Clipper 5mg gastro-resistant modified-release tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Beclometasone dipropionate

Commercializzato da:

Chiesi Ltd

Codice ATC:

A07EA07

INN (Nome Internazionale):

Beclometasone dipropionate

Dosaggio:

5mg

Forma farmaceutica:

Modified-release tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 01050200; GTIN: 5028613002742

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
GASTRO-RESISTANT PROLONGED-RELEASE TABLETS
BECLOMETASONE DIPROPIONATE
IMPORTANT THINGS YOU NEED TO KNOW ABOUT CLIPPER TABLETS
•
BECLOMETASONE DIPROPIONATE IS A STEROID MEDICINE, prescribed for
many different conditions, including serious illnesses.
•
YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.
•
DON’T STOP TAKING THIS MEDICINE without talking to your doctor - you
may need to reduce the dose gradually.
•
BECLOMETASONE DIPROPIONATE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4 below).
Some problems such as mood changes (feeling
depressed, or ‘high’), or stomach problems can happen straight
away.
If
you feel unwell in any way, keep taking your tablets, but SEE YOUR
DOCTOR STRAIGHT AWAY.
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS.
These
include weakness of arms and legs, or developing a rounder face (read
section 4 for more information).
•
IF YOU TAKE IT FOR MORE THAN 3 WEEKS, YOU WILL GET A BLUE ‘STEROID
CARD’: always keep it with you and show it to any doctor or nurse
treating you.
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKENPOX OR SHINGLES, if you
have never had them. They could affect you severely. If you do come
into contact with chickenpox or shingles, SEE YOUR DOCTOR STRAIGHT
AWAY.
NOW READ THE REST OF YOUR LEAFLET. It includes other important
information
on the safe and effective use of this medicine that might be
especially
important for you. THIS LEAFLET WAS LAST UPDATED ON 11/2017.
WHAT IS IN THIS LEAFLET:
1.
WHAT CLIPPER TABLETS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLIPPER
TABLETS
3.
HOW TO TAKE CLIPPER TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLIPPER TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CLIPPER TABLETS IS AND WHAT IT IS USED FOR
Beclometasone dipropionate belongs 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

Scheda tecnica

OBJECT 1
CLIPPER 5MG SUSTAINED RELEASE TABLETS
Summary of Product Characteristics Updated 22-Jan-2018 | Chiesi
Limited
1. Name of the medicinal product
Clipper 5 mg gastro-resistant prolonged-release tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg of beclometasone dipropionate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant prolonged-release tablets
Each ivory white, coated tablet is round and convex
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
_METHOD OF ADMINISTRATION _
Tablets must be swallowed whole with a little liquid. The tablets
should not be broken or chewed.
_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_
_Children_
There is no experience with Clipper tablets in children. Clipper is
not recommended for use in children.
4.3 Contraindications
Clipper 5 mg gastro-resistant prolonged release tablets are
contraindicated in patients with:
- hypersensitivity to beclometasone dipropionate or to any of the
excipients listed in section 6.1
- tubercular, local mycotic and viral infections
4.4 Special warnings and precautions for use
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, osteoporosi