Bratiti

Package Leaflet: Information for the User

Bratiti, 10 mg, coated tablets

Bratiti, 20 mg, coated tablets

Bratiti, 30 mg, coated tablets

apremilast

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

• Keep this leaflet. 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 get 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 and other information

• 1. What is Bratiti and what is it used for
• 2. Before you take 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 to 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 called "disease-modifying antirheumatic drugs (DMARDs)" or if they have tried one of these medicines but it did not work.
• Chronic plaque psoriasis of moderate to severe severity -if the patient cannot take one of the following treatments, or if they have tried one of these therapies but it did not work:
• phototherapy - a treatment where parts of the skin are exposed to ultraviolet light.
• systemic therapy - a treatment that affects the whole body, not just a specific part; examples include medicines such as "cyclosporin", "methotrexate", or "psoralen".
• Behçet's disease (BD)- to treat mouth 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 patches 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 mouth ulcers.

How does Bratiti work

Psoriatic arthritis, psoriasis, and Behçet's disease are usually long-term 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 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 mouth 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 before.

2. Before you take Bratiti

When not to take Bratiti

• if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or think you may be pregnant.

Warnings and precautions

Before taking Bratiti, discuss this with your doctor or pharmacist.

Depression and suicidal thoughts

If you have worsening depression with suicidal thoughts, discuss this with your doctor before taking Bratiti.
The patient or their caregiver should also immediately inform the doctor of 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 you have severe kidney disease, your dose will be different - see section 3.

If you are underweight

If you experience unintended weight loss while taking Bratiti, tell your doctor.

Gastrointestinal problems

Tell your doctor if you experience severe diarrhea, nausea, or vomiting.

Children and adolescents

There have been no studies 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

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. This includes medicines that can be obtained without a prescription and herbal medicines. This is because Bratiti may affect the way other medicines work. Other medicines may also affect the way Bratiti works.
In particular, tell your doctor or pharmacist before taking Bratiti if you 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 for mild anxiety and depression.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the use of Bratiti in pregnant women. Women should not become pregnant while taking this medicine and should use effective contraception while taking Bratiti.
It is not known whether Bratiti passes into breast milk. Bratiti should not be taken during breastfeeding.

Driving and using machines

Bratiti has no influence on the ability to drive and use machines.

Bratiti contains lactose

Bratiti contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to take Bratiti

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose of Bratiti

• If you are starting to take Bratiti for the first time, you will receive a "treatment initiation pack" which contains all the doses as described in the table below.
• The "treatment initiation pack" is clearly described to ensure that you take 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 completing 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 12 hours apart, with or without food.
• The total daily dose is 60 mg. By the end of day 6, you will have reached the recommended dose.
• After reaching the recommended dose, you will receive only 30 mg tablets in the prescribed packages. You only need to go through this dose titration phase once, even if you need to restart treatment.

Patients with severe kidney disease

If you have severe kidney disease, the recommended dose of Bratiti is 30 mg once a day (morning dose).
Your doctor will tell you how to increase the dose when you first start taking Bratiti.

How and when to take Bratiti

• This medicine is for oral use.
• Swallow the tablets whole, preferably with a glass of water. Do not crush or break the tablets, as this may affect their properties.
• The 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 your condition does not improve after six months, you should contact your doctor.

What to do if you take more Bratiti than you should

If you take more Bratiti than you should, contact your doctor or go to the hospital immediately. Take the package and this leaflet with you.

What to do if you miss a dose of Bratiti

• If you miss a dose of Bratiti, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

What to do if you stop taking Bratiti

• You should take Bratiti until your doctor tells you to stop.
• Do not stop taking Bratiti without consulting your doctor first.

If you have any further questions on 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.

Severe side effects – depression and suicidal thoughts

Tell your doctor immediately if you experience any changes in behavior or mood, feelings of sadness, or suicidal thoughts or behaviors (these 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
• diarrhea
• sleep problems (insomnia)
• indigestion or heartburn
• inflammation and swelling of the airways in the lungs (bronchitis)
• cold (inflammation of the nose and throat)
• 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 (which may include swelling of the face, lips, mouth, tongue, or throat, leading 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, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bratiti

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 blister or carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any signs of damage to the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will 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 apremilast.
• Bratiti 20 mg coated tablets: each coated tablet contains 20 mg apremilast.
• Bratiti 30 mg coated tablets: each coated tablet contains 30 mg apremilast.
• The other ingredients are:
• Core: microcrystalline cellulose, lactose, sodium croscarmellose, colloidal silicon dioxide, anhydrous, 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 "10" embossed on one side and smooth on the other, 8 mm long and 3 mm wide.
Bratiti 20 mg coated tablet is orange, elongated, with "20" embossed 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 "30" embossed 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 Authorisation Holder and Manufacturer

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

Manufacturer:

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 authorised 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: