APREMILAST SANDOZ 10 mg + 20 mg + 30 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Apremilast Sandoz 10 mg + 20 mg + 30 mg film-coated tablets EFG

Treatment initiation pack

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Apremilast Sandoz contains the active substance “apremilast”. It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.

What Apremilast Sandoz is used for

Apremilast is used to treat adults with the following diseases:

• Active psoriatic arthritis:if you cannot use other types of medicines called “Disease-Modifying Antirheumatic Drugs” (DMARDs) or when you have already tried one of these medicines and it did not work.
• Chronic moderate to severe plaque psoriasis:if you cannot use one of the following treatments or when you have already tried one of these treatments and it did not work:
• • phototherapy: a treatment where certain areas of the skin are exposed to ultraviolet light,
  • systemic treatment: a treatment that acts on the whole body instead of a localized 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, an inflammatory disease of the skin.

What is plaque psoriasis

Psoriasis is an inflammatory disease of the skin, which can produce red, scaly, thickened, itchy, or painful lesions on the skin, 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 oral ulcers.

How Apremilast Sandoz works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually chronic diseases that currently have no cure. Apremilast 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 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, treatment with apremilast produces an improvement in inflamed and painful joints and can improve overall physical function.

In psoriasis, treatment with apremilast reduces psoriasis plaques on the skin and other signs and symptoms of the disease.

In Behçet's disease, treatment with apremilast reduces the number of oral ulcers and can make them disappear completely. It can also reduce associated pain.

Apremilast has also shown that it improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means that the impact of their disease on daily activities, relationships, and other factors should be less than before.

2. What you need to know before you take Apremilast Sandoz

Do not take Apremilast Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Apremilast Sandoz.

Depression and suicidal thoughts

Tell your doctor before starting treatment with apremilast if you have depression that could worsen with suicidal thoughts.

You or your caregiver should also inform your doctor immediately of any change in behavior or mood, feelings of depression, and any suicidal thoughts you may have after taking apremilast.

Severe kidney problems

If you have severe kidney problems, the dose will be different, see section 3.

If you have a weight below normal

Talk to your doctor while taking apremilast if you lose weight without wanting to.

Gastrointestinal problems

If you suffer from severe diarrhea, nausea, or vomiting, you should inform your doctor.

Children and adolescents

Apremilast has not been studied in children and adolescents; therefore, it is not recommended for use in children and adolescents 17 years or younger.

Other medicines and Apremilast Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because apremilast can affect the way other medicines work. Additionally, some medicines can affect the way apremilast works.

In particular, tell your doctor or pharmacist before starting to take apremilast if you are taking any of the following medicines:

• rifampicin: an antibiotic used for 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited information on the effects of apremilast during pregnancy. You should not become pregnant while taking this medicine and should use effective contraceptive methods during treatment with apremilast. It is not known whether this medicine passes into breast milk. Apremilast should not be used while breastfeeding.

Driving and using machines

The influence of apremilast on the ability to drive and use machines is nil.

Apremilast Sandoz contains lactose and sodium

Apremilast Sandoz contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially “sodium-free”

3. How to take Apremilast Sandoz

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

• When you start taking apremilast for the first time, you will receive a “treatment initiation pack” that contains all the doses as described in the table below.
• The “treatment initiation pack” is clearly labeled to ensure you take the correct dose at the correct time.
• Your treatment will start at a lower dose and will gradually increase over the first 6 days of treatment.
• The “treatment initiation pack” will also contain enough tablets for an additional 8 days at the recommended dose (days 7 to 14).
• The recommended dose of apremilast is 30 mg twice a day after completing the titration phase, one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours, with or without food.
• This results in 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, the prescribed packs will contain only 30 mg tablets. You will only need to go through this dose escalation process once, even if you need to restart treatment.

People with severe kidney problems

If you have severe kidney problems, the recommended dose of apremilast is 30 mg once a day (morning dose). Your doctor will tell you how to increase the dose when you start taking apremilast for the first time.

How and when to take Apremilast Sandoz

• Apremilast is taken orally.
• Swallow the tablets whole, preferably with water.
• You can take the tablets with or without food.
• • Take apremilast approximately at the same time every day, one tablet in the morning and one tablet in the evening.

If your disease does not improve after six months of treatment, consult your doctor.

If you take more Apremilast Sandoz than you should

If you take more apremilast than you should, consult a doctor or go to a hospital immediately. Take the medicine pack and this leaflet with you.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the medicine pack and leaflet to the healthcare professional.

If you forget to take Apremilast Sandoz

• If you miss a dose of apremilast, take it as soon as possible. If it is near the time of the next dose, skip the missed dose. Take the next dose at your usual time.
• Do not take a double dose to make up for missed doses.

If you stop taking Apremilast Sandoz

• You should continue taking apremilast until your doctor tells you to stop.
• Do not stop taking apremilast without consulting your doctor first.

If you have any further questions on 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 everybody gets them.

Serious side effects, depression, and suicidal thoughts

Tell your doctor immediately if you experience any change in behavior or mood, feelings of depression, or suicidal thoughts or behaviors (this is uncommon).

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

• diarrhea,
• 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,
• fatigue,
• stomach pain,
• loss of appetite,
• frequent bowel movements,
• difficulty sleeping (insomnia),
• indigestion or stomach upset,
• inflammation and swelling of the airways leading to the lungs (bronchitis),
• common cold (nasopharyngitis),
• depression,
• migraine,
• tension headache.

Uncommon side effects(may affect up to 1 in 100 people)

• rash,
• hives,
• weight loss,
• allergic reaction,
• bleeding in the intestine or stomach,
• suicidal ideation or behavior.

Rare side effects(frequency cannot be estimated from the available data)

• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that can cause difficulty breathing or swallowing).

If you are 65 years or older, you may have a higher risk of suffering from severe diarrhea, nausea, and vomiting. If your gastrointestinal problems become severe, you should talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Apremilast Sandoz

• 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 carton or blister after EXP. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any deterioration or signs of tampering with the medicine pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Apremilast Sandoz

The active substance is apremilast.

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

The other ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, and magnesium stearate.

• The coating contains hypromellose 2910 (E464), macrogol 3350 (E1521), lactose monohydrate, titanium dioxide (E171), and red iron oxide (E172).
• The 20 mg film-coated tablet also contains yellow iron oxide (E172).
• The 30 mg film-coated tablet also contains yellow iron oxide (E172) and black iron oxide (E172).

Appearance and packaging

Apremilast Sandoz 10 mg film-coated tablets

Pale pink, oval, film-coated tablet without a score, approximately 8 mm long and 4 mm wide, with “AM” engraved on one side and “10” on the other side.

Apremilast Sandoz 20 mg film-coated tablets

Pale brown, oval, film-coated tablet without a score, approximately 10 mm long and 5 mm wide, with “AM” engraved on one side and “20” on the other side.

Apremilast Sandoz 30 mg film-coated tablets

Pink, oval, film-coated tablet without a score, approximately 11 mm long and 6 mm wide, with “AM” engraved on one side and “30” on the other side.

Pack sizes

• The treatment initiation pack contains blisters with 27 film-coated tablets or unit-dose blisters with 27x1 film-coated tablets: 4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg.
• The maintenance pack contains blisters with 56, 168, 196 film-coated tablets of 30 mg or unit-dose blisters with 56x1, 168x1, and 196x1 film-coated tablets of 30 mg.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova Ulica, 57

1526 Ljubljana

Slovenia

Or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

Date of last revision of this leaflet:04/2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.