Ibuprofen-Hemofarm Valium n / 400mg film about 30 pc

Description

Composition
Active substance:
1 coated tablet contains ibuprofen – 400 mg 1 effervescent tablet contains ibuprofen, DL-lizinat- 34 mg (which corresponds to ibuprofen – 200 mg).
Excipients:
1 coated tablet contains microcrystalline cellulose PH 101, sodium carboxymethyl starch, colloidal silicon dioxide, anhydrous, stearic acid; film coating: Methacrylic acid-ethyl acrylate copolymer (1: 1), talc, titanium dioxide, E 171, polysorbate 80. 1 effervescent tablet comprises sodium carbonate, sodium dihydrogen citrate, sodium hydrogen carbonate, povidone K-25, sodium saharinag, aspartame, xylitol, flavor lemon, simethicone emulsion water (Si 1 far SE-4).
Description:
Tablets, film-coated: Round, biconvex tablets, film-coated, white to yellowish white color, with the mark on one side, on the fracture from white to yellowish white
Product form:
Tablets, film-coated, 400 mg.
10 tablets in blister PVC / AL. 3 blisters with instructions for use in a cardboard pack.
Contraindications
Hypersensitivity to ibuprofen or any of the components comprising the drug; complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and the intolerance of acetylsalicylic acid (ASA) and other NSAIDs (including history); erosive and ulcerative diseases of the gastrointestinal (including gastric ulcer and duodenal ulcer, Crohn’s disease, ulcerative colitis) or ulcer bleeding in the active phase or in history (two or more episodes of proven peptic ulcer or ulcer bleeding); bleeding or perforation of ulcers of the gastrointestinal tract history provoked NSAIDs; severe heart failure (class IV according to the classification of New York Heart Association (NYHA)); severe liver failure or liver disease in active phase; severe renal failure severity (creatinine clearance
Dosage
400 mg
Indications
Headache, toothache, migraine, painful menstruation, neuralgia, back pain, joint pain, muscular and rheumatic pain, fever with the flu and colds.
Interaction with other drugs
It should avoid the simultaneous use of ibuprofen with the following drugs:
Acetylsalicylic acid: with the exception of low-dose acetylsalicylic acid (not more than 75 mg per day), prescribed by the doctor, since the combined use may increase the risk of side effects. With simultaneous use of ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving as antiplatelet agents acetylsalicylic acid, low dose, after initiation of ibuprofen). Other NSAIDs, in particular, selective COX-2 inhibitors: avoid simultaneous use of two or more agents from the group of NSAIDs due to possible increased risk of side effects.
Precautions used simultaneously with the following drugs: Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants, particularly warfarin and thrombolytic agents.
Antihypertensive agents (angiotensin converting enzyme (ACE) and angiotensin II) and diuretics NSAIDs may reduce efficacy of these groups. In some patients with impaired renal function (e.g., patients with dehydration or in elderly patients with impaired renal function) co-administration of ACE inhibitors or antagonists of angiotensin II and agents that inhibit cyclooxygenase, may lead to a deterioration of renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs simultaneously with ACE inhibitors or angiotensin II. Therefore, the combined use of the above means should be used with caution, especially in elderly patients. It is necessary to prevent dehydration in patients, and consider monitoring renal function after initiation of such combination therapy, and periodically – in the future. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
Steroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
Cardiac glycosides: co-administration of NSAIDs and cardiac glycosides can lead to aggravation of heart failure, decreased glomerular filtration rate and an increase in concentration of cardiac glycosides in blood plasma. of lithium drugs, there are data on the probability of increasing the concentration of lithium in blood plasma during treatment with NSAIDs. Methotrexate is there data on the probability of increasing concentration of methotrexate in the blood plasma during treatment with NSAIDs.
Cyclosporine increased risk of nephrotoxicity with concomitant administration of NSAIDs and cyclosporine.
Mifepristone NSAIDs should be started no earlier than 8-12 days after mifepristone administration as NSAIDs can reduce the efficacy of mifepristone.
Tacrolimus with concomitant administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Zidovudine simultaneous use of NSAIDs and zidovudine could result in increased gematotoksichnosti. There is evidence of increased risk of haemarthrosis and hematoma in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen.
Quinolone antibiotics number of patients receiving collaborative care NSAIDs and quinolone antibiotics series, may increase the risk of seizures. Myelotoxic drugs gain gematotoksichnosti.
Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin: an increase in the incidence hypoprothrombinemia.
Drugs that block tubular secretion: reducing clearance and increase plasma concentrations of ibuprofen.
Inductors mikrosomalnogo oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of active hydroxylated metabolites increased risk of severe intoxication.
Oxidation inhibitors mikrosomalnogo: reducing the risk of hepatotoxicity. Oral hypoglycemic drugs and insulin, sulfonylurea derivatives potentiation of drugs.
Antacids and colestyramine decrease absorption.
Uricosuric drugs decrease in efficacy.
Estrogens, ethanol: an increased risk of side effects.
Caffeine: increased analgesic effect.
Overdose
In children, the symptoms of overdose may occur after ingestion of a dose exceeding 400 mg / kg body weight.
In adults, a dose-dependent effect of an overdose is less pronounced.
The half-life of the drug overdose is 1.5-3 hours.
Symptoms include nausea, vomiting, epigastric pain, or more rarely, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: drowsiness, rarely – excitement, convulsions, disorientation, coma. In cases of severe poisoning can develop metabolic acidosis and increased prothrombin time, kidney failure, liver damage tissue, blood pressure, respiratory depression and cyanosis. Patients with asthma may increase the disease.
Treatment: symptomatic, with obligatory airway, monitoring ECG and vital signs up to the normalization condition of the patient. We recommend the use of activated charcoal oral or gastric lavage for 1 hours after administration of potentially toxic doses of ibuprofen. If ibuprofen has already been absorbed, it can be assigned to alkaline water with the aim of removing the acid derivative of ibuprofen kidney diuresis. Frequent or prolonged convulsions should be to stop the intravenous administration of diazepam or lorazepam. When deterioration of asthma recommend the use of bronchodilators.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NPV11).
Pharmacological properties:
It has anti-inflammatory. antipyretic, analgeziruyushee action. Indiscriminate cyclooxygenase blocks 1 and tsiklookesh snazu II. The mechanism of action of ibuprofen due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and giiertsrmicheskoy reaction.
Attenuates pain, including joint pain at rest and in motion; reduce morning stiffness and swelling of joints, improves range of motion.
Pharmacodynamics:
The mechanism of action of ibuprofen, the propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs) is due to the inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic response. Indiscriminately blocked cyclooxygenase 1 (COX-1) and cyclooxygenase-II (COX-2), thereby inhibits the synthesis of prostaglandins. It provides quick directional effect against pain (analgesic), anti-inflammatory and antipyretic activity. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
Pharmacokinetics:
Absorption – high, rapidly and almost completely absorbed from the gastrointestinal tract (GIT). After ingestion fasting maximum concentration (Cmax) in plasma of ibuprofen is achieved in 30-35 minutes. The drug together with food can increase the time to peak concentration (TSmah). Communication with the plasma proteins more than 90%. Slowly into the joint cavity, it is retained in the synovial fluid, making it larger concentration than in blood plasma. After absorption of about 60% pharmacologically inactive R-form is transformed slowly into the active S-shape. It is metabolized in the liver. The half-life (T1 / 2) – 2 hr. Excreted by the kidneys (in unmodified form are not more than 1%) and, to a lesser extent in the bile. Older people have not detected significant differences in the pharmacokinetic profile of ibuprofen compared with younger people. In limited studies, ibuprofen was detected in breast milk in very low concentrations.
Pregnancy and breast-feeding
Do not use this drug in the III trimester. It should avoid the use of the drug in the I-II trimester of pregnancy should consult a physician if necessary dose. There is evidence that ibuprofen in small quantities can penetrate into breast milk without any adverse effects on the baby’s health, so it is usually in short-term need for the reception termination of breastfeeding does not arise. If necessary, long-term use of the drug should consult a doctor to decide on the termination of breastfeeding during treatment.
Conditions of supply of pharmacies
Without recipe.
side effects
The risk of side effects can be minimized, if you take a short course of the drug in the lowest effective dose needed to control symptoms. In the elderly there is an increased frequency of adverse reactions to treatment with NSAIDs, especially gastrointestinal bleeding and perforation, in some cases fatal. Side effects are mainly dose dependent. The following adverse reactions were observed at short ibuprofen in doses not to exceed 1200 mg / day (6 tablets). In the treatment of chronic conditions and long-term use may cause other adverse reactions.
The incidence of adverse reactions (HP), the following is given according to the following classification: very frequent (> 10%), frequent (> 1%, 0.1% and 0.01%, but
Blood disorders and lymphatic system
Very rare disorders of hematopoiesis (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis).
The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and bruising, bleeding, and bruising of unknown etiology.
Violations by the immune system
Infrequent hypersensitivity reactions – nonspecific allergic reactions and anaphylactic reaction by the airway reactions (asthma, including its exacerbation, bronchoconstriction, dyspnea, dyspnea), skin reactions (pruritus, urticaria, purpura, angioedema, exfoliative and bullous dermatoses including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.
Very rare severe hypersensitivity reactions, including swelling of the face, tongue and throat, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).
Disorders of the gastrointestinal tract
Infrequent abdominal pain, nausea, dyspepsia (including heartburn, bloating).
Occasional diarrhea, bloating, constipation, and vomiting.
Very rare peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis.
Frequency unknown exacerbation colitis and Crohn’s disease.
Disorders of the liver and biliary tract
Very rare abnormal liver function (especially with prolonged use), the increase in “liver” enzymes, hepatitis, jaundice.
Violations of the kidneys and the urinary tract
Rare acute renal failure (compensated and decompensated) especially in long-term use, in combination with increasing concentrations of urea in the blood plasma and the appearance of edema, proteinuria and hematuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.
Disorders of the nervous system
Infrequent headache.
Very rare aseptic meningitis.
Violations of the cardiovascular system
Frequency unknown cardiac insufficiency, peripheral edema, with prolonged use at increased risk of thrombotic complications (e.g., myocardial infarction), hypertension.
Violations of the respiratory system and organs of the mediastinum
The frequency is unknown, asthma, bronchospasm, dyspnea.
Laboratory parameters hematocrit or hemoglobin (can be reduced); Bleeding time (may be increased); concentration in plasma glucose (may be reduced); creatinine clearance (may decrease); plasma creatinine concentration (may be increased); Activity “liver” transaminases (may be increased).
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
It is recommended to take the drug the maximum possible short-course, and in the lowest effective dose needed to control symptoms. If necessary, the administration of the drug for more than 10 days, you must consult your doctor. In patients with bronchial asthma or allergic disease in the acute phase as well as in patients with a history of asthma / allergy disorders preparation may provoke bronchospasm. Use of the drug in patients with systemic lupus erythematosus or mixed connective tissue disease associated with an increased risk of aseptic meningitis. During long-term treatment is required to monitor patterns of peripheral blood and functional state of the liver and kidneys. When symptoms gastropathy shown careful control, comprising carrying esophagogastroduodenoscopy, total blood (hemoglobin), analysis of fecal occult blood. If necessary, the definition of 17-ketosteroids drug should be discontinued 48 hours prior to the study. During the period of treatment is not recommended intake of ethanol. Patients with renal failure should consult a physician before using the product, since there is a risk of deterioration of renal function. Patients with hypertension, including a history of and / or chronic heart failure, it is necessary to consult a physician before using the drug as the drug can cause fluid retention, high blood pressure n swelling. Patients with uncontrolled hypertension, congestive heart failure, H-W class NYHA, ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease prescribe ibuprofen should be only after a careful assessment of the benefit-risk, thus it is necessary to avoid high doses of ibuprofen (> 2400 mg / day). The use of NSAIDs in patients with varicella may be associated with an increased risk of severe septic complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid use of the drug varicella. Information for women planning pregnancy ibuprofen inhibits cyclooxygenase and prostaglandin synthesis, affects ovulation, disrupting women’s reproductive function (reversible after discontinuation of treatment).
Effects on ability to drive vehicles and mechanisms of view when taking ibuprofen, should avoid driving vehicles or machinery control.
Storage conditions
Tablets, film-coated tablets and effervescent stored in a dry place at a temperature of from 15 to 25 ° C.
Keep out of the reach of children!.
Dosing and Administration
Inside, after a meal.
Doses ibu profen picked individually, so that the use of the lowest possible doses to obtain the desired therapeutic effect.
Designate adults and children over 12 years, inside after eating, the tablets must be swallowed whole with a little liquid. Adults and children over 12 years – inside 1 tablet (400 mg). Repeated reception not earlier than 4 h. Adults do not take more than 3 tablets in 24 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children between 12-18 years of age is 1,000 mg. If you are taking the drug for 2-3 days, the symptoms persist, you must stop treatment and seek medical advice.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist