Active ingredients: Ketoprofen
FASTUM 25 mg Tablets
Why is Fastum used? What is it for?
WHAT IS IT
FASTUM 25 mg TABLETS belongs to the category of anti-inflammatory and antirheumatic drugs.
- WHY IT IS USED
FASTUM 25 mg TABLETS is used for pain of different origins and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone pain.
Contraindications When Fastum should not be used
The product should not be used in patients with gastritis, chronic digestive disorders (dyspepsia), active peptic ulcer or a history of gastrointestinal bleeding, ulceration or perforation. History of gastrointestinal bleeding or perforation following previous NSAID therapy. The product should not be administered in subjects with porphyria (congenital changes in the formation of hemoglobin) or with leukopenia (reduction in the number of white blood cells) or thrombocytopenia (reduction in the number of platelets). The product must not be administered in patients with ongoing bleeding. o bleeding diathesis (predisposition to bleeding), during treatment with anticoagulants, in patients with severe renal, hepatic or cardiac insufficiency.
Do not administer in the third trimester of pregnancy and during lactation (see What to do during pregnancy and lactation). Pediatrics, geriatrics and specific clinical pictures: The drug should not be administered to children and young people under 15 years.
Ketoprofen is contraindicated in patients with hypersensitivity (allergy) to the active substance or to any of the excipients of the drug.
The drug should also not be administered in patients with a history of hypersensitivity such as bronchospasm, skin rash, rhinitis, asthma attacks, urticaria and other allergic reactions or in which substances with a similar mechanism of action (for example acetylsalicylic acid or other NSAIDs) have previously caused allergic-type reactions; severe, rarely fatal, anaphylactic reactions have been observed in these patients.
Patients undergoing major surgery.
When it can be used only after consulting your doctor
In asthmatic patients the product should be used with caution, consulting your doctor before taking it, as well as in patients with a previous (previous) peptic ulcer, liver disease or nephropathy, as well as in patients with a history of heart disease or stroke or risk factors for these. conditions.
It is not recommended to administer it together with other anti-inflammatory drugs and acetylsalicylic acid.
Pregnancy and Breastfeeding (see What to do during pregnancy and breastfeeding)
Precautions for use What you need to know before taking Fastum
The concomitant use of Fastum 25 mg Tablets with other NSAIDs should be avoided, including selective cyclo-oxygenase-2 inhibitors.
Patients with a history of hypertension and / or mild to moderate heart failure should exercise caution and contact their doctor or pharmacist as fluid retention, hypertension and edema have been reported in association with NSAID treatment.
In asthmatic patients the product should be used with caution, consulting your doctor before taking it, as well as in patients with previous peptic ulcer, or inflammatory bowel disease (ulcerative colitis, Crohn's disease), heart disease (heart failure), hypertension, liver disease or nephropathy.
Patients with active or previous peptic ulcer
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see Undesirable effects).
At the start of treatment, renal function should be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal failure, especially if the patient is elderly.
As with other NSAIDs, in the case of infectious diseases, the anti-inflammatory, analgesic and antipyretic properties of ketoprofen can mask the typical signs of the progression of the infection such as fever.
In patients with abnormal liver function tests or with a history of liver disease, transaminase levels should be monitored periodically, especially during long-term therapy.
Rare cases of jaundice and hepatitis with ketoprofen have been described.
The use of FASTUM 25 mg tablets, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women who intend to become pregnant (see section "What to do during pregnancy and" breastfeeding ").
Administration of FASTUM 25 mg tablets should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and / or nasal polyposis have an increased risk of allergy to aspirin and / or NSAIDs compared to the rest of the population. Administration of this pharmaceutical product may cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section "WHEN IT SHOULD NOT BE USED").
As with all NSAIDs, caution should be exercised in patients with uncontrolled high blood pressure, congestive heart failure, ischemic heart disease, peripheral arterial disease, and / or cerebrovascular disease, and in patients with long-term treatment risk for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes mellitus, smoking).
Patients with a history of hypertension and / or mild to moderate heart failure should exercise caution and contact their doctor or pharmacist as fluid retention, hypertension and edema have been reported in association with NSAID treatment.
If visual disturbances, such as blurred vision, occur, treatment should be discontinued.
Interactions Which drugs or foods can modify the effect of Fastum
Since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides that should be administered concurrently.
Combinations with other medicinal products to be avoided:
Other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors) and high doses of salicylates: increased risk of gastrointestinal ulceration and bleeding.
Anticoagulants (heparin and warfarin) and antiplatelet agents (e.g. ticlopidine and clopidogrel): increased risk of bleeding (see section Important to know). If concomitant use is unavoidable, patients should be closely monitored. NSAIDs can amplify the effects of anticoagulants, such as warfarin.
Lithium: in the course of therapy with lithium-based drugs, the simultaneous administration of non-steroidal anti-inflammatory drugs causes an increase in plasma levels of lithium which can sometimes reach toxic levels due to a decrease in its renal excretion. If necessary, plasma lithium levels should be monitored closely and dosages adjusted during and after therapy with Fastum 25 mg tablets.
Methotrexate in doses above 15 mg / week:
Increased risk of haematological toxicity of methotrexate, particularly when administered at high doses (> 15 mg / week), possibly related to displacement of methotrexate from the protein binding site and decreased renal clearance.
Combinations with medicinal products requiring caution:
Methotrexate at doses below 15 mg / week:
During the first few weeks of concomitant treatment, complete blood counts should be monitored weekly. If there is renal impairment or if the patient is elderly, monitoring should be performed more frequently.
Diuretics: Patients, and particularly dehydrated patients, taking diuretics are at increased risk of developing secondary renal impairment due to decreased renal blood flow caused by prostaglandin inhibition. Such patients should be adequately hydrated before starting therapy. concomitant and monitoring of renal function should be considered at initiation of therapy (see section "Precautions for use").
ACE inhibitors and angiotensin II antagonists: in some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the concomitant administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclooxygenase system can lead to further deterioration of renal function, which includes possible acute renal failure. These changes should be considered in patients taking FASTUM 25 mg tablets concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, and only after consultation with the physician, especially in elderly patients.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section "It is important to know that").
Pentoxifylline: There is an increased risk of bleeding. More frequent clinical monitoring and monitoring of bleeding time is required.
Sulfonylureas: Any interactions with oral hypoglycemic agents should be kept in mind
Associations that need to be considered:
Diphenylhydantoin and sulfonamides:
As the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides that should be administered concurrently.
Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section "It is important to know that").
Antihypertensive agents (beta blockers, angiotensin converting enzyme inhibitors, diuretics): risk of decreased antihypertensive potency (inhibition of the vasodilating action of prostaglandins by NSAIDs).
Thrombolytics: increased risk of bleeding.
Probenecid:
Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
Ciclosporin and Tacrolimus:
Risk of additive nephrotoxic effects, especially in elderly patients
If you are using other medicines ask your doctor or pharmacist for advice
Warnings It is important to know that:
Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks).
Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section "What medicines or foods can change the "effect of the medicine").
Concomitant use of FASTUM 25 mg tablets with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a history of serious gastrointestinal events.
Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of severe gastrointestinal toxicity, compared to other NSAIDs, especially at high doses (see section "When it should not be used").
The risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses of NSAIDs, in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section "When it should not be used"), and in the elderly. These patients should start treatment with the lowest available dose.
The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section "Which Medicines or foods may change the "effect of the medicine").
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
When gastrointestinal bleeding or ulceration occurs in patients taking FASTUM 25 mg tablets the treatment should be discontinued.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section "How to use this medicine").
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 "Undesirable effects"). In the early stages of therapy i patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. FASTUM 25 mg tablets should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke). They are not Sufficient data are currently available to exclude a similar risk for ketoprofen.
If you have heart problems, have a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your treatment with your doctor or pharmacist.
What to do during pregnancy and breastfeeding
Pregnancy
During the first and second trimester: Since the safety of ketoprofen has not been evaluated in pregnant women, the use of ketoprofen during the first and second trimester of pregnancy is not recommended.
During the third quarter:
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors, including ketoprofen, can induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding can occur in both mother and baby.
Therefore, ketoprofen is contraindicated during the last trimester of pregnancy.
Pregnancy
Since traces of ketoprofen have been detected in breast milk following oral administration, in lactating women, the use of the medicinal product is contraindicated.
Driving and using machines
There are no known effects on the ability to drive and use machines. However, due to the potential for drowsiness, the possible onset of headache, dizziness or convulsions, the patient should avoid driving, operating machinery and performing activities that require particular vigilance.
Dosage and method of use How to use Fastum: Dosage
How many
Warning: do not exceed the indicated doses without medical advice.
Adults and children over 15 years: 1 tablet.
In case of asthma, past (previous) peptic ulcer, heart disease, liver disease or nephropathy, you should contact your doctor.
When and for how long
Once, or repeated 2-3 times a day, in the painful forms of greater intensity.
It is advisable to take the medicine after meals.
Do not use for more than three days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
It is preferable to take the product on a full stomach, swallowing it whole with a glass of water.
Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above.
Overdose What to do if you have taken too much Fastum
Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases, the symptoms observed were benign and limited to lethargy, drowsiness, as well as epigastric pain, nausea and vomiting.
Gastrointestinal bleeding, hypotension, respiratory depression and cyanosis can also occur.
There are no specific antidotes for ketoprofen overdoses. In the event of an overdose, seek immediate medical attention so that the appropriate therapeutic measures are applied.
In case of accidental ingestion / intake of an excessive dose of FASTUM, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Fastum
Like all medicines, this can cause side effects, although not everybody gets them.
Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, particularly in the elderly (see It is important to know that).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of FASTUM 25 mg tablets (see Important to know).
Gastritis has been observed less frequently.
Adverse reactions are reported by organ type and frequency according to the following convention: very common (≥1 / 10), common (≥1 / 100,
Adverse reactions associated with the use of ketoprofen in adults are as follows:
Disorders of the blood and lymphatic system:
- rare: haemorrhagic anemia
- not known: agranulocytosis, thrombocytopenia, bone marrow failure
Immune system disorders:
- not known: anaphylactic reactions (including shock). In exceptional cases, the manifestations of hypersensitivity can take the character of severe systemic reactions (edema of the larynx, edema of the glottis, dyspnoea, palpitation) up to anaphylactic shock. In these cases, immediate medical assistance is required
Psychiatric disorders;
not known: mood changes
Nervous system disorders
- uncommon: headache, dizziness, somnolence;
- rare: paraesthesia
- not known: convulsions, dysgeusia
Eye disorders:
- rare: blurred vision (see section "Special warnings and precautions for use")
Ear and labyrinth disorders
- rare: tinnitus
Cardiac pathologies
- not known: heart failure
Vascular pathologies
- not known: hypertension, vasodilation
Respiratory, thoracic and mediastinal disorders
- rare: asthma
- not known; bronchospasm (particularly in patients with known hypersensitivity to ASA and other NSAIDs), rhinitis
Gastrointestinal disorders:
- common: nausea, vomiting, abdominal pain, dyspepsia;
- uncommon: constipation, diarrhea, flatulence, gastritis;
- rare: stomatitis, peptic ulcer
- not known: gastrointestinal haemorrhage and perforation, aggravation of colitis and Crohn's disease, melaena and haematemesis.
Hepatobiliary disorders
- rare: hepatitis, elevated transaminases, elevated serum bilirubin due to hepatitis
Skin and subcutaneous tissue disorders
- uncommon: rash, pruritus
- not known: photosensitivity reactions, alopecia, urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Renal and urinary disorders
- not known: acute renal failure, tubulointerstitial nephropathy, nephritic syndrome, renal function test abnormal
General disorders and administration site conditions:
- uncommon: edema, fatigue, asthenia
Diagnostic tests
rare: weight gain
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke) (see section "It is important to know that")
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. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
Expiry and Retention
Expiry: See the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
COMPOSITION
Each tablet contains:
Active ingredient: ketoprofen 25 mg.
Excipients: microcrystalline cellulose, pregelatinised maize starch, colloidal silica, magnesium stearate.
- HOW IT LOOKS
FASTUM 25 mg TABLETS comes in tablet form for oral use. The contents of the pack are: 5, 10 or 20 tablets.
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
FASTUM 25 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
active ingredient: ketoprofen 25 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablet
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Pain of different origin and nature, and in particular:
headache, toothache, neuralgia, menstrual pain, muscle and bone pain.
04.2 Posology and method of administration
Adults and children over 15 years: 1 tablet, in a single dose, or repeated 2-3 times a day, in the painful forms of greater intensity.
It is preferable to take the product on a full stomach (with a glass of water).
Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above.
The duration of the therapy must be limited to the overcoming of the painful episode.
04.3 Contraindications
The drug should not be administered in the following cases:
• hypersensitivity to the active ingredient or to other similar drugs (anti-inflammatory drugs, acetylsalicylic acid and its derivatives, etc.), hypersensitivity to any of the excipients;
• manifestations with skin rashes, rhinitis or asthma;
• Known or suspected pregnancy (see section 4.6 - Pregnancy and lactation), during lactation and in children under 15 years;
• gastritis and chronic dyspepsia;
• subjects with porphyria, leukopenia or thrombocytopenia, with ongoing bleeding or haemorrhagic diathesis, undergoing treatment with anticoagulants;
• patients with severe renal or hepatic insufficiency;
• patients undergoing major surgery.
Furthermore, concomitant administration with other anti-inflammatory drugs and acetylsalicylic acid is not recommended.
Active peptic ulcer, or a history of gastrointestinal bleeding, ulceration or perforation.
Severe heart failure.
04.4 Special warnings and appropriate precautions for use
The product should only be used under medical supervision in subjects with bronchospasm or with chronic obstructive pulmonary disease, allergic rhinitis (hay fever) or nasal polyposis, as well as in case of nephropathy.
After a few days of treatment without appreciable results, consult your doctor.
The use of FASTUM 25 mg tablets, as well as any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women who intend to become pregnant.
Administration of FASTUM 25 mg tablets should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
Concomitant use of FASTUM 25 mg tablets with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks)
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2 - Posology and method of administration).
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of severe gastrointestinal toxicity compared to other NSAIDs, especially at high doses (see also sections 4.2 - Posology and method of administration and 4.3 - Contraindications).
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3 - Contraindications), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5 - Interactions with other medicines and other forms of interaction).
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5 - Interactions with other medicinal products. and other forms of interaction).
When gastrointestinal bleeding or ulceration occurs in patients taking FASTUM 25 mg tablets the treatment should be discontinued.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8 - Undesirable effects).
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 - Undesirable effects). In the early stages of therapy i patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. FASTUM 25 mg tablets should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Cardiovascular and cerebrovascular effects
Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke). There are currently insufficient data to exclude a similar risk for ketoprofen when it is administered at a daily dose of 25mg, as a single dose, or repeated 2-3 times a day.
04.5 Interactions with other medicinal products and other forms of interaction
Since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides that should be administered concurrently. During therapy with lithium-based drugs, the simultaneous administration of non-steroidal anti-inflammatory drugs causes an increase in plasma lithium levels.
Any interactions with the following drugs should be kept in mind: oral hypoglycemic agents (sulfamides), ticlopidine, anti-inflammatories and methotrexate.
Therefore, patients undergoing treatment with such drugs should consult their doctor before taking the product.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4 - Special warnings and precautions for use).
Anticoagulants: NSAIDs may amplify the effects of anticoagulants, such as warfarin (see section 4.4 - Special warnings and precautions for use).
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4 - Special warnings and precautions for use).
Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These changes should be considered in patients taking FASTUM 25 mg tablets concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy.
04.6 Pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the third trimester 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;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Feeding time
Do not administer while breastfeeding
04.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive and use machines. However, due to the possible onset of headache or dizziness, the patient should avoid driving vehicles or carrying out activities that require particular vigilance.
04.8 Undesirable effects
Gastrointestinal system: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4 - Special warnings and precautions for use). The frequency and extent of these effects are significantly reduced by taking the drug on a full stomach.
Following administration of FASTUM 25 mg tablets, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported (see section 4.4 - Special warnings and precautions use).
Gastritis has been observed less frequently.
More rarely, disturbances affecting the hematopoietic system and effects affecting the central nervous system have been reported: headache, dizziness, asthenia and modification of mood. Equally rare is the finding of allergic manifestations such as skin rash, pruritus, edema. In exceptional cases , the manifestations of hypersensitivity can take the character of severe systemic reactions (edema of the larynx, edema of the glottis, dyspnoea, palpitation) up to anaphylactic shock. In these cases immediate medical assistance is required.
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely.
Disorders of the immune system
- hypersensitivity, anaphylaxis
Psychiatric disorders
- mood alterations
Nervous system disorders
- headache dizziness
Cardiac pathologies
- palpitation, heart failure
Vascular pathologies
- hypertension
Respiratory, thoracic and mediastinal disorders
- dyspnoea, edema of the larynx, edema of the glottis
Gastrointestinal disorders
- diarrhea, nausea, vomiting, constipation, flatulence, gastritis, abdominal pain, dyspepsia, ulcerative stomatitis, melaena, haematemesis, gastrointestinal bleeding, duodenal ulcer and perforation, gastric ulcer and perforation, aggravation of colitis and Crohn's disease
Skin and subcutaneous tissue disorders
- pruritus, edema, rash, Stevens Johnson syndrome, toxic epidermal necrolysis
General disorders and administration site conditions
- asthenia, edema
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (eg, myocardial infarction or stroke) ( see section 4.4 - Special warnings and precautions for use).
04.9 Overdose
Overdose syndromes may include: central nervous system disorders, such as headache, dizziness, confusion and loss of consciousness, as well as pain, nausea and vomiting. Gastrointestinal bleeding, hypotension, respiratory depression and cyanosis can also occur.
In the event of accidental or deliberate ingestion, the normal measures required in these cases must be implemented.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-inflammatory / antirheumatic drugs, non-steroids - derivatives of propionic acid.
ATC code: M01AE03.
Ketoprofen is a non-steroidal antirheumatic with a powerful anti-inflammatory action that is expressed at least in part through the inhibition of prostaglandin synthesis (Arch. Int. Pharmacodyn. 237, 169, 1978), and of interesting analgesic and antipyretic properties. These pharmacological properties, studied in numerous experimental models, also in comparison with other non-steroidal anti-inflammatory drugs, occur at well tolerated doses on the main organs and systems.
05.2 Pharmacokinetic properties
Absorption of the product, in humans as in animals, is rapid: maximum blood concentrations are reached after oral administration of a single dose within 2 hours.
The plasma half-life of ketoprofen ranges from 1.5 to 2 hours; plasma protein binding is 60-90%.
Elimination occurs essentially via the kidney and in conjugated glucuronide form; 30-90% of the administered dose is excreted within 24 hours.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Microcrystalline cellulose, pregelatinised maize starch, colloidal silica, magnesium stearate.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
No special storage precautions are required
06.5 Nature of the immediate packaging and contents of the package
PVC / PVDC / Alu blisters
Pack sizes: 5, 10, 20 tablets
Not all pack sizes may be marketed
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Florence.
08.0 MARKETING AUTHORIZATION NUMBER
5 tablets A.I.C. n. 023417076.
10 tablets A.I.C. n. 023417088.
20 tablets A.I.C. n. 023417090.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: February 1999
Date of last renewal: May 2010
10.0 DATE OF REVISION OF THE TEXT
May 2012
