Dailiport

Package leaflet: Information for the patient

Dailiport, 0.5 mg, prolonged-release capsules, hard
Dailiport, 1 mg, prolonged-release capsules, hard
Dailiport, 2 mg, prolonged-release capsules, hard
Dailiport, 3 mg, prolonged-release capsules, hard
Dailiport, 5 mg, prolonged-release capsules, hard
Tacrolimus
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Dailiport is and what it is used for

Dailiport contains the active substance tacrolimus. It is an immunosuppressive medicine. After an organ transplant (liver, kidney), the patient's immune system may try to reject the new organ. Dailiport is used to control the immune response and to allow the body to accept the transplanted organ.
Dailiport may also be used in cases of ongoing rejection of transplanted liver, kidney, heart, or other organs, when prior treatment has failed to control the body's immune response following transplantation.
Dailiport is used in adult patients.

2. Important information before using Dailiport

When not to use Dailiport
if the patient is allergic (hypersensitive) to tacrolimus or to any of the other
ingredients of this medicine (listed in section 6);
if the patient is allergic to sirolimus or to any macrolide antibiotic (e.g.
erythromycin, clarithromycin, josamycin);
if the patient is allergic to peanuts or soya.

Warnings and precautions
Tacrolimus in immediate-release capsules and Dailiport contain the same
active substance, tacrolimus. However, Dailiport is taken once daily, whereas tacrolimus
in immediate-release capsules is taken twice daily. Dailiport capsules allow prolonged (slower and longer-lasting) release of tacrolimus. Dailiport and tacrolimus in immediate-release capsules are not interchangeable.
Before using Dailiport, discuss with your doctor or pharmacist if:

• the patient is taking any of the medicines listed later in section “Dailiport with other medicines”,
• the patient has or has had liver function disorders in the past,
• the patient has had diarrhoea lasting longer than 1 day,
• the patient experiences severe abdominal pain with or without other symptoms such as chills, fever, nausea or vomiting,
• the patient has been diagnosed with an electrical heart disorder known as “QT interval prolongation”,
• the patient has or has had damage to the smallest blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Inform the doctor if 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 occur (see section 4). If tacrolimus is taken together with sirolimus or everolimus, the risk of these symptoms may increase.
• The patient should avoid taking any herbal products, e.g. St John’s wort (Hypericum perforatum) or any other herbal preparations, as they may affect the effectiveness and required dosage of Dailiport. If in doubt, consult your doctor before taking any herbal products or supplements.

Tell your doctor immediately if, during treatment, the following occur:

• vision problems, such as blurred vision, changes in colour vision, difficulty perceiving details or reduced field of vision.

Your doctor may decide to adjust the dose of Dailiport.
Regularly consult your doctor. Your doctor may periodically recommend blood tests, urine tests, heart function tests and vision examinations to determine the appropriate dose of Dailiport.
While taking Dailiport, limit exposure to sunlight and UV radiation due to increased risk of skin cancer. Wear protective clothing and use sunscreen with a high protection factor.

Precautions for handling
When preparing, avoid direct contact with any part of the body, such as skin or eyes, or inhalation of products containing tacrolimus in solution, powder or granule form. If such contact occurs, wash the skin and eyes thoroughly.

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

Dailiport with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those obtained without prescription, as well as herbal supplements.
Concomitant use of Dailiport with cyclosporine (another medicine used to prevent organ transplant rejection) is not recommended.
If visiting a doctor other than a transplant specialist, inform the doctor that you are taking tacrolimus. The doctor may wish to consult with a transplant specialist regarding whether you should take another medicine that may increase or decrease tacrolimus blood levels.
Dailiport and other concomitantly administered medicines may interact and affect each other’s blood concentrations. It may be necessary to discontinue, increase or decrease the dose of Dailiport.
In some patients, blood levels of tacrolimus have increased when taking other medicines. This may lead to serious adverse effects such as kidney dysfunction, nervous system disorders and cardiac arrhythmias (see section 4).
Changes in Dailiport blood levels may occur very quickly after starting another medicine, so frequent monitoring of Dailiport blood levels may be required during the first few days after starting another medicine and frequently during continued treatment. Some other medicines may reduce tacrolimus blood levels, which could increase the risk of organ transplant rejection. Inform your doctor especially if the patient is taking or has recently taken the following medicines:
antifungal medicines and antibiotics (especially so-called 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 human cytomegalovirus (CMV);
HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the pharmacokinetic booster cobicistat, and combination tablets or non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine);
HCV protease inhibitors (e.g. telaprevir, boceprevir, and the 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 peptic ulcer disease 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 aluminium hydroxide used to treat heartburn;
oral contraceptives or other hormonal therapies containing ethinylestradiol, or danazol hormonal therapy;
medicines used to treat high blood pressure or heart function disorders (e.g. nifedipine, nicardipine, diltiazem and verapamil);
antiarrhythmic medicines (amiodarone) used to control arrhythmias (irregular heartbeat);
statins used to treat elevated cholesterol and triglyceride levels;
carbamazepine, phenytoin or phenobarbital used to treat epilepsy;
metamizole, a medicine used to treat pain and fever;
corticosteroids prednisolone and methylprednisolone used to treat inflammation or to suppress immune system function (e.g. in transplant rejection);
nefazodone used to treat depression;
herbal medicines containing St John’s wort (Hypericum perforatum) or extracts from Chinese magnolia vine (Shisandra sphenanthera);
cannabidiol (a medicine used, among others, to treat seizures).

Inform your doctor if you are being treated for hepatitis C. Treatment for hepatitis C may alter liver function and affect tacrolimus blood levels. Tacrolimus blood levels may decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may wish to closely monitor tacrolimus blood levels and make necessary dose adjustments to Dailiport after starting treatment for hepatitis C.
Tell your doctor if you are taking or plan to take ibuprofen (used to treat fever, inflammation and pain), antibiotics (co-trimoxazole, vancomycin or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections) or antiviral medicines (used to treat viral infections, i.e. acyclovir, ganciclovir, cidofovir, foscarnet). These medicines, when taken together with Dailiport, may increase kidney or nervous system disorders.
Inform your doctor if you are taking sirolimus or everolimus. Concurrent use of tacrolimus with sirolimus or everolimus may increase the risk of thrombotic microangiopathy, thrombotic thrombocytopenic purpura and hemolytic uremic syndrome (see section 4).
Also inform your doctor if, while taking Dailiport, you are also taking potassium supplements or certain diuretics used to treat heart failure, hypertension and kidney disease (e.g. amiloride, triamterene or spironolactone) or antibiotics trimethoprim or co-trimoxazole, which may increase blood potassium levels, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used to treat fever, inflammation and pain, anticoagulants (blood thinners) or oral antidiabetic medicines.
If the patient is due to receive any vaccination, inform the doctor beforehand.

Dailiport with food and drink
While taking Dailiport, avoid eating grapefruit or drinking grapefruit juice due to the potential effect on drug blood levels.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using Dailiport. In one study, pregnancy outcomes were evaluated in women treated with tacrolimus and women treated with other immunosuppressive medicines. Although this study did not provide sufficient evidence to draw definitive conclusions, a higher rate of miscarriages was observed among liver and kidney transplant patients treated with tacrolimus, as well as a higher rate of kidney transplant patients with persistent hypertension associated with proteinuria developing during pregnancy or postpartum (a condition called pre-eclampsia). No increased risk of serious congenital malformations associated with Dailiport use has been demonstrated.
Dailiport passes into human milk. Breastfeeding is not recommended while taking Dailiport.

Driving and operating machinery
If after taking Dailiport the patient experiences dizziness, drowsiness or vision disturbances, the patient should not drive or operate machinery. These symptoms are more likely if alcohol is consumed while taking Dailiport.

Dailiport 0.5 mg and Dailiport 2 mg contain lactose, azo dyes containing sodium and soya
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains azo dyes: sunset 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, meaning the medicine is considered “sodium-free”.
The ink used to mark the capsules contains soya lecithin. If the patient is allergic to peanuts or soya, the patient should not take this medicine.

Dailiport 1 mg, Dailiport 3 mg and Dailiport 5 mg contain lactose, azo dyes containing sodium and soya.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains azo dyes: sunset 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, meaning the medicine is considered “sodium-free”.
The ink used to mark the capsules contains soya lecithin. If the patient is allergic to peanuts or soya, the patient should not take this medicine.

3. How to use Dailiport

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. This medicine is prescribed only by doctors experienced in managing transplant patients.
When dispensing the prescription, ensure that the same medicine containing tacrolimus is dispensed each time, unless the transplant specialist has specifically recommended switching to another medicine containing tacrolimus.
This medicine should be taken once daily. If the medicine looks different than usual or if dosing instructions have changed, contact your doctor or pharmacist as soon as possible to confirm that the correct medicine has been dispensed.
The initial dose used to prevent rejection of the transplanted organ is determined by the doctor based on the patient's body weight. Initial doses administered shortly after transplantation generally range from 0.10 to 0.30 mg per kilogram of body weight per day (depending on the transplanted organ). The same doses may be used in the treatment of ongoing transplant rejection.
The recommended dose depends on the patient's general condition and on which other immunosuppressive medicines are being taken.
After starting treatment with Dailiport, your doctor will frequently order blood tests to determine the appropriate dose. Continued treatment may require regular blood tests to establish the correct dose and to adjust it periodically. Once the patient's condition has stabilized, the doctor will usually reduce the dose of Dailiport. The doctor will clearly specify how many capsules to take and how often.
Dailiport should be taken daily for as long as immunosuppression is required to prevent rejection of the transplanted organ. Regular consultations with your doctor are essential.
Dailiport should be taken orally once daily in the morning. The medicine should be taken on an empty stomach or 2 to 3 hours after a meal. 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.
Do not swallow the desiccant contained in the foil packaging.
Taking more Dailiport than prescribed
If too much Dailiport is taken by accident, contact your doctor immediately or go to the nearest hospital emergency department.
Missing a dose of Dailiport
If a patient forgets to take the morning capsule, it should be taken as soon as possible on the same day. Do not take a double dose the next morning to make up for the missed dose.
Stopping Dailiport treatment
Discontinuing treatment with Dailiport may increase the risk of rejection of the transplanted organ. Do not stop treatment without medical advice.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Dailiport weakens the body's defence mechanism, resulting in the immune system being less effective at fighting infections than normal. Therefore, while taking Dailiport, you may be more susceptible to infections. Some infections may be severe or lead to death and may include infections caused by bacteria, viruses, fungi, parasites, or other infections. You should immediately inform your doctor if you 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, serious brain infection that can lead to death (progressive multifocal leukoencephalopathy, PML).

Severe adverse reactions, including allergic and anaphylactic reactions, may occur. Following administration of tacrolimus, both benign and malignant tumours have been reported.
You should immediately inform your doctor if any of the following severe adverse reactions occur or are suspected:
Severe, common adverse reactions (may occur in fewer than 1 in 10 people):

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

Severe, uncommon adverse reactions (may occur in fewer than 1 in 100 people):

• thrombotic microangiopathy (damage to the smallest blood vessels), including haemolytic uraemic syndrome – a condition with the following symptoms: low urine output or absence of urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and unexplained bruising or abnormal bleeding, and signs of infection.

Severe, rare adverse reactions (may occur in fewer than 1 in 1000 people):

• Thrombotic thrombocytopenic purpura: a condition involving damage to the smallest blood vessels, characterised by fever and subcutaneous bruises appearing as red, pinpoint spots, with or without unexplained extreme fatigue, disorientation, yellowing of the skin or eyes (jaundice), symptoms of acute kidney failure (low urine output or absence of urine output), loss of vision, and seizures.
• toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red swollen skin which may peel off over large areas of the body.
• blindness.

Severe, very rare adverse reactions (may occur in fewer than 1 in 10,000 people):

• Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, a serious and severe illness with blistering of the skin, mouth, eyes, and genital organs, urticaria, swelling of the tongue, red or purple skin rash that spreads, skin peeling.
• Torsades de pointes: change in heart rate, which may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness or nausea, palpitations (awareness of heartbeat), and difficulty breathing.

Severe adverse reactions – frequency unknown (frequency cannot be estimated from available data):

• opportunistic infections (bacterial, fungal, viral, and protozoal): persistent diarrhoea, fever, and sore throat.
• benign and malignant tumours have been reported following treatment due to immunosuppression, including skin cancers and a rare type of cancer that may present as skin lesions called Kaposi's sarcoma. Symptoms include skin changes such as new or changing discolourations, spots, or nodules.
• cases of pure red cell aplasia (severe reduction in red blood cells), haemolytic anaemia (reduced number of red blood cells due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (reduced number of white blood cells that fight infection, with concurrent fever) have been reported. The exact frequency of these adverse reactions is unknown. The patient may not experience any symptoms or, depending on the severity of the disease, may experience: fatigue, apathy, abnormal paleness of the skin (pallor), shortness of breath, dizziness, headache, chest pain, and cold sensation in hands and feet.
• cases of agranulocytosis (markedly reduced number of white blood cells, accompanied by mouth ulcers, fever, and infection/infections). The patient may have no symptoms or may experience sudden fever, chills, and sore throat.
• allergic and anaphylactic reactions with the following symptoms: sudden itchy rash (urticaria), swelling of the 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 may be symptoms 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): vision problems such as blurred vision, changes in colour vision, difficulty perceiving details, or visual field defects.

The following adverse reactions may also occur after taking Dailiport, which may be severe:
Very common adverse reactions (may occur in more than 1 in 10 people):
increased blood glucose levels, diabetes, increased blood potassium levels
sleep disturbances
tremor, headache
increased blood pressure
abnormal liver function test results
diarrhoea, nausea
kidney function disorders
Common adverse reactions (may occur in fewer than 1 in 10 people):
decreased number of blood cells (platelets, red or white blood cells), increased number of white blood cells, changes in red blood cell count (detected in blood tests)
decreased blood magnesium, phosphate, potassium, calcium, or sodium levels, fluid retention, increased blood uric acid or lipid levels, decreased appetite, increased blood acidity, other changes in blood electrolytes (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) in hands and feet, dizziness, reduced writing ability, nervous system disorders
blurred vision, increased light sensitivity, eye disorders
tinnitus
reduced blood flow in heart vessels, increased heart rate
bleeding, partial or complete obstruction of blood vessels, decreased blood pressure
shallow breathing, changes in lung tissue, fluid accumulation around the lungs, sore throat, cough, flu-like symptoms
stomach disorders such as inflammation or ulcers causing abdominal pain or diarrhoea, gastrointestinal bleeding, inflammation or ulceration of the oral mucosa, fluid accumulation in the abdominal cavity, vomiting, abdominal pain, indigestion, constipation, bloating (also with gas passage), loose stools
biliary tract disorders, jaundice due to liver dysfunction, liver tissue damage, and hepatitis
itching, rash, hair loss, acne, excessive sweating
joint, limb, back, and foot pain, muscle cramps
inadequate kidney function, reduced urine production, disturbed or painful urination
general weakness, fever, fluid accumulation in the body, pain and discomfort, increased blood alkaline phosphatase activity, weight gain, sensation of temperature disturbances
Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
changes in blood coagulation, decreased number of all types of blood cells (detected in blood tests)
dehydration
abnormal blood test results: decreased protein or glucose levels, increased phosphate levels
coma, intracranial haemorrhage, stroke, paralysis, brain function disorders, speech and language abnormalities, memory problems
lens opacities, hearing impairment
irregular heart function, cardiac arrest, impaired heart function, myocardial disorders, heart muscle enlargement, stronger heart function, abnormal ECG, abnormal heart rate and pulse
venous thrombosis in a limb, shock
breathing difficulties, respiratory disorders, bronchial asthma
intestinal obstruction, increased blood amylase activity, reflux of stomach contents into the oesophagus (reflux), delayed gastric emptying
skin inflammation, burning sensation upon exposure to sunlight
joint disorders
inability to urinate, painful menstruation, and abnormal menstrual bleeding
multiple organ failure, flu-like symptoms, increased sensitivity to heat and cold, chest tightness, nervousness or altered well-being, increased blood lactate dehydrogenase activity, weight loss
Rare adverse reactions (may occur in fewer than 1 in 1000 people):
minor bleeding within the skin due to blood clot formation
increased muscle stiffness
hearing loss
fluid accumulation around the heart
acute shortness of breath
cyst formation in the pancreas
impaired blood flow through the liver
excessive hair growth
serious illness with blistering of the skin, mouth, eyes, and genital organs
thirst, falls, chest tightness, reduced mobility, ulcers
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
muscle weakness
abnormal echocardiogram
liver failure
painful urination and presence of blood in urine
increased fatty tissue
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Dailiport

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and aluminium foil pouch after EXP. The expiry date refers to the last day of the stated month.
All capsules should be used within 1 year of opening the aluminium foil pouch, and before the expiry date.
Store in the original packaging (aluminium foil pouch) to protect from light and moisture.
Capsules should be taken immediately after removal from the blister.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging 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 tacrolimus monohydrate).
Other ingredients are:
Capsule contents: ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate
Capsule shell:
Dailiport 0.5 mg, Dailiport 2 mg
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, Dailiport 3 mg
brilliant blue FCF (E 133), Allura red AC (E 129), titanium dioxide (E 171), sunset yellow FCF (E 110), gelatin
Dailiport 5 mg
brilliant blue FCF (E 133), Allura red AC (E 129), titanium dioxide (E 171), sunset yellow FCF (E 110), gelatin, erythrosine (E 127)
Printing ink: shellac, aluminium lake of Allura red AC (E 129), aluminium lake of brilliant blue FCF (E 133), aluminium lake of sunset yellow FCF (E 110), propylene glycol, lecithin (soya), simethicone
See section 2: “Dailiport 1 mg, Dailiport 3 mg and Dailiport 5 mg contain lactose, sodium-containing azo dyes and soya.”
See section 2: “Dailiport 0.5 mg and Dailiport 2 mg contain lactose, sodium-containing azo dyes and soya.”

What Dailiport looks like and contents of the pack
Dailiport 0.5 mg
Size 5 (length 10.7–11.5 mm) gelatin capsule with a light brown body and a light yellow cap, printed in black with “0.5 mg”, containing a white to yellowish powder or compressed powder.
Dailiport 1 mg
Size 4 (length 14.0–14.6 mm) gelatin capsule with a light brown body and a white cap, printed in black with “1 mg”, containing a white to yellowish powder or compressed powder.
Dailiport 2 mg
Size 3 (length 15.6–16.2 mm) gelatin capsule with a light brown body and a dark green cap, printed in black with “2 mg”, containing a white to yellowish powder or compressed powder.
Dailiport 3 mg
Size 2 (length 17.7–18.3 mm) gelatin capsule with a light brown body and a light orange cap, printed in black with “3 mg”, containing a white to yellowish powder or compressed powder.
Dailiport 5 mg
Size 0 (length 21.4–22.0 mm) gelatin capsule with a light brown body and a pink cap, printed in black with “5 mg”, containing a white to yellowish powder or compressed powder.

Dailiport capsules are packed in PVC/PVDC/Aluminium foil blisters in an aluminium foil pouch containing a desiccant.
The desiccant must not be swallowed.

Pack sizes: 30, 50, 60 (2x30), and 100 (2x50) hard capsules in blisters, and 30x1, 50x1, 60x1 (2x30), and 100x1 (2x50) capsules in perforated unit dose blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

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

For further information about the medicinal product and its names in the Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00