Rofixdol Pain Relief 40mg Ketoprofen Powder For Oral Solution 12 Sachets

Rofixdol Pain Relief is a powdered drug in sachets based on ketoprofen lysine salt.

Therapeutic indications

Rofixdol Antidolore is used in the symptomatic of pain of different origin and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone pain.

Dosage and Posology

Take according to the following doses:

• Adults

Take 1 sachet up to three times a day with meals

• Children aged 6 to 14 and the elderly

The posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.

• Patients with hepatic insufficiency

It is advisable to start therapy at the minimum daily dosage.

• Patients with mild or moderate renal insufficiency

It is advisable to monitor the volume of diuresis and renal function.

How to use

Oral use. Pour the contents of the sachet into half a glass of water and mix.

Overdose

Cases of overdose have been reported with ketoprofen doses above 2.5 g. In many cases the symptoms observed were benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes for ketoprofen intoxication. In cases of suspected massive overdose, gastric lavage is recommended and symptomatic and supportive therapy instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. In case of kidney failure, hemodialysis can be helpful in removing the medicine from the bloodstream.

Contraindications

This medicine is contraindicated:

• in patients with a history of hypersensitivity reactions such as bronchospasm, asthma attacks, rhinitis, urticaria or allergic reactions to substances with a similar mechanism of action (e.g. acetylsalicylic acid or other NSAIDs).

Serious anaphylactic reactions, rarely fatal, have been reported in these patients:

• in patients with hypersensitivity to any of the excipients;
• third trimester of pregnancy;
• severe heart failure;
• active peptic / haemorrhagic ulcer or history of recurrent peptic ulcer (two or more episodes of known ulceration or bleeding);
• history of gastrointestinal bleeding or perforation following previous NSAID therapy;
• Crohn's disease or ulcerative colitis;
• hemorrhagic diathesis;
• severe hepatic insufficiency;
• severe kidney failure;
• Children under the age of 6

Side effects

The following undesirable effects have been observed following administration of ketoprofen in adults: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000); frequency not known (frequency cannot be estimated from the available data).

- Disorders of the blood and lymphatic system

• Rare: haemorrhagic anemia
• Very rare: Single cases of leukocytosis, lymphangitis, purpura, thrombocytopenic purpura, thrombocytopenia and leukocytopenia have been reported respectively.
• Not known: agranulocytosis, bone marrow failure.

- Disorders of the immune system

• Very rare: allergic and anaphylactoid reactions, anaphylactic shock, edema of the mouth.

- Psychiatric disorders

• Not known: mood changes.

- Nervous system disorders

• Uncommon: headache, dizziness, somnolence.
• Rare: paraesthesia.
• Very rare: dizziness. A single case of tremor and hyperkinesis has been reported in an elderly patient treated concomitantly with a quinolone antibiotic.
• Not known: convulsions, dysgeusia.

- Eye disorders

• Rare: blurred vision.
• Very rare: periorbital edema.

- Ear and labyrinth disorders

• Rare: tinnitus.

- Cardiac pathologies

• Very rare: palpitations, tachycardia, hypotension, heart failure.
• Cases of vasculitis and skin redness have been exceptionally reported.
• The use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

- Vascular pathologies

• Very rare: hypertension.
• Not known: vasodilation.

- Respiratory, thoracic and mediastinal disorders

• Rare: asthma.
• Very rare: bronchospasm (particularly in patients with known hypersensitivity to acetylsalicylic acid and NSAIDs), dyspnoea, laryngeal edema and laryngospasm. A single case of acute respiratory failure with fatal outcome has been reported in an aspirin sensitive and asthmatic patient.
• Not known: rhinitis.

- Gastrointestinal disorders

• Common: dyspepsia, nausea, abdominal pain, vomiting.
• Uncommon: constipation, diarrhea, flatulence, gastritis.
• Rare: stomatitis, peptic ulcer.
• Very rare: gastric pain, heartburn. Occasionally severe gastrointestinal haemorrhages, erosive gastritis with gastrointestinal perforation and / or haemorrhage, sometimes fatal, have been reported particularly in the elderly. In two single cases, haematemesis or melaena, exacerbation of colitis and Chron's disease respectively occurred. Two single cases of ulcerative stomatitis and tongue edema have been reported, respectively.
• Not known: gastrointestinal perforation.

- Hepatobiliary disorders

• Rare: hepatitis, increased transaminases, elevated serum bilirubin levels due to liver disorders.

- Skin and subcutaneous tissue disorders

• Uncommon: rash, pruritus.
• Very rare: urticaria, erythema, rash, maculo-papular rash, angioedema, dermatitis, rash.
• Not known: photosensitivity reactions, alopecia, bullous eruptions including Stevens-Johnson syndrome, toxic epidermal necrolysis.

- Renal and urinary disorders

• Very rare: face edema and haematuria. A single case of oliguria has been reported.
• Not known: acute renal failure, tubulointerstitial nephritis, nephrotoxic syndrome, renal function test abnormal.

- General disorders and administration site conditions

• Uncommon: edema, fatigue.
• Very rare: Single cases of peripheral edema and syncope have been reported, respectively.

- Diagnostic tests

• Rare: weight gain.

A single case of anxiety, visual hallucinations, hyperexcitability and altered behavior was reported in a pediatric patient who received twice the dose recommended in the CPR. Symptoms disappeared spontaneously within 1-2 days.

Adverse reactions of a serious nature, all very rare, predominantly include cases of skin reactions (urticaria, erythema, rash, angioedema), gastrointestinal and respiratory tract reactions (bronchospasm, dyspnoea, laryngeal edema), as well as episodic cases of allergic / anaphylactoid reactions, anaphylactic shock and edema of the mouth.

As already mentioned, a single case of acute respiratory failure, which occurred in an asthmatic and aspirin-sensitive patient, had a fatal outcome. Most of the reactions in allergic / asthmatic patients and / or with known hypersensitivity to NSAIDs were severe in nature. Clinical studies and epidemiological data suggest that the use of NSAIDs (especially at high doses and for prolonged periods) may be associated with an increased risk of arterial thrombotic events.

Pregnancy and breastfeeding

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 was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors resulted 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. Therefore ketoprofen lysine salt should not be administered during the first and second trimester of pregnancy unless strictly necessary. If ketoprofen lysine salt is used in women who wish to become pregnant or during the first and second trimester of pregnancy, the dosage should be kept as low as possible for the shortest possible treatment duration.

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 can occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, ketoprofen lysine salt is contraindicated during the third trimester of pregnancy. No data are available on the excretion of ketoprofen lysine salt in breast milk. Ketoprofen lysine salt is not recommended while breastfeeding.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. In patients receiving 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, should be used with caution. of lysine 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 with all NSAIDs at any stage of treatment with or without warning symptoms or a history of serious gastrointestinal reactions. The risk of gastrointestinal bleeding, ulceration and perforation is higher with higher doses of NSAIDs, in patients with a history of ulcer, especially if complicated with haemorrhage or perforation, and in the elderly.

These patients should begin treatment at the lowest possible 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. Patients with a history of gastrointestinal toxicity, especially when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Elderly: The elderly have a higher frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which can be fatal. When gastrointestinal bleeding or ulceration occurs in patients taking Rofixdol Antidolore the treatment should be discontinued. In some pediatric patients treated with ketoprofen lysine salt, gastrointestinal haemorrhages, occasionally severe, and ulcer have been reported; therefore the medicine must be administered under strict supervision of the doctor who will have to evaluate the necessary dosage schedule from time to time.

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 appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Treatment with ketoprofen lysine salt should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Clinical and epidemiological studies suggest that the use of some NSAIDs (particularly at high doses and in long-term treatments) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). The data are insufficient to exclude the same type of risk for ketoprofen. 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. 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 impairment, particularly if the patients are elderly. In these patients the administration of ketoprofen can cause a decrease in renal blood flow caused by the inhibition of prostaglandins and lead to renal failure. Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment.

As with other NSAIDs, in the presence of an infection, it must be taken into account that the anti-inflammatory, analgesic and antipyretic properties of ketoprofen lysine salt can mask the usual symptoms of the progression of the infection such as fever. As with all NSAIDs, the drug can increase plasma urea nitrogen and creatinine. As with other NSAIDs, the drug can cause transient small increases in some liver parameters and also significant increases in SGOT and SGPT. In the event of a significant increase in these parameters, therapy must be discontinued. In patients with abnormal liver function values or with a history of liver disease, transaminase levels should be evaluated periodically, especially during long-term therapy.

Rare cases of jaundice and hepatitis have been reported with the use of ketoprofen. Ketoprofen lysine salt should be administered with caution in patients with haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disorders. The use of ketoprofen lysine salt, as well as any drug that inhibits prostaglandin synthesis and cyclo-oxygenase, may impair female fertility and is not recommended in women intending to become pregnant. The administration of ketoprofen lysine salt should be discontinued in women who have fertility problems or who are undergoing fertility investigations. Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyps have a higher risk of allergy to aspirin and / or NSAIDs than the rest of the population. Administration of this medicine can cause asthma attacks or bronchospasm, especially in people allergic to aspirin or NSAIDs.

As with other NSAIDs, patients with uncontrolled hypertension, established ischemic cardiomyopathy congestive heart failure, peripheral arterial disease and / or cerebrovascular disease should only be treated with ketoprofen lysine salt after careful consideration. Similar considerations must be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes mellitus, smoking). Treatment should be discontinued if visual disturbances such as blurred vision appear. Rofixdol Pain Relief contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine

Expiry and Retention

No particular precautions.

Warning: do not use Rofixdol Antidolore after the expiry date stated on the package

Composition

One bipartite sachet of Rofixdol Pain Relief contains

Active principle

Ketoprofen 40 mg lysine salt (equivalent to 25 mg ketoprofen)

Excipients

Sorbitol (Neosorb P60), sorbitol (Neosorb P30 / P60), povidone, anhydrous colloidal silica, sodium chloride, sodium saccharin, glycyrised ammonium, mint flavor.