PHOMILOT 10 mg + 20 mg + 30 mg FILM-COATED TABLETS

1. What is Phomilot and what is it used for

What is Phomilot

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

What is Phomilot used for

Phomilot 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 has not worked.
• Moderate to severe chronic plaque psoriasis:if you cannot use one of the following treatments or when you have already tried one of these treatments and it has not worked:
• • phototherapy: a treatment in which 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 Phomilot works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually chronic diseases that currently have no cure. Phomilot 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, Phomilot 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 Phomilot improves inflamed and painful joints and can improve overall physical function.

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

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

Phomilot 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 Phomilot

Do not take Phomilot

• 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 Phomilot.

Depression and suicidal thoughts

Tell your doctor before starting treatment with Phomilot 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 this medicine.

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 this medicine 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 of age or younger.

Other medicines and Phomilot

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 Phomilot can affect the way other medicines work. Additionally, some medicines can affect the way Phomilot works.

In particular, tell your doctor or pharmacist before starting treatment with Phomilot 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 Phomilot during pregnancy. You should not become pregnant while taking this medicine and should use effective contraceptive methods during treatment with Phomilot.

It is not known whether this medicine passes into breast milk. Phomilot should not be used while breastfeeding.

Driving and using machines

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

Phomilot contains lactose and sodium

Phomilot 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 tablet, which is essentially “sodium-free”.

3. How to take Phomilot

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

How much to take

• When you start taking Phomilot for the first time, you will receive a “initial treatment pack” that contains all the doses as described in the table below.
• The “initial treatment 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 “initial treatment pack” will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
• The recommended dose of Phomilot 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 makes a total daily dose of 60 mg. By the end of day 6, you will have already 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 Phomilot is 30 mg once a day (morning dose). Your doctor will tell you how to increase the dose when you start taking this medicine for the first time.

How and when to take Phomilot

• This medicine is taken orally.
• Swallow the tablets whole, preferably with water. Do not crush or chew the tablets as this can affect their characteristics.
• You can take the tablets with or without food.
• Take this medicine 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 Phomilot than you should

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

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Phomilot

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

If you stop taking Phomilot

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

If you have any other 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 everybody gets them.

Severe 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 rare).

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 (sinusitis)

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 heartburn
• 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 of age 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Phomilot

• 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, carton, or packaging after EXP. The expiry date is the last day of the month indicated.
• 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 packaging.

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 Phomilot

The active substance is apremilast.

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

The other ingredients are:

• The tablet core: microcrystalline cellulose (E 460), lactose, sodium croscarmellose (E 468), colloidal anhydrous silica (E 551), and magnesium stearate (E 470b).
• The coating: hydroxypropylcellulose (E 463); hypromellose (E 464); titanium dioxide (E 171); talc; Red Iron Oxide (E 172) and Yellow Iron Oxide (E 172).
• The 30 mg film-coated tablet also contains Black Iron Oxide (E172).

Appearance of the product and pack contents

Phomilot 10 mg: is a film-coated tablet, pink, oblong, and with the “10” engraved on one face and smooth on the other, 8 mm long and 3 mm wide.

Phomilot 20 mg: is a film-coated tablet, orange, oblong, with the “20” engraved on one face and smooth on the other, 12 mm long and 6 mm wide.

Phomilot 30 mg: is a film-coated tablet, reddish-brown, oblong, smooth on both sides, 13 mm long and 7 mm wide.

Pack sizes

• The initial treatment pack is a foldable box that contains 27 film-coated tablets: 4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg.
• The standard pack for one month contains 56 film-coated tablets of 30 mg.
• The standard pack for three months contains 168 film-coated tablets of 30 mg.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SKM MEDICINA ESTRATÉGICA, S.L.

C/ Gobelas, 15,

28023, Madrid,

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

or

Adalvo Limited

Malta Life Sciences Park, Building 1, Level 4

Sir Temi Zammit Buildings

San Gwann SGN 3000

Malta.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain Phomilot 10 mg + 20 mg + 30 mg film-coated tablets EFG

Phomilot 30 mg film-coated tablets EFG

Iceland Phomilot 10 mg + 20 mg + 30 mg film-coated tablets,

Phomilot 30 mg film-coated tablets

Italy Phomilot

Date of last revision of this leaflet:12/2023

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