Tivlemak

Package leaflet: Information for the patient

TIVLEMAQ, 10 mg, coated tablets
TIVLEMAQ, 20 mg, coated tablets
TIVLEMAQ, 30 mg, coated tablets
Apremilastum

Please read carefully all the information in this leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What the medicine is and what it is used for

This medicine contains the active substance "apremilast". It belongs to a group of medicines known as
phosphodiesterase 4 inhibitors, which help reduce inflammation.
What the medicine is used for
This medicine is used to treat adults with the following conditions:

• Active psoriatic arthritis – if the patient cannot take another type of medicine called conventional disease-modifying antirheumatic drugs (DMARDs), or if treatment with one of these medicines has been ineffective.
• Moderate to severe chronic plaque psoriasis – if the patient cannot take one of the following treatments, or if treatment with one of these has been ineffective:
  • phototherapy – a treatment in which certain areas of skin are exposed to ultraviolet light.
  • systemic therapy – treatment that affects the entire body rather than a specific part; examples include medicines such as "cyclosporine", "methotrexate", or "psoralen".
• Behçet's disease (BD) – for the treatment of oral ulcers, which are a common symptom in people with this disease.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, an inflammatory skin condition.
What is plaque psoriasis
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 is Behçet's disease
Behçet's disease is a rare inflammatory condition affecting multiple parts of the body. The most common symptom is oral ulcers.
How the medicine works
Psoriatic arthritis, psoriasis, and Behçet's disease are generally lifelong conditions, and there is currently no cure. The medicine works by reducing the activity in the body of an enzyme called "phosphodiesterase 4", which is involved in the inflammatory process. By reducing the activity of this enzyme, the medicine 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 this medicine leads to improvement in swollen and painful joints and may improve the patient's overall physical function.
In psoriasis, treatment with this medicine leads to a reduction in psoriatic skin lesions and other signs and symptoms of the disease.
In Behçet's disease, treatment with this medicine reduces the number of oral ulcers and may lead to their complete resolution. It may also reduce associated pain.
It has also been shown that this medicine improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means that the impact of the disease on daily activities, relationships, and other factors should be less than before.

2. Important information before taking the medicine

When not to take the medicine

• 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 to take this medicine, discuss it with your doctor or pharmacist.
Depression and suicidal thoughts
If the patient suffers from worsening depression with suicidal thoughts, this should be discussed with a doctor before starting treatment with this medicine.
The patient or their caregiver should also immediately inform the doctor about any changes in behaviour or mood, feelings of depression, or any suicidal thoughts that occur after starting the medicine.
Severe kidney disease
If the patient has severe kidney disease, the dose taken will be different – see section 3.
In case of low body weight
If the patient experiences unintended weight loss during treatment, 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 this medicine in children and adolescents have not been conducted. Therefore, this medicine is not recommended for use in children and adolescents under 18 years of age.
Medicines 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 they plan to take. This includes medicines available without a prescription and herbal medicines. This is important because this medicine may affect the action of other medicines. Likewise, other medicines may affect the action of this medicine.
In particular, inform your doctor or pharmacist before starting to take this medicine 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 (Hypericum perforatum) – 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 this medicine in pregnant women. Women should not become pregnant while taking this medicine and should use an effective method of contraception during treatment.
It is not known whether the medicine passes into human milk. The medicine should not be used during breastfeeding.
Driving and using machines
This medicine has no influence on the ability to drive or operate machinery.
The medicine contains lactose
This medicine 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.

3. How to take the medicine

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose

• If the patient is starting the medicine for the first time, they will receive a "starting pack" containing all the doses listed in the table below.
• The "starting pack" is clearly labelled to ensure that the patient takes the correct tablet at the correct time.
• Treatment begins with a lower dose, which is gradually increased over the first 6 days of treatment.
• The "starting pack" also contains tablets at the recommended dose for the next 8 days (days 7 to 14).
• The recommended dose after completing 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 patient will reach the recommended dose by the end of day 6.
• Once the recommended dose is reached, the patient will receive only 30 mg tablets in the prescribed packaging. This dose-escalation phase needs to be completed only once, even if treatment is restarted later.

| Day | Morning dose | Evening dose | Total daily dose | |--------|------------------|------------------|------------------------| | Day 1 | 10 mg (light pink) | No dose | 10 mg | | Day 2 | 10 mg (light pink) | 10 mg (light pink) | 20 mg | | Day 3 | 10 mg (light pink) | 20 mg (light brown) | 30 mg | | Day 4 | 20 mg (light brown) | 20 mg (light brown) | 40 mg | | Day 5 | 20 mg (light brown) | 30 mg (pink) | 50 mg | | Day 6 and onwards | 30 mg (pink) | 30 mg (pink) | 60 mg |

Patients with severe kidney disease
If the patient has severe kidney disease, the recommended dose of the medicine is 30 mg once daily (morning dose). Your doctor will advise you on how to increase the dose when starting the medicine for the first time.

How and when to take the medicine
This medicine is for oral use.
Tablets should be swallowed whole, preferably with water.
Tablets may be taken with or without food.
The 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 medicine than recommended
If the patient takes more medicine than prescribed, they should contact their doctor immediately or go to a hospital. Bring the packaging and this leaflet with you.

Missed dose
If the patient forgets to take a dose, they should take it as soon as possible. If it is almost time for the next dose, the missed dose should be skipped and the next dose taken at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping the medicine
The patient should continue taking the medicine until their doctor advises stopping treatment.
Do not stop taking the medicine without first consulting the doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions – depression and suicidal thoughts
Inform your doctor immediately about any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (these occur uncommonly).

Very common adverse reactions (may affect more than 1 in 10 people)

• diarrhoea
• nausea
• headache
• upper respiratory tract infections, such as colds, runny nose, sinus infection

Common adverse reactions (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 symptoms (nasopharyngitis)
• depression
• migraine
• tension-type headache

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

• rash
• urticaria
• weight loss
• allergic reaction
• bleeding in the intestine or stomach
• suicidal thoughts or behaviour

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 or 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C PL-02 222 Warsaw
Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any signs of damage to the packaging or evidence of tampering with the medicine's packaging.
Medicines must 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 Packaging and Other Information

What the medicine contains
The active substance is apremilast.
, 10 mg, film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
, 20 mg, film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
, 30 mg, film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

Other ingredients in the tablet core are: microcrystalline cellulose, lactose monohydrate,
sodium croscarmellose, and magnesium stearate.

The tablet coating contains hypromellose type 2910 – 15 mPas (E 464), macrogol (3350) (E 1521),
spray-dried lactose monohydrate, titanium dioxide (E 171), and iron oxide red (E 172).

The 20 mg tablets also contain iron oxide yellow (E 172).
The 30 mg tablets also contain iron oxide yellow (E 172) and iron oxide black (E 172).

What the medicine looks like and contents of the packaging
, 10 mg, film-coated tablets
The , 10 mg film-coated tablet is a light pink, oval film-coated tablet without a break line, approximately 8 mm in length and 4 mm in width, embossed with "AM" on one side and "10" on the other.

, 20 mg, film-coated tablets
The , 20 mg film-coated tablet is a light brown, oval film-coated tablet without a break line, approximately 10 mm in length and 5 mm in width, embossed with "AM" on one side and "20" on the other.

, 30 mg, film-coated tablets
The , 30 mg film-coated tablet is a pink, oval film-coated tablet without a break line, approximately 11 mm in length and 6 mm in width, embossed with "AM" on one side and "30" on the other.

Pack sizes
The starter pack contains blisters with 27 film-coated tablets or single-dose blisters with 27 x 1 film-coated tablet: 4 x 10 mg tablets, 4 x 20 mg tablets, and 19 x 30 mg tablets.

The continuation pack contains blisters with 56, 168, or 196 film-coated 30 mg tablets, or blisters with 56 x 1, 168 x 1, and 196 x 1 film-coated 30 mg tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Poland

Manufacturer
Lek Pharmaceuticals d.d
Verovškova Ulica 57
1526 Ljubljana, Slovenia

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

This medicine is authorised for marketing in the European Economic Area (EEA) under the following names:

Netherlands
Tivlemaq 10 mg, 20 mg, 30 mg filmomhulde tabletten
Tivlemaq 30 mg, filmomhulde tabletten

Austria
Tivlemaq 10 mg, 20 mg, 30 mg – Filmtabletten Starterpackung
Tivlemaq 30 mg – Filmtabletten

Bulgaria
ТИВЛЕМАК 10 mg филмирани таблетки
ТИВЛЕМАК 20 mg филмирани таблетки
ТИВЛЕМАК 30 mg филмирани таблетки
TIVLEMAQ 10 mg film-coated tablet
TIVLEMAQ 20 mg film-coated tablet
TIVLEMAQ 30 mg film-coated tablet
ТИВЛЕМАК 30 mg филмирани таблетки
TIVLEMAQ 30 mg film-coated tablet

Croatia
Tivlemaq 10 mg, 20 mg, 30 mg filmom obložene tablete
Tivlemaq 30 mg filmom obložene tablete

Poland
TIVLEMAQ

Slovenia
Tivlemaq 10 mg filmsko obložene tablete
Tivlemaq 20 mg filmsko obložene tablete
Tivlemaq 30 mg filmsko obložene tablete (packaging for initiation of treatment)
Tivlemaq 30 mg filmsko obložene tablete

Slovakia
TIVLEMAQ 10 mg
TIVLEMAQ 20 mg
TIVLEMAQ 30 mg
TIVLEMAQ 30 mg