Fastumdol anti-inflammatory 25 mg - pain treatment 20 tablets

Product Description

Tablets for muscle pain, painful menstruation and toothache.

Indications

Fastumdol Anti-inflammatory 25 mg is a painkiller belonging to the family of nonsteroidal anti-inflammatory drugs.
It is used for the treatment of mild to moderate pain, such as muscle pain (back pain), menstrual pain and toothache.

Fastumdol anti-inflammatory has a double effect:

• It acts rapidly against pain.
• It fights the inflammation that causes it.

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

Ingredients

Active ingredients: Each tablet contains 25 mg of dexketoprofen as dexketoprofen trometamol.
Excipients:

• Tablet core: maize starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate.
• Film coating: dry lacquer composed of hypromellose, titanium dioxide, macrogol 6000, propylene glycol.

Directions for use and Dosage

Adults
Depending on the nature and intensity of the pain, the recommended dose is generally 12.5 mg every 4-6 hours or 25 mg every 8 hours.
The total daily dose should not exceed 75 mg.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Fastumdol Anti-inflammatory tablets are not indicated for long-term treatment and administration should be limited to the symptomatic period only.
Paediatric population
Fastumdol Anti-inflammatory has not been studied in children and adolescents.
Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.
Elderly
In elderly patients, it is recommended to start therapy at the lower end of the therapeutic range (50 mg total daily dose).
The dosage can be adjusted according to the patient's needs. be increased to reach that used for the general population only after good general tolerability has been ascertained.
Hepatic impairment
Patients with mild to moderate hepatic impairment should start therapy at reduced doses (50 mg total daily dose) and should be subjected to close medical supervision.
Fastumdol Anti-inflammatory should not be used in patients with severe hepatic impairment.
Renal impairment
In patients with mild renal impairment (creatinine clearance 60 - 89 ml/min), the initial dosage should be reduced to 50 mg total daily dose.
Fastumdol Anti-inflammatory tablets should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤ 59 ml/min).
Method of administration
The tablet should be swallowed with a sufficient quantity of liquid (e.g. a glass of water). Concomitant administration of food delays the rate of absorption of the drug, therefore in case of acute pain it is recommended that administration takes place at least 30 minutes before meals.

Warnings

Use with caution in patients with a history of allergic conditions.
Concomitant use of Fastumdol Anti-inflammatory and other NSAIDs, including selective cyclooxygenase 2 inhibitors, should be avoided.
Undesirable effects can be minimized by using the lowest effective dose for the highest effective dose. shortest possible duration of treatment necessary to control symptoms.
Gastrointestinal safety
Gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported with all NSAIDs at various stages of treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
If gastrointestinal bleeding or ulceration occurs in patients receiving Fastumdol Anti-inflammatory, the treatment should be discontinued.
The risk of gastrointestinal bleeding, ulceration or perforation increases with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly.
The elderly have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
These patients should start treatment with the lowest possible dose.
As with all NSAIDs, before starting treatment with dexketoprofen trometamol, it is necessary to investigate previous histories of esophagitis, gastritis and/or peptic ulcer and ensure their complete recovery. Patients with gastrointestinal symptoms or a history of gastrointestinal disorders should be carefully monitored for digestive disturbances, especially gastrointestinal bleeding.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.
Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients receiving concomitant low-dose aspirin or other drugs likely to increase gastrointestinal risk.
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution is advised in patients receiving concomitant medications which 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.
Renal Safety
To be used with caution in patients with impaired renal function.
In these patients, the use of NSAIDs may cause worsening of renal function, fluid retention and edema.
Caution is also required in patients undergoing diuretic therapy or in those patients who may develop hypovolemia, due to an increased risk of nephrotoxicity.
During treatment, adequate fluid intake must be ensured to prevent dehydration associated with a possible increase in renal toxicity.
Like all NSAIDs, the medicine may cause an increase in blood urea nitrogen and creatinine levels.
As with other prostaglandin synthesis inhibitors, it may cause an increase in renal function. be associated with adverse renal effects that may lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome, and acute renal failure.
Elderly patients are more likely to easily to have reduced renal function.
For further information, see the package leaflet.

Contraindications

Fastumdol Anti-inflammatory tablets should not be used in the following cases:

• patients with hypersensitivity to the active substance, or to other NSAIDs, or to any of the excipients;
• patients in whom active substances with similar action (e.g. acetylsalicylic acid, or other NSAIDs) trigger asthma attacks, bronchospasm, acute rhinitis, or are the cause of nasal polyps, urticaria or angioneurotic edema;
• photoallergic or phototoxic reactions known during treatment with ketoprofen or fibrates;
• patients with a history of gastrointestinal bleeding or perforation in relation to previous therapy with NSAIDs;
• patients with peptic ulcer active gastrointestinal bleeding/haemorrhage or a history of gastrointestinal bleeding, ulceration or perforation;
• patients with chronic dyspepsia;
• patients who have other active bleeding or coagulation disorders;
• patients with Crohn's disease or ulcerative colitis;
• patients with severe heart failure;
• patients with moderate to severe renal dysfunction (creatinine clearance ≤ 59 ml/min);
• patients with severely impaired hepatic function (Child-Pugh score 10 -15);
• patients with bleeding diathesis and other coagulation disorders;
• patients with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake);
• during the third trimester of pregnancy and breastfeeding.

Interactions

The following interactions are characteristic of nonsteroidal anti-inflammatory drugs (NSAIDs) in general:
Combinations not recommended:

• other NSAIDs, including high doses of salicylates (3 g/day): the concomitant administration of several NSAIDs may increase the risk of ulcers and gastrointestinal bleeding due to a synergistic effect;
• anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin due to the high plasma protein binding of dexketoprofen and the inhibition of platelet function and damage to the gastroduodenal mucosa.
  If the combination cannot be used, the patient should be advised to discontinue use of dexketoprofen. If the combination cannot be avoided, careful clinical observation and monitoring of laboratory parameters are required;
• heparins: increased risk of haemorrhage (due to inhibition of platelet function and damage to the gastroduodenal mucosa).
  If the combination cannot be avoided, careful clinical observation and monitoring of laboratory parameters are required;
• corticosteroids: increased risk of gastrointestinal ulceration or bleeding;
• lithium (described with various NSAIDs): NSAIDs increase blood levels of lithium which may increase the risk of haemorrhage. reach toxic levels (decreased renal excretion of lithium).
  This parameter therefore requires careful monitoring during the institution, adjustment and interruption of treatment with dexketoprofen;
• methotrexate, used at high doses such as 15 mg/week or more: increased haematological toxicity of methotrexate due to a decrease in its renal clearance, caused by anti-inflammatory drugs in general;
• hydantoins and sulfonamides: the toxic effects of these substances may be potentiated.

For further information, consult the package leaflet.

Undesirable effects

The table below, grouped by organ system and listed in order of frequency, reports adverse events, probably related to dexketoprofen trometamol, which occurred during the course of clinical studies and after the product was marketed:

Gastrointestinal: side effects The most common are gastrointestinal in nature.
Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially in the elderly, may occur.
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration.
Less frequently, gastritis has been observed.
Edema, hypertension and cardiac failure have been reported in association with NSAID therapy.
As with other NSAIDs, the following adverse effects may occur: aseptic meningitis, which may occur predominantly in patients with systemic lupus erythematosus or connective tissue diseases; Haematological reactions (purpura, aplastic and haemolytic anaemia, and rarely agranulocytosis and bone marrow hypoplasia).
Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
Clinical study and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

Pregnancy and Breastfeeding

Contraindicated during the third trimester of pregnancy and during breastfeeding.
Pregnancy:
Inhibition of prostaglandin synthesis may lead to a decrease in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). may adversely affect pregnancy and/or embryo/fetal development.
Results from 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 is increased from less than 1% to approximately 1.5%.
The risk is believed to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
However, animal studies with dexketoprofen trometamol have not shown any significant effects on the development of prostaglandin synthesis inhibitors. Reproductive toxicity is indicated.
During the first and second trimester of pregnancy, dexketoprofen trometamol should not be administered unless clearly necessary.
If dexketoprofen trometamol is used by a woman attempting to conceive, 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 may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may lead to:
  • progress to renal failure with oligo-hydroamniosis;

  the mother and the newborn, at the end of pregnancy, to:

  • possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses;
  • inhibition of uterine contractions resulting in delayed or prolonged labor.

  Breastfeeding:
  It has not been established whether dexketoprofen is secreted in breast milk.
  Fertility:
  As with other NSAIDs, the use of dexketoprofen trometamol may impair the ability to conceive. reduce female fertility and is not recommended in women attempting to conceive.
  Discontinuation of treatment with dexketoprofen trometamol should be considered in women who have difficulties conceiving or who are undergoing investigation of infertility.

  Format

  20 tablets

  Product Code:FRCM174608