Components:
Treatment option:
Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 18.03.2022
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GSL
For the relief of mild to moderate pain including rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness and for the relief of the symptoms of cold and influenza.
For oral administration and short-term use only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Adults, the elderly, and children and adolescents over 12 years of age:
If in children and adolescents, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
For adults aged 18 years or older the minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen, or persist, the patient should consult a pharmacist or a doctor.
1 or 2 tablets to be taken up to three times a day, as required. The tablets should be taken with water.
Leave at least 4 hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period.
Not to be given to children under 12 years of age.
Hypersensitivity to Spidifen 400 mg Comprimidos or any of the constituents in the product.
Spidifen 400 mg Comprimidos is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
Active or previous peptic ulcer (two or more episodes of proven ulceration or bleeding).
History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
Patients with severe hepatic failure, renal failure or severe heart failure (NYHA Class IV).
Use in last trimester of pregnancy.
Caution is required in patients with certain conditions:
- Systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis.
- Gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn's disease).
- Caution is required prior to starting treatment in patients with a history of hypertension and or heart/failure. Oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.
- Renal impairment as renal function may deteriorate.
- Hepatic dysfunction.
Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration to control symptoms (see GI and cardiovascular risks below).
The elderly are at increased risk of the serious consequences of adverse reactions especially gastrointestinal bleeding and perforation which may be fatal.
Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided .
Cardiovascular and cerebrovascular effects
Clinical studies suggest that use of Spidifen 400 mg Comprimidos, particularly at high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Overall, epidemiological studies do not suggest that low dose Spidifen 400 mg Comprimidos (e.g. ≤1200mg daily) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Spidifen 400 mg Comprimidos after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of Spidifen 400 mg Comprimidos (2400 mg/day) are required.
There is some evidence that drugs, which inhibit cyclooxygenase/ prostaglandin synthesis, may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Gastro-intestinal (GI) bleeding, ulceration, or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI effects (including ulcerative colitis, Crohn's disease).
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation , and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin uptake inhibitors or anti-platelet agents such as aspirin.
Where GI bleeding or ulceration occurs in patients receiving Spidifen 400 mg Comprimidos, the treatment should be withdrawn immediately.
Dermatological
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 for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Spidifen 400 mg Comprimidos should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Patients with rare hereditary problems of fructose intolerance should not take this medicine as this product contains sucrose.
Each tablet contains 67mg of sucrose. This should be taken into account in patients with diabetes mellitus.
There is a risk of renal impairment in dehydrated children and adolescents, between the ages of 12-18 year olds.
The label will include:
12-18 years: if symptoms worsen, or persist for more than 3 days, or you get new symptoms consult your doctor.
Adults: if symptoms worsen, or persist for more than 10 days, or you get new symptoms consult your pharmacist or doctor.
Read the enclosed leaflet before taking this product.
Do not take if you:
- have ever had a stomach ulcer, perforation or bleeding
- are allergic to Spidifen 400 mg Comprimidos (or anything else in this medicine), aspirin or other related painkillers
- are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
- are in the last 3 months of pregnancy.
Speak to a pharmacist or your doctor before taking if you:
- have asthma, diabetes, high cholesterol, high blood pressure, had a stroke, heart, liver, kidney or bowel problems
- are a smoker
- are pregnant
None expected at recommended doses and duration of therapy.
Hypersensitivity reactions have been reported and these may consist of
a) Non specific allergic reactions and anaphylaxis,
b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea or
c) Various skin reactions, e.g. pruritus, urticaria, angioedema, and more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis, and erythema multiforme).
The list of the following adverse effects relates to those experienced with Spidifen 400 mg Comprimidos at OTC doses, from short-term use. In chronic conditions, under long-term treatment, additional adverse effects may occur.
| Infections and infestations | Very rare: | Aseptic meningitis |
| Blood and lymphatic disorders | Very rare: | Haematopoietic disorders (anaemia, hemolytic anemia, aplastic anemia), leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. |
| Immune system disorders | Uncommon: | Hypersensitivity reactions with urticaria and pruritus. |
| Very rare: | In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with Spidifen 400 mg Comprimidos, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed. Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm. | |
| Psychiatric disorders | Very rare: | Nervousness |
| Nervous System | Uncommon: | Headache |
| Eye disorders | Very rare: | Visual disturbance |
| Ear and labyrinth disorders | Very rare: | Tinnitus and vertigo |
| Cardiac disorders | Very rare: | Cardiac failure |
| Vascular disorders | Very rare: | Hypertension |
| Respiratory, thoracic and mediastinal disorders | Very rare: | Asthma, broncospasm, dyspnoea and wheezing |
| Gastrointestinal disorders | Uncommon: | Abdominal pain, abdominal distension, dyspepsia and nausea. |
| Rare: | Diarrhoea, flatulence, constipation and vomiting. | |
| Very rare: | Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Exacerbation of ulcerative colitis and Crohn's disease. Mouth ulceration. | |
| Hepatobiliary disorders | Very rare: | Liver disorders, especially in long-term treatment, hepatitis and jaundice. |
| Skin and subcutaneous tissue disorders | Uncommon: | Various skin rashes. |
| Very rare: Not known: | Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur. Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) | |
| Renal and urinary disorders | Very rare: | Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. Haematuria, interstitial nephritis, nephritic syndrome, proteinuria |
| General disorders and administration site conditions | Very rare: | Oedema, peripheral oedema. |
| Investigations | Very rare: | Decreased hematocrit and hemoglobin levels. |
Clinical studies suggest that use of Spidifen 400 mg Comprimidos, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Symptoms
Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as vertigo, headache, respiratory depression, dyspnoea, drowsiness, occasionally excitation and disorientation or coma. Occasionally patents develop convulsions. In serious poisoning, hypotension, hyperkalaemia, and metabolic acidosis may occur and the prothrombin time / INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
Management
Should be symptomatic and supportive and include maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
Pharmacotherapeutic group: Propionic acid derivatives.
ATC Code: M01AE
Spidifen 400 mg Comprimidos is a phenylpropionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, Spidifen 400 mg Comprimidos reduces inflammatory pain, swelling and fever. Furthermore, Spidifen 400 mg Comprimidos reversibly inhibits platelet aggregation.
Experimental data suggest that Spidifen 400 mg Comprimidos may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of Spidifen 400 mg Comprimidos 400mg were taken within 30 min after immediate release aspirin (acetylsalicylic acid) dosing (81 mg), a decreased effect of aspirin (acetylsalicylic acid) on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of Spidifen 400 mg Comprimidos may reduce the cardioprotective effect of low-dose aspirin (acetylsalicylic acid) cannot be excluded. No clinically relevant effect is considered to be likely for occasional Spidifen 400 mg Comprimidos use.
Spidifen 400 mg Comprimidos is rapidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.
The half life of Spidifen 400 mg Comprimidos is about 2 hours.
In limited studies, Spidifen 400 mg Comprimidos appears in the breast milk in very low concentrations.
No relevant information additional to that already contained elsewhere in the SmPC.
None known.
Not applicable.
However, we will provide data for each active ingredient
