Apremilast Day Zero

Package leaflet: Information for the patient

Apremilast Day Zero 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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Apremilast Day Zero is and what it is used for

Apremilast Day Zero contains the active substance "apremilast". This active substance belongs to a
group of medicines called "phosphodiesterase 4 inhibitors", which help reduce
inflammation.
Apremilast Day Zero 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 for people with this disease.

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis, a skin inflammatory disease.
What plaque psoriasis is
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick patches,
with itching and pain on the skin, and which 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 Day Zero works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Day Zero 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 Day Zero can help control
the inflammation associated with psoriatic arthritis, psoriasis and Behçet’s disease, thereby alleviating the
signs and symptoms of these conditions.
In adults with psoriatic arthritis, treatment with Apremilast Day Zero leads to an improvement
in joint swelling and pain, and may improve overall physical function.
In adults with psoriasis, treatment with Apremilast Day Zero reduces psoriatic plaques on the skin and other signs and symptoms of the disease.
In adults with Behçet’s disease, treatment with Apremilast Day Zero reduces the number of
mouth ulcers and may stop them completely. It may also reduce associated pain.
Apremilast Day Zero has also been shown to improve the quality of life in adult 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 Day Zero

Do not take Apremilast Day Zero

• 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 Day Zero.
Depression and suicidal thoughts
Inform your doctor before starting Apremilast Day Zero if you have depression that is worsening, with suicidal thoughts.
You or the person caring for you must also inform your doctor immediately of any changes in behaviour or mood, feelings of depression, or suicidal thoughts that you may experience after taking Apremilast Day Zero.
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 Day Zero 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 Day Zero 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 range.
Apremilast Day Zero 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 Day Zero
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 Day Zero may affect the action of other medicines, and other medicines may affect the action of Apremilast Day Zero.
In particular, inform your doctor or pharmacist before taking Apremilast Day Zero if you are taking any of the following medicines:

• rifampicin – an antibiotic for tuberculosis
• phenytoin, phenobarbital, and carbamazepine – medicines used to treat seizures or epilepsy
• St. John’s wort – a herbal medicine used for mild anxiety and depression.

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

3. How to take Apremilast Day Zero

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

Dosage

• When you start taking Apremilast Day Zero, 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 right 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 one single tablet from the prescribed packs.
• This dose titration schedule should be followed only once, even if you restart treatment after an interruption.

Adults

• The recommended dose of Apremilast Day Zero 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.

Patients with severe renal impairment
If you are an adult with severe kidney problems, the recommended dose of Apremilast Day Zero is 30 mg once daily (morning dose).
Your doctor will explain how to increase the dose when starting treatment with Apremilast Day Zero.
Your doctor may advise you to take only the morning dose shown in the table above, appropriate for you, and to skip the evening dose.
How and when to take Apremilast Day Zero

• Apremilast Day Zero is for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Day Zero at approximately the same time each day: one tablet in the morning and one tablet in the evening.
• To remove the tablets from the blister, fold the blister and tear along the perforation to obtain a single unit. Then gently peel off the paper label from the single unit, starting from the arrow mark. Do not push the tablet through the paper foil.

If your condition has not improved after six months of treatment, you must consult your doctor.
If you take more Apremilast Day Zero than you should
If you take more Apremilast Day Zero than you should, consult your doctor or go to hospital immediately.
Take the medicine pack and this leaflet with you.
If you forget to take Apremilast Day Zero

• If you forget to take a dose of Apremilast Day Zero, 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 a forgotten dose.

If you stop taking Apremilast Day Zero

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

If you have any questions about 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 everyone gets them.
Serious side effects – depression and suicidal thoughts
Tell 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 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, 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 Day Zero

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the carton after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Apremilast Day Zero contains

• The active substance is apremilast. Apremilast Day Zero 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast. Apremilast Day Zero 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast. Apremilast Day Zero 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

The other ingredients present in the tablet core are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide red (E172).
Apremilast Day Zero 20 mg film-coated tablets also contain iron oxide yellow (E172).

Description of the appearance of Apremilast Day Zero and contents of the pack
Apremilast Day Zero 10 mg film-coated tablets are light pink, oval-shaped, film-coated tablets, marked with “TV” on one side and “Y2” on the other side. The tablet measures approximately 9 mm x 5 mm.
Apremilast Day Zero 20 mg film-coated tablets are beige, oval-shaped, film-coated tablets, marked with “TV” on one side and “Y3” on the other side. The tablet measures approximately 11 mm x 6 mm.
Apremilast Day Zero 30 mg film-coated tablets are pink, oval-shaped, film-coated tablets, marked with “TV” on one side and “Y4” on the other side. The tablet measures approximately 12 mm x 7 mm.

• Apremilast Day Zero 10 mg, 20 mg and 30 mg film-coated tablets (starter pack)
  The starter pack contains 27 film-coated tablets (4 x 10 mg tablets, 4 x 20 mg tablets, 19 x 30 mg tablets) in divisible blisters made of PVC/PCTFE/PVC - aluminium/PET/paper.

• Apremilast Day Zero 30 mg film-coated tablets
  Divisible blister made of PVC/PCTFE/PVC - aluminium/PET/paper

  • The standard one-month pack contains 56 film-coated tablets of 30 mg.
  • The standard three-month pack contains 168 film-coated tablets of 30 mg.

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Day Zero ehf.
Reykjavíkurvegur 62
Hafnarfjörður 220
Iceland

Manufacturer
Pliva Hrvatska d.o.o
Prilaz baruna Filipovica 25
Zagreb, 10000
Croatia
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
Kraków, 31-546
Poland