Dailiport

1. What is Dailiport and what is it used for

Dailiport contains the active substance tacrolimus. It is an immunosuppressive medicine. After organ transplantation (liver, kidney), the patient's immune system tries to reject the new organ. Dailiport is used to control the immune system's response and allow the body to accept the transplanted organ.
Dailiport can also be used in cases of ongoing rejection of a transplanted liver, kidney, heart, or other organs, when previous treatments have not been able to control the immune system's response after transplantation.
Dailiport is used in adult patients.

2. Important information before taking Dailiport

When not to take Dailiport

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);
if the patient is allergic to peanuts or soy.

Warnings and precautions

Tacrolimus in immediate-release capsules and Dailiport contain the same active substance, tacrolimus. However, Dailiport is taken once a day, while tacrolimus in immediate-release capsules is taken twice a day. Dailiport capsules allow for prolonged (slower) release of tacrolimus. Dailiport and tacrolimus in immediate-release capsules should not be used interchangeably.
Before taking Dailiport, you should discuss it with your doctor or pharmacist if:

• the patient is taking any of the medicines listed later in the "Dailiport and other medicines" section,
• the patient has or has had liver function disorders,
• the patient has had diarrhea lasting more than 1 day,
• the patient experiences severe abdominal pain with other symptoms such as chills, fever, nausea, or vomiting, or without such symptoms,
• the patient has been diagnosed with changes in the electrical activity of the heart called "QT interval prolongation"
• the patient has or has had damage to the smallest blood vessels, known as microangiopathy/thrombotic microangiopathy/hemolytic-uremic syndrome. The patient should inform their doctor if they experience fever, bruising under the skin (which may appear as red dots), unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output, vision loss, and seizures (see section 4). If tacrolimus is taken with sirolimus or everolimus, the risk of these symptoms may increase.
• One should avoid taking any herbal products, such as St. John's Wort (Hypericum perforatum) or other herbal products, as they may affect the efficacy and dose of Dailiport that needs to be taken. In case of doubts, before taking any products or herbal preparations, one should consult a doctor.

The patient should immediately tell their doctor if they experience:

• vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or limited field of vision.

The doctor may decide to change the dose of Dailiport.
The patient should regularly consult their doctor. The doctor may from time to time recommend blood, urine, heart, and vision tests to determine the correct dose of Dailiport and adjust it from time to time. During Dailiport treatment, the patient should limit exposure to sunlight and UV radiation due to the increased risk of skin cancer. The patient should wear protective clothing and use sunscreens with a high protection factor.

Precautions for handling

When preparing, one should avoid direct contact with any part of the body, such as skin or eyes, or inhaling products containing tacrolimus in the form of a solution, powder, or granules. If such contact occurs, the skin and eyes should be rinsed.

Children and adolescents

Dailiport is not recommended for use in children and adolescents under 18 years of age.

Dailiport and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription and herbal preparations.
It is not recommended to take Dailiport with cyclosporin (another medicine used to prevent organ rejection).

In case of a visit to a doctor other than a transplant specialist, the patient should inform the doctor that they are taking tacrolimus. The doctor may want to consult with a transplant specialist to determine if the patient should take a different medicine that may increase or

decrease the concentration of tacrolimus in the bloodand.
Dailiport and other medicines taken at the same time may affect each other's concentration in the blood. It may be necessary to discontinue, increase, or decrease the dose of Dailiport.
In some patients, an increase in tacrolimus concentration in the blood has been observed when taking other medicines. This can lead to serious side effects, such as kidney function disorders, nervous system disorders, and heart rhythm disorders (see section 4).
The effect on Dailiport concentration in the blood may occur very quickly after starting another medicine, so it may be necessary to frequently monitor Dailiport concentration in the blood during the first few days after starting another medicine and often during continued treatment with another medicine. Some other medicines may cause a decrease in tacrolimus concentration in the blood, which may increase the risk of organ rejection. The patient should especially inform their doctor if they are taking or have recently taken the following medicines:
antifungal and antibiotic medicines (especially macrolide antibiotics) used to treat infections, such as 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 human cytomegalovirus (CMV)
HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), a medicine that increases pharmacokinetics, cobicistat, and tablets or non-nucleoside reverse transcriptase inhibitors (efavirenz, etravirine, nevirapine) used to treat HIV infection;
HCV protease inhibitors (e.g. telaprevir, boceprevir, and a combination of ombitasvir, paritaprevir, and ritonavir with or without dasabuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir) used to treat hepatitis C;
nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide, or mitotane (medicines used to treat certain cancers);
mycophenolic acid used to suppress the immune system to prevent transplant rejection;
medicines used to treat stomach ulcers and reflux (e.g. omeprazole, lansoprazole, or cimetidine);
antiemetic medicines used to treat nausea and vomiting (e.g. metoclopramide);
cisapride or antacids containing magnesium hydroxide and aluminum hydroxide, used to treat heartburn;
oral contraceptives or other hormone therapy with ethinylestradiol, hormone therapy with danazol;
medicines used to treat high blood pressure or heart function disorders (e.g. nifedipine, nicardipine, diltiazem, and verapamil);
antiarrhythmic medicines (amiodarone) used to control arrhythmia (uneven heart function);
statin medicines used to treat high cholesterol and triglyceride levels;
carbamazepine, phenytoin, or phenobarbital used to treat epilepsy;
corticosteroids prednisolone and methylprednisolone used to treat inflammation or suppress immune system function (e.g. in case of transplant rejection);
nefazodone used to treat depression;
herbal products containing St. John's Wort (Hypericum perforatum) or extracts of Chinese schisandra (Schisandra sphenanthera);
metamizole, a medicine used to treat pain and fever;
cannabidiol (a medicine used, among other things, to treat seizures).
The patient should inform their doctor about treatment for hepatitis C. Hepatitis C treatment may change liver function and affect tacrolimus concentration in the blood. Tacrolimus concentration in the blood may decrease or increase depending on the medicines prescribed for hepatitis C. The doctor may want to closely monitor tacrolimus concentrations in the blood and make necessary dose adjustments of Dailiport after starting hepatitis C treatment.
The patient should tell their doctor if they are taking or plan to take ibuprofen (used to treat fever, inflammation, or pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections), or antiviral medicines (used to treat viral infections, e.g. acyclovir, ganciclovir, cidofovir, foscarnet). These medicines taken with Dailiport may increase kidney or nervous system function disorders.
The patient should also inform their doctor if they are taking sirolimus or everolimus. When tacrolimus is taken with sirolimus or everolimus, the risk of microangiopathic hemolytic anemia, thrombotic thrombocytopenic purpura, and hemolytic-uremic syndrome may increase (see section 4).
The patient should also inform their doctor if they are taking potassium supplements or certain diuretics used to treat heart failure, high blood pressure, and kidney disease (e.g. amiloride, triamterene, or spironolactone) or antibiotics trimethoprim or cotrimoxazole, which may increase potassium levels in the blood, nonsteroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used to treat fever, inflammation, or pain, anticoagulant medicines (blood thinners), or oral antidiabetic medicines.
If the patient is to undergo any vaccination, they should inform their doctor in advance.

Dailiport with food and drink

While taking Dailiport, the patient should avoid eating grapefruits and drinking grapefruit juice due to the possible effect on the medicine's concentration in the blood.

Pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
Dailiport passes into breast milk. While taking Dailiport, the patient should not breastfeed.

Driving and using machines

If after taking Dailiport the patient feels dizzy, sleepy, or has vision disturbances, they should not drive or operate machinery. These symptoms occur more frequently if the patient drinks alcohol while taking Dailiport.

Dailiport 0.5 mg and Dailiport 2 mg contain lactose, azo dyes containing sodium, and soy

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains azo dyes: orange yellow (E 110), Allura Red AC (E 129), and tartrazine (E 102), which may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule, which means the medicine is considered "sodium-free".
The ink used to mark the capsules contains soy lecithin. If the patient is allergic to peanuts or soy, they should not take this medicine.

Dailiport 1 mg, Dailiport 3 mg, and Dailiport 5 mg contain lactose, azo dyes containing sodium, and soy

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains azo dyes: orange yellow (E 110) and Allura Red AC (E 129), which may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule, which means the medicine is considered "sodium-free".
The ink used to mark the capsules contains soy lecithin. If the patient is allergic to peanuts or soy, they should not take this medicine.

3. How to take Dailiport

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The medicine is prescribed only by a doctor with experience in treating transplant patients.
When dispensing, one should ensure that the same medicine containing tacrolimus is always dispensed, unless a transplant specialist has recommended switching to a different tacrolimus-containing medicine.
This medicine should be taken once a day. If the medicine looks different than usual or the dosage recommendations have changed, the patient should consult their doctor or pharmacist as soon as possible to ensure that the correct medicine has been dispensed.
The initial dose used to prevent organ rejection is determined by the doctor based on the patient's body weight. Initial doses given shortly after transplantation are usually in the range of 0.10 to 0.30 mg per kilogram of body weight per day (depending on the transplanted organ). The same doses can be used to treat ongoing rejection of a transplanted organ.
The recommended dose depends on the patient's overall condition and the other immunosuppressive medicine being taken.
After starting Dailiport, the doctor will frequently order blood tests to determine the correct dose, and continued treatment may require regular blood tests to determine the correct dose and adjust it from time to time. Once the patient's condition has stabilized, the doctor will usually decrease the dose of Dailiport. The doctor will specify how many capsules and how often they should be taken.
Dailiport should be taken every day, for as long as immunosuppression is necessary to prevent organ rejection. The patient should regularly consult their doctor.
Dailiport is taken orally once a day, in the morning. The medicine should be taken on an empty stomach or 2 to 3 hours after a meal. The patient should wait at least 1 hour before eating the next meal. The capsules should be taken immediately after removal from the blister pack and swallowed whole, with a glass of water.
The desiccant contained in the foil packaging should not be swallowed.

Taking a higher dose of Dailiport than recommended

In case of accidental ingestion of too much Dailiport, the patient should immediately contact their doctor or go to the emergency room of the nearest hospital.

Missing a dose of Dailiport

If the patient has forgotten to take the morning dose, they should take it as soon as possible on the same day. The patient should not take a double dose the next morning to make up for the missed dose.

Stopping Dailiport treatment

Stopping Dailiport treatment may increase the risk of organ rejection. The patient should not stop treatment without their doctor's recommendation.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dailiport can cause side effects, although not everybody gets them.
Dailiport weakens the body's defense mechanism, as a result of which the immune system will not fight infections as effectively as usual. Therefore, while taking Dailiport, the patient may be more susceptible to infections. Some infections can be severe or life-threatening and can include bacterial, viral, fungal, parasitic, or other infections. The patient should immediately inform their doctor if they experience symptoms of infection, including:

• fever, cough, sore throat, weakness, or general malaise
• memory loss, difficulty thinking, difficulty walking, or loss of vision - these may be caused by a very rare, severe brain infection that can lead to death (progressive multifocal leukoencephalopathy, PML).

Severe side effects, including allergic and anaphylactic reactions, may occur. Tacrolimus has been associated with the development of benign and malignant tumors.

The patient should immediately inform their doctor if they experience or suspect any of the following severe side effects:

Severe, frequent side effects (may occur in less than 1 in 10 people):

• perforation of the gastrointestinal tract: severe abdominal pain, which may be accompanied by other symptoms such as chills, fever, nausea, or vomiting.
• organ dysfunction.
• blurred vision.

Severe, less frequent side effects (may occur in less than 1 in 100 people):

• microangiopathic hemolytic anemia (damage to the smallest blood vessels), including hemolytic-uremic syndrome - a condition with the following symptoms: small amount of urine or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and unexplained bruising or bleeding and signs of infection.

Severe, rare side effects (may occur in less than 1 in 1000 people):

• thrombotic thrombocytopenic purpura: a condition characterized by damage to the smallest blood vessels and marked by fever and bruising under the skin (which may appear as red dots), with or without extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with signs of acute kidney failure (small amount of urine or no urine output), vision loss, and seizures.
• toxic epidermal necrolysis: erosion and blistering of the skin and mucous membranes, red swollen skin that can peel off over large areas of the body.
• blindness.

Severe, very rare side effects (may occur in less than 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 skin rash that spreads, peeling of the skin.
• Torsades de pointes: a change in heart rate, which may be accompanied by (or not) symptoms such as chest pain (angina pectoris), fainting, dizziness, or nausea, palpitations (feeling of heartbeat), and difficulty breathing.

Severe side effects - frequency not known (frequency cannot be estimated from available data):

• opportunistic infections (bacterial, fungal, viral, and parasitic): prolonged diarrhea, fever, and sore throat.

benign and malignant tumors have been reported after immunosuppressive treatment, including skin cancers and a rare type of cancer that can occur in the skin, called Kaposi's sarcoma. Symptoms include skin changes, such as new or changed discoloration, spots, or bumps.

benign and malignant tumors have been reported after immunosuppressive treatment, including skin cancers and a rare type of cancer that can occur in the skin, called Kaposi's sarcoma. Symptoms include skin changes, such as new or changed discoloration, spots, or bumps.

• selective red cell aplasia (a significant decrease in the number of red blood cells), hemolytic anemia (a decrease in the number of red blood cells due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (a decrease in the number of white blood cells that fight infections, with accompanying fever). The frequency of these side effects is not known. The patient may not experience any symptoms or, depending on the severity of the disease, may experience: fatigue, apathy, abnormal paleness (pallor), shortness of breath, dizziness, headache, chest pain, and a feeling of coldness in the hands and feet.
• agranulocytosis (a significant decrease in the number of white blood cells, accompanied by mouth ulcers, fever, and infection/infections). The patient may not experience any symptoms or may experience sudden fever, chills, and sore throat.
• allergic reactions and anaphylaxis with symptoms: 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 vision disturbances. These may be symptoms of a condition known as posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
• optic neuropathy (abnormality of the optic nerve): vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or limited field of vision.

Dailiport may also cause the following side effects, which may be severe:
Very common side effects (may occur in more than 1 in 10 people):
increased blood sugar levels, diabetes, increased potassium levels in the blood
sleep disturbances
tremors, headache
increased blood pressure
abnormal liver function test results
diarrhea, nausea
kidney function disorders
Common side effects (may occur in less than 1 in 10 people):
decreased number of blood cells (platelets, red blood cells, or white blood cells), increased number of white blood cells, changes in red blood cell count (detected in blood tests)
decreased magnesium, phosphate, potassium, calcium, or sodium levels in the blood, fluid retention, increased uric acid or lipid levels in the blood, decreased appetite,
increased blood acidity, other changes in blood electrolyte levels (detected in blood tests)
anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, psychiatric disorders
seizures, disturbances of consciousness, tingling and numbness (sometimes painful) of hands and feet, dizziness, decreased writing ability, nervous system disorders
blurred vision, increased sensitivity to light, eye diseases
ringing in the ears
decreased blood flow in the coronary arteries, accelerated heart rate
bleeding, partial or complete blockage of blood vessels, decreased blood pressure
shortness of breath, changes in lung tissue, fluid accumulation in the space around the lungs, inflammation of the throat, cough, flu-like symptoms
stomach diseases, such as inflammation or ulcers causing abdominal pain or diarrhea, bleeding in the stomach, inflammation or ulceration of the mouth mucosa,
fluid accumulation in the abdominal cavity, vomiting, abdominal pain, indigestion, constipation, bloating (also with gas passage), loose stools
disorders of the bile ducts, yellowing of the skin due to liver function disorders, liver tissue damage, and hepatitis
itching, rash, hair loss, acne, increased sweating
joint pain, limb pain, back pain, and foot pain
kidney function disorders, decreased urine output, painful or difficult urination
general weakness, fever, fluid accumulation in the body, pain and discomfort, increased alkaline phosphatase activity in the blood, weight gain, feeling of temperature disturbances in the body
Uncommon side effects (may occur in less than 1 in 100 people):
changes in blood clotting, decreased number of all types of blood cells (detected in blood tests)
dehydration, inability to urinate
abnormal blood test results: decreased protein or sugar levels, increased phosphate levels, increased lactate dehydrogenase activity in the blood
coma, brain bleeding, stroke, paralysis, brain function disorders, speech and language disorders, memory problems
cataracts, hearing loss
irregular heart rhythm, cardiac arrest, decreased heart function, heart muscle disorders, heart muscle enlargement, increased heart function, abnormal ECG, abnormal heart rate and rhythm
blood clot in a limb vein, shock
breathing difficulties, respiratory tract disorders, asthma
intestinal obstruction, increased amylase activity in the blood, reflux, delayed stomach emptying
skin inflammation, burning sensation when exposed to sunlight
joint diseases
painful menstruation and abnormal menstrual bleeding
multiple organ failure, flu-like symptoms, increased sensitivity to heat and cold, feeling of chest tightness, nervousness or changed mood, weight loss
Rare side effects (may occur in less than 1 in 1000 people):
minor bleeding in the skin due to blood clots
increased muscle stiffness
hearing loss
fluid accumulation in the space around the heart
acute shortness of breath
pancreatic cyst formation
disorders of blood flow through the liver
severe disease with blistering of the skin, mouth, eyes, and genitals, increased hair growth
thirst, falls, feeling of chest tightness, decreased mobility, ulcers
Very rare side effects (may occur in less than 1 in 10,000 people):
muscle weakness
abnormal heart echo
liver failure
painful urination and blood in the urine
increased amount of fatty tissue

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dailiport

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the blister pack and foil sachet after EXP. The expiry date refers to the last day of the month stated.
All capsules should be used within 1 year of opening the aluminum foil sachet, before the expiry date.
The medicine should be stored in its original packaging (aluminum foil sachet) to protect it from light and moisture.
The capsules should be taken immediately after removal from the blister pack.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dailiport contains

The active substance of the medicine is tacrolimus. Each capsule contains 0.5 mg, 1 mg, 2 mg, 3 mg, or 5 mg of tacrolimus (as tacrolimus monohydrate).
The other ingredients are:
capsule contents:ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate
capsule:
Dailiport, 0.5 mg, Dailiport, 2 mg
brilliant blue FCF (E 133), Allura Red AC (E 129), titanium dioxide (E 171), orange yellow FCF (E 110), gelatin, tartrazine (E 102)
Dailiport, 1 mg, Dailiport, 3 mg
brilliant blue FCF (E 133), Allura Red AC (E 129), titanium dioxide (E 171), orange yellow FCF (E 110), gelatin
Dailiport, 5 mg
brilliant blue FCF (E 133), Allura Red AC (E 129), titanium dioxide (E 171), orange yellow FCF (E 110), gelatin, erythrosine (E 127)
printing ink:shellac, Allura Red AC aluminum lake (E 129), brilliant blue FCF aluminum lake (E 133), orange yellow FCF aluminum lake (E 110), propylene glycol, soy lecithin, simethicone
See section 2: "Dailiport 1 mg, Dailiport 3 mg, and Dailiport 5 mg contain lactose, azo dyes containing sodium, and soy".
See section 2: "Dailiport 0.5 mg and Dailiport 2 mg contain lactose, azo dyes containing sodium, and soy".

What Dailiport looks like and contents of the pack

Dailiport, 0.5 mg
A hard gelatin capsule, size 5 (length 10.7-11.5 mm), with a light brown body and light yellow cap, with black printing "0.5 mg", containing a white to yellowish powder or compressed powder.
Dailiport, 1 mg
A hard gelatin capsule, size 4 (length 14.0-14.6 mm), with a light brown body and white cap, with black printing "1 mg", containing a white to yellowish powder or compressed powder.
Dailiport, 2 mg
A hard gelatin capsule, size 3 (length 15.6-16.2 mm), with a light brown body and dark green cap, with black printing "2 mg", containing a white to yellowish powder or compressed powder.
Dailiport, 3 mg
A hard gelatin capsule, size 2 (length 17.7-18.3 mm), with a light brown body and light orange cap, with black printing "3 mg", containing a white to yellowish powder or compressed powder.
Dailiport, 5 mg
A hard gelatin capsule, size 0 (length 21.4-22.0 mm), with a light brown body and pink cap, with black printing "5 mg", containing a white to yellowish powder or compressed powder.
Dailiport capsules are packaged in PVC/PVDC/Aluminum blisters in an aluminum foil sachet, containing a desiccant, in a cardboard box.
The desiccant should not be swallowed.
Package sizes: 30, 50, 60 (2x30), and 100 (2x50) hard capsules in blisters, as well as 30x1, 50x1, 60x1 (2x30), and 100x1 (2x50) capsules in perforated single-dose blisters.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
Domaniewska Street 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the leaflet:02/2025
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