Apremilast Zentiva

Patient Information Leaflet

Apremilast Zentiva 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Apremilast Zentiva is and what it is used for
2. What you need to know before taking Apremilast Zentiva
3. How to take Apremilast Zentiva
4. Possible side effects
5. How to store Apremilast Zentiva
6. Contents of the pack and other information

1. What Apremilast Zentiva is and what it is used for

What Apremilast Zentiva is
Apremilast Zentiva contains the active substance “apremilast”. This active substance belongs to a group of medicines called “phosphodiesterase 4 inhibitors”, which help reduce inflammation.

What Apremilast Zentiva is used for
Apremilast Zentiva is used to treat adults with the following conditions:

• Active psoriatic arthritis – if another type of medicine called “disease-modifying antirheumatic drugs” (DMARDs) cannot be used, or if treatment with one of these medicines has been tried but was not effective.
• Moderate to severe chronic plaque psoriasis – if one of the following treatments cannot be used, or if one of these treatments has been tried but was not effective:
  • Phototherapy – a treatment in which certain areas of the skin are exposed to ultraviolet light;
  • Systemic therapy – a treatment that affects the whole body rather than just one area, such as “ciclosporin”, “methotrexate”, or “psoralen”.
• Behçet’s disease (BD) – for the treatment of mouth ulcers, which are a common problem in people with this disease. Apremilast Zentiva is used to treat children and adolescents aged 6 years and older and weighing at least 20 kg, with the following condition:
  • Moderate to severe plaque psoriasis – if your doctor determines that it is appropriate for you to receive systemic therapy such as Apremilast Zentiva.

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, an inflammatory skin condition.

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

What Behçet’s disease is
Behçet’s disease is a rare type of inflammatory disease that affects many parts of the body. The most common problem is mouth ulcers.

How Apremilast Zentiva works
Psoriatic arthritis, psoriasis, and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Zentiva 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, Apremilast Zentiva can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet’s disease, thereby reducing the signs and symptoms of these conditions.

In adults with psoriatic arthritis, treatment with Apremilast Zentiva leads to improvement in joint swelling and pain, and may improve overall physical function.

In adults, and in children and adolescents aged 6 years and older and weighing at least 20 kg with psoriasis, treatment with Apremilast Zentiva reduces psoriatic plaques on the skin and other signs and symptoms of the disease.

In adults with Behçet’s disease, treatment with Apremilast Zentiva reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.

Apremilast has also been shown to improve quality of life in adult and pediatric patients with psoriasis, in adult patients with psoriatic arthritis, and in adult patients with Behçet’s disease. This means that the impact of the disease on daily activities, relationships, and other factors would be less than before.

2. What you need to know before taking Apremilast Zentiva

Do not take Apremilast Zentiva

• if you are allergic to apremilast or to 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
Talk to your doctor or pharmacist before taking Apremilast Zentiva.
Depression and suicidal thoughts
Before starting Apremilast Zentiva, inform your doctor if you have depression that is worsening, with suicidal thoughts.
You or the person caring for you must also immediately inform your doctor of any changes in behaviour or mood, feelings of depression, or suicidal thoughts that you may experience after taking Apremilast Zentiva.
Severe kidney problems
If you have severe kidney problems, your dose will be different – see section 3.
If you are underweight
Talk to your doctor if you lose weight unintentionally while taking Apremilast Zentiva.
Gastrointestinal problems
If you develop severe diarrhoea, nausea, or vomiting, you must discuss this with your doctor.
Children and adolescents
Apremilast Zentiva is not recommended for use in children under 6 years of age or weighing less than 20 kg with moderate to severe plaque psoriasis, as it has not been studied in this age group and body weight category.
Apremilast Zentiva is not recommended for use in children and adolescents under 18 years of age for other indications, as safety and efficacy have not been established in this age group.
Other medicines and Apremilast Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines. This is because Apremilast Zentiva may affect the action of other medicines, and other medicines may affect the action of Apremilast Zentiva.
In particular, inform your doctor or pharmacist before taking Apremilast Zentiva if you are taking any of the following medicines:

• rifampicin – an antibiotic used for tuberculosis;
• phenytoin, phenobarbital, and carbamazepine – medicines used in the treatment of seizures or epilepsy;
• St. John’s wort – a herbal medicine used for mild forms of anxiety and depression.

Pregnancy and breastfeeding
Do not take Apremilast Zentiva if you are pregnant or think you may be pregnant.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is limited information on the effects of apremilast during pregnancy. You must not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast Zentiva.
It is not known whether this medicine passes into breast milk. You must not use Apremilast Zentiva while breastfeeding.
Driving and using machines
Apremilast Zentiva does not affect the ability to drive or use machinery.
Apremilast Zentiva contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Apremilast Zentiva

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage

• When you start taking Apremilast Zentiva, you will receive a "starter pack" containing enough tablets for a total of two weeks of treatment.
• The "starter pack" is clearly labeled to ensure you take the correct tablet at the correct time.
• Treatment will begin with a lower dose, which will be gradually increased during the first week of treatment (titration phase).
• The "starter pack" will also contain enough tablets for an additional week of treatment at the recommended dose.
• Once the recommended dose is reached, you will take only a single tablet from the prescribed packs.
• You need to follow this dose titration schedule only once, even if you restart treatment after an interruption.

Adults

• The recommended dose of Apremilast Zentiva for adult patients is 30 mg twice daily after completion of the dose titration phase, as shown in the table below.
• One 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 60 mg.

Dose
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) No dose 10 mg
Day 2 10 mg (pink) 10 mg (pink) 20 mg
Day 3 10 mg (pink) 20 mg (yellow) 30 mg
Day 4 20 mg (yellow) 20 mg (yellow) 40 mg
Day 5 20 mg (yellow) 30 mg (brown – dark brown) 50 mg
From Day 6 onwards 30 mg (brown – dark brown) 30 mg (brown – dark brown) 60 mg

Children and adolescents aged 6 years and older

• The dose of Apremilast Zentiva will be based on body weight.

For patients weighing 20 kg to less than 50 kg: The recommended dose of Apremilast Zentiva is 20 mg twice daily after completion of the dose titration phase, as shown in the table below – one 20 mg dose in the morning and one 20 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 40 mg.
Apremilast Zentiva is not available in the pack sizes required for the initial and maintenance treatment of patients weighing from 20 kg to less than 50 kg. Your doctor will prescribe another suitable medicine.

For patients weighing 50 kg or more: The recommended dose of Apremilast Zentiva is 30 mg twice daily after completion of the dose titration phase (same dose as adults), as shown in the table below – one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 60 mg.

Patients with severe renal impairment

• If you are an adult with severe kidney problems, the recommended dose of Apremilast Zentiva is 30 mg once daily (morning dose).
• In children and adolescents aged 6 years and older with severe renal impairment:
  • For patients weighing 50 kg or more: the recommended dose of Apremilast Zentiva is 30 mg once daily (morning dose).
  • For children weighing between 20 kg and less than 50 kg: the recommended dose is 20 mg once daily (morning dose).

Your doctor will explain how to increase the dose when starting treatment with Apremilast Zentiva. Your doctor may advise you to take only the morning dose shown in the table above, appropriate for you (for adults or for children/adolescents), and to skip the evening dose.

How and when to take Apremilast Zentiva

• Apremilast Zentiva is for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Zentiva at approximately the same time each day: one tablet in the morning and one tablet in the evening.

If your condition has not improved after six months of treatment, you should consult your doctor.

If you take more Apremilast Zentiva than you should

If you take more Apremilast Zentiva than you should, consult your doctor or go to a hospital immediately. Bring the medicine pack and this leaflet with you.

If you forget to take Apremilast Zentiva

• If you forget to take a dose of Apremilast Zentiva, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Apremilast Zentiva

• Continue taking Apremilast Zentiva until your doctor tells you to stop.
• Do not stop taking Apremilast Zentiva without first consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Serious side effects – depression and suicidal thoughts
Immediately inform your doctor if you experience any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (this is not common).
Very common side effects (may affect more than 1 in 10 people)

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

Common side effects (may affect up to 1 in 10 people)

• cough
• back pain
• vomiting
• feeling tired
• stomach pain
• loss of appetite
• frequent bowel movements
• difficulty sleeping (insomnia)
• indigestion or heartburn
• inflammation and swelling of the lung airways (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• tension headache

Uncommon side effects (may affect up to 1 in 100 people)

• skin rash
• hives
• weight loss
• allergic reaction
• bleeding in the intestine or stomach
• suicidal ideation or behaviour

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 cause difficulty breathing or swallowing).

If you are aged 65 or older, you may be at higher risk of complications due to severe diarrhoea, nausea and vomiting. If your intestinal problems become severe, you must speak to your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apremilast Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, the carton, or the box after Exp. The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Apremilast Zentiva contains
The active substance is apremilast.

• Apremilast Zentiva 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
• Apremilast Zentiva 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
• Apremilast Zentiva 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

The other components in the tablet core are monohydrate lactose, microcrystalline cellulose (E460), sodium croscarmellose (E468) and magnesium stearate (E572).
The tablet film coating contains hypromellose (E464), macrogol, titanium dioxide (E171), talc (E553b) and red iron oxide (E172) for Apremilast Zentiva 10 mg; yellow iron oxide for Apremilast Zentiva 20 mg; and red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) for Apremilast Zentiva 30 mg.

Description of the appearance of Apremilast and contents of the pack
The 10 mg film-coated tablet of Apremilast Zentiva is a round, pink film-coated tablet with a diameter of approximately 6 mm.
The 20 mg film-coated tablet of Apremilast Zentiva is an oblong, yellow film-coated tablet with approximate dimensions of 11 x 6 mm.
The 30 mg film-coated tablet of Apremilast Zentiva is a round film-coated tablet, brown to dark brown in colour, with a diameter of approximately 9 mm.

Pack sizes

• The starter pack is a wallet pack containing 27 film-coated tablets: 4 tablets of 10 mg, 4 tablets of 20 mg and 19 tablets of 30 mg.
• The standard pack for one month contains 56 film-coated tablets of 30 mg.
• The standard pack for three months contains 168 film-coated tablets of 30 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20212 Milano, Italy

Manufacturer
LABORMED-PHARMA S.A.
Bd. Theodor Pallady nr. 44B, sector 3
032 266, Bucharest
Romania

This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic, Germany, France, Italy, Spain, Austria, Sweden: Apremilast Zentiva