Clipper 5mg Gastroresistant Prolonged Release Tablets
1. What Clipper Tablets are and what they are used for
2. Before you take Clipper Tablets
5. How to store Clipper Tablets
C Chiesi
PACKAGE LEAFLET: INFORMATION FOR THE USER
^clipper*5 mg
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. Tf 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 ana 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 this leaflet. It includes other important information
on the safe and effective use of this medicine that might be especially
01/2009.
In this leaflet:
1. What Clipper Tablets are and what they are used for
2. Before you take Clipper Tablets
3. How to take Clipper Tablets
4. Possible side effects
5. How to store Clipper Tablets
6. Further information
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 whicn 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 Dowel, where the coating breaks down for the beclometasone dipropionate to be released slowly.
Do not take Clipper Tablets:
• if you are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients contained in your tablets (these are listed in section 6, Further Information)
• 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
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 ofthe 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 about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Taking other medicines:
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, likely to become pregnant or are breast-feeding, you must tell your doctor before taking this medicine.
Driving and using machines:
ClipperTablets should not affect your ability to drive or operate machinery. However, some people 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.
Important information about some of the ingredients of Clipper Tablets:
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 —>
3. How to take Clipper Tablets
Always take Clipper Tablets exactly as your doctor has told you. You should 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.
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Clipper Tablets 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 pains • anxiety
• flu-like illness • sleepiness
• fever • muscle cramps
Taking high doses of beclometasone dipropionate over a long period of time can cause systemic 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. While 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.
• Keep out of the reach and sight of children.
• Do not take Clipper Tablets after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Clipper Tablets contain
• 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 look like and 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 Ltd,
Cheadle Royal Business Park, Highfield, Cheadle,
SK8 3GY, UK.
The manufacturer of Clipper is Doppel Farmaceutici S.r.l, Via Martiri della Foibe 1, Cortemaggiore (Piacenza), Italy.
This medicinal product is authorised in the Member States of the EEA under the following names:
Italy Bidiclin
Spain Bidiclin
Greece Bidiclin
UK Clipper