Bidiclin 5 mg prolonged-release gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BIDICLIN 5 mg Prolonged-release gastro-resistant tablets

Beclometasone dipropionate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Bidiclin is and what it is used for

Bidiclin tablets contain 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 to treat various conditions involving inflammation. Beclometasone dipropionate reduces this inflammation; otherwise, the condition would worsen. You must 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) 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 on the affected area to reduce inflammation.

They are called prolonged-release gastro-resistant 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 your condition worsens or does not improve.

2. What you need to know before taking Bidiclin

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 a fungal or viral infection in the colon or rectum
• if you have severe liver disease.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Bidiclin tablets.

Take special care with Bidiclin 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 fragile, brittle bones
• Addison's disease or hypoadrenalism, 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 this applies 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 another infectious disease, 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 improve if the dose is reduced or treatment is stopped. However, if such problems occur, they may require treatment.

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 Bidiclin 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 Bidiclin, 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, 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 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, operate machinery, or perform any task requiring concentration and alertness.

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

3. How to take Bidiclin

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, 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 split or chew your tablets.

Dosage:

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

Your treatment will usually last for four 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 Bidiclin Tablets than you should

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

If you forget to take Bidiclin 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 missed dose.

If you stop taking Bidiclin 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 experiences 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 behaviour, 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 adverse 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 to you.

Uncommon adverse effects: may affect up to 1 in every 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 prolonged period may lead to systemic effects. These rare adverse effects, which may affect up to 1 in every 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
• marked 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), identified as class effects of corticosteroids, include:

• blurred vision
• hiccups

If you consider any of the adverse effects you experience to be severe or if they last for many days, please inform your doctor or pharmacist. While taking these tablets, if you notice any unusual or unlisted adverse effect in this leaflet, 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 may also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es

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

5. Storage of Bidiclin 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 refers to 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. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Bidiclin Tablets

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

Appearance of the medicine and contents of the pack

Bidiclin 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 some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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, 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 authorized in the Member States of the European Economic Area under the following names:

Date of the most recent 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.