Bratiti

Package leaflet: Information for the user

Bratiti, 10 mg, coated tablets
Bratiti, 20 mg, coated tablets
Bratiti, 30 mg, coated tablets
apremilast
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What Bratiti is and what it is used for
2. What you need to know 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 Bratiti is and what it is used for

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

What Bratiti is used for
Bratiti is used to treat adult patients with the following conditions:

• Active psoriatic arthritis – if the patient cannot take another type of medicine called "disease-modifying antirheumatic drugs (DMARDs)", or if they have already tried such medicines but they were ineffective.
• Moderate to severe chronic plaque psoriasis – if the patient cannot take one of the following treatment options, or if they have already tried one of these therapies but they were ineffective:
  • Phototherapy – a treatment in which areas of skin are exposed to ultraviolet light.
  • Systemic therapy – treatment that affects the whole body, not just a specific part; examples include 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 psoriatic arthritis is
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, an inflammatory skin condition.

What plaque psoriasis is
Psoriasis is an inflammatory skin disease that may cause red, scaly, thick, itchy, and painful skin lesions. It may also affect the scalp and nails.

What Behçet's disease is
Behçet's disease is a rare inflammatory disorder affecting multiple parts of the body. The most common symptom is oral ulcers.

How Bratiti works
Psoriatic arthritis, psoriasis, and Behçet's disease are generally lifelong conditions, as there is currently no cure. Bratiti works by reducing the activity of an enzyme called "phosphodiesterase 4", which plays a key role in the inflammatory process. By reducing the activity of this enzyme, Bratiti may help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet's disease, thereby reducing the signs and symptoms of these conditions.

In psoriatic arthritis, treatment with Bratiti reduces joint swelling and pain and may 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, treatment with Bratiti reduces the number of oral ulcers and may lead to their complete resolution. It may also reduce associated pain.

Bratiti has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means a reduction in the impact of the disease on the patient's daily activities, relationships with others, and other factors, compared to before treatment.

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 suspects she may be pregnant.

Warnings and precautions
Before starting Bratiti, discuss this with your doctor or pharmacist.
Depression and suicidal thoughts
If the patient suffers from worsening depression with suicidal thoughts, this should be discussed with the doctor before starting treatment with Bratiti.
The patient or their caregiver should also immediately inform the doctor of any changes in behaviour or mood, feelings of depression, or any suicidal thoughts that occur after taking this medicine.
Severe kidney disease
If the patient has severe kidney disease, the dose taken will be different – see section 3.
If the patient is underweight
If the patient experiences unintentional weight loss during treatment with Bratiti, they should inform their doctor.
Gastrointestinal problems
Inform the doctor if severe diarrhoea, nausea, or vomiting occurs.
Children and adolescents
Studies on the use of Bratiti in children and adolescents have not been conducted; therefore, this medicine is not recommended for use in children and adolescents under 17 years of age.
Bratiti and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes also medicines available without prescription and herbal medicines. This is important because Bratiti may affect the action of other medicines. Likewise, other medicines may affect the action of Bratiti.
In particular, inform your doctor or pharmacist before starting Bratiti if the patient is 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 for mild anxiety and depression.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is limited data on the use of Bratiti in pregnant women. Women should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Bratiti.
It is not known whether the medicine passes into human milk. Bratiti should not be used during breastfeeding.
Driving and operating machinery
Bratiti has no influence on the ability to drive or operate machinery.
Bratiti contains lactose
Bratiti contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
This medicine contains sodium. Bratiti contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Bratiti

This medicine should always be taken exactly as directed by the physician. In case of doubts, consult
the physician or pharmacist.
Recommended dose of the medicine

• If the patient is starting treatment with Bratiti for the first time, they will receive a "starting kit" containing all doses as described in the table below.
• The "starting kit" is clearly labeled to ensure that the patient takes the correct tablet at the correct time.
• Treatment will begin with a lower dose, which will be gradually increased over the first 6 days of treatment.
• The "starting kit" also contains tablets at the recommended dose for the following 8 days (days 7 to 14).
• The recommended dose of Bratiti after completion of the dose-escalation period is 30 mg twice daily—one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food.
• The total daily dose is 60 mg. The recommended dose will be reached by the end of day 6.
• After reaching the recommended dose, the patient will receive only 30 mg tablets in the prescribed packaging. This dose-escalation phase must be completed only once, even if treatment needs to be restarted later.

Patients with severe kidney disease
If the patient has severe kidney disease, the recommended dose of Bratiti is 30 mg once daily (morning dose).
The doctor will inform the patient how to increase the dose when starting treatment with Bratiti for the first time.
How and when to take Bratiti

• This medicine is intended for oral administration.
• Tablets should be swallowed whole, preferably with water. Do not crush or split the tablets, as this may affect their properties.
• Tablets may be taken with or without food.
• This medicine should be taken at the same time each 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 more Bratiti than recommended If the patient takes more Bratiti than recommended, they should contact their doctor or go to hospital immediately. The package and this leaflet should be brought along. If the patient forgets to take Bratiti
• If the patient forgets to take a dose of Bratiti, they should take it as soon as possible. If it is almost time for the next dose, the missed dose should be skipped. The next dose should be taken at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Bratiti

• The patient should continue taking Bratiti until the doctor advises stopping treatment.
• Do not stop taking Bratiti without consulting the doctor first.

If there are any further doubts concerning the use of this medicine, consult the
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions – depression and suicidal thoughts
Inform your doctor immediately about any changes in behaviour or mood, feeling depressed, or having suicidal thoughts or behaviours (these occur not commonly).
Very common adverse reactions (may affect more than 1 in 10 patients)

• Diarrhoea
• Nausea
• Headache
• Upper respiratory tract infections, such as colds, nasal congestion, sinus infection

Common adverse reactions (may affect up to 1 in 10 patients)

• 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)
• Common cold (nasopharyngitis)
• Depression
• Migraine
• Tension headache

Uncommon adverse reactions (may affect up to 1 in 100 patients)

• Rash
• Urticaria
• Weight loss
• Allergic reaction
• Bleeding in the intestines or stomach
• Suicidal thoughts or behaviours

Adverse reactions with unknown frequency (frequency cannot be estimated from 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 years and older, there may be an increased risk of complications such as severe diarrhoea, nausea and vomiting. If intestinal problems worsen, inform your doctor. Reporting of adverse reactions If any adverse reactions occur, including any adverse reactions not listed in this

leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Bratiti

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or cardboard container following EXP. The expiry date refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Do not use this medicine if there are any signs of tampering with the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Bratiti contains

• The active substance 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:
• Tablet core: microcrystalline cellulose, lactose, sodium croscarmellose, colloidal silicon dioxide, anhydrous magnesium stearate.
• Tablet coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), talc, red iron oxide (E172), and yellow iron oxide (E172). The 30 mg tablets also contain black iron oxide (E172).

What Bratiti looks like and contents of the pack
Bratiti 10 mg coated tablet is pink, oblong-shaped, with the imprint "10" on one side and smooth on the other, measuring 8 mm in length and 3 mm in width.
Bratiti 20 mg coated tablet is orange, oblong-shaped, with the imprint "20" on one side and smooth on the other, measuring 12 mm in length and 6 mm in width.
Bratiti 30 mg coated tablet is red-brown, oblong-shaped, with the imprint "30" on one side and smooth on the other, measuring 13 mm in length and 7 mm in width.

Pack sizes:

• The starter pack is a folding carton containing 27 coated tablets: 4 tablets x 10 mg, 4 tablets x 20 mg, and 19 tablets x 30 mg, in a cardboard box.
• The standard one-month pack contains 56 coated tablets of 30 mg in a cardboard box.
• The standard three-month pack contains 168 coated tablets of 30 mg in a cardboard box.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 medicinal product is authorised for marketing 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 filmuhúðaðar töflur,
Bratiti 30 mg filmuhúðaðar töflur
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 tablet
Bratiti 30 mg filmom obalené tablety