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Soft capsules for rapid action against joint and muscle pain and headaches.
Flectorgo 25 mg is a medicine based on diclofenac epolamine, useful for the treatment of rheumatic and muscle pain, back pain, but also pain of various origins and nature from mild to moderate (toothache, headache and menstrual pain).
Active ingredients:
Each soft capsule contains diclofenac in the form of 30.76 mg of diclofenac epolamine equivalent to 25 mg of diclofenac potassium.
Excipients:
Capsule contents: Macrogol 600 Anhydrous glycerol Water purified
Capsule: Gelatin Glycerol anhydrous Sorbitol liquid, partially dehydrated (E420) Purified water Hydroxypropylbetadex Sodium hydroxide
Dosage
Adults and adolescents over 14 years of age should start with 1 or 2 soft capsules and then continue with 1 or 2 soft capsules every 4 - 6 hours, as needed.
In any case, no more than 1 or 2 soft capsules should be taken. of 3 soft capsules (equivalent to 75 mg of diclofenac potassium) over 24 hours.
Flectorgo should be taken for a short period of time.
The duration of treatment should be 3 days.
If symptoms persist or worsen, consult a doctor.
Paediatric population
The use of Flectorgo is not recommended in children and adolescents under 14 years of age.
Elderly
No particular dosage adjustment is necessary.
Given the possible adverse effect profile, the elderly should be monitored with particular care.
Renal impairment
Diclofenac is contraindicated in patients with severe renal impairment.
No dose reduction is necessary in patients with mild to moderate renal impairment.
Caution is advised when administering diclofenac to patients with mild to moderate renal impairment.
Hepatic impairment
Diclofenac is contraindicated in patients with severe hepatic impairment.
No dose reduction is necessary in patients with mild to moderate hepatic function.
Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment.
Method of administration
The soft capsules should be swallowed whole with a drink of water.
The rate of absorption 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.
Undesirable effects can be minimised by administering the lowest effective dose for the shortest duration necessary to control symptoms.
Concomitant use of Flectorgo with other NSAIDs, including selective serotonin reuptake inhibitors (SSRIs), may increase the risk of serious side effects. cyclooxygenase-2 (COX-2), should be avoided given the lack of any evidence demonstrating synergistic benefits and the possibility of additive adverse effects.
On a basic medical basis, caution is advised in the elderly.
In particular, in frail elderly patients or those with a low body weight, the use of the lowest effective dose is recommended.
As with other NSAIDs, with diclofenac, in rare cases, allergic reactions, including anaphylactic/anaphylactoid reactions, may occur even without previous exposure to the drug.
Like other NSAIDs, diclofenac may cause allergic reactions. mask the signs and symptoms of infection due to its pharmacodynamic properties.
Gastrointestinal effects
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment.
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 imperative and particular caution should be exercised when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders, or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation.
The risk of GI bleeding is greater in patients with GI disorders. high with increased doses of NSAIDs and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may 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 likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding).
Caution is advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents, or selective aspirin reuptake inhibitors. serotonin.
Close medical supervision and caution should also be exercised in patients with ulcerative colitis or Crohn's disease as these conditions may be exacerbated.
Hepatic Effects
When prescribing diclofenac to patients with hepatic insufficiency, close medical supervision is necessary as their condition may be exacerbated.
As with other NSAIDs, including diclofenac, the values of one or more of the following NSAIDs may increase: liver enzymes.
During prolonged treatment with diclofenac, regular monitoring of liver function is indicated as a precautionary measure.
If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (e.g., eosinophilia, rash), treatment with diclofenac should be discontinued.
Hepatitis with diclofenac use may occur without prodromal symptoms.
Particular caution should be exercised when using diclofenac in patients with hepatic porphyria, as it may trigger an attack.
Renal effects
Since Fluid retention and edema have been reported in association with NSAID therapy, including diclofenac. Particular caution is required in patients with cardiac or renal insufficiency, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly affect renal function, and those patients with substantial extracellular volume depletion from any cause, e.g., before or after major surgery.
In such cases, monitoring of renal function is recommended as a precaution when administering diclofenac.
Discontinuation of therapy is usually followed by recovery 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.
In the early stages of therapy, patients appear to be more at risk of developing allergic reactions. high 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 sign of hypersensitivity.
SLE and mixed connective tissue disease
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis.
Cardiovascular and cerebrovascular effects
Adequate monitoring and advice are necessary in patients with a history of hypertension and/or mild congestive heart failure (NYHA class I) since Fluid retention and edema have been reported in association with NSAID treatment.
Clinical trial and epidemiological data consistently point to a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high doses (150 mg/day) and in long-term treatment.
Patients with significant risk factors for cardiovascular events (for example hypertension, hyperlipidaemia, diabetes mellitus, smoking) should be treated with diclofenac only 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 symptomatic relief should be re-evaluated periodically.
Pre-existing asthma
In patients with asthma, seasonal allergic rhinitis, mucosal swelling nasal congestion (i.e. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially if associated with symptoms similar to allergic rhinitis), reactions to NSAIDs such as asthma exacerbations (so-called analgesic intolerance/analgesic asthma), Quincke's edema or urticaria, are more frequent than in other patients.
Therefore, special precaution is recommended in such patients (prepare for an emergency).
This also applies to patients allergic to other substances, e.g. with skin reactions, pruritus, or urticaria.
Like other drugs that inhibit the activity of prostaglandin synthase, diclofenac epolamine and other NSAIDs may precipitate bronchospasm if administered to patients suffering 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 may temporarily inhibit platelet aggregation.
Patients with haemostatic defects, haemorrhagic diathesis or haematological abnormalities should be carefully monitored.
Further information
Flectorgo contains sorbitol (E420).
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
The following interactions include those observed with other pharmaceutical forms of diclofenac.
Digoxin, phenytoin, lithium:Concomitant use of Flectorgo and digoxin, phenytoin or lithium may increase the risk of serious side effects. increase the concentration of these drugs in the blood.
Serum lithium concentrations 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 [ACE] inhibitors) may increase the risk of hypertension. 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 consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity.
Concomitant treatment with potassium-sparing drugs may be associated with an increase in serum potassium levels, which should therefore 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 risk of nephrotoxicity. Increase the frequency of gastrointestinal side effects such as gastrointestinal ulcers or bleeding.
Anticoagulants and antiplatelet agents: Caution is recommended as concomitant administration may increase the risk of bleeding.
Although clinical investigations do not appear to indicate that diclofenac affects the action of anticoagulants, there are reports of an increased risk of haemorrhage 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.
Antidiabetics: Clinical studies have shown that diclofenac may increase the risk of gastrointestinal bleeding. Diclofenac can be administered together with oral antidiabetic drugs without influencing their clinical effect.
However, isolated cases of hypoglycaemic and hyperglycaemic effects have been reported which required dosage adjustments of antidiabetic drugs during treatment with diclofenac.
For this reason, monitoring of blood glucose levels 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 recommended when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with methotrexate, since the risk of hypoglycaemic and hyperglycaemic effects is high. Blood concentrations of methotrexate and the toxicity of this substance may increase.
Tacrolimus: nonsteroidal anti-inflammatory drugs (such as diclofenac) may increase the renal toxicity of tacrolimus.
Cyclosporin: diclofenac, like other NSAIDs, may increase the renal toxicity of tacrolimus. increase the nephrotoxicity of ciclosporin due to the effect on renal prostaglandins.
Therefore, it should be administered at lower doses than would be used in patients not treated with ciclosporin.
Quinolone antibacterials: Isolated cases of convulsions have been reported, 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 the administration of colestipol/cholestyramine.
Cardiac glycosides: The concomitant use of cardiac glycosides and NSAIDs in patients with cyclosporine may increase the risk of diclofenac nephrotoxicity. exacerbate heart failure, reduce renal glomerular filtration rate and increase plasma glycoside levels.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration because they may reduce its effect.
Potent CYP2C9 inhibitors: Caution is recommended when prescribing diclofenac concomitantly with potent CYP2C9 inhibitors (such as probenecid, sulfinpyrazone and voriconazole) which may lead to a significant increase in peak plasma concentration and exposure to diclofenac, due to inhibition of its metabolism.
The most common adverse events are: Commonly observed reactions involve the gastrointestinal tract.
Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur.
Adverse reactions (Table 1) are listed in order of frequency, the most frequent first, using the following convention:
Table 1. Tabular list of adverse reactions
| Blood and lymphatic system disorders | |
| Very rare | Thrombocytopenia, leukopenia, pancytopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis |
| Immune system disorders | |
| Rare | Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock) Angioneurotic oedema (including facial oedema) |
| Psychiatric disorders | |
| Very rare | Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions |
| Nervous system disorders | |
| Common | Headache, dizziness |
| Rare | Drowsiness |
| Very rare | Paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident |
| Eye disorders | |
| Very rare | Vision disturbances, blurred vision, diplopia |
| Ear and labyrinth disorders | |
| Common | Vertigo |
| Very rare | Tinnitus, hearing impaired |
| Cardiac disorders | |
| Very rare | Palpitations, chest pain, cardiac failure, myocardial infarction |
| Vascular disorders | |
| Very rare | Hypertension, vasculitis |
| Respiratory, thoracic and mediastinal disorders | |
| Rare | Asthma (including dyspnoea) |
| Very rare | Pneumonia |
| Gastrointestinal disorders | |
| Common | Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia |
| Rare | Gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhoea, 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 disorder, diaphragm-like intestinal stenosis, pancreatitis |
| Not known | Ischemic colitis |
| Hepatobiliary disorders | |
| Uncommon | Increased transaminases |
| Rare | Hepatitis, jaundice |
| Very rare | Hepatic failure |
| Skin and subcutaneous tissue disorders | |
| Common | Rash, pruritus |
| Rare | Urticaria |
| Very rare | Bullous eruptions, 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, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. |
| General disorders and administration site conditions | |
| Rare | Oedema |
Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg/day) and in long term treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Symptoms
There is no typical clinical picture following diclofenac overdose.
Overdose may occur. cause symptoms such as nausea, vomiting, gastrointestinal bleeding, diarrhea, headache, dizziness, drowsiness, tinnitus, unconsciousness, or convulsions.
In cases of significant poisoning, acute renal failure and liver damage are possible.
Hypotension, respiratory depression, and cyanosis may also occur.
Therapeutic measures
Management of acute poisoning with NSAIDs, including diclofenac, consists primarily of supportive measures and symptomatic treatment, which should be adopted for complications such as hypotension, renal failure, convulsions, gastrointestinal disturbance, and respiratory depression.
Specific therapies, such as forced diuresis, dialysis, or hemoperfusion, are unlikely to be helpful in eliminating NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism.
After ingestion of a potentially toxic overdose, serious complications may occur. Consider the use of activated charcoal, while after ingestion of a potentially life-threatening overdose, gastric emptying (e.g. vomiting, gastric lavage) may be considered.
Pregnancy
Inhibition of prostaglandin synthesis may cause adverse 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.
Furthermore, 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 trimesters of pregnancy, Diclofenac should not be administered unless clearly necessary.
If diclofenac is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose should be as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose:
Consequently, Flectorgo is contraindicated during the third trimester of pregnancy.
Breastfeeding
Like other NSAIDs, diclofenac passes into breast milk in small amounts.
Therefore, diclofenac should not be administered during breastfeeding to avoid unwanted effects in the newborn.
Fertility
As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive.
In women who have difficulties conceiving or who are undergoing diagnostic tests for infertility, discontinuation of diclofenac should be considered.
Store below 25°C.
Store in the original package to protect from light and moisture.
20 soft capsules
This product has been on sale since 17/11/2020
In the last 30 days, the product's lowest price was 4,53 €
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