TACROLIMUS STADAFARMA 5 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information Leaflet

Tacrolimus Stadafarma 0.5 mg prolonged-release hard capsules EFG

Tacrolimus Stadafarma 1 mg prolonged-release hard capsules EFG

Tacrolimus Stadafarma 3 mg prolonged-release hard capsules EFG

Tacrolimus Stadafarma 5 mg prolonged-release hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tacrolimus Stadafarma and what is it used for
2. What you need to know before you take Tacrolimus Stadafarma
3. How to take Tacrolimus Stadafarma
4. Possible side effects
5. Storage of Tacrolimus Stadafarma
6. Contents of the pack and other information

1. What is Tacrolimus Stadafarma and what is it used for

Tacrolimus Stadafarma contains the active substance tacrolimus. It is an immunosuppressant. After your organ transplant (liver, kidney), your body's immune system will try to reject the new organ. Tacrolimus is used to control your body's immune response, allowing it to accept the transplanted organ.

You may also receive tacrolimus to treat rejection that is occurring in your liver, kidney, heart, or other transplanted organ when any previous treatment you were following did not control this immune response after your transplant.

Tacrolimus is used in adults.

2. What you need to know before you take Tacrolimus Stadafarma

Do not take Tacrolimus Stadafarma

• if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sirolimus or any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).

Warnings and precautions

Tacrolimus immediate-release capsules and tacrolimus prolonged-release capsules both contain the active substance tacrolimus. However, tacrolimus prolonged-release capsules are taken once daily, while immediate-release capsules are taken twice daily. This is because tacrolimus prolonged-release capsules allow for prolonged release (slower release over a longer period of time) of tacrolimus.

Tacrolimus prolonged-release capsules and tacrolimus immediate-release capsules are notinterchangeable.

Tell your doctor if you experience any of the following:

• if you are taking any other medicine (mentioned below in “Other medicines and Tacrolimus Stada”)
• if you have or have had liver problems
• if you have had diarrhea for more than a day
• if you feel strong abdominal pain accompanied by other symptoms such as chills, fever, nausea, or vomiting
• if you have an alteration in the electrical activity of your heart called “prolonged QT interval”.
• if you have or have had damage to the small blood vessels, known as thrombotic microangiopathy/thrombocytopenic purpura/hemolytic uremic syndrome. Tell your doctor if you develop fever, bruising under the skin (which may appear as red spots), unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output, loss of vision, and seizures (see section 4). When taking tacrolimus with sirolimus or everolimus, the risk of these symptoms may increase.

Please avoid taking any herbal preparations, e.g. St. John's Wort (Hypericum perforatum) or any other plant-based product, as this may affect the effectiveness and dose of tacrolimus you need to receive.

If you have any doubts, please consult your doctor before taking any plant-based product or preparation.

Your doctor may need to adjust your dose of tacrolimus.

You should stay in regular contact with your doctor. From time to time, to establish the correct dose of tacrolimus, your doctor may need to perform blood and urine tests, heart tests, eye tests.

You should limit your exposure to sunlight and UV (ultraviolet) while taking tacrolimus. This is because immunosuppressants can increase the risk of skin cancer. Wear protective clothing and use a sunscreen with a high sun protection factor.

Handling precautions:

Avoid contact with any part of the body, such as skin or eyes, as well as inhaling the powder contained in the capsules. If such contact occurs, wash the skin and eyes.

Children and adolescents

Tacrolimus is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Tacrolimus Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tacrolimus should not be used with cyclosporin (another medicine used to prevent organ transplant rejection).

If you need to visit a different doctor than your transplant specialist, tell the doctor that you are taking tacrolimus.It is possible that your doctor will need to consult with your transplant specialist if you need to use another medicine that may increase or decrease your blood levels of tacrolimus.

Tacrolimus blood levels may be changed due to other medicines you are taking, and blood levels of other medicines may be changed by the administration of tacrolimus, which may require interruption, increase, or decrease of the dose of tacrolimus.

Some patients have experienced increases in tacrolimus blood levels while taking other medicines. This could cause serious side effects, such as kidney problems, nervous system problems, and heart rhythm disorders (see section 4).

The effect on tacrolimus blood levels may occur soon after starting to use another medicine, so it may be necessary to monitor the blood level of tacrolimus frequently and continuously during the first days of use of another medicine and frequently while continuing its use. Some other medicines may cause tacrolimus blood levels to decrease, which may increase the risk of transplant rejection. In particular, you should inform your doctor if you are taking or have recently taken medicines such as:

• antifungals and antibiotics, especially macrolide antibiotics, used to treat infections, e.g. ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, caspofungin, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniazid, and flucloxacillin
• letermovir, used to prevent diseases caused by CMV (human cytomegalovirus)
• HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the pharmacoenhancer cobicistat, and combination tablets, or non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine) used to treat HIV infections
• HCV protease inhibitors (e.g. telaprevir, boceprevir, the combination 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 types of cancer)
• mycophenolic acid, used to suppress the immune system as prevention of transplant rejection
• medicines for stomach ulcers and acid reflux (e.g. omeprazol, lansoprazol, or cimetidine)
• antiemetics, used to treat nausea and vomiting (e.g. metoclopramide)
• cisapride or the antacid aluminum-magnesium hydroxide, used to treat acidity
• the contraceptive pill or other hormonal treatments with ethinylestradiol, hormonal treatments with danazol
• medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem, and verapamil)
• antiarrhythmic medicines (amiodarone) used to control arrhythmia (irregular heartbeat)
• medicines known as “statins” used to treat high cholesterol and triglycerides
• carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy
• metamizole, used to treat pain and fever
• corticosteroids prednisolone or methylprednisolone, belonging to the class of corticosteroids used to treat inflammation or suppress the immune system (e.g. transplant rejection)
• nefazodone, used to treat depression
• plant-based medicines containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
• cannabidiol (its use includes, among others, the treatment of epileptic seizures)

Tell your doctor if you are receiving treatment for hepatitis C. The pharmacological treatment for hepatitis C may change your liver function and may affect your tacrolimus blood levels. Tacrolimus blood levels may decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor your tacrolimus blood levels and make necessary adjustments to your tacrolimus dose after starting hepatitis C treatment.

Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation, and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections), or antivirals (used to treat viral infections, e.g. acyclovir, ganciclovir, cidofovir, foscarnet). These medicines may worsen kidney or nervous system problems when taken with tacrolimus.

Tell your doctor if you are taking sirolimus or everolimus. When taking tacrolimus with sirolimus or everolimus, the risk of thrombotic microangiopathy, thrombocytopenic purpura, and hemolytic uremic syndrome may increase (see section 4).

Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, high blood pressure, and kidney disease (e.g. amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim and cotrimoxazole, which may increase potassium levels in your blood, non-steroidal anti-inflammatory medicines (NSAIDs, e.g. ibuprofen) used for fever, inflammation, and pain, anticoagulants (which prevent blood clotting), or oral medicines for diabetes treatment, while taking tacrolimus.

If you are planning to get vaccinated, consult your doctor.

Taking Tacrolimus Stada with food and drinks

Avoid grapefruit (also in juice) while being treated with tacrolimus, as it may affect your blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Tacrolimus passes into breast milk. Therefore, you should not breastfeed while taking tacrolimus.

Driving and using machines

Do not drive or use tools or machines if you feel dizzy or drowsy, or have problems seeing clearly after taking tacrolimus. These effects are more frequent if you also drink alcohol.

Tacrolimus Stada contains lactose and red iron oxide (E172)

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains red iron oxide (E172).

It may cause allergic reactions.

3. How to take Tacrolimus Stadafarma

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again. This medicine should only be prescribed by a doctor with experience in the treatment of patients with transplants.

Make sure you receive the same medicine with tacrolimus each time you collect your prescription, unless your transplant specialist has agreed to change to another medicine with tacrolimus. This medicine should be taken once a day. If the appearance of this medicine is not the same as usual, or if the dosing instructions have changed, consult your doctor or pharmacist as soon as possible to ensure you have the correct medicine.

The initial dose to prevent rejection of your transplanted organ will be determined by your doctor based on your body weight. The daily initial doses just after transplantation will generally be within the range of

0.10 - 0.30 mg per kilogram of body weight and per day

depending on the transplanted organ. For treating rejection, these same doses may be used.

Your dose depends on your general condition and any other immunosuppressive medication you may be taking.

After starting treatment with tacrolimus, your doctor will perform frequent blood tests to determine the correct dose. Afterward, your doctor will need to perform blood tests regularly to determine the correct dose and to adjust the dose from time to time. Your doctor will usually decrease your dose of tacrolimus once your condition has stabilized. Your doctor will tell you exactly how many capsules to take.

You will need to take tacrolimus every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should stay in regular contact with your doctor.

Tacrolimus is taken orally once a day, in the morning. Take tacrolimus on an empty stomach or 2 to 3 hours after a meal. Wait at least one hour until the next meal.

Take the capsules immediately after removing them from the blister pack. The capsules should be swallowed wholewith a glass of water. Do not swallow the desiccant contained in the aluminum pouch.

If you take more Tacrolimus Stadafarma than you should

If you accidentally take too many capsules, contact your doctor or go to the emergency department of the nearest hospital.

If you forget to take Tacrolimus Stadafarma

If you have forgotten to take your capsules in the morning, take them as soon as possible on the same day. Do not take a double dose the next morning.

If you stop taking Tacrolimus Stadafarma

Stopping your treatment with tacrolimus may increase the risk of rejection of your transplanted organ. Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Tacrolimus reduces the body's defense mechanisms (immune system), which will not work as well when fighting infections. Therefore, if you are taking tacrolimus, you will be more prone to suffering from infections.

Some infections can be serious or fatal and may include infections caused by bacteria, viruses, fungi, parasites, or other infections.

Inform your doctor immediately if you have symptoms of an infection, including:

• Fever, cough, sore throat, feeling of weakness or general malaise
• Memory loss, problems thinking, difficulty walking, or loss of vision – these symptoms may be due to a rare and serious brain infection (progressive multifocal leukoencephalopathy or PML)

Severe effects can occur, including allergic reactions and anaphylaxis. Benign and malignant tumors have been reported after treatment with tacrolimus.

Inform your doctor immediately if you suspect you are suffering from any of the following serious adverse effects:

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

• Gastrointestinal perforation: severe abdominal pain accompanied or not by other symptoms such as chills, fever, nausea, or vomiting.
• Insufficient function of the transplanted organ.
• Blurred vision.

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

• Microangiopathic thrombocytopenia (lesions in small blood vessels) including hemolytic uremic syndrome with the following symptoms: low or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and bruising or abnormal bleeding and signs of infection.

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

• Thrombotic thrombocytopenic purpura: includes lesions in small blood vessels and is characterized by fever and bruising under the skin that can appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute kidney failure (low or no urine output), loss of vision, and convulsions.
• Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that can peel off in large areas of the body.
• Blindness.

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

• Stevens-Johnson syndrome: unexplained generalized skin pain, facial swelling, severe illness with blistering of the skin, mouth, eyes, and genitals, rash, swelling of the tongue, red or purple skin rash that spreads, peeling of the skin.
• Torsades de Pointes: change in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness, or nausea, palpitations (feeling heartbeats) and difficulty breathing.

Adverse effects of unknown frequency (frequency cannot be estimated from available data):

• Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
• Benign and malignant tumors have been reported after treatment as a result of immunosuppression, including malignant skin cancers and a rare type of cancer that can include skin lesions known as Kaposi's sarcoma. Symptoms include changes in the skin, such as new or changing discoloration, lesions, or lumps.
• Cases of pure red cell aplasia (a very severe reduction in red blood cell count), hemolytic anemia (decrease in the number of red blood cells due to abnormal breakdown, accompanied by fatigue), and febrile neutropenia (a decrease in the type of white blood cells that fight infections, accompanied by fever) have been reported. The exact frequency with which these adverse effects occur is not known. You may not have symptoms or, depending on the severity of the condition, you may feel: fatigue, apathy, abnormal paleness of the skin (pallor), difficulty breathing, dizziness, headache, chest pain, and feeling cold in hands and feet.
• Cases of agranulocytosis (a significant decrease in the number of white blood cells, accompanied by sores in the mouth, fever, and infection(s)) have been reported. You may not have symptoms or you may feel sudden fever, chills, and sore throat.
• Allergic reactions and anaphylaxis with the following symptoms: sudden itchy skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing or breathing), and you may feel like you are going to faint.
• Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood changes, seizures, and vision disturbances. These could be signs of a disorder known as posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
• Optic neuropathy (nerve damage): vision problems such as blurred vision, changes in color vision, difficulty seeing details, or reduced visual field.

After receiving tacrolimus, the following adverse effects can also occur and may be serious:

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

• Increased blood sugar, diabetes mellitus, increased potassium in the blood
• Difficulty sleeping
• Tremors, headache
• Increased blood pressure
• Abnormalities in liver function tests
• Diarrhea, nausea
• Kidney problems

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

• Reduction in the number of blood cells (platelets, red blood cells, or white blood cells), increased white blood cell count, changes in red blood cell counts (see blood test)
• Reduction of 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 salts (see blood test)
• Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders
• Seizures, disorders of consciousness level, tingling and numbness (sometimes painful) in hands and feet, dizziness, decreased ability to write, nervous system disorders
• Increased sensitivity to light, eye disorders
• Ringing in the ears
• Reduced blood flow in coronary vessels, faster heart rate
• Bleeding, partial or complete blockage of blood vessels, decreased blood pressure
• Shortness of breath, respiratory tract disorders, asthma
• Intestinal obstruction, increased blood level of amylase enzyme, reflux of stomach contents into the throat, delayed emptying of the stomach
• Skin inflammation, sensation of sunburn
• Joint disorders
• Difficulty urinating, painful and abnormal menstrual bleeding
• Multi-organ failure, catarrhal disease, increased sensitivity to heat and cold, feeling of pressure in the chest, restlessness or abnormal feeling, increased lactate dehydrogenase enzyme in the blood, weight loss

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

• Changes in blood coagulation, reduction in the number of all types of blood cells (see blood test)
• Dehydration
• Reduction of proteins or sugar in the blood, increased phosphate in the blood
• Coma, cerebral hemorrhage, stroke, paralysis, brain disorders, speech and language disorders, memory problems
• Cataract
• Hearing impairment
• Irregular heartbeat, cardiac arrest, decreased cardiac output, heart muscle disorders, increased heart muscle size, stronger heartbeat, abnormal ECG, abnormal heart rate and pulse
• Blood clot in a limb vein, shock
• Breathing difficulties, respiratory tract disorders, asthma
• Intestinal obstruction, increased blood level of amylase enzyme, reflux of stomach contents into the throat, delayed emptying of the stomach
• Skin inflammation, sensation of sunburn
• Joint disorders
• Difficulty urinating, painful and abnormal menstrual bleeding
• Multi-organ failure, catarrhal disease, increased sensitivity to heat and cold, feeling of pressure in the chest, restlessness or abnormal feeling, increased lactate dehydrogenase enzyme in the blood, weight loss

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

• Small skin bleeding due to blood clots
• Increased muscle stiffness
• Deafness
• Fluid accumulation around the heart
• Acute shortness of breath
• Pancreatic cyst formation
• Liver blood flow problems
• Severe illness with blistering of the skin, mouth, eyes, and genitals; increased hairiness
• Thirst, falls, feeling of chest stiffness, decreased mobility, ulcer

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

• Muscle weakness
• Abnormal cardiac ultrasound
• Liver failure
• Painful urination, with blood in the urine
• Increased fatty tissue

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tacrolimus Stadafarma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister after "EXP". The expiration date is the last day of the month indicated.

Use all hard prolonged-release capsules within the year following the opening of the aluminum packaging.

Store below 30 °C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tacrolimus Stadafarma

• The active ingredient is tacrolimus.

Each 0.5 mg Tacrolimus Stadafarma capsule contains 0.5 mg of tacrolimus (as monohydrate).

Each 1 mg Tacrolimus Stadafarma capsule contains 1 mg of tacrolimus (as monohydrate).

Each 3 mg Tacrolimus Stadafarma capsule contains 3 mg of tacrolimus (as monohydrate).

Each 5 mg Tacrolimus Stadafarma capsule contains 5 mg of tacrolimus (as monohydrate).

• The other ingredients are:

Contents of the capsule: ethylcellulose, butylhydroxytoluene, hypromellose, lactose monohydrate, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Printing ink: shellac, red allura lacquer (E129), propylene glycol (E1520), titanium dioxide (E171).

Appearance of the Product and Package Contents

Tacrolimus Stadafarma 0.5 mg are hard gelatin prolonged-release capsules, with an opaque yellow body and an opaque orange body, size 5, with a length of 11.2 ± 0.5 mm, printed with "0.5 mg" in red ink on the cap.

Tacrolimus Stadafarma 0.5 mg is supplied in transparent PVC/PE/PVDC-aluminum paper blisters or unit-dose perforated blisters, wrapped in an aluminum bag, including a desiccant incorporated into the film layer.

Packaging of 30, 50, and 100 hard prolonged-release capsules is available in blisters, and 30 × 1, 50 × 1, and 100 × 1 hard prolonged-release capsules are available in unit-dose perforated blisters.

Tacrolimus Stadafarma 1 mg are hard gelatin prolonged-release capsules, with an opaque white body and an opaque orange body, size 4, with a length of 14.1 ± 0.5 mm, printed with "1 mg" in red ink on the cap.

Tacrolimus Stadafarma 1 mg is supplied in transparent PVC/PE/PVDC-aluminum paper blisters or unit-dose perforated blisters, wrapped in an aluminum bag, including a desiccant incorporated into the film layer.

Packaging of 30, 50, 60, and 100 hard prolonged-release capsules is available in blisters, and 30 × 1, 50 × 1, 60 × 1, and 100 × 1 hard prolonged-release capsules are available in unit-dose perforated blisters.

Tacrolimus Stadafarma 3 mg are hard gelatin prolonged-release capsules, with an opaque orange body and an opaque orange body, size 1, with a length of 19.1 ± 0.5 mm, printed with "3 mg" in red ink on the cap.

Tacrolimus Stadafarma 3 mg is supplied in transparent PVC/PE/PVDC-aluminum paper blisters or unit-dose perforated blisters, wrapped in an aluminum bag, including a desiccant incorporated into the film layer.

Packaging of 30, 50, and 100 hard prolonged-release capsules is available in blisters, and 30 × 1, 50 × 1, and 100 × 1 hard prolonged-release capsules are available in unit-dose perforated blisters.

Tacrolimus Stadafarma 5 mg are hard gelatin prolonged-release capsules, with an opaque gray-red body and an opaque orange body, size 0, with a length of 21.4 ± 0.5 mm, printed with "5 mg" in red ink on the cap.

Tacrolimus Stadafarma 5 mg is supplied in transparent PVC/PE/PVDC-aluminum paper blisters or unit-dose perforated blisters, wrapped in an aluminum bag, including a desiccant incorporated into the film layer.

Packaging of 30, 50, and 100 hard prolonged-release capsules is available in blisters, and 30 × 1, 50 × 1, and 100 × 1 hard prolonged-release capsules are available in unit-dose perforated blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5

Rodopi

69300 Greece

or

Pharmathen SA

6 Dervenakion Str.

Pallini, Attiki

15351 Greece

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31 D

4814NE Breda

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark: Tacrolimus Stada

Germany: Tacrolimus AL 0.5 mg Hartkapseln, retardiert, Tacrolimus AL 1 mg Hartkapseln, retardiert, Tacrolimus AL 3 mg Hartkapseln, retardiert, Tacrolimus AL 5 mg Hartkapseln, retardiert

Spain: Tacrólimus Stadafarma 0.5 mg cápsulas de liberación prolongada EFG, Tacrólimus Stadafarma 1 mg cápsulas de liberación prolongada EFG, Tacrólimus Stadafarma 3 mg cápsulas de liberación prolongada EFG, Tacrólimus Stadafarma 5 mg cápsulas de liberación prolongada EFG

France: Tacrolimus EG 0.5 mg, gélule à libération prolongée, Tacrolimus EG 1 mg, gélule à libération prolongée, Tacrolimus EG 3 mg, gélule à libération prolongée, Tacrolimus EG 5 mg, gélule à libération prolongée

Hungary: Tacrolimus Stada 0.5 mg retard kemény kapszula, Tacrolimus Stada 1 mg retard kemény kapszula, Tacrolimus Stada 3 mg retard kemény kapszula, Tacrolimus Stada 5 mg retard kemény kapszula

Italy: Tacrolimus EG

Netherlands: Tacrolimus CF 0.5 mg, harde capsules met verlengde afgifte, Tacrolimus CF 1 mg, harde capsules met verlengde afgifte, Tacrolimus CF 3 mg, harde capsules met verlengde afgifte, Tacrolimus CF 5 mg, harde capsules met verlengde afgifte

Poland: Tacrolimus STADA

Date of the last revision of this leaflet:May 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)