Menarini Fastumdol Anti-inflammatory 20 Sachets Of 25mg

Fastumdol anti-inflammatory has a double effect :

• It acts quickly against pain
• Combats the inflammation that causes it

Fastumdol Anti-inflammatory is available in packs of 20 Sachets and 10 Tablets.
Each sachet and tablet of Fastumdol Anti-inflammatory contains 25 mg of Dexketoprofen.

In case of acute pain, Fastumdol anti-inflammatory can also be taken
on an empty stomach.

What is it indicated for?

Fastumdol Antiinflammatory 25mg is a pain reliever belonging to the family of nonsteroidal anti-inflammatory drugs. It is used to treat pain of mild to moderate intensity, such as muscle pain (back pain), menstrual pain and toothache.

Dosage and method of administration

The recommended dose is generally 1 sachet or 1 tablet (25 mg) every 8 hours and no more than 3 tablets per day (75 mg).

COMPOSITION OF FASTUMDOL BAGS ANTI-INFLAMMATORY

Each sachet of granules for oral solution contains 12.5 mg or 25 mg of dexketoprofen as dexketoprofen trometamol Excipients with known effect: sucrose with colloidal silica: 1.20 respectively? 1.22 g or 2.40? 2.44 g.

PACKAGE LEAFLET

04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Short-term symptomatic treatment of painful affections of mild to moderate intensity, such as acute musculoskeletal pain, dysmenorrhea and dental pain.
04.2 Posology and method of administration
Posology Adults Depending on the nature and intensity of the pain, the recommended dose is 12.5 mg every 4? 6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Side effects can be minimized by using the lowest effective dose for the time strictly necessary to eliminate the symptoms (see section 4.4). FASTUMDOL ANTINFLAMMATORY is indicated only for short-term treatments and administration should be limited to the symptomatic period only. Elderly In elderly patients it is recommended to start therapy with the lowest therapeutic dose (50 mg the total daily dose). The dosage can be increased to reach that recommended for adults only after good tolerability has been ascertained. Due to the risk profile (see section 4.4), the elderly should be monitored with particular attention. Hepatic dysfunction Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) under close medical supervision. FASTUMDOL ANTINFLAMMATORY should not be used in patients with severe liver dysfunction. Renal dysfunction In patients with mild renal impairment (creatinine clearance 60? 89 ml / min) the initial dosage should be reduced to 50 mg total daily dose (see section 4.4). FASTUMDOL ANTINFLAMMATORY should not be used in patients with moderate to severe renal impairment (creatinine clearance? 59 ml / min) (see section 4.3). Pediatric population FASTUMDOL ANTI-INFLAMMATORY granules for oral solution have not been studied in children and adolescents. Therefore, as no safety and efficacy data are available, the product should not be used in children and adolescents. Method of administration Dissolve the entire contents of each sachet in a glass of water: mix well to dissolve completely. The solution thus obtained must be ingested immediately after reconstitution. The concomitant administration of food delays the rate of absorption of the drug (see "Pharmacokinetic properties"), therefore, in case of acute pain, it is recommended to administer the drug at least 15 minutes before meals.
04.3 Contraindications
FASTUMDOL ANTI-INFLAMMATORY granules for oral solution must not be administered in the following cases:? patients with hypersensitivity to the active substance, or to any other NSAID, or any of the excipients listed in section 6.1; ? patients who have developed asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioedema after exposure to substances with a similar mechanism of action (e.g. acetylsalicylic acid, or other NSAIDs)? patients with known photoallergic or phototoxic reactions during treatment with ketoprofen or? fibrates; ? patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy; ? patients with active peptic ulcer / gastrointestinal bleeding in progress or any previous history of gastrointestinal bleeding, ulceration or perforation; ? patients with chronic dyspepsia; ? patients who have other bleeding or clotting disorders; ? patients with Crohn's disease or ulcerative colitis; ? patients with severe heart failure; ? patients with moderate to severe renal impairment (creatinine clearance? 59 ml / min); ? patients with severe hepatic impairment (Child? Pugh score 10? 15); ? patients with hemorrhagic diathesis and other clotting disorders; ? patients with severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake); ? during the third trimester of pregnancy and breastfeeding (see section 4.6).
04.4 Special warnings and special precautions for use
Use with caution in patients with a history of allergic conditions. Should concomitant use of FASTUMDOL ANTI-INFLAMMATORY with other NSAIDs, including selective cyclooxygenase inhibitors, be avoided? 2. Side effects can be minimized by using the lowest effective dose for the time strictly necessary to eliminate the symptoms (see section 4.2 and the gastrointestinal and cardiovascular risks below). Gastrointestinal safety Gastrointestinal bleeding, ulceration or perforation Potentially fatal bleeding, ulceration or gastrointestinal perforation has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or previous history of serious gastrointestinal events. When gastrointestinal bleeding or ulceration occurs in patients receiving FASTUMDOL ANTI-INFLAMMATORY, therapy should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID dosage in patients with previous ulcer, especially if complicated by bleeding or perforation (see section 4.3) and in the elderly. Elderly: the elderly have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which can be fatal (see section 4.2). These patients should start treatment with the lowest available dose. As with all NSAIDs, prior to starting treatment with dexketoprofen trometamol, it is necessary to investigate previous esophagitis, gastritis and / or peptic ulcers and to ensure their total recovery. Patients with gastrointestinal symptoms or a history of gastrointestinal disease should be carefully monitored for the appearance of digestive disorders, especially gastrointestinal bleeding. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions can be exacerbated (see section 4.8). Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients receiving a low concomitant dose of aspirin or other drugs that may increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastrointestinal toxicity, especially if elderly, must report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. Caution is advised in patients who are given concomitantly medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors and antiplatelet agents such as aspirin (see section 4.5). Renal safety Use with caution in patients with impaired renal function. In these patients the use of NSAIDs can cause deterioration of kidney function, fluid retention and edema. Caution should be exercised for an increased risk of nephrotoxicity, even in patients on diuretic therapy or who are at risk of developing hypovolemia. During treatment, adequate fluid intake must be guaranteed to prevent dehydration and the risk of renal toxicity. Like all NSAIDs, the product can cause an increase in blood urea nitrogen and creatinine. As with other prostaglandin synthesis inhibitors, kidney side effects may occur which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. Elderly patients are most exposed to the risk of renal failure (see section 4.2). Hepatic safety Caution should be exercised in patients with hepatic impairment. Like other NSAIDs, it can cause small transient increases in some liver function parameters, as well as significant increases in GOT and GPT. In the event of a significant increase in these parameters, therapy must be stopped. Elderly patients are most exposed to the risk of liver function failure (see section 4.2). Cardiovascular and cerebrovascular safety Appropriate monitoring is required for patients with a history of hypertension and / or mild to moderate heart failure. Particular caution should be exercised in cardiac patients, especially if with a history of heart failure since there is an increased risk of heart failure, as fluid retention and edema have been reported in association with the use of NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high dosages and protracted therapies) may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude this risk for dexketoprofen trometamol. Therefore patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with dexketoprofen trometamol after careful consideration. Similar attention must be paid before starting long-term treatment in patients with risk factors for cardiovascular diseases (for example hypertension, hyperlipidemia, diabetes mellitus, smoking). All non-selective NSAIDs are able to inhibit platelet aggregation and prolong bleeding time by inhibiting the synthesis of prostaglandins. The use of dexketoprofen trometamol is therefore not recommended in patients receiving another therapy that interferes with hemostasis, such as warfarin or other coumarin or heparin (see section 4.5). Elderly patients are more likely to develop cardiovascular impairment (see section 4.2). Skin reactions Serious skin reactions (some of them fatal), including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients seem to be at higher risk: the onset of reactions occurs, in most cases, within the first month of treatment. At the first appearance of skin rash, mucosal lesions or any other symptoms of hypersensitivity, therapy with FASTUMDOL ANTI-INFLAMMATORY should be stopped. Other information Special caution is required in patients with:? congenital abnormalities of porphyrin metabolism (e.g. acute intermittent porphyria)? dehydration? immediately after major surgery If your doctor considers long-term therapy with dexketoprofen necessary, liver, kidney and blood count should be checked regularly. Severe reactions from acute hypersensitivity (e.g. anaphylactic shock) have been observed in very rare cases. At the first manifestation of severe hypersensitivity reactions after taking FASTUMDOL ANTINFLAMMATORY, stop treatment immediately. Depending on the symptoms, immediately initiate the necessary medical procedures with qualified medical personnel. Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis have a greater risk of allergy to acetylsalicylic acid and / or NSAIDs than the rest of the population. The administration of this medicine can cause asthma attacks or bronchospasm especially in people allergic to acetylsalicylic acid or NSAIDs (see section 4.3). In exceptional cases chickenpox can be associated with serious infectious complications of the skin and soft tissues. To date, a role of NSAIDs in the aggravation of these infections cannot be excluded, so it is advisable to avoid the use of FASTUMDOL ANTI-INFLAMMATORY in patients with chicken pox. FASTUMDOL ANTINFLAMMATORY should be administered with caution to patients suffering from hematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disease. Like other NSAIDs, dexketoprofen can mask the symptoms of infectious diseases. This medicine contains sucrose. Patients with fructose intolerance, glucose? Galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. To be taken into consideration by people with diabetes mellitus. Pediatric population Safety of use in children and adolescents has not been established. 04.5 Interaction with other medicinal products and other forms of interaction - The following interactions are characteristic of nonsteroidal anti-inflammatory drugs (NSAIDs) in general:
Associations not recommended
Other NSAIDs (including selective oxygen cycle inhibitors? 2) and high doses of salicylates (? 3 g / day): the simultaneous administration of multiple NSAIDs can increase the risk of gastrointestinal ulceration and bleeding due to a synergistic effect;
Anticoagulants: NSAIDs may potentiate the effects of anticoagulants, such as warfarin (see section 4.4), due to the high plasma protein binding of dexketoprofen, inhibition of platelet function and damage to the gastro-duodenal mucosa. If association cannot be avoided, rigorous clinical observation and monitoring of laboratory parameters are required.
Heparin: increased risk of bleeding (due to inhibition of platelet function and damage to the gastrointestinal mucosa). If association cannot be avoided, rigorous clinical observation and monitoring of laboratory parameters are required.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Lithium (described with many NSAIDs): NSAIDs increase blood lithium levels with the risk of reaching toxic values (decreased renal lithium excretion); therefore, this parameter requires careful monitoring at the beginning, during the adjustment and at the end of the treatment with dexketoprofen.
Methotrexate when used in high doses (? 15 mg / week): increased haematological toxicity of methotrexate due to a decrease in its renal clearance, generally with NSAIDs.
Idantoins and sulfonamides: the toxic effects of these substances can be enhanced. Associations requiring caution
Diuretics, ACE inhibitors, aminoglycoside antibiotics and angiotensin II receptor antagonists: dexketoprofen can reduce the effect of diuretics and antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), concomitant administration of cyclooxygenase inhibiting agents and ACE inhibitors, angiotensin II receptor blockers or aminoglycoside antibiotics may cause an further deterioration of renal function, usually reversible. In the event of a concomitant prescription of dexketoprofen and a diuretic, it is essential to ensure adequate hydration of the patient and check renal function both at the beginning of the treatment and periodically thereafter. Concomitant administration of FASTUMDOL ANTI-INFLAMMATORY and potassium-sparing diuretics can cause hyperkalemia. Blood potassium concentrations should be monitored (see section 4.4).
Methotrexate when used in low doses (<15 mg / week): increased haematological toxicity of methotrexate due to a decrease in its renal clearance generally caused by anti-inflammatory drugs. Check blood counts weekly for the first few weeks of combination therapy. Increase surveillance in elderly patients and in the presence of even mild renal failure.
Pentoxifylline: increased risk of bleeding. Monitor carefully and check the bleeding time more frequently.
Zidovudine: increased risk of erythrocyte line toxicity due to action on reticulocytes, with possible onset of severe anemia one week after starting NSAID treatment. Perform complete blood count and reticulocyte control every 7-14 days during treatment with NSAIDs. Sulphonylureas: NSAIDs can increase the hypoglycaemic effect of sulphonylureas by saturation of plasma protein binding sites.
Associations to be carefully evaluated
Beta blockers: treatment with NSAIDs may decrease their antihypertensive effect due to the inhibition of prostaglandin synthesis.
Cyclosporine and tacrolimus: NSAIDs can potentiate nephrotoxicity due to the effects mediated by renal prostaglandins. During therapy, check kidney function.
Thrombolytics: increased risk of bleeding.
Anti-platelet agents and SSRIs (selective serotonin reuptake inhibitors): increased risk of gastrointestinal bleeding (see section 4.4).
Probenecid: can increase the plasma concentrations of dexketoprofen; this interaction may be due to an inhibitory mechanism at the level of renal tubule secretion and glucuronjugation and requires an adjustment of the dose of dexketoprofen.
Cardioactive glycosides: NSAIDs can increase the plasma concentrations of cardioactive glycosides.
Mifepristone: there is a theoretical risk that prostaglandin? Synthetase inhibitors may alter the efficacy of mifepristone. Limited evidence suggests that concomitant administration of NSAIDs on the same day as prostaglandin administration does not adversely affect the effects of mifepristone or prostaglandins on cervical maturation or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.
Quinolones: animal studies indicate that high doses of quinolone antibiotics in combination with NSAIDs may increase the risk of seizures.
04.6 Pregnancy and breastfeeding
FASTUMDOL ANTINFLAMMATORY is contraindicated in the third trimester of pregnancy and during breastfeeding (see section 4.3).
Pregnancy
Inhibition of prostaglandin synthesis can have negative effects on pregnancy and / or on the development of the embryo or fetus. Results of epidemiological studies suggest an increased risk of spontaneous abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations had increased from less than 1% to about 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre loss? and post-implantation and embryo mortality is fetal. Furthermore, an increase in the incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. However, animal studies with dexketoprofen trometamol did not show reproductive toxicity (see section 5.3).
During the first and second trimester of pregnancy, dexketoprofen trometamol should only be administered in strictly necessary cases. If dexketoprofen trometamol is used by a woman awaiting conception or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
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);
kidney dysfunction, which can progress to kidney failure with oligohydramnios; the mother and the newborn at the end of pregnancy to:
possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low dosages;
inhibition of uterine contractions, with consequent delay or prolongation of labor.
Fertility
The use of FASTUMDOL ANTI-INFLAMMATORY can damage female fertility and it is not recommended to be administered to women who wish to become pregnant. In the case of women with conception difficulties or who are undergoing tests for infertility, consider stopping the administration of dexketoprofen trometamol.
Feeding time
It is not known whether dexketoprofen is excreted in breast milk. FASTUMDOL ANTINFLAMMATORY is contraindicated during breastfeeding (see section 4.3).
04.7 Effects on ability to drive and use machines
FASTUMDOL ANTI-INFLAMMATORY granules for oral solution can cause side effects such as dizziness, visual disturbances or drowsiness. In such cases, the ability to react, drive cars or operate machinery may be impaired.
04.8 Undesirable effects
Adverse events, probably related to dexketoprofen trometamol, which occurred during clinical studies and after the marketing of FASTUMDOL ANTINFLAMMATORY granules, are grouped by system and listed in order of frequency. The plasma Cmax levels of dexketoprofen in the granule formulation are higher than those reported for the tablet formulation, therefore a potential increase in the risk of adverse events (gastrointestinal) cannot be excluded. Classification Systemic organ Common (from? 1/100 to <1/10) Uncommon (from? 1 / 1,000 to <1/100) Rare (from? 1 / 10,000 to <1 / 1,000) Very rare / Isolated cases (< 1 / 10,000) Blood and lymphatic system disorders Neutropenia, thrombocytopenia Immune system disorders Edema of the larynx Anaphylactic reactions, including anaphylactic shock Metabolism and nutrition disorders Anorexia Psychiatric disorders Insomnia; anxiety Nervous system disorders Headache, dizziness, somnolence Paraesthesia, syncope Eye disorders Vision blurred Ear and labyrinth disorders Dizziness Tinnitus Cardiac disorders Palpitations Tachycardia Vascular disorders Hot flashes Hypertension Hypotension Respiratory, thoracic and mediastinal disorders Bradypnea Gastrointestinal disorders Nausea and / or vomiting, abdominal pain, diarrhea, dyspepsia Gastritis, constipation, dry mouth, flatulence Peptic ulcer, hemorrhage or perforation from peptic ulcer (see section 4.4) Pancreatitis Hepatobiliary disorders Hepatocellular damage Skin and subcutaneous tissue disorders Rash Urticaria, acne, increased sweating Steven Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), angioedema, facial edema, photosensitivity reaction, itching Musculoskeletal and connective tissue disorders Back pain Kidney and urine diseases air Polyuria, acute renal failure Nephritis or nephrotic syndrome Reproductive system and breast disorders Menstrual disorders. Prostate disorders Systemic disorders and administration site disorders Fatigue, pain, fatigue, chills, feeling unwell Peripheral edema Diagnostic tests Abnormalities in liver function tests The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal especially in the elderly, may occur (see section 4.4). Following administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported (see section 4.4). Gastritis has been reported less frequently. Edema, hypertension and heart failure have been reported in association with NSAID therapy. The results of clinical trials and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long periods) may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). As with other NSAIDs, the following side effects may appear: aseptic meningitis, which can occur mainly in patients with systemic lupus erythematosus or mixed connective tissue disease; hematological reactions (purpura, aplastic and hemolytic anemia, and rarely agranulocytosis and bone marrow hypoplasia). Reporting of suspected adverse reactions Reporting of suspected adverse reactions 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 at: www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose
The symptoms of overdose are unknown. Similar medicinal products have caused gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, dizziness, disorientation, headache) disorders. In case of accidental or excessive intake, immediately adopt adequate symptomatic therapy based on the patient's clinical condition. Activated charcoal should be administered within an hour if more than 5 mg / kg have been ingested by an adult or child. Trometamol dexketoprofen can be eliminated by dialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: propionic acid derivatives. ATC code: M01AE17. Dexketoprofen trometamol is the trometamine salt of S? (+)? 2? (3? Benzoylphenyl) propionic acid, an analgesic, anti-inflammatory and antipyretic drug belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs) (M01AE). Mechanism of action The mechanism of action of NSAIDs is related to the decrease in prostaglandin synthesis by inhibiting the cyclooxygenase pathway. Specifically, is there an inhibition of the transformation of arachidonic acid into cyclic endoperoxides, PGG2 and PGH2, which produce prostaglandins PGE1, PGE2, PGF2? and PGD2, and also prostacycline PGI2 and thromboxanes (TxA2 and TxB2). In addition, the inhibition of the synthesis of prostaglandins can affect other inflammatory mediators, such as quinines, causing an additional action in addition to the direct one. Pharmacodynamic effects Dexketoprofen has been shown to be effective in inhibiting COX? 1 and COX? 2 activities in experimental animals and humans. Clinical efficacy and safety Clinical studies conducted on different pain models have demonstrated the analgesic efficacy of dexketoprofen trometamol. The onset of analgesic activity was achieved in some studies 30 minutes after administration. Does the analgesic effect persist for 4? 6 hours.
05.2 Pharmacokinetic properties
Absorption After oral administration, dexketoprofen trometamol is rapidly absorbed: if administered as a granulate, the maximum plasma concentration is reached after 0.25? 0.33 hours. The comparison between standard release tablets and dexketoprofen granules at doses of 12.5 and 25 mg showed that the two formulations are bioequivalent in terms of bioavailability (AUC). Peak concentrations (Cmax) are approximately 30% higher after administration of granules than tablets. When the drug is administered concomitantly with food, the dose AUC does not vary, but the Cmax of dexketoprofen trometamol decreases and its absorption rate is delayed (tmax increased). Distribution The distribution and elimination half-lives of dexketoprofen trometamol are 0.35 and 1.65 hours, respectively. As with other drugs with high plasma protein binding (99%), its volume of distribution has an average value of less than 0.25 l / kg. Biotransformation and elimination The main elimination mechanism of dexketoprofen is glucuronoconjugation, followed by renal excretion. After administration of dexketoprofen trometamol, only levels of S? (+) Enantiomer are found in the urine, demonstrating that there is no conversion to enantiomer R in humans? (?). In multiple dose pharmacokinetic studies it has been observed that the AUC after the last administration does not differ from that obtained after a single dose, demonstrating that no drug accumulation occurs.
05.3 Preclinical safety data
Preclinical data based on conventional pharmacological safety studies, repeated dose toxicity studies, genotoxicity, reproductive toxicity and immunopharmacology confirm that there are no special hazards for humans. Chronic toxicity studies conducted in mice and monkeys reported an Undetected Adverse Effects Level (NOAEL) of 3 mg / kg / day. The main adverse effects observed at high doses were gastrointestinal erosions and ulcers with dose-dependent development. As found for the entire pharmacological class of NSAIDs, dexketoprofen trometamol can cause changes in embryo-fetal survival in animal models, indirectly through gastrointestinal toxicity of pregnant mothers and directly on the development of the fetus.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ammonium glycyrrhizinate Neoheperperin? Dihydrocalcone Quinoline yellow (E104) Lemon flavor Sucrose Colloidal hydrated silica
06.2 Incompatibility
Not relevant.
06.3 Validity period
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage precautions.
06.5 Nature of primary packaging and contents of package
The granules for oral solution are supplied in heat-sealed single-dose sachets made of aluminum-coated polyethylene.
FASTUMDOL ANTI-INFLAMMATORY 12.5 mg? packs of 2, 10, 20, 30, 40, 50, 100 and 500 sachets
FASTUMDOL ANTI-INFLAMMATORY 25 mg? packs of 2, 4, 10, 20, 30, 40, 50, 100 and 500 sachets Not all pack sizes may be marketed.
06.6 Instructions for use and handling
The unused medicine and the waste derived from it must be disposed of in accordance with the local regulations in force.
07.0 MARKETING AUTHORIZATION HOLDER
AIC holder: Menarini International Operations Luxembourg SA? 1, Avenue de la Gare? L? 1611 Luxembourg (Luxembourg)
Sales dealer: A. Menarini Industrie Farmaceutiche Riunite srl? Via Sette Santi, 3? 50131 Florence
08.0 MARKETING AUTHORIZATION NUMBER
-AIC n. 034041119? 12.5 mg granules for oral solution, 2 single-dose Al / PE sachets
AIC n. 034041121? 12.5 mg granules for oral solution, 10 single-dose Al / PE sachets
AIC n. 034041133? 12.5 mg granules for oral solution, 20 single-dose Al / PE sachets
AIC n. 034041145? 12.5 mg granules for oral solution, 30 single dose Al / PE sachets
AIC n. 034041158? 12.5 mg granules for oral solution 40 single dose Al / PE sachets
AIC n. 034041160? 12.5 mg granules for oral solution, 50 single dose Al / PE sachets
AIC n. 034041172? 12.5 mg granules for oral solution, 100 single dose Al / PE sachets
AIC n. 034041184? 12.5 mg granules for oral solution, 500 single-dose Al / PE sachets
AIC n. 034041196? 25 mg granules for oral solution, 2 single-dose Al / PE sachets
AIC n. 034041208? 25 mg granules for oral solution, 4 single dose Al / PE sachets
AIC n. 034041210? 25 mg granules for oral solution, 10 single dose Al / PE sachets
AIC n. 034041222? 25 mg granules for oral solution, 20 single-dose Al / PE sachets
AIC n. 034041234? 25 mg granules for oral solution, 30 single dose Al / PE sachets
AIC n. 034041246? 25 mg granules for oral solution, 40 single dose Al / PE sachets
AIC n. 034041259? 25 mg granules for oral solution, 50 single dose Al / PE sachets
AIC n. 034041261? 25 mg granules for oral solution, 100 single dose Al / PE sachets
AIC n. 034041273? 25 mg granules for oral solution, 500 single dose Al / PE sachets
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 23rd July 2012 Date of last renewal: 20th May 2015 10.0