Universal reference book for medicines
Product name: NAKLOFEN DUO (NAKLOFEN DUO)

Active substance: diclofenac

Type: NSAIDs

Manufacturer: KRKA (Slovenia)
Composition, form of production and packaging
Capsules with a modified release
with a white body and a blue lid;
contents of capsules - pellets from white to yellowish color.
1 caps.

diclofenac sodium 75 mg,

in t.ch.
diclofenac sodium (in enteric-soluble pellets) 25 mg
diclofenac sodium (in pellets with sustained release) 50 mg

Auxiliary substances: enteric-soluble pellets - sugar spheres (sugar content not more than 92%), giprolose (hydroxypropylcellulose), hypromellose, magnesium carbonate heavy, methacrylic acid-ethyl acrylate copolymer (1: 1) 30% dispersion, triethyl citrate, talc, titanium dioxide, sodium carboxymethylcellulose, macrogol, sodium hydroxide;
pellets with prolonged release - sugar spheres (sugar content not more than 92%), ammonium methacrylate copolymer (type A), ammonium methacrylate copolymer (type B), giprolose (hydroxypropyl cellulose), triethyl citrate, talc.
The contents of the contents of the capsule: enteric-soluble pellets, pellets with prolonged release, talc *.

The composition of the capsule body: gelatin (EP), titanium dioxide (E171).

Composition of capsule capsule: gelatin (EP), titanium dioxide (E171), indigo carmine dye FD & C Blue 2 (E132).

10 pieces.
- blisters (2) - packs of cardboard.
* 0.2% of talc is mixed with pellets before filling the capsules;
talc prevents the appearance of electrostatic charge of pellets during the filling of capsules.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

NSAIDs that have analgesic, anti-inflammatory and antipyretic effects.
The main mechanism of its action and the associated side effects are indiscriminate inhibition of the activity of COX-1 and COX-2, which leads to a disruption of the metabolism of arachidonic acid, a decrease in the synthesis of prostaglandins, prostacyclin and thromboxane. The level of various prostaglandins in urine, gastric mucosa and synovial fluid.
The 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. In injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.
Like all NSAIDs, diclofenac has antiaggregant activity.
In therapeutic doses, diclofenac sodium has virtually no effect on bleeding time. With prolonged treatment, the analgesic effect of diclofenac sodium does not decrease.
PHARMACOKINETICS

Suction

Absorption is fast and complete.
Diclofenac is contained in capsules of Naklofen Duo in the form of enteric-soluble pellets and pellets with prolonged release, so Naklofen Duo capsules have an immediate and prolonged effect. C max in plasma is noted 30-60 min after administration. The therapeutic concentration is maintained twice as long as when using tablets coated with an enteric film coating. The concentration in the plasma is linear depending on the amount of the dose taken. Changes in the pharmacokinetics of diclofenac against the background of repeated administration are not noted. Do not cumulate while observing the recommended interval between meals.
Distribution

Bioavailability - 50%.
The connection with plasma proteins is more than 99% (most of it is associated with albumins). Penetrates into the synovial fluid. C max in synovial fluid is observed 2-4 hours later than in plasma. Diclofenac is more slowly excreted from the synovial fluid than from the plasma.
V d - 550 ml / kg.
Diclofenac penetrates into breast milk.
Metabolism and excretion

50% of the active substance is metabolized during the "first pass" through the liver.
Metabolism occurs as a result of multiple or one-time hydroxylation and conjugation with glucuronic acid. The enzymes of cytochrome P450 are involved in the metabolism of the drug. The pharmacological activity of metabolites is lower than that of diclofenac.
Systemic clearance is 260 ml / min, T 1/2 - 2 hours. About 70% of the administered dose is excreted as pharmacologically inactive metabolites by the kidneys;
less than 1% is unchanged, the rest of the dose is excreted as metabolites with bile.
Pharmacokinetics in special clinical cases

In patients with severe renal failure (CC less than 10 ml / min), excretion of metabolites with bile is increased, while there is no increase in their concentration in the blood.

In patients with chronic hepatitis or compensated cirrhosis of the liver, as well as elderly patients, the pharmacokinetic parameters of diclofenac do not change.

INDICATIONS

- inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease), gouty arthritis, arthritis in Reiter's disease, rheumatic soft tissue damage, osteoarthritis of peripheral joints and spine, including with radicular syndrome, tendovaginitis, periarthritis, bursitis, myositis, synovitis);

- pain syndrome of mild or moderate severity (neuralgia, myalgia, lumboeishalgia, posttraumatic pain syndrome, accompanied by inflammation, postoperative pain, headache, migraine, algodismenorea, adnexitis, proctitis, toothache, renal and biliary colic);

- in the complex therapy of infectious and inflammatory diseases of the ENT organs with severe pain syndrome (pharyngitis, tonsillitis, otitis);

febrile syndrome.

The drug is intended for symptomatic therapy and does not affect the progression of the disease.

DOSING MODE

The drug is taken orally.
The capsule should be swallowed whole, with water at the end or after meals, usually in the morning.
Assigned individually, taking into account the severity of the disease.
Adults usually appoint 75 mg (1 caps.) 1-2 times / day. The maximum daily dose is 150 mg.
SIDE EFFECT

Often - 1-10%;
sometimes - 0.1-1%; rarely - 0.01-0.1%; very rarely - less than 0.01%, including individual cases.
On the part of the digestive system: often - epigastric pain, abdominal cramps, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased activity of aminotransferases;
rarely - gastritis, bleeding from the gastrointestinal tract (vomiting with blood, melena, diarrhea with a trace of blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, impaired liver function; very rarely - stomatitis, glossitis, dryness of the mucous membranes (including the mouth), damage to the esophagus, diaphragm-like intestinal strictures (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis.
From the nervous system: often - headache, dizziness;
rarely - drowsiness; very rarely - a violation of sensitivity, incl. paresthesia, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmares, irritability, agitation, mental disorders.
From the senses: often - vertigo;
very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, a violation of taste sensations.
From the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis, edema.

On the part of the organs of hematopoiesis: very rarely - thrombocytopenia, leukopenia, eosinophilia, hemolytic and aplastic anemia, agranulocytosis.

Allergic reactions: anaphylactic / anaphylactoid reactions, including a marked decrease in blood pressure and shock;
very rarely - angioedema (including face). The drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions.
From the cardiovascular system: very rarely - palpitations, tachycardia, extrasystole, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.

On the part of the respiratory system: rarely - cough, bronchial asthma (including dyspnea);
very rarely - pneumonitis, laryngeal edema.
Dermatological reactions: often - skin rash;
rarely - hives; very rarely - bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome, exfoliative dermatitis, skin itching, hair loss, photosensitivity, purpura, incl. allergic.
CONTRAINDICATIONS

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including in anamnesis);

- period after aortocoronary shunting;

- erosive and ulcerative changes in the mucosa of the stomach or duodenum, active gastrointestinal bleeding;

- Inflammatory bowel disease in the phase of exacerbation (NNC, Crohn's disease);

- cerebrovascular bleeding or other bleeding and hemostasis disorders;

- severe hepatic impairment or active liver disease;

- marked renal failure (QC less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease;

Decompensated heart failure;

- oppression of bone marrow hematopoiesis;

- III trimester of pregnancy;

- the period of lactation (breastfeeding);

- Children's age (up to 18 years);

hypersensitivity to diclofenac.

With caution should prescribe the drug in IHD, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, smoking, CC less than 60 ml / min, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of infection caused by Helicobacter pylori with prolonged use of NSAIDs , frequent use of alcohol, severe somatic diseases, induced porphyria, epilepsy, diverticulitis, systemic connective tissue diseases, a significant decrease in BCC (including after massaging
about surgical intervention), patients of advanced age (appointed in lower doses), incl. (for example, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticoids (eg, prednisolone), antipsychotic drugs (eg, prednisolone), diuretics, weakened patients and patients with low body weight, in the first and second trimesters of pregnancy, with concomitant therapy selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).
PREGNANCY AND LACTATION

The use of diclofenac in pregnancy is possible only when the expected benefit exceeds 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 amounts, its use during breast-feeding is not recommended.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: marked renal failure (QC less than 30 ml / min), including confirmed hyperkalemia, progressive kidney disease.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindication: severe hepatic impairment or active liver disease.

APPLICATION FOR CHILDREN

Contraindicated in childhood (under 18 years).

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients (prescribed in lower doses).

SPECIAL INSTRUCTIONS

In order to quickly achieve the desired therapeutic effect, take the drug 30 minutes before meals.
In other cases, take before, during or after a meal wholly, with plenty of water.
To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used as little as possible.

Caution should be used for ulcerative colitis and Crohn's disease because of 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 prostaglandins in maintaining renal blood flow, care should be taken when administering the drug to patients with cardiac or renal insufficiency, as well as in the treatment of elderly people taking diuretics and patients who for some reason have a reduced BCC (for example, after major surgical intervention).
If diclofenac is prescribed in such cases, it is recommended to monitor kidney function as a precautionary measure.
Caution should be given to diclofenac patients with blood clotting disorders, porphyria, epilepsy, as well as patients receiving anticoagulants or fibrinolytics.

When carrying out long-term therapy, it is necessary to monitor the picture of peripheral blood, to conduct a fecal occult blood test.

In connection with the negative effect on fertility, women who want to become pregnant, the drug is not recommended.
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: lactase enzyme deficiency, galactosemia, and glucose / galactose uptake syndrome.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, it is possible to reduce the speed of mental and motor reactions, so it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: vomiting, nausea, abdominal pain, bleeding from the gastrointestinal tract, diarrhea, headache, dizziness, tinnitus, increased excitability, hyperventilation with increased convulsive readiness, convulsions, with a significant overdose - acute renal failure, hepatotoxic effect.

Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating blood pressure increase, renal dysfunction, seizures, gastrointestinal irritation, respiratory depression.
Forced diuresis, hemodialysis are ineffective (significant association with proteins and intensive metabolism).
DRUG INTERACTION

With simultaneous use of diclofenac increases the concentration in the plasma digoxin, methotrexate, lithium and cyclosporine.

Diclofenac reduces the effect of diuretics, against the background of potassium-sparing diuretics, the risk of hyperkalemia increases.

When taking diclofenac against the background of anticoagulants, antiaggregant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases (more often from the gastrointestinal tract).

With simultaneous use of diclofenac reduces the effect of hypotensive and hypnotic drugs.

Diclofenac increases the likelihood of side effects of other NSAIDs
and GCS (bleeding from the gastrointestinal tract), toxicity of methotrexate and nephrotoxicity of cyclosporine.
Acetylsalicylic acid reduces the concentration of diclofenac in the blood.
Simultaneous use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.
When taking hypoglycemic medications with diclofenac, hypo- or hyperglycemia may occur.
With this combination of funds, blood sugar levels need to be monitored;
Cefamandol, cefoperazone, cefotetan, valproic acid and plikamycin with simultaneous application with diclofenac increase the frequency of hypoprothrombinemia.

Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.

Selective serotonin reuptake inhibitors increase the risk of bleeding from the gastrointestinal tract against the background of simultaneous use of diclofenac.

Simultaneous administration of diclofenac with ethanol, colchicine, corticotropin and preparations of St. John's wort increases the risk of bleeding in the gastrointestinal tract.

Medicines that cause photosensitivity, increase the sensitizing effect of diclofenac to ultraviolet radiation.

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

With the simultaneous administration of diclofenac antibacterial drugs from the quinolone group, there is a risk of seizures.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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