Active ingredients: Lysine acetylsalicylate
FLECTADOL 500 mg powder for oral solution
FLECTADOL 1000 mg powder for oral solution
Flectadol package inserts are available for pack sizes: - FLECTADOL 500 mg powder for oral solution, FLECTADOL 1000 mg powder for oral solution
- FLECTADOL 500 mg / 2.5 ml powder and solvent for solution for injection, FLECTADOL 1 g / 5 ml powder and solvent for solution for injection
Why is Flectadol used? What is it for?
Pharmacotherapeutic group
Other analgesics and antipyretics, salicylic acid and derivatives.
Therapeutic indications
Pain of any nature and entity. Acute joint rheumatism and its complications. Primary and secondary degenerative arthropathies. Myalgia.
Contraindications When Flectadol should not be used
- Hypersensitivity to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) (cross-reactivity) or to any of the excipients.
- History of asthma induced by administration of acetylsalicylates or substances with similar activity, especially non-steroidal anti-inflammatory drugs
- Third trimester of pregnancy (beyond 24 weeks of gestation) (see - Pregnancy and breastfeeding)
- Active peptic ulcer
- Any constitutional or acquired hemorrhagic disease
- Bleeding risk
- Severe hepatic insufficiency
- Severe renal insufficiency (ClCr
- Severe, uncontrolled heart failure
- Co-administration of methotrexate used at doses> 15 mg / week with acetylsalicylic acid at anti-inflammatory or analgesic or antipyretic doses (see Interactions)
- Co-administration of oral anticoagulants with acetylsalicylic acid used at anti-inflammatory doses, or at analgesic or antipyretic doses and in patients with a history of gastro-duodenal ulcers (see Interactions).
- Patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid can induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).
The medicine is contraindicated in children and young people under the age of sixteen. Hypersensitivity to salicylates. The drug is contraindicated in intensive diuretic therapy, haemorrhagic diathesis, during anticoagulant treatments as it synergizes its action.
Precautions for use What you need to know before taking Flectadol
Use with caution in cases of asthma and in patients with mild and moderate hepatic insufficiency. Alcohol may increase the risk of gastrointestinal injury and prolong bleeding time when taken together with acetylsalicylic acid. Therefore, alcoholic beverages should be used with caution by patients during and for 36 hours after taking acetylsalicylic acid (see " Interactions ").
In patients receiving varicella vaccine the use of acetylsalicylic acid should be avoided for 6 weeks following vaccination (see Interactions).
Interactions Which drugs or foods can modify the effect of Flectadol
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Several substances are involved in interactions due to their properties to inhibit platelet aggregation:
Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, ticlopidine and tirofiban.
The use of different inhibitors of platelet aggregation increases the risk of bleeding, as does their combination with heparin or related molecules, oral anticoagulants or with other thrombolytics, and this possibility must be considered, maintaining regular clinical monitoring.
Contraindicated combinations (see Contraindications):
- Methotrexate at doses> 15 mg / week at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid).
- Oral anticoagulants at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid and in patients with a history of gastro-duodenal ulcer: increased risk of bleeding.
Combinations not recommended:
- Oral anticoagulants at analgesic or antipyretic doses of acetylsalicylic acid and in patients with no history of gastro-duodenal ulcer: increased risk of bleeding.
- Oral anticoagulants at doses of acetylsalicylic acid used for the inhibition of platelet aggregation and in patients with a history of gastro-duodenal ulcer: increased risk of bleeding.
- Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.
- Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses in elderly patients (≥ 65 years), regardless of heparin dose, and for anti-inflammatory doses of acetylsalicylic acid or for analgesic or antipyretic doses of acid acetylsalicylic: increased risk of bleeding (inhibition of platelet aggregation and lesion of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory drug or another analgesic or antipyretic should be given.
- Clopidogrel (in addition to the approved indications for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. If co-administration cannot be avoided, clinical monitoring is recommended.
- Uricosurics (benzbromarone, probenecid): reduction of the uricosuric effect due to competition for the elimination of uric acid in the renal tubules.
- Ticlopidine: increased risk of bleeding. If co-administration cannot be avoided, clinical monitoring is recommended.
- Glucocorticoids (except hydrocortisone replacement therapy) for anti-inflammatory doses of acetylsalicylic acid: increased risk of bleeding.
- Pemetrexed in patients with mild or moderate renal insufficiency (creatinine clearance between 45 ml / min and 80 ml / min): increased risk of toxicity of pemetrexed (due to the reduced renal clearance of pemetrexed by acetylsalicylic acid) at doses anti-inflammatory drugs of acetylsalicylic acid.
Associations requiring precautions for use:
- Diuretics, angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists at anti-inflammatory or analgesic and antipyretic doses of acetylsalicylic acid: acute renal failure may occur in dehydrated patients due to reduced glomerular filtration rate secondary to decreased renal prostaglandin synthesis. Reduction of the antihypertensive effect may also occur. Make sure the patient is hydrated and that kidney function is checked at the start of treatment.
- Methotrexate at doses ≤ 15 mg / week at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid) Blood cell counts should be checked weekly during the first few weeks of concomitant administration.Careful monitoring is required in patients with (even mild) renal insufficiency, as well as in elderly patients.
- Methotrexate at doses> 15 mg at doses of acetylsalicylic acid used for inhibition of platelet aggregation: increased toxicity of methotrexate, particularly haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid). Blood cell counts should be checked weekly during the first few weeks of co-administration.Careful monitoring is required in patients with (even mild) renal insufficiency, as well as in elderly patients.
- Clopidogrel (in the approved indications for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. Clinical monitoring is recommended.
- Topical gastrointestinal, antacids and charcoal: increased renal excretion of acetylsalicylic acid due to alkalinization of the urine. It is recommended that gastrointestinal topicals and antacids be administered at least 2 hours away from acetylsalicylic acid.
- Pemetrexed in patients with normal renal function: increased risk of pemetrexed toxicity (due to reduced renal clearance of pemetrexed by acetylsalicylic acid) at anti-inflammatory doses of acetylsalicylic acid. Renal function should be monitored.
- Low molecular weight heparins (and related molecules) and unfractionated heparins, at preventive doses in patients under 65 years of age: the co-administration of drugs that act at different levels of haemostasis increases the risk of bleeding. Therefore, in patients less than 65 years of age, co-administration of preventive dose heparins (or related molecules), and acetylsalicylic acid, regardless of dose, should be evaluated, maintaining clinical and laboratory monitoring. , when necessary.
- Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses or in elderly patients (≥ 65 years), regardless of the dose of heparin, and for doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increase the risk of haemorrhage (inhibition of platelet aggregation and lesion of the gastroduodenal mucosa by acetylsalicylic acid).
- Thrombolytics: increased risk of bleeding.
- Oral anticoagulants at doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of haemorrhage.
- Other non-steroidal anti-inflammatory drugs (NSAIDs) with doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of gastrointestinal ulcers and bleeding.
- Glucocorticoids (except hydrocortisone for replacement therapy) for analgesic and antipyretic doses of acetylsalicylic acid: increased risk of haemorrhage.
- Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): increased risk of bleeding.
- Acetazolamide: Caution is advised in case of concomitant administration of salicylates and acetazolamide as there is an increased risk of metabolic acidosis.
- Chickenpox vaccine: It is recommended that patients who have received chickenpox vaccination should not be given salicylates for a period of six weeks after vaccination. Cases of Reye's syndrome have occurred as a result of the use of salicylates during chickenpox infection.
- Alcohol: when taken together with acetylsalicylic acid, alcohol can increase the risk of gastrointestinal lesions and prolong bleeding time. Therefore, alcoholic beverages should be taken with caution by patients during and for 36 hours after taking acetylsalicylic acid ( see "Precautions for use").
The medicine can interact with:
- hypoglycemic sulfonylureas;
- anti-rejection drugs (eg cyclosporine, tacrolimus);
- ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly;
- metamizole when taken concomitantly with acetylsalicylic acid can reduce its effect on platelet aggregation.
Warnings It is important to know that:
This medicine should not be used in children and young people under the age of 16 (see Contraindications). The 1 g sachets of powder for oral solution are not suitable for use in children weighing less than 50 kg.
The 500 mg sachets of powder for oral solution are not suitable for use in children weighing less than 30 kg in the analgesic and antipyretic indications, and in children weighing less than 20 kg in the anti-inflammatory (rheumatic) indications.
People over the age of 70, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor. If prolonged vomiting and profound drowsiness occur during treatment, discontinue administration. The pre-operative use can hinder intraoperative haemostasis. For the interaction with the arachidonic acid, the drug can cause in asthmatics and predisposed subjects, crises of bronchospasm and possibly shock and other allergic phenomena.
Use with caution in cases of asthma and in patients with mild and moderate hepatic insufficiency.
- In case of co-administration with other medicines, in order to avoid any risk of overdose, make sure that acetylsalicylic acid is absent from the composition of the other medicines.
- Reye's syndrome, a very rare and life-threatening disease, has been observed in children and adolescents with signs of viral infection (particularly chicken pox and flu-like episodes) who were taking acetylsalicylic acid. Consequently, acetylsalicylic acid should be administered to children and adolescents with these conditions following medical warnings, when other treatments have failed. In case of persistent vomiting, disturbed consciousness or abnormal behavior, treatment with acetylsalicylic acid should be discontinued.
- In children under 1 month of age, the administration of acetylsalicylic acid is justified only in specific situations and on medical prescription.
- In case of long-term administration of analgesics in high doses, the onset of headache should not be treated with higher doses.
- Regular use of analgesics, particularly the combination of analgesics, can lead to persistent kidney damage, with the risk of kidney failure.
- In patients with G6PD deficiency, acetylsalicylic acid should be administered under careful medical supervision due to the risk of haemolysis (see Undesirable effects).
- Treatment monitoring should be strengthened in the following cases:
- in patients with a history of gastric or duodenal ulcer, or gastrointestinal bleeding, or gastritis
- in patients with renal insufficiency
- in patients with hepatic insufficiency
- in patients with asthma: the occurrence of an asthma attack, in some patients, may be linked to an allergy to non-steroidal anti-inflammatory drugs or to acetylsalicylic acid, in this case, this medicine is contraindicated (see Contraindications)
- in patients with metrorrhagia or menorrhagia (risk of increasing the volume and duration of menstrual periods)
- Gastrointestinal bleeding or ulcers / perforations can occur at any time during treatment, without necessarily the presence of recent signs or a history in the patient. The relative risk is increased in elderly subjects, in subjects with low body weight, and in patients treated with anticoagulants or platelet aggregation inhibitors (see Interactions). In case of gastrointestinal bleeding, treatment should be stopped immediately.
- In consideration of the inhibitory effect of acetylsalicylic acid on platelet aggregation, which occurs even at very low doses and which persists for several days, the patient must be warned of the risk of haemorrhage in the event of surgery, even of a minor nature ( e.g. tooth extraction).
- At analgesic or antipyretic doses, acetylsalicylic acid inhibits the excretion of uric acid; at the doses used in rheumatology (anti-inflammatory doses), acetylsalicylic acid has a uricosuric effect.
- At high doses used in rheumatology (anti-inflammatory doses), patients should be monitored for the possible occurrence of symptoms of overdose. In case of ringing in the ears, hearing difficulties or dizziness, the treatment modalities should be re-evaluated. In children, it is recommended to monitor for salicilism, especially at the start of treatment.
- The use of this medicine is not recommended during breastfeeding (see Pregnancy and breastfeeding)
- There is evidence that the drug, by inhibiting cyclo-oxygenase / prostaglandin synthesis, may cause a reduction in female fertility through an effect on ovulation. This effect is reversible on discontinuation of the drug.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Low doses below 100 mg / day:
Clinical studies indicate that acetylsalicylic acid at doses below 100 mg / day appears to be safe only in extremely limited obstetric cases, which require specialist monitoring.
Doses between 100 and 500 mg / day:
There are insufficient clinical data regarding the use of acetylsalicylic acid at doses between 100 mg / day and up to 500 mg / day. Therefore, the recommendations below for doses of 500 mg / day and above also apply to this range. dosage (see paragraph below).
Doses of 500 mg / day and more:
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first 24 weeks of pregnancy, acetylsalicylic acid should not be administered except in strictly necessary cases.
If acetylsalicylic acid is used by a woman attempting to conceive or during the first 24 weeks of pregnancy, the dose and duration of treatment should be kept as low as possible.
Beyond 24 weeks of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios.
At the end of pregnancy, the mother and the newborn may have:
- prolongation of bleeding time due to inhibition of platelet aggregation, which can occur even after administration of very low doses of acetylsalicylic acid
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy (after 24 weeks of gestation) (see Contraindications).
Feeding time
Acetylsalicylic acid passes into breast milk: acetylsalicylic acid is therefore not recommended during breastfeeding.
Effects on ability to drive and use machines
No effects on the ability to drive or use machines have been observed.
Dosage and method of use How to use Flectadol: Dosage
1-2 sachets 2-3 times a day for the dosage of 500 mg and 1 sachet 2-3 times a day for the dosage of 1000 mg, or according to medical prescription.
In the treatment of elderly patients, the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
Pour the contents of the sachet into a glass, add water, shake a few seconds and drink.
FLECTADOL sachets should be taken on a full stomach, particularly when it is necessary to administer the medicine in high doses for prolonged periods of time.
Overdose What to do if you have taken too much Flectadol
No cases of overdose have been reported.
The toxic doses for acetylsalicylic acid are between 200 mg / kg and 300 mg / kg for oral administration.
The risk of overdose is important in the elderly and particularly in young children (therapeutic overdose or, more frequently, accidental intoxication), where it can be fatal. Non-cardiogenic pulmonary edema may occur with acute and chronic overdose of acetylsalicylic acid (see Undesirable Effects).
Symptoms
- Moderate poisoning: ringing in the ears, feeling of decreased hearing acuity, headache and dizziness are indicative of overdose and can be controlled by a reduction in dosage.
- Severe poisoning: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia.
In children, an overdose can be fatal as early as 100 mg / kg in a single intake.
Overdose with salicylates, particularly in young children, can lead to severe hypoglycemia and potentially fatal intoxication.
Emergency management
- Immediate transfer to a specialized hospital unit
- Gastric lavage and administration of activated charcoal
- Control of acid-base balance
- Urine alkalinization with urine pH monitoring
- Hemodialysis in cases of severe poisoning
- Symptomatic treatment.
In case of accidental ingestion / intake of an overdose of FLECTADOL sachets, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of FLECTADOL sachets, ask your doctor or pharmacist.
Side Effects What are the side effects of Flectadol
Like all medicines, FLECTADOL sachets can cause side effects, although not everybody gets them.
Frequencies cannot be reliably estimated from the available data. Therefore the frequencies are listed as "not known".
- Disorders of the blood and lymphatic system: hemorrhagic syndromes (epistaxis, bleeding of the gums, purpura, etc.) with an increase in bleeding time. The risk of bleeding may persist for 4-8 days after discontinuation of acetylsalicylic acid. It may cause an increased risk of bleeding in the event of surgery. Intracranial and gastrointestinal bleeding may also occur. Intracranial bleeding could be fatal, especially when the drug is given to the elderly. Thrombocytopenia. Haemolytic anemia in patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency (see Special warnings). Pancytopenia, bilinear cytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leukopenia.
- Immune system disorders: hypersensitivity reactions, anaphylactic reactions, asthma, angioedema.
- Nervous system disorders: headache, dizziness, sensation of hearing loss, tinnitus, which are usually indicative of an overdose. Intracranial haemorrhage which can be fatal, especially in the elderly.
- Gastrointestinal disorders: abdominal pain, occult or overt gastrointestinal bleeding (haematemesis, melaena, etc.) with consequent iron deficiency anemia. The risk of bleeding is dose dependent.
- Upper gastrointestinal disorders: esophagitis, erosive duodenitis, erosive gastritis, esophageal ulcers, ulcers, perforations.
- Diseases of the lower gastrointestinal tract: ulcers of the small (jejunum and ileus) and large intestine (colon and rectum), colitis and intestinal perforations. These reactions may or may not be associated with haemorrhage and may occur with any dose of acetylsalicylic acid and in patients with or without predictive symptoms and with or without a history of serious gastrointestinal events. Acute pancreatitis in the context of a hypersensitivity reaction to acetylsalicylic acid.
- Hepatobiliary disorders: increased liver enzymes, liver damage, especially hepatocellular, chronic hepatitis.
- Skin and subcutaneous tissue disorders: urticaria, skin reactions, fixed eruptions.
- General disorders and administration site conditions: Reye's syndrome (see Special Warnings).
- Respiratory, thoracic and mediastinal disorders: non-cardiogenic pulmonary edema during chronic use and in a context of hypersensitivity reaction to acetylsalicylic acid
- Renal and urinary disorders: renal failure
- Vascular disorders: vasculitis including Schönlein-Henoch purpura.
- Cardiac disorders: Kounis syndrome in the context of a hypersensitivity reaction to acetylsalicylic acid.
- Reproductive system and breast disorders: Not known: haematospermia.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use after the expiry date shown on the package.
KEEP IN THE ORIGINAL PACKAGING AT TEMPERATURE NOT EXCEEDING 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
Deadline "> Other information
Composition
One sachet of FLECTADOL 500 contains:
Active ingredient: lysine acetylsalicylate 900 mg (equal to 500 mg of acetylsalicylic acid)
Excipients: glycocol, mandarin aroma, glycyrrhized ammonium.
One sachet of FLECTADOL 1000 contains:
Active ingredient: 1800 mg lysine acetylsalicylate (equal to 1000 mg of acetylsalicylic acid)
Excipients: glycocol, mandarin aroma, glycyrrhized ammonium.
Pharmaceutical form and content
Water-soluble powder for oral use
500 mg powder for oral solution
- 20 sachets
1000 mg powder for oral solution
- 10 sachets
- 20 sachets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
FLECTADOL POWDER FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
FLECTADOL 500
One sachet contains
lysine acetylsalicylate 0.9 g
(equal to 0.5 g of acetylsalicylic acid)
FLECTADOL 1000
One sachet contains
lysine acetylsalicylate 1.8 g
(equal to 1 g of acetylsalicylic acid)
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM -
Sachets.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Pain of any nature and entity. Acute joint rheumatism and its complications. Primary and secondary degenerative arthropathies. Myalgia.
04.2 Posology and method of administration -
FLECTADOL 500
1-2 sachets 2-3 times a day or according to medical prescription.
FLECTADOL 1000
1 sachet 2-3 times a day or according to medical prescription.
How to use
Pour the powder into a glass, add water, shake a few seconds and drink. The oral use preparations must be taken on a full stomach.
In the treatment of elderly patients, the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
04.3 Contraindications -
• Hypersensitivity to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) (cross-reactivity) or to any of the excipients listed in section 6.1.
• History of asthma induced by administration of acetylsalicylates or substances with similar activity, especially non-steroidal anti-inflammatory drugs
• Third trimester of pregnancy (beyond 24 weeks of gestation) (see section 4.6)
• Active peptic ulcer
• Any constitutional or acquired bleeding disease
• Bleeding risk
• Severe hepatic insufficiency
• Severe renal insufficiency (ClCr
• Severe, uncontrolled heart failure
• Co-administration of methotrexate used at doses> 15 mg / week with acetylsalicylic acid at anti-inflammatory doses, or at analgesic or antipyretic doses (see section 4.5)
• Co-administration of oral anticoagulants with acetylsalicylic acid used at anti-inflammatory, analgesic or antipyretic doses and in patients with a history of gastro-duodenal ulcers (see section 4.5).
• Patients with pre-existing mastocytosis, in whom the use of acetylsalicylic acid can induce severe hypersensitivity reactions (including circulatory shock with flushing, hypotension, tachycardia and vomiting).
The use of this medicine is contraindicated in children and young people under the age of sixteen.
Hypersensitivity to salicylates.
The drug is contraindicated in the course of intensive diuretic therapy, haemorrhagic diathesis, in the course of treatments with anticoagulants as it synergizes their action.
04.4 Special warnings and appropriate precautions for use -
This medicinal product should not be used in children and young people under the age of 16 (see section 4.3).
The 1 g sachets of powder for oral solution are not suitable for use in children weighing less than 50 kg.
The 500 mg sachets of powder for oral solution are not suitable for use in children weighing less than 30 kg in the analgesic and antipyretic indications, and in children weighing less than 20 kg in the anti-inflammatory (rheumatic) indications.
People over the age of 70, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor.
If prolonged vomiting and profound drowsiness occur during treatment, discontinue administration.
Preoperative use can hinder intraoperative haemostasis.
For the interaction with the metabolism of arachidonic acid, the drug can cause in asthmatics and predisposed subjects, crises of bronchospasm and possibly shock and other allergic phenomena.
Use with caution in cases of asthma and in patients with mild and moderate hepatic insufficiency.
• In case of co-administration with other medicines, in order to avoid any risk of overdose, make sure that acetylsalicylic acid is absent from the composition of the other medicines.
• Reye's syndrome, a very rare and life-threatening disease, has been observed in children and adolescents with signs of viral infection (particularly chicken pox and flu-like episodes) who were taking acetylsalicylic acid. Consequently, acetylsalicylic acid should be administered to children and adolescents with these conditions following medical warnings, when other treatments have failed. In case of persistent vomiting, disturbed consciousness or abnormal behavior, treatment with acetylsalicylic acid should be discontinued.
• In children under 1 month of age, the administration of acetylsalicylic acid is justified only in specific situations and on medical prescription.
• In case of long-term administration of analgesics in high doses, the onset of headache should not be treated with higher doses.
• Regular use of analgesics, particularly the combination of analgesics, can lead to persistent kidney damage, with the risk of kidney failure.
• In patients with G6PD deficiency, acetylsalicylic acid should be administered under careful medical supervision due to the risk of haemolysis (see section 4.8).
• Treatment monitoring should be strengthened in the following cases:
- in patients with a history of gastric or duodenal ulcer, or gastrointestinal bleeding, or gastritis
- in patients with renal insufficiency
- in patients with hepatic insufficiency
- in patients with asthma: the occurrence of an asthma attack, in some patients, may be linked to an allergy to non-steroidal anti-inflammatory drugs or to acetylsalicylic acid, in this case, this medicinal product is contraindicated (see section 4.3 )
- in patients with metrorrhagia or menorrhagia (risk of increasing the volume and duration of menstrual periods)
• Gastrointestinal bleeding or ulcers / perforations can occur at any time during treatment, without necessarily the presence of recent signs or a history of the patient. The relative risk is increased in elderly subjects, in subjects with low body weight, and in patients treated with anticoagulants or platelet aggregation inhibitors (see section 4.5). In case of gastrointestinal bleeding, treatment should be stopped immediately.
• In consideration of the inhibitory effect of acetylsalicylic acid on platelet aggregation, which occurs even at very low doses and which persists for several days, the patient must be warned of the risk of bleeding in the event of surgery, even of a minor nature. (e.g. tooth extraction).
• At analgesic or antipyretic doses, acetylsalicylic acid inhibits the excretion of uric acid; at the doses used in rheumatology (anti-inflammatory doses), acetylsalicylic acid has a uricosuric effect.
• At high doses used in rheumatology (anti-inflammatory doses), patients should be monitored for possible symptoms of overdose. In case of ringing in the ears, hearing difficulties or dizziness, the treatment modalities should be re-evaluated. In children, it is recommended to monitor for salicilism, especially at the start of treatment.
• The use of this medicinal product is not recommended during lactation (see section 4.6)
• There is evidence that the drug, by inhibiting cyclo-oxygenase / prostaglandin synthesis, may cause a reduction in female fertility through an effect on ovulation. This effect is reversible on discontinuation of the drug.
04.5 Interactions with other medicinal products and other forms of interaction -
Several substances are involved in interactions due to their properties to inhibit platelet aggregation:
Abciximab, acetylsalicylic acid, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, ticlopidine and tirofiban.
The use of different inhibitors of platelet aggregation increases the risk of bleeding, as does their combination with heparin or related molecules, oral anticoagulants or with other thrombolytics, and this possibility must be considered, maintaining regular clinical monitoring.
Combinations contraindicated (see section 4.3):
• Methotrexate at doses> 15 mg / week at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid).
• Oral anticoagulants at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid and in patients with a history of gastro-duodenal ulcer: increased risk of bleeding.
Combinations not recommended:
• oral anticoagulants at analgesic or antipyretic doses of acetylsalicylic acid and in patients with no history of gastro-duodenal ulcer: increased risk of bleeding.
• oral anticoagulants at doses of acetylsalicylic acid used for the inhibition of platelet aggregation and in patients with a history of gastro-duodenal ulcer: increased risk of bleeding. Other non-steroidal anti-inflammatory drugs (NSAIDs), at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased risk of gastrointestinal ulcers and bleeding.
• low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses in elderly patients (≥ 65 years), regardless of the dose of heparin, and for anti-inflammatory doses of acetylsalicylic acid or for analgesic or antipyretic doses of acetylsalicylic acid: increased risk of bleeding (inhibition of platelet aggregation and lesion of the gastroduodenal mucosa by acetylsalicylic acid). Another anti-inflammatory drug or another analgesic or antipyretic should be given.
• Clopidogrel (in addition to the approved indications for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. If co-administration cannot be avoided, clinical monitoring is recommended.
• Uricosurics (benzbromarone, probenecid): reduction of the uricosuric effect due to competition for the elimination of uric acid in the renal tubules.
• Ticlopidine: increased risk of bleeding. If co-administration cannot be avoided, clinical monitoring is recommended.
• Glucocorticoids (except hydrocortisone replacement therapy) for anti-inflammatory doses of acetylsalicylic acid: increased risk of bleeding.
• Pemetrexed in patients with mild or moderate renal insufficiency (creatinine clearance between 45 ml / min and 80 ml / min): Increased risk of pemetrexed toxicity (due to the reduced renal clearance of pemetrexed by acetylsalicylic acid) a anti-inflammatory doses of acetylsalicylic acid.
Associations requiring precautions for use:
• Diuretics, angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists at anti-inflammatory or analgesic and antipyretic doses of acetylsalicylic acid: acute renal failure may occur in dehydrated patients due to reduced glomerular filtration rate secondary to decreased synthesis of renal prostaglandins. Reduced antihypertensive effect may also occur. Make sure the patient is hydrated and that kidney function is checked at the start of treatment.
• Methotrexate at doses ≤ 15 mg / week at anti-inflammatory or analgesic or antipyretic doses of acetylsalicylic acid: increased toxicity of methotrexate, in particular haematological toxicity (due to the reduction of the renal clearance of methotrexate by acetylsalicylic acid Blood cell counts should be checked weekly during the first few weeks of concomitant administration.Careful monitoring is required in patients with (even mild) renal insufficiency, as well as in elderly patients.
• Methotrexate at doses> 15 mg at doses of acetylsalicylic acid used for inhibition of platelet aggregation: increased toxicity of methotrexate, particularly haematological toxicity (due to the reduction of renal clearance of methotrexate by acetylsalicylic acid). Blood cell counts should be checked weekly during the first few weeks of co-administration.Careful monitoring is required in patients with (even mild) renal insufficiency, as well as in elderly patients.
• Clopidogrel (in the approved indications for this combination in patients with acute coronary syndrome): increased risk of haemorrhage. Clinical monitoring is recommended.
• Topical gastrointestinal, antacids and charcoal: increased renal excretion of acetylsalicylic acid due to alkalinization of the urine. It is recommended that gastrointestinal topicals and antacids be administered at least 2 hours away from acetylsalicylic acid.
• Pemetrexed in patients with normal renal function: increased risk of pemetrexed toxicity (due to reduced renal clearance of pemetrexed by acetylsalicylic acid) at anti-inflammatory doses of acetylsalicylic acid. Renal function should be monitored.
• Low molecular weight heparins (and related molecules) and unfractionated heparins, at preventive doses in patients under 65 years of age: the co-administration of drugs that act at different levels of haemostasis increases the risk of bleeding. Therefore, in patients less than 65 years of age, co-administration of preventive dose heparins (or related molecules), and acetylsalicylic acid, regardless of dose, should be evaluated, maintaining clinical and laboratory monitoring. , when necessary.
• Low molecular weight heparins (and related molecules) and unfractionated heparins at therapeutic doses or in elderly patients (≥ 65 years), regardless of the dose of heparin, and for doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of bleeding (inhibition of platelet aggregation and lesion of the gastroduodenal mucosa by acetylsalicylic acid).
• Thrombolytics: increased risk of bleeding.
• Oral anticoagulants at doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of bleeding.
• Other non-steroidal anti-inflammatory drugs (NSAIDs) with doses of acetylsalicylic acid used for the inhibition of platelet aggregation: increased risk of gastrointestinal ulcers and bleeding.
• Glucocorticoids (except hydrocortisone for replacement therapy) for analgesic and antipyretic doses of acetylsalicylic acid: increased risk of bleeding.
• Selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline): increased risk of bleeding.
The medicine can interact with:
- hypoglycemic sulfonylureas
- anti-rejection drugs (eg cyclosporine, tacrolimus).
Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when drugs are co-administered (see section 5.1). However, the limitations of these data and the uncertainties regarding extrapolation of the former data. alive to the clinical situation imply that no firm conclusions can be made for continued use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen.
04.6 Pregnancy and breastfeeding -
Pregnancy
- Low doses below 100 mg / day
Clinical studies indicate that acetylsalicylic acid at doses below 100 mg / day appears to be safe only in extremely limited cases requiring specialist monitoring.
- Doses between 100 and 500 mg / day
There are insufficient clinical data regarding the use of acetylsalicylic acid at doses between 100 mg / day and up to 500 mg / day. Therefore, the recommendations below for doses of 500 mg / day and above also apply to this range. dosage (see paragraph below).
- Doses of 500 mg / day and more
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first 24 weeks of pregnancy, acetylsalicylic acid should not be administered except in strictly necessary cases.
If acetylsalicylic acid is used by a woman attempting to conceive or during the first 24 weeks of pregnancy, the dose and duration of treatment should be kept as low as possible.
Beyond 24 weeks of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios.
At the end of pregnancy, the mother and the newborn may have:
- prolongation of bleeding time due to inhibition of platelet aggregation, which can occur even after the administration of very low doses of acetylsalicylic acid
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy (after 24 weeks of gestation) (see section 4.3).
.
In pregnant or lactating women, the product should be used in case of need and under direct medical supervision.
Feeding time
Acetylsalicylic acid passes into breast milk: acetylsalicylic acid is therefore not recommended during breastfeeding (see section 4.4).
04.7 Effects on ability to drive and use machines -
No effects on the ability to drive or use machines have been observed.
04.8 Undesirable effects -
Frequencies cannot be reliably estimated from the available data. Therefore the frequencies are listed as "not known".
Disorders of the blood and lymphatic system
bleeding syndromes (epistaxis, gum bleeding, purpura, etc.) with an increase in bleeding time.
The risk of bleeding may persist for 4-8 days after discontinuation of acetylsalicylic acid. It may cause an increased risk of bleeding in the event of surgery. Intracranial and gastrointestinal bleeding may also occur. Intracranial bleeding could be fatal, especially when the drug is given to the elderly.
Thrombocytopenia.
Haemolytic anemia in patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency (see section 4.4).
Pancytopenia, bilinear cytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leukopenia.
Disorders of the immune system
Hypersensitivity reactions, anaphylactic reactions, asthma, angioedema
Nervous system disorders
Headache, dizziness, feeling of hearing loss, tinnitus, which are usually indicative of an overdose.
Intracranial haemorrhage which can be fatal, especially in the elderly.
Gastrointestinal disorders
Abdominal pain, occult or overt gastrointestinal bleeding (haematemesis, melaena, etc.) resulting in iron deficiency anemia. The risk of bleeding is dose-dependent.
• Upper gastrointestinal disorders:
esophagitis, erosive duodenitis, erosive gastritis, esophageal ulcers, ulcers, perforations.
• Lower gastrointestinal disorders:
ulcers of the small (jejunum and ileus) and large intestine (colon and rectum), colitis and intestinal perforations.
These reactions may or may not be associated with haemorrhage and may occur with any dose of acetylsalicylic acid and in patients with or without predictive symptoms and with or without a history of serious gastrointestinal events.
Hepatobiliary disorders
Increased liver enzymes, liver damage, especially hepatocellular, chronic hepatitis.
Skin and subcutaneous tissue disorders
Hives, skin reactions, fixed eruptions.
General disorders and administration site conditions
Reye's syndrome (see section 4.4)
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary edema during chronic use and in a context of hypersensitivity reaction to acetylsalicylic acid
Renal and urinary disorders
Kidney failure
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
No cases of overdose have been reported. For acetylsalicylic acid the toxic doses are between 200 mg / kg and 300 mg / kg per os.
The risk of overdose is important in the elderly and particularly in young children (therapeutic overdose or, more frequently, accidental intoxication), where it can be fatal. Non-cardiogenic pulmonary edema may occur with acute and chronic overdose of acetylsalicylic acid (see section 4.8).
Symptoms
Moderate poisoning:
ringing in the ears, feeling of decreased hearing acuity, headache and dizziness are indicative of overdose and can be controlled by a reduction in dosage.
Severe poisoning: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular collapse, respiratory failure, severe hypoglycemia.
In children, an overdose can be fatal as early as 100 mg / kg in a single intake.
Overdose with salicylates, particularly in young children, can lead to severe hypoglycemia and potentially fatal intoxication.
Emergency management
- Immediate transfer to a specialized hospital unit
- Gastric lavage and administration of activated charcoal
- Control of the acid-base balance
- Alkalization of urine with monitoring of urine pH
- Hemodialysis in cases of severe poisoning
- Symptomatic treatment
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Medicinal product category: Other analgesics and antipyretics, salicylic acid and derivatives.
ATC code: N02BA01
FLECTADOL consists of lysine acetylsalicylate, a water-soluble salt of acetylsalicylic acid.
Lysine acetylsalicylate is very soluble in water (solubility greater than 40%) while simple acetylsalicylic acid is very poorly soluble (0.3%). FLECTADOL has the same therapeutic properties of acetylsalicylic acid: analgesic, anti-inflammatory and antipyretic.
Thanks to the solubility of lysine acetylsalicylate, FLECTADOL, used orally, is quickly absorbed by the digestive mucosa so that faster effects and better gastric tolerance can be obtained.
The presentation in heat-sealed sachets offers several advantages: the possibility of storing the product away from light and humidity, of making the product itself inaccessible to children since the sachets used are practically inviolable from them and, finally, of carrying with them - where necessary - the dose of medication needed for the day.
Since it does not provide sodium ions, FLECTADOL can also be administered to patients with a tendency to salt and water retention.
Experimental data suggest that ibuprofen may inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly.
In a study following the administration of a single 400 mg dose of ibuprofen, taken within 8 hours before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on the formation of thromboxane and on platelet aggregation. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; it seems that there are no clinically relevant effects from the use occasional ibuprofen.
05.2 "Pharmacokinetic properties -
The absorption after oral administration is rapid and 3 times higher than that of acetylsalicylic acid at 10 minutes from intake. After 30 minutes the salicilemias obtained with FLECTADOL are double compared to those produced by acetylsalicylic acid and remain significantly higher even after one hour.
05.3 Preclinical safety data -
Acute toxicity
In mice and rats the LD50 is greater than 2200 mg / kg per os and 1600 mg / kg i.p.
Chronic toxicity
In rats, doses of 400 mg / kg / day os and 200 mg / kg / day s.c. for 15 weeks they did not induce changes in the biohumoral parameters or macroscopic and microscopic alterations of the various organs and parenchyma.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
glycocol, mandarin aroma, glycyrrhized ammonium.
06.2 Incompatibility "-
None known.
06.3 Period of validity "-
30 months.
06.4 Special precautions for storage -
Store in the original packaging at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
FLECTADOL 500
Box of 20 sachets containing non-effervescent powder.
FLECTADOL 1000
Box of 10 sachets containing non-effervescent powder.
Box of 20 sachets containing non-effervescent powder.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Sanofi S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER -
FLECTADOL 500, 20 sachets: AIC n ° 022620215
FLECTADOL 1000, 10 sachets: AIC n ° 022620227
FLECTADOL 1000, 20 sachets: AIC n ° 022620239
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Renewal: 01/06/2010
10.0 DATE OF REVISION OF THE TEXT -
October 2014
