Apremilast Sandoz

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before you take 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 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 effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

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

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, thick patches on the skin that may be itchy and painful, and may 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 Sandoz works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Sandoz 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 Sandoz 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 Sandoz leads to improvement in joint swelling and pain, and may improve overall physical function.
In psoriasis, treatment with Apremilast Sandoz reduces psoriatic plaques on the skin and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast Sandoz reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.
Apremilast Sandoz 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 Sandoz

Do not take Apremilast Sandoz:

• 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 Sandoz.
Depression and suicidal thoughts
Tell your doctor before starting Apremilast Sandoz 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 Sandoz.
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 Sandoz 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 Sandoz has not been studied in children and adolescents; therefore, use is not recommended in children and adolescents under 18 years of age.
Other medicines and Apremilast Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal medicines. This is because Apremilast Sandoz may affect the action of other medicines, and other medicines may affect the action of Apremilast Sandoz.
In particular, tell your doctor or pharmacist before taking Apremilast Sandoz 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 are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. There is limited information on the effects of Apremilast Sandoz during pregnancy. You must not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast Sandoz.
It is not known whether this medicine passes into breast milk. You must not use Apremilast Sandoz while breastfeeding.
Driving and using machines
Apremilast Sandoz does not affect the ability to drive or use machines.
Apremilast Sandoz contains lactose
Apremilast Sandoz 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.

3. How to take Apremilast Sandoz

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 Sandoz, you will receive a "starter pack" containing all the doses listed in the table below.
• The "starter pack" is clearly labelled 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 Sandoz is 30 mg twice daily, once the gradual dose escalation has been completed: 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 has been reached, you will only take the 30 mg tablets from the prescribed packs. You should follow this gradual dose escalation only once, even if you restart treatment after an interruption.

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

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

How and when to take Apremilast Sandoz

• Apremilast Sandoz is for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Sandoz 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 Sandoz than you should
If you take more Apremilast Sandoz than you should, consult your doctor or go to hospital immediately. Take the medicine pack and this patient information leaflet with you.

If you forget to take Apremilast Sandoz

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

• Continue taking Apremilast Sandoz until your doctor tells you to stop.
• Do not stop treatment with Apremilast Sandoz 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 everyone gets them.
Serious side effects – depression and suicidal thoughts
Inform your doctor immediately of any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (this is not uncommon).
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

• 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)

• 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 aged 65 or over, you may be at higher risk of complications due to severe diarrhoea, nausea and vomiting. If your intestinal problems become severe, 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 can 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 Sandoz

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister or 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 Sandoz contains
The active substance is apremilast.

• Apremilast Sandoz 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
• Apremilast Sandoz 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
• Apremilast Sandoz 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

The other components in the tablet core are microcrystalline cellulose, lactose monohydrate,
sodium croscarmellose and magnesium stearate.
The film coating contains hypromellose 2910 (E464), macrogol 3350 (E1521), lactose monohydrate,
titanium dioxide (E171), iron oxide red (E172).

• The film-coated tablet of Apremilast Sandoz 20 mg also contains iron oxide yellow (E172).
• The film-coated tablet of Apremilast Sandoz 30 mg also contains iron oxide yellow (E172) and iron oxide black (E172).

Description of the appearance of Apremilast Sandoz and contents of the pack
Apremilast Sandoz 10 mg film-coated tablets
Apremilast Sandoz 10 mg film-coated tablet is oval-shaped, light pink in colour, without a break line, approximately 8 mm in length and 4 mm in width, with "AM" imprinted on one side and "10" on the other side.
Apremilast Sandoz 20 mg film-coated tablets
Apremilast Sandoz 20 mg film-coated tablet is oval-shaped, light brown in colour, without a break line, approximately 10 mm in length and 5 mm in width, with "AM" imprinted on one side and "20" on the other side.
Apremilast Sandoz 30 mg film-coated tablets
Apremilast Sandoz 30 mg film-coated tablet is oval-shaped, pink in colour, without a break line, approximately 11 mm in length and 6 mm in width, with "AM" imprinted on one side and "30" on the other side.

Pack sizes

• The starter pack contains blisters of 27 film-coated tablets or unit-dose divisible blisters of 27x1: 4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg.
• The maintenance pack contains blisters of 56, 168, or 196 film-coated tablets of 30 mg, or unit-dose divisible blisters of 56x1, 168x1, 196x1 film-coated tablets of 30 mg.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium Apremilast Sandoz 10 mg – 20 mg – 30 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Apremilast Sandoz 30 mg filmomhulde tabletten
Cyprus Apremilast/Sandoz 10 mg + 20 mg + 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
Apremilast/Sandoz 30 mg επικαλυμμένα με λεπτό υμένιο δισκία
Finland Apremilast Sandoz 10 mg, 20 mg, 30 mg tabletit, kalvopäällysteiset
Apremilast Sandoz 30 mg tabletit, kalvopäällysteiset
France APREMILAST SANDOZ 10 mg, 20 mg, 30 mg, comprimé pelliculé
APREMILAST SANDOZ 30 mg, comprimé pelliculé
Germany Apremilast HEXAL 10 mg + 20 mg + 30 mg Filmtabletten
Apremilast HEXAL 30 mg Filmtabletten
Greece Apremilast/Sandoz
Ireland Apremilast Rowex 10 mg, 20 mg & 30 mg film-coated tablets
Apremilast Rowex 30 mg film-coated tablets
Italy Apremilast Sandoz
Netherlands Apremilast Sandoz 10 mg, 20 mg, 30 mg filmomhulde tabletten
Apremilast Sandoz 30 mg, filmomhulde tabletten
Spain Apremilast Sandoz 10 mg + 20 mg + 30 mg, comprimidos recubiertos con película EFG
Apremilast Sandoz 30 mg comprimidos recubiertos con película EFG
Sweden Apremilast Sandoz
Hungary Apremilast Sandoz 10 mg + 20 mg + 30 mg filmtabletta kezdőcsomag
Apremilast Sandoz 30 mg filmtabletta