NIMESIL Grant. 100 mg. 15 granule

 

What is in your medicine?

One sachet with 2 g granules for oral suspension (for oral administration) contain:

 

Active substance:

 

100 mg nimesulide

 

Excipients

 

Sucrose, orange flavor, citric acid, maltodextrin, tsetomakrogol.

 

Package

 

Nimesil is 9.15 or packs of 30 sachets.

  

How does Nimesil?

 

Nimesil is medicine of the nonsteroidal anti-inflammatory drugs (NSAIDs).

 

 

When applied Nimesil?

 

 Treatment of acute pain.

  Symptomatic treatment of painful osteoarthritis.

  Painful menstruation.

 

When you need to apply Nimesil?

 

 When a known hypersensitivity to nimesulide or to any of the excipients;

  evidence of hypersensitivity reactions (eg bronchospasm, rhinitis, hives) after administration of aspirin or other NSAIDs;

  evidence of liver injury following administration of nimesulide;

  ulcer of the stomach or duodenum, data recurrent ulcers or bleeding from the gastrointestinal tract (two or more distinct episodes of proven ulceration or bleeding), including those caused by NSAID use, cerebrovascular hemorrhage, other active bleeding or bleeding disorders;

  severe bleeding disorders;

  severe heart failure

  severe renal impairment;

  hepatic impairment;

  Children under 12 years of age;

  the last three months of pregnancy or during lactation.

 

What you should know before you start treatment with Nimesil?

 

The risk of side effects may be reduced if Nimezil apply to the lowest effective dose in the shortest possible time. In the absence of effect, treatment should be discontinued.

If during treatment with Nimezil develops symptoms similar to those of liver damage (eg, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) or appear abnormal liver function, treatment should be discontinued. In these cases should not be treated again with nimesulide. After administration of the drug has been reported liver damage, which in most cases is reversible.

 

Concomitant administration of drugs that damage the liver, and alcohol should be avoided during treatment with Nimezil, as this may increase the risk of liver reactions.

 

During treatment Nimezil should not take other analgesics. Concomitant use of other NSAIDs.

 

Bleeding from the gastrointestinal tract or ulcer / perforation can occur at any time during treatment, with or without warning symptoms. The same can be observed for evidence of similar prior gastrointestinal disorders. In the gastro-intestinal tract or ulcer, administration of nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including the data for peptic ulcers or signs of bleeding from the gastrointestinal tract, ulcerative colitis or Crohn's disease.

 

Caution is recommended in patients with renal impairment or heart complaints as the use of nimesulide may cause renal dysfunction. In case of deterioration, treatment should be discontinued.

 

Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including bleeding or perforation of the gastrointestinal, renal, cardiac or hepatic function. It is therefore recommended that adequate clinical monitoring.

 

Since it is possible nimesulide affect platelet function should be used with caution in patients with bleeding tendency. Nimesulide can be used instead of aspirin for cardiovascular prophylaxis.

 

NSAIDs may mask fever due to a bacterial infection of the subject.

Caution should be exercised in patients with a history of hypertension or heart failure because of the risk of fluid retention and swelling.

 

Very rarely in association with the use of NSAIDs, severe skin reactions. These effects occur in the majority of cases within the first month of treatment. Discontinue at the first skin symptoms.

 

 

What interactions occur between Nimesil other medicines you are taking?

 

Patients using drugs that inhibit blood clotting, are at increased risk of bleeding during treatment with nimesulide. If the combination can not be avoided, Anticoagulant activity should be monitored carefully. Nimesulide may reduce the effects of certain medications that increase urine output (furosemide).

 

Co-administration of lithium and NSAIDs increases the serum lithium levels and therefore may increase the side effects. Prescribe nimesulide If a patient is being treated with lithium, lithium levels should be carefully monitored.

 

Nimesulide may increase the side effects of methotrexate. Therefore, nimesulide should be used with caution, not less than 24 hours before or after administration of methotrexate.

Nimesulide may potentiate the effects of cyclosporine on the kidney.

 

 

Can be used Nimesil during pregnancy and lactation?

 

Nimezil should not apply in the last three months of pregnancy and during lactation.

The use of nimesulide may impair fertility in women and is not recommended for women who are trying to conceive, who had problems conceiving or who are carrying out research into infertility.

 

 

3 Alters Nimesil you the ability to drive and use machines?

 

If after taking Nimesil experience dizziness, vertigo or drowsiness, do not drive or operate machinery.

  

How and how much time should be given Nimezil?

 

Nimesil should be used depending on the clinical situation in the shortest possible time.

Nimesil should not be used in children under 12 years of age.

 

Adults and adolescents 12 to 18 years

 

At one sachet (100 mg nimesulide) twice daily after meals. Elderly

There is no need for dose reduction in the elderly. Impaired renal function

 

In patients with mild to moderate renal impairment (creatinine clearance 30-80 ml / min) no dose adjustment. Nimezil should not be used in patients with severe renal impairment (creatinine clearance <30 ml / min).

  

Hepatic Impairment

 

Nimezil should not be administered to patients with hepatic impairment. The contents of one sachet (100 mg nimesulide) dissolved in a glass of water.

 

What should I do in case of overdose Nimesil!

 

Symptoms following acute NSAID overdoses are usually limited to fatigue, dizziness, nausea, vomiting and abdominal pain, which are generally reversible with supportive care administered. Can manifest bleeding from the gastrointestinal tract. Rarely observed hypertension, acute renal failure, respiratory depression and coma. In the administration of therapeutic doses of NSAIDs, and an overdose can occur anaphylactic (allergic) reactions.

 

After overdosage with NSAIDs should be given symptomatic and supportive treatment. There is no specific antidote. It can cause vomiting and / or apply charcoal (60 to 100 g in adults) and / or osmotic laxatives in patients with up to 4 hours after administration of an overdose or at high doses. Forced diuresis (causing release of large amounts of urine), alkalinization of urine, hemodialysis, or hemoperfusion may not be effective due to high protein binding. You should monitor renal and hepatic function.

 

In case of taking higher than recommended dose, please, consult your doctor!

 

What side effects can cause Nimesil?

 

These side effects are based on controlled clinical trials * (in about 7800 patients) and subsequent observations by Frequencies are classified as very common (> 1/10), common (> 1/100, <1/10) Uncommon (> 1/1000, <1/100), rare (> 1/10000, <1/1000), very rare (<1/10000), including isolated reports.

 

Side of blood disorders

 

Rare Decreased erythrocytes or hemoglobin (anemia) *

 

Increased number of eosinophils (eosinophilia) *

 

Very rare

 

Decreased platelet count (thrombocytopenia)

 

Decreased number of blood cells (pancytopenia)

 

Bleeding under skin and mucous membranes (purpura)

 

Immune System

 

Rare Hypersensitivity

 

Very rare Anaphylaxis (renal) reaction

 

Metabolism and nutrition

 

Rare Elevated potassium levels in the blood

 

Psychiatric Disorders

 

Rare Anxiety  Nervousness

Nightmare

 

Nervous System

Nechesgi Dizziness

 

Very rare Drowsiness Headache encephalopathy (brain damage syndrome Ray)

 

Disorders of the Eye

 

Rare Blurred vision

 

Eye disorders Very rare

 

Disorders of the Ear and labyrinth

 

Very rare Vertigo

 

Cardiac disorders

 

Rare Fast heart rate

 

Vascular Disorder 

Nechesgi Increased blood pressure

 

Rare Bleeding  Fluctuating blood pressure  Hot flushes

 

 

Respiratory disorders

 

Nechesgi Breathlessness *

 

Very rare Asthma bronchial spasm

 

 

Digestive disorders

 

Frequent Diarrhea  Nausea  Vomiting

 

Nechesgi constipation  Bloating gas (flatulence) * Gastritis

 

Very rare Abdominal pain Indigestion Inflammation of the mouth (stomatitis) Katranenocherni feces due to bleeding from the gastrointestinal tract (melena) Bleeding from gastrointestinal ulceration and perforation of duodenal ulcer and gastric perforation

 

Hepatobiliary disorders (see "What you should know before you start treatment with Nimezil?")

 

Very rare lightning Hepatitis hepatitis (including fatal) Jaundice stagnation of bile

  

Disorders of the side skin and the subcutis

 

 Itchy Rash Nechesgi * Increased sweating

 

Rare Flushing  Dermatitis

 

Very rare Hives (urticaria) Angioedema (swelling of the face, neck, larynx) Facial edema Erythema multiforme (mnogoformeno redness) Stevens-Johnson syndrome (skin rash with blistering) Toxic epidermal necrolysis (localized damage to the upper binder the skin)

 

Disorders of the urinary tract

 

Rare Pain with urination  blood in urine Urinary retention

 

Very rare renal failure Decreased urine output Interstitial nephritis (kidney inflammation)

 

General disorders

Nechesgi Swelling

 

Rare Weakness  Fatigue

 

Very rare low temperature

 

Abnormal laboratory

 

Common Elevation of liver enzymes

 

In the event of any adverse reaction which is not described in the table or in poor general condition, tell your doctor immediately!

  

How to store Nimesil?

 

Protect from light, moisture and heat! Keep out of reach of children!

 

Expiration date

 

2 years

 

Do not use after the expiry date printed on the package!