Apremilast Sandoz GmbH: detailed information

Package leaflet: Information for the patient

Apremilast Sandoz GmbH 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 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, 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 yours, as it may be harmful.
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:

What Apremilast Sandoz GmbH is and what it is used for
What you need to know before taking Apremilast Sandoz GmbH
How to take Apremilast Sandoz GmbH
Possible side effects
How to store Apremilast Sandoz GmbH
Contents of the pack and other information

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

Apremilast Sandoz GmbH 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 GmbH is used for
Apremilast Sandoz GmbH 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 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 that are itchy and painful 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 that affects many parts of the body. The most common problem is mouth ulcers.
How Apremilast Sandoz GmbH works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Sandoz GmbH 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 GmbH 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 GmbH leads to improvement in joint swelling and pain, and may improve overall physical function.
In psoriasis, treatment with Apremilast Sandoz GmbH reduces psoriatic plaques on the skin and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast Sandoz GmbH reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.
Apremilast Sandoz GmbH 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 should know before taking Apremilast Sandoz GmbH

Do not take Apremilast Sandoz GmbH:

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 GmbH.
Depression and suicidal thoughts
Before starting Apremilast Sandoz GmbH, inform your doctor if you have depression that is worsening, or if you have suicidal thoughts.
You or the person caring for you must also inform your doctor immediately if you experience any changes in behaviour or mood, feelings of depression, or suicidal thoughts after starting Apremilast Sandoz GmbH.
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 GmbH 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 Sandoz GmbH has not been studied in children and adolescents; therefore, its use is not recommended in children and adolescents aged 17 years and younger.
Other medicines and Apremilast Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because Apremilast Sandoz GmbH may affect the action of other medicines, and other medicines may affect the action of Apremilast Sandoz GmbH.
In particular, inform your doctor or pharmacist before taking Apremilast Sandoz GmbH if you are taking any of the following medicines:

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

3. How to take Apremilast Sandoz GmbH

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 GmbH, 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 GmbH 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 take only the 30 mg tablets from the prescribed packs. You will only need to follow this gradual dose escalation once, even if you restart treatment after an interruption.

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

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

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

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

If you have any doubts about how to use this medicine, consult 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 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

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 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 years or older, you may have a 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 GmbH

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

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

The other components in the tablet core are monohydrate lactose, microcrystalline cellulose,
sodium croscarmellose, and magnesium stearate.
10 mg: the film coating contains hypromellose 2910 (E464), titanium dioxide (E171),
polydextrose (E1200), talc (E553b), maltodextrin, medium-chain triglycerides, red iron oxide (E172).
20 mg: the film coating contains hypromellose 2910 (E464), polydextrose (E1200), yellow iron oxide (E172), titanium dioxide (E171), talc (E553b), maltodextrin, medium-chain triglycerides, red iron oxide (E172).
30 mg: the film coating contains hypromellose 2910 (E464), polydextrose (E1200), titanium dioxide (E171), talc (E553b), maltodextrin, medium-chain triglycerides, red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Apremilast Sandoz GmbH and contents of the pack
Apremilast Sandoz GmbH 10 mg film-coated tablet is diamond-shaped, pink in colour, engraved with "10" on one side, and measures 8.3 mm x 4.5 mm.
Apremilast Sandoz GmbH 20 mg film-coated tablet is diamond-shaped, brown in colour, engraved with "20" on one side, and measures 10.4 mm x 5.6 mm.
Apremilast Sandoz GmbH 30 mg film-coated tablet is diamond-shaped, beige in colour, engraved with "30" on one side, and measures 11.9 mm x 6.4 mm.

Pack sizes

The starter pack contains one box with 1 blister of 4 tablets of 10 mg, 1 blister of 4 tablets of 20 mg, and 1 blister of 19 tablets of 30 mg.
The standard one-month therapy pack contains 56 film-coated tablets of 30 mg in blister packs.
The standard three-month therapy pack contains 168 film-coated tablets of 30 mg in blister packs.

Marketing Authorization Holder
Marketing Authorization Holder:
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Local representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milano
Italy

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area,
41500 Larissa
Greece

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria Apremilast Sandoz Starterpackung 10 mg + 20 mg + 30 mg – Filmtabletten
Apremilast Sandoz 30 mg – Filmtabletten
Belgium Apremilast Sandoz GmbH 10 mg filmomhulde tabletten
Apremilast Sandoz GmbH 20 mg filmomhulde tabletten
Apremilast Sandoz GmbH 30 mg filmomhulde tabletten
Apremilast Sandoz GmbH 30 mg filmomhulde tabletten
Cyprus Apremilast Ebewe
Croatia Apremilast Sandoz 10 mg filmom obložene tablete
Apremilast Sandoz 20 mg filmom obložene tablete
Apremilast Sandoz 30 mg filmom obložene tablete
Finland Apremilast Hexal 10 mg tabletit, kalvopäällysteiset
Apremilast Hexal 20 mg tabletit, kalvopäällysteiset
Apremilast Hexal 30 mg tabletit, kalvopäällysteiset
France APREMILAST GNR 10 mg, comprimé pelliculé
APREMILAST GNR 20 mg, comprimé pelliculé
APREMILAST GNR 30 mg, comprimé pelliculé
APREMILAST GNR 30 mg, comprimé pelliculé
Germany Apremilast HEXAL 10 mg + 20 mg + 30 mg Filmtabletten
Apremilast HEXAL 30 mg Filmtabletten
Greece Apremilast/Ebewe
Italy Apremilast Sandoz GmbH
Malta Apremilast Sandoz 10 mg + 20 mg + 30 mg film coated tablet
Apremilast Sandoz 30 mg film coated tablet
Czech Republic Apremilast Sandoz
Slovakia Apremilast Sandoz 10 mg
Apremilast Sandoz 20 mg
Apremilast Sandoz 30 mg
Apremilast Sandoz 30 mg
Sweden Apremilast Hexal