0.5, 1, and 5 mg capsule, hard
tacrolimus respectively
What Tacni is and what it is used for
Tacna belongs to a group of medicines called immunosuppressants. After your organ transplant (e.g. liver, kidney, heart), your body’s immune system tries to reject the new organ. Tacni is used to control your body’s immune system to accept the transplanted organ. Tacni is often used in combination with other drugs that also suppress the immune system.
You may also be given Tacni against an ongoing rejection reaction of your transplanted liver, kidney, heart, or another organ, or if other previous treatments you received failed to control the immune system after your transplant.
The tacrolimus contained in Tacni may also be approved to treat 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 you take Tacni
Do not take Tacni
- if you are allergic to tacrolimus or any other ingredient in this medicine. (listed in section 6).
- if you are allergic (hypersensitive) to any antibiotic belonging to the macrolide antibiotic subgroup (eg erythromycin, clarithromycin, josamycin).
Warnings and precautions
Talk to your doctor or pharmacist before taking Tacni:
- You will need to take Tacni every day for as long as you need immunosuppression to prevent rejection of the transplanted organ. You must keep in regular contact with your doctor.
- While you are receiving Tacni, your doctor may occasionally want to do several tests (eg blood, urine, heart function, vision, and nerve function). This is completely normal and will help your doctor determine the appropriate dose of Tacni for you.
- Avoid taking (traditional) herbal medicines, e.g. St. John’s wort (Hypericum perforatum) or any other herbal product as these may affect the effect and dose of Tacni that you need to take. If you are unsure, consult your doctor before taking any herbal product or any such medicine.
- 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 Tacni you receive.
- If you get 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 because it may be necessary to adjust your Tacni dosage.
- If you have or have had a change in the heart rhythm known as “QT prolongation”, presence of “QT prolongation” in the family, heart failure, low heart rate, electrolyte disturbances, or if you take medicines that prolong the QT interval or that cause electrolyte disturbances
- When taking Tacni, you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and sunscreen with a high SPF. 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 Tacni have been reported to have an increased risk of developing lymphoma (see section 4). Consult your doctor for specific advice about these disorders.
Contact your doctor immediately if during treatment 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 restricted.
Other medicines and Tacni
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tacni must not be taken together with ciclosporin.
Blood concentrations of Tacni may be affected by other medicines you are taking and blood levels of other medicines may be affected by your taking Tacni, which may mean that the dose of Tacni may need to be increased or decreased. You should especially tell your doctor if you are taking or have recently taken medicines such as:
- medicines against fungal infections and antibiotics, especially so-called macrolide antibiotics used to treat infections, such as ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole and isavuconazole, erythromycin, telithromycin, clarithromycin, josamycin, rifampicin, and rifabutin.
- letermovir is used to prevent diseases caused by CMV ( human cytomegalovirus )
- antibiotics used to treat tuberculosis ( isoniazid )
- HIV protease inhibitors (eg ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat, and combination tablets used to treat HIV infection
- HCV protease inhibitors (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)
- antiemetics used to treat nausea and vomiting (eg metoclopramide)
- magnesium aluminum hydroxide (antacid), used to treat heartburn
- hormone treatments with ethinylestradiol (e.g. birth control pills ) or danazol
- oral contraceptive pills
- medicines to treat high blood pressure or heart problems (eg nifedipine, nicardipine, diltiazem, or verapamil)
- antiarrhythmics ( amiodarone ), used to treat arrhythmia (irregular heartbeat)
- medicines known as ‘statins’ used to treat elevated cholesterol and triglycerides
- the antiepileptic drugs phenytoin , phenobarbital or carbamazepine
- corticosteroids such as prednisolone and methylprednisolone or corticosteroids that are normally taken for a longer period (maintenance therapy)
- the antidepressant drug nefazodone
- (Traditional) herbal medicines containing St. John’s wort ( Hypericum perforatum ) or extracts of Schisandra sphenanthera
Tell your doctor if you are taking or need to take ibuprofen or other pain-relieving medicines (eg NSAIDs ), amphotericin B, medicines for viral infections (eg aciclovir, ganciclovir), or certain antibiotics (eg aminoglycosides, gyrase inhibitors, vancomycin, sulfamethoxazole + trimethoprim). They may worsen kidney or nervous system problems if taken with Tacni.
Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (eg, amiloride, triamterene, or spironolactone ), metamizole (pain reliever), anticoagulants (blood thinners), or oral diabetes medications while you are taking Tacni.
If you need to be vaccinated, tell your doctor in advance that you are taking this medicine.
Tacni with food and drink
You should normally take Tacni on an empty stomach or 1 hour before or 2 to 3 hours after a meal. Grapefruit and grapefruit juice should be avoided while being treated with Tacni.
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 using this medicine.
Tacrolimus passes into breast milk. Therefore, you should not breastfeed while taking Tacni.
Driving ability and use of machinery
Do not drive or use any tools or machines if you feel dizzy or sleepy or have trouble seeing clearly after taking this medicine. These effects are more common if Tacni is taken with alcohol.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Tacni contains lactose and sodium
Tacni contains lactose . If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, i.e. almost sodium-free.
How to take Tacni
Always take this medicine as directed by your doctor. 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 that you should switch to a different tacrolimus medicine.
This medicine should be taken twice daily. If the appearance of the medicine is not the same as usual or if the dosage 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 and calculated according to your body weight. The starting doses immediately after transplantation are normally in the range of 0.075 – 0.30 mg per kg of body weight per day, depending on which organ was transplanted.
Does one depend on your general condition and on what other immunosuppressive medication you are taking? 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 the doctor when your condition has stabilized. Your doctor will tell you exactly how many capsules to take and how often.
Tacni is taken orally twice daily, usually in the morning and in the evening. You should take the capsule 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 while taking Tacni.
Do not swallow the desiccant contained in the aluminum bag.
If you have taken too much Tacni
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Tacni
Do not take a double dose to make up for a missed dose.
If you forget to take your capsules, wait until it is time for your next dose and then continue as usual.
If you stop taking Tacni
Stopping treatment may increase the risk of rejection of your transplanted organ. Do not stop your treatment until your doctor tells you to.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tacni reduces your body’s own 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 take Tacni, you may therefore get more infections than usual, such as infections in the skin, mouth, gastrointestinal tract, lungs, liver, urinary tract, and nervous system.
Serious 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 protozoa ): prolonged diarrhea, fever, and sore throat
- Benign and malignant tumors ( lymphoma ) have been reported after treatment, as a result of immunosuppression.
- Thrombotic thrombocytopenic purpura (or TTP): a condition characterized by fever and bruising under the skin that may look like red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute kidney failure (low or no urine production).
- Cases of pure erythrocyte aplasia (a very severe decrease in the number of red blood cells ) and hemolytic anemia (decreased number of red blood cells due to increased breakdown, accompanied by fatigue) and febrile neutropenia (a decrease in the white blood cells that fight infection, accompanied by fever) has been reported. It is not known exactly how often these side effects occur. You may be asymptomatic or experience symptoms such as fatigue, apathy, abnormal pallor, shortness of breath, dizziness, headache, chest pain, and cold hands and feet, depending on the severity of the condition.
- Cases of agranulocytosis (severe reduction in the number of white blood cells along with mouth sores, fever, and infection (s)). You may be symptom-free 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 in swallowing or breathing) and you may feel that you are about to faint.
- Posterior Reversible Encephalopathy Syndrome (PRES): headache, altered mental status, epileptic seizures, and visual disturbances.
- Torsades de Pointes: change in heart rate that may, but may not, be accompanied by symptoms such as chest pain (angina), weakness, dizziness or nausea, palpitations, and difficulty breathing.
- Gastrointestinal perforation: severe abdominal pain possibly accompanied by other symptoms, such as chills, fever, nausea, or vomiting.
- Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, severe illness with blistering of the skin, mouth, eyes, and genitals, hives, swollen tongue, the red or purple rash that spreads, flaky skin.
- Toxic epidermal necrolysis: lesions and blisters on the skin or mucous membranes, red swollen skin that can detach from large parts of the body.
- The hemolytic uremic syndrome is a condition with the following symptoms: low or no urine production ( acute kidney failure ), extreme fatigue, yellowing of the skin or eyes (jaundice), and abnormal bruising or bleeding and signs of infection.
- Inadequate function of the transplanted organ
The side effects listed below may also occur after you receive Tacni:
Very common (may affect more than 1 in 10 users):
- increased blood sugar, diabetes mellitus, increased level of potassium in the blood
- sleep difficulties
- tremors, headache
- increased blood pressure
- diarrhea, nausea
- kidney problems
Common (may affect up to 1 in 10 users):
- changes in the number of certain blood cells (e.g. red or white blood cells, platelets ),
- decrease in 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 acid content in the blood, and other changes in blood salts (seen by blood tests).
- anxiety, confusion, disorientation, depression, mood changes, nightmares, hallucinations, mental illness
- convulsions, disturbances of consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous disorders
- blurred vision, increased sensitivity to light, eye diseases
- earrings
- reduced blood flow in the vessels of the heart, faster heartbeat
- bleeding, partial or complete blockage of blood vessels decreased blood pressure.
- shortness of breath, changes in lung tissue, fluid accumulation around the lung, inflammation of the pharynx, cough, flu-like symptoms
- inflammation or ulcers causing abdominal pain or diarrhea, bleeding in the stomach, inflammation or ulcers in the mouth, fluid retention in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, flatulence, loose stools, stomach problems
- changes in liver enzyme values and function, yellowing of the skin due to liver problems, damage to liver tissue, and inflammation of the liver
- itching, rash, hair loss, acne, increased sweating
- pain in the joints, legs or arms, back and feet, muscle cramps
- insufficient kidney function decreased urine production, impaired or painful urination
- general weakness, fever, fluid accumulation in the body, pain, and discomfort, increase in enzymes and alkaline phosphatases in the blood, weight gain, the sensation of disturbed temperature perception
Uncommon (may affect up to 1 in 100 users):
- changes in the clotting ability of the blood, reduction in the number of all types of blood cells
- dehydration, decrease in protein or sugar in the blood, increase in phosphate in the blood
- coma, cerebral hemorrhage, stroke, paralysis, brain disease, speech and language difficulties, memory problems
- cloudiness in the lens of the eye
- impaired hearing
- irregular heartbeats, cardiac arrest, decreased force of the heart, heart muscle disease, enlargement of the heart muscle, stronger heartbeat, abnormal EKG, abnormal pulse and heart rate
- insufficient blood flow to tissues (resulting in cell death), blood clot in a vein in a leg or arm, shock
- breathing difficulties, respiratory disease, asthma
- obstruction of the intestinal passage, increased blood level of the enzyme amylase, acid reflux, delayed emptying of the stomach
- skin inflammation, burning sensation in the sun
- joint diseases
- inability to urinate, painful periods, and abnormal menstrual bleeding
- failure of certain organs, flu-like symptoms, increased sensitivity to heat and cold, pressure on the chest, nervousness or abnormal feeling, increase in the enzyme lactate dehydrogenase in the blood, weight loss
Rare (may affect up to 1 in 1,000 users):
- small bleeding in the skin due to blood clots
- 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
- increased hair growth
- thirst falls, feeling of pressure on the chest, reduced mobility, ulcers
Very rare (may affect up to 1 in 10,000 users):
- muscle weakness
- abnormal echocardiogram
- liver failure, narrowing of the bile duct
- painful urination with blood in the urine
- the increased amount of adipose tissue
Frequency not known (cannot be estimated from available data):
- optic nerve involvement ( optic neuropathy )
How to store Tacni
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated after Exp. date/EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Store in the original packaging (in the aluminum bag). Light sensitive. Moisture sensitive.
From the time the aluminum bag is opened, the product must be used within 1 year.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
0.5 mg
The active substance is tacrolimus. Each capsule contains 0.5 mg tacrolimus.
Other ingredients are:
- Capsule contents: Povidone K-30, croscarmellose sodium (E 468), lactose, magnesium stearate.
- Capsule shell: Titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.
1 mg
The active substance is tacrolimus. Each capsule contains 1 mg tacrolimus.
Other ingredients are:
- Capsule contents: Povidone K-30, croscarmellose sodium (E 468), lactose, magnesium stearate.
- Capsule shell: Titanium dioxide (E 171), gelatin.
5 mg
The active substance is tacrolimus. Each capsule contains 5 mg tacrolimus.
Other ingredients are:
- Capsule contents: Povidone K-30, croscarmellose sodium (E 468), lactose, magnesium stearate.
- Capsule shell: Titanium dioxide (E 171), red iron oxide (E 172), gelatin.
Appearance and package sizes of the medicine
0.5 mg
Ivory-colored cap and ivory-colored hard capsule shell with white powder.
1 mg
White cap and white hard capsule shell with white powder.
5 mg
Red cap and red hard capsule shell with white powder.
The hard capsules are supplied in blister cards of 10 capsules in a protective aluminum bag with a desiccant to protect the capsules from moisture. The desiccant must not be swallowed.
Tacni is supplied in blister packs of 20, 30, 50, 50 x 1, 60, 90, and 100 capsules containing blister cards of 10 capsules each.
Not all pack sizes may be marketed.
Marketing
Manufacturer:
Laboratorios Cinfa, SA, Olaz-Chipi, 10-Políg Areta 31620 Huarte-Pamplona, Navarre, Spain
Pharmachemie BV, Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Pharma BV, Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Operations Poland Sp. z o. o., Ul. Mogilska 80, 31-546 Kraków, Poland