Tacni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Tacni 0.5 mg hard capsules, 1 mg hard capsules, 5 mg hard capsules

Tacrolimus
Generic medicine
Please read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Tacni is and what it is used for
2. Before you take Tacni
3. How to take Tacni
4. Possible side effects
5. How to store Tacni
6. Further information

1. What Tacni is and what it is used for

Tacni belongs to a group of medicines called immunosuppressants. After an organ transplant
(for example, liver, kidney, or heart), your body's immune system will try to reject the
new organ.
Tacni is used to control your body's immune response, enabling it to accept the transplanted organ.
Tacni is often used in combination with other immunosuppressive medicines.
You may also receive Tacni for ongoing rejection of a transplanted liver, kidney, heart, or other organ, or
if one of the treatments you were taking was not effective in controlling the immune response after transplantation.

2. What you should know before taking Tacni

Do not take Tacni

• If you are allergic (hypersensitive) to tacrolimus or to any of the excipients in TACNI (see section 6);
• If you are allergic to any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).

Warnings and precautions
Inform your doctor or pharmacist before taking Tacni.

• • You will need to take Tacni every day for as long as immunosuppression is required to prevent rejection of your transplanted organ. Regular contact with your doctor is recommended.
• While taking Tacni, your doctor may occasionally request a series of tests (including blood and urine tests, heart function monitoring, vision checks, and neurological assessments). This is standard practice and will help your doctor determine the most appropriate dose of Tacni for you.
• Please avoid taking any herbal remedies, such as St. John’s wort (Hypericum perforatum) or any other herbal products, as they may alter the effectiveness and required dose of Tacni. If in doubt, consult your doctor before taking any herbal product or remedy.
• Inform your doctor if you have liver problems or a history of liver disease, as this may affect the dose of Tacni you require.
• If you experience severe abdominal pain, with or without other symptoms such as chills, fever, nausea, or vomiting.
• If you have diarrhoea for more than one day, inform your doctor, as it may be necessary to adjust your Tacni dose.
• If you have an abnormality in the electrical activity of the heart known as “QT interval prolongation”, a family history of “QT interval prolongation”, reduced heart function, low heart rate, electrolyte imbalance, or if you are taking medicines known to prolong the QT interval or cause electrolyte imbalances.
• Limit your exposure to sunlight and UV rays during Tacni treatment by wearing protective clothing and using a high-protection sunscreen, due to the potential risk of malignant skin changes associated with immunosuppressive therapy.
• If you require any vaccination, inform your doctor beforehand. Your doctor will advise you on the best course of action.
• Lymphoproliferative disorders have been reported in patients treated with Tacni (see section 4). Ask your doctor for specific information about these disorders.

Immediately report to your doctor if, during treatment, you experience:

• Vision problems, such as blurred vision, changes in colour vision, difficulty seeing details, or narrowing of the visual field.

Other medicines and Tacni
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tacni must not be taken together with cyclosporine.
Tacni blood levels may be affected by other medicines you are taking, and conversely, blood levels of other medicines may be altered by taking Tacni. This may require interruption, dose increase, or dose reduction of Tacni.
In particular, inform your doctor if you are taking or have recently taken medicines containing the following active substances:

• Antifungal and antibiotic medicines, particularly so-called macrolide antibiotics used to treat infections, such as ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, isavuconazole, erythromycin, telithromycin, clarithromycin, josamycin, rifampicin, and rifabutin
• Letermovir, used to prevent a disease caused by CMV (human cytomegalovirus)
• Antibiotics used to treat tuberculosis (isoniazid)
• HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat, and fixed-dose combination tablets used to treat HIV infection
• HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir) used to treat hepatitis C
• Nilotinib and imatinib (used to treat certain types of cancer)
• Mycophenolic acid, used to suppress the immune system and prevent transplant rejection
• Medicines for stomach ulcer or acid reflux (e.g. omeprazole, lansoprazole, or cimetidine)
• Antiemetics, used to treat nausea and vomiting (e.g. metoclopramide)
• Magnesium-aluminium hydroxide (antacid), used to treat heartburn
• Hormonal treatments with ethinylestradiol (e.g. for oral contraception) or danazol
• Oral contraceptive pills
• Medicines for high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem, and verapamil)
• Antiarrhythmic medicines (amiodarone) used to control arrhythmias (irregular heartbeat)
• Medicines known as "statins" used to treat high cholesterol and triglycerides
• The antiepileptic medicines phenytoin, phenobarbital, or carbamazepine
• The corticosteroids prednisolone and methylprednisolone, or corticosteroids in general taken over a long period (maintenance therapy)
• The antidepressant nefazodone
• Herbal preparations containing St. John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.

Inform your doctor if you are taking or need to take ibuprofen or other painkillers (e.g. non-steroidal anti-inflammatory drugs), amphotericin B, antivirals (e.g. aciclovir, ganciclovir), or certain antibiotics (e.g. aminoglycosides, gyrase inhibitors, vancomycin, sulfamethoxazole + trimethoprim). These may worsen kidney or nervous system problems when taken together with Tacni.
Your doctor also needs to know if you are taking potassium supplements or certain potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone), metamizole (a painkiller), anticoagulants, or oral medicines for diabetes while taking Tacni.
If you need to receive vaccinations, please inform your doctor beforehand.
Tacni with food and drink
You should generally take Tacni on an empty stomach, or at least 1 hour before or 2–3 hours after meals. Grapefruit and grapefruit juice must be avoided during treatment with Tacni.
Pregnancy and breastfeeding
If you are planning a pregnancy, suspect you are pregnant, or are pregnant, consult your doctor or pharmacist before taking any medicine.
Tacni is excreted in breast milk. Therefore, you must not breastfeed during treatment with Tacni.
Driving and using machines
Do not drive or operate tools or machinery if you feel unsteady, drowsy, or have problems seeing clearly after taking Tacni. These effects are more commonly observed when Tacni is taken with alcoholic beverages.
Tacni contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. essentially “sodium-free”.

3. How to take Tacni

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Make sure you always receive the same formulation of tacrolimus when you collect your prescription, unless your transplant specialist has agreed to a change in the tacrolimus formulation.
This medicine must be taken twice daily. If the appearance of the medicine is different than usual or if the dosing instructions have changed, contact your doctor or pharmacist as soon as possible to ensure you have received the correct medicine.
The initial dose to prevent rejection of the transplanted organ will be determined by your doctor and calculated based on your body weight. The initial dose immediately after transplantation is generally in the range of 0.075–0.30 mg per kg of body weight per day, depending on the transplanted organ.
Your dose depends on your general condition and on any other immunosuppressive medicines you are taking. Your doctor will ask you to have regular blood tests to determine the correct dose and adjust it as needed. Your doctor will usually reduce your Tacni dose once your condition has stabilized. Your doctor will tell you exactly how many capsules to take and how often.
Tacni must be taken orally twice daily, usually in the morning and evening. The capsules are generally taken on an empty stomach, or at least one hour before or 2–3 hours after meals. Swallow the capsules whole with a glass of water. Avoid grapefruit and grapefruit juice while taking Tacni.
Do not ingest the desiccant contained in the aluminum packaging.
If you take more Tacni than you should
If you have accidentally taken too much of the medicine, contact your doctor or the nearest hospital emergency department immediately.
If you forget to take Tacni
Do not take a double dose to make up for a forgotten dose.
If you have forgotten to take your capsules, wait until the next scheduled dose and then continue as before.
If you stop taking Tacni
Stopping treatment may increase the risk of rejection of your transplanted organ. Do not discontinue treatment unless your doctor tells you to do so.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Tacni may cause adverse reactions, although not everyone experiences them.
Tacni reduces your body's natural defense mechanism so that it stops rejecting the transplanted organ. As a result, your body may become less effective at fighting infections. Therefore, if you are taking Tacni, you may be at an increased risk of developing infections compared to usual, such as infections of the skin, mouth, stomach, intestine, lungs, liver, urinary tract, and central nervous system.

Serious adverse reactions may occur, including those listed below. Immediately consult your doctor if you have or think you may have any of the following serious adverse reactions:

• Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
• Benign and malignant tumors have been reported following treatment with immunosuppressants.
• Thrombotic thrombocytopenic purpura (TTP), a condition characterized by fever and bruising under the skin appearing as small red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), and symptoms of acute kidney failure (low or no urine output).
• Cases of pure red cell aplasia (a severe reduction in red blood cell count), hemolytic anemia (reduced red blood cell count due to abnormal destruction, accompanied by fatigue), and febrile neutropenia (a decrease in a type of white blood cell that fights infections, accompanied by fever) have been reported. The exact frequency of these adverse reactions is unknown. You may have no symptoms, or depending on the severity of the condition, you may experience: fatigue, apathy, unusual paleness of the skin, shortness of breath, dizziness, headache, chest pain, and cold hands and feet.
• Cases of agranulocytosis (severely reduced white blood cell count accompanied by mouth ulcers, fever, and infections) have been reported. You may have no symptoms or may experience sudden fever, stiffness, or sore throat.
• Allergic or anaphylactic reactions with the following symptoms: sudden itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing and breathing), and feeling weak.
• Posterior reversible encephalopathy syndrome (PRES): headache, altered mental status, seizures, and visual disturbances.
• Torsades de pointes: changes in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), weakness, dizziness or nausea, palpitations (awareness of your heartbeat), and difficulty breathing.
• Gastrointestinal perforation: severe abdominal pain with or without other symptoms such as chills, fever, nausea, and vomiting.
• Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, severe illness with blistering of the skin, mouth, eyes, and genitals, urticaria, tongue swelling, red or purplish skin rash spreading over the body, skin peeling.
• Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that may peel off large areas of the body.
• Hemolytic uremic syndrome, a condition with the following symptoms: reduced or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), bruising or abnormal bleeding, and signs of infection.
• Insufficient function of the transplanted organ.

The following adverse reactions may also occur after taking Tacni.

Very common adverse reactions (may affect more than 1 in 10 people):

• Increased blood glucose, diabetes mellitus, increased blood potassium
• Difficulty sleeping
• Tremor, headache
• Increased blood pressure
• Diarrhea, nausea
• Kidney disorders

Common adverse reactions (may affect up to 1 in 10 people):

• Changes in the number of certain blood cells (e.g., red/white blood cells, platelets)
• Decreased magnesium, phosphate, potassium, calcium, or sodium in the blood, fluid overload, increased uric acid or blood lipids, decreased appetite, increased blood acidity, other changes in blood electrolyte balance
• Anxiety symptoms, confusion and disorientation, depression, mood swings, nightmares, hallucinations, mental disorders
• Seizures, altered consciousness, tingling and numbness (sometimes painful) in hands and feet, sense of instability, impaired writing ability, nervous system disorders
• Blurred vision, increased light sensitivity, eye disorders
• Ringing in the ears
• Reduced blood flow in blood vessels, increased heart rate
• Bleeding, partial or complete blockage of blood vessels, low blood pressure
• Shortness of breath, changes in lung tissue, fluid accumulation around the lung, pharyngitis, cough, flu-like symptoms
• Gastric disorders such as inflammation or ulcers causing abdominal pain or diarrhea, stomach bleeding, mouth inflammation or ulcers, fluid accumulation in the stomach, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, loose stools, stomach problems
• Changes in liver enzymes and liver function, jaundice due to liver problems, liver tissue damage, liver inflammation
• Itching, rash, hair loss, acne, increased sweating
• Joint, limb, back, and foot pain, muscle spasms
• Impaired kidney function, reduced urine production, reduced or painful urination
• General weakness, fever, fluid retention in the body, pain and discomfort, increased blood alkaline phosphatase enzyme, weight gain, altered perception of temperature

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Changes in blood clotting processes, reduced count of all blood cells
• Dehydration, reduced blood protein or sugar levels, increased blood phosphate
• Coma, cerebral hemorrhage, stroke, paralysis, brain disorders, language and expression difficulties, memory problems
• Lens opacification
• Hearing impairment
• Irregular heartbeat, cardiac arrest, reduced heart output, heart muscle disorders, thickening of the heart muscle, increased heartbeat, abnormal ECG, altered heart rhythm and rate
• Reduced blood supply to tissues (leading to cell death), thrombosis in a limb vein, shock
• Breathing difficulties, respiratory disorders, asthma
• Intestinal obstruction, increased blood amylase levels, gastroesophageal reflux, delayed gastric emptying
• Dermatitis, burning sensation upon sun exposure
• Arthropathies
• Inability to urinate, painful menstruation, abnormal menstrual bleeding
• Impairment of certain organs, flu-like illness, increased sensitivity to heat and cold, chest tightness, restlessness and discomfort, increased blood lactate dehydrogenase enzyme, weight loss

Rare adverse reactions (may affect up to 1 in 1,000 people):

• Small skin hemorrhages caused by blood clots
• Increased muscle stiffness
• Blindness
• Deafness
• Fluid accumulation around the heart
• Acute respiratory distress syndrome
• Cyst formation in the pancreas
• Blood circulation problems in the liver
• Increased hair growth
• Thirst, fainting, chest tightness, reduced mobility, ulcer

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• Muscle weakness
• Abnormal echocardiogram
• Liver failure, bladder contraction
• Painful urination with blood in the urine
• Increased fatty tissue

Not known (frequency cannot be estimated from available data):

• Optic nerve abnormalities (optic neuropathy)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Tacni

Keep out of the reach and sight of children.
Do not use this medicinal product after the expiry date stated on the carton and blister after {Exp.}. The expiry date refers to the last day of the month.
Store below 30°C.
Store in the original packaging (inside the aluminium foil wrapper) to protect from moisture and light.
Once the aluminium foil wrapper has been opened, the product should be used within 1 year.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tacni contains
0.5 mg

• The active substance is tacrolimus. Each capsule contains 0.5 mg of tacrolimus.
• The other components are: Capsule contents: povidone K-30, sodium croscarmellose (E 468), anhydrous lactose, magnesium stearate. Capsule shell: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin

1 mg

• The active substance is tacrolimus. For 1 mg: each capsule contains 1 mg of tacrolimus.
• The other components are: Capsule contents: povidone K-30, sodium croscarmellose (E 468), lactose, magnesium stearate. Capsule shell: titanium dioxide (E 171), gelatin

5 mg

• The active substance is tacrolimus. For 5 mg: each capsule contains 5 mg of tacrolimus.
• The other components are: Capsule contents: povidone K-30, sodium croscarmellose (E 468), lactose, magnesium stearate. Capsule shell: titanium dioxide (E 171), red iron oxide (E 172), gelatin

Description of the appearance of Tacni and the contents of the pack
0.5 mg
Hard capsules with an ivory body and an ivory cap, containing white powder.
1 mg
Hard capsules with a white body and a white cap, containing white powder.
5 mg
Hard capsules with a red body and a red cap, containing white powder.
The hard capsules are supplied in blisters of 10 capsules, packed in a protective pouch containing a desiccant to protect the capsules from moisture. The desiccant must not be ingested.
Tacni is available in packs of 20, 30, 50, 50x1, 60, 90 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer responsible for batch release
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10-Políg Areta 31620 Huarte-Pamplona, Navarra, (Spain)
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem (The Netherlands)
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem (The Netherlands)
Teva Operations Poland Sp. z o.o,
Ul. Mogilska 80, 31-546 Kraków (Poland)
This summary of product characteristics was last approved on: