0.5 mg, 1 mg, and 5 mg hard
tacrolimus capsules
What Prograf is and what it is used for
Prograf belongs to a group of medicines called immunosuppressants. After an organ transplant (eg liver, kidney, heart) your body tries to repel the new organ. Prograf is used to check the immune system in your body for it to accept the transplanted organ.
Prograf is often used in combination with other drugs that also suppress the immune system.
You can also be given Prograf for an ongoing rejection reaction in your transplanted liver, kidney, heart, or another organ, or if other treatment you have received has not been able to control the immune system after your transplant.
Tacrolimus contained in Prograf 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.
What you need to know before taking Prograf
Do not take Prograf
- If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Prograf (listed in section 6).
- If you are allergic (hypersensitive) to any antibiotic that belongs to the subgroup of macrolide antibiotics (eg erythromycin, clarithromycin, josamycin).
Warnings and cautions
Talk to your doctor or pharmacist before taking Prograf.
- You will need to take Prograf every day for as long as you need immunosuppression to prevent rejection of the transplanted organ. You should keep in regular contact with your doctor.
- While taking Prograf, your doctor may occasionally want to perform several tests (such as blood, urine, heart function, vision, and nerve function). This is completely normal and will help your doctor determine the appropriate dose of Prograf for you.
- Avoid taking herbal medicines, e.g. St. John’s wort (Hypericum perforatum) or any other herbal product as these may affect the effect and dose one of Prograf that you need to take. If you are not sure, talk to your doctor before taking any herbal medicines or products.
- 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 Prograf you receive.
- If you experience severe abdominal pain with or without other symptoms, such as chills, fever, nausea, or vomiting.
- If you get diarrhea for more than a day, tell your doctor as it may be necessary to adjust your dose of Prograf.
- If you have a change in heart rate called “QT prolongation”.
- When taking Prograf, you should limit your exposure to sunlight and UV light 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 course of action.
- Patients treated with Prograf have been reported to be at increased risk of developing lymphoma (see section 4). Contact your doctor for specific advice on these disorders.
Handling Precautions:
Direct contact with any part of the body, such as skin or eyes, or inhalation of solution for injection, powder, or granules with tacrolimus should be avoided. In case of such contact, skin and eyes should be rinsed.
Other medicines and Prograf
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 medicines.
Prograf must not be taken with ciclosporin.
If you need to see a doctor other than your transplant specialist, tell your doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you are taking another medicine that may increase or decrease the tacrolimus concentration in your blood.
The blood levels of Prograf may be affected by other medicines you are taking and blood levels of other medicines may be affected by your taking Prograf, which means that the dose of Prograf may need to be stopped, increased, or decreased.
In some patients, tacrolimus concentrations in the blood have increased when they were taking other medicines at the same time. This can lead to serious side effects, such as problems with the kidneys and nervous system as well as disorders of the heart rhythm (see section 4).
Effects on Prograf concentrations in the blood may occur very quickly after starting another medicine. Therefore, continuous monitoring of the concentration of Prograf in the blood may be needed for the first few days after you start taking another medicine and at frequent intervals for the duration of treatment with the other medicine. Some other medicines may reduce the tacrolimus concentration in the blood, which may increase the risk of transplant rejection. You should especially tell your doctor if you are taking or have recently taken medicines that contain substances such as:
- Medicines for fungal infections and antibiotics, especially so-called macrolide antibiotics that are used to treat infections, e.g. ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniaxillin, and fluid
- Letermovir, is used to prevent diseases caused by CMV ( human cytomegalovirus )
- HIV protease inhibitors (eg ritonavir, nelfinavir, saquinavir), the booster drug cobicistat and combination tablets, or non-nucleoside reverse transcriptase inhibitors against HIV (efavirenz, etravirine, nevirapine) used to treat HIV infection
- HCV – protease inhibitors (eg telaprevir, boceprevir, the combination of ombitasvir / paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir and glecaprevir / pibrentasvir), used to treat hepatitis C infection
- Nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide or mitotane (used to treat certain cancers)
- Mycophenolic acid, 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 (eg metoclopramide)
- Magnesium aluminum hydroxide (antacid) used to treat heartburn
- Hormone therapies with Ethinyl estradiol (eg, birth control pills ) or danazol
- Medicines for high blood pressure or heart problems such as nifedipine, nicardipine, diltiazem, or verapamil
- Antiarrhythmics ( amiodarone ), are used to treat arrhythmias (irregular heartbeat)
- Drugs are known as “statins” used to treat high cholesterol and triglycerides
- The antiepileptic drugs carbamazepine, phenytoin and phenobarbital
- Metamizole used to treat pain and fever
- The corticosteroids prednisolone and methylprednisolone
- The antidepressant drug nefazodone
- Herbal medicines contain St. John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
Tell your doctor if you are receiving treatment for hepatitis C. Drug treatment for hepatitis C can affect liver function and thus the tacrolimus concentration in the blood. Tacrolimus blood levels may decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may need to check your tacrolimus blood levels carefully and adjust your Prograf dose one after you start treatment for hepatitis C.
Tell your doctor if you are taking or need to take ibuprofen, amphotericin B, antibiotics (trimethoprim/sulfamethoxazole, vancomycin, or so-called aminoglycoside antibiotics such as gentamicin), or medicines for viral infections (eg aciclovir, ganciclovir, cidofovir or foscarnet). They can aggravate kidney problems or problems with the nervous system if taken with Prograf.
Your doctor must also know if you are taking potassium supplements or potassium-sparing diuretics (eg amiloride, triamterene, or spironolactone ), or trimethoprim or trimethoprim/sulfamethoxazole antibiotics that may increase the levels of potassium in your blood, certain painkillers (so-called NSAIDs, t (eg ibuprofen ), blood thinners or oral medication to treat diabetes while you are taking Prograf.
If you need to be vaccinated, tell your doctor in advance.
Graduate with food and drink
You should normally take Prograf on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. Grapefruit and grapefruit juice should be avoided when taking Prograf.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Prograf is excreted in breast milk. Therefore, you should not breastfeed while taking Prograf.
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 Prograf. These effects are more common when Prograf is taken 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.
Prograf contains lactose, sodium and lecithin (soy)
Prograf 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.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, ie essentially ‘sodium-free’.
The printing ink used on Prograf 0.5 mg and 1 mg capsules contains soy lecithin. If you are allergic to peanuts or soy, consult your doctor to determine if you should use this medicine.
How to take Prograf
Always take Prograf 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 doctor has decided to switch to another tacrolimus medicine.
This medicine should be taken twice 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 the transplant are normally within the range
0.075–0.30 mg per kg body weight per day
depending on the organ transplanted.
Dose one depends on your general condition and on which other immunosuppressive drug (s) you are receiving. Regular blood tests are required by your doctor to determine the correct dose and to adjust the dose from time to time. The dose is usually reduced by your doctor once your condition has stabilized. Your doctor will tell you exactly how many capsules to take and how often.
Prograf is taken twice daily, usually in the morning and in the evening. You should take Prograf on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. The capsules should be swallowed whole with a glass of water. Avoid grapefruit and grapefruit juice when taking Prograf. Do not swallow the desiccant contained in the aluminum bag.
If you take more Prograf than you should
If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or hospital and Finland tel. 0800 147 111) immediately for risk assessment and advice.
If you forget to take Prograf
Do not take a double dose to make up for a forgotten dose.
If you forget to take your dose of Prograf capsules, wait until the next dose and then continue as usual.
If you stop taking Prograf
Ending treatment with Prograf 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.
Possible side effects
Like all medicines, Prograf can cause side effects, although not everybody gets them.
Prograf weakens the body’s defense mechanisms to prevent you from rejecting the transplanted organ. As a result, your body will not be as good as usual at fighting infection. If you use Prograf, you can thus get more infections than normal, such as infections in the skin, mouth, gastrointestinal tract, lungs, and urinary tract. Some infections can be serious or life-threatening and can include infections caused by bacteria, viruses, fungi, parasites, or other infections.
Contact a doctor immediately if you get signs of infection, such as:
- Fever, cough, sore throat, feeling weak or generally unwell
- Memory loss, difficulty thinking, difficulty walking, or vision loss – can be due to a very rare, serious infection in the brain, which can be life-threatening ( progressive multifocal leukoencephalopathy, or PML)
Serious side effects, including those listed below, may occur.
Contact a doctor immediately if you have or suspect you have any of the following serious side effects:
Serious side effects (may affect up to 1 in 10 people):
- Gastrointestinal perforation: severe abdominal pain possibly accompanied by other symptoms, such as chills, fever, nausea, or vomiting.
- The insufficient function of the transplanted organ.
- Dimsyn.
Serious uncommon side effects (may affect up to 1 in 100 people):
- Hemolytic uremic syndrome, s 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.
Serious rare side effects (may affect up to 1 in 1,000 people):
- Thrombotic thrombocytopenic purpura (or 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).
- Toxic epidermal necrolysis: damage and blisters on the skin or mucous membranes, red swollen skin that can become detached from 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 pain in the skin, swelling of the face, severe disease with blistering of the skin, mouth, eyes, and genitals, hives, swollen tongue, red or purple skin rash spreading, flaky skin.
- Torsades de Pointes: change in heart rate that may, but does not have to, be accompanied by symptoms such as chest pain (angina), weakness, dizziness or nausea, palpitations, and difficulty breathing.
Serious side effects ar – no known frequency (frequency can not be calculated from the available data):
- Opportunistic infections (caused by bacteria, fungi, viruses, and protozoa ): prolonged diarrhea, fever, and sore throat.
- Benign and malignant tumors have been reported after treatment due to immunosuppression.
- Cases of pure erythrocyte plasma (a very severe decrease in red blood cell count ), hemolytic anemia (decreased red blood cell count due to increased degradation, together with fatigue), and febrile neutropenia (a decrease in white blood cells fighting infection, together with fever ) have been reported. It is not known exactly how often these side effects occur. You may be asymptomatic or experience symptoms such as fatigue, lethargy, abnormal pallor, shortness of breath, dizziness, headache, chest pain, and cold in the 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 (s)). 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 you may feel that you are about to faint.
- Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood swings, seizures, and visual disturbances. This may be a sign of a disease called posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
- Optic neuropathy (visual nerve damage): problems with your vision such as blurred vision, changes in color vision, difficulty seeing details, or that your field of vision is limited.
The side effects listed below can also occur after you receive Prograf and can be serious:
Very common side effects (may affect more than 1 user in 10):
- Increased blood sugar, diabetes mellitus, and increased levels of potassium in the blood.
- Difficulty sleeping.
- Shaking, headache.
- Increased blood pressure.
- Abnormal liver function tests.
- 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 amount of fluid in the body, increased amount of uric acid or fats in the blood, decreased appetite, increased acidity in the blood, and other changes in blood salts.
- Anxiety, confusion, difficulty orienting oneself, depression, mood swings, nightmares, hallucinations, and mental illnesses.
- Seizures, disturbances of consciousness, crawling or numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, and disorders of the nervous system.
- Increased photosensitivity, eye diseases.
- Earrings.
- Decreased blood flow in the heart vessels, and a 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, and flu-like symptoms.
- Inflammation or ulcers that cause abdominal pain or diarrhea, bleeding in the stomach, inflammation or ulcers in the mouth, fluid accumulation in the abdomen, vomiting, abdominal pain, digestive problems, constipation, gas problems, bloating, loose stools, and stomach problems.
- Changes in liver enzyme values and function, yellowing of the skin due to liver problems, damage to liver tissue, and hepatitis.
- 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, feeling of disturbed temperature perception.
Uncommon side effects (may affect up to 1 in 100 people):
- Changes in the blood’s ability to coagulate, a decrease in the number of all kinds of blood cells.
- Dehydration.
- Decreased protein or sugar in the blood, increased phosphate in the blood.
- Coma, cerebral hemorrhage, stroke, paralysis, brain disease, speech and language difficulties, and 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.
- Blood clot in a friend in leg or arm, shock.
- Breathing difficulties, respiratory disease, asthma.
- Obstacles in the intestinal passage increased blood levels of enzyme et amylase, acid reflux, and slow emptying of the stomach.
- Eczema is, a burning sensation in the sun.
- Joint diseases.
- Inability to urinate, painful menstruation, and abnormal menstrual bleeding.
- Failure of certain organs, flu-like symptoms, increased sensitivity to heat and cold, pressure over the chest, nervousness or abnormal feeling, increase of enzyme and lactate dehydrogenase in the blood, and weight loss.
Rare side effects (may affect up to 1 in 1,000 people):
- Small skin bleeds due to clotted blood.
- Increased muscle stiffness.
- Deafness.
- Accumulation of fluid around the heart.
- Acute breathing difficulties.
- Cyst formation in the pancreas.
- Problems with blood flow in the liver.
- 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.
- Liver failure, narrowing of the bile ducts.
- Painful urination with blood in the urine.
- The increased amount of adipose tissue.
How Prograf should be stored
Keep Prograf out of sight and reach of children.
Take the hard capsules immediately after they are pushed out of the blister.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month. All capsules should be used within one year after opening the aluminum bag.
No special temperature instructions.
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.
Contents of the pack and other information
Content declaration
Prograf 0.5 mg hard capsules:
- The active substance is tacrolimus. Each capsule contains 0.5 mg tacrolimus as tacrolimus monohydrate.
- Excipients:
Capsule contents: hypromellose, croscarmellose sodium, lactose monohydrate, magnesium stearate. Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), gelatin.
Printing inks: shellac, lecithin (soy), hydroxypropylcellulose, simethicone, red iron oxide (E172).
Prograf 1 mg hard capsules:
- The active substance is tacrolimus. Each capsule contains 1 mg of tacrolimus as tacrolimus monohydrate.
- Excipients:
Capsule contents: hypromellose, croscarmellose sodium, lactose monohydrate, magnesium stearate. Capsule shell: titanium dioxide (E171), gelatin.
Printing inks: shellac, lecithin (soy), hydroxypropylcellulose, simethicone, red iron oxide (E172).
Prograf 5 mg hard capsules:
- The active substance is tacrolimus. Each capsule contains 5 mg of tacrolimus as tacrolimus monohydrate.
- Excipients:
Capsule contents: hypromellose, croscarmellose sodium, lactose monohydrate, magnesium stearate. Capsule shell: titanium dioxide (E171), red iron oxide (E172), gelatin.
Printing inks: shellac, titanium dioxide (E171), and propylene glycol.
What the medicine looks like and the contents of the pack
Prograf 0.5 mg hard capsules:
Opaque, light yellow gelatin capsules, marked with “0.5 mg” and “[f] 607” in red, containing white powder. Prograf 0.5 mg hard capsules are supplied in pressure packs or in perforated unit dose blisters of 10 capsules each in a protective foil pouch containing desiccant which protects the capsules from moisture. The desiccant should not be swallowed. Pack sizes of 20, 30, 50, 60 and 100 hard capsules are available in blisters and pack sizes of 20×1, 30×1, 50×1, 60×1, and 100×1 hard capsules are available in perforated unit dose blisters.
Prograf 1 mg hard capsules:
Opaque white gelatin capsules, marked with “1 mg” and “[f] 617” in red, containing white powder. Prograf 1 mg hard capsules are supplied in pressure packs or in perforated unit dose blisters of 10 capsules each in a protective foil pouch containing desiccant which protects the capsules from moisture. The desiccant should not be swallowed. Pack sizes of 20, 30, 50, 60, 90, and 100 hard capsules are available in blisters and pack sizes of 20×1, 30×1, 50×1, 60×1, 90×1, and 100×1 hard capsules are available in perforated unit dose blisters.
Prograf 5 mg hard capsules:
Opaque, gray-red gelatin capsules, marked with “5 mg” and “[f] 657” in white, containing white powder. Prograf 5 mg hard capsules are supplied in pressure packs or in perforated unit dose blisters of 10 capsules each in a protective foil pouch containing desiccant that protects the capsules from moisture. The desiccant should not be swallowed. Pack sizes of 30, 50, 60 and 100 hard capsules are available in blisters and pack sizes of 30×1, 50×1, 60×1, and 100×1 hard capsules are available in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Astellas Pharma a / s
Arne Jacobsens Allé 15
2300 Copenhagen S
Denmark
Manufacturer
Astellas Ireland Co. Ltd.
Killorglin
County Kerry, V93FC86
Ireland
This medicinal product is authorized under the European Economic Area under the names:
Prograf :
Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Iceland, Ireland, Italy, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, and Sweden.
Prograf:
Belgium, Luxembourg, and the Netherlands.