Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Beclometasone dipropionate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Clipper tablets contain the active substance beclometasone dipropionate belonging to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroids (such as beclometasone dipropionate) is an effective way to treat various illnesses involving inflammation in the body. Beclometasone dipropionate reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Clipper Tablets have been prescribed by your doctor to treat your ulcerative colitis. This is a disease which affects the colon (the large intestine or bowel), the rectum (the lower end of the large intestine), and causes the lining of the colon to become ulcerated and inflamed, resulting in pain, redness and swelling. These tablets act locally in the affected area to reduce the inflammation. They are called gastro-resistant prolonged release tablets because they are made with a coating that allows them to pass through the stomach without dissolving until they reach the large intestine or bowel, where the coating breaks down for the beclometasone dipropionate to be released slowly. You must talk to a doctor if you do not feel better or if you feel worse.
e Clipper Tablets Do not take Clipper Tablets:
Warning and precautions:
Talk to your doctor, pharmacist or nurse before taking Clipper Tablets
Take special care with Clipper Tablets and always tell your doctor if you have:
Mental problems while taking beclometasone dipropionate
Mental health problems can happen while taking steroids like beclometasone dipropionate (see also section 4 – Possible side effects):
Other medicines and Clipper Tablets
Before starting treatment, please tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, if you are already using or taking other steroid medicines. Some medicines may increase the effects of Clipper Tablets and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy and breast-feeding:
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines:
Clipper Tablets should not affect your ability to drive or operate machinery. However, some patients may feel sleepy or drowsy after taking this medicine. If these tablets affect you in this way after taking them, you must not drive or operate machinery or perform any tasks which require you to concentrate and remain alert. Clipper Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Clipper Tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important that you take your tablets regularly. Clipper Tablets are specially formulated so that you only have to take your tablets once a day, preferably in the morning. It is best to take your tablets on an empty stomach or after a light breakfast. Take your tablets with a glass of liquid, e.g. water. Do not break or chew your tablets. Please read the back of this leaflet
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CHIESI FARMACEUTICI S.p.A. – Parma – Italy NOT TO TAMPER THIS DOCUMENT
Artwork Owner: M.S./Tipocrom – mail: [email protected] (1) DESCRIPTION OF MATERIAL: F.E. CLIPPER 5 mg 30 TABS CHIESI LTD (4) ITEM CHIESI:
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(2) FORMAT:
Doppel 135 x 480 After folding 135 x 31 0108004938/01 Helvetica Neue LT Std 9,5 pt /
DIMENSIONS mm: (5) REPLACE CODE: FONT AND min. SIZE: REF. STD VARNISH: COLOUR PRINT N. 4:
Black + halft. 20-50%
Cyan
Magenta
BACK
DIECUT
Reason of the change:
Request PIL for side effects (blurred vision, hiccups) CHECK BY
Name:
Date:
PROOF N. /
1
DATE
08/05/19
FROM: /CHANGE FOR
/
Dosage:
The usual adult dose, including the elderly is one 5 mg tablet once a day. Your treatment will usually last up to four weeks. Do not stop taking your medicine until your doctor tells you.
Use in children:
Children must not take this medicine.
If you take more Clipper Tablets than you should:
If you take more Clipper Tablets than you should, immediately contact your doctor or pharmacist.
If you forget to take Clipper Tablets:
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose, just take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Clipper Tablets:
Do not stop taking your tablets, even if you feel better, unless told to do so by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: tell a doctor straight away
Steroids including dexamethasone can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like dexamethasone:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Clipper Tablets
What Clipper Tablets contains
What Clipper Tablets looks like and the contents of the pack
Clipper 5 mg Gastro-resistant Prolonged-release Tablets are ivory white and are round and convex in shape. They are available in blister packs of 10 and 30 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder of Clipper is Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom. The manufacturer of Clipper is Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, Cortemaggiore (Piacenza), Italy.
This medicinal product is authorised in the Member States of the EEA under the following names: Italy Belgium Luxembourg Spain UK
Bidiclin Clipper Clipper Bidiclin Clipper
Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
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Clipper 5 mg gastro-resistant prolonged-release tablets comes as tablet containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Clipper 5 mg gastro-resistant prolonged-release tablets is beclometasone dipropionate.
This leaflet reproduces the patient information leaflet approved for Clipper 5 mg gastro-resistant prolonged-release tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Tubercular, local mycotic and viral infections
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.
In case of prolonged treatment, possible adverse effects related to the suppression of HPA-axis may occur (see section 4.8). 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.
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 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.
No interaction studies have been performed.
As beclometasone dipropionate undergoes a very rapid metabolism via esterases enzymes without involvement of cytochrome P450, it is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however, the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.
Clipper in clinical studies has been used in conjunction with oral or rectal treatment with mesalazine. Even if no specific pharmacodynamic interactions have been studied, clinical trials did not evidence any increase of adverse events severity due to the association of BDP with 5-ASA products. In addition, according to the different pharmacokinetic pathway of the two drugs, metabolic interactions are not expected to occur.
Pregnancy
Data on a large number of exposed pregnancies indicate no adverse effects of 1 mg per day beclometasone dipropionate (after inhalation), on pregnancy or on the health of the newborn child. To date, no other relevant epidemiological data on oral administration of 5 mg beclometasone dipropionate are available. High doses of systemic corticosteroids for longer periods may cause intrauterine growth retardation.
Studies in animals have shown reproductive toxicity (see section 5.3). Clipper should not be used during pregnancy, unless strictly indicated after a careful risk / benefit evaluation. Foetal growth should be monitored.
Breast-feeding
It is not known whether beclometasone dipropionate is excreted in human milk. A risk to the newborns/infants cannot be excluded. Due to the lack of data, the administration of Clipper during lactation is not recommended unless strictly indicated after a careful risk / benefit evaluation.
Clipper has no or negligible influence on the ability to drive and use machines.
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.
These may include:
SYSTEM ORGAN CLASS
UNDESIRABLE EFFECT
Infections and infestations
oropharyngeal candidiasis
Blood and the lymphatic system disorders
lymphopenia, monocytopenia, granulocytosis
Endocrine disorders
adrenal suppression, cushingoid
Metabolism and nutrition disorders
obesity
Nervous system disorders
headache, benign intracranial hypertension
Eye disorders
cataract and glaucoma
Skin and subcutaneous tissue disorders
lipohypertrophy, rosacea,
Musculoskeleta ,and connective tissue disorders
osteoporosis
Adverse events with frequency not known (cannot be estimated from the available data) have been identified as class risk effect of corticosteroids:
SYSTEM ORGAN CLASS
UNDESIRABLE EFFECT
Eye disorders
Vision blurred (see also section 4.4)
Respiratory, thoracic and mediastinal disorders
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No cases of overdose have so far been reported. However, in case of acute or chronic intake exceeding the therapeutic dose, the following measures should be taken:
Acute
Ingestion of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not require emergency action.
Chronic
Monitoring of adrenal reserve may be indicated. Treatment should be continued at a dose sufficient to control the ulcerative colitis and no more.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Beclometasone dipropionate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Clipper 5 mg gastro-resistant prolonged-release tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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