Ozlam

Package leaflet: Information for the patient

Ozlam, 10 mg, coated tablets
Ozlam, 20 mg, coated tablets
Ozlam, 30 mg, coated tablets
Apremilast
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Ozlam is and what it is used for
2. Important information before taking Ozlam
3. How to take Ozlam
4. Possible side effects
5. How to store Ozlam
6. Contents of the package and other information

1. What Ozlam is and what it is used for

What Ozlam is
Ozlam contains the active substance apremilast. It belongs to a group of medicines called
phosphodiesterase 4 inhibitors, which help reduce inflammation.

What Ozlam is used for
Ozlam is used to treat adult patients with the following conditions:

• Active psoriatic arthritis – if the patient cannot take another type of medicine known as "disease-modifying antirheumatic drugs (DMARDs)", or if the patient has already tried such medicines without improvement.
• Moderate to severe chronic plaque psoriasis – if the patient cannot take one of the treatment options listed below, or if they have tried one of these therapies without improvement:
  • Phototherapy – a treatment in which areas of skin are exposed to ultraviolet light.
  • Systemic therapy – treatment that affects the whole body rather than a specific part; examples include medicines containing substances such as: cyclosporine, methotrexate, or psoralen.
• Behçet’s disease (BD) – to treat oral ulcers, which are a common symptom in people with this condition.

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, an inflammatory skin condition.

What plaque psoriasis is
Psoriasis is an inflammatory skin disease that may cause red, scaly, thickened, itchy, and painful skin lesions; it may also affect the scalp and nails.

What Behçet’s disease is
Behçet’s disease is a rare inflammatory condition affecting multiple parts of the body. The most common symptom is oral ulcers.

How Ozlam works
Psoriatic arthritis, psoriasis, and Behçet’s disease are generally lifelong conditions, as there is currently no cure. Ozlam works by reducing the activity of an enzyme called "phosphodiesterase 4", which plays a key role in the inflammatory process. By reducing the activity of this enzyme, Ozlam may 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 Ozlam reduces joint swelling and pain and may improve the patient’s overall physical function.

In psoriasis, treatment with Ozlam leads to a reduction in psoriatic skin lesions and other signs and symptoms of the disease.

In Behçet’s disease, treatment with Ozlam reduces the number of oral ulcers and may lead to their complete resolution. It may also reduce the associated pain.

Ozlam 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 disease on daily activities, relationships with others, and other factors should be less than before.

2. Important information before taking Ozlam

When not to take Ozlam

• if the patient is allergic to apremilast or any of the other ingredients of this medicine (listed in section 6);
• if the woman is pregnant or suspects she may be pregnant.

Warnings and precautions
Before starting to take Ozlam, discuss this with your doctor or pharmacist.
Depression and suicidal thoughts
If the patient has worsening depression with suicidal thoughts, this should be discussed with the doctor before starting treatment with Ozlam.
The patient or their caregiver should also immediately inform the doctor of any changes in behaviour or mood, feelings of depression, or any suicidal thoughts that occur after taking Ozlam.
Severe kidney disease
If the patient has severe kidney disease, the dose will be different – see section 3.
If the patient is underweight
If the patient experiences unintentional weight loss while taking Ozlam, they should inform their doctor.
Gastrointestinal problems
Inform the doctor if severe diarrhoea, nausea or vomiting occur.
Children and adolescents
Studies on the use of apremilast in children and adolescents have not been conducted. Therefore, this medicine is not recommended for use in children and adolescents under 18 years of age.
Ozlam and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription and herbal medicines. This is important because Ozlam may affect the action of other medicines. Likewise, other medicines may affect the action of Ozlam.
In particular, inform your doctor or pharmacist before starting Ozlam if the patient is 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 (Hypericum perforatum) – a herbal remedy used for mild anxiety and depression.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is limited data on the use of Ozlam in pregnant women. The woman should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Ozlam. It is not known whether the medicine passes into human milk. Ozlam should not be used during breastfeeding.
Driving and operating machinery
Ozlam has no influence on the ability to drive or operate machinery.
Ozlam contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Ozlam

This medicine should always be taken exactly as instructed by the doctor. In case of doubts,
consult the doctor or pharmacist.
Recommended dose of the medicine

• If the patient is starting to take Ozlam for the first time, they will receive a "starting kit" containing all the doses listed in the table below.
• The "starting kit" is clearly labeled to ensure the patient takes the correct tablet at the correct time.
• Treatment will begin with the lowest dose, which will be gradually increased over the first 6 days of treatment.
• The "starting kit" also contains tablets at the recommended dose for the following 8 days (days 7 to 14).
• After completion of the dose-escalation period, the recommended dose of Ozlam is 30 mg twice daily
  • one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food.
• The total daily dose is 60 mg. By the end of day 6, the patient will have reached the recommended dose.
• Once the recommended dose is achieved, the patient will receive only 30 mg tablets in prescribed packaging. This dose-escalation process needs to be followed only once, even if treatment is restarted at a later time.

Patients with severe kidney disease
If the patient has severe kidney disease, the recommended dose of Ozlam is 30 mg once daily (morning dose). The doctor will inform the patient how to increase the dose when starting treatment with Ozlam for the first time.
How and when to take Ozlam

• Ozlam is intended for oral administration.
• Tablets should be swallowed whole, preferably with water.
• Tablets may be taken with or without food.
• Ozlam should be taken at the same time each day, one tablet in the morning and one tablet in the evening.

If the patient's condition does not improve after six months, they should contact their doctor.
Taking more Ozlam than recommended

• If the patient takes more Ozlam than recommended, they should contact their doctor immediately or go to hospital. The package and this leaflet should be taken along.

Missing a dose of Ozlam

• If the patient forgets to take a dose of Ozlam, they should take it as soon as possible. If it is almost time for the next dose, the missed dose should not be taken. The next dose should be taken at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Ozlam

• The patient should continue taking Ozlam until the doctor advises stopping treatment.
• Do not stop taking Ozlam without consulting the doctor first.

If you have any further questions regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions – depression and suicidal thoughts
Inform your doctor immediately about any changes in behaviour or mood, feeling depressed, or having suicidal thoughts or actions (these occur not commonly).

Very common (affects more than 1 in 10 patients):

• Diarrhoea
• Nausea
• Headache
• Upper respiratory tract infections, such as colds, nasal congestion, sinus infection

Common (affects less than 1 in 10 patients):

• Cough
• Back pain
• Vomiting
• Feeling tired
• Abdominal pain
• Loss of appetite
• Frequent bowel movements
• Sleep problems (insomnia)
• Indigestion or heartburn
• Inflammation and swelling of the airways in the lungs (bronchitis)
• Common cold (nasopharyngitis)
• Depression
• Migraine
• Tension headache

Uncommon (affects less than 1 in 100 patients):

• Rash
• Urticaria (hives)
• Weight loss
• Allergic reaction
• Bleeding in the intestines or stomach
• Suicidal thoughts or behaviours

Frequency not known (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 and swallowing)

In patients aged 65 years and older, there may be an increased risk of complications such as severe diarrhoea, nausea and vomiting. If intestinal problems worsen, inform your doctor.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ozlam

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or starter pack or on the outer carton following EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Do not store above 30°C.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ozlam contains

• The active substance is apremilast.
• Ozlam 10 mg, coated tablets: each coated tablet contains 10 mg of apremilast.
• Ozlam 20 mg, coated tablets: each coated tablet contains 20 mg of apremilast.
• Ozlam 30 mg, coated tablets: each coated tablet contains 30 mg of apremilast.
• Other ingredients are:
  • tablet core: mannitol, microcrystalline cellulose (type 102), sodium croscarmellose, magnesium stearate.
  • tablet coating: hypromellose 2910 (6 mPas), titanium dioxide (E 171), polyethylene glycol (8000), talc (only for 10 mg and 30 mg strengths), yellow iron oxide (E 172) (only for 10 mg and 20 mg strengths), red iron oxide (E 172) (only for 20 mg and 30 mg strengths).

What Ozlam looks like and contents of the pack
Ozlam 10 mg, coated tablets
Oval, biconvex, light yellow coated tablets, engraved with the mark "10" on one side, 8.0–8.6 mm in length and 4.1–4.7 mm in width.
Ozlam 20 mg, coated tablets
Oval, biconvex, yellow coated tablets, engraved with the mark "20" on one side, 10.2–10.8 mm in length and 5.3–5.9 mm in width.
Ozlam 30 mg, coated tablets
Oval, biconvex, light pink to pink coated tablets, engraved with the mark "30" on one side, 11.7–12.3 mm in length and 6.1–6.7 mm in width.
Pack sizes

• Starter pack: a folding carton containing 27 coated tablets in aluminium/PVC blisters (4 x 10 mg tablets, 4 x 20 mg tablets, and 19 x 30 mg tablets).
• Standard packs: 28, 56, 112 or 168 coated tablets of 30 mg in aluminium/PVC blisters.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01