Tacrolimus Stada 0.5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tacrolimus Stada 0.5 mg hard capsules EFG

Tacrolimus Stada 1 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tacrolimus Stada is and what it is used for
2. What you need to know before taking Tacrolimus Stada
3. How to take Tacrolimus Stada
4. Possible side effects
5. How to store Tacrolimus Stada
6. Contents of the pack and other information

1. What Tacrólimus Stada is and what it is used for

Tacrólimus Stada belongs to a group of medicines known as immunosuppressants. After your organ transplant (e.g., liver, kidney, heart), your body's immune system will attempt to reject the new organ.

Tacrólimus is used to control your body's immune response, allowing you to accept the transplanted organ.

Tacrólimus is often used in combination with other medicines that also suppress the immune system.

You may also receive tacrólimus to treat rejection of your liver, kidney, heart, or other transplanted organ that is occurring when any previous treatment you were receiving has failed to control this immune response after your transplant.

2. What you need to know before taking Tacrolimus Stada

Do not take Tacrolimus Stada

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tacrolimus Stada.

• You will need to take tacrolimus every day for as long as immunosuppression is required to prevent rejection of your transplanted organ. You must remain in regular contact with your doctor.
• While taking tacrolimus, your doctor may want to carry out periodic tests (including blood and urine tests, heart function tests, and visual and neurological examinations). This is completely normal and will help your doctor determine the most appropriate dose of tacrolimus for you.
• Please avoid taking any herbal preparations, e.g., St. John’s wort (Hypericum perforatum), or any other herbal products, as they may affect the effectiveness and required dose of tacrolimus. If you have any doubts, please consult your doctor before taking any herbal product or preparation.
• If you have liver problems or have had a disease that may have affected your liver, please inform your doctor, as this may affect the dose of tacrolimus you receive.
• If you experience severe abdominal pain, with or without other symptoms such as chills, fever, nausea, or vomiting.
• If you have diarrhea for more than one day, please inform your doctor, as your tacrolimus dose may need to be adjusted.
• If you have a disturbance in the electrical activity of the heart known as “QT interval prolongation.”
• Limit your exposure to sunlight and UV light while taking tacrolimus by wearing appropriate protective clothing and using sunscreen with a high sun protection factor. This is due to the potential risk of malignant skin changes associated with immunosuppressive therapy.
• If you need to be vaccinated, please inform your doctor beforehand. Your doctor will advise you on the best course of action.
• It has been reported that some patients treated with tacrolimus have an increased risk of developing lymphoproliferative disorders (see section 4). Ask your doctor for further information about these disorders.
• If you have or have had damage to small blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Inform your doctor if you develop fever, bruising under the skin (which may appear as red spots), unexplained fatigue, confusion, yellowing of the skin or eyes, reduced urine output, vision loss, or seizures (see section 4). The risk of developing these symptoms may increase when tacrolimus is taken together with sirolimus or everolimus.

Handling precautions

During preparation, avoid contact of any part of the body, such as skin or eyes, with the injection solutions, powder, or granules contained in tacrolimus products, and avoid breathing near these materials. If such contact occurs, wash the skin and eyes thoroughly.

Other medicines and Tacrolimus Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal preparations.

Tacrolimus must not be taken with cyclosporine.

If you need to visit a doctor other than your transplant specialist, inform the doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you require another medicine that could increase or decrease your blood levels of tacrolimus.

Blood levels of tacrolimus may be altered by other medicines you are taking, and the blood levels of other medicines may be altered by taking tacrolimus, which may require interruption or adjustment (increase or decrease) of the tacrolimus dose.

Some patients have experienced increased blood levels of tacrolimus while taking other medicines. This could lead to serious adverse effects such as kidney problems, nervous system disorders, and heart rhythm disturbances (see section 4).

The effect on tacrolimus blood levels may occur soon after starting another medicine, so it may be necessary to monitor tacrolimus blood levels frequently and continuously during the first days of taking another medicine and regularly thereafter. Some other medicines may cause tacrolimus blood levels to decrease, increasing the risk of transplanted organ rejection. In particular, inform your doctor if you are taking or have recently taken medicines containing the following active substances:

• antifungal and antibiotic agents, 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 diseases caused by CMV (human cytomegalovirus)

• HIV protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), the booster drug cobicistat and combination tablets, or non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine), used to treat HIV infection.

• HCV protease inhibitors (e.g., telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir), used to treat hepatitis C infection.

• nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide, or mitotane (used to treat certain types of cancer).

• mycophenolic acid, used to suppress the immune system to prevent transplant rejection

• medicines for stomach ulcer and acid reflux (e.g., omeprazole, lansoprazole, or cimetidine)

• antiemetics, used to treat nausea and vomiting (e.g., metoclopramide)

• magnesium-aluminum hydroxide (antacid), used to treat acidity

• hormonal treatments with ethinylestradiol (e.g., oral contraceptive pill) or danazol

• medicines used to treat high blood pressure or heart problems (such as nifedipine, nicardipine, diltiazem, and verapamil)

• antiarrhythmic medicines (amiodarone) used to control arrhythmia (irregular heartbeat)

• medicines known as “statins” used to treat high cholesterol and triglycerides

• antiepileptic medicines carbamazepine, phenytoin, or phenobarbital

• metamizole, a medicine used to treat pain and fever

• corticosteroids prednisone and methylprednisolone

• the antidepressant nefazodone

• herbal preparations containing St. John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.

• cannabidiol (used, among others, for the treatment of seizures).

Inform your doctor if you are receiving treatment for hepatitis C. Pharmacological treatment for hepatitis C may alter your liver function and may affect tacrolimus blood levels. Tacrolimus blood levels may decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor your tacrolimus blood levels and make necessary dose adjustments after starting hepatitis C treatment.

Inform your doctor if you are taking or need to take ibuprofen, amphotericin B, antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), or antivirals (e.g., aciclovir, ganciclovir, cidofovir, foscarnet). These may worsen kidney or nervous system problems when administered simultaneously with tacrolimus.

Inform your doctor if you are taking sirolimus or everolimus. When tacrolimus is taken together with sirolimus or everolimus, the risk of thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and hemolytic uremic syndrome may increase (see section 4).

Your doctor also needs to know if you are taking potassium supplements or certain potassium-sparing diuretics used for heart failure, high blood pressure, and nephropathy (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole, which may increase blood potassium levels, certain painkillers (so-called NSAIDs, e.g., ibuprofen) used for fever, inflammation, and pain, anticoagulants (blood thinners), or oral medicines for the treatment of diabetes, while taking tacrolimus.

If you need to be vaccinated, inform your doctor beforehand.

Taking Tacrolimus Stada with food and drink

Take tacrolimus on an empty stomach or 2 to 3 hours after a meal. Wait at least one hour before the next meal. Avoid grapefruit (including grapefruit juice) while being treated with tacrolimus, as it may affect your blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Tacrolimus passes into breast milk. Therefore, you must not breastfeed while receiving tacrolimus.

Driving and using machines

Do not drive and do not operate tools or machinery if you feel dizzy or drowsy, or have blurred vision after taking this medicine. These effects are more likely if you also consume alcohol.

Tacrolimus Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Tacrolimus Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Make sure that you receive the same tacrolimus medicine each time you collect your prescription, unless your transplant specialist has agreed to switch to a different tacrolimus medicine.

This medicine must be taken twice daily. If this medicine looks different than usual, or if the dosage instructions have changed, consult your doctor or pharmacist as soon as possible to ensure you have the correct medicine.

The initial dose to prevent rejection of your transplanted organ will be determined by your doctor based on your body weight. Initial doses just after transplantation will generally be within the range of 0.075–0.30 mg per kg of body weight per day, depending on your transplanted organ.

Your dose depends on your general condition and on any other immunosuppressive medication you may be taking. Your doctor will need to perform regular blood tests to determine the correct dose and to adjust it from time to time. Your doctor will usually reduce your tacrolimus dose once your condition has stabilized. Your doctor will tell you exactly how many capsules to take and how often.

Tacrolimus is taken orally twice a day, usually in the morning and at night. Generally, you should take tacrolimus capsules on an empty stomach, either at least one hour before or 2 to 3 hours after eating. The capsules should be swallowed whole with a glass of water. Avoid grapefruit and grapefruit juice while taking tacrolimus capsules. Do not ingest the desiccant included in the aluminum pouch.

If you take more Tacrolimus Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Tacrolimus Stada

Do not take a double dose to make up for missed doses.

If you forget to take your capsules, wait until the time for your next dose and then continue as before.

If you stop taking Tacrolimus Stada

Stopping your treatment may increase the risk of rejection of your transplanted organ. Do not stop treatment unless your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tacrolimus reduces your body's natural defense mechanism to prevent rejection of the transplanted organ. As a result, your body will not work as effectively as usual in fighting infections. Therefore, if you are taking tacrolimus, you may be more prone to infections, for example, infections of the skin, mouth, stomach and intestines, lungs, and urinary tract.

Some infections may be serious or life-threatening and may include those caused by bacteria, viruses, fungi, parasites, or other pathogens. Inform your doctor immediately if you experience signs of infection, including:

• fever, cough, sore throat, weakness, or general malaise
• memory loss, difficulty thinking, difficulty walking, or vision loss: these may be due to a very rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML)

Serious adverse effects may occur, including those listed below.

Inform your doctor immediately if you suspect you are experiencing any of the following serious adverse effects:

Frequent serious adverse effects (may affect up to 1 in 10 people):

• gastrointestinal perforation: severe abdominal pain with or without other symptoms such as chills, fever, nausea, or vomiting
• inadequate function of your transplanted organ
• blurred vision

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

• thrombotic microangiopathy (damage to the smallest blood vessels), including hemolytic uremic syndrome, a condition with the following symptoms: low or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and abnormal bruising or bleeding, along with signs of infection

Rare serious adverse effects (may affect up to 1 in 1,000 people):

• thrombotic thrombocytopenic purpura (TTP), a condition involving damage to the smallest blood vessels, characterized by fever and bruising under the skin appearing as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), signs of acute kidney failure (low or no urine output), vision loss, and seizures
• toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red swollen skin that may peel off in large areas of the body
• blindness

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

• Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, severe illness with blisters on the skin, mouth, eyes, and genitals, hives, tongue swelling, red or purple rash that spreads, and skin peeling
• Torsade de Pointes: change in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness, or nausea, palpitations (awareness of heartbeat), and difficulty breathing

Serious adverse effects with unknown frequency (frequency cannot be estimated from available data):

• opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat
• benign and malignant tumors have been reported following treatment due to immunosuppression, including malignant skin cancers and a rare type of cancer that may include skin lesions known as Kaposi's sarcoma. Symptoms include skin changes such as new or changing discoloration, lesions, or lumps
• cases of pure red cell aplasia (a very severe reduction in red blood cell count), hemolytic anemia (decrease in red blood cells due to abnormal destruction, accompanied by fatigue), and febrile neutropenia (a decrease in the type of white blood cells that fight infections, accompanied by fever) have been reported. The exact frequency of these adverse effects is unknown. You may have no symptoms, or depending on the severity, you may experience: fatigue, apathy, abnormal paleness of the skin (pallor), difficulty breathing, dizziness, headache, chest pain, and cold sensation in hands and feet
• cases of agranulocytosis (a marked decrease in white blood cell count accompanied by mouth ulcers, fever, and infection(s)). You may have no symptoms or may suddenly experience fever, chills, and sore throat
• allergic and anaphylactic reactions with the following symptoms: sudden itchy skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and feeling faint
• posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood changes, seizures, and visual disturbances. These could be signs of a disorder known as posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus
• optic neuropathy (damage to the optic nerve): vision problems such as blurred vision, changes in color vision, difficulty seeing details, or reduced visual field

The following adverse effects may also occur after receiving tacrolimus and may be serious:

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

• increased blood sugar, diabetes mellitus, increased blood potassium
• difficulty sleeping
• tremor, headache
• increased blood pressure
• abnormalities in liver function tests
• diarrhea, nausea
• kidney problems

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

• decreased blood cell counts (platelets, red blood cells, or white blood cells), increased white blood cell count, changes in red blood cell count (see blood tests)
• decreased magnesium, phosphate, potassium, calcium, or sodium in blood, fluid overload, increased blood uric acid or lipids, decreased appetite, increased blood acidity, other changes in blood electrolytes
• anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, psychiatric disorders
• seizures, disturbances of consciousness, tingling and numbness (sometimes painful) in hands and feet, dizziness, decreased ability to write, nervous system disturbances
• increased sensitivity to light, eye disorders
• ringing in the ears
• reduced blood flow in heart vessels, faster heartbeat
• bleeding, partial or complete blockage of blood vessels, decreased blood pressure
• difficulty breathing, changes in lung tissue, fluid accumulation around the lungs, inflammation of the pharynx, cough, flu-like symptoms
• inflammation or ulcers causing abdominal pain or diarrhea, stomach bleeding, mouth inflammation or ulcers, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, loose stools, stomach problems
• changes in liver function and liver enzymes, yellowing of the skin due to liver problems, liver tissue damage, and liver inflammation
• itching, rash, hair loss, acne, increased sweating
• joint, limb, back, and foot pain, muscle spasms
• kidney insufficiency, reduced urine output, difficulty or pain when urinating
• general weakness, fever, fluid retention, pain and discomfort, increased blood alkaline phosphatase enzyme, weight gain, altered temperature sensation

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

• changes in blood clotting, decreased count of all blood cells
• dehydration, decreased blood proteins or sugar, increased blood phosphate
• coma, brain hemorrhages, stroke, paralysis, brain disorder, speech and language disturbances, memory problems
• cataract (lens opacity)
• hearing difficulty
• irregular heartbeat, cardiac arrest, reduced heart function, heart muscle disorder, enlarged heart muscle, stronger heartbeat, abnormal electrocardiogram, abnormal heart rate and pulse
• blood clots in a vein of a limb, shock
• breathing difficulties, respiratory tract disorders, asthma
• intestinal obstruction, increased blood amylase levels, stomach contents reflux into the throat, delayed stomach emptying
• dermatitis, burning sensation under sunlight
• joint disorders
• difficulty urinating, painful menstruation, abnormal menstrual bleeding
• organ failure, flu-like illness, increased sensitivity to heat and cold, chest pressure sensation, nervousness or unusual sensation, increased blood lactate dehydrogenase enzyme, weight loss

Rare adverse effects (may affect up to 1 in 1,000 people)

• small skin hemorrhages due to blood clots
• increased muscle stiffness
• blindness
• deafness
• fluid accumulation around the heart
• acute breathing difficulty
• cyst formation in the pancreas
• problems with blood flow in the liver
• severe illness with blisters on the skin, mouth, eyes, and genitals, increased body hair
• thirst, hair loss, chest tightness, decreased mobility, ulcer

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

• muscle weakness
• abnormal echocardiogram
• liver failure, narrowing of the bile duct
• painful urination with blood in the urine
• increased fatty tissue

Adverse effects with unknown frequency (cannot be estimated from available data)

• optic nerve disorder (optic neuropathy)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tacrolimus Stada

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Keep in the original packaging (inside the aluminum pouch) to protect it from moisture and light.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated. Once the aluminum pouch is opened, the medicine should be used within one year.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tacrolimus Stada

Tacrolimus Stada 0.5 mg hard capsules EFG

The active substance is tacrolimus.

Each capsule contains 0.5 mg of tacrolimus.

The other components are:

• Capsule contents: Povidone K-30, sodium croscarmellose (E-468), lactose, magnesium stearate.
• Capsule shell: titanium dioxide (E-171), yellow iron oxide (E-172), gelatin.

Tacrolimus Stada 1 mg hard capsules EFG

The active substance is tacrolimus.

Each capsule contains 1 mg of tacrolimus.

The other components are:

• Capsule contents: Povidone K-30, sodium croscarmellose (E-468), lactose, magnesium stearate.
• Capsule shell: titanium dioxide (E-171), gelatin.

Appearance of the product and pack size

Tacrolimus Stada 0.5 mg hard capsules EFG

Hard capsules with ivory-colored cap and body containing white powder.

Tacrolimus Stada 1 mg hard capsules EFG

Hard capsules with white cap and body containing white powder.

Tacrolimus Stada is supplied in aluminum-protected blister strips containing 10 capsules, each pack including a desiccant to protect the capsules from moisture. The desiccant must not be swallowed.

Tacrolimus Stada is available in blister packs containing 10 capsules each. Pack sizes of 30, 50, 60, 100 and 150 capsules.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Laboratorios Cinfa, S.A.
Olaz-Chipi, 10.
Polígono Industrial Areta (Huarte-Pamplona (Navarra)) - 31620
Spain

or

STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 (Bad Vilbel)
Germany

or

Eurogenerics, N.V.
Heizel Esplanade, b22 (Brussels) - 1020
Belgium

This medicinal product is authorized in EEA Member States under the following names:

Germany Tacro-cell 0.5 mg/1 mg Hard Capsules
Spain Tacrolimus Stada 0.5 mg/1 mg hard capsules EFG

Date of the most recent review of this leaflet: August 2025

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