Bula do remedy Scaflam

the package insert of the medicine Scaflam. Therapeutic class of the Anti-inflammatory non-steroidal. Active principles Nimesulida.

what For?

Scaflam is indicated as an analgesic, antipyretic and anti-inflammatory in the treatment of inflammatory processes, painful, states, febrile and infectious of the upper airways such as sinusitis, faringoamigdalites, otitis, laringotraqueites, bronchitis and flu-like, also being used after amigdalectomias and/or adenoidectomias.

Scaflam is indicated in cases osteoarticular, such as myalgias, miosites, lombociatalgias and post-surgery pain.

In gynecology is used in dysmenorrhoea.

Scaflam can be used in adults to reduce fever or relieve symptoms related to colds and flu.

Use adult and children above 12 years – oral Use

Pharmacokinetics

How it works?

Scaflam is a medicine based nimesulida, which has properties anti-inflammatory, analgesic and antipyretic.

Contraindications

When should I not use?

Scaflam is contraindicated in the following conditions:

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  • known Hypersensitivity to nimesulida or to any excipient of the Scaflam;
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  • History of hypersensitivity reactions (eg bronchospasm, rhinitis, urticaria, and angioedema) in response to acetylsalicylic acid or other anti-inflammatory non-steroidal;
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  • History of hepatic reactions to the product;
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  • peptic Ulcer disease in the active phase, gastric or duodenal ulcer, history of ulcerations recurring with bleeding gastrointestinal or inflammatory bowel disease or another disorder hemorrhagic active;
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  • Disorders cerebrovascular or other bleeding disorders active;
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  • Patients with severe disturbances of coagulation;
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  • heart failure severe;
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  • acute renal Failure;
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  • liver Failure;
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  • Children under the age of 12 years;

Scaflam in pregnancy and lactation: the use of Scaflam is against-indicated during pregnancy.

As with any NSAID, Scaflam is not recommended in women trying to become pregnant and known to inhibit the synthesis of prostaglandin, the nimesulida may cause premature closing of the ducts arterial, pulmonary hypertension, oliguria, oligâmnio, increased risk of bleeding, inertia, uterine, and peripheral oedema.

there have Been reported isolated cases of renal failure in newborn babies whose mothers treated with the drug at the end of the pregnancy.

Studies in rabbits have shown a toxicity atypical reproduction and there is no data in the appropriate use of the drug in pregnant women.

This way, the potential risk in humans is unknown and prescribing Scaflam during pregnancy is contra-indicated.

it is Not established if the nimesulida is excreted in human milk.

Scaflam is against-indicated during lactation.

Dosage

How to use?

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  • Tablets or granules – 100 mg two times per day after meals.
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  • Drops (patients 40 Kg or more) – 100 mg (40 drops) every 12 hours.
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  • Suspension patients 40 Kg or more) – 100 mg (10 ml or 2 teaspoons) twice a day.

In the case of granules, dissolve the contents of an envelope in a little water.

This medicine may not be saved after its reconstitution, shall be immediately consumed.

Both the tablets and the granules should be taken preferably after meals.

In case of moderate renal insufficiency, there is no need of dose reduction.

The oral daily dose can be divided into two or three administrations, and based on the age, body weight and adherence of the patient.

The duration of treatment is not more than 5 days, depending on the indication.

Generally should not exceed 7 days in the treatment of acute pain and fever.

For the symptomatic treatment of osteoarthritis, should establish cycles of recurrent treatment during the painful attacks.

as with all Nsaids, it is recommended to use the lowest dose possible for the shortest possible time.

Side Effects

What are the evils that can cause me?

side Effects reported in controlled clinical trials, with approximately 7800 patients include:

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  • Common – Diarrhea, nausea, vomiting, increase of liver enzymes.
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  • Uncommon – Dizziness, hypertension, dyspnea, constipation, flatulence, gastritis, pruritus, rash, increased sweating, and edema.
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  • Rare – Anemia, eosinophilia, hypersensitivity, hyperkalemia, anxiety, nervous, nightmare, blurred vision, tachycardia, hemorrhage, fluctuation of the arterial blood pressure wave of heat, erythema, dermatitis, dysuria, hematuria, urinary retention, malaise, and asthenia.
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  • Very rare – Thrombocytopenia, purpura, pancytopenia, anaphylaxis, headache, drowsiness, encephalopathy Syndrome (reye ‘ s), visual disturbances, vertigo, asthma, bronchospasm, abdominal pain, dyspepsia, stomatitis, melena, gastrointestinal bleeding, perforation and duodenal ulcer perforation, and gastric ulcer, hepatitis, fulminant hepatitis (including fatal cases), jaundice, colestasia, hives, swelling angioneurótico, facial oedema, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, renal failure, oliguria, interstitial nephritis and
    hypothermia.

Warnings and Precautions

what should I know before using?

The unwanted effects can be reduced with the use of the lowest effective dose for the shortest period possible.

Patients treated for a long period with nimesulida should be subjected to laboratory tests for monitoring adverse effects.

Rarely, Scaflam has been associated with hepatic reactions serious, including very rare fatal cases.

Patients who present with symptoms associated with hepatic injury during treatment with nimesulida (ex. anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine or jaundice) should discontinue the treatment.

Patients should be advised to consult a doctor immediately if they have a lack of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine or yellowing of eyes or skin.

Patients who develop abnormal liver function should discontinue the treatment. These patients should not be depicted with nimesulida.

liver Damage, reversible in the majority of cases, it was seen after short exposure to the medicine.

concurrent Administration with drugs hepatotoxic and abuse of alcohol should be avoided during treatment with nimesulida, as it can increase the risk of hepatic reactions.

During treatment with nimesulida, patients should be cautioned to avoid the use of other analgesics.

The simultaneous use of a different anti-inflammatory non-steroidal is not recommended.

gastrointestinal Bleeding or ulceration can occur in patients in treatment with Scaflam.

as with other anti-inflammatory non-steroidal (Nsaids), these events can occur at any time during treatment, with or without symptoms or previous history of events and gastrointestinal.

in Case of gastrointestinal bleeding or ulceration, treatment should be discontinued.

The nimesulida should be used with caution in patients with gastrointestinal disorders, including history of peptic ulcer, hemorrhage, gastrointestinal, ulcerative colitis or Crohn’s disease.

you Must have caution in patients with renal failure or with heart problems, because the use of Nsaids may lead to deterioration of renal function.

The assessment of renal function should occur before initiation of therapy and periodically after the start.

In the event of deterioration in kidney, the treatment should be discontinued.

As Nsaids can interfere with platelet aggregation, these should be used with caution in patients with haemorrhagic diathesis.

However, Scaflam is not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular disease.

Teenagers should not be treated with medicines that contain nimesulida if they are present symptoms of viral infection, since the nimesulida may be associated with the Syndrome of reye ‘ s in some patients.

elderly patients are particularly susceptible to the adverse effects of Nsaids, including bleeding and perforation of the gi-tract, kidney, heart and liver.

elderly Patients should follow the treatment with Scaflam only under strict medical supervision.

Therefore, monitoring clinical appropriate is recommended, and its prolonged use is not recommended.

When you require a prolonged therapy, the patient should be regularly evaluated Scaflam should be used with caution in patients with a history of ulceration or inflammatory bowel disease.

As Nsaids can interfere with function in platelet adhesion, should be used with caution in patients with bleeding intra-cranial and haemorrhagic diathesis.

treatment should be reviewed at regular intervals of time and, in the case of the absence of benefits, this should be discontinued.

Nsaids may mask fever related to bacterial infection.

The use of Scaflam may impair female fertility and is not recommended for women trying to become pregnant.

In women who have difficulties to become pregnant or who are under investigation of infertility, withdrawal of the drug should be considered.

The nimesulida has no effect insignificante, or none, in the ability to drive or use machines.

However, patients who have vertigo or somnolence after receiving the medicine should not drive or operate machinery.

Attention: Scaflam Suspension and Granular contains sugar, therefore should be used with caution in patients with Diabetes.

Drug Interactions

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  • Scaflam should not be administered concomitantly with drugs are potentially hepatotoxic.
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  • food intake does not interfere with the absorption and bioavailability of the drug.
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  • The use of nimesulida should be avoided in patients who are receiving treatment with other drugs acid-containing clavulanic acid or who have received this medication less than 2 months.
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  • During treatment with Scaflam, patients should be cautioned to avoid the use of other analgesics. The simultaneous use of a different anti-inflammatory non-steroidal is not recommended.
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  • concomitant administration with anticoagulants, including aspirin, may generate additive effects. For this reason, this combination is not recommended and is contraindicated in patients with disorder of severe clotting. If this combination cannot be avoided, the activity of anticoagulant should be monitored carefully.
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  • nimesulida may antagonize the effects of diuretics and, in particular, to block the increased activity of plasma renin induced by furosemide. The analysis of the pharmacokinetics of concentration nimesulida in patients on concomitant treatment with a diuretic (furosemide) has shown that there is a small difference in volume of distribution, but there is no clinical evidence of this. The concomitant treatment of furosemide with Scaflam requires caution in patients with susceptibility to renal and heart.
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  • anti-inflammatory non-inflammatory drugs have been reported to reduce clearance of lithium, resulting in high serum and toxicity of lithium. If the nimesulida is prescribed for a patient on treatment with lithium, its level in the body should be carefully monitored.
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  • The potential interaction with the glibenclamide, theophylline, warfarin, digoxin, cimetidine, and a preparation of antacids (in general a preparation of magnesium hydroxide and aluminum hydroxide) has also been studied in vivo. No significant change was observed.
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  • Scaflam inhibits CYP2C9. The plasma concentration of drugs metabolized by this enzyme should increase when they are administered concomitantly with nimesulida.
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  • it Is necessary to caution if Scaflam is used before or after 24 hours of treatment with methotrexate, since the serum levels of methotrexate may increase, thereby increasing its toxicity.
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  • Due to the effects on prostaglandins in kidney, the inhibitors of prostaglandin synthetase, as Scaflam, they should increase the nephrotoxicity of ciclosporinas.
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  • concomitant administration of nimesulida with salicylates, acid valproico or tolbutamide may affect your serum levels and, consequently, therapeutic response. In vitro studies have shown that the tolbutamide, salicylic acid and the acid valproico can move the nimesulida of their binding sites. However, despite a possible effect on plasma level, these interactions have not demonstrated clinical results significant.

Overdose

what to do if someone use a larger amount than is recommended?

Symptoms followed of overdosage acute Nsaids are usually limited to lethargy, drowsiness, nausea, vomiting, and with epigastric pain, which are generally reversible with the aid appropriate.

it Can occur gastrointestinal bleeding. Hypertension, acute renal failure, respiratory depression and coma may occur but are rare.

anaphylactic Reactions have been checked with the ingestion of Nsaids and may happen followed by an overdose.

in a Few cases superdose intentional have been reported and exhibited no signs of intoxication.

symptomatic Treatment and support should be started in case of superdose.

there are No specific antidotes, or information available regarding the removal of nimesulida by hemodialysis, but based on its high degree of protein binding (up to 97.5%) dialysis is not indicated in the superdose.

Êmese and/or activated charcoal (60 to 100 g in adults) and/or osmosis cathartic may be indicated in patients who ingested the drug in a period up to 4 hours.

Diuresis, forced, alkalinization of urine, hemodialysis, or hemoperfusão should not be used due to high protein binding.

The kidney and liver functions should be monitored.