Apremilast Krka

Patient Information Leaflet: Information for the Patient

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

Apremilast
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

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

What is Apremilast Krka
Apremilast Krka contains the active substance “apremilast”. This active substance belongs to a group of
medicines called “phosphodiesterase 4 inhibitors”, which help reduce inflammation.
What Apremilast Krka is used for
Apremilast Krka is used to treat adults with the following conditions:

• Active psoriatic arthritis – when it is not possible to use another type of medicine called “disease-modifying antirheumatic drugs” (DMARDs), or when treatment with one of these medicines has been tried but was not effective.
• Moderate to severe chronic plaque psoriasis – when one of the following treatments cannot be used, or when 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.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, a skin inflammatory condition.
What is plaque psoriasis
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick patches on the skin, which may be itchy and painful, and can also affect the scalp and nails.
What is Behçet’s disease
Behçet’s disease is a rare type of inflammatory disorder that affects many parts of the body. The most common problem is mouth ulcers.
How Apremilast Krka works
Psoriatic arthritis, psoriasis, and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Krka 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 Krka can 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 Apremilast Krka leads to improvement in joint swelling and pain, and may improve overall physical function.
In psoriasis, treatment with Apremilast Krka reduces psoriatic skin plaques and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast Krka reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.

Apremilast Krka has also been shown to improve 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 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 to any of the other ingredients of this medicine (listed in section 6).
• if you are or think you may be 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 have depression that is worsening, with suicidal thoughts.
You or the person caring for you must also inform your doctor immediately about any changes in behaviour or mood, feelings of depression, or 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 lose weight unintentionally.
Gastrointestinal problems
If you develop severe diarrhoea, nausea or vomiting, you must discuss this with your doctor.
Children and adolescents
Apremilast Krka has not been studied in children and adolescents; therefore, its use is not recommended in children and adolescents aged 17 years or younger.
Other medicines and Apremilast Krka
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 Krka may affect the action of other medicines, and other medicines may affect the action of Apremilast Krka.
In particular, inform 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 used for mild forms of anxiety and depression.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, 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 Krka during pregnancy. You must not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast Krka.
It is not known whether this medicine passes into breast milk. You must not use Apremilast Krka during breastfeeding.
Driving and using machines
Apremilast Krka does not affect the ability to drive or use machinery.
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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dosage

• When you start taking Apremilast Krka, you will receive a "starter pack" containing all the doses listed in the table below.

• 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 over the first 6 days of treatment.

• The "starter pack" will also contain enough tablets for an additional 8 days of treatment at the recommended dose (from day 7 to day 14).

• The recommended dose of Apremilast Krka is 30 mg twice daily, once the gradual 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. By the end of day 6, you will have reached this recommended dose.

• Once the recommended dose is reached, you will only take the 30 mg tablets from the prescribed packs. This gradual dose escalation should only be followed once, even if you restart treatment after an interruption.

Dosage
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) Do not take a dose 10 mg
Day 2 10 mg (pink) 10 mg (pink) 20 mg
Day 3 10 mg (pink) 20 mg (orange-brown) 30 mg
Day 4 20 mg (orange-brown) 20 mg (orange-brown) 40 mg
Day 5 20 mg (orange-brown) 30 mg (light brownish-violet) 50 mg
From day 6 onwards 30 mg (light brownish-violet) 30 mg (light brownish-violet) 60 mg

Patients with severe renal impairment
If you have severe kidney problems, the recommended dose of Apremilast Krka is 30 mg once daily (morning dose). Your doctor will explain how to increase the dose when starting 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 may take the tablets with or without food.
• Take Apremilast Krka 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 Krka than you should
If you take more Apremilast Krka than prescribed, consult your doctor or go to hospital immediately. Bring the medicine pack and this leaflet with you.

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 the next dose at the scheduled time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Apremilast Krka

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

If you have any questions about how to use 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
Inform your doctor immediately 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 65 years of age or older, you may be at higher risk of complications from severe diarrhoea, nausea and vomiting. If your bowel 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, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects 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 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 via 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 Krka contains

• The active substance is apremilast. Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast.
• The other components (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, red iron oxide (E172) – for 20 mg and 30 mg only, and yellow iron oxide (E172) – for 30 mg only.

Description of the appearance of Apremilast Krka and pack contents
Apremilast Krka 10 mg film-coated tablets
Film-coated tablets, pink in colour, round, biconvex, with "10" engraved on one side of the tablet.
Tablet size: diameter approx. 6 mm

Apremilast Krka 20 mg film-coated tablets
Film-coated tablets, orange-brown in colour, round, biconvex, with "20" engraved 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" engraved on one side of the tablet.
Tablet size: diameter approx. 10 mm

Apremilast Krka 30 mg film-coated tablets are available in:

• packs containing a blister with 14, 56 or 168 film-coated tablets
• Starter pack: Each pack containing 27 film-coated tablets includes:
  • 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 Authorization 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 authorized in the Member States of the European Economic Area under the following names: