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CLIPPER 5MG GASTRORESISTANT PROLONGED RELEASE TABLETS

Active substance(s): BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE / BECLOMETASONE DIPROPIONATE

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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 you 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 09/2015.

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 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.

2. What you need to know before you take Clipper Tablets
Do not take Clipper Tablets:

• if you are allergic (hypersensitive) to beclometasone dipropionate or any
of the other ingredients of this medicine (listed in section 6).
• if you have tuberculosis (TB)
• if you have an infection of the colon or rectum caused by a fungus or virus.
• if you have a serious liver disease

Warning and precautions:

Talk to your doctor or nurse before taking Clipper Tablets

Take special care with Clipper Tablets and always tell your doctor
if you have:









liver problems
kidney problems
diabetes
an ulcer of the stomach or intestine
high blood pressure
osteoporosis, a condition where loss of bony tissue results in brittle bones
Addison’s disease or hypoadrenalism, a condition caused by low secretions
of corticosteroid hormone from the adrenal glands
• increased pressure in your eyes, called glaucoma
• a cataract, a condition where the lens of the eye becomes opaque leading
to poor vision or blindness
• an infection of the bowel
• severe depression or manic-depression (bipolar disorder), or if any of your
close family has had these illnesses. This includes having had depression
while taking steroid medicines like beclometasone dipropionate.
If this applies to you, talk to a doctor before taking beclometasone
dipropionate.
If you are going to start taking, or are already taking steroid medicines,
such as Clipper, for more than three weeks, your doctor or pharmacist will
give you a “steroid warning card”. It is important that you always carry this
card with you until your doctor tells you that you don’t need to.
If you have never had chickenpox, shingles or measles, do not have close
contact with people whom you know have these diseases. If you become
ill, or are exposed to someone with chickenpox, shingles, measles or an
infectious disease contact your doctor immediately.

Mental problems while taking beclometasone dipropionate

Mental health problems can happen while taking steroids like beclometasone
dipropionate (see also section 4 – Possible side effects):
• these illnesses can be serious
• usually they start within a few days or weeks of starting the medicine
• they are more likely to happen at high doses
• most of these problems go away if the dose is lowered or the medicine
is stopped. However, if problems do happen they might need treatment.
Talk to a doctor if you (or someone taking this medicine), show any signs
of mental problems. This is particularly important if you are depressed, or
might be thinking of suicide. In a few cases, mental problems have
happened when doses are being lowered or stopped.

Other medicines and Clipper Tablets

Before starting treatment, please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines, including medicines
obtained without a prescription.
In particular, if you are already using or taking other steroid medicines.

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.
Please read the back of this leaflet

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3. How to take 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.

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.

4. Possible side effects
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:
• feeling depressed, including thinking about suicide
• feeling high (mania) or moods that go up and down
• feeling anxious, having problems sleeping, difficulty in thinking or being
confused and losing your memory
• feeling, seeing or hearing things which do not exist. Having strange
and frightening thoughts, changing how you act or having feelings of
being alone.
If you notice any of these problems talk to a doctor straight away.
The following side effects have also been reported. Tell your doctor as soon
as possible if you suffer from any of these side effects but do not stop
treatment unless told to do so. If you are not sure what the side effects
below are, ask your doctor to explain them to you.
Uncommon side effects which may affect fewer than 1 in 100 people are:
• feeling sick (nausea)
• very heavy periods
• constipation
• headache
• stomach pain
• anxiety
• flu-like illness
• sleepiness
• fever
• muscle cramps.
Taking high doses of beclometasone dipropionate over a long period of
time can cause systematic effects. These are rare side effects which may
affect fewer than 1 in 1000 people and include:
• problems with how your adrenal glands work (adrenosuppression)
• a round, puffy face (called “moon face”)
• a build up of fat on the back of the neck (called “buffalo hump”)
• a build up of excess fat in the body (obesity)
• yeast infection in the mouth
• a decrease in the number of white blood cells called leucocytes and
monocytes, which help the body fight infection by destroying harmful
micro-organisms in the blood
• an abnormal increase in the number of white blood cells called granulocytes
• severe redness and inflammation of facial skin
• headache
• raised pressure within the skull
• decrease in bone mineral density (thinning of the bones)
• increased pressure in your eyes (glaucoma)
• cataracts
If you experience any of the above side effects and they cause you
distress, are severe or last for several days, please tell your doctor or
pharmacist. Whilst taking these tablets if you notice anything unusual or
a side effect which is not mentioned in this leaflet, contact your doctor or
pharmacist immediately.

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. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Clipper Tablets
• Keep this medicine out of the sight and reach of children
• Do not take this medicine after the expiry date which is stated on the
carton and label. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Clipper Tablets contains

• The active substance is beclometasone dipropionate.
• The other ingredients are lactose monohydrate, hypromellose (E464),
microcrystalline cellulose, maize starch, magnesium stearate, macrogol
4000, methacrylic acid-methyl methacrylate copolymer, titanium dioxide
(E171) and talc.

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.

CP0004/6

30101456.002

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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