SPEDIFEN Uses, Dosage, Side Effects, Precautions & Warnings
spedifen 400 >> Generic drug of the Therapeutic class: Analgesics
active ingredients: Ibuprofen
what is spedifen 400 used for and indication?
- This medicine contains a nonsteroidal anti-inflammatory drug: ibuprofen.
- It is indicated, in the adult and the child of more than 20 kg (is approximately 6 years), in the short
- treatment of the fever and / or pains such as headaches, flu-like states, dental pains, body aches, painful periods.
- Swallow the tablet, without chewing, with a large glass of water, preferably during meals.
spedifen 400 mg dosage
The occurrence of side effects can be minimized by using the lowest possible dose for the shortest duration of treatment required to relieve symptoms ( see Warnings and Precautions section ).
ADAPTED TO THE ADULT AND TO THE CHILD FROM 20 KG (about 6 years).
Painful and / or febrile conditions
- In children, the usual dose is 20 to 30 mg / kg / day in 3 doses per day (without exceeding 30 mg / kg / day).
- In children from 20 to 30 kg (approximately 6 to 11 years): 1 tablet (200 mg), to be renewed if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (600 mg).
- In adults and children over 30 kg (approximately 11-12 years): 1 to 2 tablets (200 mg to 400 mg), to be renewed if necessary after 6 hours.
- In all cases, do not exceed 6 tablets per day (1200 mg).
- As age does not affect the kinetics of ibuprofen, the dosage should not need to be changed according to this parameter.
- However precautions must be taken ( see section Warnings and precautions for use ).
Frequency of administration
- Systematic catches prevent pain or fever oscillations.
- They should be spaced at least 6 hours.
Duration of the treatment
If the pain persists for more than five days or if it worsens, or if the fever persists for more than three days or if a new disorder occurs, the patient is advised to seek medical advice.
This medication is contraindicated in the following situations:
- – beyond 24 weeks of amenorrhea (completed 5 months of pregnancy) (see section Pregnancy and breast-feeding ),
- Hypersensitivity to ibuprofen or to any of the excipients of the product,
- – history of asthma triggered by taking ibuprofen or substances of similar activity such as: other NSAIDs, acetylsalicylic acid,
- History of bleeding or perforation of the digestive system during previous treatment with NSAIDs,
- Gastrointestinal haemorrhage, cerebrovascular haemorrhage or other active haemorrhage,
- – progressive peptic ulcer, history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified),
Severe hepatic impairment
Severe renal impairment
Severe heart failure
Systemic lupus erythematosus.
Taking a tablet or capsule is contraindicated in children under 6 years of age because it can lead to a wrong route.
How it works SPEDIFEN
ATC Code: N02B.
Ibuprofen is a nonsteroidal anti-inflammatory drug belonging to the group of propionics derived from aryl carboxylic acid. It has the following properties:
- Analgesic property,
- Antipyretic property,
- Anti-inflammatory property,
- Short-term inhibition property of platelet functions.
All of these properties are related to an inhibition of prostaglandin synthesis.
In post-extracorporeal pain, the analgesic effect of SPEDIFEN was observed earlier than for a conventional form of ibuprofen.
Experimental evidence suggests that ibuprofen may inhibit the platelet anti-aggregating effect of low-dose aspirin when taken concomitantly.
One study showed a decrease in the effect of aspirin on thromboxane formation or platelet aggregation when ibuprofen 400 mg was taken within 8 hours of aspirin 80 mg immediate release, or within 30 minutes. However, the limitations of these ex-vivo data and the uncertainties as to their extrapolation in the clinic, do not allow to formally conclude with regard to the regular use of ibuprofen; Moreover, with regard to ibuprofen used occasionally, the occurrence of
SPEDIFEN Side Effects
Clinical studies suggest that the use of ibuprofen, particularly at high dose (2400 mg daily) is likely to be associated with a slightly increased risk of arterial thrombotic events (myocardial infarction or stroke, by example) ( see Warnings and Precautions ).
The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in the elderly ( see Warnings and Precautions ).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melaena, hematemesis, exacerbation of ulcerative colitis or Crohn’s disease ( see Warnings and Precautions for Use ) have been reported in following administration of NSAIDs. Less frequently, gastritis has been observed.
Edema, hypertension and heart failure have been reported in combination with NSAID therapy.
- Gastrointestinal disorders such as nausea, vomiting, gastralgia, dyspepsia, transit disorders, digestive ulcerations with or without haemorrhage, occult or non-occult haemorrhage have usually been reported. These are all the more frequent as the dosage used is high and the duration of treatment extended.
- Hypersensitivity reactions:
- Dermatological: rashes, rash, pruritus, edema, urticaria, aggravation of chronic urticaria.
- Respiratory: the onset of asthma attack in certain subjects may be related to an allergy to acetylsalicylic acid or to a nonsteroidal anti-inflammatory drug ( see Contraindications ).
- General: anaphylactic shock, angioedema.
- Very rarely, bullous reactions (Stevens-Johnson syndrome, Lyell syndrome) have been observed.
- Exceptionally, occurrence of serious infectious skin and soft tissue complications during chickenpox ( see Warnings and Precautions ).
Effects on the central nervous system:
- Ibuprofen may exceptionally be responsible for vertigo and headache.
- Some rare cases of visual disturbances have been reported.
- Oliguria, renal failure.
- The discovery of aseptic meningitis with ibuprofen should seek out systemic lupus erythematosus or connective tissue disease.
Some biological modifications could be observed:
- Hepatic transient increase in transaminases, exceptional cases of hepatitis.
- Hematologic: agranulocytosis, hemolytic anemia.
Drugs interactions :
Risk related to hyperkalemia:
- Certain drugs or therapeutic classes may promote the occurrence of hyperkalemia: potassium salts, potassium diuretics, angiotensin-converting enzyme inhibitors, angiotensin II antagonists, nonsteroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), immunosuppressants such as ciclosporin or tacrolimus, trimethoprim.
- The combination of these drugs increases the risk of hyperkalemia. This risk is particularly important with potassium-sparing diuretics, especially when they are combined with one another or with potassium salts, whereas the combination of an ACE inhibitor and an NSAID, for example, is safer as soon as possible. the moment that the recommended precautions are implemented.
- To know the risks and stress levels specific to hyperkalemic drugs, it is necessary to refer to the interactions specific to each substance.
- However, some substances, such as trimethoprim, are not the subject of specific interactions with regard to this risk. Nevertheless, they can act as contributing factors when combined with other drugs such as those mentioned above.
- The simultaneous administration of ibuprofen with the following products requires a rigorous monitoring of the clinical and biological status of the patient:
( Cf Warnings and Precautions for use .)
- Other NSAIDs: increased risk of ulcerative and digestive bleeding.
- Acetylsalicylic acid at anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g daily) or at analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g daily): increased risk of ulcerogenic disease and digestive hemorrhagic.
- Oral anticoagulants: increased risk of haemorrhage of oral anticoagulant (aggression of the gastroduodenal mucosa by NSAIDs). NSAIDs may increase the effects of anticoagulants such as warfarin ( see Warnings and Precautions ). If the association can not be avoided, close clinical and biological monitoring.
- Unfractionated heparins, low molecular weight heparins and related (in curative doses and / or in the elderly): increased risk of haemorrhage (aggression of the gastroduodenal mucosa by NSAIDs). If the association can not be avoided, close clinical supervision.
- Lithium: increase of the lithemia which can reach toxic values (decrease of the renal excretion of lithium). If the combination can not be avoided, closely monitor for lithium and adjust the dosage of lithium during the combination and after stopping the NSAID.
- Methotrexate, used at doses greater than 20 mg / week: increased toxicity, including haematological toxicity, of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory drugs).
- Pemetrexed (patients with low to moderate renal function, creatinine clearance between 45 ml / min and 80 ml / min): risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs).
Requiring precautions for use:
- Ciclosporin, tacrolimus: risk of addition of nephrotoxic effects, especially in the elderly. Monitor renal function at the beginning of treatment with the NSAID.
- Diuretics, ACE inhibitors, angiotensin II antagonists (AIIA): acute renal failure in the at-risk patient (elderly and / or dehydrated) by reduction of glomerular filtration (inhibition of vasodilator prostaglandins by NSAIDs). Moreover, reduction of the antihypertensive effect. Hydrate the patient. Look at the kidney function at the start of the treatment.
- Methotrexate, used at doses less than or equal to 20 mg / week: increased toxicity, including haematological toxicity, of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory drugs). Weekly control of the blood count during the first weeks of the association. Increased monitoring for impaired (even mild) renal function, as well as in the elderly.
- Pemetrexed (patients with normal renal function): risk of increased toxicity of pemetrexed (decreased renal clearance by NSAIDs). Biological monitoring of the renal function.
To consider :
- Acetylsalicylic acid at anti-aggregating doses (50 mg to 375 mg per day in one or more doses): increased risk of ulcerative and digestive bleeding.
Concomitant administration of ibuprofen with acetylsalicylic acid is generally not recommended because of the increased potential for adverse effects.
The experimental data suggest that ibuprofen competitively inhibits the effect of low doses of acetylsalicylic acid on platelet aggregation when administered concomitantly. Although there are uncertainties in extrapolating these data to clinical situations, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic can not be excluded. No clinically relevant effect is considered likely for occasional use of ibuprofen ( see Pharmacodynamics).
- Platelet antiaggregants and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding ( see Warnings and Precautions).
- Beta-blockers (except esmolol): reduced antihypertensive effect (inhibition of vasodilator prostaglandins by NSAIDs and retention of water with NSAIDs pyrazole).
- Deferasirox: increased risk of ulcerative and digestive bleeding.
- Glucocorticosteroids (except hydrocortisone as replacement therapy): increased risk of ulceration and gastrointestinal bleeding ( see Warnings and Precautions ).
- Heparins of low molecular weight and related and unfractionated heparins (at preventive doses): increased risk of haemorrhage.
Warnings and Precautions
- Concomitant use of SPEDIFEN 200 mg tablet with other NSAIDs, including selective cyclooxygenase 2 (cox-2) inhibitors, should be avoided.
- The occurrence of adverse effects may be minimized by the use of the lowest possible dose for the shortest duration of treatment required to relieve symptoms (see section 4.2) and gastrointestinal and cardiovascular effects. -Dessous).
- Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis, have a risk of allergic manifestation when taking acetylsalicylic acid and / or nonsteroidal anti-inflammatory drugs higher than the rest of the population.
- The administration of this specialty may lead to an asthma attack, particularly in some people allergic to acetylsalicylic acid or NSAIDs (see section Contraindications ).
- Elderly patients have an increased risk of adverse effects to NSAIDs, particularly gastrointestinal bleeding and potentially fatal perforations.
- Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, has been reported with all NSAIDs at any time during treatment, without necessarily warning signs or a history of adverse effects. gastrointestinal symptoms.
- The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with the dose used in patients with a history of ulcer, particularly in the case of complications such as haemorrhage or perforation.
- as well as in the elderly. In these patients, treatment should be started at the lowest dose possible. A mucosal protective treatment (eg misoprostol or proton pump inhibitor) should be considered for these patients, as for patients requiring treatment with low doses of acetylsalicylic acid or treated with other drugs that may increase gastrointestinal risk (see below and sectionInteractions with other drugs and other forms of interaction ).
- Patients with a gastrointestinal history, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment.
- Special attention should be paid to patients receiving associated therapies that may increase the risk of ulceration or bleeding, such as oral corticosteroids, oral anticoagulants such as warfarin, selective reuptake inhibitors, and Serotonin (SSRI) and antiplatelet agents such as acetylsalicylic acid (see section 4.5 ).
- If bleeding or ulceration occurs in a patient receiving SPEDIFEN 200 mg tablets, treatment should be discontinued.
- NSAIDs should be administered with caution and under close supervision in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), because of a risk of aggravation of the pathology .
Cardiovascular and cerebrovascular effects
- Adequate monitoring and recommendations are required in patients with a history of hypertension and / or mild to moderate heart failure, with cases of fluid retention and edema associated with NSAID therapy.
- Clinical studies and epidemiological data suggest that the use of ibuprofen, especially when used at high doses (2400 mg per day) over a long course of treatment, may be associated with a slight increase in the risk of arterial thrombotic event (eg, myocardial infarction or stroke) (see Warnings and Precautions ) section. However, epidemiological data do not suggest that low doses of ibuprofen ( £ 1200 mg daily) are associated with an increased risk of myocardial infarction.
- Patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and / or a history of stroke (including transient ischemic attack) should be treated with ibuprofen only after a careful examination.
- Similar attention should be paid to initiating long-term treatment in patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes, or smoking).
- Serious skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndromes, and Lyell syndromes have been reported very rarely in NSAID therapy .
- The incidence of these adverse effects appears to be greater at the beginning of treatment, the delay of onset being, in the majority of cases, during the first month of treatment. SPEDIFEN 200 mg tablet should be discontinued at the onset of skin rash, mucosal lesions or other signs of hypersensitivity.
- Varicella can exceptionally cause serious skin and soft tissue complications. To date, the role promoting NSAIDs in worsening these infections can not be ruled out. It is therefore prudent to avoid the use of SPEDIFEN 200 mg tablet in case of chickenpox.
Functional renal insufficiency
NSAIDs, by inhibiting the vasodilator action of renal prostaglandins, are likely to cause functional renal failure by decreasing glomerular filtration. This side effect is dose dependent.
At the beginning of treatment or after dose increase, monitoring of diuresis and renal function is recommended in patients with the following risk factors:
- Elderly subjects,
- Associated drugs such as: ACE inhibitors, sartans, diuretics (see section Interactions with other medicinal products and other forms of interaction ),
- Hypovolemia, whatever the cause,
- Heart failure,
- Chronic renal failure,
- Nephrotic syndrome,
- Lupus nephropathy,
- Decompensated hepatic cirrhosis.
- Hydro-Sodium retention with possibility of edema, hypertension or hypertension, worsening of heart failure.
- Clinical monitoring is necessary from the beginning of treatment in case of hypertension or heart failure.
- A decrease in the effect of antihypertensives is possible (see section Interactions with other medicinal products and other forms of interaction ).
- Hyperkalemia favored by diabetes or concomitant treatment with hyperkalemic drugs (see section Interactions with other medicinal products and other forms of interaction ).
- Regular monitoring of serum potassium should be performed under these circumstances.
- This medication should be avoided if treated with another nonsteroidal anti-inflammatory drug, oral anticoagulant, lithium, analgesic, antipyretic or anti-inflammatory acetylsalicylic acid, with methotrexate doses greater than 20 mg per week, with low molecular weight and related heparins and unfractionated heparins (at curative doses and / or in the elderly), with pemetrexed, in patients with low to moderate renal function (see section Interactions with other medicines and other forms of interaction ).
Special precautions for use
- Ibuprofen, like any drug that inhibits the synthesis of cyclooxygenases and prostaglandins, can impair fertility. Its use is not recommended for women who want to conceive a child.
- In case of visual disturbances occurring during treatment, a complete ophthalmological examination must be performed.
- During prolonged treatments, it is recommended to check the blood count, liver function and kidney function.
- This medicine contains sodium. This medicine contains 41 mg of sodium per tablet. To be taken into account in patients following a strict sodium diet.
Drive and use machines
SPEDIFEN and PREGNANCY / BREAST FEEDING / FERTILITY
SPEDIFEN in Pregnancy
Malformative aspect: 1st quarter
- Studies in animals have not shown any teratogenic effect.
- In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in humans have been shown to be teratogenic in animals in well conducted studies on 2 species.
- In the human species, no particular malformative effects related to administration during the first trimester of pregnancy have been reported. However, further epidemiological studies are needed to confirm the absence of risk.
Fetotoxic and neonatal Appearance: 2 nd and 3 rd quarters
- This is a class toxicity for all prostaglandin synthesis inhibitors.
- The administration during the 2 nd and 3 rd trimesters exposes to:
Renal functional impairment:
- in utero can be observed as early as 12 weeks of amenorrhea (initiation of fetal diuresis): oligoamnios (most often reversible at the end of treatment), even anamnios especially during prolonged exposure.
- at birth, renal insufficiency (reversible or not) may persist especially in case of late and prolonged exposure (with a risk of delayed severe hyperkalemia).
A risk of cardiopulmonary involvement:
- Partial or complete constriction in utero of the arterial canal. The constriction of the arterial duct may occur after 5 months and may lead to fetal or neonatal right heart failure or even fetal death in utero .
- This risk is even more important that the catch is close to the term (less reversibility). This effect exists even for a punctual catch.
· A risk of increased bleeding time for the mother and the child.
- Up to 12 weeks of amenorrhea: use of SPEDIFEN 200 mg tablet should only be considered if necessary.
- Between 12 and 24 weeks of amenorrhea (between the beginning of fetal diuresis and 5 months): a brief dose should only be prescribed if necessary. Prolonged intake is strongly discouraged.
- Beyond 24 weeks of amenorrhea (5 months): any even punctual intake is contraindicated (see Contraindications section ). An accidental intake beyond 24 weeks of amenorrhea (5 months) justifies cardiac and renal, fetal and / or neonatal monitoring according to the term of exposure. The duration of this monitoring will be adapted to the elimination half-life of the molecule.
SPEDIFEN in feeding
- NSAIDs passing into breast milk, as a precaution, should be avoided in women who are breastfeeding.
What happens if I overdose from SPEDIFEN ?
Immediate transfer to hospital.
- Rapid evacuation of the product ingested by gastric lavage.
- Activated carbon to decrease the absorption of ibuprofen.
- Symptomatic treatment.
What is Forms and Composition?
White oblong tablet.
- 200 mg tablet: Box of 20, blister pack.
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