TACNI 0.5 MG Hard capsules

Зміст інструкції

1. Tacni hard capsules 0.5 mg, hard capsules 1 mg, hard capsules 5 mg
   1. What is Tacni and what is it used for
   2. What you need to know before taking Tacni
   3. How to take Tacni
   4. POSSIBLE SIDE EFFECTS
   5. How to store Tacni
   6. Package Contents and Other Information

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

Tacrolimus
Generic medicine
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 is Tacni and what is it used for

Tacni belongs to a group of medicines called immunosuppressants. Following organ transplantation
(e.g., of liver, kidney, heart), your body's immune system will try to reject the
new organ.
Tacni is used to control your body's immune response by putting it in a condition to
accept the transplanted organ.
Tacni is often used in combination with other immunosuppressant medicines.
You may also receive Tacni for an ongoing rejection of the liver, kidney, heart or other transplanted organ or
if one of the treatments you were taking has not proven able to control this immune response
after transplantation.

2. What you need to know before taking Tacni

Do not take Tacni

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

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

• - You will need to take Tacni every day as long as you need immunosuppressive action to prevent rejection of the organ that has been transplanted. Regular contact with your doctor is recommended.
• While you are taking Tacni, your doctor may ask you to undergo a series of tests (including blood, urine, cardiac function, vision check and neurological function) from time to time. This procedure is quite normal and will help your doctor decide the most appropriate dose of Tacni for you.
• Please avoid taking any remedies of herbal origin, e.g. St. John's wort (Hypericum perforatum) or any other product of plant origin, as it may alter the efficacy and dose of Tacni you need to receive. If you have any doubts, please consult your doctor before taking any product or remedy of herbal origin.
• If you have liver problems or have had a disease that may have damaged the liver, please inform your doctor as this may affect the dose of Tacni you need to take.
• If you have severe abdominal pain accompanied or not by other symptoms, such as chills, fever, nausea and vomiting.
• If you have diarrhea for more than one day, report it to your doctor, as it may be necessary to adjust the dose of Tacni you are receiving.
• If you have an alteration of the electrical activity of the heart, called "QT interval prolongation", a family history of "QT interval prolongation", reduced heart performance, low heart rate, electrolyte imbalance or if you are taking medicines known to prolong the QT interval or cause electrolyte imbalance.
• Limit exposure to the sun and UV rays while undergoing therapy with Tacni by wearing protective clothing and using a sunscreen with a high protection factor. This is due to the potential risk of malignant changes at the skin level caused by immunosuppressive therapy.
• If you need to be vaccinated, inform your doctor beforehand. Your doctor will advise you on how to proceed.
• Patients treated with Tacni have been reported to have an increased risk of developing lymphoproliferative disorders (see section 4). Ask your doctor for specific information regarding these disorders.

Immediately report to your doctor if you experience:

• eye problems, such as blurred vision, changes in color vision, difficulty seeing details or if the field of vision narrows.

Other medicines and Tacni
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tacni must not be taken together with cyclosporine.
The concentrations of Tacni in your blood may be affected by other drugs you are
taking and vice versa, the concentrations in the blood of other medicines may be altered
by taking Tacni, which may require an interruption, increase or reduction
in the dose of Tacni.
In particular, you must inform your doctor if you are taking or have recently taken medicines
containing active ingredients such as:

• antifungal and antibiotic medicines, in particular the 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, 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 potentiator medicine cobicistat, and the 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 inhibit the immune system and prevent transplant rejection
• medicines for stomach ulcers or acid reflux (e.g. omeprazole, lansoprazole or cimetidine)
• anti-emetics, used to treat nausea and vomiting (e.g. metoclopramide)
• magnesium-aluminum 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 or phenobarbital or carbamazepine
• the corticosteroids prednisolone and methylprednisolone or corticosteroids in general taken for a long period of time (maintenance therapy)
• the antidepressant nefazodone
• herbal preparations containing St. John's wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.

Tell your doctor if you are taking or if you 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). They may worsen kidney or
nervous system problems when taken together with Tacni.
The doctor also needs to know if you, while taking Tacni, are taking potassium supplements or some potassium-sparing diuretics (e.g. amiloride, triamterene or
spironolactone), metamizole (a painkiller), anticoagulants, or oral diabetes medicines.
If you need to be vaccinated, please inform your doctor beforehand.

Tacni with food and drink
Generally, you should take Tacni on an empty stomach or at least 1 hour before or 2–3 hours after
meals. Grapefruit and grapefruit juice should be avoided while using Tacni.

Pregnancy and breastfeeding
If you are planning a pregnancy, suspect you are pregnant or are pregnant, ask your doctor or
pharmacist for advice before taking any medicine.
Tacni is excreted in breast milk. Therefore, you should not breastfeed during therapy with Tacni.

Driving and using machines
Do not drive and do not use tools or machines if you feel unstable or drowsy or if you
have trouble seeing clearly after taking Tacni. These effects are more frequently observed
if Tacni is taken with alcoholic beverages.

Tacni contains lactose and sodium
If your doctor has diagnosed you with intolerance to certain sugars, ask your doctor for advice
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 your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
Make sure you always receive the same formulation of tacrolimus when you pick up your prescription, unless
your transplant specialist has agreed to change the formulation of
tacrolimus.
This medicine must be taken twice a day. If the appearance of the medicine is not the same
as usual or if the dosage instructions have changed, contact your doctor or pharmacist as soon as
possible to make sure you have received the correct medicine.
The initial dose to prevent organ rejection after your transplant will be determined by your doctor
and calculated based on your weight. The initial dose shortly after transplantation will generally be 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 any other immunosuppressant medicine you are
taking. Your doctor will ask you to undergo blood tests regularly to determine the
correct dose and to adjust this dose from time to time. Your doctor will generally reduce your dose of
Tacni 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 a day, 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. The capsules should be swallowed whole with a glass of water. Avoid grapefruit and grapefruit juice during
the intake of Tacni.

Do not ingest the desiccant contained in the aluminum blister.
If you take more Tacni than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor
or the emergency room of the nearest hospital immediately.

If you forget to take Tacni
Do not take a double dose to make up for a missed dose.
If you have forgotten to take the capsules, wait until the time of the next dose and then continue
as before.

If you stop taking Tacni
Stopping treatment may increase the risk of organ rejection after your
transplant. Do not stop treatment unless your doctor tells you to do so.
If you have any doubts about the use of the product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tacni can cause side effects, although not everybody gets them.
Tacni reduces the defense mechanism of your body, in order to stop the rejection of the organ that has
been transplanted to you. Consequently, your body may no longer be as efficient in fighting
infections. Therefore, if you are taking Tacni, you may be at a higher risk of developing
infections than usual, such as infections of the skin, mouth, stomach, intestine,
lungs, liver, urinary tract and the central nervous system.
Serious side effects can occur, including those listed below. Ask
your doctor immediately if you have or think you have any of the following serious side effects:

• Opportunistic infections (bacterial, fungal, viral and protozoal): prolonged diarrhea, fever and sore throat.
• Benign and malignant tumors have been reported to occur following treatment with immunosuppressants.
• Thrombotic thrombocytopenic purpura (TTP), a condition characterized by fever and bruising under the skin that may appear as red 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 output).
• Cases of pure red cell aplasia (a very serious decrease in red blood cell count), hemolytic anemia (reduced number of red blood cells due to their abnormal destruction accompanied by fatigue) and febrile neutropenia (a decrease in the number of a type of white blood cells that fight infections, accompanied by fever) have been reported. It is not known exactly how often these side effects occur. You may have no symptoms, or depending on the severity of the condition, you may experience: fatigue, apathy, abnormal paleness of the skin, shortness of breath, dizziness, headache, chest pain and cooling of the hands and feet.
• Cases of agranulocytosis (a strongly reduced number of white blood cells accompanied by mouth ulcers, fever and infections) have been reported. You may not have any symptoms or you may have a sudden fever, stiffness or sore throat.
• Allergic or anaphylactic reactions with the following symptoms: sudden itching (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing and breathing) and you may feel weak.
• Reversible posterior encephalopathy syndrome (PRES): headache, altered mental status, seizures and visual disturbances.
• Torsades de Pointes: change in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), weakness, dizziness or nausea, palpitations (perception of your heartbeat) and difficulty breathing.
• Gastrointestinal perforation: severe abdominal pain accompanied or not by other symptoms such as chills, fever, nausea and vomiting.
• Stevens-Johnson syndrome: widespread unexplained skin pain, facial swelling, a severe illness with blistering on the skin, mouth, eyes and genitals, hives, tongue swelling, red or purple skin rash that spreads, skin peeling.
• Toxic epidermal necrolysis: erosion and blistering on the skin or mucous membranes, reddened and swollen skin that may detach from large areas of the body.
• Hemolytic uremic syndrome, a condition with the following symptoms: reduced or no urine output (acute renal failure), extreme fatigue, yellowing of the skin or eyes (jaundice) and unusual bruising or bleeding and signs of infection.
• Insufficient function of the transplanted organ.

The following side effects can also occur after taking Tacni.

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

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

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

• Changes in the number of some blood cells (for example red blood cells/white blood cells, platelets)
• Decreased magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased blood acidity, other changes in blood salt balance
• Symptoms of anxiety, confusion and disorientation, depression, mood swings, nightmares, hallucinations, mental disorders
• Seizures, altered consciousness, tingling and numbness (sometimes painful) in the hands and feet, feeling of instability, impaired ability to write, nervous system disorders
• Blurred vision, increased sensitivity to light, eye disorders
• Ringing in the ears
• Reduced blood flow in blood vessels, increased heart rate
• 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
• Gastric disorders such as inflammation or ulcers causing abdominal pain or diarrhea, bleeding in the stomach, inflammation or ulcers in the mouth, accumulation of fluids in the stomach, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, soft stools, stomach problems
• Changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue damage and liver inflammation
• Itching, rash, hair loss, acne, increased sweating
• Joint pain, limb pain, back pain and foot pain, muscle spasms
• Insufficient kidney function, reduced urine production, painful or reduced urination
• General weakness, fever, fluid retention in the body, pain and discomfort, increased alkaline phosphatase enzyme in the blood, weight gain, feeling of altered temperature perception

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

• Alterations in blood clotting processes, reduction in the count of all blood cells
• Dehydration, reduced proteins or sugar in the blood, increased phosphate in the blood
• Coma, cerebral hemorrhage, stroke, paralysis, brain disorders, alterations in language and expression, memory problems
• Opacification of the lens
• Hearing impairment
• Irregular heartbeat, cardiac arrest, reduced cardiac output, heart muscle disorders, thickening of the heart muscle, increased heartbeat, abnormal ECG, altered heart rate and rhythm
• Decreased blood supply to tissues (resulting in cell death), blood clot in a vein in the limbs, shock
• Difficulty breathing, respiratory system disorders, asthma
• Intestinal blockage, increased levels of the enzyme amylase in the blood, reflux of stomach contents into the throat, delayed gastric emptying
• Dermatitis, burning sensation during exposure to the sun
• Arthropathies
• Inability to urinate, painful and abnormal menstrual periods
• Impairment of some organs, flu-like illness, increased sensitivity to heat and cold, feeling of tightness in the chest, feeling of restlessness and discomfort, increased lactate dehydrogenase enzyme in the blood, weight loss

Rare side effects: (may affect up to 1 in 1000 people):

• Small hemorrhages of the skin caused by blood clots
• Increased muscle stiffness
• Blindness
• Deafness
• Fluid accumulation around the heart
• Acute respiratory distress syndrome
• Cyst formation in the pancreas
• Problems with blood circulation at the level of the liver
• Increased hair growth
• Thirst, fainting, feeling of constriction in the chest, decreased mobility, ulcer

Very rare side effects: (may affect up to 1 in 10000 people):

• Muscle weakness
• Altered echocardiogram
• Liver failure, narrowing of the bladder
• Painful urination with blood in the urine
• Increased adipose tissue

Not known (frequency cannot be estimated based on available data):

• Optic nerve abnormalities (optic neuropathy)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects 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 medicine after the expiry date indicated on the package and blister after
{Scad.}. The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Store in the original package (inside the aluminum wrapper) to protect from
moisture and light.
Once the aluminum wrapper is opened, the product must be used within 1 year.
Medicines should not be disposed of via drains or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Tacni
0.5 mg contains

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

1 mg

• The active ingredient is tacrolimus. For 1 mg: each capsule contains 1 mg of tacrolimus.
• The 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 ingredient is tacrolimus. For 5 mg: each capsule contains 5 mg of tacrolimus.
• The 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

Description of the appearance of Tacni and package contents
0.5 mg
Hard capsule with ivory body and ivory cap, containing white powder.

1 mg
Hard capsule with white body and white cap, containing white powder.

5 mg
Hard capsule with red body and red cap, containing white powder.
The hard capsules are supplied in blisters of 10 capsules inserted into a protective wrapper containing
a desiccant substance to protect the capsules from moisture. The desiccant unit 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 Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan

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 (Netherlands)
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem (Netherlands)
Teva Operations Poland Sp. z o.o,
Ul. Mogilska 80, 31-546 Kraków (Poland)