Apremilast Macleods

Patient Information Leaflet: Information for the User

Apremilast Macleods 30 mg film-coated tablets

apremilast
equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may 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 Macleods is and what it is used for
2. What you need to know before taking Apremilast Macleods
3. How to take Apremilast Macleods
4. Possible side effects
5. How to store Apremilast Macleods
6. Contents of the pack and other information

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

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

• Active psoriatic arthritis – if it is not possible to use another type of medicine called “disease-modifying antirheumatic drugs” (DMARDs), 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 Macleods 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 decides that it is appropriate for you to receive systemic therapy such as Apremilast Macleods.

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, a skin inflammatory condition.
What plaque psoriasis is
Psoriasis is an inflammatory skin disease that can cause red, scaly, thickened 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 affecting many parts of the body. The most common problem is mouth ulcers.
How Apremilast Macleods works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Macleods 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 Macleods 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 Macleods 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 Macleods reduces psoriatic skin plaques and other signs and symptoms of the disease.
In adults with Behçet’s disease, treatment with Apremilast Macleods reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.
Apremilast Macleods has also been shown to improve the 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 should know before taking Apremilast Macleods

Do not take Apremilast Macleods

• 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 Macleods.
Depression and suicidal thoughts
Tell your doctor before starting Apremilast Macleods 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 starting Apremilast Macleods.
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 Macleods if you lose weight unintentionally.
Gastrointestinal problems
If you develop severe diarrhoea, nausea or vomiting, you must talk to your doctor.
Children and adolescents
Apremilast Macleods is not recommended for use in children with moderate to severe plaque psoriasis under 6 years of age or weighing less than 20 kg, as it has not been studied in this age group and body weight group.
Apremilast Macleods 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 Macleods
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 Macleods may affect the action of other medicines, and other medicines may affect the action of Apremilast Macleods.
In particular, tell your doctor or pharmacist before taking Apremilast Macleods 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 anxiety and depression

Pregnancy and breastfeeding
Do not take Apremilast Macleods 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 Macleods during pregnancy. You must not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast Macleods.
It is not known whether this medicine passes into breast milk. You must not use Apremilast Macleods while breastfeeding.
Driving and using machines
Apremilast Macleods does not impair the ability to drive or operate machinery.
Apremilast Macleods contains lactose
Apremilast Macleods contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Apremilast Macleods contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. essentially ‘sodium-free’.

3. How to take Apremilast Macleods

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

Dosage

• When you start taking Apremilast Macleods, 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 (dose escalation phase).
• The "starter pack" will also contain tablets sufficient 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 escalation phase once, even if you restart treatment after an interruption.

Adults

• The recommended dose of Apremilast Macleods for adult patients is 30 mg twice daily, after completing the dose escalation phase: 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.

Total daily dose
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) Do not take any dose 10 mg
Day 2 10 mg (pink) 10 mg (pink) 20 mg
Day 3 10 mg (pink) 20 mg (brown) 30 mg
Day 4 20 mg (brown) 20 mg (brown) 40 mg
Day 5 20 mg (brown) 30 mg (beige) 50 mg
From Day 6 onwards 30 mg (beige) 30 mg (beige) 60 mg

Children and adolescents aged 6 years and older

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

For patients weighing 20 kg to less than 50 kg: The recommended dose of Apremilast Macleods is 20 mg twice daily, after completing the dose escalation phase, as shown in the following table: 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.

Weight between 20 kg and less than 50 kg
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) Do not take any dose 10 mg
Day 2 10 mg (pink) 10 mg (pink) 20 mg
Day 3 10 mg (pink) 20 mg (brown) 30 mg
Day 4 20 mg (brown) 20 mg (brown) 40 mg
Day 5 20 mg (brown) 20 mg (brown) 40 mg
From Day 6 onwards 20 mg (brown) 20 mg (brown) 40 mg

For patients weighing 50 kg or more: The recommended dose of Apremilast Macleods is 30 mg twice daily, after completing the dose escalation phase (same dose as adults), as shown in the following table: 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.

Weight equal to or greater than 50 kg
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) Do not take any dose 10 mg
Day 2 10 mg (pink) 10 mg (pink) 20 mg
Day 3 10 mg (pink) 20 mg (brown) 30 mg
Day 4 20 mg (brown) 20 mg (brown) 40 mg
Day 5 20 mg (brown) 30 mg (beige) 50 mg
From Day 6 onwards 30 mg (beige) 30 mg (beige) 60 mg

Dose titration is not possible with Apremilast Macleods. Other medicines are available.

Patients with severe renal impairment

• If you are an adult with severe kidney problems, the recommended dose of Apremilast Macleods 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 Macleods 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 Macleods. 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 Macleods

• Apremilast Macleods is for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Macleods 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 Macleods than you should

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

If you forget to take Apremilast Macleods

• If you forget to take a dose of Apremilast Macleods, 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 Macleods

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

If you have any doubts 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
Contact your doctor immediately if you experience any changes in behaviour or mood,
feelings of depression, suicidal thoughts or suicidal behaviour (this is not uncommon).
Very common (may affect more than 1 in 10 people)

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

Common (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 (may affect up to 1 in 100 people)

• rash
• hives (urticaria)
• weight loss
• allergic reaction
• bleeding in the stomach or intestines
• 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 due to severe diarrhoea, nausea, and vomiting. If your intestinal problems become severe, you must consult 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 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 Macleods

• 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, carton or box after Exp. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Do not use this medicine if you notice 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 required. This will help protect the environment.

6. Package contents and other information

What Apremilast Macleods contains

• The active substance is apremilast.
• Each film-coated tablet contains 30 mg of apremilast.
• The other components present in the tablet core are: microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose (E 468), magnesium stearate (E 572), isopropyl alcohol. The film coating contains: polyvinyl alcohol (E1203), polyethylene glycol 6000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

Description of the appearance of Apremilast Macleods and contents of the pack
The Apremilast Macleods 30 mg film-coated tablet is beige in colour, round, biconvex, film-coated, with "U 49" printed on one side and smooth on the other side. (Diameter: approximately 8.5 mm and Thickness: approximately 5.40 mm)
Packs

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

Not all pack sizes may be marketed.
Marketing Authorization Holder
Macleods Pharma España S.L.U.
World Trade Center Barcelona
Moll de Barcelona, s/n,
08039 Barcelona,
Spain
Manufacturer
Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzędz,
62-020, Poland