinoline yellow (E 104), iron oxide yellow (E 172), macrogol 6000.
Medicinal form
Enteric-soluble tablets.
The main physical and chemical properties: biconvex tablets covered with a film cover, yellow-ochre color, imprinted with "mp" on one side and "O 50" on the other.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory and anti-rheumatic agents. ATX code M01A B05.
Pharmacological properties
Pharmacodynamics.
The drug Olfen®-50 Lactab contains the sodium salt of diclofenac - a substance of nonsteroidal structure that has anti-inflammatory, analgesic and antipyretic effects. The main mechanism of action of diclofenac, demonstrated in experimental conditions, is considered to be inhibition of the biosynthesis of prostaglandins, which play an important role in causing inflammation, pain, and increased body temperature. In in vitro studies, diclofenac sodium in concentrations equivalent to those achieved in the treatment of patients did not inhibit the biosynthesis of proteoglycans in cartilage tissue.
In rheumatic diseases, the anti-inflammatory and analgesic properties of the drug provide the most pronounced clinical effect, characterized by a significant reduction in the severity of such symptoms of diseases as pain at rest and during movement, morning stiffness and swelling of the joints, as well as an improvement in the function of the joints.
In case of post-traumatic/post-operative inflammations, Olfen®-50 Lactab caused a rapid reduction of spontaneous pain and pain during movements, and also reduced inflammatory swellings and wound swellings.
In clinical studies, the pronounced analgesic effect of the drug was also demonstrated in moderate and severe pain syndrome of a non-rheumatic nature.
In primary dysmenorrhoea, Olfen®-50 Lactab drug reduces the manifestations of pain and the intensity of menstrual bleeding.
Pharmacokinetics.
Absorption. After passing through the stomach, diclofenac is quickly and completely absorbed from Olfen®-50 Lactab tablets, which are resistant to the action of gastric juice. Although absorption is fast, its onset may be delayed due to the presence of a gastro-resistant coating on the tablet. After a single dose of 1 tablet of Olfen®-50 Lactab, the maximum concentration in the blood plasma is on average 1.5 μg/ml (5 μmol/l).
In the case of taking a diclofenac tablet during or after a meal, its passage through the stomach slows down (compared to when taken on an empty stomach), but this does not have a negative effect on the amount of the active substance that is absorbed.
Distribution Binding of diclofenac to blood plasma proteins is 99.7%, mainly to albumin - 99.4%. The observed volume of distribution is 0.12-0.17 l/kg.
Diclofenac penetrates into the synovial fluid, where the maximum concentration of the drug is reached 2-4 hours later than in blood plasma. The observed half-life from synovial fluid is 3-6 hours. Thanks to this, even 2 hours after the introduction of the drug, the concentration of the active substance in the synovial fluid is higher than in the blood plasma, and they remain at higher levels for 12 hours.
Diclofenac was detected in a low concentration (100 ng/ml) in the breast milk of one woman. The estimated amount of the drug entering the body of an infant with breast milk is equivalent to a dose of 0.03 mg/kg/day.
Metabolism. Metabolism of diclofenac occurs partially through glucuronidation of the unchanged molecule, but mainly through single and multiple hydroxylation and methoxylation, which leads to the formation of several phenolic metabolites (3-hydroxy-, 4-hydroxy-, 5-hydroxy-, 4,5-hydroxy- and 3-hydroxy-4-methoxydiclofenac), most of which are converted into glucuronide conjugates. Two of the phenolic metabolites formed in this process are pharmacologically active, but to a lesser extent than diclofenac sodium itself.
Derivation The total systemic clearance of diclofenac is 263±56 ml/min (mean ± SD). The final elimination period is 1-2 hours. The half-life of 4 metabolites, including two pharmacologically active ones, is also short and is 1-3 hours. The practically inactive metabolite 3-hydroxy-4-methoxy-diclofenac has a longer half-life. About 60% of the drug dose is excreted in the urine in the form of metabolites, and less than 1% of diclofenac is excreted unchanged. The rest of the applied dose of the drug is excreted in the form of metabolites through bile and feces.
Pharmacokinetics in separate groups of patients.
In patients with impaired kidney function who received therapeutic doses, accumulation of the unchanged active substance may not be expected, given the kinetics of the drug after a single administration. With a creatinine clearance of less than 10 ml/min, the calculated equilibrium concentrations of metabolites of diclofenac are approximately 4 times higher than in healthy volunteers. Despite this, metabolites are ultimately excreted only with bile.
In patients with impaired liver function (chronic hepatitis, compensated liver cirrhosis), the pharmacokinetics and metabolism of diclofenac are similar to those in patients with normal liver function.
Indications for use
Inflammatory and degenerative forms of rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis);
pain syndromes from the spine;
rheumatic diseases of extra-articular soft tissues;
acute attacks of gout;
post-traumatic and post-operative pain syndromes accompanied by inflammation and edema, for example after dental and orthopedic interventions;
gynecological diseases that are accompanied by pain syndrome and inflammation, for example, primary dysmenorrhea or adnexitis;
as an auxiliary agent for severe inflammatory diseases of the ENT organs, which are accompanied by severe pain syndrome, for example, with pharyngotonsillitis, otitis media.
In accordance with general therapeutic principles, the main disease should be treated with the means of basic therapy. Fever in itself is not an indication for the use of the drug.
Contraindications
§ Hypersensitivity to the active or auxiliary substances of the medicinal product;
§ acute stomach or intestinal ulcer; gastrointestinal bleeding or perforation;
§ bleeding or perforation of the gastrointestinal tract in history, associated with previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs);
§ active form of ulcer disease/bleeding or recurrent ulcer disease/bleeding in history (two or more separate episodes of established ulcer or bleeding);
§ like other NSAIDs, diclofenac is also contraindicated for patients in whom the use of ibuprofen, acetylsalicylic acid or other NSAIDs provokes attacks of bronchial asthma, angioneurotic edema, urticaria, acute rhinitis, nasal polyps and other allergic symptoms;
§ inflammatory bowel diseases (for example, Crohn's disease or ulcerative colitis);
§ liver failure;
§ renal failure (glomerular filtration rate 15 ml/min/1.73 m2);
§ congestive heart failure (NYHA II-IV);
§ ischemic heart disease in patients with angina pectoris, previous myocardial infarction;
§ cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks;
§ diseases of peripheral arteries;
§ treatment of perioperative pain in coronary artery bypass grafting (or use of an artificial blood circulation device);
§ Third trimester of pregnancy.
Interaction with other medicinal products and other types of interaction
When using Olfen®-50 Lactab and/or other diclofenac drugs, the following interactions may occur.
Cast, digoxin. When used simultaneously with these drugs, diclofenac can increase the concentration of lithium and digoxin in blood plasma. It is recommended to control the levels of lithium and digoxin in the blood serum.
Diuretics and other antihypertensive drugs. Like other NSAIDs, taking diclofenac sodium simultaneously with diuretics or antihypertensive agents (for example, beta-blockers, angiotensin-converting enzyme [ACE] inhibitors) can cause a decrease in the antihypertensive effect of these drugs (due to inhibition of the synthesis of vasodilating prostaglandins). Such combinations should be used with caution, and blood pressure in these patients, especially in the elderly, should be monitored. Patients need to receive an adequate amount of fluid, it is also recommended to monitor kidney function at the beginning of concomitant therapy and periodically during therapy, especially when taking diuretics and ACE inhibitors, considering the increased risk of nephrotoxicity.
Drugs causing hyperkalemia. Concomitant treatment with potassium-sparing diuretics, cyclosporine, tacrolimus, or trimethoprim may be associated with an increase in the level of potassium in blood serum, so monitoring of the patient's condition should be carried out more often (see the section "Peculiarities of use").
Anticoagulants and antiplatelet drugs. Caution should be exercised when using diclofenac sodium with anticoagulants and antiplatelet drugs, since their combined use may increase the risk of bleeding (see the section "Peculiarities of use"). Although clinical studies have not revealed evidence of the influence of diclofenac on the action of anticoagulants, there have been reports of an increased risk of bleeding in patients taking diclofenac and anticoagulants at the same time. Therefore, it is recommended to carefully monitor patients who simultaneously use diclofenac and anticoagulants, and if necessary, adjust the dosage of anticoagulants. Like other nonsteroidal anti-inflammatory drugs, diclofenac in high doses can reversibly suppress platelet aggregation.
Selective serotonin reuptake inhibitors (SSRIs). Simultaneous use of systemic NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding (see the section "Particulars of use").
Antidiabetic drugs. Clinical studies have shown that diclofenac sodium can be administered together with oral antidiabetic drugs without affecting their clinical effect. However, there have been separate reports of hypoglycemic and hyperglycemic reactions after the administration of diclofenac sodium, which required changes in the doses of antidiabetic drugs. Therefore, against the background of such combined therapy, it is recommended to control the level of glucose in the blood.
There are also separate reports of cases of metabolic acidosis with simultaneous use with diclofenac, especially in patients with pre-existing renal dysfunction.
Methotrexate. Diclofenac can suppress the clearance of methotrexate in the renal tubules, which leads to increased levels of methotrexate. Caution should be exercised when prescribing NSAIDs, including diclofenac, less than 24 hours before or after the use of methotrexate, since in such cases the concentration of methotrexate in the blood may increase and its toxic effect may increase. Cases of serious toxicity have been reported when the interval between the use of methotrexate and NSAIDs, including diclofenac, was within 24 hours. This interaction is mediated due to the accumulation of methotrexate as a result of impaired renal excretion in the presence of NSAIDs.
Cyclosporine and tacrolimus. Diclofenac sodium, like other NSAIDs, can increase the nephrotoxicity of cyclosporine or tacrolimus due to its effect on kidney prostaglandins. Therefore, the drug should be prescribed in smaller doses than patients who do not receive ciclosporin or tacrolimus.
Antibacterial quinolones. Convulsions may develop in patients who simultaneously used quinolone derivatives and NSAIDs. The development of convulsions can be observed in patients both with epilepsy and convulsions in the anamnesis, and without them. Thus, caution should be exercised when deciding on the use of quinolone in patients who are already receiving NSAIDs.
Phenytoin. When using phenytoin simultaneously with diclofenac, it is recommended to monitor the concentrations of phenytoin in the blood plasma due to the expected increase in the effect of phenytoin.
Colestipol and cholestyramine. These drugs can delay or reduce the absorption of diclofenac. Thus, it is recommended to prescribe diclofenac at least 1 hour before or 4-6 hours after the administration of colestipol/cholestyramine.
Cardiac glycosides. The simultaneous use of cardiac glycosides and NSAIDs can increase heart failure, reduce the rate of glomerular filtration (GFR) and increase the level of glycosides in the blood plasma.
Mifepristone. NSAIDs should not be used for 8-12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.
CYP2C9 inhibitors. Caution is necessary when diclofenac is co-administered with CYP2C9 inhibitors (for example, with voriconazole, sulfinpyrazone). This can lead to a significant increase in the maximum concentration in blood plasma and diclofenac exposure.
SUR2C9 inductors. Care should be taken when diclofenac is co-administered with SUR2C9 inducers (for example, rifampicin). This can lead to a significant decrease in blood plasma concentration and diclofenac exposure.
Features of application
General
To minimize unwanted effects, treatment should begin with the lowest effective dose for the shortest period of time necessary to control symptoms.
Placebo-controlled studies revealed an increased risk of developing thrombotic cardiovascular and cerebrovascular complications when using certain selective COX-2 inhibitors. The direct correlation of this risk with the selectivity of individual NSAIDs to COX-1/COX-2 has not yet been established. Due to the lack of comparable clinical research data regarding long-term treatment with maximum doses of diclofenac, the possibility of such an increased risk cannot be excluded. Therefore, before prescribing diclofenac, a careful risk-benefit assessment should be carried out for patients with clinically confirmed coronary heart disease, cerebrovascular disorders, occlusive diseases of peripheral arteries, or significant risk factors (such as arterial hypertension, hyperlipidemia, diabetes, smoking). Considering this risk, the lowest effective dose should be used for the shortest possible treatment period.
NSAIDs affect the kidneys, causing fluid retention with edema and/or arterial hypertension. Therefore, diclofenac should be used with caution in patients with impaired cardiac function and other conditions that contribute to fluid retention. Caution should also be observed in patients who take concomitant diuretics or ACE inhibitors or are prone to the development of hypovolemia.
As a rule, the consequences are more serious in elderly patients. Care should be taken when prescribing the drug to persons over 65 years of age. In particular, it is recommended to apply the lowest effective dose to weakened patients of elderly age or with low body weight.
As with the use of other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur even without prior exposure to diclofenac. Hypersensitivity reactions can also progress to Kounis syndrome, a severe allergic reaction that can cause myocardial infarction. Symptoms of such a reaction are chest pain that occurs in combination with an allergic reaction to diclofenac.
Olfen®-50 Lactab, like other NSAIDs, can mask signs and symptoms of infection.
Influence on the digestive system
When using all NSAIDs (including selective COX-2 inhibitors), including diclofenac, cases of gastrointestinal bleeding (cases of vomiting blood, melena), formation of ulcers or perforations, which can be fatal and occur at any time during treatment with or without warning symptoms or serious manifestations from the gastrointestinal tract in the anamnesis, have been reported. These phenomena usually have more serious consequences in elderly patients. If patients receiving diclofenac experience gastrointestinal bleeding or ulceration, the drug should be discontinued.
When using NSAIDs, including diclofenac, in patients with symptoms indicating disorders of the gastrointestinal tract, medical supervision and special caution are mandatory. The risk of gastrointestinal bleeding, formation of ulcers or perforations is higher when increasing the dose of NSAIDs, including diclofenac, as well as in patients with a history of ulcers, especially with complications in the form of bleeding or perforation. In elderly patients, adverse reactions to the use of NSAIDs occur more often, especially gastrointestinal bleeding and perforation, which can be fatal.
To reduce the risk of toxic effects on the digestive system, treatment is started and maintained with low effective doses. For such patients, as well as those who require concomitant use of low doses of acetylsalicylic acid (ASA/aspirin) or other drugs that increase the risk of adverse effects on the digestive system, additional protective agents (for example, proton pump inhibitors or misoprostol) should be considered. Patients with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially bleeding in the gastrointestinal tract). Precautions are also necessary for patients who are simultaneously receiving drugs that increase the risk of ulcers or bleeding, such as systemic corticosteroids, anticoagulants (for example, warfarin), antithrombotic agents (for example, ASA) or selective serotonin reuptake inhibitors (see the section "Interaction with other drugs and other types of interactions").
When using NSAIDs, including diclofenac, the risk of leakage from the gastrointestinal anastomosis increases, careful medical supervision is necessary when using diclofenac after surgical interventions on the gastrointestinal tract.
Effect on the liver
Careful medical supervision is necessary when Olfen®-50 Lactab is prescribed to patients with impaired liver function, as their condition may worsen.
This phenomenon was very often observed when using diclofenac in clinical studies (approximately in 15% of patients), but very rarely accompanied by clinical symptoms. Most of these cases are associated with increases at the limit of the norm. Often (in 2.5% of cases) a moderate increase (from ≥3 to <8 times the upper limit of the norm) was observed, while the frequency of a pronounced increase (≥8 times the upper limit of the norm) remained approximately at the level of 1%. Elevated liver enzymes were accompanied by clinically significant liver damage in 0.5% of cases in the above-mentioned clinical studies.
During long-term treatment with the drug Olfen®-50 Laktab, regular monitoring of liver functions and levels of liver enzymes is prescribed as a precautionary measure. If liver function disorders persist or worsen, if clinical signs or symptoms of progressive liver disease or other manifestations (for example, eosinophilia, rash) appear, the use of Olfen®-50 Lactab should be discontinued.
In addition to elevated liver enzymes, there have been rare reports of severe liver reactions, including jaundice and fulminant hepatitis, liver necrosis and liver failure, which in some cases have led to death.
When using diclofenac, hepatitis can occur without prodromal symptoms. Caution is necessary if Olfen®-50 Lactab should be used in patients with hepatic porphyria, due to the possibility of provoking an attack.
Effects on the kidneys
NSAIDs, including diclofenac, reduce the level of prostaglandins, which are important for maintaining renal blood flow.
Since in the treatment of NSAIDs, including diclofenac, cases of fluid retention, edema and hypertension were often (1-10%) reported, special attention should be paid to patients with heart or kidney function disorders, arterial hypertension in the anamnesis, elderly patients, patients receiving concomitant therapy with diuretics or drugs that significantly affect kidney function, as well as patients with a significant decrease in extracellular fluid volume for any reason, for example, before or after serious surgical intervention (see section "Contraindications"). In such cases, monitoring of renal function is recommended as a precautionary measure. Discontinuation of therapy usually leads to a return to the condition that preceded the treatment.
Effect on the skin
In connection with the use of NSAIDs, including Olfen®-50 Lactab, serious skin reactions (some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported in very rare cases (see the Adverse Reactions section). In patients, the highest risk of developing these reactions is observed at the beginning of the course of therapy: the appearance of the reaction is observed in most cases during the first month of treatment. The use of Olfen®-50 Lactab should be stopped at the first appearance of skin rashes, lesions of the mucous membrane or at the appearance of any other signs of hypersensitivity.
SLE and mixed connective tissue diseases
Patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases have an increased risk of developing aseptic meningitis.
Cardiovascular and cerebrovascular effects
Treatment with diclofenac, as a rule, is not recommended for patients with diagnosed cardiovascular diseases (heart failure, ischemic heart disease, peripheral artery diseases) or uncontrolled arterial hypertension.
Diclofenac can be prescribed to patients with significant risk factors for cardiovascular events (such as arterial hypertension, hyperlipidemia, diabetes, smoking) only after careful clinical evaluation and only in doses up to 100 mg per day with a course of treatment of more than 4 weeks. Since the cardiovascular risks of diclofenac can increase with an increase in the dose and duration of treatment, it should be used for as short a period as possible and in the lowest effective dose. It is necessary to periodically review the patient's need for the use of diclofenac to relieve symptoms and respond to therapy, especially if the treatment lasts more than 4 weeks.
Patients with a history of arterial hypertension and/or congestive heart failure of mild or moderate severity should be monitored and given recommendations, as cases of fluid retention and edema have been reported with the use of NSAIDs, including diclofenac.
Diclofenac should be used with caution in patients taking concomitant diuretics or ACE inhibitors or who are at increased risk of hypovolemia.
Diclofenac is not recommended for patients with uncontrolled arterial hypertension, congestive heart failure, persistent ischemic heart disease, peripheral artery disease and/or cerebrovascular disease; if necessary, use is possible only after a careful risk-benefit assessment, only in a dosage of no more than 100 mg per day for no more than 4 weeks.
Patients must be informed about the possibility of serious thrombotic symptoms (chest pain, shortness of breath, weakness, speech disorder) at any time during treatment. In this case, you should immediately consult a doctor.
Influence on hematological indicators
With long-term use of this drug, as with other NSAIDs, monitoring of a complete blood count is recommended.
Diclofenac can temporarily suppress platelet aggregation. Patients with impaired hemostasis, hemorrhagic diathesis or hematological disorders should be carefully monitored.
History of asthma
Patients with asthma, seasonal allergic rhinitis, edema of the nasal mucosa (ie, nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (especially associated with allergic rhinitis-like symptoms) are more likely to experience reactions to NSAIDs such as asthma exacerbation (so-called intolerance to analgesics/analgesic asthma), Quincke's edema, or urticaria. Therefore, special precautions are recommended for such patients (readiness to provide emergency care). This also applies to patients with allergic reactions to other substances, such as rash, itching or hives.
Like other drugs that suppress the activity of prostaglandin synthetase, diclofenac sodium and other NSAIDs can provoke the development of bronchospasm when used in patients suffering from bronchial asthma or patients with a history of bronchial asthma.
Auxiliary substances
This medicine contains less than 1 mmol (23 mg) of sodium in one tablet, that is, it is practically sodium-free.
Use during pregnancy or breastfeeding
Pregnancy
Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryo/fetus development. Data from epidemiological studies indicate an increased risk of pregnancy termination, heart defects and gastroschisis after the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The absolute risk of cardiovascular diseases increased from less than 1% to approximately 1.5%. It is believed that this risk increases with an increase in the dose of drugs and the duration of therapy. It is recorded that in animals, the introduction of an inhibitor of prostaglandin synthesis leads to an increase in pre- and post-implantation losses and the lethality of the embryo/fetus. In addition, in animals receiving an inhibitor of prostaglandin synthesis during the period of organogenesis, an increased frequency of various malformations, including those of the cardiovascular system, was recorded.
Starting from the 20th week of pregnancy, the use of diclofenac can cause oligohydramnios due to fetal kidney dysfunction. This disorder can occur soon after the start of treatment and is usually reversible after its termination. In addition, there are reports of narrowing of the ductus arteriosus after treatment in the second trimester of pregnancy, most of which resolved after treatment was discontinued. Therefore, diclofenac sodium should not be used during the I and II trimesters of pregnancy, unless absolutely necessary. If diclofenac sodium is used by a woman who is trying to get pregnant, or in the I or II trimesters of pregnancy, the dose of the drug should be minimal, and the duration of treatment should be as short as possible.
Antenatal monitoring regarding oligohydramnios and narrowing of the ductus arteriosus after the use of diclofenac for several days, starting from the 20th week of pregnancy, may be useful. In case of detection of oligohydramnios or narrowing of the ductus arteriosus, the use of diclofenac should be discontinued.
Diclofenac sodium is contraindicated in the III trimester of pregnancy (see the section "Contraindications") due to the fact that all prostaglandin synthesis inhibitors can:
expose the fetus to the following risks:
cardiopulmonary toxicity (premature narrowing/closure of the arterial duct and pulmonary hypertension);
renal dysfunction (see above);
expose the mother and newborn to the following risks:
possible prolongation of bleeding time - an effect associated with the inhibition of platelet aggregation, which can appear even against the background of taking very low doses of the drug;
inhibition of the contraction of the uterine muscles, which leads to a delay or prolongation of childbirth.
Breast feeding
Like other NSAIDs, diclofenac penetrates into breast milk in small quantities. Therefore, in order to prevent the development of adverse reactions in infants, this drug should not be used during breastfeeding. If treatment is necessary, breastfeeding should be stopped.
Like other NSAIDs, Olfen®-50 Lactab can negatively affect female fertility and is therefore not recommended for women planning pregnancy. Consideration should be given to stopping the use of the drug in women who cannot become pregnant, as well as in women who are being examined for infertility.
Based on the relevant animal research data, it is impossible to rule out a violation of reproductive function in males. The relevance of these data for humans has not been established.
The ability to influence the speed of reaction when driving a motor vehicle or other mechanisms
Patients who experience visual disturbances, dizziness, vertigo, drowsiness, lethargy, increased fatigue or other disorders of the central nervous system during treatment with Olfen®-50 Lactab should refrain from driving a car or working with other mechanisms.
Method of application and dosage
The doctor selects the dose individually. The drug should be used in the smallest effective doses for a short period of time, taking into account the goal of treatment in each individual patient.
Adults
Tablets should preferably be taken before food, washed down with liquid, they should not be split or chewed.
The initial daily dose of sodium diclofenac is usually 100-150 mg, that is, 2-3 tablets of Olfen®-50 Lactab. In less severe cases and with long-term therapy, it is usually sufficient to use 75-100 mg/day (to obtain a dose of 75 mg, use the drug in the dosage form with the appropriate dosage). The daily dose, as a rule, is divided into 2-3 receptions.
To prevent night pain and morning stiffness, taking Olfenu®-50 Lactab during the day can be combined with rectal suppositories before bedtime, but the maximum daily dose of diclofenac should not exceed 150 mg.
With primary dysmenorrhea, the daily dose is selected individually and is, as a rule, 50-150 mg. The initial dose can be 50-100 mg, if necessary, it can be increased during several menstrual cycles, but not more than 150 mg/day. Treatment should begin when the first symptoms appear and continue for several days, depending on the dynamics of the regression of symptoms.
The recommended maximum daily dose of Olfen®-50 Lactab is 150 mg.
Elderly patients (from 65 years)
Although in elderly patients, the pharmacokinetics of Olfen®-50 Lactab does not deteriorate to any clinically significant degree, nonsteroidal anti-inflammatory drugs should be used with special caution in such patients, as they are more prone to the development of adverse reactions. In particular, for weakened elderly patients or for patients with a low body weight, it is recommended to use the lowest effective doses; Also, patients should be examined for gastrointestinal bleeding during treatment with NSAIDs.
Existing cardiovascular diseases or significant risk factors
Diclofenac can be prescribed to patients with significant risk factors for cardiovascular events (such as arterial hypertension, hyperlipidemia, diabetes, smoking) only after careful clinical assessment. Since the cardiovascular risks of diclofenac can increase with an increase in the dose and duration of treatment, it should be used for as short a period as possible and in the lowest effective dose. It is necessary to periodically review the patient's need for the use of diclofenac for symptom relief and response to therapy.
Patients with impaired kidney function
Diclofenac is contraindicated in patients with renal failure (glomerular filtration rate 15 ml/min/1.73 m2).
Specific studies involving patients with impaired renal function have not been conducted, and there are no recommendations for dose correction. Diclofenac should be administered with caution to patients with moderate or severe renal impairment.
Patients with impaired liver function
Diclofenac is contraindicated in patients with liver failure.
Specific studies involving patients with impaired liver function have not been conducted, and there are no recommendations for dose correction. Diclofenac should be prescribed with caution to patients with moderate or severe liver dysfunction.
Children
Tablets in a dose of 50 mg should not be used in children because of
