Package Insert: Information for the UserUser

BIDICLIN5 mg Gastric-Resistant Tablets for Prolonged Release

BBeclometasone dipropionate

Read this package insert carefully before starting to take thismedicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

Bidiclin tablets contain the active substancebeclometasona dipropionate belonging to a group of medicines called steroids. Its full name iscorticosteroids. These corticosteroids are naturally found in the body, and help maintain health and well-being. Treatment with corticosteroids (such as dipropionate of beclometasona) is an effective way to treat various diseases that involve inflammation. Dipropionate of beclometasona reduces this inflammation, otherwise the problem would worsen. You should take the medicine regularly to achieve the maximum benefit.

Bidiclin 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 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, where the coating breaks down and beclometasona dipropionate is released slowly.

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

Do not take Bidiclin 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 any 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 Bidiclin tablets.

Be especially careful with Bidiclin 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 the loss of bone tissue 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 medications 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 conditions can 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 medication), 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 Bidiclin 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 medications.

Some medicines may increase the effects of Bidiclin, 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

Bidiclin 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.

Bidiclin Tablets contain lactose monohydrate.If your doctor has told you that you have an intolerance to certain sugars, consult with them 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.

Bidiclin 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 moreBidiclin Tabletsthan you should

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

If you forgot to takeBidiclin 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 withBidiclinTablets

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 medicinecan 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 with memory loss

- feeling, seeing, or hearing things that do not exist. Having strange 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 stopthe treatment unless you are told to. If you are unsure what the side effects below are, ask your doctor to explain them to you.

Less common 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)

-mouth infection by fungi

-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 of the face

-headache

-increased intracranial pressure

-reduction in bone mineral density (osteoporosis)

-increased eye pressure (glaucoma)

-cataracts

Side effects ofunknown frequency(cannot be estimated with the available data) as class effects of corticosteroids have been identified:

-blurred vision

-hypotension

If you consider that any of the side effects you experience are severe or last for many days, please inform your doctor or pharmacist. While taking these tablets, if you notice any unusual or unmentioned side effects in this leaflet, please inform 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 of Pharmacovigilance of Medicines for Human Use https://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 in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Bidiclin 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 contents of the packaging

Bidiclin 5 mg prolonged-release gastro-resistant tablets 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 packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

The marketing authorization holder is:

PROMEDICA S.r.l.

Vía Palermo 26/A

43122 Parma (Italy)

Local representative:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

The manufacturer responsible is:

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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.