Tacrolimus Stada

Leaflet attached to the packaging: patient information

TACROLIMUS STADA, 0.5 mg, prolonged-release hard capsules

TACROLIMUS STADA, 1 mg, prolonged-release hard capsules

TACROLIMUS STADA, 3 mg, prolonged-release hard capsules

TACROLIMUS STADA, 5 mg, prolonged-release hard capsules

Tacrolimus

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is TACROLIMUS STADA and what is it used for

TACROLIMUS STADA contains the active substance tacrolimus. It is an immunosuppressive medicine. After organ transplantation (liver, kidney), the immune system tries to reject the new organ. TACROLIMUS STADA is used to control the immune system's response and allow the transplanted organ to be accepted. TACROLIMUS STADA may also be used in cases of rejection of a transplanted liver, kidney, heart, or other organs, if previous treatments have not controlled the immune system's response after organ transplantation. TACROLIMUS STADA is used in adult patients.

2. Important information before taking TACROLIMUS STADA

When not to take TACROLIMUS STADA

• If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sirolimus or any macrolide antibiotic (e.g., erythromycin, clarithromycin, josamycin).

Warnings and precautions

Tacrolimus immediate-release capsules and TACROLIMUS STADA contain the same active substance, tacrolimus. However, TACROLIMUS STADA is taken once a day, while tacrolimus immediate-release capsules are taken twice a day. This is because TACROLIMUS STADA capsules allow for prolonged release (slower release over a longer period) of tacrolimus. TACROLIMUS STADA and tacrolimus immediate-release capsules must not be used interchangeably. Before starting treatment with TACROLIMUS STADA, you should tell your doctor or pharmacist if you are taking any of the following medicines: if you have liver disease or have had it in the past; if you have diarrhea that lasts more than one day; if you experience severe abdominal pain with accompanying symptoms such as chills, fever, nausea, or vomiting; if you have a change in the electrical activity of the heart called "QT prolongation"; if you have or have had damage to the smallest blood vessels, known as microangiopathy/thrombotic microangiopathy/hemolytic-uremic syndrome. You should inform your doctor if you experience: fever, bruising under the skin (which may look like red dots), unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output, vision loss, and seizures (see section 4). If you take tacrolimus with sirolimus or everolimus, the risk of developing these symptoms may increase.

You should avoid taking any herbal products, such as St. John's Wort (Hypericum perforatum) or other herbal products, as they may affect the effectiveness and dosage of TACROLIMUS STADA. If in doubt, consult your doctor before taking any products or herbal preparations. Your doctor may need to adjust the dose of TACROLIMUS STADA. You should remain in constant contact with your doctor. From time to time, your doctor may order blood tests, urine tests, heart function tests, or eye exams to determine the correct dose of TACROLIMUS STADA. When taking TACROLIMUS STADA, you should limit your exposure to sunlight and ultraviolet radiation (UV). Immunosuppressive medicines may increase the risk of skin cancer. You should wear protective clothing and use sunscreens with a high protection factor. Precautions for preparing the medicine: when preparing, you should avoid direct contact with any part of the body, such as skin or eyes, or inhaling products containing tacrolimus in solution, powder, or granule form. If such contact occurs, you should rinse your skin and eyes.

Children and adolescents

TACROLIMUS STADA is not recommended for use in children and adolescents under 18 years of age.

TACROLIMUS STADA and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription and herbal preparations. It is not recommended to take TACROLIMUS STADA at the same time as cyclosporin (another medicine used to prevent organ rejection). If you need to visit a doctor other than a transplant specialist, you should inform them that you are taking tacrolimus. The doctor may want to consult with a transplant specialist to determine if you should take a different medicine that may increase or decrease the level of tacrolimus in your blood. The level of TACROLIMUS STADA in your blood may change due to the use of other medicines, and the level of other medicines in your blood may change due to the use of TACROLIMUS STADA, which may require discontinuation of TACROLIMUS STADA or an increase or decrease in its dose. In some patients, an increase in tacrolimus levels in the blood has been observed when taking other medicines. This may have led to severe side effects, such as kidney dysfunction, nervous system disorders, and heart rhythm disorders (see section 4). The effect on TACROLIMUS STADA levels in the blood may occur very quickly after starting another medicine, so it may be necessary to frequently monitor TACROLIMUS STADA levels in the blood during the first few days after starting another medicine and during continued treatment with another medicine. Some other medicines may cause a decrease in tacrolimus levels in the blood, which could increase the risk of organ rejection. In particular, you should inform your doctor about currently used or previously used medicines containing active substances such as: antifungal and antibiotic medicines, especially macrolide antibiotics, used to treat infections (e.g., ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, caspofungin, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniazid, and flucloxacillin); letermovir, used to prevent cytomegalovirus (CMV) diseases; HIV protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), a medicine that increases the pharmacokinetics of cobicistat, and non-nucleoside reverse transcriptase inhibitors or nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine, nevirapine) used to treat HIV infection; HCV protease inhibitors (e.g., telaprevir, boceprevir, ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir) used to treat hepatitis C; nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide, or mitotane (used to treat certain cancers); mycophenolic acid, used to suppress the immune system to prevent organ rejection; medicines used to treat stomach ulcers and acid reflux (e.g., omeprazole, lansoprazole, or cimetidine); antiemetic medicines used to treat nausea and vomiting (e.g., metoclopramide); cisapride or antacids containing aluminum hydroxide and magnesium hydroxide, used to treat heartburn; oral contraceptives or other hormonal medicines containing ethinyl estradiol or danazol; medicines used to treat high blood pressure or heart disease (e.g., nifedipine, nicardipine, diltiazem, and verapamil); antiarrhythmic medicines (amiodarone) used to control heart rhythm disorders (irregular heartbeat); medicines known as "statins," used to treat high cholesterol and triglycerides; carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy; metamizole, used to treat pain and fever; corticosteroids prednisolone and methylprednisolone, belonging to the group of corticosteroids used to treat inflammation or to suppress the immune system (e.g., in organ rejection); nefazodone, used to treat depression; herbal preparations containing St. John's Wort (Hypericum perforatum) or Schisandra sphenanthera extract; cannabidiol (used, among other things, to treat seizures). You should inform your doctor if you are being treated for hepatitis C.

• C. Treatment of hepatitis C may change liver function and may affect tacrolimus levels in the blood. Tacrolimus levels in the blood may decrease or increase, depending on the medicines prescribed for hepatitis C. Your doctor may want to closely monitor tacrolimus levels in the blood and make necessary dose changes to TACROLIMUS STADA after starting hepatitis C treatment. You should inform your doctor if you are taking or plan to take ibuprofen (a medicine used for fever, inflammation, or pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (a medicine used to treat fungal infections), or antiviral medicines (used to treat viral infections, e.g., acyclovir, ganciclovir, cidofovir, or foscarnet). These medicines taken with TACROLIMUS STADA may increase the risk of kidney dysfunction and nervous system disorders. You should inform your doctor if you are taking sirolimus or everolimus. If you take tacrolimus with sirolimus or everolimus, the risk of developing microangiopathic hemolytic anemia, thrombocytopenic purpura, and hemolytic-uremic syndrome may increase (see section 4).

You should inform your doctor if you are taking potassium or certain diuretics used in heart failure, high blood pressure, and kidney disease (e.g., amiloride, triamterene, or spironolactone) or antibiotics trimethoprim or cotrimoxazole, which may increase potassium levels in the blood, nonsteroidal anti-inflammatory medicines (NSAIDs, e.g., ibuprofen) used for fever, inflammation, or pain, anticoagulant medicines (blood thinners), or oral antidiabetic medicines. You should inform your doctor about any planned vaccinations.

Taking TACROLIMUS STADA with food and drink

During treatment with TACROLIMUS STADA, you should avoid eating grapefruits (also in the form of juice), as they may affect the level of the medicine in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. TACROLIMUS STADA passes into breast milk. Therefore, you should not breastfeed while taking TACROLIMUS STADA.

Driving and using machines

You should not drive or operate machinery or use tools if you experience dizziness or drowsiness after taking this medicine, or if you have vision disturbances. These symptoms occur more frequently if you also consume alcohol.

TACROLIMUS STADA contains lactose

If your doctor has previously determined that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

TACROLIMUS STADA contains the colorant Allura Red AC (E129),

which may cause allergic reactions.

3. How to take TACROLIMUS STADA

This medicine should always be taken exactly as your doctor has instructed. If you are in doubt, you should consult your doctor or pharmacist. This medicine can only be prescribed by a doctor with experience in treating patients after organ transplantation. When collecting your prescription, make sure you receive the same tacrolimus-containing medicine each time, unless the transplant specialist has advised you to switch to a different tacrolimus-containing medicine. The medicine should be taken once a day. If the medicine looks different than usual or there are different instructions regarding its dosage, you should consult your doctor or pharmacist as soon as possible to ensure you have received the correct medicine. Your doctor will determine the initial dose to prevent organ rejection based on your body weight. The initial daily dose of the medicine given immediately after transplantation depends on the type of transplanted organ and is usually between 0.10 mg/kg body weight/day and 0.30 mg/kg body weight/day. The same doses can be used to treat organ rejection. The dose depends on your overall health and other immunosuppressive medicines you are taking. After starting treatment with TACROLIMUS STADA, your doctor will perform frequent blood tests to determine the correct dose. To adjust the dose and modify it if necessary during treatment, further regular blood tests will be required. If your clinical condition is stable, your doctor will reduce the dose of TACROLIMUS STADA. Your doctor will tell you exactly how many capsules to take. You should take TACROLIMUS STADA every day, as long as immunosuppression is required to prevent organ rejection. You should remain in constant contact with your doctor. TACROLIMUS STADA is taken orally once a day, in the morning. TACROLIMUS STADA is taken on an empty stomach or 2 to 3 hours after a meal. The next meal can be eaten after at least 1 hour. The capsules should be taken immediately after removal from the blister pack. The capsules should be swallowed whole, with a glass of water. Do not swallow the desiccant found in the packaging.

Taking a higher dose of TACROLIMUS STADA than recommended

If you accidentally take a higher dose of TACROLIMUS STADA than recommended, you should contact your doctor or go to the nearest hospital immediately.

Missing a dose of TACROLIMUS STADA

If you forget to take TACROLIMUS STADA in the morning, you should take it as soon as possible on the same day. Do not take a double dose the next morning.

Stopping treatment with TACROLIMUS STADA

Stopping treatment with TACROLIMUS STADA may increase the risk of organ rejection. You should not stop treatment unless your doctor decides to do so. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. TACROLIMUS STADA reduces the body's defense mechanism (immune system), which may not fight infections as well. Therefore, if you are taking TACROLIMUS STADA, you may be more prone to infections. Some infections can be severe or life-threatening and may include bacterial, viral, fungal, parasitic, or other infections. You should immediately inform your doctor if you experience symptoms of infection, including:

• fever, cough, sore throat, weakness, or general malaise
• memory loss, difficulty thinking, difficulty walking, or loss of vision - these may be caused by a very rare, severe brain infection that can be life-threatening (progressive multifocal leukoencephalopathy, PML).

Severe side effects, including allergic and anaphylactic reactions, have been reported during treatment with TACROLIMUS STADA. Benign and malignant tumors have also been reported.

If you experience or suspect any of the following severe side effects, you should immediately inform your doctor:

Frequent severe side effects (may occur in less than 1 in 10 patients):

• perforation of the digestive tract: severe abdominal pain, with or without other symptoms, such as chills, fever, nausea, or vomiting
• organ dysfunction
• blurred vision

Less frequent severe side effects (may occur in less than 1 in 100 patients):

• microangiopathic hemolytic anemia (damage to the smallest blood vessels), including hemolytic-uremic syndrome, with symptoms such as: decreased urine output or absence of urine, extreme fatigue, yellowing of the skin or eyes, and unexplained bruising or bleeding

Rare severe side effects (may occur in less than 1 in 1,000 patients):

• thrombotic thrombocytopenic purpura: a condition characterized by damage to the smallest blood vessels and symptoms such as fever and bruising under the skin (which may look like red dots) with unexplained extreme fatigue, confusion, yellowing of the skin or eyes, decreased urine output, vision loss, and seizures
• toxic epidermal necrolysis: peeling or blistering of the skin and mucous membranes; red, swollen skin may peel off over large areas of the body
• loss of vision

Very rare severe side effects (may occur in less than 1 in 10,000 patients):

• Stevens-Johnson syndrome: unexplained, widespread skin pain, facial swelling, severe illness, with blisters on the skin, mouth, eyes, and genitals, hives, tongue swelling, and a spreading red or purple skin rash
• Torsades de pointes: a change in heart rate, which may be accompanied by symptoms such as chest pain (angina), fainting, dizziness, or nausea, and palpitations (feeling of heartbeat) and breathing difficulties

Severe side effects - frequency not known (frequency cannot be estimated from available data):

• opportunistic infections (bacterial, fungal, viral, and parasitic): prolonged diarrhea, fever, and sore throat
• benign and malignant tumors during treatment, resulting from immunosuppression, including skin cancers and a rare type of cancer that may appear as skin changes, called Kaposi's sarcoma. Symptoms include skin changes, such as new or changed pigmentation, spots, or lumps
• aplastic anemia (a significant decrease in red blood cells), hemolytic anemia (a decrease in red blood cells due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (a decrease in white blood cells that fight infections, with accompanying fever). The exact frequency of these side effects is unknown. You may not have any symptoms or, depending on the severity of the disease, you may experience fatigue, apathy, unnatural paleness (pallor), shortness of breath, dizziness, headache, chest pain, and coldness in hands and feet
• agranulocytosis (a significant decrease in white blood cells, with accompanying mouth ulcers, fever, and infection/infections). You may not have any symptoms or you may experience sudden temperature increase, chills, and sore throat

Other side effects that may occur after taking TACROLIMUS STADA include:

• Very common side effects(may occur in more than 1 in 10 patients): increased blood sugar levels, diabetes, increased potassium levels in the blood, insomnia, tremors, muscle tremors, headache, high blood pressure, abnormal liver function tests, diarrhea, nausea, kidney dysfunction

Common side effects(may occur in less than 1 in 10 patients):

• decreased blood cell count (platelets, red blood cells, or white blood cells), increased white blood cell count, changes in red blood cell count (visible in blood tests), decreased magnesium, phosphorus, potassium, calcium, or sodium levels in the blood, fluid retention in the body, increased uric acid or fat levels in the blood, decreased appetite, increased blood acidity, other electrolyte disorders (visible in blood tests), anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders
• seizures, impaired consciousness, tingling and numbness (sometimes painful) of hands and feet, dizziness, impaired writing ability, nervous system disorders
• increased sensitivity to light, eye disorders
• ringing in the ears
• decreased blood flow in coronary arteries, rapid heartbeat
• bleeding, partial or complete blockage of blood vessels, decreased blood pressure
• shortness of breath, changes in lung tissue, fluid accumulation in the pleura, pharyngitis, cough, flu-like symptoms
• inflammatory or ulcerative conditions causing abdominal pain or diarrhea, gastrointestinal bleeding, mouth ulcers, liver dysfunction, jaundice, vomiting, abdominal pain, indigestion, constipation, bloating and gas, loose stools, gastrointestinal symptoms
• bile duct disorders, liver dysfunction, jaundice, liver cell damage, and liver inflammation
• itching, rash, hair loss, acne, excessive sweating
• joint pain, limb pain, back pain, and foot pain, muscle cramps
• kidney dysfunction, decreased urine output, painful or difficult urination
• general weakness, fever, fluid retention in the body, pain and discomfort, increased alkaline phosphatase activity in the blood, weight gain, temperature regulation disorders

Uncommon side effects(may occur in less than 1 in 100 patients):

• changes in blood clotting and bleeding parameters, decreased blood cell count (visible in blood tests)
• dehydration
• decreased blood protein or sugar levels, increased phosphate levels in the blood
• coma, cerebral hemorrhage, stroke, paralysis, and paresis, cerebral disorders, speech disorders, and language disorders, memory problems
• cataract
• hearing loss
• irregular heartbeat, cardiac arrest, heart failure, heart muscle disorders, heart muscle enlargement, rapid heartbeat, abnormal ECG results, abnormal heart rate and rhythm
• blood clots in the veins of the limbs, shock
• breathing difficulties, respiratory system disorders, asthma
• intestinal obstruction, increased amylase activity in the blood, gastroesophageal reflux, delayed gastric emptying
• skin inflammation, increased sensitivity to sunlight
• joint disorders
• urination disorders, painful or irregular menstrual bleeding
• multi-organ failure, flu-like symptoms, increased sensitivity to heat and cold, feeling of pressure in the chest, irritability or malaise, increased lactate dehydrogenase activity in the blood, weight loss

Rare side effects(may occur in less than 1 in 1,000 patients):

• small, bloody spots on the skin due to blood clots
• increased muscle tension
• deafness
• fluid accumulation around the heart
• severe shortness of breath
• pancreatic cyst
• impaired blood flow through the liver
• severe skin disorders with peeling skin, mouth, eyes, and genital lesions, excessive hair growth
• thirst, falls, feeling of pressure in the chest, decreased mobility, ulcers

Very rare side effects(may occur in less than 1 in 10,000 patients):

• muscle weakness
• abnormal heart scan
• liver failure
• painful urination with blood in the urine
• increased fat tissue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TACROLIMUS STADA

The medicine should be stored out of sight and reach of children. Do not use TACROLIMUS STADA after the expiry date stated on the packaging after {EXP}. The expiry date refers to the last day of the month stated. After opening the aluminum foil sachet, the prolonged-release hard capsules are suitable for use for 12 months, but no later than the expiry date. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What TACROLIMUS STADA contains

• The active substance is tacrolimus.

Each TACROLIMUS STADA 0.5 mg prolonged-release hard capsule contains 0.5 mg of tacrolimus (as tacrolimus monohydrate). Each TACROLIMUS STADA 1 mg prolonged-release hard capsule contains 1 mg of tacrolimus (as tacrolimus monohydrate). Each TACROLIMUS STADA 3 mg prolonged-release hard capsule contains 3 mg of tacrolimus (as tacrolimus monohydrate). Each TACROLIMUS STADA 5 mg prolonged-release hard capsule contains 5 mg of tacrolimus (as tacrolimus monohydrate).

• Other ingredients are: capsule contents: ethylcellulose, butylhydroxytoluene, hypromellose, lactose monohydrate, magnesium stearate. capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172). ink: shellac, Allura Red AC, aluminum lake (E 129), propylene glycol, titanium dioxide (E 171).

What TACROLIMUS STADA looks like and contents of the pack

TACROLIMUS STADA 0.5 mg prolonged-release hard capsules are yellow and orange, size 5, 11.2±0.5 mm in length, with a red print "0.5 mg" on the cap. TACROLIMUS STADA 0.5 mg is available in PVC/PE/PVDC/Aluminum blister packs, in an aluminum sachet with a desiccant, in a cardboard box. The pack contains 30 prolonged-release hard capsules. TACROLIMUS STADA 1 mg prolonged-release hard capsules are white and orange, size 4, 14.1±0.5 mm in length, with a red print "1 mg" on the cap. TACROLIMUS STADA 1 mg is available in PVC/PE/PVDC/Aluminum blister packs, in an aluminum sachet with a desiccant, in a cardboard box. The pack contains 30 prolonged-release hard capsules. TACROLIMUS STADA 3 mg prolonged-release hard capsules are orange and orange, size 1, 19.1±0.5 mm in length, with a red print "3 mg" on the cap. TACROLIMUS STADA 3 mg is available in PVC/PE/PVDC/Aluminum blister packs, in an aluminum sachet with a desiccant, in a cardboard box. The pack contains 30 prolonged-release hard capsules. TACROLIMUS STADA 5 mg prolonged-release hard capsules are red and orange, size 0, 21.4±0.5 mm in length, with a red print "5 mg" on the cap. TACROLIMUS STADA 5 mg is available in PVC/PE/PVDC/Aluminum blister packs, in an aluminum sachet with a desiccant, in a cardboard box. The pack contains 30 prolonged-release hard capsules.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer

Pharmathen International S.A, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece; Pharmathen SA, 6 Dervenakion Str., Pallini, Attiki 15351, Greece; STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany; Centrafarm Services B.V., Van de Reijtstraat 31 D, 4814NE Breda, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: TACROLIMUS STADA; Germany: Tacrolimus AL 0.5 mg Hartkapseln, retardiert, Tacrolimus AL 1 mg Hartkapseln, retardiert, Tacrolimus AL 3 mg Hartkapseln, retardiert, Tacrolimus AL 5 mg Hartkapseln, retardiert; Spain: Tacrolimus STADAFARMA 0.5 mg cápsulas de liberación prolongada EFG, Tacrolimus STADAFARMA 1 mg cápsulas de liberación prolongada EFG, Tacrolimus STADAFARMA 3 mg cápsulas de liberación prolongada EFG, Tacrolimus STADAFARMA 5 mg cápsulas; France: TACROLIMUS EG LP 0.5 mg, gélule à libération prolongée, TACROLIMUS EG LP 1 mg, gélule à libération prolongée, TACROLIMUS EG LP 3 mg, gélule à libération prolongée, TACROLIMUS EG LP 5 mg, gélule à libération prolongée; Hungary: TACROLIMUS STADA 0.5 mg retard kemény kapszula, TACROLIMUS STADA 1 mg retard kemény kapszula, TACROLIMUS STADA 3 mg retard kemény kapszula, TACROLIMUS STADA 5 mg retard kemény kapszula; Italy: TACROLIMUS EG; Netherlands: Tacrolimus CF 0.5 mg, harde capsules met verlengde afgifte, Tacrolimus CF 1 mg, harde capsules met verlengde afgifte, Tacrolimus CF 3 mg, harde capsules met verlengde afgifte, Tacrolimus CF 5 mg, harde capsules met verlengde afgifte; Poland: TACROLIMUS STADA

To obtain more detailed information, you should contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

Date of last revision of the leaflet:03/2025