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 case 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 must not be used interchangeably. Before starting TACROLIMUS STADA, tell your doctor or pharmacist if you are taking any of the following medicines:

• any of the medicines listed below in the "TACROLIMUS STADA and other medicines" section
• if you have liver disease or have had it in the past
• if you have diarrhea that lasts more than one day
• if you have severe abdominal pain with or without other 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 tell 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.

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. Stay 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, limit exposure to sunlight and ultraviolet (UV) radiation. Immunosuppressive medicines may increase the risk of skin cancer. 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal products. Do 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, tell the doctor 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.

Tell your doctor if you are taking potassium or certain diuretics used to treat heart failure, high blood pressure, and kidney disease (e.g., amiloride, triamterene, or spironolactone) or antibiotics such as trimethoprim or cotrimoxazole, which may increase potassium levels in the blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) used for fever, inflammation, and pain, anticoagulants (blood thinners), or oral anti-diabetic drugs. Tell your doctor about any planned vaccinations.

Taking TACROLIMUS STADA with food and drink

While taking TACROLIMUS STADA, avoid eating grapefruits (including 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 baby, consult your doctor or pharmacist before taking this medicine. TACROLIMUS STADA passes into breast milk. Therefore, do not breastfeed while taking TACROLIMUS STADA.

Driving and using machines

Do 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 are more common if you also drink alcohol.

TACROLIMUS STADA contains lactose

If your doctor has told you that you have an intolerance to some sugars, 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

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. This medicine can only be prescribed by a doctor with experience in treating patients who have had organ transplants. When collecting your prescription, make sure you receive the same tacrolimus-containing medicine each time, unless your transplant specialist has advised you to switch to a different tacrolimus-containing medicine. Take the medicine once a day. If the medicine looks different than usual or there are different instructions for its use, 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 TACROLIMUS STADA, your doctor will perform regular 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 condition is stable, your doctor will reduce the dose of TACROLIMUS STADA. Your doctor will tell you exactly how many capsules to take. Take TACROLIMUS STADA every day, for as long as immunosuppression is needed to prevent organ rejection. Stay 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, 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, take them as soon as possible on the same day. Do not take a double dose the next morning.

Stopping TACROLIMUS STADA treatment

Stopping TACROLIMUS STADA treatment may increase the risk of organ rejection. Do not stop treatment unless your doctor decides to. If you have any further questions about the use of this medicine, consult your 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 you are taking TACROLIMUS STADA, you may be more prone to infections. Some infections can be severe or life-threatening and may include bacterial, fungal, viral, parasitic, or other infections. 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, serious brain infection that can be life-threatening (progressive multifocal leukoencephalopathy, PML).

Severe side effects, including allergic and anaphylactic reactions, have been reported during TACROLIMUS STADA treatment. Cancer and benign tumors have also been reported during TACROLIMUS STADA treatment. If you experience any of the following severe side effects, tell your doctor immediately:

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

• 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 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, 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, decreased urine output, vision loss, and seizures
• toxic epidermal necrolysis: a condition characterized by blistering and peeling of the skin and mucous membranes
• blindness

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

• Stevens-Johnson syndrome: a condition characterized by a severe skin and mucous membrane reaction, with symptoms such as skin pain, blistering, and peeling
• Torsades de pointes: a change in heart rhythm, which may be accompanied by symptoms such as chest pain, fainting, dizziness, or nausea and palpitations

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, including skin cancer and a rare type of cancer called Kaposi's sarcoma, which may appear as skin lesions, such as new or changed moles, spots, or lumps
• pure red cell aplasia (a significant decrease in red blood cell count), hemolytic anemia (a decrease in red blood cell count due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (a decrease in white blood cell count, accompanied by 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, shortness of breath, dizziness, headache, chest pain, and coldness in the hands and feet.
• agranulocytosis (a significant decrease in white blood cell count, accompanied by mouth ulcers, fever, and infection/infections). You may not have any symptoms or you may experience sudden fever, chills, and sore throat.

In addition to the above side effects, the following have also been reported:

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
• high 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 and disorientation, depression, mood changes, nightmares, hallucinations, mental disturbances
• 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
• inflammatory or ulcerative conditions causing abdominal pain or diarrhea, gastrointestinal bleeding, mouth ulcers, fluid accumulation in the abdomen, 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, muscle cramps
• kidney failure, decreased urine output, painful or difficult urination
• general weakness, fever, fluid retention, discomfort, increased alkaline phosphatase activity in the blood, weight gain, disturbances in temperature sensation

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

• changes in blood clotting and bleeding, changes in 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 language disorders
• cataract
• hearing loss
• irregular heartbeat, cardiac arrest, heart failure, heart muscle disorders, enlarged heart muscle, rapid heartbeat, abnormal ECG results, irregular heartbeat and pulse 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 gastric emptying, bloating and gas
• skin inflammation, increased sensitivity to sunlight
• joint disorders
• inability to urinate, painful or irregular menstrual bleeding
• multi-organ failure, flu-like symptoms, increased sensitivity to heat and cold, feeling of pressure in the chest, discomfort, 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 disorders with peeling, mouth, eye, and genital lesions, excessive hair growth
• thirst, falls, feeling of pressure in the chest, decreased mobility, ulcers

Very rare side effects (may affect less than 1 in 10,000 people):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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

Keep this medicine out of the sight and reach of children. Do not use TACROLIMUS STADA after the expiration date stated on the packaging after {EXP}. The expiration 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 before the expiration date. Store in a temperature below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 blisters, in an aluminum sachet with a desiccant, in a cardboard box. The packaging 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 blisters, in an aluminum sachet with a desiccant, in a cardboard box. The packaging contains 30 prolonged-release hard capsules. TACROLIMUS STADA 3 mg prolonged-release hard capsules are 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 blisters, in an aluminum sachet with a desiccant, in a cardboard box. The packaging 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 blisters, in an aluminum sachet with a desiccant, 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

For more information, contact 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