Affida Fort granules for oral suspension 100 mg in a sachet of 2 g 30 pcs.

Active ingredient: nimesulide;

1 sachet of 2 g of granules contains nimesulide 100 mg;

Excipients: cetomacrogol 1000, maltodextrin, citric acid, sucrose, orange flavoring.

• hypersensitivity to nimesulide or to any excipient of this drug;
• history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria, nasal polyps), including reactions to acetylsalicylic acid or other NSAIDs;
• hepatotoxic reactions to nimesulide in history;
• simultaneous use of other potentially hepatotoxic substances;
• alcoholism, drug addiction;
• history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
• history of active or recurrent peptic ulcer/bleeding (two or more distinct episodes of confirmed ulceration or bleeding);
• cerebrovascular bleeding or other active bleeding, or bleeding disorders;
• severe blood clotting disorders;
• severe heart failure;
• severe renal impairment;
• liver dysfunction;
• patients with fever and/or flu-like symptoms;
• children under 12 years old;
• third trimester of pregnancy and breastfeeding period.

To minimize possible unwanted side effects, the minimum effective dose should be used for the shortest possible time. It is recommended to take after meals.

The maximum duration of the treatment course is 15 days.

Pregnant women

Contraindicated.

Children

Apply to children over 12 years of age.

Drivers

With caution.

Symptoms of acute NSAID overdose are usually limited to apathy, drowsiness, nausea, vomiting, epigastric pain, which are usually reversible with supportive therapy. Gastrointestinal bleeding may occur. In addition, arterial hypertension, acute renal failure, respiratory depression and coma may occur, but these phenomena occur rarely. There have been reports of anaphylactoid reactions with therapeutic doses of NSAIDs, which can occur in case of overdose.

Gastrointestinal adverse reactions are the most common. Peptic ulcers, perforations or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, black stools, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have also been observed after treatment. Gastritis has been observed less frequently.

In vitro studies have shown that nimesulide is displaced from binding sites by tolbutamide, salicylic acid and valproic acid. Although these interactions have been identified in plasma, these effects have not been observed during clinical use of the drug.

Store at a temperature not exceeding 25 °C out of the reach of children.

Shelf life – 3 years.