NAKLOFEN WP PILLS PROLONGED 100MG

Dosage form

Coated tablets

Composition

1 pill of film coated contains: Diclofenac sodium 100 mg

Auxiliary substances: Sucrose, cetyl alcohol, povidone, colloidal silicon dioxide, anhydrous, Magnesium stearate

Shell: Hypromellose, iron dye red oxide (E172), titanium dioxide, macrogol 6000, polysorbate 80, talc

Packing

In the blister of 10 tablets. In carton pack 2 blisters.

Mechanism of action

Naklofen CP is a non-steroidal anti-inflammatory drug that has an analgesic, anti-inflammatory and antipyretic effect.

The main mechanism of its action and the associated side effects are the indiscriminate inhibition of the activity of the cyclooxygenase 1 and 2 enzyme (COX 1 and COX 2), which leads to disruption of arachidonic acid metabolism, reduced synthesis of prostaglandins, prostacyclin and thromboxane. Synthesis of prostaglandins in the kidneys, gastric mucosa and synovial fluid is reduced.

Most effective for inflammatory pain. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac significantly reduces the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. With injuries in the postoperative period, diclofenac reduces pain and inflammatory edema. Like all nonsteroidal anti-inflammatory drugs (NSAIDs), diclofenac has antiplatelet activity.

At therapeutic doses, diclofenac has virtually no effect on bleeding time.

With long-term treatment, the analgesic effect of diclofenac is not reduced.

Indications and usage

Inflammatory and degenerative diseases of the musculoskeletal system:
- Rheumatoid arthritis.
- Psoriatic arthritis.
- Juvenile chronic arthritis.
- Ankylosing spondylitis (ankylosing spondylitis).
- Gouty arthritis (with an acute attack, it is preferable to use fast-acting dosage forms).
- Arthritis in Reiter’s disease.
- Rheumatic soft tissue damage.
- Osteoarthritis of the peripheral joints and spine, including those with:
- Radicular syndrome.

- Neuralgia.
- Mialgia.
- Lumboishialgia.
- Post-traumatic pain syndrome, accompanied by inflammation.
- Postoperative pain.
- Headache.
- Migraine (in an acute attack, it is preferable to use fast-acting dosage forms).
- Algodismenorrhea.
- Adnexitis.
- Proctitis.
- Toothache.
- Renal and biliary colic.

- Pharyngitis.
- Tonsillitis.
- Otitis.

Contraindications

- Hypersensitivity (including to other NSAIDs), complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa and paranasal sinuses and intolerance to Acetylsalicylic acid or other NSAIDs (including in history).
- The period after coronary artery bypass surgery.
- Erosive and ulcerative changes of the mucous membrane of the stomach or duodenum 12, active Gastrointestinal bleeding.
- Inflammatory bowel disease (including ulcerative colitis (UC), Crohn's disease) in the acute phase.
- Cerebrovascular bleeding or other bleeding and impaired hemostasis.
- Severe liver failure or active liver disease.
- Severe renal failure (CC less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease.
- Decompensated heart failure.
- Inhibition of bone marrow hematopoiesis.
- III trimester of pregnancy, breastfeeding period.
- Children's age (up to 18 years).

With caution:

- Coronary heart disease.
- Cerebrovascular diseases.
- Dyslipidemia / hyperlipidemia.
- Diabetes.
- Diseases of peripheral arteries.
- Smoking.
- Creatinine clearance 30-60 ml / min.
- Anamnestic data on the development of ulcerative lesions of the gastrointestinal tract.
- The presence of Helicobacter pylori infection.
- Prolonged use of NSAIDs.
- Frequent alcohol use.
- Severe somatic diseases.
- Induced porphyria.
- Epilepsy.
- Diverticulitis.
- Systemic diseases of the connective tissue.
- A significant reduction in circulating blood volume (BCC) (including after extensive surgical intervention).
- Elderly patients (including receiving diuretics, weakened patients and with low body mass).
- Pregnancy (I-II trimester).
- Concomitant therapy with the following drugs:
- Anticoagulants (for example, warfarin).
- Antiplatelet agents (for example, acetylsalicylic acid, clopidogrel).
- Oral glucocorticosteroids (for example, prednisone).
- Selective serotonin reuptake inhibitors (for example, citalopram, Fluoxetine, paroxetine, sertraline).

Pregnancy and Breastfeeding

The use of diclofenac in pregnant women is possible only when the expected benefit outweighs the potential risk to the fetus.

Diclofenac is not recommended for use during the last trimester of pregnancy.

Despite the fact that diclofenac is found in breast milk in small quantities, its use during breastfeeding is not recommended.

Dosage and administration

Inside, the pills should be swallowed whole, not chewed, squeezed with a sufficient amount of water during or after a meal.

Naklofen CP, long-acting tablets, 100 mg should be used for long-term therapy.

Adults initial and maintenance doses are 1 pill per day. If necessary, increase the dose to 150 mg per day. Naklofen CP should be combined with 50 mg Naklofen pills or suppositories.

Adverse reactions

On the part of the digestive system: Often - epigastric pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases. Rarely - gastritis, proctitis, bleeding from the gastrointestinal tract (GIT) (vomiting blood, melena, diarrhea mixed with blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, impaired liver function. Very rarely - stomatitis, glossitis, dry mucous membranes (including the mouth), erosive and ulcerative lesions of the esophagus, diaphragm-like strictures of the intestine, nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis, fulminant hepatitis.

On the part of the nervous system: Often - headache, dizziness. Rarely - drowsiness. Very rarely - a violation of sensitivity, incl. paresthesias, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmares, irritability, mental disorders.

From the senses: Often - vertigo. Very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, taste impairment.

On the part of the urinary system: Very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

From the side of blood-forming organs: Very rarely - thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis.

Anaphylactic / anaphylactoid reactions, including marked reduction in blood pressure (BP) and shock: Very rarely - angioedema (including faces).

Cardiovascular: Very rarely - heartbeat, beats, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.

On the part of the respiratory system: Rarely - cough, bronchial asthma (including shortness of breath). Very rarely - pneumonitis, laryngeal edema.

On the part of the skin: Often - skin rash. Rarely - urticaria. Very rarely - bullous eruptions, erythema, incl. multiforme and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, pruritus, hair loss, photosensitization, purpura, incl. allergic.

Special notes

To reduce the risk of developing adverse effects on the gastrointestinal tract, a minimum effective dose of the shortest possible course should be used.

With caution should use the drug for ulcerative colitis and Crohn's disease due to possible exacerbation of the disease.

With prolonged use of diclofenac, it is possible, although in rare cases, the development of serious hepatotoxic reactions, and therefore, it is recommended to regularly examine the function of the liver. Due to the important role of prostaglandins in maintaining renal blood flow, special care should be taken when prescribing the drug to patients with cardiac or renal failure, as well as in the treatment of elderly people taking diuretics and patients who for some reason have a decrease in circulating blood volume after major surgery). If diclofenac is prescribed in such cases, it is recommended to monitor kidney function as a precautionary measure.

Precautions should be prescribed diclofenac in patients with severe renal or hepatic insufficiency, heart failure, coagulation disorders, porphyria, epilepsy, as well as in patients receiving anticoagulants or fibrinolytics. When conducting long-term therapy, it is necessary to monitor the picture of peripheral blood, to analyze the feces for occult blood.

Due to the negative effect on fertility, the drug is not recommended for women who want to become pregnant.In patients with infertility (including those undergoing examination), it is recommended to cancel the drug.

Patients taking the drug should refrain from drinking alcohol. In infectious diseases, the anti-inflammatory and antipyretic effects of diclofenac sodium can mask the symptoms of these diseases.

The amount of sucrose contained in the preparation does not affect patients with the following conditions: enzyme lactase deficiency, galactosemia and glucose / galactose impaired absorption syndrome.

Influence on the ability to drive a car or other mechanical means: During the period of treatment, the rate of mental and motor reactions may decrease, therefore it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Increases plasma concentration of Digoxin, Methotrexate, lithium and cyclosporine drugs.

Reduces the effect of diuretics, against the background of potassium-saving diuretics increases the risk of developing hyperkalemia, against the background of anticoagulants, antiplatelet and thrombolytic drugs (alteplase, streptokinase, urokinase) increases the risk of bleeding (often the gastrointestinal tract).

Reduces the effect of antihypertensives and hypnotic drugs.

Increases the likelihood of side effects of other NSAIDs and glucocorticosteroids (bleeding from the gastrointestinal tract), the toxicity of methotrexate and cyclosporine nephrotoxicity.

Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Simultaneous use with Paracetamol increases the risk of the development of the nephrotoxic effects of diclofenac.

Reduces the effect of hypoglycemic drugs.

Cefamundol, cefoperazone, cefotetan, valproic acid and plykamycin increase the incidence of hypoprothrombinemia.

Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity. Selective serotonin reuptake inhibitors increase the risk of bleeding from the gastrointestinal tract.

The simultaneous appointment with ethanol, colchicine, corticotropin and preparations of Hypericum perforatum increases the risk of bleeding in the gastrointestinal tract.

Drugs that cause photosensitization, increase the sensitizing effect of diclofenac to ultraviolet irradiation.

Drugs that block tubular secretion, increase plasma concentration of diclofenac, thereby increasing its toxicity.

Anti-bacterial drugs from the quinolone group - the risk of seizures.

Symptoms: vomiting, nausea, abdominal pain, gastrointestinal bleeding, diarrhea, headache, dizziness, tinnitus, increased excitability, hyperventilation with increased convulsive readiness, convulsions, with a significant overdose - acute renal failure, hepatotoxic action.
Treatment: gastric lavage, Activated carbon, symptomatic therapy aimed at eliminating increased blood pressure, impaired renal function, seizures, gastrointestinal irritation, respiratory depression. Forced diuresis, hemodialysis are ineffective (significant connection with proteins and intensive metabolism).

Store at a temperature not higher than 25 ° С.

5 years.

Naklofen Wed