Nobedolak - instructions for use, dose, side effects, contraindications

Active substanceEto-dolacEto-dolac

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Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey

Dosage form: & nbspfilm-coated tablets

Composition:

one tablet contains active substance etodolac DC (98%) (contains 96.0 - 99.5 % etodolaka (in terms of anhydrous substance) and 0.5 - 4.0 % povidone K30) in terms of etodolac 400 mg;

Excipients: lactose anhydrous 146,50 mg, microcrystalline cellulose M 102 245.00 mg, croscarmellose sodium 34.50 mg, silicon dioxide colloidal anhydrous (Aerosil 200) 2.0 mg, povidone K30 16.00 mg, magnesium stearate 13.00 mg ;

film sheath: Opaprai pink OY-34948: hypromellose 2910 25,6984 mg, macrogol 400 2,5816 mg, iron stain red oxide E 172 0.16 mg, titanium dioxide 11.56 mg.

Description:oblong biconvex, film-coated pills of light pink color, with a risk on one side and with engraving NOBEL another. The core on the cross section is white or almost white.

Pharmacotherapeutic group:nonsteroidal anti-inflammatory drug.

ATX: & nbsp

M.01.A.B.08 Eto-dolac

Pharmacodynamics:

It is a non-steroidal anti-inflammatory drug (NSAID) with an analgesic, anti-inflammatory and antipyretic effect. The drug reduces the synthesis of prostaglandins from arachidonic acid,thereby reducing the sensitivity of receptors to mediators of pain (histamine, bradykinin), exudation, migration of leukocytes, as well as sensitivity of hypothalamic centers of thermoregulation to the action of endogenous pyrogenes decreases.

Pharmacokinetics:

Well absorbed from the gastrointestinal tract, the absolute bioavailability of meloxicam - 80%. Simultaneous food intake does not change the intake. The maximum concentration in plasma is reached after 60 minutes and is 18 μg / ml. The binding with plasma proteins is 95%, the free fraction is 1.2% -4.7%. Half-life is about 7 hours. Eto-dolac metabolized in the liver and excreted mainly by the kidneys (up to 60% in the form of metabolites).

Indications:

- Inflammatory and degenerative diseases of the musculoskeletal system: psoriatic, rheumatoid, gouty arthritis, ankylosing spondylitis (Bechterew's disease), osteoarthritis.

- Pain syndrome: myalgia, ossalgia, arthralgia, headache and toothache, posttraumatic pain syndrome, accompanied by inflammation, algo dysmenorrhea.

- It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.

Contraindications:

- hypersensitivity to the active substance or ancillary components;

- intolerance of acetylsalicylic acid and drugs of pyrazolone series;

- contraindicated in the period after aortocoronary bypass surgery;

- Decompensated heart failure;

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

- erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal hemorrhage;

- inflammatory bowel disease (ulcerative colitis, Crohn's disease);

- rare hereditary diseases (lactose intolerance, lactase deficiency or glucose-galactose malabsorption);

- cerebrovascular bleeding or other bleeding;

- severe hepatic impairment or active liver disease;

- marked renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml / min), progressive kidney disease including. confirmed hyperkalemia;

- pregnancy, the period of breastfeeding;

- children's age till 15 years.

Carefully:

Ischemic heart disease, cerebrovascular diseases, chronic heart failure, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial diseases, smoking, liver failure, CRF (KK 30-60 ml / min). Anamnestic data on the development of gastrointestinal lesions, the presence of infection Helicobacter pylori, old age, prolonged use of NSAIDs, frequent alcohol use, severe physical illness, concomitant therapy with the following drugs:

- anticoagulants (for example, warfarin)

- antiaggregants (eg, acetylsalicylic acid, clopidogrel)

- oral glucocorticosteroids (for example, prednisolone)

- selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline)

- children's age till 18 years.

To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

Dosing and Administration:

Adults and children over 18 years of age: the recommended daily dose of the drug Nobelolak® is 400 - 1200 mg. The maximum daily dose is 1200 mg.The drug is prescribed twice a day: 1 tablet in the morning and evening after eating. If necessary, the dose may be increased to 3 tablets per day.

In patients with a body weight of less than 60 kg, the maximum daily dose of the drug should not exceed 20 mg / kg.

In rheumatic diseases treatment depends on the effectiveness of therapy and the nature of the disease. Given a long course of therapy, the dose should be corrected every 2-3 weeks.

In the treatment of pain conditions due to acute inflammatory processes (such as toothache, myositis, tendinitis), as well as postoperative pain syndromes, the course of treatment is 5 days. For head and menstrual pain, Noubedolac® is prescribed 1 to 2 tablets per day as needed, for no more than 3 days.

Side effects:

From the digestive system: nausea, epigastric pain, diarrhea, bloating, erosion, ulcers, bleeding.

From the skin: itching, rash, multiforme exudative erythema, hyperpigmentation, photosensitization.

From the respiratory system: bronchospasm, rhinitis.

From the nervous system: dizziness, headache, fatigue.

From the cardiovascular system: peripheral edema, increased blood pressure, palpitations, "hot flashes" of blood to the skin of the face.

From the hematopoiesis: increased activity of "hepatic" transaminases, leukopenia, anemia, thrombocytopenia.

From the urinary system: disturbance of water-electrolyte metabolism, hypernatremia, hyperkalemia, increase of serum creatinine, dysuric phenomena.

Allergic reactions: urticaria, Quincke's edema, anaphylactic shock, Lyell's syndrome, allergic interstitial nephritis.

Overdose:

Symptoms: nausea, vomiting, epigastric pain, gastrointestinal bleeding, hypernatremia, hyperkalemia, edema, increased blood pressure, allergic interstitial nephritis, jaundice, hepatitis, bronchospasm.

Treatment: there is no specific antidote; with an overdose of the drug should be washed stomach, taking activated charcoal (within the next hour), symptomatic therapy.

Interaction:

When used simultaneously with other non-steroidal anti-inflammatory drugs (as well as with acetylsalicylic acid)the risk of erosive and ulcerative lesions and bleeding of the gastrointestinal tract increases.

With simultaneous use with antihypertensive drugs, it is possible to reduce the effectiveness of the latter.

With simultaneous use with lithium preparations, development of cumulation of lithium and increase of its toxic effect (it is recommended to control the concentration of lithium in the blood). With simultaneous use with methotrexate, the side effect of the latter on the hematopoietic system is increased (the risk of anemia and leukopenia, periodic monitoring of the general blood test is shown).

With simultaneous use with diuretics and with cyclosporine, the risk of developing kidney failure increases.

When used simultaneously with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin), the risk of bleeding increases (periodic monitoring of blood coagulability indices is necessary).

Special instructions:

Care should be taken when using the drug in patients who have a history of peptic ulcer and duodenal ulcer,who are on anticoagulant therapy. In such patients, the risk of erosive and ulcerative diseases of the gastrointestinal tract is increased. Caution should be exercised and the indicators of renal function should be monitored when the drug is used in elderly patients, patients with chronic heart failure with clinical manifestations, in patients with cirrhosis of the liver, as well as in patients with hypovolemia as a result of surgical interventions.

In patients with renal insufficiency, if the creatinine clearance is more than 30 ml / min, dosage adjustment is not required.

If allergic reactions (itching, skin rash, urticaria, photosensitivity) occur during treatment, it is necessary to stop taking the drug.

Effect on the ability to drive transp. cf. and fur:The use of the drug may cause undesirable effects in the form of headaches and dizziness. It should abandon the management of vehicles and maintenance of machines and mechanisms that require concentration of attention.

Form release / dosage:Film-coated tablets 400 mg.

Packaging:

For 7 or 14 tablets, film-coated in a blister of PVC / Al.

14 tablets, film-coated / 2 blisters / 1 package (7 tablets / 1 blister).

28 tablets, film-coated / 2 blisters / 1 package (14 tablets / 1 blister).

Together with the instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:4 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001013

Date of registration:18.10.2011

The owner of the registration certificate:Nobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey

Manufacturer: & nbsp

NOBEL ILAC SANAYII VE TICARET, A.S. Turkey

Representation: & nbspNobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh.Russia

Information update date: & nbsp07.10.2015

Illustrated instructions

Instructions

Nobedolak® (Nobedolak®)