0.5 mg, 1 mg, 2 mg, 3 mg, 5 mg hard prolonged- 
release capsules tacrolimuss

1. What Dailiport is and what it is used for

Dailiport contains the active substance tacrolimus. It is an immunosuppressive drug. After an organ transplant (liver, kidney), your body tries to repel the new organ. Dailiport is used to control the immune system in your body to accept the transplanted organ.

You can also be given Dailiport for an ongoing rejection reaction in your transplanted liver, kidney, heart, or other organs when another treatment you have received has not been able to control the immune system after your transplant.

Dailiport is used for adults.

Tacrolimus contained in Dailiport may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Dailiport

Do not take Dailiport

  • if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to sirolimus or any macrolide antibiotic (eg erythromycin, clarithromycin, josamycin).
  • if you are allergic to peanuts or soy.

Warnings and cautions

Immediate release tacrolimus capsules and Dailiport both contain the active substance tacrolimus. However, Dailiport is taken once daily, while immediate-release tacrolimus capsules are taken twice daily. This is because the Dailiport capsules have delayed-release (slower release for a longer period of time) of tacrolimus. Dailiport and immediate-release tacrolimus capsules are not interchangeable.

Talk to your doctor or pharmacist before taking Dailiport:

  • if you are taking any of the medicines mentioned below under the heading “Other medicines and Dailiport”
  • if you have or have had liver problems
  • if you have diarrhea that lasts more than a day
  • if you get severe abdominal pain accompanied or not by other symptoms such as chills, fever, nausea, or vomiting
  • if you have a change in your heart rhythm called “QT prolongation”, which is shown in the ECG.

Contact your doctor immediately if you suffer from:

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

Your doctor may need to adjust the Dailiport dose.

You should have regular contact with your doctor, who may occasionally need tests of blood, urine, heart function, and eyes, to determine the correct dose of Dailiport.

You should limit exposure to sunlight and UV light (ultraviolet light) while taking Dailiport. This is because immunosuppressive drugs may increase the risk of skin cancer. Wear suitable protective clothing and sunscreen with a high sun protection factor.

Children and young people

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

Other drugs and Dailiport

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 remedies.

Concomitant treatment with Dailiport and ciclosporin (another medicine used to counteract the rejection of transplanted organs) is not recommended.

Blood levels of Dailiport may be affected by other medicines you are taking and blood levels of other medicines may be affected by you taking Dailiport, which means that the dose of Dailiport may need to be increased, decreased, or stopped. You should especially tell your doctor if you are taking or have recently taken any medicines such as:

  • medicines for fungal infections and antibiotics, especially so-called macrolide antibiotics used to treat infections, e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole and isavuconazole, erythromycin, clarithromycin, josamycin and rifampicin
  • HIV – protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), and booster medicine cobicistat combination tablets used to treat HIV – infection
  • HCV – protease inhibitor (eg telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir), used to treat hepatitis C infection
  • nilotinib and imatinib (used to treat certain cancers)
  • mycophenolic acid, which is used to suppress the immune system to prevent rejection of the transplanted organ
  • medicines for stomach ulcers and acid reflux (eg omeprazole, lansoprazole, or cimetidine)
  • medicines for nausea and vomiting (eg metoclopramide)
  • cisapride or magnesium- aluminum hydroxide, used to treat heartburn
  • birth control pills or other hormone treatments that contain Ethinyl estradiol, hormone treatments with danazol
  • medicines for high blood pressure or heart problems (eg nifedipine, nicardipine, diltiazem, and verapamil)
  • antiarrhythmics ( amiodarone ), medicines used to treat arrhythmias (irregular heartbeat)
  • medicines are known as “statins” used to treat elevated cholesterol and triglyceride s
  • phenytoin and phenobarbital used to treat epilepsy
  • corticosteroids are prednisolone and methylprednisolone, a type of corticosteroids that are used to treat inflammation s or suppress the immune system (such as in transplant rejection)
  • nefazodone used to treat depression
  • an herbal medicine containing St. John’s wort ( Hypericum perforatum ) or extract of Schisandra sphenanthera.

Tell your doctor if you are taking or need to take ibuprofen (medicines for fever, inflammation, and pain), amphotericin B (medicines for bacterial infections), or medicines for viral infections (eg aciclovir). These can aggravate kidney problems or nervous system problems when taken with Dailiport.

Your doctor must also know if you are taking potassium supplements or certain diuretics used for heart failure, high blood pressure, and kidney disease (eg amiloride, triamterene, or spironolactone ), certain medicines used for fever, inflammation, and pain (so-called NSAIDs, t (eg ibuprofen ), blood thinners or oral medication to treat diabetes while you are taking Dailiport.

If you need to be vaccinated, tell your doctor in advance.

Dailiport with food and drink

Avoid grapefruit (including grapefruit juice) when you are being treated with Dailiport, as it affects your blood levels

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dailiport passes into breast milk. Therefore, you should not breast-feed while taking Dailiport.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dailiport contains excipients

Dailiport contains lactose , para-orange (E110), allura red AC (E129) and soy.

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

Dailiport contains para-orange (E110) and Allura red AC (E129) which may cause allergic reactions.

The printing ink used to label the Dailiport capsules contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Dailiport 0.5 mg contains tartrazine (E102).

Dailiport contains tartrazine (E102) which may cause allergic reactions.

Dailiport 2 mg contains tartrazine (E102).

Dailiport contains tartrazine (E102) which may cause allergic reactions.

3. How to take Dailiport

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. This medicine should only be prescribed to you by a doctor who has experience in the treatment of transplant patients.

Make sure you get the same tacrolimus medicine every time you pick up your prescription unless your transplant doctor has decided to switch you to another tacrolimus medicine. This medicine should be taken once daily. If the appearance of the medicine is not the same as usual, or if the dosing instructions have been changed, talk to your doctor or pharmacist as soon as possible to make sure you have received the correct medicine.

The starting dose to prevent rejection of your transplanted organ is determined by your doctor and is calculated according to your body weight. The starting doses immediately after transplantation are normally in the range of 0.10 – 0.30 mg per kg body weight per day, depending on the organ transplant. In the treatment of rejection, the same dosage can be used.

Dose one depends on your general condition and what other immunosuppressive drug (s) you are receiving.

After starting treatment with Dailiport, your doctor will take blood samples frequently to arrive at the correct dose. Then regular blood tests are required for your doctor to determine the correct dose and to adjust the dose from time to time. Dose one for Dailiport is usually reduced by your doctor once your condition has stabilized. Your doctor will tell you exactly how many capsules to take.

You will need to take Dailiport every day for as long as you need immunosuppression to prevent rejection of your transplanted organ. You should be in regular contact with your doctor.

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 for the next meal. Take the capsules immediately after removing them 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 ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Dailiport

If you forget to take your dose of Dailiportkapslar in the morning, take them as soon as possible on the same day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dailiport

Discontinuation of treatment with Dailiport may increase the risk of rejection of your transplanted organ. Do not stop your treatment as long as your doctor does not tell you to.

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

4. Possible side effects

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

Dailiport weakens the body’s defense mechanism (immune system), which impairs the body’s ability to fight infection. When you take Dailiport you can therefore get more infection than usual.

Serious side effects have been reported, including allergic and anaphylactic reactions. Benign and malignant tumors have been reported during treatment with Dailiport.

Cases of pure erythrocyte plasma (very severe decrease in red blood cell count ), agranulocytosis (severe decrease in white blood cell count ) and hemolytic anemia(decreased red blood cell count due to increased degradation) have been reported.

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

  • Increased blood sugar, diabetes mellitus, increased potassium in the blood
  • Difficulty sleeping
  • Tremors, headaches
  • Increased blood pressure
  • Abnormal liver function values
  • Diarrhea, nausea
  • Kidney problems

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

  • Decreased number of blood cells ( platelets, red or white blood cells ), increased number of white blood cells, changes in the number of red blood cells (seen in blood samples)
  • Decreased magnesium, phosphate, potassium, calcium, or sodium in the blood, increased water content in the body, increased amount of uric acid or fats in the blood, decreased appetite, increased acidity in the blood, other changes in blood salts (seen in blood samples)
  • Anxiety, confusion, and difficulty orienting, depression, mood swings, nightmares, hallucinations, mental illness
  • Seizures, disturbances in consciousness, ant crawling or numbness (sometimes painful) in the hands and feet, dizziness, reduced writing ability, nerve diseases
  • Blurred vision, increased photosensitivity, eye diseases
  • Earrings
  • Decreased blood flow in the heart vessels, faster heartbeat
  • Bleeding, partial or complete blockage of blood vessels decreased blood pressure
  • Shortness of breath, changes in the lungs, fluid accumulation around the lungs, inflammation of the throat, cough, flu-like symptoms
  • Stomach problems such as inflammation or sores that cause abdominal pain or diarrhea, bleeding in the stomach or inflammation or sores in the mouth, fluid accumulation in the abdomen, vomiting, abdominal pain, digestive problems, constipation, flatulence, flatulence, loose stools
  • Bile duct problems, yellowing of the skin due to liver problems, damage to liver tissue, and liver inflammation
  • Itching, rash, hair loss, acne, increased sweating
  • Pain in joints, limbs, back, and feet, muscle twitching
  • Insufficient renal function, decreased urine output, impaired or painful urination
  • General weakness, fever, fluid retention in the body, pain, and discomfort, increase in alkaline phosphatases in the blood, weight gain, disturbed temperature perception
  • The insufficient function of the transplanted organ

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

  • Changes in blood clotting ability, decrease in the number of all kinds of blood cells(seen in blood samples)
  • Dehydration, inability to throw water
  • Abnormal blood test results: decreased protein or sugar, increased phosphate, increased enzyme, and lactate dehydrogenase
  • Coma, cerebral hemorrhage, stroke, paralysis, brain disease, speech and language difficulties, memory problems
  • Clouding in the lens of the eye, impaired hearing
  • Irregular heartbeat, cardiac arrest, decreased heart rate, heart muscle disease, enlargement of the heart muscle, heavier heartbeat, abnormal ECG, abnormal heart rate, and heart rate
  • A blood clot in a friend in leg or arm, shock
  • Breathing difficulties, respiratory disease, asthma
  • Obstacles in the intestinal passage, increased level of enzyme and amylase in the blood, regurgitation of contents from the stomach to the throat, slowed emptying of the stomach
  • Skin inflammation, burning sensation in the sun
  • Joint diseases
  • Painful menstruation and abnormal menstrual bleeding
  • Impaired function of several organs, flu-like symptoms, increased sensitivity to heat and cold, pressure over the chest, nervousness or abnormal feeling, weight loss

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

  • Small skin bleeds due to clotted blood
  • Increased muscle stiffness
  • Blindness, deafness
  • Accumulation of fluid around the heart
  • Acute breathing difficulties
  • Cyst formation in the pancreas
  • Problems with blood flow in the liver
  • Severe disease with blistering of the skin, mouth, eyes, and genitals; increased hair
  • Thirst falls, feeling of pressure over the chest, decreased mobility, sores

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

  • Muscle weakness
  • Abnormal echocardiogram ( ECG )
  • Liver failure
  • Painful urination with blood in the urine
  • The increased amount of adipose tissue

No known frequency (cannot be calculated from the available data):

  • Visual nerve damage ( optic neuropathy )

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 aluminum bag after EXP. The expiration date is the last day of the specified month. Use all capsules within 1 year after opening the aluminum bag and before the expiry date.

Store in the original packaging (aluminum bag). Sensitive to light and sensitive to moisture.

Take the capsule immediately after removing it from the blister.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is tacrolimus. One capsule contains 0.5 mg, 1 mg, 2 mg, 3 mg, or 5 mg tacrolimus (as monohydrate).
  • Other ingredients are Capsule contents: ethylcellulose, hypromellose, lactose, magnesium stearate.Capsule shell:Dailiport 0.5 mgBrilliant blue FCF (E133), Allura red AC (E129), titanium dioxide (E171), para-orange (E110), gelatin, tartrazine (E102).
    Dailiport 1 mgBrilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), para-orange (E110), gelatin.
    Dailiport 2 mgBrilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), para-orange (E110), gelatin, tartrazine (E102).
    Dailiport 3 mgBrilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), para-orange (E110), gelatin.
    Dailiport 5 mgBrilliant blue FCF (E133), allura red AC (E129), titanium dioxide (E171), para-orange (E110), gelatin, erythrosine (E127).
    Printing pink shellac, all-red AC aluminum lacquer (E129), brilliant blue FCF aluminum lacquer (E133), para-orange aluminum lacquer (E110), propylene glycol (E1520), soy lecithin, simethicone. See section 2 “Dailiport contains lactose, para-orange (E110), Allura red AC (E129) and soy.”See section 2 “Dailiport 0.5 mg contains tartrazine (E102).”See section 2 “Dailiport 2 mg contains tartrazine (E102).”

What the medicine looks like and the contents of the pack

Dailiport 0.5 mg prolonged-release hard capsules

Gelatin capsule size 5 with the light brown lower part and light yellow upper part, with “0.5 mg” printed in black, containing white to yellowish powder or compressed powder (length 10.7‑11.5 mm).

Dailiport 1 mg hard prolonged-release capsules

Gelatin capsule size 4 with light brown base and white top, with “1 mg” printed in black, containing white to yellowish powder or compressed powder (length 14.0‑14.6 mm).

Dailiport 2 mg hard prolonged-release capsules

Gelatin capsule size 3 with light brown base and dark green top, with “2 mg” printed in black, containing white to yellowish powder or compressed powder (length 15.6‑16.2 mm).

Dailiport 3 mg hard prolonged-release capsules

Gelatin capsule size 2 with the light brown lower part and light orange upper part, with “3 mg” printed in black, containing white to yellowish powder or compressed powder (length 17.7‑18.3 mm).

Dailiport 5 mg hard prolonged-release capsules

Gelatin capsule size 0 with the light brown lower part and pink upper part, with “5 mg” printed in black, containing white to yellowish powder or compressed powder (length 21.4‑22.0 mm).

PVC / PVDC / aluminum blisters in an aluminum bag with desiccant. The desiccant must not be swallowed.

Pack sizes: 30, 50, 60 and 100 capsules in blisters and 30 x 1, 50 x 1, 60 x 1 and 100 x 1 capsules in perforated unit dose blisters.

Several capsules per aluminum bag:

30 capsules in 1 bag

50 capsules in 1 bag

60 capsules in 2 bags (2 x 30 capsules)

100 capsules in 2 bags (2 x 50 capsules)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovskova ulica 57, 1526 Ljubljana, Slovenia

or

Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia

Muhammad Nadeem

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