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Components:
Flurbiprofen
Method of action:
Analgesic, Anti-Inflammatory, Antipyretic, Cox Inhibitory, Nonsteroidal Anti-Inflammatory, Ophthalmologic Agent, Ophthalmologicals, Throat Preparations, Topical Products For Joint And Muscular Pain
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.11.15

Name of the medicinal product

Acustop Cataplasma

Qualitative and quantitative composition

Flurbiprofen

Therapeutic indications

The information provided in Therapeutic indications of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains.

Flurbiprofen is also indicated for its analgesic effect in the relief of mild to moderate pain in conditions such as dental pain, post-operative pain, dysmenorrhoea and migraine.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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For oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Adults:

150 to 200 mg daily in two, three or four divided doses. In patients with severe symptoms or disease of recent origin, or during acute exacerbations, the total daily dosage may be increased to 300 mg in divided doses.

For dysmenorrhoea, a dosage of 100 mg may be administered at the start of symptoms followed by 50 or 100 mg given at four- to six-hour intervals. The maximum total daily dosage should not exceed 300 mg.

Children:

Not recommended for use in children under 12 years.

Elderly:

The elderly are at increased risk of the serious consequences of adverse reactions. Although flurbiprofen is generally well tolerated in the elderly, some patients, especially those with impaired renal function, may eliminate NSAIDs more slowly than normal. In these cases, flurbiprofen should be used with caution and dosage should be assessed individually.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Contraindications

The information provided in Contraindications of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Flurbiprofen is contraindicated in patients with hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the inactive ingredients.

Flurbiprofen is contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to flurbiprofen, aspirin or other NSAIDs.

Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Flurbiprofen should not be used in patients with active, or history of, ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).

Flurbiprofen is contraindicated in patients with severe heart failure, hepatic failure and renal failure.

Flurbiprofen is contraindicated during the last trimester of pregnancy.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Patients with rare hereditary problems of galactose intolerance, fructose intolerance, the Lapp lactose deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medication.

The use of flurbiprofen with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to the potential for additive effects.

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

Gastrointestinal bleeding, ulceration and perforation

GI bleeding, ulceration or perforation has been reported with all NSAIDs at any time during treatment.).

Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be 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 anti-platelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.

Respiratory disorders

Caution is required if flurbiprofen is administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

Cardiovascular, renal and hepatic impairment

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.).

Flurbiprofen should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with flurbiprofen administration.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with flurbiprofen administration and NSAID therapy.

Clinical trial 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 such as myocardial infarction or stroke.).

Dermatological effects

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 of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

Haematological effects

Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Flurbiprofen should be used with caution in patients with a potential for abnormal bleeding.

Impaired female fertility

The use of flurbiprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of flurbiprofen should be considered.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Undesirable effects

The information provided in Undesirable effects of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, dyspepsia, flatulence, constipation, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following flurbiprofen administration. Less frequently, gastritis, has been observed. Pancreatitis has been reported very rarely.

Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).

Cardiac disorders and Vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Respiratory, thoracic and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, dyspnoea).

Other adverse events reported less commonly and for which causality has not necessarily been established include:

Blood and lymphatic system disorders: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Psychiatric disorders: Depression, confusional state, hallucination

Nervous system disorders: Cerebrovascular accident, optic neuritis, headache, paraesthesia, dizziness, and somnolence.

Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation).

Eye disorders: Visual disturbance

Ear and labyrinth disorders: Tinnitus, vertigo

Hepatobiliary disorders: Abnormal liver function, hepatitis and jaundice.

Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritis, urticaria, purpura and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme) and photosensitivity reaction.

Renal and urinary disorders: Toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

General disorders and administration site conditions: Malaise, fatigue

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 directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Symptoms

Symptoms of overdosage may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic measures

Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient's clinical condition.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Flurbiprofen has analgesic, anti-inflammatory and antipyretic properties. These are thought to result from the drug's ability to inhibit prostaglandin synthesis.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 90 minutes after ingestion. It is about 99% protein-bound and has an elimination half-life of about three to four hours.

The rate of urinary excretion of flurbiprofen and its two major metabolites ([2-(2-fluoro-4′-hydroxy-4-biphenylyl) propionic acid] and [2-(2-fluoro-3′-hydroxy-4′-methoxy-4-biphenylyl) propionic acid]) in both free and conjugated states is similar for both the oral and rectal routes of administration. Metabolic patterns are quantitatively similar for both routes of administration.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Anti-inflammatory agents, non-steroids

Preclinical safety data

The information provided in Preclinical safety data of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Incompatibilities

The information provided in Incompatibilities of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acustop Cataplasma is based on data of another medicine with exactly the same composition as the Acustop Cataplasma of the medicine (Flurbiprofen). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acustop Cataplasma directly from the package or from the pharmacist at the pharmacy.
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None stated.

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