APREMILAST 10 mg/20 mg /30 Mg Фильм-Coated Таблетки

Содержание инструкции

1. Apremilast Krka 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets
   1. What is Apremilast Krka and what is it used for
   2. What you need to know before taking Apremilast Krka
   3. How to take Apremilast Krka
   4. Possible side effects
   5. How to store Apremilast Krka
   6. Contents of the pack and other information

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

Apremilast

Generic medicine

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

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

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

What is Apremilast Krka used for
Apremilast Krka 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” (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 entire body rather than just one 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.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, a
inflammatory skin disease.

What is plaque psoriasis
Psoriasis is an inflammatory skin disease 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 Krka work
Psoriatic arthritis, psoriasis and Behçet's disease are usually lifelong diseases for which there is currently no cure. Apremilast Krka 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 Krka can help to control the inflammation associated with psoriatic arthritis,
psoriasis and Behçet's disease and thus alleviate the signs and symptoms of these clinical conditions.
In psoriatic arthritis, treatment with Apremilast Krka produces an improvement in swelling and
pain in the joints and can improve overall physical function.
In psoriasis, treatment with Apremilast Krka produces a reduction in psoriatic plaques on the skin
and other signs and symptoms of the disease.
In Behçet's disease, treatment with Apremilast Krka reduces the number of mouth ulcers and can
stop them completely. It can also reduce associated pain.
It has also been shown that Apremilast Krka 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, on
relationships and on other factors would be less than before.

2. What you need to know before taking Apremilast Krka

Do not take Apremilast Krka

• if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
• if you are or might become pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast Krka.

Depression and suicidal thoughts
Tell your doctor before starting Apremilast Krka 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, feeling of depression and suicidal thoughts that you may
experience after taking Apremilast Krka.

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 taking Apremilast Krka if you unintentionally lose weight.

Intestinal problems
If you develop severe diarrhoea, nausea or vomiting, you should talk to your doctor.

Children and adolescents
Apremilast Krka has not been studied in children and adolescents; therefore, use is not recommended in
children and adolescents aged 17 years or younger.

Other medicines and Apremilast Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription and herbal medicines. This is because
Apremilast Krka can affect the action of other medicines and other medicines can affect the action of
Apremilast Krka.
In particular, tell your doctor or pharmacist before taking Apremilast Krka 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
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the effects of Apremilast Krka during pregnancy. You should not become
pregnant while taking this medicine and should use effective contraception during
treatment with Apremilast Krka.
It is not known whether this medicine passes into breast milk. You should not use Apremilast Krka during
breastfeeding.

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

Apremilast Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Apremilast Krka

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 Krka, you will receive a “treatment start pack” containing all the doses listed in the following table.
• The “treatment start pack” has clear labeling to ensure you take the right tablet at the right time.
• Treatment will begin with a lower dose, which will be gradually increased over the first 6 days of treatment.
• The “treatment start pack” will also contain enough tablets for another 8 days of

treatment at the recommended dose (from day 7 to 14).

• The recommended dose of Apremilast Krka is 30 mg twice a day, once the dose escalation phase is complete: 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. You will have reached this recommended dose by the end of day 6.
• Once the recommended dose is reached, you will only take the 30 mg tablet in the prescribed packs. You will only need to follow this dose escalation phase once, even if you restart treatment after an interruption.

Dose
total
daily
Day 110 mg (pink) Do not take any 10 mg dose

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

Day 310 mg (pink) 20 mg (brown orange) 30 mg

Day 420 mg (brown orange) 20 mg (brown orange) 40 mg

Day 520 mg (brown orange) 30 mg (light brownish purple) 50 mg

From day 6 onwards30 mg (light brownish purple) 30 mg (light brownish purple) 60 mg

People with severe kidney problems
If you have severe kidney problems, the recommended dose of Apremilast Krka is 30 mg once a day (morning dose). Your doctor will explain how to increase the dose when you start treatment with Apremilast
Krka.

How and when to take Apremilast Krka

• Apremilast Krka is for oral use.
• Swallow the tablets whole, preferably with water.
• You can take the tablets with or without food.
• Take Apremilast Krka 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 Krka than you should
If you take more Apremilast Krka than you should, consult your doctor or go to hospital immediately.

If you forget to take Apremilast Krka

• If you forget to take a dose of Apremilast Krka, 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 scheduled time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Apremilast Krka

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

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

DayMorning doseEvening dose

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

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 common 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
• tension headache

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

• skin rash
• urticaria (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 Krka

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 pack after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Apremilast Krka contains

• The active ingredient is apremilast. Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast.
• The other ingredients (excipients) are: Tablet core: mannitol (E421), microcrystalline cellulose, sodium croscarmellose (see section 2 “Apremilast Krka contains sodium”) and magnesium stearate (E470b). Film coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide red (E172), iron oxide yellow (E172) - only for 20 mg and 30 mgand iron oxide black (E172) - only for 30 mg.

Description of the appearance of Apremilast Krka and contents of the pack
Apremilast Krka 10 mg film-coated tablets
Film-coated tablets, pink in colour, round, biconvex, with 10 imprinted on one side of the
tablet.
Tablet size: diameter approx. 6 mm
Apremilast Krka 20 mg film-coated tablets
Film-coated tablets, brown-orange in colour, round, biconvex, with 20 imprinted on one side
of the tablet.
Tablet size: diameter approx. 8 mm
Apremilast Krka 30 mg film-coated tablets
Film-coated tablets, light brownish-purple in colour, round, biconvex, with 30 imprinted on one
side of the tablet.
Tablet size: diameter approx. 10 mm
Apremilast Krka 30 mg film-coated tablets is available in:

• packs containing a blister with 14, 56 or 168 film-coated tablets
• Starter pack: Each pack with 27 film-coated tablets contains:
• 4 film-coated tablets of Apremilast Krka 10 mg
• 4 film-coated tablets of Apremilast Krka 20 mg
• 19 film-coated tablets of Apremilast Krka 30 mg

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
KRKA, d.d., Šmarješka cesta 6 8501 Novo mesto, Slovenia

Local representative for Italy:
Krka Farmaceutici Milano S.r.l. – Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: