Apremilast Teva

Patient Information Leaflet

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

apremilast
Equivalent medicine
Please read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it could 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

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

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

Apremilast Teva contains the active substance “apremilast”. This active substance belongs to a group of
medicines called “phosphodiesterase 4 inhibitors”, which help reduce inflammation.
Apremilast Teva is used to treat adults with the following clinical 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 a localized area, such as “cyclosporine”, “methotrexate” or “psoralen”.
• Behçet’s disease (BD) – for the treatment of mouth ulcers, a common problem in people with this disease.

What is psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, a skin inflammatory disease.
What is plaque psoriasis
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick patches on the skin, which may be itchy and painful, and can 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 mouth ulcers.
How Apremilast Teva works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Teva 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 Teva can help control the inflammation associated with psoriatic arthritis, psoriasis and Behçet’s disease, thereby reducing the signs and symptoms of these clinical conditions.
In psoriatic arthritis, treatment with Apremilast Teva leads to improvement in joint swelling and pain and may improve overall physical function.
In psoriasis, treatment with Apremilast Teva reduces psoriatic plaques on the skin and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast Teva reduces the number of mouth ulcers and may completely stop their development. It may also reduce associated pain.
Apremilast Teva has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis or Behçet’s disease. This means that the impact of the condition on daily activities, relationships and other factors should be less than before.

2. What you need to know before taking Apremilast Teva

Do not take Apremilast Teva:

• if you are allergic to apremilast or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or suspect you may be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast Teva.
Depression and suicidal thoughts
Inform your doctor before starting treatment with Apremilast Teva if you suffer from 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 may occur after taking Apremilast Teva.
Severe kidney problems
If you have severe kidney problems, your dose will be different; see section 3.
Underweight
Talk to your doctor if you experience unintentional weight loss during treatment with Apremilast Teva.
Gastrointestinal problems
If you develop severe diarrhoea, nausea, or vomiting, consult your doctor.
Children and adolescents
Apremilast Teva 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 Teva
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.
Apremilast Teva may affect the action of certain other medicines, and some other medicines may affect the action of Apremilast Teva.
In particular, inform your doctor or pharmacist before taking Apremilast Teva 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;
• St. John’s wort – a herbal medicine used for mild forms of anxiety and depression.

Pregnancy and breastfeeding
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 Teva during pregnancy. Do not become pregnant while taking this medicine, and use an effective method of contraception during treatment with Apremilast Teva.
It is not known whether this medicine passes into breast milk. Do not use Apremilast Teva during breastfeeding.
Driving and using machines
Apremilast Teva does not affect the ability to drive or operate machinery.
Apremilast Teva contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
Apremilast Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Apremilast Teva

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
Dosage

• When you start taking Apremilast Teva, 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 Teva is 30 mg twice daily, once the dose escalation phase 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 is reached, you will only take the 30 mg tablets from the prescribed packs. You will only need to follow this dose escalation phase 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 Teva is 30 mg once daily
(morning dose). Your doctor will explain how to increase the dose when starting treatment with
Apremilast Teva.
How and when to take Apremilast Teva

• Apremilast Teva is for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Teva at approximately the same time each day, one tablet in the morning and one tablet in the evening.
• To remove the tablets from the blister pack, fold the blister and tear along the perforated line to detach a single unit. Then gently peel back the aluminium foil from the single unit starting at the arrow. Do not push the tablet through the foil.

If your condition has not improved after six months of treatment, consult your doctor.
If you take more Apremilast Teva than you should
If you take more Apremilast Teva than you should, contact your doctor or go to hospital
immediately. Take the medicine pack and this leaflet with you.
If you forget to take Apremilast Teva

• If you forget to take a dose of Apremilast Teva, 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 your usual time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Apremilast Teva

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

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 (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
• Back pain
• Vomiting
• Feeling of tiredness
• Stomach ache
• 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 (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 aged 65 years or older, 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
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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 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 Teva contains

• The active substance is apremilast.
• Apremilast Teva 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
• Apremilast Teva 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
• Apremilast Teva 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

The other components of the tablet core are: monohydrate lactose, microcrystalline cellulose,
sodium croscarmellose, and magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, and red iron oxide (E172).
Apremilast Teva 20 mg film-coated tablets also contain yellow iron oxide (E172).

Description of the appearance of Apremilast Teva and package contents
Apremilast Teva 10 mg film-coated tablets are oval, light pink, film-coated tablets, marked with “TV” on one side and “Y2” on the opposite side. The tablet dimensions are approximately 9 mm x 5 mm.
Apremilast Teva 20 mg film-coated tablets are oval, beige, film-coated tablets, marked with “TV” on one side and “Y3” on the opposite side. The tablet dimensions are approximately 11 mm x 6 mm.
Apremilast Teva 30 mg film-coated tablets are oval, pink, film-coated tablets, marked with “TV” on one side and “Y4” on the opposite side. The tablet dimensions are approximately 12 mm x 7 mm.

Apremilast Teva 10 mg, 20 mg, 30 mg film-coated tablets (starter pack)
The starter pack contains 27 film-coated tablets (4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg) in perforated PVC/aluminum blisters.
Pack sizes: 27 tablets (in common blister)
27x1 tablet (in unit-dose divisible blister)

Apremilast Teva 30 mg film-coated tablets
Perforated PVC/aluminum blister
Pack sizes: 30x1 (in unit-dose divisible blister), 56, 56x1 (in unit-dose divisible blister), 60, 168x1 (in unit-dose divisible blister)
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Teva Operations Poland Sp. z o.o
ul. Mogilska 80
31-546 Krakow
Poland