IMMUFALK 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Immufalk 75 mg film-coated tablets

Azathioprine

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

1. What is Immufalk and what is it used for

Immufalk contains the active substance azathioprine, which belongs to a group of medicines called immunosuppressants, which reduce the activity of your immune system.

Immufalk can be used to help your body accept a transplanted organ, such as a new kidney, heart, or liver, or to treat certain diseases in which your immune system is reacting against your own body (autoimmune diseases).

Immufalk can also be used alone or in combination with other medicines to treat:

• severe rheumatoid arthritis(a disease in which the immune system attacks the cells that line the joints, causing swelling, pain, and stiffness of the joints)
• severe intestinal inflammation(Crohn's disease or ulcerative colitis)
• systemic lupus erythematosus(a disease in which the immune system attacks many of the body's organs and tissues, including the skin, joints, kidneys, brain, and other organs, causing intense fatigue, fever, stiffness, and joint pain)
• dermatomyositis and polymyositis(a group of diseases that cause inflammation of the muscles, muscle weakness, and skin rash)
• chronic active autoimmune hepatitis(a disease in which the immune system attacks the liver cells, causing liver inflammation, fatigue, muscle pain, yellowing of the skin and eyes, and fever)
• polyarteritis nodosa(a rare disease that causes inflammation of the blood vessels)
• autoimmune hemolytic anemia(a severe blood disorder in which the immune system destroys red blood cells faster than they can be produced, with symptoms of weakness and difficulty breathing)
• chronic refractory idiopathic thrombocytopenic purpura(a disorder with low platelet counts, which can cause easy bruising and bleeding)

Your doctor has chosen this medicine to suit you and your condition.

Immufalk can be used alone, but it is most often used in combination with other medicines.

It may take weeks or months before a therapeutic effect is observed.

2. What you need to know before you take Immufalk

Do not take Immufalk

• If you are allergicto azathioprine, mercaptopurine, or any of the other ingredients of this medicine (listed in section 6).
• An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• If you have a severe infection
• If you have a severe liver or bone marrow disorder
• If you have pancreatitis(inflammation of the pancreas)
• If you have been vaccinatedrecently with a live attenuated vaccinesuch as smallpox or yellow fever
• If you are pregnant(unless your doctor tells you to)
• If you are breast-feeding

Warnings and precautions

Consult your doctor before starting to take Immufalk.

You must not take Immufalk unless you can be monitored to control side effects. You must immediately inform your doctor if you develop throat ulcers, fever, infections, bruising, or bleeding.

Consult your doctor immediately:

Consult your doctor before starting to take Immufalk:

Liver damage

Treatment with Immufalk can affect your liver, and your doctor will periodically monitor your liver function. Inform your doctor if you experience symptoms of liver damage (see section 4 "Possible side effects")

Infections

When you receive treatment with Immufalk, the risk of viral, fungal, and bacterial infections is greater, and these infections can be more severe. See also section 4.

Before starting treatment, inform your doctor if you have had or not had chickenpox, herpes, or hepatitis B (a liver disease caused by a virus). When you take Immufalk, avoid contact with people who have chickenpox or shingles.

Pellagra

Inform your doctor immediately if you notice diarrhea, a pigmented rash (dermatitis), deterioration of memory, reasoning, and thinking ability (dementia), as these symptoms can indicate a deficiency of vitamin B3 (niacin/pellagra deficiency).

NUDT15 gene mutation

If you have an inherited mutation in the NUDT15 gene (a gene involved in the breakdown of azathioprine in the body), you have a higher risk of infections and hair loss, and in this case, your doctor may give you a lower dose.

Your doctor may also perform genetic tests (e.g., analyze your TPMT and/or NUDT15 genes) before or during your treatment to determine if your response to this medicine may be affected by your genetics. Your doctor may change your azathioprine dose after these tests.

If you are receiving immunosuppressive treatment, taking Immufalk may increase your risk of:

• Tumors, including skin cancer. Therefore, when taking Immufalk, avoid excessive exposure to sunlight, wear protective clothing, and use sunscreens with a high protection factor.
• Lymphoproliferative disorders
• Treatment with Immufalk increases your risk of having a type of cancer called lymphoproliferative disorder. With treatment that contains several immunosuppressants (including thiopurines), this can be fatal.
• The combination of multiple immunosuppressants, administered simultaneously, increases the risk of lymphatic system disorders due to a viral infection (Epstein-Barr virus-associated lymphoproliferative disorders).
• A previously acquired hepatitis B virus infection that is reactivated
• Other infections such as progressive multifocal leukoencephalopathy (PML), which is an opportunistic infection. If you experience any signs of infection, contact your doctor (see section 4 "Possible side effects").

Taking Immufalk may increase your risk of:

• developing a severe condition called hemophagocytic lymphohistiocytosis (excessive activation of white blood cells associated with inflammation), which usually occurs in people with certain types of arthritis.

If you are not sure if any of the above applies to you, talk to your doctor, nurse, or pharmacist before taking Immufalk.

Blood tests

You will need to have a blood test once a week for the first 8 weeks of treatment. You may need more frequent blood tests if:

• you are elderly
• you are taking a high dose
• you have bone marrow disorders
• you have an overactive spleen
• you have a kidney function disorder. Your doctor will reduce the dose if necessary
• you have a liver function disorder. Your doctor will regularly monitor your liver function and reduce the dose if necessary
• you are taking other potentially hepatotoxic medications

It is important to use effective contraception (such as condoms) since Immufalk can cause birth defects in both men and women.

Other medicines and Immufalk

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Immufalk can affect how some medicines work. Also, other medicines can affect how Immufalk works. In particular, tell your doctor if you are taking or are planning to take:

• allopurinol, oxypurinol, thiopurinolor other xanthine oxidase inhibitors such as febuxostat (used mainly to treat gout)
• other immunosuppressantssuch as cyclosporine or tacrolimus

• infliximab(used mainly in the treatment of ulcerative colitis and Crohn's disease)

• aminosalicylates, e.g., olsalazine, mesalazine, or sulfasalazine(used mainly in the treatment of ulcerative colitis and Crohn's disease)
• warfarin or phenprocoumon(to thin the blood)

• ACE inhibitors (treatments for high blood pressure or heart failure)
• cimetidine(used to treat stomach ulcers and indigestion)
• indomethacin, cyclophosphamide, chlorambucil, melphalan(treatments for rheumatoid arthritis)

• cancer treatmentsor treatments that slow down or stop the production of new blood cells
• co-trimoxazole(an antibiotic used to treat bacterial infections)
• ribavirin, peginterferon(used to treat viral infections)
• methotrexate(used mainly to treat cancers)

• furosemide(a diuretic to treat heart failure)
• vaccinessuch as hepatitis B vaccine
• any live vaccine
• muscle relaxants, e.g., tubocurarine or succinylcholine(used during operations), as they may interact with Immufalk. You must inform your anesthesiologist of your treatment with Immufalk before surgery.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Immufalk.

Receiving vaccines while taking Immufalk

If you need to receive a vaccine, talk to your doctor or nurse before doing so. If you take Immufalk, you must not receive a live attenuated vaccine (e.g., flu vaccine, measles vaccine, BCG vaccine, etc.) until at least 3 months after the end of treatment or until your doctor tells you it is safe to do so. This is because some vaccines can cause you to become infected if you receive them while taking Immufalk. If you need inactivated vaccines, your doctor may need to monitor your immune response.

Immufalk with food and drinks

You must take your medicine at least 1 hour before or 2 hours after taking milk or dairy products.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Do not take Immufalk if you are pregnant unless your doctor tells you to. Inform your doctor if you are pregnant or think you may be pregnant. Both male and female patients of childbearing age must use contraceptive measures that are not intrauterine devices (e.g., spiral or copper T).

You must continue to use contraception for 6 months after treatment with Immufalk. If you have fertility problems due to chronic uremia, you should know that fertility usually returns to normal after transplantation, and you must use contraceptives.

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Do not breast-feed during treatment with Immufalk, as the metabolic products produced in the body pass into breast milk and can harm the baby.

Driving and using machines

It is safe to drive or use machines while taking Immufalk unless you experience dizziness. Dizziness can be increased by alcohol, so you must not drive or use machines if you have taken alcohol.

Immufalk contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Immufalk

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

The amount of Immufalk may vary from one patient to another and will be prescribed by your doctor. The dose depends on the disorder being treated.

You can take Immufalk with food or on an empty stomach, but the choice of method should be the same every day. Some patients feel nauseous when they are first given Immufalk, which can be relieved by taking the tablets after meals.

When taking Immufalk, your doctor will perform regular blood tests. This is to check the number and type of cells present in your blood and to ensure that your liver is functioning properly.

Your doctor may also request other blood and urine tests to monitor the functioning of your kidneys and measure uric acid levels. Uric acid is a natural substance produced in your body, and uric acid levels may increase while taking Immufalk. High uric acid levels can damage your kidneys.

Occasionally, your doctor may change your dose of Immufalk as a result of these tests.

Swallow the tablets whole with plenty of liquid (at least 20 ml). Do not chew them. The tablets should not be broken or crushed.

It is essential that caregivers are aware of the need to handle this medication safely. If you or your caregiver handle broken tablets, wash your hands immediately. Consult your doctor or pharmacist for advice.

Dose

Adults who have received an organ transplant: on the first day of treatment, the usual dose is up to 5 mg per kilogram of body weight, and subsequently, the usual daily dose is between 1 mg and 4 mg per kilogram of body weight. During treatment, your doctor will adjust the dose based on your reaction to the medication.

Adults with other disorders: the usual initial dose is between 1 mg and 3 mg per kilogram of body weight, and subsequently, the usual daily dose is less than between 1 mg and 3 mg per kilogram of body weight. During treatment, your doctor will adjust the dose based on your reaction to the medication.

Use in children and adolescents

Immufalk is not recommended for use in children under 18 years of age due to insufficient data on the treatment of juvenile chronic arthritis, systemic lupus erythematosus, dermatomyositis, and polyarteritis nodosa.

For other indications, the same dosage recommendation is used in children and adolescents as in adults.

Children who are considered overweight may require a higher dose.

Elderly patients

Elderly patients may need to reduce the dose.

Patients with liver or kidney disorders may need to reduce the dose.

Patients with severe liver problems should not take Immufalk.

Your doctor will decide the duration of treatment with Immufalk.

If you think the effect of Immufalk is too strong or too weak, please consult your doctor.

If you take more Immufalk than you should

Contact your doctor, pharmacist, or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Immufalk

Do not take a double dose to make up for the missed dose. Inform your doctor if you forget to take a dose. If it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time. Otherwise, take it as soon as you remember and then take the doses as you would normally.

If you interrupt treatment with Immufalk

Any suspension of Immufalk should be done gradually and under careful monitoring. Please consult your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Severe side effects:

If you experience any of the following severe side effects, consult your doctor or go to the hospital immediately:

• If you suddenly have wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching (especially if it affects the whole body).
• Potentially fatal severe liver damage, especially in patients receiving long-term treatment (such as liver injury, non-cirrhotic portal hypertension, portosinusoidal vascular disease). Inform your doctor if you experience any of the following symptoms: yellowing of the skin and the whites of the eyes (jaundice), easy bruising, abdominal discomfort, loss of appetite, fatigue, nausea, or vomiting.

Contact your doctor immediately if you develop any of the following side effects:

• severe discomfort
• diarrhea
• fever, chills
• muscle or bone pain, muscle stiffness
• fatigue, dizziness
• inflammation of the blood vessels
• kidney disorders (symptoms that may include changes in the amount of urine and changes in its color)
• heart dysfunction
• high temperature (fever) or other signs of infection such as sore throat, mouth ulcers, urinary problems, or chest infection that causes difficulty breathing and coughing

The following side effects have also been reported:

• Very common: may affect more than 1 in 10 users
• • infections caused by viruses, fungi, or bacteria in the case of patients who have received a transplant
  • blood and bone marrow problems, with signs such as weakness, fatigue, pallor, easy bruising, unusual bleeding, or infections

• Common: may affect up to 1 in 10 users
• • low platelet count, which can lead to bruising or bleeding.
  • nausea and vomiting, loss of appetite (anorexia)

• Uncommon: may affect up to 1 in 100 users
• • infections caused by viruses, fungi, or bacteria in the case of all patients except those who have received a transplant
  • low red blood cell count, which can cause fatigue, headaches, shortness of breath when exercising, dizziness, and pallor
  • allergic reactions, which can cause generalized discomfort, dizziness, discomfort, vomiting, diarrhea, fever, chills, skin reactions such as rash, cutaneous nodules, and eruption, inflammation of the blood vessels, muscle and joint pain, low blood pressure, kidney or liver disorders, and intestinal problems
  • pancreatitis, which can cause severe pain in the upper abdomen with nausea and vomiting
  • liver disorders, which can lead to pale stools, dark urine, itching, and yellowing of the skin and eyes, and abnormalities in liver function test results.
  • cholestasis of pregnancy, a buildup of bile that causes liver inflammation, which can cause severe itching, especially on the hands and feet

• Rare: may affect up to 1 in 1,000 users
• blood and bone marrow disorders that can cause weakness, fatigue, pallor, headaches, tongue pain, difficulty breathing, bruising, or infections
• intestinal disorders that cause diarrhea, abdominal pain, constipation, and discomfort (nausea and vomiting)
• potentially fatal severe liver damage
• hair loss that may improve even if Immufalk tablets are continued
• different types of cancer, including skin cancer, blood cancer, and lymphomas.

Very rare: may affect up to 1 in 10,000 users

• rash or redness of the skin, which can become potentially life-threatening skin reactions, including generalized rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (toxic epidermal necrolysis)
• sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness

• intestinal problems that cause diarrhea, abdominal pain, constipation, nausea, or vomiting (intestinal perforation)

• pulmonary inflammation that causes difficulty breathing, coughing, and fever
• irregular and uncoordinated contractions of the upper heart chambers (atrial fibrillation)

Frequency not known: cannot be estimated from the available data

• You may experience a skin rash (red, pink, or purple raised bumps that are painful to the touch), especially on your arms, hands, fingers, face, and neck, which may also be accompanied by fever (Sweet's syndrome, also known as acute febrile neutrophilic dermatosis).
• photosensitivity (sensitivity to light or sunlight)
• a certain type of lymphoma (hepatosplenic T-cell lymphoma). You may experience nosebleeds, fatigue, significant night sweats, weight loss, and fever (high temperature) of unknown origin.
• excessive breakdown of red blood cells that causes fatigue and pallor of the skin (hemolytic anemia), excess of eosinophils (a type of white blood cell) (eosinophilia)
• overactivation of macrophages and T lymphocytes that causes hyperinflammation and a cytokine storm associated with cytomegalovirus disease and Epstein-Barr virus infection
• Drug hypersensitivity reaction with eosinophilia and systemic symptoms (DRESS)
• pellagra, a vitamin B3 deficiency (niacin deficiency), associated with pigmented rash, diarrhea, or memory loss
• acute generalized exanthematous pustulosis (AGEP)
• severe liver damage (such as liver injury, non-cirrhotic portal hypertension, or portosinusoidal vascular disease)
• burning or tingling sensation in the mouth or lips (mucositis, stomatitis)
• cracked or swollen lips (cheilitis)
• decrease in coagulation factors
• inflammation of the salivary glands (sialadenitis).

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 medication.

5. Storage of Immufalk

Keep this medication out of sight and reach of children.

Store in the original package to protect it from light.

Do not use Immufalk after the expiration date shown on the package and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

Do not use Immufalk if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Immufalk

The active ingredient is azathioprine.

Each film-coated tablet contains 75 mg of azathioprine.

The other ingredients (excipients) are:

Tablet core: sodium croscarmellose, anhydrous colloidal silica, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, pregelatinized corn starch, povidone K25.

Tablet coating: macrogol 3350, polysorbate 80, polyvinyl alcohol, talc

Appearance and package contents

Immufalk 75 mg film-coated tablets are yellow, round, biconvex tablets, 10.0 mm in diameter, marked with "75" on one side.

The tablets should not be crushed. If the tablet coating is damaged or the tablet is completely crushed, avoid skin contact or inhalation of tablet particles. For long-term dosing, other medications containing 25 mg should be used if necessary.

Packages:

The film-coated tablets are packaged in PVC/aluminum blisters in a cardboard box.

Immufalk 75 mg film-coated tablets are available in packages of: 20, 30, 50, 60, 90, or 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Phone +49 (0) 761 / 1514-0

Fax +49(0) 761 / 1514-321

Email: [email protected]

You can request more information about this medication from the local representative of the marketing authorization holder:

Dr. Falk Pharma España

Camino de la zarzuela, 21

28023 Madrid

Spain

Phone +34 91 3729508

This medication is authorized in EEA member states under the following names:

Germany, Austria, Slovenia, Lithuania, and Portugal: Azafalk.

Spain: Immufalk.

Date of the last revision of this leaflet: July 2025

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

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The following information is intended only for healthcare professionals:

Immufalk 75 mg film-coated tablets

Handling and disposal instructions

There are no risks associated with handling tablets with intact coating. In this case, no special safety precautions are necessary.

However, if the film-coated tablets have been crushed, Immufalk film-coated tablets should be handled strictly according to the guidelines for handling cytotoxic agents. Excess medication and contaminated devices should be stored temporarily in clearly labeled containers. Any unused product or waste should be disposed of according to local requirements.