BIDICLIN 5 mg PROLONGED-RELEASE GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for theuser

BIDICLIN5 mg Gastro-resistant prolonged-release tablets

Beclometasone dipropionate

Read all of this leaflet carefully before you start taking thismedicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What isBidiclinand what is it used for
2. What you need to know before you takeBidiclin
3. How to takeBidiclin
4. Possible side effects
5. StoringBidiclin
6. Contents of the pack and further information

1. What is Bidiclin and what is it used for

Bidiclin tablets contain the active substance beclometasone dipropionate, which belongs to a group of medicines called steroids. The 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 to treat various diseases that involve inflammation. Beclometasone dipropionate reduces this inflammation; otherwise, the problem would worsen. You should take the medicine regularly to get the maximum benefit.

Bidiclin tablets have been prescribed for you by your doctor to treat ulcerative colitis. This disease affects the colon (large intestine), the rectum (the last part of the large intestine), and causes the lining of the colon to become ulcerated and inflamed, causing pain, redness, and swelling. These tablets act locally in the affected area, reducing 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, where the coating breaks down and the beclometasone dipropionate is released slowly.

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

2. What you need to know before you take Bidiclin

Do not take Bidiclin 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 any infection in the colon or rectum caused by a fungus or virus
• if you have severe liver disease.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Bidiclin tablets.

Be particularly careful with Bidiclin Tablets and always contact your doctor if you have:

• liver problems
• kidney problems
• diabetes
• stomach or intestinal ulcers
• high blood pressure
• osteoporosis, a disorder in which bone tissue loss causes brittle bones
• Addison's disease or hypoadrenalism, a disorder caused by low secretion of corticosteroid hormone from the adrenal glands
• increased eye pressure, called glaucoma
• cataracts, a disorder in which the lenses of the eye become opaque, causing poor vision or blindness
• an infection of the large intestine
• severe depression or manic-depression (bipolar disorder), or if a close relative has 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 had chickenpox, herpes, or measles, do not come into close contact with people who may have these diseases. If you become ill or are exposed to someone with chickenpox, herpes, measles, or an infectious disease, contact your doctor immediately.

Mental problems while taking beclometasone dipropionate

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

• these diseases can be severe
• they usually start a few days or weeks after treatment begins
• they occur 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 problems. It is particularly important if you are depressed or have suicidal thoughts. In some cases, mental problems appear when the dose is reduced or treatment is stopped.

Taking Bidiclin with other medicines

Before you start treatment, please inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, including those obtained 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 monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancyand 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

Bidiclin Tablets should not affect your ability to drive or use machines. However, some patients may feel drowsy after taking this medicine. If you are affected by this, do not drive or use machines, 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.

3. How to take Bidiclin

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist again. It is important that you take your tablets regularly.

Bidiclin Tablets are specially formulated so that you only need to take one tablet a day, preferably in 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.

Dose:

The usual dose in adults, including the elderly, is one5 mg tablet once a day.

Your treatment will normally last up to 4 weeks. Do not stoptaking your medicine until your doctor tells you to.

Use in children

Children should nottake this medicine.

If you take moreBidiclin Tabletsthan you should

If you have taken more Bidiclin Tablets than you should, consult your doctor or pharmacist immediately.

If you forget to takeBidiclin 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 nottake the missed dose, just take the next dose when it is due. Do not take a double doseto make up for the missed dose.

If you stop takingBidiclinTablets

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: see a doctor immediately

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

• feeling depressed, including having suicidal thoughts
• feeling overexcited (mania) or having mood swings
• feeling anxious, having problems sleeping, difficulty thinking, or feeling confused and having memory loss
• seeing, hearing, or feeling things that do not exist. Having strange thoughts or fears, changing your behavior, or feeling alone.

If you notice any of these problems, talk 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, but do not stoptreatment unless your doctor tells you to. If you are unsure what these side effects are, ask your doctor to explain them to you.

Uncommon side effects:may affect up to 1 in 100 people

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

Taking high dosesof beclometasone dipropionate for a long time can cause systemic effects. These rareside effects may affect up to 1 in 1,000 people and include:

• problems with the functioning of the adrenal gland (adrenal suppression)
• round, puffy face (called "moon face")
• fat deposits at the base of the neck (called "buffalo hump")
• excess fat 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 skin on the face
• headache
• increased cranial pressure
• reduction in bone mineral density (thinning of the bones)
• increased eye pressure (glaucoma)
• cataracts

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

• blurred vision
• hypo

If you think any of the side effects you are experiencing are serious or last for a long time, please tell your doctor or pharmacist. While taking these tablets, if you notice any unusual side effects or those not mentioned in this leaflet, inform your doctor or pharmacist immediately.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Medicines Surveillance System for Human Use https://www.notificaram.es

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

5. Storing Bidiclin Tablets

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date is the last day of the month stated.
• This medicine 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. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bidiclin Tablets

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

Appearance and packaging

Bidiclin 5 mg gastro-resistant prolonged-release tablets are ivory-white and have a round, convex 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 is:

PROMEDICA S.r.l.

Via Palermo 26/A

43122 Parma (Italy)

Local representative:

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

The manufacturer is:

Doppel Farmaceutici, S.r.l.

Via Martiri delle Foibe 1, Cortemaggiore

Piacenza (Italy)

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: 06/2019

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