FlectorGo 20 softgels 12.5mg

  • IBSA Farmaceutici Italia S.r.l.
  • 044608026

Flectorgo is a drug based on the active ingredient diclofenac epolamine, belonging to the category of NSAID analgesics and specifically derivatives of acetic acid and related substances. Flectorgo can be prescribed with OTC Recipe - self-medication. For the short-term symptomatic treatment of: mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain and muscle aches)

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FLECTORGO * 20CPS 12.5MG

Therapeutic indications

For the short-term symptomatic treatment of: - mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain and muscle aches)

Dosage and method of use

Dosage: Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).For FLECTORGO 12.5 mg: Unless otherwise prescribed, adults and adolescents over 14 years of age should start with 1 or 2 soft capsules and continue with 1 or 2 soft capsules every 4 - 6 hours as needed thereafter. In any case, no more than 6 soft capsules (equivalent to 75 mg of diclofenac potassium) should be taken in any 24 hour period.For FLECTORGO 25 mg:Unless otherwise prescribed, adults and adolescents over 14 years of age should start with 1 soft capsule and then continue with 1 soft capsule every 4 - 6 hours as needed. In any case, no more than 3 soft capsules (equivalent to 75 mg of diclofenac potassium) should be taken in any 24 hour period. FLECTORGO must be taken for a short period of time. The duration of treatment should be 3 days. If symptoms persist or worsen, see a doctor. Pediatric population: FLECTORGO is not recommended for use in children and adolescents under 14 years of age. Elderly people: No special dosage adjustment is necessary. In view of the profile of possible undesirable effects, the elderly should be monitored with particular care (see section 4.4). Kidney damage: Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3). No dose reduction is required in patients with mild to moderate renal function. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment (see section 4.4). Hepatic impairment: Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3). No dose reduction is required in patients with mild to moderate hepatic function. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (see section 4.4).Method of administration:The soft capsules should be swallowed whole with a drink of water. The absorption rate of diclofenac is reduced when FLECTORGO is taken with food. It is therefore recommended not to take the soft capsules during or immediately after meals.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; • Active stomach or intestinal ulcer, bleeding or perforation; • Alterations of unknown origin of hematopoiesis; • History of gastrointestinal bleeding or perforation related to previous NSAID therapy; • History of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of known ulceration or bleeding); • Overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and / or cerebral vasculopathy; • Last trimester of pregnancy (see section 4.6); • severe hepatic, renal or cardiac insufficiency (see section 4.4); • Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom acetylsalicylic acid or other NSAIDs trigger attacks of bronchospasm, asthma, urticaria or acute rhinitis.

Side effects

The most commonly observed adverse events concern the gastrointestinal tract. Peptic ulcers, perforation or GI bleeding, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Adverse reactions (Table 1) are listed in order of frequency, most frequent first, using the following convention: very common: (≥1 / 10); common (≥1 / 100, Table 1. Tabular list of adverse reactions

Disorders of the blood and lymphatic system
Very rare Thrombocytopenia, leukopenia, pancytopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis
Disorders of the immune system  
Rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock) Angioneurotic edema (including face edema)
Psychiatric disorders  
Very rare Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions
Nervous system disorders  
Common Headache, dizziness
Rare Drowsiness
Very rare Paraesthesia, memory impairment, seizures, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accidents
Eye disorders  
Very rare Disturbed vision, blurred vision, diplopia
Ear and labyrinth disorders  
Common Dizziness
Very rare Tinnitus, hearing impairment
Cardiac pathologies  
Very rare Palpitations, chest pain, heart failure, myocardial infarction
Not known Kounis syndrome
Vascular pathologies  
Very rare Hypertension, vasculitis
Respiratory, thoracic and mediastinal disorders  
Rare Asthma (including dyspnoea)
Very rare Pneumonia
Gastrointestinal disorders  
Common Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia
Rare Gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhea, melaena, gastrointestinal ulcer (with or without bleeding or perforation)
Very rare Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorders, diaphragm-like intestinal stricture, pancreatitis
Not known Ischemic colitis
Hepatobiliary disorders  
Uncommon Increased transaminases
Rare Hepatitis, jaundice
Very rare Hepatic insufficiency
Skin and subcutaneous tissue disorders  
Common Skin rash, itching
Rare Urticaria
Very rare Bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, allergic purpura
Renal and urinary disorders  
Very rare Acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions  
Rare Edema

Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment (for contraindications and special warnings and precautions for use, see sections 4.3 and 4.4)Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

General: Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular effects). The concomitant use of FLECTORGO with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided due to the lack of any evidence demonstrating synergistic benefits and the possibility of additional undesirable effects (see section 4.5). . On a basic medical level, caution is required in the elderly. In particular, in frail elderly patients or in those with a low body weight, the use of the lowest effective dose is recommended. As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may occur in rare cases with diclofenac, even without prior exposure to the medicinal product. Hypersensitivity reactions can also develop into Kounis syndrome, a severe allergic reaction that can lead to myocardial infarction. Current symptoms of such reactions may include chest pain occurring in association with an allergic reaction to diclofenac. Like other NSAIDs, diclofenac can mask the signs and symptoms of infection due to its pharmacodynamic properties.Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation, which may be fatal, with or without warning symptoms or a previous history of serious gastrointestinal events, has been reported during treatment with all NSAIDs, including diclofenac. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be discontinued. As with all NSAIDs, including diclofenac, close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders or with a history indicative of gastric or intestinal ulceration, bleeding or perforation. (see section 4.8). The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation. The elderly have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose. Concomitant use of protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA) or other drugs that may increase gastrointestinal risk (see section 4.5). Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents or selective serotonin reuptake inhibitors (see section 4.5). Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease as these conditions may be exacerbated (see section 4.8). NSAIDs, including diclofenac, may be associated with an increased risk of leakage from gastrointestinal anastomosis. Close medical surveillance and caution are recommended when using diclofenac following gastrointestinal surgery.Hepatic effects: Close medical surveillance is required when prescribing diclofenac to patients with hepatic insufficiency, as their condition may be exacerbated. As with other NSAIDs, including diclofenac, the values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular checks of liver function are indicated as a precautionary measure. If abnormal liver function parameters persist or worsen, if clinical signs or consistent symptoms of liver disease develop, or if other manifestations (e.g. eosinophilia, rash) occur, diclofenac treatment should be discontinued. A hepatitis with the use of diclofenac can occur without prodromal symptoms. Particular caution should be exercised in the use of diclofenac in patients with hepatic porphyria, as it could trigger an attack.Kidney effects: Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, special caution is required in case of cardiac or renal failure, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medicinal products that may significantly affect renal function and in those patients with substantial extracellular volume depletion due to any cause, e.g. before or after major surgery (see section 4.3). In such cases, monitoring of renal function is recommended as a precaution when administering diclofenac. Discontinuation of therapy is usually followed by a return to pre-treatment conditions.Skin effects:Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk for these reactions; the onset of the reaction occurs in most cases within the first month of treatment. FLECTORGO should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.SLE and mixed connective tissue disease: There may be an increased risk of aseptic meningitis in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders (see section 4.8).Cardiovascular and cerebrovascular effectsAdequate monitoring and instruction are required in patients with a history of hypertension and / or mild congestive heart failure (NYHA class I) as fluid retention and edema have been reported in association with NSAID treatment. Clinical trials and epidemiological data consistently indicate a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used for the shortest duration possible. The response to therapy and the need for symptom improvement should be reassessed periodically.Pre-existing asthma: In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to allergic rhinitis), reactions to NSAIDs such as exacerbations of asthma (so-called analgesic intolerance / analgesic asthma), Quincke's edema or urticaria are more frequent than in other patients. Special precaution is therefore recommended in such patients (prepare for emergency). This also applies to patients allergic to other substances, eg. with skin reactions, itching or hives. Like other drugs that inhibit the activity of prostaglandin synthetase, diclofenac epolamine and other NSAIDs can precipitate bronchospasm when administered to patients who suffer from it or with a previous history of bronchial asthma.Hematological effects: FLECTORGO is intended for short-term use. During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of blood counts is recommended. Like other NSAIDs, diclofenac can temporarily inhibit platelet aggregation. Patients with haemostatic defects, haemorrhagic diathesis or haematological abnormalities should be carefully monitored (see section 4.5).Other information: This medicinal product contains a maximum of 8.02 mg and 10.07 mg of sorbitol in each 12.5 mg and 25 mg capsule, respectively. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products and the daily dietary intake of sorbitol (or fructose) must be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. This medicinal product contains less than 1 mmol (23 mg) sodium per dose unit, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may have negative effects on pregnancy and / or embryo / fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to a maximum of approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals treated with a prostaglandin synthesis inhibitor during the period of organogenesis. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman trying to conceive or during the first and second trimester of pregnancy, the dose should be as low as possible and the duration of treatment should be as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose: • thefetusto cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension) and to renal dysfunction, which can progress to renal failure with oligo-hydroamnios; • themother and newborn, at the end of pregnancy, to a possible prolongation of bleeding time and to an anti-aggregating effect that can occur even at very low doses, as well as to the inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, FLECTORGO is contraindicated during the third trimester of pregnancy.Feeding time: Like other NSAIDs, diclofenac passes in small amounts into breast milk. Therefore, diclofenac should not be administered during breastfeeding to avoid undesirable effects in the newborn.Fertility: As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women trying to conceive. In women who have difficulty conceiving or who are undergoing diagnostic tests for infertility, discontinuation of diclofenac should be considered.

Expiration and retention

Store at a temperature below 25 ° C. Store in the original package in order to protect from light and moisture.

Interactions with other drugs

The following interactions include those seen with other pharmaceutical forms of diclofenac.Digoxin, phenytoin, lithium:concomitant use of FLECTORGO and digoxin, phenytoin or lithium may increase the concentration of these medicines in the blood. Serum lithium concentration should be monitored. Monitoring of serum digoxin and phenytoin concentrations is recommended.Diuretics and antihypertensive agents:as with other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensives (e.g. beta-blockers, angiotensin converting enzyme inhibitors[ACE]) can cause a reduction in their antihypertensive effect. Therefore, the combination should be administered with caution and blood pressure should be monitored periodically in patients, particularly the elderly. Patients should be adequately hydrated and renal function monitoring should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity (see section 4.4). . Concomitant treatment with potassium-sparing drugs may be associated with an increase in serum potassium levels, which therefore should be monitored frequently.Other NSAIDs including selective cyclooxygenase-2 inhibitors and corticosteroids:concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects such as gastrointestinal ulcers or bleeding (see section 4.4).Anticoagulants and antiplatelet agents:Caution is recommended as concomitant administration may increase the risk of bleeding (see section 4.4). Although clinical investigations do not seem to indicate that diclofenac affects the action of anticoagulants, there are reports of an increased risk of bleeding in patients treated with diclofenac concomitantly with anticoagulants. Careful monitoring of such patients is therefore recommended.Selective Serotonin Reuptake Inhibitors (SSRIs):concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4).Antidiabetics:clinical studies have shown that diclofenac can be administered together with oral antidiabetics without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycemic effects requiring dose adjustments of antidiabetics during treatment with diclofenac. For this reason, blood glucose monitoring is recommended as a precautionary measure during concomitant therapy.Methotrexate:diclofenac may inhibit the renal tubular clearance of methotrexate, thereby increasing its levels. Caution is advised when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with methotrexate, as blood concentrations of methotrexate and toxicity of this substance may increase.Tacrolimus:non-steroidal anti-inflammatory drugs (such as diclofenac) may increase the renal toxicity of tacrolimus.Ciclosporin:diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine due to the effect on renal prostaglandins. Therefore, it should be given at lower doses than would be used in patients not treated with cyclosporine.Quinolone antibacterials:There have been isolated reports of seizures, which could be due to the concomitant use of quinolones and NSAIDs.Colestipol and cholestyramine: these drugs may induce a delay or decrease in the absorption of diclofenac. Therefore, it is recommended to administer diclofenac at least one hour before or 4-6 hours after colestipol / cholestyramine administration.Cardiac glycosides:concomitant use of cardiac glycosides and NSAIDs in patients may exacerbate heart failure, reduce renal glomerular filtrate and increase plasma glycoside levels.Mifepristone:NSAIDs should not be used for 8-12 days after administration of mifepristone as these may reduce its effect.Potent CYP2C9 inhibitors:Caution is advised when prescribing diclofenac concomitantly with potent CYP2C9 inhibitors (such as probenecid, sulfinpyrazone and voriconazole) which could result in a significant increase in peak plasma concentration and diclofenac exposure due to inhibition of its metabolism.

Overdose

SymptomsThere is no typical clinical picture following diclofenac overdose. Overdose can cause symptoms such as nausea, vomiting, gastrointestinal bleeding, diarrhea, headache, dizziness, somnolence, tinnitus, unconsciousness or convulsions. In case of significant poisoning, acute renal failure and liver damage are possible. Hypotension, respiratory depression and cyanosis may also occur.Therapeutic measuresManagement of acute NSAID poisoning, including diclofenac, essentially consists of supportive measures and symptomatic treatment, which must be adopted for complications such as hypotension, renal failure, seizures, gastrointestinal disturbance and respiratory depression. Specific therapies, such as forced diuresis, dialysis or haemoperfusion are not likely to help in eliminating NSAIDs, including diclofenac, due to their strong binding to plasma proteins and their high metabolism. After ingestion of a potentially toxic overdose, the use of activated charcoal may be considered, while after ingestion of a potentially life-threatening overdose gastric emptying (e.g. vomiting, gastric lavage) may be considered.

Active principles

For FLECTORGO 12.5 mg:Each soft capsule contains diclofenac as 15.38 mg diclofenac epolamine equivalent to 12.5 mg diclofenac potassium.For FLECTORGO 25 mg: Each soft capsule contains diclofenac in the form of 30.76 mg of diclofenac epolamine equivalent to 25 mg of diclofenac potassium.Excipient (s) with known effects: For FLECTORGO 12.5 mg: Sorbitol (E420) maximum 8.02 mg.For FLECTORGO 25 mg: Sorbitol (E420) maximum 10.07 mg. For the full list of excipients, see section 6.1.

Excipients

Capsule contents:Macrogol 600 Anhydrous glycerol Purified waterCapsule:Gelatin Glycerol anhydrous Liquid sorbitol, partially dehydrated (E420) Purified water Hydroxypropylbetadex Sodium hydroxide

044608026

Data sheet

Packaging
12.5 mg 20 soft capsules
Product Type
HUMAN DRUG
ATC code
M01AB05
ATC description
Diclofenac
Therapeutic Group
NSAID analgesics
Active principle
diclofenac epolamine
Class
C.
Pharmaceutical form
capsule
Type of Administration
oral
Container
blister
Quantity
20 capsule
Quantity of the Active Ingredient
12.5MG
Recipe required
OTC - self-medication medicine
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