APREMILAST TSENTIVA 10 mg/20 mg/30 mg Film-coated tablets

Содержание инструкции

1. Apremilast Zentiva 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets
   1. What is Apremilast Zentiva and what is it 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. Package contents and other information

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

Generic medicine
Read 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 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 you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Apremilast Zentiva and what is it used for

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

What is Apremilast Zentiva used for
Apremilast Zentiva is used for the treatment of adults suffering from the following diseases:

• active psoriatic arthritis - if another type of medicines called “disease-modifying antirheumatic drugs” (DMARDs) cannot be used or if treatment with one of these medicines has been attempted, but has not been effective.
• moderate to severe chronic plaque psoriasis - if one of the following treatments cannot be used or if one of these treatments has been attempted, but has not been 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 an area, such as “cyclosporine”, “methotrexate” or “psoralene”.
• Behçet's disease (BD) - for the treatment of mouth ulcers which is a common problem for people with this disease. Apremilast Zentiva is used for the treatment of children and adolescents aged 6 years and over and with a minimum weight of 20 kg, with the following conditions:
• Moderate to severe plaque psoriasis- if the doctor determines that systemic therapy such as Apremilast Zentiva is appropriate for you.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, 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 and which can also affect 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 problem is mouth ulcers.

How does Apremilast Zentiva work
Psoriatic arthritis, psoriasis and Behçet's disease are usually lifelong conditions and
for which there is currently no cure. Apremilast Zentiva works by reducing the activity of an enzyme
present in the body, called “phosphodiesterase 4”, 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 and thus alleviate the signs and symptoms
of these clinical conditions.
In adults with psoriatic arthritis, treatment with Apremilast Zentiva produces an improvement in
swelling and pain in the joints and can improve overall physical function.
In adults and in children and adolescents aged 6 years and over and with a minimum weight of 20 kg with
psoriasis, treatment with Apremilast Zentiva produces a reduction in 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 ulcers in
the mouth and may stop them completely. It can also reduce associated pain.
Apremilast has also been shown to improve the quality of life of adult and pediatric patients
with psoriasis, adult patients with psoriatic arthritis and 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 any of the other ingredients of this medicine (listed in section 6);
• if you are or think you might be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast Zentiva.
Depression and suicidal thoughts
Tell your doctor before starting Apremilast Zentiva if you suffer from depression that is worsening
with suicidal thoughts.
You or the person who cares for you should also immediately inform your doctor of any
changes in behaviour or mood, feelings of depression and 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 while you are taking Apremilast Zentiva if you lose weight unintentionally.
Intestinal problems
If you develop severe diarrhoea, nausea or vomiting, you should talk to your doctor.

Children and adolescents
Apremilast Zentiva is not recommended for use in children with plaque psoriasis, from moderate to
severe, under 6 years of age or weighing less than 20 kg, because it has not been studied in this age group
and in this weight group.
Apremilast Zentiva is not recommended for use in children and adolescents under 18
years of age for other indications, because safety and efficacy have not been established in this age group.

Other medicines and Apremilast Zentiva
Tell 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 can affect the action of other medicines and other medicines can affect
the action of Apremilast Zentiva.
In particular, tell 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 to treat seizures or epilepsy;
• St John's wort - a herbal medicine for mild anxiety and depression.

Pregnancy and breastfeeding
Do not take Apremilast Zentiva if you are or think you might be pregnant.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the effects of apremilast during pregnancy. You should not become
pregnant while taking this medicine and should use effective contraception
during treatment with Apremilast Zentiva.
It is not known whether this medicine passes into breast milk. You should not use Apremilast Zentiva
during breastfeeding.

Driving and using machines
Apremilast Zentiva does not affect the ability to drive or operate machines.

Apremilast Zentiva contains lactose monohydrate and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicine.
This medicine contains less than 1mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take Apremilast Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

Dosage

• When you start taking Apremilast Zentiva, you will receive a “treatment start pack”, containing an amount of tablets sufficient for a total of two weeks of treatment.
• The “treatment start pack” has clear labelling to ensure you take the right tablet at the right time.
• Treatment will begin with a lower dose, which will be gradually increased during the first week of treatment (ramp-up phase).
• The “treatment start pack” will also contain enough tablets for another 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 will only need to follow this dose ramp-up phase once, even if you restart treatment after an interruption.

Adults

• The recommended dose of Apremilast Zentiva for adult patients is 30 mg twice daily, once the dose ramp-up phase is completed, as shown in the following table
• a 30 mg dose in the morning and a 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
total
daily
Day 110 mg (pink) Do not take any dose10 mg

Day 210 mg (pink) 10 mg (pink) 20 mg

Day 310 mg (pink) 20 mg (yellow) 30 mg

Day 420 mg (yellow) 20 mg (yellow) 40 mg

Day 520 mg (yellow) 30 mg (brown – dark brown)

DayMorning doseEvening dose
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 over

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

For patients weighing between 20 kg and less than 50 kg:The recommended dose of Apremilast Zentiva
is 20 mg twice daily, once the dose ramp-up phase is completed, as shown
in the following table - a 20 mg dose in the morning and a 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 packs necessary for the initial and
maintenance treatment of patients weighing from 20 kg to less than 50 kg. Your doctor will prescribe another
medicine suitable for you.

For patients weighing 50 kg or more:The recommended dose of Apremilast Zentiva is
30 mg twice daily, once the dose ramp-up phase is completed (same dose
as adults), as shown in the following table - a 30 mg dose in the morning and a 30 mg dose
in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose
of 60 mg.
20 mg (yellow)
20 mg (yellow) 20 mg (yellow)
20 mg (yellow) 30 mg (brown –
dark brown)
30 mg (brown –
dark brown)

Patients with severe kidney problems
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 over, with severe renal impairment, for patients
weighing 50 kg or more, the recommended dose of Apremilast Zentiva is 30 mg once daily
(morning dose)and 20 mg once daily (morning dose), for children weighing
between 20 kg and less than 50 kg.
Your doctor will explain how to increase the dose when you start treatment with Apremilast Zentiva. Your
doctor may advise you to take only the morning dose, shown in the table above, suitable 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 can take the tablets with or without food.
• Take Apremilast Zentiva at about 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 hospital

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 the 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.

If you stop taking Apremilast Zentiva

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

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.

Serious side effects - depression and suicidal thoughts
Tell your doctor immediately about any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (this is uncommon).

Very common side effects(may affect more than 1 in 10 people)

• diarrhoea
• nausea
• headache
• upper respiratory tract infection 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 airways (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• muscle 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 based on available data):

• severe allergic reaction (may include swelling of the face, lips, mouth, tongue or throat, which can cause difficulty breathing or swallowing).

If you are 65 years of age or older, you may be at increased risk of complications from severe diarrhoea, nausea
and vomiting. If your bowel problems become severe, you should talk to your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 which is stated on the blister or on the pack or on the
box after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine if you notice damage or signs of tampering with the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Apremilast Zentiva contains
The active ingredient 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 ingredients present in the tablet core are lactose monohydrate, 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 Apremilast and package contents
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, light brown to dark brown film-coated tablet with a diameter of approximately 9 mm.
Pack sizes

• The starter pack is a wallet-style carton 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

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

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