Leaflet: information for the user

CLIPPER 5 mg Gastric-resistant prolonged-release tablets

Beclometasone dipropionate

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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Clipper contains the active substancebeclometasona dipropionato which belongs to a group of medications called steroids. Its full name iscorticosteroids. These corticosteroids are naturally found in the body, and help to maintain health and well-being. Treatment with corticosteroids (such as dipropionato of beclometasona) is an effective way to treat various diseases that are characterized by inflammation. Dipropionato of beclometasona reduces this inflammation, otherwise the problem would worsen. You should take the medication 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), the rectum (the final part of the large intestine), and causes the colon lining to ulcerate and inflame, resulting in pain, redness, and swelling. These tablets act locally on the affected area reducing inflammation.

They are calledgastro-resistant tablets with prolonged release because they are made with a coating that allows them to pass through the stomach without dissolving until they reach the large intestine, where the coating breaks down and the dipropionato of beclometasona is released slowly.

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

Do not take Clipper Tablets:

-if you are allergic 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 in the colon or rectum caused by a fungus or virus

- if you have a severe liver disease.

Warnings and Precautions

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

Be especially careful with Clipper Tablets and contact your doctor if you have:

-liver problems

-kidney problems

-diabetes

-stomach or intestinal ulcer

-high blood pressure

-osteoporosis, a condition in which bone loss causes brittle bones

-addison's disease or hypoadrenalism, a condition caused by low hormone corticosteroid secretions from the adrenal glands

-high eye pressure, called glaucoma

-cataracts, a condition in which the lenses of the eye become opaque causing poor vision or blindness

-large intestine infection

-severe depressionor manic-depression (bipolar disorder), or ifany close relativehas had these diseases. That is, if you have had depression while taking steroid medicines like beclometasone dipropionate.

If this happens 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 hadchickenpox, herpes or measles, do not come into close contact with people who may be suffering from these diseases. If you become ill, or are exposed to someone with chickenpox, herpes, measles or an infectious diseasecontact your doctor immediately.

Mental health problems while taking beclometasone dipropionate

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

• these diseases may be serious
• they usually start within a few days or weeks after starting treatment
• they appear more frequently at high doses
• many of these problems disappear if the dose is reduced or treatment is stopped. However, if problems appear, they need treatment.

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

Taking Clipper with other medicines

Please inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those bought 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 make close checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Driving and operating machinery

Clipper Tablets should not affect your ability to drive or operate machinery. However, some patients may feel drowsy after taking this medicine. If this happens to you, do not drive, operate machinery or perform any task that requires concentration and staying alert.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is essential to take your tablets regularly.

Clipper Tablets are especially formulated so that you only have to takeone tablet a day, preferably in the morning. It is better to take the tablets with 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.

Dose:

The usual dose in adults, including the elderly isone5 mg tablet once a day.

Your treatment will usually last up to 4 weeks.Do not stop taking your medication until your doctor speaks with you.

Use in children

Childrenshould nottake this medication.

If you take moreClipper Tabletsthan you should

If you have taken moreClipper Tabletsthan you should, consult your doctor or pharmacist immediately.

If you forgot to takeClipper Tablets:

If you forgot to take a dose, take it as soon as you remember. If it is almost time for the next dose,do nottake the missed dose, only take the next dose when it is due.Do not take a double doseto make up for the missed dose.

If you interrupt treatment with Clipper Tablets:

Do not stoptaking your tablets, even if you feel better, unless your doctor tells you to.

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

Severe side effects: consult your doctor immediately

Corticosteroids, including dexamethasone, can cause serious mental health problems. These are common in both adults and children. They may affect 5 out of 100 people who take medicines like dexamethasone:

- feeling depressed, including suicidal thoughts

- feeling overexcited (mania) or having mood swings

- feeling anxious, with difficulty sleeping, difficulty thinking, or feeling confused and having memory loss

- feeling, seeing, or hearing things that do not exist. Having unusual or fearful thoughts, changing your behavior, or feeling lonely.

If you notice any of these problemstalk to your doctor immediately.

The following side effects have also been reported. Talk to your doctor as soon as possible if you experience any of these side effects butdo not stoptreatment unless you are told to. If you are unsure what the side effects below are, ask your doctor to explain them to you.

Rare side effects:may affect up to 1 in 100 patients

-feeling dizzy (nausea)

-constipation

-stomach pain.

-flu-like illness

-fever

-heavy menstrual bleeding

-headache.

-anxiety

-drowsiness

-muscle cramps.

Taking high dosesof dipropionato de beclometasona for a long period of time may cause systemic side effects. These rare side effectsthat may affect up to 1 in 1,000 patients include:

- problems with the functioning of the adrenal gland (adrenosuppression)

- round, puffy face (called "moon face")

-accumulation of fat at the back of the neck (called "buffalo hump")

- accumulation of excess fat in the body (obesity)

-oral thrush infection

-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

-significant redness and inflammation of the skin on the face

-headache

-increased intracranial pressure

-reduction in bone mineral density (bone thinning).

-increased eye pressure (glaucoma)

-cataracts

Rare side effects ofunknown frequency(cannot be estimated with available data) as a class effect of corticosteroids:

- blurred vision

-hypotension

If you consider any of the side effects you are experiencing to be severe or lasting for many days, please inform your doctor or pharmacist. While taking these tablets, if you notice any unusual or unmentioned side effects, please report them to your doctor or pharmacist immediately.

Reporting side effects

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

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

- Keep this medication out of the sight and reach of children.

- Do not use this medication after the expiration date that appears on the box and labeling. The expiration date is the last day of the month indicated.

- This medication does not require special storage conditions.

- Medications should not be disposed of through drains or trash.Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Clipper Tablets

• The active ingredient is dipropionate of beclometasone.
• The other components are lactose monohydrate, hypromellose (E464), microcrystalline cellulose, cornstarch, magnesium stearate, macrogol 4000, copolymer of methacrylic acid and methacrylic acid ester, titanium dioxide (E171), and talc.

Appearance of the product and content of the packaging

Clipper 5 mg Gastrorresistant tablets for prolonged release are off-white in color and have a rounded and convex shape.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

The holder of the marketing authorization is:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

The manufacturer is responsible for:

Doppel Farmaceutici, S.r.l.

Via Martiri delle Foibe 1, Cortemaggiore

Piacenza (Italy)

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 06/2019.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es .