Spididol 400 mg - 24 anti-inflammatory and anti-rheumatic tablets

Product Description

Tablets for general pain

Indications

Spididol 400 mg are anti-inflammatory and antirheumatic tablets useful in cases of:

• Headache.
• Toothache.
• Neuralgia.
• Bone, joint and muscle pain.
• Menstrual pain.

Adjuvant in the symptomatic treatment of fever and flu.

Composition

Active ingredients: ibuprofen arginine salt, equivalent to ibuprofen 400 mg.
Excipients: l-Arginine, sodium bicarbonate, crospovidone, magnesium stearate, hydroxypropyl methylcellulose, sucrose, titanium dioxide, polyethylene glycol.

Directions for use and Dosage

Adults and children over 12 years: 1 film-coated tablet two to three times a day.
The maximum daily dose should not exceed 1200 mg per day.
Elderly: Elderly patients should adhere to the minimum dosages indicated above.
In the treatment of elderly patients, the dosage must be carefully established by the physician who will have to evaluate a possible reduction of the dosages indicated above.
In patients with impaired renal, hepatic or cardiac function, the dosages should be reduced.
Hepatic insufficiency: caution should be exercised when treating patients with reduced hepatic function. In such patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in case of prolonged treatment.
The use of this medicine is contraindicated in patients with severe hepatic insufficiency.
Renal insufficiency: caution should be exercised when treating patients with reduced renal function.
In such patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in case of prolonged treatment.
The use of this medicine is contraindicated in patients with severe renal insufficiency.
In adolescents (aged >= 12 years to <= 18 years): if use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of symptoms, a doctor must be consulted.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Method of administration: the tablet It should be swallowed with some water.
For patients with a more sensitive stomach, it is recommended to take it with food.

Warnings

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Appropriate monitoring and advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported in association with NSAID therapy.
Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg/day) are associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg/day) are associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). mg/day) are associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration, and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses (2400 mg/day) of ibuprofen are required.
The use of this drug should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
There is a risk of impaired renal function in dehydrated adolescents.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.
These patients should initiate treatment with the lowest dose available.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low-dose aspirin or other drugs likely to increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment.
At daily doses greater than 1000 mg, ibuprofen may prolong bleeding time.
Caution should be exercised 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.
If gastrointestinal bleeding or ulceration occurs in patients receiving this medicine, 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. Severe 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.
Patients appear to be at highest risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment.
Acute generalized exanthematous pustulosis (AGEP) has been reported in association with medicines containing ibuprofen.
This medicine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Hepatotoxic reactions may occur in the context of generalized hypersensitivity reactions.
For further information, read the package leaflet carefully.

Contraindications

Hypersensitivity to active ingredient or other substances closely related from a chemical point of view and/or to any of the excipients.
History of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs).
History of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Active and recurrent peptic ulcer.
Gastrointestinal bleeding.
Other active bleeding such as cerebrovascular bleeding.
Ulcerative colitis and Crohn's disease.
Severe hepatic and/or renal insufficiency.
Hemorrhagic diathesis.
Severe heart failure (NYHA class IV).
Due to the possibility of cross-allergic reactions with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, the product is contraindicated in patients in whom these drugs induce allergic reactions. Allergic reactions such as bronchospasm, asthma, urticaria, rhinitis, nasal polyposis, angioedema.
Third trimester of pregnancy.
For further information, read the package leaflet carefully.

Interactions

Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
In some patients with compromised renal function (for example, dehydrated patients or elderly patients with compromised renal function), the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible.
These interactions should be considered in patients taking this drug 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 consideration should be given to monitoring renal function after initiation of concomitant therapy.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
Furosemide and thiazide diuretics: Reduced efficacy of furosemide and thiazide diuretics may occur, probably due to sodium retention associated with inhibition of renal prostaglandin synthase.
Beta-blockers: The hypotensive effect of beta-blockers may be reduced.
Concomitant use of NSAIDs and beta-blockers may be associated with the risk of acute renal failure.
/>Other nonsteroidal anti-inflammatory drugs (NSAIDs) including selective COX-2 inhibitors: Ibuprofen should be used with caution in combination with other NSAIDs because it may increase the risk of adverse reactions in the gastrointestinal tract.
Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly.
Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. doses.
No clinically relevant effect is considered likely following occasional use of ibuprofen.
For further information, read the package leaflet carefully.

Undesirable effects

Undesirable effects are mainly related to the pharmacological effect of ibuprofen on prostaglandin synthesis.
Gastrointestinal disorders: the most common adverse events are: Commonly observed are gastrointestinal in nature.
Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur.
Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, heartburn, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of this drug.
Less frequently, gastritis has been observed.
Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis (very rare) and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
Cardiac and vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
A table of the frequency of adverse events is given below:

• very common (>=1/10);
• common (>=1/100, <1/10);
• uncommon (>=1/1000, <1/100);
• rare (>=1/10000, <1/1000);
• very rare (<1/10000);
• not known (cannot be estimated from the available data).

Gastrointestinal disorders.
Very common: dyspepsia, diarrhoea. Common: abdominal pain, heartburn, nausea, flatulence, abdominal discomfort; uncommon: peptic ulcers, gastrointestinal haemorrhage, vomiting, melaena, gastritis, stomatitis; rare: gastrointestinal perforation, constipation, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease; Not known: anorexia.
Systemic disorders and administration site conditions.
Not known: edema, fever.
Cardiac disorders.
Not known: cardiac failure.
Vascular disorders.
Not known: hypertension, arterial thrombosis, hypotension.
Paediatric population.
From cumulative clinical experience, there are no clinically relevant differences in the nature, frequency, severity, and reversibility of adverse reactions between the safety profile in adults and the approved paediatric population (>=12 years).
Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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
For further information, read the package leaflet carefully.

Pregnancy and Breastfeeding

Pregnancy. Inhibition of prostaglandin synthesis may may 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%, up to approximately 1.5%.
The risk was 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 administered prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimesters of pregnancy, this drug should not be administered if not in strictly necessary cases.
If this medicine 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 progress to renal failure with oligo-hydroamniosis;

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

• possible prolongation of bleeding time, and antiaggregant effect which may occur at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor

Consequently, this drug is contraindicated during the third trimester of pregnancy.
The use of the product during breastfeeding and in childhood is also not recommended.

Storage

Store at a temperature not exceeding 30 degrees C.

Format

24 tablets