Teralen 275 Table n / 275mg film about 12 pc

Description

Composition
Active substance:
1 tablet contains naproxen sodium 275 mg.
Excipients:
Microcrystalline Cellulose – 55 mg, povidone K30 – 12.5 mg talc – 15.75 mg magnesium stearate – 2.63 mg; film coating: Opadry Blue YS-1-4215 – 9 mg: Macrogol 8000, indigo carmine, titanium dioxide, hypromellose.
Description:
Tablets, film-coated blue color, oval, biconcave; on one side of the tablet engraving “NPS-275”; at the turn of the core of the tablet is white.
Product form:
Tablets, film-coated, 275 mg 12 tablets in PVC / Al blister pack (1). 1 or 2 blisters together with instructions for use in a cardboard pack.
Contraindications
Hypersensitivity to naproxen or naproxen sodium;
Full or partial combination of asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including history);
Since the aortocoronary bypass surgery;
Erosive and ulcerative changes in the mucosa of the stomach or duodenum;
Active gastrointestinal bleeding;
Inflammatory bowel disease (ulcerative colitis, Crohn’s disease) in acute phase;
Hemophilia and other bleeding disorders and disorders of hemostasis;
Cerebrovascular bleeding or other bleeding;
Decompensated heart failure.
Severe hepatic insufficiency or active liver disease;
Renal failure (creatinine clearance less than 30 mL / min), progressive renal disease;
Confirmed by hyperkalemia;
Pregnancy;
Lactation;
Children up to age 15 years.
Dosage
275 mg
Indications
Diseases of the musculoskeletal system: rheumatic soft tissue; osteoarthritis of peripheral joints and spine, including with radicular syndrome; tenosynovitis; bursitis.
Pain syndrome weak or moderate severity: neuralgia; ossalgia; myalgia; sciatica;
post-traumatic pain (sprains and injuries), accompanied by inflammation; headache, migraine; algomenorrhea; toothache.
In the combined therapy of infectious and inflammatory diseases of the ear, nose and throat from severe pain: pharyngitis; tonsillitis; otitis.
Feverish syndrome with “cold”, and infectious diseases.
Preparation teralen 275 is used for symptomatic therapy (to reduce pain, reduce inflammation, and elevated body temperature) and the progression of the underlying disease is not affected.
Interaction with other drugs
275 teralen drug is not recommended during pregnancy and lactation.
Overdose
Symptoms: Significant naproxen overdosage may be characterized by drowsiness, dyspeptic disorders (heartburn, nausea, vomiting, abdominal pain), weakness, tinnitus, irritability, and in severe cases – hematemesis, melena, disturbance of consciousness, convulsions and renal failure.
Treatment: The patient, who took either accidentally or intentionally a large amount of drug teralen 275, wash stomach take activated charcoal and symptomatic therapy: antacids, histamine H2 receptor inhibitors, proton pump. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug
Pharmacodynamics:
Preparation teralen 275 represents naproxen, has analgesic, antipyretic and antiinflammatory action. The mechanism of action is related to non-selective inhibition of cyclooxygenase-1 and -2 (COX-1, COX-2).
Pharmacokinetics:
Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability – 95% (eating virtually no effect on the completeness or the rate of absorption). The time to reach Cmax plasma – 1-2 ch.Svyazyvanie plasma proteins> 99%. T1 / 2 -. 12-15 h metabolism occurs in the liver to dimetilnaproksena involving this isozyme SUR2S9.Klirens – 0.13 ml / min / kg. Is displayed on the kidneys 98%, 10% excreted unchanged, in the bile – 0.5-2.5%. Css in plasma determined after taking 4-5 doses (2-3 days) .If renal insufficiency possible accumulation of metabolites.
Pregnancy and breast-feeding
Do not use this drug teralen 275 during pregnancy and breast vskarmlivaniya.Primenenie naproxen, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, is not recommended for women planning pregnancy
side effects
Adverse effects that may develop during treatment with naproxen, are classified in accordance with the following frequency of occurrence: very often (> 1/10), often (by> 1/100 to 1/1000 to 1/10000 to
In each group, adverse events are listed in descending order sereznostiSo the gastrointestinal tract: the most commonly observed adverse effects on the gastrointestinal tract. Perhaps the development of peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in elderly patients (see. Section “Special instructions”).
From the blood and lymphatic system: Infrequent – eosinophilia, granulocytopenia, leukopenia, thrombocytopenia.
From the nervous system: often – headache, vertigo, dizziness, drowsiness; rarely – depression, insomnia, inability to concentrate, insomnia, malaise.
From a sight organ: often – blurred vision.
On the part of the ear and labyrinth disorders: often – tinnitus, hearing impairment; infrequently – decreased hearing.
Of the heart: often – swelling, palpitations; infrequently – congestive heart failure.
The respiratory system, thorax and mediastinum: often – shortness of breath; infrequently – eosinophilic pneumonia.
On the part of the digestive tract: often – constipation, abdominal pain, dyspepsia, nausea, diarrhea, stomatitis, flatulence; rarely – gastrointestinal bleeding and / or perforation of the stomach, hematemesis, melena, vomiting; very rarely – relapse or exacerbation of ulcerative colitis or Crohn’s disease; the frequency is unknown – gastritis.
Of the liver and biliary tract: rarely – increased activity of liver enzymes, jaundice.
Skin and subcutaneous tissue disorders: often – itching, skin rash, ecchymosis, purpura; rare – alopecia, photodermatosis; very rare – bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
On the part of the musculoskeletal system and connective tissue disorders: rarely – myalgia and muscle weakness.
The kidneys and the urinary tract: infrequently – glomerulonephritis, hematuria, interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis.
General disorders: often – thirst, increased sweating; infrequently – hypersensitivity reactions, menstrual disorders, pyrexia (fever and chills).
If NSAID therapy reported occurrence of edema and heart failure symptoms, increased blood pressure.
Clinical studies and epidemiological data suggest that use of some NSAIDs (particularly high doses and long-term treatment) may be associated with a small increased risk of arterial thrombosis (eg myocardial infarction or stroke).
Undesirable effects, a causal relationship has not been established that naproxen using.
From the blood and lymphatic system: aplastic anemia, hemolytic anemia.
From the nervous system: aseptic meningitis, cognitive dysfunction.
Skin and subcutaneous tissue disorders: erythema multiforme, photosensitivity reactions like porphyria cutanea tarda and epidermolysis bullosa, urticaria.
On the part of the vessels: vasculitis.
General disorders: angioneurotic edema, hyperglycemia, hypoglycemia.
If the patient has noticed similar phenomena, you should stop taking the drug and, if possible, consult a doctor.
special instructions
Do not exceed the dosage specified in the instructions. To reduce the risk of adverse effects on the gastrointestinal tract should use the lowest effective dose of the lowest possible short course.
If pain and fever persist or become stronger, you should consult a doctor. Patients with asthma, with bleeding disorders, as well as in patients with hypersensitivity to other analgesics before taking this medication teralen 275 should consult a doctor.
Caution should be used in patients with liver diseases and renal failure.
In chronic alcoholic and other forms of cirrhosis the concentration of unbound naproxen is increased, however such patients are recommended lower doses. After two weeks of use of the drug should be monitored indicators pecheni.U function in patients with renal failure is necessary to control the spacecraft. When CC less than 30 ml / min is not suitable for use naproxen. Teralen 275 drug should not be taken with other anti-inflammatory and analgesic drugs, except for medical appointments. Elderly patients are also recommended lower doses.
Avoid receiving naproxen for 48 hours before surgical vmeshatelstva.Pri need to identify 17-corticosteroid preparation should be discontinued 48 hours before the study. Similarly, naproxen may affect the determination of 5-hydroxyindoleacetic acid in the urine.
Each tablet formulation teralen 275 contains approximately 25 mg of sodium. While limiting salt intake it is necessary to take into account.
Effect on driving ability.
Naproxen slows down the reaction rate in patients. This should be taken into account when driving and performing tasks that require attention.
Storage conditions
Store at a temperature not higher than 25 ° C
Dosing and Administration
Inside. The tablets should be taken with plenty of water.
Adults and children 15 years and older: The daily dose used for pain relief, is 2-3 tablets (550-825 mg).
The maximum daily dose – 3 tablets (825 mg).
Duration of application – not more than 5 days.
In applying the drug teralen 275 as antipyretic initial dose is 2 tablets taken further to 1 tablet (275 mg) every 8 hours.
For the prevention and treatment of migraine initial recommended dose is 2 tablets (550 mg), you can take 1 tablet (275 mg) every 8-12 hours, if necessary. The maximum daily dose – 3 tablets (825 mg).
To relieve menstrual pain and cramps, pain after administration of intra-uterine and other gynecological pain recommended use of the drug in the initial dose of 2 tablets (550 mg), followed by 1 tablet (275 mg) every 8 hours.
Children: 275 teralen drug is contraindicated for use in children under the age of 15 years.
Elderly patients (over 65 years): the drug should be taken as needed every 12 hours.
To reduce the risk of adverse effects of the drug from the gastrointestinal tract should be taken in the lowest effective dose of the lowest possible short course.
If the patient has the impression that the effect of the drug is very strong or weak, you should inform your doctor or pharmacist.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist