Naklofen Duo long-acting capsules 75mg №10×2

Name Naklofen Duo caps. prolongation d-via 75mg in a blister pack. No. 10×2 The main active ingredient is diclofenac Release form Capsules Dosage 75 mg Special instructions Use in case of impaired liver function Naklofen duo is contraindicated in patients with hepatic insufficiency. Caution is advised when using Naklofen duo in patients with mild to moderate hepatic impairment. Application for violations of renal function Naklofen duo is contraindicated in patients with renal insufficiency. Caution is advised when using Naklofen Duo in patients with mild to moderate renal impairment. Use in Elderly Patients Elderly patients should be given Naklofen duo with caution. Use in children Naklofen duo should not be taken by children under 14 years of age. Special instructions General Side effects of the drug can be minimized by using the lowest effective dose for the shortest period necessary to control (alleviate) symptoms. Naklofen duo should be used with caution in elderly patients. In particular, for the treatment of elderly debilitated patients or persons with low body weight, the administration of the smallest effective dose is recommended. When taking diclofenac, like other NSAIDs, in patients who have not previously taken the drug, in rare cases, allergic reactions, including anaphylactic / anaphylactoid reactions, may occur. Masking of infection Due to its anti-inflammatory and antipyretic effects, diclofenac sodium can mask signs and symptoms characteristic of infectious and inflammatory diseases. The combined use of Naklofen duo and other NSAIDs, including selective COX-2 inhibitors, should be avoided due to the lack of data on a synergistic therapeutic effect and possible additive adverse reactions. Effects on the gastrointestinal tract When taking NSAIDs, including diclofenac, gastrointestinal bleeding, ulcers or perforations, sometimes fatal, are possible, which can occur during any period of treatment against the background of warning symptoms, or in the absence of them, or in patients with serious gastrointestinal diseases in history. As a rule, such phenomena have more serious consequences in elderly patients. If an ulcer or gastrointestinal bleeding occurs, the drug should be discontinued. When conducting therapy with NSAIDs, including diclofenac, medical supervision is necessary, especially caution should be exercised when prescribing diclofenac to patients with symptoms indicative of gastrointestinal disorders, to persons with a stomach or intestinal ulcer, bleeding or perforation in history. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dose of NSAIDs, especially in patients with a history of ulcer complicated by bleeding or perforation. In elderly patients, there is a higher incidence of adverse reactions associated with taking NSAIDs, in particular, gastrointestinal bleeding and perforation. To reduce the risk of toxic effects on the gastrointestinal tract in patients with a history of peptic ulcer, in particular, complicated by bleeding or perforation, as well as in elderly patients, treatment should begin with the lowest effective dose of the drug and adhere to it in the future. In such patients, as well as in those who require the concomitant use of drugs containing low doses of acetylsalicylic acid, or other drugs that increase the risk of adverse reactions from the gastrointestinal tract, the advisability of combination therapy with protective agents (for example, proton pump inhibitors) should be considered. or misoprostol). Patients with a history of gastrointestinal disorders, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to the doctor, in particular at the initial stage of treatment. Caution should be exercised in patients taking concomitant medicinal products that may increase the risk of bleeding and ulceration, such as systemic corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (eg, aspirin). Strict medical supervision is also necessary for patients suffering from ulcerative colitis or Crohn’s disease, because. the course of these diseases can be aggravated. Effect on liver function Patients with impaired liver function should be under medical supervision due to the possible deterioration of their condition. When using NSAIDs, including diclofenac, there may be an increase in the activity of one or more liver enzymes. With long-term use of diclofenac, a regular study of liver function is indicated as a precautionary measure. If violations of liver function parameters persist or increase, clinical signs or symptoms characteristic of liver diseases appear, and if other side effects occur (eg, eosinophilia, rash), diclofenac should be stopped immediately. It should be borne in mind that hepatitis when taking diclofenac may occur without previous symptoms. Caution should be exercised when prescribing the drug to patients with hepatic porphyria, because. the drug can provoke an exacerbation of the disease. Effects on kidney function Cases of fluid retention and edema have been reported with NSAIDs, including diclofenac. Particular care should be taken in patients with impaired cardiac or renal function, in patients with a history of arterial hypertension, in the appointment of elderly patients, in patients receiving concomitant therapy in the form of diuretics or drugs that can significantly affect renal function, as well as in patients who have a significant decrease in circulating plasma volume of any etiology, for example, before or after major surgery. In such cases, when prescribing diclofenac, regular monitoring of renal function is recommended as a precautionary measure. Cancellation of the drug usually leads to the restoration of kidney function to its original level. Influence on the cardiovascular and cerebrovascular systems Due to the possibility of fluid retention in the body and the development of edema during treatment with non-selective NSAIDs, patients with arterial hypertension and / or mild to moderate congestive heart failure in history require medical supervision. Based on clinical trial data and epidemiological data, it can be assumed that the use of diclofenac sodium, in particular at high doses (150 mg/day) and over a long period of time, may be associated with an increased risk of cardiovascular thrombotic events (for example, myocardial infarction). myocardial or stroke). Special care should be taken when prescribing the drug to patients at risk (for example, people with arterial hypertension, hyperlipidemia, diabetes mellitus, smokers). Since the risk of developing side effects from the cardiovascular system increases with increasing dose and duration of treatment, it is recommended to prescribe the drug at the lowest effective dose and for the shortest period. The patient’s condition and response to treatment should be periodically reassessed. Effects on the skin and subcutaneous tissue In very rare cases, the use of NSAIDs has been reported serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Patients are most at risk at the beginning of therapy: in most cases, the observed adverse reactions occurred in the first month of treatment. At the first signs of rashes on the skin and mucous membranes, as well as other symptoms of hypersensitivity, treatment should be discontinued. Hematological effects The use of diclofenac is recommended for a short period of time. During long-term treatment with diclofenac, as with other NSAIDs, it is recommended to periodically monitor the parameters of the general blood test. Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Strict medical supervision is recommended for patients with impaired hemostasis. History of asthma Patients with asthma, seasonal allergic rhinitis, nasal edema (eg, nasal polyps), COPD, or chronic respiratory infections (especially those associated with allergic rhinitis or with similar symptoms) are more likely than others to experience bronchial flare-ups. asthma (so-called analgesic intolerance), Quincke’s edema or urticaria. Therefore, such patients, as well as patients suffering from allergies to other substances, manifested in the form of skin reactions, itching or urticaria, are advised to take special precautions (readiness for emergency care). Special information about some of the ingredients of Naklofen Duo contains sucrose. Patients with rare hereditary disorders such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take the drug. Influence on the ability to drive vehicles and control mechanisms Naklofen duo has a weak or moderate effect on the ability to drive vehicles or work with other mechanisms. Patients who experience visual impairment, vertigo, drowsiness and / or other undesirable effects from the central nervous system while taking the drug should refrain from driving a car or working with other technical devices that require increased concentration and speed of psychomotor reactions. Indications for use Naklofen duo is indicated for children over 14 years of age and adults with: inflammatory and degenerative rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, arthrosis, extra-articular rheumatism); pain syndrome and inflammation of rheumatic or post-traumatic origin; for the symptomatic treatment of primary dysmenorrhea. Dosing and Administration The drug is taken orally, during or immediately after a meal. The capsule should be swallowed whole with a small amount of liquid. If symptoms appear most often at night or in the morning, the drug is preferably taken in the evening. When treating, regardless of the number of dosage forms used (one or more), the total daily dose of the drug should be taken into account, which should not exceed 150 mg. If necessary, in the presence of extremely severe symptoms of the disease (especially in the first half of the day), for a short period of time, the maximum daily dose of the drug Naklofen duo (2 caps) can be used as a single dose. Dosage should be adjusted individually. Side effects of the drug can be reduced by using the lowest effective dose for the shortest period necessary to relieve symptoms. As a rule, for elderly patients, adjustment of the initial dose is not required. However, it is recommended to use diclofenac sodium in the smallest effective doses. This is especially true for debilitated elderly patients or those with low body weight. In patients with congestive heart failure (NYHA Class I) or significant risk factors for the development of cardiovascular events, diclofenac can only be used after careful evaluation, and with a duration of therapy of more than 4 weeks, only at doses ≤100 mg / day. Naklofen duo is contraindicated in patients with renal insufficiency. Since special studies have not been conducted in patients with impaired renal function, specific recommendations for dose adjustment cannot be made. Caution is advised when using Naklofen Duo in patients with mild to moderate renal impairment. Naklofen duo is contraindicated in patients with hepatic insufficiency. Since special studies have not been conducted in patients with impaired liver function, specific recommendations for dose adjustment cannot be made. Caution is advised when using Naklofen duo in patients with mild to moderate hepatic impairment. Naklofen duo should not be taken by children under 14 years of age. Use during pregnancy and lactation Pregnancy Suppression of prostaglandin synthesis may adversely affect the course of pregnancy and / or intrauterine development of the fetus. Data from epidemiological studies indicate an increased risk of miscarriage, development of heart defects and gastroschisis after taking prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular disease increases from less than 1% to approximately 1.5%. It is believed that the risk increases with increasing dose and duration of therapy. It has been shown that administration of prostaglandin synthesis inhibitors in animals leads to disruption of implantation and death of the embryo. In addition, in animals treated with a prostaglandin synthesis inhibitor during organogenesis, the incidence of various malformations, including developmental disorders of the cardiovascular system, increased. Diclofenac should not be given during the first two trimesters of pregnancy unless the benefit outweighs the risk to the fetus. If diclofenac sodium is used by a woman planning a pregnancy, or in the I and II trimesters of pregnancy, the dose of the drug should be minimal, and the treatment time should be as short as possible. When taking inhibitors of prostaglandin synthesis in the third trimester of pregnancy in the fetus, the following are possible: – pneumocardial toxic lesions (premature closure of the arterial duct and pulmonary hypertension), renal dysfunction, the progression of which develops renal failure with oligohydroamnion; when taken at the end of pregnancy, in the mother and newborn, it is possible: – prolongation of bleeding time, anti-aggregation effect (even after taking very low doses of diclofenac), – development of weak labor and an increase in the duration of labor. Thus, Naklofen duo is contraindicated in the third trimester of pregnancy. Lactation Period Like other NSAIDs, diclofenac is excreted in breast milk in small amounts. Thus, in order to avoid the manifestation of undesirable effects in a child, diclofenac should not be used during breastfeeding. Reproductive function Like other NSAIDs, diclofenac sodium can lead to impaired female fertility, so it is not recommended for women planning a pregnancy. In women who have difficulty conceiving or who are being tested for infertility, discontinuation of the drug should be considered. Interaction with other drugs Lithium: when used together, it is possible to increase the concentration of lithium in plasma. It is recommended to control the concentration of lithium in plasma. Digoxin: when used together, it is possible to increase the concentration of digoxin in plasma. It is recommended to control the concentration of digoxin in plasma. Diuretics and antihypertensive drugs: Like other NSAIDs, diclofenac, when taken together with diuretics or antihypertensive drugs (eg, beta-blockers, ACE inhibitors), may reduce their antihypertensive effect. Therefore, when combining these drugs, care should be taken, and patients, especially the elderly, should periodically monitor blood pressure. Due to the increased risk of nephrotoxicity, especially when diuretics and ACE inhibitors are co-administered, patients should drink adequate fluids, and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically during its continuation. Simultaneous use with potassium-sparing drugs can lead to an increase in the content of potassium in the plasma. Frequent monitoring of this indicator is required. Drugs known to cause hypercalcemia: Concomitant use with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may be associated with an increase in plasma potassium. Frequent monitoring of this indicator is required. Other NSAIDs and corticosteroids: Co-administration of diclofenac and other NSAIDs or corticosteroids may increase the incidence of gastrointestinal adverse events. Anticoagulants and antiplatelet agents: It is recommended to use with caution due to a possible increase in the risk of bleeding when taken together. Despite the fact that clinical studies have not revealed the effect of diclofenac on the action of anticoagulants, there are separate reports of an increased risk of bleeding in patients receiving diclofenac and anticoagulants at the same time. Such patients should be under close medical supervision. Selective serotonin reuptake inhibitors (SSRIs): simultaneous administration of systemic NSAIDs, incl. diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding. Antidiabetic drugs: in clinical studies it was found that diclofenac does not affect the clinical effect of oral antidiabetic drugs. However, there are separate reports of both hypoglycemic and hyperglycemic effects that have necessitated a change in the dose of antidiabetic drugs during treatment with diclofenac. Therefore, during concomitant therapy, as a precautionary measure, it is recommended to control the concentration of glucose in the blood. Methotrexate: Diclofenac may inhibit renal tubular clearance of methotrexate and thereby increase its concentration. Caution should be exercised when using NSAIDs, incl. diclofenac, less than 24 hours before or after taking methotrexate, since it is possible to increase the concentration in the blood of the latter and, consequently, increase its toxicity. Cyclosporine and tacrolimus: Diclofenac, like other NSAIDs, due to its effect on renal prostaglandins, may increase the nephrotoxicity of cyclosporine. In such cases, diclofenac is recommended to be administered at doses lower than those that would be prescribed to patients not receiving cyclosporine or tacrolimus. Antibacterial drugs of the quinolone group: there are separate reports of the development of seizures, which may have been associated with the simultaneous use of quinolones and NSAIDs. Phenytoin: With the simultaneous use of phenytoin and diclofenac, periodic monitoring of the concentration of phenytoin in the blood plasma is recommended due to its possible increase. Colestipol and cholestyramine: Co-administration may slow down or decrease the absorption of diclofenac. Therefore, it is recommended to take diclofenac at least 1 hour before or 4-6 hours after taking colestipol/colestyramine. Potent CYP2C9 inhibitors: It is recommended that diclofenac be used with caution in conjunction with potent CYP2C9 inhibitors (eg, sulfinpyrazone and voriconazole), as a significant increase in plasma Cmax and AUC of diclofenac is possible due to inhibition of its metabolism. Potent CYP2C9 inducers: Caution should be exercised with concomitant use (eg with rifampicin). A significant decrease in plasma concentration and AUC of diclofenac is possible. Mifepristone: Given that NSAIDs may reduce the effectiveness of mifepristone, they should be taken no earlier than 8 to 12 days after mifepristone has ended. Contraindications hypersensitivity to diclofenac sodium or any component of the drug, other analgesics, antipyretics, other NSAIDs, and in particular to acetylsalicylic acid; hypersensitivity to salicylates or other NSAIDs, manifested as bronchial asthma, urticaria or rhinitis; gastric or intestinal ulcer in the acute phase, bleeding or perforation; inflammatory bowel disease (Crohn’s disease or ulcerative colitis); liver failure (Child Pugh class C) (liver cirrhosis or ascites); renal failure (GFR <15 ml / min / 1.73 m2); established congestive heart failure (NYHA II-IV); treatment of postoperative pain after coronary bypass surgery (or with the use of a heart-lung machine); III trimester of pregnancy. Composition Diclofenac sodium 75 mg* * 25 mg in the form of enteric pellets and 50 mg in the form of extended release pellets. Excipients: sucrose, hydroxypropylcellulose (E463), hypromellose (E464), magnesium carbonate, copolymer of methacrylic acid and ethyl acrylate, triethyl citrate (E1505), talc (E553b), titanium dioxide (E171), sodium carboxymethylcellulose (E466), macrogol 6000, sodium hydroxide (E524), ammonium methacrylate copolymer (type A and B). The composition of the capsule shell: titanium dioxide (E171), indigo carmine (E132), gelatin (E441). Overdose Symptoms There is no typical clinical picture characteristic of an overdose of diclofenac. Overdose may be accompanied by symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In case of severe poisoning, acute renal failure and liver damage may develop. Treatment Therapeutic tactics of acute poisoning with NSAIDs, incl. diclofenac, consists of supportive and symptomatic therapy. Supportive and symptomatic treatment is indicated for complications such as arterial hypotension, renal failure, convulsions, gastrointestinal disorders and respiratory depression. Special measures such as forced diuresis, hemodialysis or hemoperfusion will probably not have the desired effect in terms of the elimination of NSAIDs, incl. diclofenac, due to the significant binding of these active substances to plasma proteins and extensive metabolism. In case of an overdose, it is necessary to take activated charcoal, in case of a potentially life-threatening one, take measures to remove the drug from the stomach (induce vomiting, rinse the stomach). There is no specific antidote. Treatment is symptomatic. Side effects Side effects are classified into appropriate groups depending on the frequency of occurrence: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rare ( ≥1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated based on available data). The most commonly observed side effects are from the gastrointestinal tract. Possible, especially in elderly patients, peptic ulcer, perforation or gastrointestinal bleeding, incl. with a lethal outcome. On the part of the hematopoietic system: very rarely - thrombocytopenia, leukopenia, agranulocytosis, anemia (including hemolytic and aplastic). From the immune system: rarely - hypersensitivity reactions, anaphylactic and anaphylactoid reactions (including bronchospasm, hypotension and shock); very rarely - angioedema (including swelling of the face). Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability, psychotic disorders. From the nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular accident. On the part of the organ of vision: very rarely - blurred vision, blurred vision, diplopia. On the part of the organ of hearing and the labyrinth system: often - vertigo; very rarely - tinnitus, hearing impairment. From the side of the cardiovascular system: infrequently - * palpitations, chest pain, heart failure, myocardial infarction; very rarely - hypertension, vasculitis. From the respiratory system: rarely - asthma (including shortness of breath); very rarely - pneumonitis. From the digestive system: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, loss of appetite; rarely - gastritis, gastrointestinal bleeding, vomiting with blood, melena, hemorrhagic diarrhea, stomach or intestinal ulcers with or without bleeding or perforation, which can lead to peritonitis; very rarely - ischemic colitis (including hemorrhagic, exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal disorders, diaphragm-like intestinal strictures, pancreatitis; frequency unknown - inflammatory conditions in the lower intestine (in the small and large intestine) with the formation of pseudomembranes and strictures. From the hepatobiliary system: often - increased activity of transaminases; rarely - jaundice, hepatitis, impaired liver function; very rarely - fulminant hepatitis, hepatonecrosis, liver failure. From the skin and subcutaneous tissues: often - rash; rarely - urticaria; very rarely - bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reactions, purpura, allergic purpura, itching. From the urinary system: often - fluid retention, edema and arterial hypertension; very rarely - acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. Other: rarely - edema. * The frequency reflects the data of long-term therapy using the drug at a high dose (150 mg / day). Clinical studies and data from epidemiological studies indicate that the use of diclofenac increases the risk of thrombotic complications (for example, myocardial infarction or stroke), especially with prolonged use or at high doses (150 mg / day). Visual disturbances Impaired vision, blurred vision, or double vision are common side effects of the NSAID class and are usually reversible upon discontinuation. A possible mechanism of occurrence is inhibition of the synthesis of prostaglandins and other compounds that disrupt the regulation of retinal blood flow, causing possible visual disturbances. If such disorders occur during treatment with diclofenac, an ophthalmological examination should be performed to exclude other possible causes of their occurrence. If severe side effects occur, diclofenac should be discontinued. Storage conditions The drug should be stored in its original packaging in order to protect it from moisture, out of the reach of children at a temperature not exceeding 30°C. Buy Naklofen Duo long-acting capsules 75mg No. 10x2 Price for Naklofen Duo long-acting capsules 75mg No. 10x2