Apremilast Noucor

Patient Information Leaflet

Apremilast Noucor 30 mg film-coated tablets

Apremilast
Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

This medicine contains the active substance 'apremilast'. This substance belongs to a group of
medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.
What Apremilast Noucor is used for
Apremilast is used to treat adults with the following conditions:

• Active psoriatic arthritis – if you cannot use another type of medicine called “disease-modifying antirheumatic drugs” (DMARDs), or if you have tried treatment with one of these medicines but it was not effective.
• Moderate to severe plaque psoriasis – if you cannot use one of the following treatments, or if you have tried one of these treatments but it 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) – to treat oral ulcers, a common problem in people with this disease.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, a skin inflammatory condition.
What is plaque psoriasis
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 is Behçet’s disease
Behçet’s disease is a rare type of inflammatory disease that affects many parts of the body. The most common problem is oral ulcers.
How Apremilast Noucor works
Psoriatic arthritis, psoriasis, and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Noucor 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 Noucor 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 Noucor leads to improvement in joint swelling and pain and may improve overall physical function.
In psoriasis, treatment with Apremilast Noucor reduces psoriatic skin plaques and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast Noucor reduces the number of oral ulcers and may stop them completely. It may also reduce associated pain.
Apremilast Noucor 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 Noucor

Do not take Apremilast Noucor:

• 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 Noucor.
Depression and suicidal thoughts
Inform your doctor before starting treatment with Apremilast Noucor if you suffer from depression worsening with suicidal thoughts.
You or your caregiver must also inform your doctor immediately of any changes in behaviour or mood, feelings of depression, or any suicidal thoughts 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 while taking Apremilast Noucor if you lose weight unintentionally.
Gastrointestinal problems
Contact your doctor if you experience severe diarrhoea, nausea or vomiting.
Children and adolescents
This medicine has not been studied in children and adolescents; therefore, its use is not recommended in children and adolescents under or equal to 17 years of age.
Other medicines and Apremilast Noucor
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines and herbal medicines. This is because apremilast may affect the action of other medicines. In addition, other medicines may affect the action of apremilast.
In particular, inform your doctor or pharmacist before taking Apremilast Noucor if you are taking any of the following medicines:

• rifampicin – an antibiotic used for tuberculosis
• phenytoin, phenobarbital and carbamazepine – medicines used to treat epileptic 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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information available on the effects of Apremilast Noucor during pregnancy. Do not become pregnant while taking this medicine and use an effective method of contraception during treatment with Apremilast Noucor.
It is not known whether this medicine passes into breast milk. You must not use Apremilast Noucor while breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or use machinery.
Apremilast Noucor contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Apremilast Noucor

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, 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 is 30 mg twice daily, once the titration 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 only take 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 Do not take a dose 10 mg
Day 2 10 mg 10 mg 20 mg
Day 3 10 mg 20 mg 30 mg
Day 4 20 mg 20 mg 40 mg
Day 5 20 mg 30 mg 50 mg
From day 6 onwards 30 mg 30 mg 60 mg
Dose titration is not possible with this medicine. Other presentations are available for initiating treatment before using Apremilast Noucor.
Patients with severe renal impairment
If you have severe kidney problems, the recommended dose of apremilast 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 Noucor

• Apremilast tablets are for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take the 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, consult your doctor.
If you take more Apremilast Noucor than you should
If you take more medicine 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 Noucor

• If you forget to take a dose of this medicine, 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 Noucor

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

If you have any questions 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
Tell your doctor immediately if you experience any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (not common).

Very common side effects (may affect more than 1 in 10 people)

• diarrhoea
• nausea
• headache
• Bacterial infections of the upper respiratory tract 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 passages (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
• intestinal or gastric bleeding
• suicidal ideation and 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 lead to difficulty breathing or swallowing)

If you are 65 years of age or older, you may have an increased risk of complications from severe diarrhoea, nausea and vomiting. If gastrointestinal 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 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 Noucor

• 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 pack and carton after "Exp.". The expiry date refers to the last day of the month indicated.
• 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 Noucor contains

The active substance is apremilast. Each film-coated tablet contains 30 mg of apremilast.
The other components in the tablet core are microcrystalline cellulose,
sodium croscarmellose, anhydrous colloidal silica and magnesium stearate.
The coating film contains polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), yellow iron oxide (E172) and ferroso-ferric/ black iron oxide (E172).
Description of the appearance of Apremilast Noucor and pack sizes
The film-coated tablet is a beige, biconvex, round tablet with a diameter of 9.5 mm.
Pack sizes

• The standard one-month pack contains blisters of aluminium foil in PVC/PCTFE (Polychlorotrifluoroethylene)/PVC with 56 film-coated 30 mg tablets.
• The standard three-month pack contains blisters of PVC/PCTFE (Polychlorotrifluoroethylene)/PVC in aluminium foil with 168 film-coated 30 mg tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Noucor Health S.A.
Avinguda Camí Reial, 51-57
08184 Palau-Solità I Plegamans
Barcelona – Spain
Other sources of information

{www.aifa.gov.it}