Ozlam

Package Leaflet: Information for the Patient

Ozlam, 10 mg, Coated Tablets

Ozlam, 20 mg, Coated Tablets

Ozlam, 30 mg, Coated Tablets

Apremilast

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for one person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Ozlam and what is it 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 pack and other information

1. What is Ozlam and what is it used for

What is Ozlam

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

What is Ozlam used for

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

• Active psoriatic arthritis -if the patient cannot take another type of medication called "disease-modifying antirheumatic drugs (DMARDs)" or if the patient has already tried taking one of these medications but without improvement.
• Chronic moderate to severe plaque psoriasis -if the patient cannot take one of the following treatments, or if they have tried one of these therapies but without improvement:
• phototherapy - a treatment in which parts of the skin are exposed to ultraviolet light.
• systemic treatment - a treatment that affects the whole body, not just a specific part; examples include medications 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 disease.

What is psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease that usually occurs with psoriasis, an inflammatory skin disease.

What is plaque psoriasis

Psoriasis is an inflammatory skin disease that can cause red, scaly, thick, itchy, and painful skin lesions; it can also cause changes in 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 symptom is oral ulcers.

How Ozlam works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually lifelong diseases, as there is no cure yet. Ozlam works by reducing the activity of an enzyme called phosphodiesterase 4, which is involved in the inflammation process. By reducing the activity of this enzyme, Ozlam can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet's disease, and thus reduce the signs and symptoms of these diseases.
In psoriatic arthritis, taking Ozlam results in reduced joint swelling and pain, and may also 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, taking Ozlam reduces the number of oral ulcers and may cause them to disappear completely. It may also alleviate associated pain.
It has also been shown that Ozlam improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means that the impact of the patient's 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 medication (listed in section 6);
• if the woman is pregnant or thinks she may be pregnant.

Warnings and precautions

Before starting to take Ozlam, discuss it with a doctor or pharmacist.

Depression and suicidal thoughts

If the patient has worsening depression with suicidal thoughts, they should discuss it with their doctor before starting Ozlam.
The patient or their caregiver should also immediately inform the doctor about any changes in behavior or mood, feelings of sadness, and 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 unintended weight loss while taking Ozlam, they should inform their doctor.

Gastrointestinal problems

The patient should inform their doctor about severe diarrhea, nausea, or vomiting.

Children and adolescents

No studies have been conducted on the use of apremilast in children and adolescents. Therefore, this medication is not recommended for use in children and adolescents under 17 years of age.

Ozlam and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. This includes over-the-counter medications and herbal remedies. This is important because Ozlam may affect the action of other medications. Other medications may also affect the action of Ozlam.
In particular, the patient should inform their doctor or pharmacist before starting Ozlam if they are taking any of the following medications:

• rifampicin - an antibiotic used to treat tuberculosis;
• phenytoin, phenobarbital, and carbamazepine - medications used to treat seizures or epilepsy;
• St. John's Wort - a herbal remedy used to treat mild anxiety and depression.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medication.
There is limited data on the use of Ozlam in pregnant women. Women should not become pregnant while taking this medication and should use effective contraception during Ozlam treatment. It is not known whether the medication passes into breast milk. Ozlam should not be used during breastfeeding.

Driving and using machines

Ozlam has no influence on the ability to drive and use machines.

Ozlam contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Ozlam

This medication should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Recommended dose of Ozlam

• If the patient is starting Ozlam for the first time, they will receive a "starter pack" that contains all the doses as described in the table below.
• The "starter pack" is precisely described to ensure that the patient takes the correct tablet at the correct time.
• Treatment will start with the lowest dose, which will be gradually increased over the first 6 days of treatment.
• The "starter pack" also includes tablets at the recommended dose for the next 8 days (days 7 to 14).
• After completing the dose titration period, the recommended dose of Ozlam is 30 mg twice a day
• one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours, with or without food.
• The total daily dose is 60 mg. By the end of day 6, the patient will reach the recommended dose.
• After reaching the recommended dose, the patient will receive only 30 mg tablets in the prescribed packaging. The patient must go through this dose titration phase only once, even if it is necessary to restart treatment.

Patients with severe kidney disease

If the patient has severe kidney disease, the recommended dose of Ozlam is 30 mg once a day (morning dose). The doctor will inform the patient how to increase the dose during the first use of Ozlam.

How and when to take Ozlam

• Ozlam is intended for oral administration.
• Tablets should be swallowed whole, preferably with water.
• Tablets can be taken with or without food.
• Ozlam should be taken at the same time every 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 than the recommended dose of Ozlam

If the patient takes more than the recommended dose of Ozlam, they should immediately contact their doctor or go to the hospital. They should bring the packaging and this package leaflet with them.

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 close to the time for the next dose, they should not take the missed dose. The next dose should be taken at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping Ozlam treatment

• The patient should take Ozlam until their doctor tells them to stop.
• Do not stop taking Ozlam without consulting a doctor first.

In case of any further doubts about the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Ozlam can cause side effects, although not everybody gets them.

Severe side effects – depression and suicidal thoughts

The patient should immediately inform their doctor about any changes in behavior or mood, feelings of sadness, suicidal thoughts, or suicidal behavior (which occur uncommonly).
Very common(occurring in more than 1 in 10 patients)

• diarrhea
• nausea
• headache
• upper respiratory tract infections, such as the common cold, runny nose, sinus infection

Common(occurring in less than 1 in 10 patients)

• cough
• back pain
• vomiting
• fatigue
• abdominal pain
• loss of appetite
• diarrhea
• sleep disorders (insomnia)
• indigestion or heartburn
• inflammation and swelling of the airways in the lungs (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• tension headache

Uncommon(occurring in less than 1 in 100 patients)

• rash
• hives
• weight loss
• allergic reaction
• bleeding in the gut or stomach
• suicidal thoughts or behavior

Frequency not known(frequency cannot be estimated from the available data)

• severe allergic reaction (which may include swelling of the face, lips, mouth, tongue, or throat, which may lead to difficulty breathing and swallowing)

In patients aged 65 and over, there may be a higher risk of complications such as severe diarrhea, nausea, and vomiting. If gastrointestinal problems worsen, the patient should inform their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Ozlam

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack or starter pack or on the carton after: EXP. The expiration date stated on the packaging indicates the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT, it indicates the batch number.
Do not store above 30°C.
Do not use this medication if the packaging is damaged or shows signs of tampering.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ozlam contains

• The active substance of Ozlam 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), macrogol 8000, talc (only for 10 mg and 30 mg), yellow iron oxide (E 172) (only for 10 mg and 20 mg), red iron oxide (E 172) (only for 20 mg and 30 mg).
• (only for 10 mg and 30 mg), yellow iron oxide (E 172) (only for 10 mg and 20 mg), red iron oxide (E 172) (only for 20 mg and 30 mg).

What Ozlam looks like and contents of the pack

Ozlam, 10 mg, coated tablets
Oval, biconvex, light yellow coated tablets with "10" engraved 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 with "20" engraved 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 with "30" engraved on one side, 11.7-12.3 mm in length and 6.1-6.7 mm in width.
Pack sizes

• The starter pack is a folding box containing 27 coated tablets in aluminum/PVC blisters (4 x 10 mg tablets, 4 x 20 mg tablets, and 19 x 30 mg tablets).
• Standard packaging contains 28, 56, 112, or 168 coated tablets of 30 mg in aluminum/PVC blisters.

Marketing authorization holder and manufacturer

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the package leaflet: