Instructions for use NAKLOFEN DUO
Are common
Side effects of the drug can be minimized by using the lowest effective dose for the shortest period necessary to control (relieve) symptoms.
Naklofen duo should be prescribed with caution to elderly patients. In particular, for the treatment of elderly debilitated patients or individuals with low body weight, the lowest effective dose is recommended.
When taking diclofenac, like other NSAIDs, in patients who have not previously taken the drug, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur in rare cases.
Masking the infection
Due to its anti-inflammatory and antipyretic effects, diclofenac sodium can mask the 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.
Effect on the gastrointestinal tract
When taking NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration or perforation, sometimes fatal, is possible, which can occur at any time during treatment against the background of warning symptoms, or in the absence of them, or in patients with a history of serious gastrointestinal diseases . Typically, such events have more serious consequences in older patients. If an ulcer or gastrointestinal bleeding occurs, the drug should be discontinued.
When conducting therapy with NSAIDs, including diclofenac, it is necessary to exercise medical supervision, especially caution should be exercised when prescribing diclofenac to patients with symptoms indicative of gastrointestinal disorders, persons with a history of gastric or intestinal ulcers, bleeding or perforation.
The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses of NSAIDs, especially in patients with a history of ulcers complicated by bleeding or perforation. Elderly patients have a higher incidence of adverse reactions associated with NSAIDs, in particular gastrointestinal bleeding and perforation.
To reduce the risk of toxic effects on the gastrointestinal tract, patients with a history of peptic ulcer, in particular, complicated by bleeding or perforation, as well as elderly patients, treatment should begin with the lowest effective dose of the drug and continue to do so.
In such patients, as well as in those who require concomitant use of drugs containing low doses of acetylsalicylic acid, or other drugs that increase the risk of developing adverse reactions from the gastrointestinal tract, 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 physician, particularly during the initial phase of treatment. Caution should be exercised in patients concomitantly taking medications 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 may worsen.
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, an increase in the activity of one or more liver enzymes may be observed. With long-term use of diclofenac, regular liver function testing is indicated as a precaution. If abnormalities in liver function parameters persist or worsen, clinical signs or symptoms characteristic of liver disease appear, and if other side effects occur (for example, eosinophilia, rash), diclofenac should be discontinued immediately. It should be borne in mind that hepatitis when taking diclofenac can occur without previous symptoms.
Caution should be exercised when prescribing the drug to patients with hepatic porphyria, because the drug may cause an exacerbation of the disease.
Effect on kidney function
Cases of fluid retention and edema have been reported when taking NSAIDs, including diclofenac. Particular caution should be exercised in patients with impaired cardiac or renal function, in patients with a history of arterial hypertension, when prescribed to elderly patients, in patients receiving concomitant therapy in the form of diuretics or drugs that may significantly affect renal function, as well as in patients who experience a significant decrease in circulating plasma volume of any etiology, for example, before or after major surgery. In such cases, when diclofenac is prescribed, regular monitoring of renal function is recommended as a precaution. Discontinuation of the drug usually results in restoration of renal function to baseline levels.
Effect 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 a history of mild or moderate congestive heart failure require medical supervision.
Clinical trial and epidemiological data suggest that the use of diclofenac sodium, particularly at high doses (150 mg/day) and over long periods of time, may be associated with an increased risk of cardiovascular thrombotic events (eg, heart attack). myocardium or stroke).
Particular caution should be exercised when prescribing the drug to patients at risk (for example, persons with arterial hypertension, hyperlipidemia, diabetes mellitus, smokers).
Since the risk of 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 re-evaluated.
Effect on skin and subcutaneous tissue
In very rare cases, serious skin reactions, some fatal, have been reported with the use of NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Patients are at greatest risk when starting therapy:
- in most cases, the observed adverse reactions occurred in the first month of treatment. When the first signs of rashes on the skin and mucous membranes, as well as other symptoms of hypersensitivity, appear, treatment should be stopped.
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 complete blood count.
Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Strict medical monitoring is recommended for patients with impaired hemostasis.
History of asthma
Patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (eg, nasal polyps), COPD, or chronic respiratory tract infections (especially those associated with allergic rhinitis or having similar symptoms) are more likely than others to experience asthma exacerbations (so called analgesic intolerance), angioedema 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 (emergency preparedness).
Special information about some components of the drug
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.
Impact on the ability to drive vehicles and operate machinery
Naklofen duo has a weak or moderate effect on the ability to drive vehicles or operate other machinery.
Patients who experience blurred vision, vertigo, drowsiness and/or other undesirable effects from the central nervous system while taking the drug should refrain from driving or operating other technical devices that require increased concentration and speed of psychomotor reactions.
Naklofen Duo, 20 pcs., 75 mg, modified release capsules
In order to quickly achieve the desired therapeutic effect, take the drug 30 minutes before meals. In other cases, take before, during or after meals as a whole, with a sufficient amount of water.
To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.
The drug should be used with caution for ulcerative colitis and Crohn's disease due to a possible exacerbation of the disease.
With long-term use of diclofenac, it is possible, although in rare cases, to develop serious hepatotoxic reactions, and therefore it is recommended to regularly examine liver function.
Because of the important role of PG in maintaining renal blood flow, special caution should be exercised when prescribing the drug to patients with heart or renal failure, as well as when treating elderly people taking diuretics, and patients who, for any reason, have a decrease in blood volume (for example after major surgery). If diclofenac is prescribed in such cases, it is recommended that renal function be monitored as a precaution.
Diclofenac should be prescribed with caution in patients with bleeding disorders, porphyria, epilepsy, as well as in patients receiving anticoagulants or fibrinolytics.
When carrying out long-term therapy, it is necessary to monitor the peripheral blood picture and conduct a stool test for occult blood.
Due to the negative effect on fertility, the drug is not recommended for women wishing to become pregnant. In patients with infertility (including those undergoing examination), it is recommended to discontinue the drug.
Patients taking the drug must refrain from drinking alcohol.
In infectious diseases, the anti-inflammatory and antipyretic effects of diclofenac sodium may mask the symptoms of these diseases.
The amount of sucrose contained in the drug does not affect patients with the following conditions: lactase enzyme deficiency, galactosemia and glucose/galactose malabsorption syndrome.
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions.
During the treatment period, the speed of mental and motor reactions may decrease, so it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
