Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Adoport 0.5 mg hard capsules EFG

Adoport 1 mg hard capsules EFG

Adoport 2 mg hard capsules

Adoport 5 mg hard capsules EFG

tacrolimus

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

Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

What Adoport is and what it is used for
What you need to know before taking Adoport
How to take Adoport
Possible adverse effects
How to store Adoport
Contents of the container and other information

1. What Adoport is and what it is used for

Adoport belongs to a group of medicines called immunosuppressants.

After your organ transplant (e.g., liver, kidney, heart), your body's immune system will attempt to reject the new organ.

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

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

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

2. What you need to know before taking Adoport

Do not take Adoport:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Adoport.

You will need to take Adoport every day for as long as immunosuppression is required to prevent rejection of your transplanted organ. You must maintain regular contact with your doctor.
While taking Adoport, your doctor may want to carry out a series of tests from time to time (including blood and urine tests, heart function tests, visual and neurological examinations). This is completely normal and will help your doctor determine the most appropriate dose of Adoport for you.
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 Adoport. If you have any doubts, please consult your doctor before taking any herbal product or preparation.
If you have liver problems or have had any illness 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, inform your doctor, as it may be necessary to adjust your dose of Adoport.
If you have an abnormality in the electrical activity of the heart called “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 more information about these disorders.
If you have or have had damage to your 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 these symptoms may increase when tacrolimus is taken together with sirolimus or everolimus.

Handling precautions:

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

Other medicines and Adoport

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 medicines.

Adoport must not be taken with cyclosporine.

If you need to visit a doctor other than your transplant specialist, tell 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.

The blood levels of Adoport may be altered by other medicines you are taking, and the blood levels of other medicines may be affected by taking Adoport. This may require interruption, increase, or decrease in the dose of Adoport.

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 while continuing its use. Some medicines may cause tacrolimus blood levels to decrease, which could increase the risk of transplanted organ rejection.

In particular, you must inform your doctor if you are taking or have recently taken medicines containing active substances such as:

antifungal and antibiotic agents (especially those known as 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 pharmacokinetic enhancer cobicistat, and combination tablets and non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine), used to treat HIV infection;
HCV protease inhibitors (e.g., telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir), used in the treatment of 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 treating stomach ulcer and acid reflux (e.g., omeprazole, lansoprazole, or cimetidine);
antiemetics, used to treat nausea and vomiting (e.g., metoclopramide);
magnesium or aluminium hydroxide (antacids) used to treat acidity;
hormonal treatments with ethinylestradiol (e.g., the 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 Shisandra sphenanthera;
cannabidiol (its uses include, among others, treatment of epileptic 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 (used to treat fever, inflammation, and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections), or antivirals (used to treat viral infections, e.g., aciclovir, ganciclovir, cidofovir, foscarnet). These medicines may worsen kidney or nervous system problems when taken together 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 diuretics used for heart failure, high blood pressure, and nephropathy (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim and cotrimoxazole, which may increase potassium levels in your blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) used for fever, inflammation, and pain, anticoagulants (which prevent blood clotting), or oral medicines for the treatment of diabetes, while taking tacrolimus.

If you need to be vaccinated, consult your doctor.

Adoport with food, drinks, and alcohol

You should generally take Adoport on an empty stomach, or at least 1 hour before a meal or 2 to 3 hours after a meal. Grapefruit or grapefruit juice must be avoided while taking Adoport.

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. A study evaluated pregnancy outcomes in women treated with tacrolimus and other immunosuppressants. Although this study did not provide sufficient evidence to draw conclusions, higher rates of spontaneous abortion were reported among liver and kidney transplant patients treated with tacrolimus, as well as higher rates of persistent hypertension associated with protein loss in the urine, occurring during pregnancy or the postpartum period (a condition called preeclampsia), among kidney transplant patients. No increased risk of major congenital malformations associated with the use of tacrolimus was found.

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

Driving and using machines

Do not drive and do not operate tools or machinery if you feel dizzy or drowsy, or have problems seeing clearly after taking Adoport. These effects are more frequently observed if Adoport is taken together with alcohol.

Adoport contains lactose and sodium

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

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

3. How to take Adoport

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If you are unsure, check with your doctor or pharmacist again.

Make sure 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 dosing 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 mg to 0.30 mg per kg of body weight per day,

depending on the transplanted organ.

Your dose depends on your general condition and 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 Adoport dose once your condition has stabilized.

Your doctor will tell you exactly how many capsules to take and how often.

Adoport is taken orally twice daily, usually in the morning and evening. Adoport should generally be taken on an empty stomach or at least one hour before or 2 to 3 hours after a meal.
The capsules must be swallowed whole with a glass of water.
Avoid grapefruit and grapefruit juice while taking Adoport.
Take the hard capsules immediately after removing them from the blister pack.
Do not ingest the desiccant included in the aluminum pouch.

If you take more Adoport than you should

If you have accidentally taken more Adoport than you should, contact your doctor immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Adoport

Do not take a double dose to make up for forgotten doses. If you forget to take your capsules, wait until the time of your next dose and then continue as before.

If you stop taking Adoport

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

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.

Adoport reduces your body's own defence mechanism that would normally allow rejection of the transplanted organ. Consequently, your body will not function as effectively as usual in fighting infections. Therefore, if you are taking Adoport, you will be more prone than usual to infections, for example, infections of the skin, mouth, stomach and intestines, lungs, and urinary tract.

Some of these infections can be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.

Inform your doctor immediately if you have symptoms of an infection, including:

Fever, cough, sore throat, feeling weak or generally unwell.
Memory loss, problems thinking, difficulty walking, or loss of vision – these symptoms 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 described below.

Inform your doctor immediately if you suspect or have experienced 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 haemolytic uraemic syndrome with the following symptoms: low or no urine output (acute kidney failure), extreme tiredness, yellowing of the skin or eyes (jaundice), and bruising or abnormal bleeding, and signs of infection.

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

Thrombotic thrombocytopenic purpura: includes damage to the smallest blood vessels and is characterised 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), symptoms of acute kidney failure (low or no urine output), loss of vision, and seizures,
Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and 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 blistering of the skin, mouth, eyes, and genitals, hives, swelling of the tongue, red or purple rash that spreads, skin peeling,
Torsades 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 diarrhoea, fever, and sore throat,
Benign and malignant tumours have been reported after treatment as a result of immunosuppression, including malignant skin cancers and a rare type of cancer that may involve skin lesions known as Kaposi's sarcoma. Symptoms include skin changes such as new skin discolourations or changes in existing ones, lesions, or lumps,
Cases of pure red cell aplasia (a marked reduction in red blood cell count), haemolytic anaemia (reduction in red blood cells due to abnormal breakdown 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 cells 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 colour vision, difficulty seeing details, or reduced visual field.

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

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

Increased blood sugar, diabetes mellitus, increased potassium in blood,
Difficulty sleeping,
Tremors, headache,
Increased blood pressure,
Abnormalities in liver function tests,
Diarrhoea, nausea,
Kidney problems.

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

Reduction in blood cell count (platelets, red blood cells, or white blood cells), increased white blood cell count, changes in red blood cell counts (see blood tests),
Decreased magnesium, phosphate, potassium, calcium, or sodium in blood, fluid overload, increased uric acid or lipids in blood, decreased appetite, increased blood acidity, other changes in blood electrolytes,
Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, psychiatric disorders,
Seizures, disturbances in consciousness, tingling and numbness (sometimes painful) in hands and feet, dizziness, difficulty writing, nervous system disorders,
Increased sensitivity to light, eye disorders,
Hearing ringing or other sounds in your ears,
Reduced blood flow in heart vessels, faster heartbeat,
Bleeding, partial or complete blockage of blood vessels, decreased blood pressure,
Shortness of breath, changes in lung tissue, fluid accumulation around the lung, inflammation of the pharynx, cough, flu-like symptoms,
Inflammations or ulcers causing abdominal pain or diarrhoea, stomach bleeding, mouth ulcers or inflammation, fluid retention in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, loose stools, stomach problems,
Changes in liver enzymes and liver function, 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, sensation of altered temperature.

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

Changes in blood clotting, decreased count of all blood cells,
Dehydration, decreased proteins or blood sugar, increased phosphate in blood,
Coma, brain haemorrhages, stroke, paralysis, brain disorder, speech and language disturbances, memory problems,
Lens opacity,
Hearing difficulty,
Irregular heartbeat, cardiac arrest, decreased heart function, heart muscle disorder, increased heart muscle size, 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 level of amylase enzyme, reflux of stomach contents 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 feeling, increased blood lactate dehydrogenase enzyme, weight loss.

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

Small skin bleedings due to blood clots,
Increased muscle stiffness,
Deafness,
Fluid accumulation around the heart,
Breathing difficulties,
Cyst formation in the pancreas,
Problems with blood flow in the liver,
Increased hair growth,
Thirst, falls, 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 vessel,
Painful urination with blood in urine,
Increase in fatty tissue.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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. Adoport Storage

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

Do not use this medicine after the expiry date stated on the packaging and on the aluminium bag after CAD/EXP. The expiry date refers to the last day of the month indicated.

After the first opening of the aluminium bag containing the blister, the capsules must be used within 12 months. Do not store above 25°C after opening the aluminium bag.

Take the capsules as soon as they are removed from the blister.

Do not store at temperatures above 30°C. Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Adoport 0.5 mg hard capsules

The active substance is tacrolimus. Each capsule contains 0.5 mg of tacrolimus (as monohydrate).
The other components are:
Capsule contents: monohydrate lactose, hypromellose (E 464), sodium croscarmellose (E 468) and magnesium stearate (E 572).
Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laurate and yellow iron oxide (E 172).

Composition of Adoport 1 mg hard capsules

The active substance is tacrolimus. Each capsule contains 1 mg of tacrolimus (as monohydrate).
The other components are:
Capsule contents: monohydrate lactose, hypromellose (E 464), sodium croscarmellose (E 468) and magnesium stearate (E 572).
Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laurate, yellow iron oxide (E 172), red iron oxide (E 172) and black iron oxide (E 172).

Composition of Adoport 2 mg hard capsules

The active substance is tacrolimus. Each capsule contains 2 mg of tacrolimus (as monohydrate).
The other components are:
Capsule contents: monohydrate lactose, hypromellose (E 464), sodium croscarmellose (E 468) and magnesium stearate (E 572).
Hard gelatin capsule: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), brilliant blue FCF (E 133), shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525) and black iron oxide (E 172).

Composition of Adoport 5 mg hard capsules

The active substance is tacrolimus. Each capsule contains 5 mg of tacrolimus (as monohydrate).
The other components are:
Capsule contents: monohydrate lactose, hypromellose (E 464), sodium croscarmellose (E 468) and magnesium stearate (E 572).
Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laurate and red iron oxide (E 172).

Appearance of the product and contents of the container

Adoport 0.5 mg are hard gelatin capsules with an opaque white body and an ivory cap, containing white to almost white powder (length: 14.5 mm).

Adoport 1 mg are hard gelatin capsules with an opaque white body and a slightly brown cap, containing white to almost white powder (length: 14.5 mm).

Adoport 2 mg are opaque dark green hard capsules, printed in black with "2 mg" on the cap, containing white to almost white powder (length: 14.5 mm).

Adoport 5 mg are hard gelatin capsules with an opaque white body and an orange cap, containing white to almost white powder (length: 15.8 mm).

Adoport is packaged in PVC/PE/PVdC/Aluminum blisters, placed in an aluminum bag with a desiccant to protect from moisture. The desiccant must not be swallowed.

Pack sizes of 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Lek Pharmaceuticals d.d.,
Verovskova 57,
1526 Ljubljana,
Slovenia

Lek Pharmaceuticals d.d.,
Trimlini 2D,
9220 Lendava,
Slovenia

LEK S.A.,
Ul. Domaniewska 50C,
02-672 Warszawa,
Poland

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
D-39179 Barleben,
Germany

Date of the last revision of this leaflet: May 2025.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/