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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 body's immune 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 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 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, you should tell your doctor or pharmacist if you are taking any of the following medicines:

• liver disease or a history of liver disease
• diarrhea lasting more than one day
• severe abdominal pain with accompanying symptoms such as chills, fever, nausea, or vomiting
• a change in the electrical activity of the heart called "QT interval 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 are taking 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 dose 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 regular 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 (UV) radiation. Immunosuppressive medicines may increase the risk of skin cancer. You should wear protective clothing and use sunscreens with a high protection factor.

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 taking, have recently taken, or plan to take, including those obtained without a prescription and herbal products. You should not take TACROLIMUS STADA with 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.

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 your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, 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 machines, or use tools, if you experience dizziness or drowsiness after taking this medicine, or if you have vision disturbances. These symptoms are more common if you also drink 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 prescribed by your doctor. If you are in doubt, 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 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 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, for as long as immunosuppression is required to prevent organ rejection. You should remain in regular 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 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 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 your TACROLIMUS STADA capsules in the morning, you should take them 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 tell your doctor immediately if you 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).

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

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

Common severe side effects (may affect up to 1 in 10 people):

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

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

• microangiopathic hemolytic anemia (damage to the smallest blood vessels), including hemolytic-uremic syndrome, with symptoms such as: little or no urine output, extreme fatigue, yellowing of the skin or eyes (jaundice), and unexplained bruising or bleeding.

Rare severe side effects (may affect up to 1 in 1,000 people):

• thrombotic thrombocytopenic purpura: a condition characterized by damage to the smallest blood vessels and symptoms such as fever, bruising under the skin (which may look like red dots), unexplained fatigue, confusion, yellowing of the skin or eyes (jaundice), decreased urine output, vision loss, and seizures.
• toxic epidermal necrolysis: a condition characterized by blistering or peeling 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 affect up to 1 in 10,000 people):

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

Severe side effects with unknown frequency (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 skin discolorations, 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 infection, 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 condition, you may experience fatigue, apathy, unnatural paleness (pallor), shortness of breath, dizziness, headache, chest pain, and coldness in the 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 increased body temperature, chills, and sore throat.

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): headache, confusion, mood changes, seizures, and blurred vision. These may be symptoms of a condition known as posterior reversible encephalopathy syndrome, which has been reported in some patients taking tacrolimus.
• optic neuropathy (abnormalities of the optic nerve): vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or restricted field of vision.

The following side effects may also occur after taking TACROLIMUS STADA, which may be severe:

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

• increased blood sugar levels, diabetes, increased potassium levels in the blood
• insomnia
• muscle tremors, headache
• increased blood pressure
• abnormal liver function test results
• diarrhea, nausea
• kidney dysfunction

Common side effects(may affect up to 1 in 10 people):

• 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, increased uric acid or fat levels in the blood, decreased appetite, increased blood acidity, other electrolyte disturbances (visible in blood tests)
• anxiety symptoms, confusion, 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 the heart vessels, 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, throat inflammation, cough, flu-like symptoms
• inflammatory or ulcerative conditions causing abdominal pain or diarrhea, stomach bleeding, mouth inflammation, fluid accumulation in the abdominal cavity, vomiting, abdominal pain, indigestion, constipation, bloating and gas, loose stools, gastrointestinal symptoms
• bile duct 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, muscle cramps
• kidney failure, decreased urine output, difficult or painful urination
• general weakness, fever, fluid retention, pain, and discomfort, increased alkaline phosphatase activity in the blood, weight gain, temperature regulation disorders

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

• changes in blood clotting and bleeding parameters, decreased blood cell count (visible in blood tests)
• dehydration
• decreased protein or sugar levels in the blood, increased phosphate levels in the blood
• coma, brain bleeding, stroke, and paralysis, brain disorders, speech disorders, and swallowing disorders, memory problems
• cataract
• hearing loss
• irregular heartbeat, cardiac arrest, heart failure, heart muscle disorders, heart enlargement, increased heart rate, abnormal EKG results, irregular heart rhythm and rate
• blood clots in the veins of the limbs, shock
• breathing difficulties, respiratory disorders, asthma
• intestinal obstruction, increased amylase activity in the blood, gastroesophageal reflux, delayed stomach emptying, abdominal pain, indigestion, constipation, bloating and gas, loose stools, gastrointestinal symptoms
• skin inflammation, increased sensitivity to sunlight
• joint disorders
• inability to urinate, 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 affect up to 1 in 1,000 people):

• 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 conditions with peeling skin, mouth, eyes, and genitals, excessive hair growth
• thirst, falls, feeling of pressure in the chest, decreased mobility, ulcers

Very rare side effects(may affect up to 1 in 10,000 people):

• 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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 carton 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 in a temperature 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).

• The 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/PE 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/PE 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-brown 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/PE 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

For more information, 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