Loading…
CLIPPER is a brand name for Beclomethasone (also known as Beclometasone). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The tablets are indicated for the treatment of mild or moderate ulcerative colitis in active phase, as add-on therapy to 5-ASA containing drugs in patients who are non-responders to 5-ASA therapy in active phase.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage Recommendations Adults One Clipper 5 mg tablet a day to be taken in the morning before or after a light breakfast. Therapy cycles of not more than four weeks are recommended. Elderly No special dose adjustment is recommended.
However, experience with Clipper in the elderly is limited. Paediatric Population There is no experience with Clipper in the paediatric population. Clipper is not recommended for use in children. Method of Administration Tablets must be swallowed whole with a little liquid.
The tablets should not be broken or chewed.
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported with systemic corticosteroids.
Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated at 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is not known.
The adverse reactions found during clinical studies in patients treated with 5 mg of Clipper were all classified as mild or moderate and were all uncommon (≤ 1/100 and > 1/1000): SYSTEM ORGAN CLASS UNDESIRABLE EFFECT Psychiatric disorders anxiety Nervous system disorders headache, somnolence Gastrointestinal disorders nausea, constipation, abdominal pain Musculoskeletal and connective tissue disorders muscle cramps Reproductive system and breast disorders menorrhagia General disorders & administration site conditions influenza like illness, pyrexia During clinical trials carried out with Clipper 5 mg tablets a reduction of plasma cortisol levels at the end of four weeks treatment has been observed in up to 25 % of patients, however, clinical symptoms associated with adrenal suppression have not been reported.
Particularly at high doses of systemic corticosteroids taken for long periods, rare (≤ 1/1000 and > 1/10000) systemic adverse events may occur. 4) Hiccups 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
As there are no data in patients with severe hepatic impairment, treatment with Clipper in these patients is not recommended. There are no data in patients with hepatic or renal insufficiency, so these patients should only be treated with caution.
Use with caution in patients with tuberculosis, diabetes mellitus, gastro-duodenal ulcer, serious arterial hypertension, osteoporosis, hypoadrenalism, glaucoma and cataract. In case of pre-existing intestinal infection, or where such infection arises during treatment, appropriate antibiotic therapy must be instituted immediately.
Clinical safety data on treatment duration of more than four weeks are not available, therefore, the use of the product for longer periods is not recommended. After four weeks of treatment a reduction of the plasmatic levels of corticosteroids has been observed in up to 25% of patients treated with Clipper 5 mg per day.
This percentage is much lower if compared to the percentage of patients treated with oral systemic corticosteroids, such as prednisolone at a dose of 40 mg per day, showing plasma cortisol levels below the normal range (76 % after eight weeks of treatment, published data).
This is due to the low systemic availability of the active metabolite, beclometasone-17-monopropionate (B-17-MP), after administration of Clipper 5 mg per day, which is approximately 20% compared to the intravenous dose. The effect on HPA–axis could be considered as transient and a recovery of HPA function is expected to occur after withdrawal of the drug.
However, due to the lack of follow up data after the usual treatment period, careful supervision of patients’ clinical symptoms is recommended. 8). The suppression of the HPA-axis can reduce the stress response. Where patients are subject to surgery or other stresses, supplementary glucocorticoids treatment is recommended.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 8). Symptoms typically emerge within a few days or weeks of starting the treatment.
1 - Tubercular, local mycotic and viral infections
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Beclomethasone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depression or manic-depressive illness and previous steroid psychosis.
Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.