FLECTORGO 20CPS 25MG

IT IS NOT RECOMMENDED TO USE THIS PRODUCT

active ingredients

FLECTORGO 12.5 mg Each soft capsule contains diclofenac in the form of 15.38 mg of epolamine diclofenac equivalent to 12.5 mg of potassium diclofenac. FLECTORGO 25 mg Each soft capsule contains diclofenac in the form of 30.76 mg of epolamine diclofenac equivalent to 25 mg of potax diclofenac. Excipient (i) with known effects: FLECTORGO 12.5 mg Sorbitol (E420) max 8,02 mg per capsule FLECTORGO 25 mg Sorbitol (E420) max 10,07 mg per capsule For the full list of excipients, see paragraph 6.1.

Excellent

Content of the capsule: Macrogol 600 Glicerol Anidro Purified Water Capsula: Gelatina Glicerol anidro Liquid Sorbitol, partially dehydrated (E420) purified water Hydroxypropylbetadex Sodium hydroxide

Therapeutic indications

FLECTORGO is indicated in adults and adolescents aged 14 or over for the short-term symptomatic treatment of: - mild to moderate pain (such as headache, toothache, menstrual pain, rheumatic pain and muscle pain)

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; • Gastric ulcer or active intestinal ulcer, bleeding or perforation; • Alterations of unknown origin of the hemopoiesi; • History of gastrointestinal bleeding or perforation, related to a previous therapy with NSAIDs; • History of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of ulceration or bleeding); • Conclaimed congestive congestive heart failure (NYHA class II-IV), ischemic cardiopathy, peripheral arteriopathy and/or cerebral vasculopathy; • Last trimester of pregnancy (see paragraph 4.6); • Hepatic or serious kidney failure (see paragraph 4.4); • Like other non-steroidal anti-inflammatory drugs (NSAID), diclofenac is also contraindicated in patients where acetylsalicylic acid or other NSAIDs trigger bronchospasm, asthma, hives or acute rhinitis.

Population

Population Undesirable effects can be reduced to a minimum by providing the minimum effective dose for the minimum duration required to control symptoms (see paragraph 4.4). FLECTORGO 12.5 mg Adults and teenagers aged or older than 14 years must start with 1 or 2 soft capsules and continue with 1 or 2 soft capsules every 4 - 6 hours, in need. In any case, you should not take more than 6 soft capsules (equivalent to 75 mg of potassium diclofenac) every 24 hours. FLECTORGO 25 mg Adults and teenagers aged or older than 14 years must start with 1 soft capsule and then continue with 1 soft capsule every 4 - 6 hours, in need. In any case, you should not take more than 3 soft capsules (equivalent to 75 mg of potassium diclofenac) every 24 hours. FLECTORGO must be taken for a short period of time. The duration of treatment must be 3 days. If symptoms persist or worsen, consult a doctor. Pediatric population The use of FLECTORGO is not recommended in children and adolescents under 14 years of age. Seniors No particular adjustment of the dosage is required. In view of the possible side effects, the elderly must be monitored with particular attention (see paragraph 4.4). Year Diclofenac is contraindicated in patients with severe kidney damage (see paragraph 4.3). No dose reduction is required in patients with mild to moderate kidney function. We recommend caution when administering diclofenac to patients with mild to moderate kidney damage (see paragraph 4.4). Epathetic Comprogation Diclofenac is contraindicated in patients with severe liver impairment (see paragraph 4.3). No dose reduction is required in patients with mild to moderate liver function. It is recommended caution when administering diclofenac to patients with mild to moderate liver impairment (see paragraph 4.4). Method of administration Soft capsules must be swallowed whole with a sip of water. The absorption rate of diclofenac is reduced when FLECTORGO is taken with food. It is therefore recommended not to take soft capsules during or immediately after meals.

Conservation

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

Warnings

General Undesirable effects can be reduced to a minimum by providing the minimum effective dose for the minimum duration needed to control symptoms (see paragraph 4.2 and below paragraphs on gastrointestinal and cardiovascular effees). Concurrent use of FLECTORGO with other NSAIDs, including selective cyclooxygenase-2 inhibitors (COX-2), must be avoided in view of the lack of any evidence showing synergistic benefits and the possibility of additional side effects (see paragraph 4.5). On the basic medical level it is required caution in the elderly. In particular, in fragile elderly patients or those with low body weight, it is recommended to use the minimum effective dose. As with other NSAIDs, with diclofenac, in rare cases, allergic reactions can occur, including anaphylactic/anaphylactic reactions, even without a previous exposure to the drug. Hypersensitivity reactions can also evolve into Kounis syndrome, a severe allergic reaction that can cause myocardial infarction. The current symptoms of such reactions may include chest pain that occurs in association with an allergic reaction to diclofenac. Like other NSAIDs, diclofenac may mask signs and symptoms of infection due to its pharmacodynamic properties. Gastrointestinal effects During treatment with all NSAIDs, including diclofenac, have been reported and may appear at any time, bleeding, ulceration or gastrointestinal perforation, which may be fatal, with or without warning symptoms or previous history of serious gastrointestinal events. They usually have more serious consequences in the elderly. If in patients in diclofenac therapy bleeding or gastrointestinal ulceration occur, the drug must be stopped. As with all NSAIDs, including diclofenac, strict medical supervision and special caution must be used in prescribing diclofenac to patients with indicative symptoms of gastrointestinal disorders (GI) or with an indicative history of ulceration, bleeding or gastric or intestinal perforation (see paragraph 4.8). The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with ulcer history, especially if complicated by hemorrhage or perforation. The elderly have a greater frequency of adverse reactions to the NSAIDs, especially bleeding and gastrointestinal perforation that can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, especially if complicated by hemorrhage or perforation, and in the elderly, treatment should be started and maintained with the minimum effective dose. Concurrent use of protective agents (e.g. protonic or misoprostol pump inhibitors) must be considered for these patients and also for patients requiring concomitant use of medicines containing low doses of acetylsalicylic acid (ASA) or other drugs that may increase gastrointestinal risk (see paragraph 4.5). Patients with GI toxicity history, especially seniors, must report any unusual abdominal symptoms (especially GI hemorrhage). Caution is recommended in patients taking concomitant medicines that could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-aggregating agents or selective serotonin reuptake inhibitors (see paragraph 4.5). Even in patients with ulcerative colitis or Crohn's disease, strict medical and caution must be exercised as such conditions may be exacerbated (see paragraph 4.8). NSAIDs, including diclofenac, may be associated with an increase in the risk of gastrointestinal anastomosis. It is recommended to have close medical and caution when using diclofenac as a result of gastrointestinal surgery. Hepatitis effects In case of prescription of diclofenac to patients suffering from liver failure it is necessary close medical surveillance, as their condition can be exacerbated. As with other NSAIDs, including diclofenac, can increase the values of one or more liver enzymes. During prolonged treatments with diclofenac, regular precautionary control of liver function is indicated. If abnormal parameters of liver function persist or worsen, if clinical signs or consistent symptoms of hepatopathy develop, or if other manifestations occur (e.g. eosinophilia, rash), diclofenac treatment must be stopped. Hepatitis with the use of diclofenac can occur without prodromic symptoms. Particular caution is needed in the use of diclofenac in patients with liver porphyria, as it could trigger an attack. Renal effects Since in association with NSAID therapy, including diclofenac, fluid and edema retention is necessary special caution in case of heart or kidney failure, history of hypertension, in the elderly, in patients in concomitant treatment with diuretics or medicines that can significantly affect kidney function and in those patients with a substantial depletion of extracellular volume due to any cause, e.g. greater or after surgery. In such cases, when diclofenac is administered, it is recommended to precaution the monitoring of kidney function. The interruption of therapy is normally 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 sign of hypersensitivity. LES and mixed connective tissue disease In patients with systemic erythematose lupus (LES) and mixed connective tissue disorders there may be a greater risk of aseptic meningitis (see paragraph 4.8). Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are required in patients with a history of hypertension and/or mild congestive heart failure (Class I of NYHA) since, in association with NSAID treatment, fluid and edema retention were found. Clinical experiments and epidemiological data consistently indicate a slight increase in the risk of arterial thrombotic events (e.g. myocardial or stroke infarction) associated with the use of diclofenac, especially at high doses (150 mg/die) and long-term treatment. Patients who present significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking) should be treated with diclofenac only after careful consideration. Since cardiovascular risks of diclofenac can increase with the dose and duration of exposure, you must use the minimum effective daily dose for the minimum duration possible. The response to therapy and the need for improved symptoms must be reassessed periodically. Pre-existing asthma In patients with asthma, seasonal allergic rhinitis, nasal mucosa swelling (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic respiratory tract infections (especially if related to symptoms similar to allergic rhinitis), reactions to NSAIDs such as as asthma exacerbations (so-called analgesic intolerance/asthma by analgesics), more orthic edema. Special precaution is therefore recommended in such patients (to prepare for emergency). This also applies to patients allergic to other substances, e.g. with skin, itching or hives. Like other drugs that inhibit the activity of synthetic prostaglandin, diclofenac epolamina and other NSAIDs can precipitate bronchospasm if administered to patients suffering from it or with pre-gress anamnesi of bronchial asthma. Ematologic effects FLECTORGO is intended for short-term use. During prolonged treatment with diclofenac, as with other NSAIDs, blood count monitoring is recommended. Like other NSAIDs, diclofenac can temporarily inhibit platelet aggregation. Patients with hemostasis defects, hemorrhagic diathesis or hematological abnormalities must be carefully monitored (see paragraph 4.5). Other information This medicine contains, respectively, a maximum of 8.02 mg and 10.07 mg of sorbitol in each capsule of 12.5 mg and 25 mg. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medicines co- administered. This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘without sodium’.

Interactions

The following interactions include those observed with other pharmaceutical forms of diclofenac. Digoxin, phenytoin, lithium: the concomitant use of FLECTORGO and digoxin, phenytoin or lithium can increase the concentration of these medicines in the blood. It is necessary to monitor the serum concentration of lithium. Monitoring of serum concentrations of digoxin and phenytoin is recommended. Diuretics and antihypertensive agents: as for other NSAIDs, the concomitant use of diclofenac with diuretics or antihypertensives (e.g. beta-blockers, inhibitors of angiotensin conversion enzyme [ACE]) may cause a reduction in their antihypertensive effect. Therefore, the association must be administered with caution and in patients, especially in the elderly, the blood pressure must be monitored periodically. Patients should be properly hydrated and renal function monitoring should be taken into account after the start of the concomitant therapy and subsequently at periodic expiry, especially for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity (see paragraph 4.4). Concurrent treatment with potassium-saving drugs can be associated with an increase in serum potassium levels, which therefore must be monitored frequently. Other NSAIDs including selective cyclooxygenase-2 inhibitors and corticosteroids: concurrent administration of diclofenac and other systemic or corticosteroid NSAIDs can increase the frequency of unwanted gastrointestinal effects such as gastrointestinal ulcers or bleeding (see paragraph 4.4). Antiagulants and antiplatelet agents: caution is recommended since concurrent administration could increase the risk of bleeding (see paragraph 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 hemorrhage in patients treated with diclofenac in conjunction with anticoagulants. Therefore, careful monitoring of these patients is recommended. Selective serotonin reuptake inhibitors (SSRI): concomitant administration of systemic NSAIDs, including diclofenac, and SSRI may increase the risk of gastrointestinal bleeding (see paragraph 4.4). Antidiabetics: clinical studies showed that diclofenac can be administered along with oral antidiabetics without affecting the clinical effect. However, isolated cases of hypoglycemic and hyperglycemic effects have been reported which have made necessary changes in the dosage of antidiabetics during treatment with diclofenac. For this reason, it is recommended to monitor the blood glucose level as a precautionary measure during concurrent therapy. Metotressed: diclofenac can inhibit the tubular renal clearance of metotressate, thus increasing the levels of the latter. It is recommended caution when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with metotressate, since hematic concentrations of metotressate and toxicity of this substance may increase. Tacrolimus: non-steroidal anti-inflammatory drugs (such as diclofenac) can increase renal toxicity of tacrolimus. Ciclosporin: diclofenac, like other NSAIDs, can increase the nephrotoxicity of cyclosporin due to the effect on kidney prostaglandins. Therefore, it should be administered at lower doses than those that would be used in patients not treated with cyclosporin. Antibacterial kinolonic: isolated cases of seizures were reported, which could be due to the concomitant use of chinoloni and NSAIDs. Colestipolo e colestiramina: these drugs may lead to delay or decrease in diclofenac absorption. Therefore, it is recommended to administer diclofenac at least one hour before or 4-6 hours after administration of choleestipol/colestiramine. Heart glycosides: concurrent use of heart glycosides and NSAIDs in patients can exacerbate heart failure, reduce renal glomerular filter and increase plasma levels of glycosides. Mifepristone: nSAIDs should not be used for 8-12 days after mifepristone administration because they can reduce their effect. Powerful inhibitors of CYP2C9: it is recommended caution when prescribing diclofenac in conjunction with powerful inhibitors of CYP2C9 (such as probenecid, sulpirazone and voriconazole) that could result in a significant increase in the plasma concentration of peak and exposure to diclofenac, due to the inhibition of its metabolism.

Effects

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

Emolinfopoietic system pathologies
Very rare	Trombocytopenia, leucopenia, pancitopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis
Immune system disorders
Rare	Hypersensitivity, anaphylactic and anaphylactic reactions (including hypotension and shock) Anjourotic edema (including facial edema)
Psychiatric disorders
Very rare	Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions
Diseases of the nervous system
Town	Kefalea, dizziness
Rare	Sleep
Very rare	Parestesia, impairment of memory, seizures, anxiety, tremors, aseptic meningitis, alterations of taste, cerebrovascular accidents
Pathologies of the eye
Very rare	Disorders of vision, blurred vision, diplopia
Ear and labyrinth pathologies
Town	Vertigo
Very rare	Tinnitus, worsening hearing
Heart disease
Very rare	Palpitations, chest pain, heart failure, myocardial infarction
Notable	Kounis Syndrome
Vascular diseases
Very rare	Hypertension, vasculitis
Respiratory, chest and mediastinic pathologies
Rare	Asthma (including dispnea)
Very rare	Polmonitis
Gastrointestinal diseases
Town	Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia
Rare	Gastrites, gastrointestinal hemorrhage, hematogenesis, hemorrhagic diarrhea, melena, gastrointestinal ulcer (with or without bleeding or perforation)
Very rare	Colite (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, diaphragm-like intestinal stenosis, pancreatis
Notable	Ischetical Colite
Hepatobiliary diseases
Not common	Increase in transaminers
Rare	Hepatitis, jaundice
Very rare	Epathetic insufficiency
Pathologies of skin and subcutaneous tissue
Town	Skin rash, itching
Rare	Orticaria
Very rare	Bollose eruptions, eczema, erythema, multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis ( Lyell syndrome), exfoliatory dermatitis, alopecia, photosensitivity reaction, purple, allergic purple
Kidney and urinary pathologies
Very rare	Acute renal insufficiency, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, kidney papillar necrosis.
Systemic pathologies and conditions for administration
Rare	Edema

Clinical experiments and epidemiological data consistently indicate an increase in the risk of arterial thrombotic events (e.g. myocardial or stroke infarction) associated with the use of diclofenac, especially at high doses (150 mg/die) and long-term treatment (see paragraphs 4.3 and 4.4) Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Synonyms There is no typical clinical picture resulting from overdose of diclofenac. Overdose can cause symptoms such as nausea, vomiting, gastrointestinal bleeding, diarrhea, headache, dizziness, drowsiness, tinnitus, unconsciousness or seizures. In case of significant poisoning, acute kidney failure and liver damage are possible. Hypotension, respiratory depression and cyanosis may also occur. Therapeutic measures The management of acute overdose by NSAIDs, including diclofenac, consists essentially of support measures and symptomatic treatment, which must be adopted for complications such as hypotension, kidney failure, seizures, gastrointestinal disorder and respiratory depression. Specific therapies, such as forced diuresis, dialysis or hemoperfusion are probably not of help in eliminating NSAIDs, including diclofenac, due to their strong link to plasma proteins and their high metabolism. After the ingestion of a potentially toxic overdose, it can be considered the use of activated carbon, while after the ingestion of a potentially dangerous overdose for life, gastric emptiness (e.g. vomiting, gastric lavender).

Pregnancy

Inhibition of prostaglandin synthesis can lead to negative effects on pregnancy and/or embryo/fetal development. The data of epidemiological studies suggest an increase in the risk of miscarriage and heart and gastroschisis malformation after the use of an inhibitor of the synthesis of prostaglandins in the early stages of pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to a maximum of 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has shown to cause an increase in pre- and post-system loss and embryo-fetal mortality. Moreover, a greater incidence of various malformations has been reported, including cardiovascular malformations, in animals treated with an inhibitor of the synthesis of prostaglandins during the period of organgenesis. From the 20th week of pregnancy onwards, the use of diclofenac could cause oligoidramnios resulting from fetal kidney dysfunction. This condition may be found shortly after the start of treatment and is usually reversible with the termination of treatment. Moreover, cases of constriction of the arterial duct were reported following treatment in the second trimester of pregnancy, most of which disappeared after the termination of treatment. Therefore, during the first and second trimester of pregnancy, diclofenac should not be administered if not clearly necessary. If diclofenac is used by a woman who is trying to conceive or during the first and second trimester of pregnancy, the dose must be as low as possible and the duration of treatment must be as short as possible. After exposure to diclofenac for several days from the 20th week of gestation onwards, it should be considered an antenatal monitoring of oligoidramnios and the constriction of arterial duct. In case of oligoidramnios or constriction of arterial duct, treatment with diclofenac must be stopped. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose: • the

fetus

a cardiopulmonary toxicity (premature constriction/closing of arterial duct and pulmonary hypertension) and renal dysfunction, which can progress to kidney failure with oligo-idroamnios (see above); • the

mother and newborn

, at the end of pregnancy, to a possible extension of bleeding time and an anti-aggregating effect that can also occur at very low doses, as well as the inhibition of uterine contractions resulting in delayed or prolonged labor. As a result, FLECTORGO is contraindicated during the third trimester of pregnancy (see paragraphs 4.3 and 5.3).

Food

Like other NSAIDs, diclofenac passes in small amounts in breast milk. Therefore, diclofenac should not be administered during breastfeeding to avoid unwanted effects in the newborn.

Fertility

As with other NSAIDs, the use of diclofenac can compromise female fertility and is not recommended in women seeking to conceive. In women who have difficulty in conceiving or undergoing diagnostic tests for infertility, diclofenac suspension should be considered.

Source: Farmadati