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

Excipients: Copovidone 19.20 mg, salted [microcrystalline cellulose 98%, colloidal dioxide 2% silicon dioxide] 226.00 mg,silicon dioxide colloidal anhydrous 6.40 mg, croscarmellose sodium 32.00 mg, magnesium stearate 8.00 mg, talc 6.40 mg; Sheath: opadrai II pink 57U34579 15.00 mg; opadrai fx silver 62W28547 7.00 mg.

Shell composition:

Opaprai II pink 57U34579

(E 464) 4,650 mg, indigo carmine dye (E 132) 0.003 mg, dye sunset yellow (E 110) 0.018 mg, reddish pencil [Ponso 4R] (E 124) 0.050 mg, maltodextrin 0.750 mg, polydextrose (E 1200) 3.900 mg, talc (E 553b) 1.050 mg, titanium

3,980 mg, triglycerides 0,600 mg);

Drop fx silver 62W28547

(dextrose monohydrate 1,064 mg, carmellose sodium (E466) 3.395 mg, soy lecithin (E 322) 0.525 mg, maltodextrin 1.316 mg, pigment based on titanium mica (potassium aluminosilicate, titanium dioxide) E 555 / E 171) 0.700 mg.

Description:Oblong, biconvex tablets covered with a film coating of light pink color with a silvery tinge, with a risk on one side. The core is white.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylpropionic acid. The anti-inflammatory effect of ibuprofen is due to inhibition of synthesis and / or release of prostaglandins.

Ibuprofen reduces inflammatory pain, swelling and fever. In patients with primary dysmenorrhea ibuprofen reduces the increased content of prostaglandins in the menstrual fluid, reduces intrauterine pressure and the frequency of uterine contractions.

Like all NSAIDs, ibuprofen exhibits antiaggregant activity.

Pharmacokinetics:

-suction: ibuprofen quickly absorbed after ingestion, especially in the form of ibuprofen lysinate. The maximum concentration in the blood is reached after 0.5 hours. It is absorbed quickly enough when taken on an empty stomach.

-distribution: ibuprofen quickly distributed in the body; as well as other drugs of his group, to a large extent (90-99%) binds to plasma proteins.

-metabolism: ibuprofen Rapidly metabolized to inactive metabolites (about 90% of the dose taken).

-excretion: is excreted by the kidneys, while more than 90% of the dose is excreted within 24 hours in the form of metabolites or their conjugates, and about 10% in unchanged form. To a lesser degree is excreted with bile. Because of rapid metabolism ibuprofen does not accumulate even with prolonged use.The half-life of ibuprofen from the plasma is about 2 hours and does not change significantly with increasing doses.

The isozyme CYP2C9 is involved in the metabolism of the drug.

Indications:

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

- Primary algodismenorea.

- Symptomatic therapy of inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, psoriatic arthritis).

- Moderate pain syndrome of various etiologies (headache, migraine, toothache, neuralgia, myalgia, postoperative pain, post traumatic pains (soft tissue injuries, sprains).

- Feverish conditions with "colds" and infectious diseases.

Contraindications:

- Hypersensitivity to the active substance or ancillary components;

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

- erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;

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

- hemophilia and other disorders of blood coagulability;

Decompensated heart failure;

- severe hepatic impairment or any active liver disease;

- glucose-galactose malabsorption;

- severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia;

- period after aortocoronary shunting;

- pregnancy III trimester;

- Children under 12 years old.

Carefully:

Bronchoobstruction, bronchospasm in the anamnesis (there is an increased risk of bronchospasm), allergies.

Ischemic heart disease, cerebrovascular disease, chronic heart failure, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, smoking, creatinine clearance 30-60 ml / min. Peptic ulcer of stomach and duodenum (in the anamnesis), gastritis, enteritis, colitis, hepatic and / or renal failure.

The presence of Helicobacter pylori infection, old age, prolonged use of NSAIDs, frequent alcohol consumption, severe physical illness, concomitant therapy with the following drugs:

- anticoagulants (for example, warfarin),

antiplatelet agents (eg, ASA, clopidogrel),

- oral glucocorticosteroids (for example, prednisolone),

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

Pregnancy I-II trimester, the period of breastfeeding.

Dosing and Administration:

Ibuprofen is prescribed for adults and children over 12 years inside, in tablets of 200 mg 3-4 times a day. Tablets should be swallowed whole, washed down with water, preferably during or after meals (the morning dose taken before meals, washed down with sufficient water (for a faster absorption of the drug), the rest of the dose taken during the day after eating). Patients with diseases of the gastrointestinal tract (gastrointestinal tract) (peptic ulcer and 12 duodenal ulcer (in the anamnesis), gastritis, enteritis, colitis) it is recommended to take tablets with food. Adults: 1-2 tablets 3-4 times a day; if necessary (with rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, psoriatic arthritis,soft tissue injuries, sprains) - 1 tablet every 4 hours. Do not take more than 4 hours. When the therapeutic effect is achieved, the daily dose of the drug is reduced to 600-800 mg.

With algodismenorea - 2 tablets 3 times a day (to achieve a rapid therapeutic effect). The interval between the two methods should be 4-6 hours. When used at regular time intervals, fluctuations in the intensity of pain are avoided.

The maximum daily intake for adults should not exceed 1200 mg (not more than 6 tablets in 24 hours). Do not exceed the indicated dose!

If the pain does not stop after 3 days of use, it is necessary to consult a doctor. The duration of the drug without a doctor's consultation is no more than 5 days.

Children over 12 years of age: 1 tablet 3 times a day. The maximum daily dose for children over 12 years of age should not exceed 1000 mg (not more than 5 tablets within 24 hours). Do not exceed the indicated dose! The interval between taking the tablets is at least 6 hours. The drug should be used only after consulting a doctor.

Side effects:

From the digestive system: NSAIDs-gastropathy (nausea,vomiting, abdominal pain, heartburn, decreased appetite, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the gastrointestinal mucosa (in some cases complicated by perforation and bleeding), exacerbation of ulcerative colitis and Crohn's disease; irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the sense organs: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis), scotoma.

From the nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

From the cardiovascular system: development or aggravation of heart failure, tachycardia, increased blood pressure (BP).

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis. Allergic reactions: skin rash (usually erythematous urticaria), skin itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, exacerbation of asthma, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell), eosinophilia, allergic rhinitis.

From the hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Other: increased sweating.

Overdose:

Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only for an hour after ingestion), reception of activated charcoal, alkaline drink, forced diuresis,symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action. Reduces the hypotensive activity of vasodilators (including b locators of slow calcium channels and angiotensin-converting enzyme inhibitors), natriuretic and diuretic - furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric medicines, increases the effect of indirect anticoagulants (warfarin), antiplatelet agents, fibrinolytics (increased risk of hemorrhagic complications), ulcerogenic effects with bleeding mineralocorticosteroids and glucocorticosteroids, colchicine, estrogens, ethanol; enhances the effect of oral hypoglycemic drugs and insulin.

Antacids and colestramine reduce the absorption of ibuprofen.

Increases the concentration in the blood of digoxin, lithium and methotrexate.

Caffeine increases the analgesic effect.

With simultaneous application ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (ASA) (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of ASA as an antiplatelet agent after taking ibuprofen). NSAIDs, ASA (only at a dose above 75 mg per day), increase the risk of gastrointestinal bleeding.

When prescribed with anticoagulant and thrombolytic drugs (AL) (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time.

Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

LS, blocking tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.

Special instructions:

Gastrointestinal bleeding, ulcers and perforations can appear at any time of NSAID treatment, with or without warning symptoms and without taking into account previous history. In this case, the drug should be discontinued immediately.

When symptoms of NSAID-gastropathy appear, careful monitoring, including esophagogastroduodenoscopy, a blood test with determination

hemoglobin, hematocrit, fecal occult blood test.

To prevent the development of NSAIDs, gastropathy is recommended to be combined with preparations of prostaglandin E (misoprostol).

Serious skin reactions are very rare, but they can include exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. In case of skin rash, damage to the mucous membrane or other symptoms of hypersensitivity, the drug should be discontinued immediately.

If there is a visual impairment during the treatment with ibuprofen, stop taking the drug.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

During the period of treatment, ethanol is not recommended.

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.

During treatment, it is necessary to monitor the functional state of the liver and kidneys.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated 200 mg.

Packaging:

Primary packaging. 10 tablets per blister are perforated from aluminum foil and PVC film.

Secondary packaging. 1 blister together with instructions for use in a pack of cardboard.

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

Shelf life:3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000195

Date of registration:07.02.2011

Expiration Date:07.02.2016

The owner of the registration certificate:Alkaloid, JSCAlkaloid, JSC Macedonia

Manufacturer: & nbsp

ALKALOID, AD Macedonia

Representation: & nbspALKALOID, AOALKALOID, AO

Information update date: & nbsp19.03.2017

Illustrated instructions

Instructions

Deblock (Deblok)