Tivlemaq

Package Leaflet: Information for the Patient

Apremilast, 10 mg, coated tablets
Apremilast, 20 mg, coated tablets
Apremilast, 30 mg, coated tablets
Apremilast

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is the medicine and what is it 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 pack and other information

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

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

What is the medicine used for

The medicine is used to treat adults with the following conditions:

• Active psoriatic arthritis- if the patient cannot take other types of medicines called disease-modifying antirheumatic drugs (DMARDs) or if the use of one of these medicines has been ineffective.
• Chronic plaque psoriasis of moderate to severe severity- if the patient cannot take one of the following treatments or if the use of one of these treatments has been ineffective:
• phototherapy - treatment in which certain areas of the skin are exposed to ultraviolet light.
• systemic treatment - treatment that affects the whole body, not just a specific part of it; examples include the use of 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 the formation of 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 the medicine work

Psoriatic arthritis, psoriasis, and Behçet's disease are usually lifelong diseases, and there is no cure yet. The medicine works by reducing the activity of an enzyme in the body called "phosphodiesterase 4", which is involved in the inflammatory process. By reducing the activity of this enzyme, the medicine 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 the medicine leads to an improvement in swollen and painful joints and may also improve the patient's overall physical function.
In psoriasis, treatment with the medicine leads to a reduction in psoriatic skin lesions and other signs and symptoms of the disease.
In Behçet's disease, taking the medicine reduces the number of oral ulcers and may cause them to disappear completely. It may also alleviate the associated pain.
It has also been shown that the 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 thinks she may be pregnant.

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their 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 to take the medicine.
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 that have occurred after taking the medicine.

Severe kidney disease

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

In case of underweight

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

Gastrointestinal problems

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

Children and adolescents

No studies have been conducted on the use of the medicine in children and adolescents. Therefore, this medicine is not recommended for use in children and adolescents under 18 years of age.

Medicine interactions

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. This includes medicines available without a prescription and herbal medicines. This is important because the medicine may affect the action of other medicines. Other medicines may also affect the action of this medicine.
In particular, the patient should inform their doctor or pharmacist before starting to take the medicine 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 the medicine in pregnant women. Women should not become pregnant while taking this medicine and should use effective contraception during treatment with this medicine.
It is not known whether the medicine passes into breast milk. The medicine should not be used during breastfeeding.

Driving and using machines

The medicine has no effect on the ability to drive or use machines.

The medicine contains lactose

The medicine 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.

3. How to take the medicine

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.

Recommended dose

• If the patient is taking the medicine for the first time, they will receive a "treatment initiation pack" that contains all the doses listed in the table below.
• The "treatment initiation pack" is precisely described to ensure that the patient takes the correct tablet at the right 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 the medicine after the dose increase 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, 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 adjustment phase once, even if it is necessary to restart treatment.

Day Morning dose Evening dose Total daily dose

Day 1

10 mg (light pink)

Do not take an evening 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 subsequent days

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 a day
(morning dose).The doctor will inform the patient how to increase the dose during the first use of the medicine.

How and when to take the medicine

The medicine is intended for oral administration.
Tablets should be swallowed whole, preferably with water.
Tablets can be taken with or without food.
The 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 the medicine than recommended

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

Missing a dose of the medicine

If the patient forgets to take a dose of the medicine, they should take it as soon as possible. If it is almost time for the next dose, they should skip the missed dose and take the next dose at the scheduled time.
The patient should not take a double dose to make up for the missed dose.

Stopping the medicine

The patient should take the medicine until their doctor tells them to stop.
The patient should not stop taking the medicine without consulting their doctor first.
If the patient has any further questions about the use of this medicine, they should ask their 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 behavior (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, or 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 behavior
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 over, 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C PL-02 222 Warsaw
Phone: +48 22 49 21 301 Fax: +48 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 the medicine.

5. How to store the medicine

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

The active substance of the medicine is apremilast.
Apremilast, 10 mg, coated tablets: each coated tablet contains 10 mg of apremilast.
Apremilast, 20 mg, coated tablets: each coated tablet contains 20 mg of apremilast.
Apremilast, 30 mg, coated tablets: each coated tablet contains 30 mg of apremilast.
The other ingredients of 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), lactose monohydrate spray-dried, 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 pack, Apremilast, 10 mg, coated tablets

The 10 mg coated tablet is light pink, oval, and has no score line, with dimensions of approximately 8 mm in length and 4 mm in width, with "AM" embossed on one side and "10" on the other side.
Apremilast, 20 mg, coated tablets
The 20 mg coated tablet is light brown, oval, and has no score line, with dimensions of approximately 10 mm in length and 5 mm in width, with "AM" embossed on one side and "20" on the other side.
Apremilast, 30 mg, coated tablets
The 30 mg coated tablet is pink, oval, and has no score line, with dimensions of approximately 11 mm in length and 6 mm in width, with "AM" embossed on one side and "30" on the other side.
Pack sizes
The treatment initiation pack contains blisters with 27 coated tablets or single-dose blisters with 27 x 1 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, 196 coated tablets of 30 mg each or blisters with 56 x 1, 168 x 1, and 196 x 1 coated tablet of 30 mg each.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw

Manufacturer

Lek Pharmaceuticals d.d
Verovškova Ulica 57
1526 Ljubljana, Slovenia
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Sandoz Polska Sp. z o.o.
Phone: +48 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Tivlemaq 10 mg, 20 mg, 30 mg film-coated tablets
Tivlemaq 30 mg, film-coated tablets
Austria
Tivlemaq 10 mg, 20 mg, 30 mg - film-coated tablets starter pack
Tivlemaq 30 mg - film-coated tablets
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 film-coated tablets
Tivlemaq 30 mg film-coated tablets
Poland
TIVLEMAQ
Slovenia
Tivlemaq 10 mg film-coated tablets
Tivlemaq 20 mg film-coated tablets
Tivlemaq 30 mg film-coated tablets
(packaging for the start of treatment)
Tivlemaq 30 mg film-coated tablets
Slovakia
TIVLEMAQ 10 mg
TIVLEMAQ 20 mg
TIVLEMAQ 30 mg
TIVLEMAQ 30 mg

Date of last revision of the leaflet: