Sandoz AS

0.5 mg, 0.75 mg, 1 mg, 2 mg and 5 mg hard capsule 
tacrolimus

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Adport is and what it is used for 
2. What you need to know before you take Adport 
3. How to take Adport 
4. Possible side effects 
5. How to store Adport 
6. Contents of the packaging and other information 

1. What Adport is and what it is used for

Adport belongs to a group of medicines called immunosuppressants.

After an organ transplant (eg liver, kidney or heart), your body’s immune system will try to repel the new organ.

Adport is used to control the immune system in your body so that it will accept the transplanted organ.

Adport is often used in combination with other drugs that also weaken the immune system.

You can also receive Adport in the event of an ongoing rejection of a liver, kidney, heart or other organ transplant, or if any previous treatment you have performed has not been able to check the immune system after your transplant.

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

2. What you need to know before taking Adport

Do not take Adport

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Adport:

  • You will need to take Adport every day for as long as you need immunosuppression to prevent rejection of the transplanted organ. You should have regular contact with your doctor.
  • While you are taking Adport, your doctor may need to perform a number of tests (including blood and urine tests, cardiac function tests, synthesis tests and neurological tests) from time to time. This is completely normal and makes it easier for your doctor to determine the most appropriate dose of Adport for you.
  • Avoid all (traditional) herbal and herbal remedies, e.g. St. John’s wort (H ypericum perforatum ) or other herbal remedies as these may affect the effect and dosage one of Adport. If you are not sure, talk to your doctor before taking any herbal remedies or other herbal remedies.
  • If you have liver problems or have had a disease that may have affected your liver, tell your doctor as this may affect the dose of Adport you receive.
  • If you experience severe abdominal pain with or without other symptoms, such as chills, fever, nausea, or vomiting.
  • If you have diarrhea for more than one day, tell your doctor as it may be necessary to adjust your dose of Adport.
  • If you have a change in the heart’s electrical activity, so-called QT extension.
  • When taking Adport, you should limit your exposure to sunlight and UV radiation by wearing appropriate protective clothing and sunscreen with a high sun protection factor. This is because there is a possible risk of malignant skin changes during immunosuppressive drug treatment.
  • If you need to be vaccinated, tell your doctor in advance. Your doctor will advise you on the best way to do this.
  • Patients treated with Adport have been reported to be at increased risk of developing lymphoproliferative disorders (see section 4). Contact your doctor for specific advice on these disorders.

Other drugs and Adport

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 (traditional) herbal and herbal medicines.

Adport must not be taken with cyclosporine.

The blood levels of Adport may be affected by other medicines you are taking and the blood levels of other medicines may be affected by your taking Adport, which may require you to stop treatment, increase or decrease the dose of Adport.

You should especially tell your doctor if you are taking or have recently taken medicines that contain active substances such as:

  • medicines for fungal infections and antibiotics (especially so-called macrolide antibiotics ) which are used to treat infections, e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole and isavuconazole, erythromycin, clarithromycin, josamycin, and rifampicin
  • letermovir, which is used to prevent diseases caused by CMV ( cytomegalovirus in humans)
  • HIV – protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), and booster medicine cobicistat combination tablets which are used to treat HIV – infection
  • HCV – protease inhibitors (eg telaprevir, boceprevir, and the combination ombitasvir / paritaprevir / ritonavir with or without dasabuvir), which are 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 used to treat nausea and vomiting (so-called antiemetics such as metoclopramide)
  • magnesium -aluminum hydroxide (antacid) used to treat heartburn
  • hormone therapy with Ethinyl estradiol (eg, birth control pills ) or danazol
  • medicines for high blood pressure or heart problems, such as nifedipine, nicardipine, diltiazem, and verapamil
  • antiarrhythmics which are used to treat arrhythmias in the heart (so-called arrhythmia eg amiodarone )
  • drugs called “statins” which are used to treat high levels of cholesterol and triglycerides (blood fats)
  • the epilepsy drugs phenytoin and phenobarbital
  • corticosteroids are prednisolone and methylprednisolone
  • the antidepressant nefazodone
  • anherbal medicine containing St. John’s wort ( Hypericum perforatum ) or extract of Schisandra sphenanthera.

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.

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

Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (eg amiloride, triamterene, or spironolactone ), certain painkillers (so-called NSAIDs, eg ibuprofen ), blood thinners, or medicines for diabetes taken via mouth while taking Adport.

If you need any vaccination, tell your doctor in advance.

Adport with food and drink

You should generally take Adport on an empty stomach or at least 1 hour before or 2-3 hours after a meal. Avoid grapefruit and grapefruit juice while taking Adport.

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.
  • Adport is excreted in breast milk. Therefore, you should not breast-feed while taking Adport.

Driving and using machines

Do not drive or use any machines if you feel dizzy or sleepy, or if you have trouble seeing clearly after taking Adport. These effects are seen more often if Adport is taken in conjunction with 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.

Adport contains lactose and sodium

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

This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, ie it is essentially ‘sodium-free’.

3. How to take Adport

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Make sure you get the same tacrolimus medicine every time you pick up your prescription, unless your transplant specialist has approved switching to another tacrolimus medicine.

This medicine should be taken twice a day. If the medicine does not look the same as usual, or if the dosing instructions have 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, who calculates the dose according to your body weight. The initial doses shortly after transplantation will normally be within the range

0.075-0.30 mg per kg body weight and day, depending on the transplanted organ.

Your dose depends on your general condition and what other immunosuppressive drugs you are taking. Regular blood tests are required to determine the correct dose and to adjust the dose over time. Your doctor will normally reduce the dose of Adport once your condition has stabilized. Your doctor will tell you exactly how many capsules to take and how often.

  • Adport is taken by mouth twice daily, usually morning and evening. You should generally take Adport on an empty stomach or at least 1 hour before or 2-3 hours after a meal.
  • Swallow the capsules whole with a glass of water.
  • Remove the hard capsules immediately after removing them from the pressure pack.
  • Avoid grapefruit and grapefruit juice when taking Adport.
  • Do not swallow the desiccant contained in the aluminum bag.

If you forget to take Adport

Do not take a double dose to make up for a forgotten dose.

If you forget to take your Adport capsules, wait until it is time for your next dose and then continue as before.

If you stop taking Adport

If you stop your treatment with Adport, this may increase the risk of rejection of the transplanted organ. Do not stop treatment unless your doctor tells you to.

If you have any further questions 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.

Adport reduces your body’s own defense mechanisms so that the transplanted organ is not rejected. This means that your body will not be as good at resisting infection as usual. If you take Adport, you may therefore get more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs, and urinary tract.

Severe side effects, including those listed below, may occur. Contact your doctor immediately if you have or suspect you may have any of the following serious side effects:

  • Infections (caused by bacteria, fungi, viruses, and unicellular organisms ( protozoa)): prolonged diarrhea, fever, and sore throat. Benign and malignant tumors ( lymphoma ) have been reported after treatment as a result of immunosuppression.
  • Thrombotic thrombocytopenia purpura (TTP), a condition characterized by fever and bruising under the skin that may appear as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure ( low or no urine production).
  • Cases of pure erythrocyte plasma (a very severe decrease in red blood cell count ) and haemolytic anemia (decreased red blood cell count due to abnormal degradation along with fatigue) and febrile neutropenia (a decrease in white blood cells fighting infection , along with fever) have reported. It is not known exactly how often these side effects occur. You may be asymptomatic or experience symptoms such as fatigue, listlessness, unusual pallor, shortness of breath, dizziness, headache, chest pain and cold hands and feet, depending on the severity of the condition.
  • Cases of agranulocytosis (severe decrease in white blood cell count along with mouth ulcers, fever and infection ). You may be asymptomatic or experience symptoms such as sudden fever, stiffness, and sore throat.
  • Allergic and anaphylactic reactions with the following symptoms: sudden itchy rash ( hives ), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and fainting.
  • Posterior reversible encephalopathy syndrome (PRES): headache, altered mental status, epileptic seizures and visual disturbances.
  • Torsades de Pointe s: change in heart rhythm that may be accompanied by symptoms such as chest pain (angina), fainting, dizziness or nausea, palpitations, and difficulty breathing.
  • Gastrointestinal perforation: severe abdominal pain with or without other symptoms, such as chills, fever, nausea or vomiting.
  • Stevens-Johnson syndrome: unexplained widespread pain in the skin, facial swelling, severe disease with blistering of the skin, mouth, eyes, and genitals, hives, swollen tongue, red or purple skin rash spreading, flaky skin.
  • Toxic epidermal necrolysis: damage and blisters on skin or mucous membranes, red swollen skin that can become detached from large parts of the body.
  • Hemolytic uremic syndrome, a condition with the following symptoms: low or no urine production ( acute renal failure ), extreme fatigue, yellowing of the skin or eyes (jaundice) and abnormal bruising or bleeding, and signs of infection.
  • The insufficient function of the transplanted organ.

The side effects listed below may also occur after you receive Adport:

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

  • high blood sugar, diabetes, increased levels of potassium in the blood
  • difficulty sleeping
  • tremors, headache
  • high blood pressure
  • diarrhea, nausea
  • kidney problems.

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

  • decreased content of magnesium, phosphate, potassium, calcium, or sodium in the blood, fluid retention, increased amount of uric acid or blood fats, decreased appetite, the increased acid content in the blood, other changes in blood salts
  • anxiety, confusion and impaired perception of time and space, depression, mood swings, nightmares, hallucinations, mental illness
  • seizures, disturbances of consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, disorders of the nervous system
  • blurred vision, increased photosensitivity, eye diseases
  • ringing in the ears ( tinnitus )
  • decreased blood flow in the heart vessels, fast pulse
  • bleeding, partial or complete blockage of blood vessels, low blood pressure
  • shortness of breath, changes in the lung tissue, accumulation of fluid around the lungs, inflammation of the throat, cough, flu-like symptoms
  • inflammation or sores that cause abdominal pain or diarrhea, bleeding in the stomach, inflammation or sores in the mouth, accumulation of fluid in the abdomen, vomiting, abdominal pain, digestive problems, constipation, flatulence (gas in the stomach), bloating, loose stools, stomach problems,
  • changes in liver enzymes and liver function, yellowing of the skin due to liver problems, damage to liver tissue, and liver inflammation
  • itching, skin rash, hair loss, acne, increased sweating
  • pain in joints, arms, legs, feet or back, muscle spasms
  • insufficient renal function decreased urine output, decreased urine output, or painful urination
  • general weakness, fever, accumulation of fluid in the body, pain, and discomfort, increase in enzyme and alkaline phosphatase in your blood, weight gain, a feeling that the body temperature is wrong.

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

  • changes in blood clotting, decreased number of all blood cell s
  • dehydration, decreased protein or sugar in the blood, increased phosphate in the blood
  • coma , cerebral haemorrhage, stroke , paralysis, brain disease, speech and language difficulties, memory problems
  • turbidity in the lens of the eye
  • impaired hearing
  • irregular heartbeat, cardiac arrest, decreased force in the heart, 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
  • difficulty breathing, respiratory disease, asthma
  • obstruction of the intestinal flow (intestinal obstruction), increased level of enzyme et amylase in the blood, acid reflux, delayed emptying of the stomach
  • skin inflammation, burning sensation in the sun
  • joint diseases
  • inability to urinate, painful menstruation, and abnormal menstrual bleeding
  • impaired function in certain organs, flu-like symptoms , increased sensitivity to heat and cold, pressure over the chest, nervousness or abnormal feeling, increase in enzyme and lactate dehydrogenase in the blood, weight loss.

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

  • slight bleeding in the skin due to clotted blood
  • increased muscle stiffness
  • blindness
  • deafness
  • accumulation of fluid around the heart
  • acute shortness of breath
  • cysts in the pancreas
  • problems with blood flow in the liver
  • increased hair
  • thirst falls, pressure over the chest, reduced mobility, sores.

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

  • muscle weakness
  • abnormal results in ultrasound examination of the heart ( echocardiography )
  • liver failure, narrowing of the bile ducts
  • painful urination with blood in the urine
  • the increased amount of adipose tissue.

Has been reported (occurs in the unknown number of users):

  • optic nerve ( optic neuropathy ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Adport

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 after EXP. or EXP. The expiration date is the last day of the specified month.

Use all capsules within 12 months after opening the aluminum bag surrounding the pressure pack. Do not store above 25 ° C after opening the aluminum bag.

Swallow the capsule immediately after removing it from the pressure pack.

Do not store above 30 ° C. Store in the original package. Moisture sensitive.

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. A hard capsule contains 0.5 mg, 0.75 mg, 1 mg, 2 mg or 5 mg tacrolimus (as tacrolimus monohydrate).
  • Other ingredients are
    • Capsule contents:  lactose monohydrate, hypromellose (E464), croscarmellose sodium (E468), and magnesium stearate (E572).
    • Hard gelatin capsule: 
      0.5 mg:
      gelatin, titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate, and yellow iron oxide (E172).0.75 mg:gelatin, titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133), shellac (E 904), propylene glycol (E1520), potassium hydroxide (E525) and black iron oxide (E172).1 mg:gelatin, titanium dioxide (E171), sodium lauryl sulphate, sorbitan laurate, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).2 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), brilliant blue FCF (E133), shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), and black iron oxide (E172).5 mg: gelatin, titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Adport 0.5 mg is a hard, white, opaque capsule with an ivory-colored top. The capsule contains a white to off-white powder (length: 14.5 mm).

Adport 0.75 mg is a hard, light green, opaque capsule, marked with “0.75 mg” printed in black on the top. The capsule contains a white to off-white powder (length: 14.5 mm).

Adport 1 mg is a hard, white, opaque capsule with a light brown top. The capsule contains a white to off-white powder (length: 14.5 mm).

Adport 2 mg is a hard, dark green, opaque capsule, marked with “2 mg” printed in black on the top. The capsule contains a white to off-white powder (length: 14.5 mm).

Adport 5 mg is a hard, white, opaque capsule with an orange top. The capsule contains a white to off-white powder (length: 15.8 mm).

Adport hard capsules are packaged in PVC / PE / PVdC / aluminum blisters in a protective aluminum bag containing desiccant that protects the capsules from moisture. The desiccant should not be swallowed.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia

or

SC Sandoz SRL, Str. Livenzeni no. 7A, RO- 540472 Targu Mures, Romania

or

LEK SA, Ul. Domaniewska 50C, 02- 672 Warsaw, Poland

or

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

Muhammad Nadeem

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