Bratiti

Leaflet attached to the packaging: information for the user

Bratiti, 10 mg, coated tablets

Bratiti, 20 mg, coated tablets

Bratiti, 30 mg, coated tablets

apremilast

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bratiti and what is it used for

What is Bratiti

Bratiti contains the active substance "apremilast". It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.

What is Bratiti used for

Bratiti is used to treat adult patients with the following diseases:

• Active psoriatic arthritis -if the patient cannot take another type of medicine from the group called "disease-modifying antirheumatic drugs (DMARDs)" or if they have already tried taking one of these medicines but they did not work.
• Chronic moderate to severe plaque psoriasis -if the patient cannot take one of the following treatments, or if they have already tried taking one of these therapies but they did not work:
• phototherapy - treatment in which parts of the skin are exposed to ultraviolet light.
• systemic treatment - treatment that affects the whole body, not just a specific part; examples include taking medicines such as "cyclosporine", "methotrexate", or "psoralen".
• Behçet's disease (BD)- to treat oral ulcers, which are a common symptom in people with this disease.

What is psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints, which is usually accompanied by psoriasis, an inflammatory disease of the skin.

What is plaque psoriasis

Psoriasis is an inflammatory disease of the skin that can cause red, scaly, thick, itchy, and painful lesions on the skin; it can also cause changes in the scalp and nails.

What is Behçet's disease

Behçet's disease is a rare type of inflammatory disease that affects many parts of the body. The most common symptom is oral ulcers.

How does Bratiti work

Psoriatic arthritis, psoriasis, and Behçet's disease are usually lifelong diseases, as there is no cure yet. Bratiti works by reducing the activity of an enzyme called "phosphodiesterase 4", which is involved in the inflammation process. By reducing the activity of this enzyme, Bratiti can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet's disease, and thus reduce the signs and symptoms of these diseases.
In psoriatic arthritis, taking Bratiti results in reduced joint swelling and pain, and may also improve the patient's overall physical function.
In psoriasis, treatment with Bratiti leads to a reduction in psoriatic skin lesions and other objective and subjective symptoms of the disease.
In Behçet's disease, taking Bratiti reduces the number of oral ulcers and may cause them to disappear completely. It may also relieve associated pain.
It has also been shown that Bratiti improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means reducing the impact of the disease on the patient's daily activities, relationships with others, and other factors, compared to what it was before.

2. Important information before taking Bratiti

When not to take Bratiti

• if the patient is allergic to apremilast or any of the other ingredients of this medicine (listed in section 6);
• if the woman is pregnant or thinks she may be pregnant.

Warnings and precautions

Before starting to take Bratiti, discuss it with your doctor or pharmacist.

Depression and suicidal thoughts

If the patient has worsening depression with suicidal thoughts, they should discuss it with their doctor before starting Bratiti.
The patient or their caregiver should also immediately inform the doctor about any changes in behavior or mood, feelings of sadness, and any suicidal thoughts or behaviors that occur after taking this medicine.

Severe kidney disease

If the patient has severe kidney disease, the dose taken by the patient will be different - see section 3.

If the patient is underweight

If the patient experiences unintended weight loss while taking Bratiti, they should tell their doctor.

Gastrointestinal problems

The patient should inform their doctor about severe diarrhea, nausea, or vomiting.

Children and adolescents

Studies have not been conducted on the use of Bratiti in children and adolescents, so this medicine is not recommended for use in children and adolescents under 17 years of age.

Bratiti and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription and herbal medicines. This is important because Bratiti may affect the action of other medicines. Other medicines may also affect the action of Bratiti.
In particular, the patient should inform their doctor or pharmacist before starting to take Bratiti if they are taking any of the following medicines:

• rifampicin - an antibiotic used to treat tuberculosis;
• phenytoin, phenobarbital, and carbamazepine - medicines used to treat seizures or epilepsy;
• St. John's Wort - a herbal medicine used to treat mild anxiety and depression.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
There are limited data on the use of Bratiti in pregnant women. The woman should not become pregnant while taking this medicine and should use an effective method of contraception while taking Bratiti.
It is not known whether the medicine passes into human milk. Bratiti should not be used during breastfeeding.

Driving and using machines

Bratiti does not affect the ability to drive or use machines.

Bratiti contains lactose

Bratiti contains lactose (a type of sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Bratiti

This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.

Recommended dose of Bratiti

• If the patient is starting to take Bratiti for the first time, they will receive a "treatment initiation pack" that contains all the doses according to the description in the table below.
• The "treatment initiation pack" is clearly described to ensure that the patient takes the correct tablet at the correct time.
• Treatment will start with a lower dose, which will be gradually increased over the first 6 days of treatment.
• The "treatment initiation pack" also contains tablets at the recommended dose for the next 8 days (days 7 to 14).
• The recommended dose of Bratiti after the dose titration period is 30 mg twice a day - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours with or without food.
• The total daily dose is 60 mg. By the end of day 6, the patient will reach the recommended dose.
• After reaching the recommended dose, the patient will receive only 30 mg tablets in the prescribed packaging. The patient only needs to go through this dose titration phase once, even if it is necessary to restart treatment.

Patients with severe kidney disease

If the patient has severe kidney disease, the recommended dose of Bratiti is 30 mg once a day (morning dose).
The doctor will inform the patient how to increase the dose when first taking Bratiti.

How and when to take Bratiti

• This medicine is intended for oral administration.
• Tablets should be swallowed whole, preferably with a glass of water. Do not crush or break the tablets, as this may affect their properties.
• Tablets can be taken with or without food.
• This medicine should be taken at the same time every day, one tablet in the morning and one tablet in the evening. If the patient's condition does not improve after six months, they should contact their doctor.

Taking a higher dose of Bratiti than recommended

If the patient takes a higher dose of Bratiti than recommended, they should immediately contact their doctor or go to the hospital. They should bring the packaging and this leaflet with them.

Missing a dose of Bratiti

• If the patient forgets to take a dose of Bratiti, they should take it as soon as possible. If it is close to the time of the next dose, they should skip the missed dose. The next dose should be taken at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Bratiti

• The patient should take Bratiti until their doctor tells them to stop.
• Do not stop taking Bratiti without consulting a doctor first.

If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Severe side effects - depression and suicidal thoughts

The patient should immediately inform their doctor about any changes in behavior or mood, feelings of sadness, suicidal thoughts, or suicidal behaviors (which occur uncommonly).
Very common side effects(may affect more than 1 in 10 people)

• diarrhea
• nausea
• headache
• upper respiratory tract infections, such as a cold, runny nose, sinus infection Common side effects(may affect up to 1 in 10 people)
• cough
• back pain
• vomiting
• feeling tired
• abdominal pain
• loss of appetite
• frequent bowel movements
• sleep problems (insomnia)
• indigestion or heartburn
• inflammation and swelling of the airways in the lungs (bronchitis)
• cold (nasopharyngitis)
• depression
• migraine
• tension headache Uncommon side effects(may affect up to 1 in 100 people)
• rash
• hives
• weight loss
• allergic reaction
• bleeding in the gut or stomach
• suicidal thoughts or behaviors Side effects with unknown frequency(frequency cannot be estimated from the available data)
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat, which may lead to difficulty breathing and swallowing) In patients aged 65 and older, there may be a higher risk of complications such as severe diarrhea, nausea, and vomiting. If gastrointestinal problems worsen, the patient should tell their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bratiti

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing this medicine.
Do not use this medicine if you notice any signs of damage to the medicine's packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bratiti contains

• The active substance of Bratiti is apremilast.
• Bratiti 10 mg coated tablets: each coated tablet contains 10 mg of apremilast.
• Bratiti 20 mg coated tablets: each coated tablet contains 20 mg of apremilast.
• Bratiti 30 mg coated tablets: each coated tablet contains 30 mg of apremilast.
• Other ingredients are:
• Core: microcrystalline cellulose, lactose, sodium croscarmellose, colloidal silicon dioxide, and magnesium stearate.
• Coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E172), talc, iron oxide red (E172), and iron oxide yellow (E172). The 30 mg tablets also contain iron oxide black (E172).

What Bratiti looks like and contents of the pack

Bratiti, 10 mg, coated tablet is pink, elongated, with the inscription "10" on one side and smooth on the other, 8 mm long and 3 mm wide.
Bratiti, 20 mg, coated tablet is orange, elongated, with the inscription "20" on one side and smooth on the other, 12 mm long and 6 mm wide.
Bratiti, 30 mg, coated tablet is red-brown, elongated, with the inscription "30" on one side and smooth on the other, 13 mm long and 7 mm wide.
Pack sizes

• The treatment initiation pack is a folding box containing 27 coated tablets: 4 x 10 mg, 4 x 20 mg, and 19 x 30 mg in a carton.
• The standard pack for one month contains 56 x 30 mg coated tablets in a carton.
• The standard pack for three months contains 168 x 30 mg coated tablets in a carton.

Marketing authorization holder and importer

Marketing authorization holder:

Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate
San Gwann SGN 3000
Malta.
Tel.: (+4) 0753 082 929

Importer:

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Iceland
Bratiti 10 mg + 20 mg + 30 mg film-coated tablets,
Bratiti 30 mg film-coated tablets
Hungary
Bratiti 10 mg + 20 mg + 30 mg filmtabletta
Bratiti 30 mg filmtabletta
Poland
Bratiti
Bulgaria
Братити 10 mg + 20 mg + 30 mg филмирани таблетки
Bratiti 10 mg + 20 mg + 30 mg film-coated tablets
Имапсун 30 mg филмирани таблетки
Bratiti 30 mg film-coated tablets
Romania
Bratiti 10 mg + 20 mg + 30 mg comprimate filmate
Bratiti 30 mg comprimate filmate
Czech Republic Bratiti
Slovakia
Bratiti 10 mg + 20 mg + 30 mg filmom obalené tablety
Bratiti 30 mg filmom obalené tablety

Date of last revision of the leaflet: