Apremilast G.L.

Patient Information Leaflet

Apremilast G.L. 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets

apremilast
Generic medicine
Please read all of this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Apremilast G.L. is and what it is used for

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

What Apremilast G.L. is used for
Apremilast G.L. 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 psoriatic arthritis is
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory skin disease.

What plaque psoriasis is
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick, itchy and painful patches on the skin, and may 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 G.L. works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast G.L. 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 G.L. can help control the inflammation associated with psoriatic arthritis, psoriasis and Behçet’s disease, thereby alleviating the signs and symptoms of these conditions.

In psoriatic arthritis, treatment with Apremilast G.L. leads to improvement in joint swelling and pain, and may improve overall physical function.

In psoriasis, treatment with Apremilast G.L. reduces psoriatic skin plaques and other signs and symptoms of the disease.

In Behçet’s disease, treatment with Apremilast G.L. reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.

Apremilast 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 G.L.

Do not take Apremilast G.L.

• 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 G.L.
Depression and suicidal thoughts
Tell your doctor before starting Apremilast G.L. if you have depression that is worsening or if you have had 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 this medicine.
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 if you lose weight unintentionally while taking this medicine.
Gastrointestinal problems
If you develop severe diarrhoea, nausea or vomiting, you must discuss this with your doctor.
Children and adolescents
Apremilast has not been studied in children and adolescents; therefore, use is not recommended in children and adolescents aged 17 years and younger.
Other medicines and Apremilast G.L.
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 G.L. may affect the action of other medicines, and other medicines may affect the action of Apremilast G.L.
In particular, inform your doctor or pharmacist before taking Apremilast G.L. 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
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is limited information on the effects of Apremilast G.L. during pregnancy. You must not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast G.L.
It is not known whether this medicine passes into breast milk. You must not use Apremilast G.L. during breastfeeding.
Driving and using machines
Apremilast G.L. does not impair the ability to drive or operate machinery.
Apremilast G.L. contains lactose and sodium
Apremilast G.L. contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Apremilast G.L. contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Apremilast G.L.

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

• When you start taking Apremilast G.L., you will receive a “starter pack” containing all the doses listed in the table below.
• The “starter pack” has clear labelling 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 (days 7 to 14).
• The recommended dose of Apremilast G.L. is 30 mg twice daily, once in the morning and once in the evening, approximately 12 hours apart, with or without food, after completion of the dose escalation phase.
• 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 take only the 30 mg tablets from the prescribed packages. You will need to follow this dose escalation regimen only once, even if you restart treatment after an interruption.

Patients with severe kidney problems
If you have severe kidney problems, the recommended dose of Apremilast G.L. is 30 mg once daily (morning dose). Your doctor will explain how to increase the dose when starting treatment with this medicine.
How and when to take Apremilast G.L.

• This medicine is for oral use.
• Swallow the tablets whole, preferably with water. Do not crush or chew the tablets, as this may alter their characteristics.
• You may take the tablets with or without food.
• Take this medicine 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 must consult your doctor.
If you take more Apremilast G.L. than you should
If you take more Apremilast G.L. 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 G.L.

• If you forget to take a dose of Apremilast G.L., 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 forgotten dose.

If you stop taking Apremilast G.L.

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

If you have any doubts about the use of this medicine, consult 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
• 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 of tiredness
• 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 stomach or intestines
• suicidal ideation or behaviour

Side effects with unknown frequency (frequency cannot be determined from the available data):

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

If you are 65 years of age or older, you may be at higher risk of complications arising 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 or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 G.L.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, or box 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 medicines 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 G.L. contains

• The active substance is apremilast.
  • Apremilast G.L. 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
  • Apremilast G.L. 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
  • Apremilast G.L. 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
• The other components are:
  • Tablet core: microcrystalline cellulose (E460); lactose; croscarmellose sodium (E 468); colloidal anhydrous silica (E551); and magnesium stearate (E 470b)
  • Film coating: hydroxypropylcellulose (E 463); hypromellose (E 464); titanium dioxide (E 171); talc; red iron oxide (E 172); and yellow iron oxide (E 172).

The 30 mg film-coated tablets also contain black iron oxide (E172).
Description of the appearance of Apremilast G.L. and package contents
Apremilast G.L. 10 mg film-coated tablet is an oblong, pink, film-coated tablet with "10" imprinted on one side and smooth on the other, measuring 8 mm in length and 3 mm in width.
Apremilast G.L. 20 mg film-coated tablet is an oblong, orange, film-coated tablet with "20" imprinted on one side and smooth on the other, measuring 12 mm in length and 6 mm in width.
Apremilast G.L. 30 mg film-coated tablet is an oblong, brownish-red, film-coated tablet, smooth on both sides, measuring 13 mm in length and 7 mm in width.
Packages

• The starter pack contains 27 film-coated tablets in a folding carton: 4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg.
• The standard monthly pack contains 56 or 60 film-coated tablets of 30 mg.
• The standard three-month pack contains 168 film-coated tablets of 30 mg.

Marketing Authorization Holder
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Manufacturer
G.L. Pharma GmbH
Industriestraße 1
8502 Lannach, Austria
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta
Marketing Authorization Holder in Italy:
G.L. Pharma Italy S.r.l.,
[email protected]
This medicinal product is authorized in the European Economic Area countries under the following names:
Iceland Apremilast G.L. Upphafspakki 10 mg + 20 mg + 30 mg
filmuhúðaðar töflur
Apremilast G.L. 30 mg filmuhúðaðar
Austria Apremilast G.L. Starterpackung 10 mg + 20 mg + 30 mg
Filmtabletten
Apremilast G.L. 30 mg-Filmtabletten
Italy Apremilast G.L.