Tacrolimus Stada

Leaflet accompanying 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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 transplantation. TACROLIMUS STADA is used in adult patients.

2. Important information before taking TACROLIMUS STADA

When not to take TACROLIMUS STADA

• If the patient is allergic (hypersensitive) to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
• If the patient is 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 should not be used interchangeably. Before starting treatment with TACROLIMUS STADA, the patient should tell their doctor or pharmacist if they are taking any of the following medicines: if they have liver disease or have had it in the past; if they have diarrhea that lasts more than one day; if they experience severe abdominal pain with accompanying symptoms such as chills, fever, nausea, or vomiting; if they have a change in the electrical activity of the heart called "QT interval prolongation"; if they have or have had damage to the smallest blood vessels, known as microangiopathy/thrombocytopenic purpura/hemolytic-uremic syndrome. The patient should inform their doctor if they experience: fever, bruising under the skin (which may look like red dots), unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output, loss of vision, and seizures (see section 4). If tacrolimus is taken with sirolimus or everolimus, the risk of developing these symptoms may increase.

The patient 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 dose of TACROLIMUS STADA. If in doubt, the patient should consult their doctor before taking any products or herbal preparations. The doctor may need to adjust the dose of TACROLIMUS STADA. The patient should stay in regular contact with their doctor. From time to time, the 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, the patient should limit their exposure to sunlight and ultraviolet (UV) radiation. Immunosuppressive medicines may increase the risk of skin cancer. The patient should wear protective clothing and use sunscreens with a high protection factor. Precautions for preparing the medicine: when preparing the medicine, the patient should avoid direct contact with any part of their body, such as skin or eyes, or inhaling products containing tacrolimus in solution, powder, or granule form. If such contact occurs, the patient should rinse their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 rejection of a transplanted organ). If the patient needs to visit a doctor other than a transplant specialist, they should inform the doctor that they are taking tacrolimus. The doctor may want to consult with a transplant specialist to determine if the patient should take a different medicine that may increase or decrease the level of tacrolimus in the blood. The level of TACROLIMUS STADA in the blood may change due to the use of other medicines, and the level of other medicines in the blood may change due to the use of TACROLIMUS STADA, which may require stopping TACROLIMUS STADA or increasing or decreasing 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 serious 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 the other medicine. Some other medicines may cause a decrease in tacrolimus levels in the blood, which could increase the risk of rejection of the transplanted organ. In particular, the patient should inform their 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 pharmacokinetic enhancer cobicistat, and non-nucleoside reverse transcriptase inhibitors or nucleoside reverse transcriptase inhibitors (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 transplant 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, which belong to the group of corticosteroids used to treat inflammation or to suppress the immune system (e.g., in transplant 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). The patient should inform their doctor if they are being treated for hepatitis C.

• C. Treatment of hepatitis C may affect 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. The doctor may want to closely monitor tacrolimus levels in the blood and make necessary dose adjustments to TACROLIMUS STADA after starting hepatitis C treatment. The patient should inform their doctor if they 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, foscarnet). These medicines taken with TACROLIMUS STADA may increase the risk of kidney dysfunction and nervous system disorders. The patient should inform their doctor if they are taking sirolimus or everolimus. If tacrolimus is taken with sirolimus or everolimus, the risk of developing microangiopathic hemolytic anemia, thrombocytopenic purpura, and hemolytic-uremic syndrome may increase (see section 4).

The patient should inform their doctor if they 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, non-steroidal anti-inflammatory medicines (NSAIDs, e.g., ibuprofen) used for fever, inflammation, or pain, anticoagulant medicines (blood thinners), or oral antidiabetic medicines. The patient should inform their doctor about any planned vaccinations.

Taking TACROLIMUS STADA with food and drink

During treatment with TACROLIMUS STADA, the patient 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. TACROLIMUS STADA passes into breast milk. Therefore, breastfeeding should be avoided during treatment with TACROLIMUS STADA.

Driving and using machines

The patient should not drive or operate machinery or use tools if they experience dizziness or drowsiness after taking this medicine, or if they have vision disturbances. These symptoms are more common if the patient also drinks alcohol.

TACROLIMUS STADA contains lactose

If the doctor has previously determined that the patient has an intolerance to some sugars, the patient should contact their doctor before taking the 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 prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. This medicine can only be prescribed by a doctor with experience in treating patients who have had organ transplants. When collecting the prescription, the patient should make sure they receive the same tacrolimus-containing medicine each time, unless the transplant specialist has recommended a change 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 for its use, the patient should consult their doctor or pharmacist as soon as possible to ensure they have received the correct medicine. The doctor will determine the initial dose to prevent rejection of the transplanted organ based on the patient's 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 rejection of the transplanted organ. The dose depends on the patient's overall health and other immunosuppressive medicines used. After starting treatment with TACROLIMUS STADA, the 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 the patient's condition is stable, the doctor will reduce the dose of TACROLIMUS STADA. The doctor will tell the patient exactly how many capsules to take. The patient should take TACROLIMUS STADA every day, as long as immunosuppression is required to prevent rejection of the transplanted organ. The patient should stay in regular contact with their doctor. TACROLIMUS STADA should be taken orally once a day, in the morning. TACROLIMUS STADA should be taken on an empty stomach or 2 to 3 hours after a meal. The next meal can be eaten at least 1 hour later. 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 the patient accidentally takes a higher dose of TACROLIMUS STADA than recommended, they should contact their doctor or go to the nearest hospital immediately.

Missing a dose of TACROLIMUS STADA

If the patient forgets to take their TACROLIMUS STADA capsules in the morning, they should take them as soon as possible on the same day. The patient should not take a double dose the next morning.

Stopping treatment with TACROLIMUS STADA

Stopping treatment with TACROLIMUS STADA may increase the risk of rejection of the transplanted organ. The patient should not stop treatment unless their doctor decides to do so. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, TACROLIMUS STADA 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 the patient is taking TACROLIMUS STADA, they may be more prone to infections. Some infections can be severe or life-threatening and may include bacterial, viral, fungal, parasitic, or other infections. The patient should inform their doctor immediately if they experience symptoms of infection, including: fever, cough, sore throat, weakness, or general feeling of being unwell; memory loss, difficulty thinking, difficulty walking, or loss of vision - these may be symptoms of a very rare, severe brain infection that can be life-threatening (progressive multifocal leukoencephalopathy, PML). Serious side effects may occur, including allergic reactions and anaphylaxis. Cancer and malignant tumors have been reported during treatment with TACROLIMUS STADA.

If the patient experiences any of the following serious side effects, they should inform their doctor immediately:

• Frequent serious side effects (may occur in less than 1 in 10 patients): perforation of the digestive tract, severe abdominal pain with accompanying symptoms such as chills, fever, nausea, or vomiting; dysfunction of the transplanted organ; blurred vision.

Less frequent serious 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 no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and unexplained bruising or bleeding.

Rare serious side effects (may occur in less than 1 in 1,000 patients): 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 (jaundice), decreased urine output, loss of vision, and seizures; toxic epidermal necrolysis, a condition characterized by blisters or peeling of the skin and mucous membranes; loss of vision.

Very rare serious side effects (may occur in less than 1 in 10,000 patients): Stevens-Johnson syndrome, an 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 rhythm, which may be accompanied by symptoms such as chest pain (angina pectoris), fainting, dizziness, or nausea, and palpitations (feeling of heartbeat) and difficulty breathing.

Unknown frequency of serious side effects (frequency cannot be estimated from available data): opportunistic infections (bacterial, fungal, viral, and parasitic), prolonged diarrhea, fever, and sore throat; cancer and malignant tumors, which may occur due to immunosuppression, including skin cancer 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 skin discolorations, spots, or lumps; pure red cell aplasia (a significant decrease in red blood cells), hemolytic anemia (a decrease in red blood cells due to abnormal breakdown, accompanied by fatigue); agranulocytosis (a significant decrease in white blood cells, accompanied by mouth ulcers, fever, and infection); allergic reactions and anaphylaxis, with symptoms such as sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and a feeling of impending fainting; posterior reversible encephalopathy syndrome (PRES), a condition characterized by headache, confusion, mood changes, seizures, and blurred vision, which may be symptoms of a condition known as posterior reversible encephalopathy syndrome; optic neuropathy (abnormalities of the optic nerve), with symptoms such as vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or limited field of vision.

The following side effects may also occur after taking TACROLIMUS STADA and may be serious:

• 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, 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 to the heart, 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, inflammation of the throat, cough, flu-like symptoms; inflammation or ulcers causing abdominal pain or diarrhea, gastrointestinal bleeding, inflammation or ulcers of the mouth, fluid accumulation in the abdominal cavity, vomiting, abdominal pain, indigestion, constipation, bloating and gas, loose stools, gastrointestinal symptoms; liver disorders, yellowing of the skin due to liver disease, liver cell damage, and liver inflammation; itching, rash, hair loss, acne, excessive sweating; joint pain, limb pain, back pain, and foot pain; urinary disorders, painful menstruation, and abnormal 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 gain, temperature regulation disorders.

Less common side effects (may occur in less than 1 in 100 patients): changes in blood clotting and bleeding, decreased blood cell count (visible in blood tests); dehydration; decreased blood protein or sugar levels, increased phosphate levels in the blood; coma, brain bleeding, stroke, paralysis, and paresis, brain disorders, speech disorders, and language disorders, memory problems; cataracts; 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 disorders, asthma; intestinal obstruction, increased amylase activity in the blood, gastroesophageal reflux disease, delayed gastric emptying; skin inflammation, increased sensitivity to sunlight; joint disorders; urinary disorders, painful menstruation, and abnormal 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 genitals, excessive hair growth; thirst, falls, feeling of pressure in the chest, irritability or malaise, increased lactate dehydrogenase activity in the blood, weight loss, 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; increased fat tissue; increased risk of cancer.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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. Reporting side effects will help to gather 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. 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. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What TACROLIMUS STADA contains

• The active substance of TACROLIMUS STADA 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). The other ingredients are: capsule contents: ethylcellulose, butylhydroxytoluene, hypromellose, lactose monohydrate, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172). Ink: shellac, Allura Red AC, aluminum lake (E129), propylene glycol, titanium dioxide (E171).

What TACROLIMUS STADA looks like and contents of the pack

TACROLIMUS STADA 0.5 mg prolonged-release hard capsules are hard gelatin capsules with a non-transparent yellow cap and a non-transparent orange body, size 5, length 11.2 ± 0.5 mm, with a red print "0.5 mg" on the cap. TACROLIMUS STADA 0.5 mg is available in blisters of transparent PVC/PE/PVDC/Aluminum, in an aluminum sachet with a desiccant integrated into the sachet's foil layers, in a cardboard box. The packaging contains 30 prolonged-release hard capsules. TACROLIMUS STADA 1 mg prolonged-release hard capsules are hard gelatin capsules with a non-transparent white cap and a non-transparent orange body, size 4, length 14.1 ± 0.5 mm, with a red print "1 mg" on the cap. TACROLIMUS STADA 1 mg is available in blisters of transparent PVC/PE/PVDC/Aluminum, in an aluminum sachet with a desiccant integrated into the sachet's foil layers, in a cardboard box. The packaging contains 30 prolonged-release hard capsules. TACROLIMUS STADA 3 mg prolonged-release hard capsules are hard gelatin capsules with a non-transparent orange cap and a non-transparent orange body, size 1, length 19.1 ± 0.5 mm, with a red print "3 mg" on the cap. TACROLIMUS STADA 3 mg is available in blisters of transparent PVC/PE/PVDC/Aluminum, in an aluminum sachet with a desiccant integrated into the sachet's foil layers, in a cardboard box. The packaging contains 30 prolonged-release hard capsules. TACROLIMUS STADA 5 mg prolonged-release hard capsules are hard gelatin capsules with a non-transparent reddish-gray cap and a non-transparent orange body, size 0, length 21.4 ± 0.5 mm, with a red print "5 mg" on the cap. TACROLIMUS STADA 5 mg is available in blisters of transparent PVC/PE/PVDC/Aluminum, in an aluminum sachet with a desiccant integrated into the sachet's foil layers, in a cardboard box. The packaging 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, the patient should contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warszawa, Tel. +48 22 737 79 20

Date of last revision of the leaflet:03/2025