Clipper 5 mg prolonged-release gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

CLIPPER 5 mg Prolonged-release gastro-resistant tablets

Beclometasone dipropionate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Clipper is and what it is used for
2. What you need to know before taking Clipper
3. How to take Clipper
4. Possible side effects
5. How to store Clipper
6. Contents of the pack and other information

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1. What Clipper is and what it is used for

Clipper contains the active substance beclometasone dipropionate, which belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help maintain health and well-being. Treatment with corticosteroids (such as beclometasone dipropionate) is an effective way of treating various inflammatory conditions. Beclometasone dipropionate reduces this inflammation; otherwise, the condition would worsen. You must take the medicine regularly to achieve the maximum benefit.

Clipper tablets have been prescribed by your doctor to treat ulcerative colitis. This disease affects the colon (large intestine) and the rectum (the final part of the large intestine), causing the lining of the colon to become ulcerated and inflamed, resulting in pain, redness, and swelling. These tablets act locally at the affected site to reduce inflammation.

They are called gastro-resistant prolonged-release tablets because they are coated in such a way that they pass through the stomach without dissolving, until they reach the large intestine, where the coating breaks down and beclometasone dipropionate is slowly released.

You should consult a doctor if you get worse or do not improve.

2. What you need to know before taking Clipper

Do not take Clipper Tablets:

• if you are allergic to beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6)
• if you have tuberculosis (TB)
• if you have a fungal or viral infection in the colon or rectum
• if you have severe liver disease.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Clipper tablets.

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

• liver problems
• kidney problems
• diabetes
• stomach or intestinal ulcer
• high blood pressure
• osteoporosis, a disorder in which loss of bone tissue causes brittle bones
• Addison's disease or adrenal insufficiency, a disorder caused by low secretion of corticosteroid hormones from the adrenal glands
• increased eye pressure, known as glaucoma
• cataracts, a condition in which the lenses of the eye become cloudy, causing poor vision or blindness
• an infection of the large intestine
• severe depression or manic-depression (bipolar disorder), or if a close family member has had these conditions. This includes having experienced depression while taking steroid medicines such as beclometasone dipropionate.

If any of these apply to you, talk to your doctor before taking beclometasone dipropionate.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you have never had chickenpox, herpes, or measles, avoid close contact with people who may have these diseases. If you become ill, or are exposed to someone with chickenpox, herpes, measles, or any infectious illness, contact your doctor immediately.

Mental health problems while taking beclometasone dipropionate

Mental health problems may occur while taking steroids such as beclometasone dipropionate (see also section 4 – Possible side effects):

• these conditions can be serious
• they usually begin within a few days or weeks after starting treatment
• they occur more frequently at high doses
• many of these problems resolve if the dose is reduced or treatment is stopped. However, if mental health problems occur, treatment is required.

Talk to your doctor if you (or someone taking the medicine) show any signs of mental health problems. This is particularly important if you are depressed or have suicidal thoughts. In some cases, mental health problems occur when the dose is reduced or treatment is stopped.

Taking Clipper with other medicines

Before starting treatment, please inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Especially, if you are already using or taking other steroid medicines.

Some medicines may increase the effects of Clipper, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Clipper Tablets should not affect your ability to drive or operate machinery. However, some patients may feel drowsy after taking this medicine. If you are affected in this way after taking these tablets, you should not drive or operate machinery or perform any task requiring concentration and alertness.

Clipper Tablets contain lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Clipper Tablets

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again. It is important that you take your tablets regularly.

Clipper Tablets are specially formulated so that you only need to take one tablet a day, preferably during the morning. It is best to take the tablets on an empty stomach or after a light breakfast.

Take the tablets with a glass of liquid, for example water. Do not break or chew your tablets.

Dosage:

The usual dose for adults, including elderly patients, is one 5 mg tablet once daily.

Your treatment will normally last up to 4 weeks. Do not stop taking your medicine until your doctor tells you to do so.

Use in children

Children must not take this medicine.

If you take more Clipper Tabletsthan you should

If you have taken more Clipper Tablets than you should, contact your doctor or pharmacist immediately.

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 at the scheduled time. 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 your doctor tells you to do so.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects: consult your doctor immediately

Steroids, including dexamethasone, can cause serious mental health problems. These are common in both adults and children. They may affect up to 5 in every 100 people taking medicines like dexamethasone:

• feeling depressed, including suicidal thoughts
• feeling overexcited (mania) or having mood swings
• feeling anxious, having trouble sleeping, difficulty thinking, feeling confused, or having memory loss
• feeling, seeing, or hearing things that are not real; having strange or fearful thoughts, changes in behavior, or feeling isolated.

If you notice any of these problems, speak to your doctor immediately.

The following adverse effects have also been reported. Speak to your doctor as soon as possible if you experience any of these effects, but do not stop treatment unless instructed to do so. If you are unsure about any of the adverse effects listed below, ask your doctor to explain them.

Uncommon adverse effects: may affect up to 1 in 100 patients

• feeling dizzy (nausea)
• constipation
• stomach pain
• flu-like illness
• fever
• heavy menstrual periods
• headache
• anxiety
• drowsiness
• muscle cramps

Taking high doses of beclometasone dipropionate for a long period of time may lead to systemic effects. These rare adverse effects, which may affect up to 1 in 1,000 patients, include:

• problems with adrenal gland function (adrenal suppression)
• round, puffy face (called "moon face")
• fat accumulation at the back of the neck (called "buffalo hump")
• excess fat accumulation in the body (obesity)
• fungal infection in the mouth
• decrease in the number of white blood cells called leukocytes and monocytes, which help the body fight infections by destroying harmful microorganisms in the blood
• increase in the number of white blood cells called granulocytes
• severe redness and inflammation of the facial skin
• headache
• increased intracranial pressure
• reduction in bone mineral density (thinning of the bones)
• increased eye pressure (glaucoma)
• cataracts

Adverse effects of unknown frequency (cannot be estimated from available data), as class effects of corticosteroids, have been identified:

• blurred vision
• hiccups

If you consider any of the adverse effects you experience to be severe or persistent for many days, please inform your doctor or pharmacist. While taking these tablets, if you notice any unusual or unlisted adverse effects, inform your doctor or pharmacist immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

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

5. Storage of Clipper Tablets

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and label. The expiry date is the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clipper Tablets

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

Nature of the product and pack contents

Clipper 5 mg Prolonged-release gastro-resistant tablets are off-white in colour, round and convex in shape.

They are available in blister packs containing 10 and 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The Marketing Authorization Holder is:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th Floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

The manufacturer is:

Doppel Farmaceutici, S.r.l.

Via Martiri delle Foibe 1, Cortemaggiore

Piacenza (Italy)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the latest review of this leaflet: 06/2019.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.