Dailiport 0.5 mg prolonged-release hard capsules – patient leaflet, side effects, dosage

1 What Dailiport is and what it is used for

metoclopramide)

• cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn
• the contraceptive pill or other hormone treatments with

Dailiport contains the active substance tacrolimus. It is an immunosuppressant. Following your organ transplant (liver, kidney), your body’s immune system will try to reject the new organ. Dailiport is used to control your body’s immune response, enabling your body to accept the transplanted organ.

ethinylestradiol, hormone treatments with danazol

• medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem and verapamil)
• anti-arrhythmic drugs (amiodarone) used to control

You may also be given Dailiport for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.

arrhythmia (uneven beating of the heart)

• medicines known as “statins” used to treat elevated cholesterol and triglycerides
• carbamazepine, phenytoin or phenobarbital, used to treat epilepsy

Dailiport is used in adults.

• metamizole, a medicine used to treat pain and fever

• the corticosteroids prednisolone and

  methylprednisolone, belonging to the class of corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant rejection)

2 What you need to know before you take

Dailiport

• nefazodone, used to treat depression
• herbal preparations containing St. John’s Wort

Do not take Dailiport:

(Hypericum perforatum) or extracts of Schisandra sphenanthera.

• if you are allergic (hypersensitive) to tacrolimus or any of

  • cannabidiol (uses amongst others include treatment of

the other ingredients of this medicine (listed in section 6).

seizures)

• if you are allergic to sirolimus or to any macrolide-

  antibiotic (e.g. erythromycin, clarithromycin, josamycin).

  Tell your doctor if you are receiving treatment for hepatitis C. The drug treatment for hepatitis C may change your liver function and may affect blood levels of tacrolimus. Tacrolimus blood levels may fall or may increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor tacrolimus blood levels and make necessary adjustments of Dailiport dose after you start treatment for hepatitis C.

• if you are allergic to peanut or soya.

Warnings and precautions

Tacrolimus immediate release capsules and Dailiport both contain the active substance, tacrolimus. However, Dailiport is taken once daily, whereas Tacrolimus immediate release capsules are taken twice daily. This is because Dailiport capsules allow for a prolonged release (more slow release over a longer period) of tacrolimus. Dailiport and Tacrolimus immediate release capsules are not interchangeable.

Tell 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. acyclovir, ganciclovir, cidofovir, foscarnet). These may worsen kidney or nervous system problems when taken together with Dailiport.

Talk to your doctor or pharmacist before taking Dailiport:

• if you are taking any medicines mentioned below under

  ‘Other medicines and Dailiport’

• if you have or have had liver problems
• if you have diarrhoea for more than one day

• if you feel strong abdominal pain accompanied or not

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

  with other symptoms, such as chills, fever, nausea or vomiting

• if you have an alteration of the electrical activity of your

  heart called “QT prolongation”.

• if you have or have had damage to the smallest

  blood vessels, known as thrombotic microangiopathy/ thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome. Tell your doctor if you develop fever, bruising under the skin (which may appear as red dots), unexplained tiredness, confusion, yellowing of the skin or eyes, reduced urine output, vision loss and seizures (see section 4). When tacrolimus is taken together with sirolimus or everolimus, the risk of developing these symptoms may increase.

  Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease, (e.g. amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole that may increase levels of potassium in your blood, nonsteroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Dailiport.

Please avoid taking any herbal remedies, e.g., St. John’s wort (Hypericum perforatum) or any other herbal products as this may affect the effectiveness and the dose of [Nationally completed name] that you need to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies.

If you need to have any vaccinations, please tell your doctor before.

Dailiport with food and drink

Avoid grapefruit (also as juice) while on treatment with Dailiport, since it can affect its levels in the blood.

Tell your doctor immediately if during treatment you suffer from:

Pregnancy and breastfeeding

If you are, think you might be or are planning to become pregnant, ask your doctor for advice before using Dailiport. One study assessed pregnancy outcomes in women treated with tacrolimus and those treated with other immunosuppressants. While there was insufficient evidence in this study to draw conclusions, higher rates of miscarriage were reported among liver and kidney transplant patients treated with tacrolimus, as well as higher rates among kidney transplant patients of persistent hypertension associated with protein loss in the urine that develops during pregnancy or the postpartum period (a condition called pre-eclampsia). No increased risk of major birth defects associated with Dailiport use was found.

• problems with your vision such as blurred vision,

  changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.

Your doctor may need to adjust your dose of Dailiport.

You should keep in regular contact with your doctor. From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Dailiport.

You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Dailiport. This is because immunosuppressants could increase the risk of skin cancer. Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.

Dailiport passes into breast milk. Therefore, you should not breastfeed whilst using Dailiport.

Driving and using machines

Precaution for handling:

Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Dailiport. These effects are more frequent if you also drink alcohol.

Direct contact with any part of your body like your skin or eyes, or breathing in of injection solutions, powder or granules contained in tacrolimus products should be avoided during preparation. If such contact occurs, wash the skin and eyes.

Dailiport 0.5 mg and 2 mg capsules contains lactose and azo colouring agents, containing sodium, and soya.

Children and adolescents

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

Other medicines and Dailiport

This medicine contains the azo colouring agents Sunset yellow FCF (E 110), Allura red AC (E 129) and tartrazine (E 102) which may cause allergic reactions.

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

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release hard capsules, that is to say essentially ‘sodium‑free’.

It is not recommended that Dailiport is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).

The printing ink used to mark Dailiport capsules contains soya lecithin. If you are allergic to peanut or soya, do not use this medicine.

If you need to attend 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 should use another medicine that could increase or decrease your tacrolimus blood level.

Dailiport 1 mg, 3 mg and 5 mg capsules contains lactose, azo colouring agents, containing sodium, and soya.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Dailiport blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Dailiport, which may require interruption, an increase or a decrease in Dailiport dose.

This medicine contains the azo colouring agents Sunset yellow FCF (E 110) and Allura red AC (E 129) which may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release hard capsules, that is to say essentially ‘sodium‑free’.

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

The printing ink used to mark Dailiport capsules contains soya lecithin. If you are allergic to peanut or soya, do not use this medicine.

An effect on the Dailiport blood levels may occur very soon after starting the use of another medicine, therefore frequent continued monitoring of your Dailiport blood level may be needed within the first few days of starting another medicine and frequently while treatment with the other medicine continues. Some other medicines may cause tacrolimus blood levels to decrease, which could increase the risk of rejecting the transplanted organ.

3 How to take Dailiport

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine should only be prescribed to you by a doctor with experience in the treatment of transplant patients.

In particular, you should tell your doctor if you are taking or have recently taken medicines like:

Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine. This medicine should be taken once a day. If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.

• antifungal medicines and antibiotics, particularly

  so-called macrolide antibiotics, used to treat infections e.g. ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, and isavuconazole, miconazole, caspofungin, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniazid and flucloxacillin

• letermovir, used to prevent illness caused by CMV

  (human cytomegalovirus)

  The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight. Initial daily doses just after transplantation will generally be in the range of 0.10 – 0.30 mg per kg body weight per day depending on the transplanted organ. When treating rejection, these same doses may be used.

• HIV protease inhibitors (e.g. ritonavir, nelfinavir,

  saquinavir), the booster medicine cobicistat, and combination tablets, or HIV non-nucleoside reverse transcriptase inhibitors (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

  Your dose depends on your general condition and on which other immunosuppressive medication you are taking.

• nilotinib and imatinib, idelalisib, ceritinib, crizotinib,

  apalutamide, enzalutamide, or mitotane (used to treat certain cancers)

• 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)

Dailiport is taken orally once daily in the morning. Take Dailiport on an empty stomach or 2 to 3 hours after a meal. Wait at least 1 hour until the next meal. Take the capsules immediately following removal from the blister. The capsules should be swallowed whole with a glass of water. Do not swallow the desiccant contained in the aluminum bag.

If you take more Dailiport than you should

If you have accidentally taken too much Dailiport, contact your doctor or nearest hospital emergency department immediately.

If you forget to take Dailiport

If you have forgotten to take your Dailiport capsules in the morning, take them as soon as possible on the same day. Do not take a double dose the next morning to make up for a forgotten tablet

If you stop taking Dailiport

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

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

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Dailiport reduces your body’s defence mechanism (immune system), which will not be as good at fighting infections. Therefore, you may be more prone to infections while you are taking Dailiport. Some infections could be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.

Tell your doctor immediately if you get signs of an infection including:

• Fever, cough, sore throat, feeling weak or generally unwell
• Memory loss, trouble thinking, difficulty walking or loss of vision - these may be due to a very rare, serious brain infection, which can be fatal (Progressive Multifocal Leukoencephalopathy or PML)

Severe effects may occur, including allergic and anaphylactic reactions. Benign and malignant tumours have been reported following Dailiport treatment.

Tell your doctor immediately if you have or suspect you may have any of the following serious side effects:

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

• Gastrointestinal perforation: strong abdominal pain

  accompanied or not with other symptoms, such as chills, fever, nausea or vomiting.

• Insufficient function of your transplanted organ.
• Blurred vision.

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

• Thrombotic microangiopathy (damage to the smallest

  blood vessels) including haemolytic uraemic syndrome, a condition with the following symptoms: low or no urine output (acute renal failure), extreme tiredness, yellowing of the skin or eyes (jaundice) and abnormal bruising or bleeding and signs of infection.

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

• Thrombotic Thrombocytopenic Purpura: a condition

  involving damage to the smallest blood vessels and characterised by fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure (low or no urine output), vision loss and seizures.

• Toxic epidermal necrolysis: erosion and blistering of

  skin or mucous membranes, red swollen skin that can detach in large parts of the body.

• Blindness.

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

• Stevens-Johnson syndrome: unexplained widespread

  skin pain, facial swelling, serious illness with blistering of skin, mouth, eyes and genitals, hives, tongue swelling, red or purple skin rash that spreads, skin shedding.

• Torsades de pointes: change in the heart frequency

  that can be accompanied or not of symptoms, such as chest pain (angina), faint, vertigo or nausea, palpitations (feeling the heartbeat) and difficulty breathing.

Serious side effects – frequency not known (frequency cannot be estimated from the available data):

• Opportunistic infections (bacterial, fungal, viral and

  protozoal): prolonged diarrhoea, fever and sore throat.

• Benign and malignant tumours have been reported

  following treatment as a result of 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 counts), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown accompanied with tiredness) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported. It is not known exactly how often these side effects occur. You may have no symptoms or depending on the severity of the condition, you may feel: fatigue, apathy, abnormal paleness of the skin (pallor), shortness of breath, dizziness, headache, chest pain and coldness in hands and feet.

• Cases of agranulocytosis (a severely lowered number of

  white blood cells accompanied with ulcers in the mouth, fever and infection(s)). You may have no symptoms or you may feel sudden fever, rigors and sore throat.

• Allergic and anaphylactic reactions with the following

  symptoms: a sudden itchy rash (hives), swelling of hands, feet, ankle, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) and you may feel you are going to faint.

• Posterior Reversible Encephalopathy Syndrome

  (PRES): headache, confusion, mood changes, fits, and disturbances of your vision. 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 (abnormality of the optic nerve):

  problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or restriction of your field of vision.

The side effects listed below may also occur after receiving [Nationally completed name] and could be serious:

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

• Increased blood sugar, diabetes mellitus, increased

  potassium in the blood

• Difficulty in sleeping
• Trembling, headache
• Increased blood pressure
• Liver function tests abnormal
• Diarrhoea, nausea
• Kidney problems

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

• Reduction in blood cell counts (platelets, red or white

  blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests)

• Reduced magnesium, phosphate, potassium, calcium

  or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts (seen in blood tests)

• Anxiety symptoms, confusion and disorientation,

  depression, mood changes, nightmare, hallucination, mental disorders

• Fits, disturbances in consciousness, tingling and

  numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders

• Blurred vision, increased sensitivity to light, eye

  disorders

• Ringing sound in your ears

• Reduced blood flow in the heart vessels, faster

  heartbeat

• Bleeding, partial or complete blocking of blood vessels,

  reduced blood pressure

• Shortness in breath, changes in the lung tissue,

  collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms

• Stomach problems such as inflammation or ulcer

  causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting, abdominal pain, indigestion, constipation, flatulence (passing wind), bloating, loose stools

  • Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver
  • Itching, rash, hair loss, acne, increased sweating
  • Pain in joints, limbs, back and feet, muscle spasms
  • Insufficient function of the kidneys, reduced production of urine, impaired or painful urination
  • General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed

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

• Changes in blood clotting, reduction in the number of all types of blood cells (seen in blood tests)
• Dehydration
• Abnormal blood test results: reduced protein or sugar, increased phosphate
• Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems
• Clouding of the eye lens
• Impaired hearing
• Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal
• Blood clot in a vein of a limb, shock
• Difficulties in breathing, respiratory tract disorders, asthma
• Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach
• Inflammation of the skin, burning sensation in the sunlight
• Joint disorders
• Inability to urinate, painful menstruation and abnormal menstrual bleeding
• Multiple organ failure, flu-like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss

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

• Small bleedings in your skin due to blood clots
• Increased muscle stiffness
• Deafness
• Collection of fluid around the heart
• Acute breathlessness
• Cyst formation in your pancreas
• Problems with blood flow in the liver
• Increased hairiness
• Serious illness with blistering of skin, mouth, eyes and genitals
• Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer

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

• Muscular weakness
• Abnormal heart scan
• Liver failure
• Painful urination with blood in the urine
• Increase of fat tissue

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Dailiport

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

Do not use this medicine after the expiry date which is stated on the carton blister and bag after “EXP”. The expiry date refers to the last day of that month. Use all the capsules within 1 year after opening the aluminium bag and before the expiry date.

Store in the original package (aluminium bag) in order to protect from light and moisture.

Take the capsule immediately after removing from the blister.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other

information

What Dailiport contains

• The active substance is tacrolimus. Each capsule contains 0.5 mg, 1 mg, 2 mg, 3 mg or 5 mg of tacrolimus (as monohydrate).

• The other ingredients are:

  Capsule content: ethylcellulose, hypromellose, lactose, magnesium stearate.

  Capsule shell:

  Dailiport 0.5 mg and 2mg capsules

  Brilliant blue FCF (E 133), Allura red AC (E 129), titanium dioxide (E 171), Sunset yellow FCF (E 110), gelatin, tartrazine (E 102).

  Dailiport 1 mg and 3mg capsules

  Brilliant blue FCF (E 133), Allura red AC (E 129), titanium dioxide (E 171), Sunset yellow FCF (E 110), gelatin.

  Dailiport 5 mg capsules

  Brilliant blue FCF (E 133), Allura red AC (E 129), titanium dioxide (E 171), Sunset yellow FCF (E 110), gelatin, erythrosin (E 127).

  Printing ink

  Shellac Glaze, Allura Red AC Aluminum Lake (E 129), Brilliant blue FCF Aluminum Lake (E 133), Sunset Yellow FCF Aluminum Lake (E 110), propylene glycol (E 1520), lecithin (soya), simeticone

  Dailiport 1 mg, 3 mg and 5 mg capsules

  See section 2 “Dailiport 1 mg, 3 mg and 5 mg capsules contains lactose, azo colouring agents, containing sodium, and soya.”

  Dailiport 0.5 mg and 2 mg capsules

  See section 2 “Dailiport 0.5 mg and 2 mg capsules contains lactose, azo colouring agents, containing sodium, and soya.”

What Dailiport looks like and contents of the pack

Dailiport 0.5 mg prolonged-release hard capsules Gelatin capsule size 5 with a light brown body and a light yellow cap, imprinted in black with “0.5 mg”, containing white to yellowish powder or compacted powder (length 10.7 – 11.5 mm).

Dailiport 1 mg prolonged-release hard capsules Gelatin capsule size 4 with a light brown body and a white cap, imprinted in black with “1 mg”, containing white to yellowish powder or compacted powder (length 14.0 – 14.6 mm).

Dailiport 2 mg prolonged-release hard capsules Gelatin capsule size 3 with a light brown body and a dark green cap, imprinted in black with “2 mg”, containing white to yellowish powder or compacted powder (length 15.6 – 16.2 mm).

Dailiport 3 mg prolonged-release hard capsules Gelatin capsule size 2 with a light brown body and a light orange cap, imprinted in black with “3 mg”, containing white to yellowish powder or compacted powder (length 17.7 – 18.3 mm).

Dailiport 5 mg prolonged-release hard capsules Gelatin capsule size 0 with a light brown body and a pink cap, imprinted in black with “5 mg”, containing white to yellowish powder or compacted powder (length 21.4 – 22.0 mm).

PVC/PVDC // aluminium blister with desiccant sealed in aluminium bag. The dessicant should not be swallowed.

Packs sizes: 30, 50, 60 (2x30) and 100 (2x50) capsules in blister and 30x1, 50x1, 60x1(2x30) and 100x1(2x50) capsules in unit-dose perforated blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Limited

Maxis 1, Western Road

Bracknell

RG12 1RF

United Kingdom

Manufacturer(s):

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220 Lendava

Slovenia

This leaflet was last revised in 04/2025