Tacrolimus Stadafarma 5 mg prolonged-release hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

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 the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

What Tacrolimus Stadafarma is and what it is used for
What you need to know before taking Tacrolimus Stadafarma
How to take Tacrolimus Stadafarma
Possible side effects
How to store Tacrolimus Stadafarma
Contents of the pack and other information

1. What Tacrólimus Stadafarma is and what it is 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 attempt to reject the new organ. Tacrolimus is used to control your body's immune response, enabling you to accept the transplanted organ.

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

Tacrolimus is used in adults.

2. What you need to know before taking Tacrolimus Stadafarma

Do not take Tacrolimus Stadafarma

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

Warnings and precautions

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

Tacrolimus prolonged-release capsules and tacrolimus immediate-release capsules are not interchangeable.

Inform your doctor if any of the following apply to you:

if you are taking any medicines (listed below in “Other medicines and Tacrolimus Stada”)
if you have or have had liver problems
if you have had diarrhoea for more than one day
if you experience severe abdominal pain, with or without other symptoms such as chills, fever, nausea or vomiting
if you have an abnormality in the electrical activity of your heart known as “QT interval prolongation”.
if you have or have had damage to small blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Inform your doctor if you develop fever, bruising under the skin (which may appear as red spots), unexplained tiredness, confusion, yellowing of the skin or eyes, reduced urine volume, vision loss, or seizures (see section 4). The risk of these symptoms may increase when tacrolimus is taken together with sirolimus or everolimus.

Please avoid taking any herbal preparations, e.g., St. John’s wort (Hypericum perforatum) or any other herbal products, as they may affect the effectiveness and required dose of tacrolimus.

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

Your doctor may need to adjust your dose of tacrolimus.

You should maintain regular contact with your doctor. Periodically, to determine the appropriate dose of tacrolimus, your doctor may need to perform blood and urine tests, cardiac tests, or eye examinations.

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

Handling precautions:

Avoid contact with any part of the body, such as skin or eyes, and avoid inhaling dust from the capsule contents. If such contact occurs, wash the skin and eyes thoroughly.

Children and adolescents

The use of tacrolimus is not recommended in children and adolescents under 18 years of age.

Other medicines and Tacrolimus Stada

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

The use of tacrolimus with cyclosporine (another medicine used to prevent transplanted organ rejection) is not recommended.

If you need to visit a doctor other than your transplant specialist, inform the doctor that you are taking tacrolimus. Your doctor may need to consult your transplant specialist if you need to take another medicine that could increase or decrease your blood levels of tacrolimus.

Blood levels of tacrolimus may be altered by other medicines you are taking, and blood levels of other medicines may be altered by tacrolimus, which may require interruption or adjustment (increase or decrease) of the tacrolimus dose.

Some patients have experienced increased blood levels of tacrolimus when taking other medicines. This could lead to serious adverse effects such as kidney problems, nervous system disorders, and heart rhythm disturbances (see section 4).

Changes in blood levels of tacrolimus may occur soon after starting another medicine, so it may be necessary to monitor tacrolimus blood levels frequently and continuously during the first days of treatment with another medicine, and regularly while continuing its use. Some other medicines may cause tacrolimus blood levels to decrease, which could increase the risk of transplanted organ rejection. In particular, inform your doctor if you are taking or have recently taken medicines such as:

antifungal and antibiotic medicines, especially those known as 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 to prevent transplant rejection
medicines for stomach ulcer and acid reflux (e.g., omeprazole, lansoprazole or cimetidine)
antiemetics, used to treat nausea and vomiting (e.g., metoclopramide)
cisapride or magnesium-aluminum hydroxide antacid, used to treat heartburn
contraceptive pill or other hormonal treatments containing 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
herbal medicines containing St. John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.
cannabidiol (used, among others, for the treatment of epileptic seizures)

Inform your doctor if you are receiving treatment for hepatitis C. Pharmacological treatment for hepatitis C may alter your liver function and may affect 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 tacrolimus blood levels and make necessary dose adjustments after starting hepatitis C treatment.

Inform 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., aciclovir, ganciclovir, cidofovir, foscarnet). These medicines may worsen kidney or nervous system problems when taken together with tacrolimus.

Inform your doctor if you are taking sirolimus or everolimus. When tacrolimus is taken together with sirolimus or everolimus, the risk of thrombotic microangiopathy, thrombotic 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, hypertension, and nephropathy (e.g., amiloride, triamterene or spironolactone), or the antibiotics trimethoprim and cotrimoxazole, which may increase potassium levels in your blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) used for fever, inflammation and pain, anticoagulants (which prevent blood clotting), or oral medicines for the treatment of diabetes, while taking tacrolimus.

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

Taking Tacrolimus Stada with food and drink

Avoid grapefruit (including grapefruit 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 plan to become pregnant, consult your doctor before using this medicine.

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

Driving and using machines

Do not drive or operate tools or machinery if you feel dizzy or drowsy, or have problems seeing clearly after taking tacrolimus. These effects are more likely if you also consume alcohol.

Tacrolimus Stada contains lactose and Allura Red AC aluminium lake (E129)

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

This medicine contains Allura Red AC aluminium lake (E129).

It may cause allergic reactions.

3. How to take Tacrolimus Stadafarma

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. This medicine should only be prescribed by a doctor experienced in managing transplant patients.

Make sure you receive the same tacrolimus medicine each time you collect your prescription, unless your transplant specialist has agreed to switch to a different tacrolimus medicine. This medicine should be taken once daily. If the appearance of this medicine is not the same as usual, or if the dosage 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 initial daily doses just after transplantation will generally be within the range of

0.10–0.30 mg per kg of body weight per day

depending on the transplanted organ. These same doses may be used to treat rejection.

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

After starting your treatment with tacrolimus, your doctor will carry out frequent blood tests to determine the correct dose. Afterwards, your doctor will need to perform regular blood tests to determine the correct dose and to adjust it from time to time. Your doctor will usually reduce your tacrolimus dose once your condition has stabilized. Your doctor will tell you exactly how many capsules to take.

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

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

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

If you take more Tacrolimus Stadafarma than you should

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

If you forget to take Tacrolimus Stadafarma

If you forget to take your capsules in the morning, take them as soon as possible on the same day. Do not take a double dose the following 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 instructed by your doctor.

If you have any further questions about 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 everyone will experience them.

Tacrolimus reduces your body's defence mechanisms (immune system), so that it will not work as effectively in fighting infections. Therefore, if you are taking tacrolimus, you will be more likely to develop infections.

Some infections may be serious or fatal and may include those 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 weak or generally unwell
Memory loss, difficulty thinking, difficulty walking or loss of vision – these symptoms may be due to a very rare and serious brain infection that can be fatal (progressive multifocal leukoencephalopathy or PML)

Severe reactions, including allergic and anaphylactic reactions, may occur. Benign and malignant tumours have been reported after treatment with tacrolimus.

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

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

Gastrointestinal perforation: severe abdominal pain with or without other symptoms such as chills, fever, nausea or vomiting.
Inadequate function of your transplanted organ.
Blurred vision.

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

Thrombotic microangiopathy (damage to the smallest blood vessels), including haemolytic uraemic syndrome, with the following symptoms: low or no urine output (acute kidney failure), extreme tiredness, 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 damage to the smallest blood vessels and is characterised by fever and bruising under the skin that may appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), symptoms of acute kidney failure (low or no urine output), loss of vision and seizures.
Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that may 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 widespread skin pain, facial swelling, serious illness with blistering of the skin, mouth, eyes and genitals, hives, tongue swelling, red or purple rash that spreads, skin peeling.
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 (awareness of heartbeats), and difficulty breathing.

Serious adverse effects with unknown frequency (frequency cannot be estimated from available data):

Opportunistic infections (bacterial, fungal, viral and protozoal): prolonged diarrhoea, fever and sore throat.
Benign and malignant tumours have been reported after treatment as a result of immunosuppression, including malignant skin cancers and a rare type of cancer that may include skin lesions known as Kaposi's sarcoma. Symptoms include changes in the skin, such as new or changing discolouration, lesions or lumps.
Cases of pure red cell aplasia (a very severe reduction in red blood cell count), haemolytic anaemia (decrease in red blood cells due to abnormal breakdown accompanied by tiredness) and febrile neutropenia (a decrease in the type of white blood cells that fight infections, accompanied by fever) have been reported. The exact frequency of these adverse effects is unknown. You may have no symptoms, or depending on the severity, you may experience: fatigue, apathy, abnormal paleness of the skin (pallor), difficulty breathing, dizziness, headache, chest pain and a cold sensation in hands and feet.
Cases of agranulocytosis (a marked decrease in white blood cells accompanied by mouth ulcers, fever and infection(s)). You may have no symptoms or may suddenly experience fever, chills and sore throat.
Allergic and anaphylactic reactions with the following symptoms: sudden itchy rash (hives), swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing) and feeling faint.
Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood changes, seizures and visual 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 (damage to the optic nerve): vision problems such as blurred vision, changes in colour vision, difficulty seeing details or reduced visual field.

The following adverse effects may also occur after receiving tacrolimus and may be serious:

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

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

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

Reduction in blood cells (platelets, red blood cells or white blood cells), increased white blood cell count, changes in red blood cell counts (see blood tests)
Reduction in 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 tests)
Anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, psychiatric disorders
Seizures, disturbances in level of consciousness, tingling and numbness (sometimes painful) in hands and feet, dizziness, reduced ability to write, nervous system disorders
Increased sensitivity to light, eye disorders
Ringing in the ears
Reduced blood flow in heart vessels, faster heartbeat
Bleeding, partial or complete blockage of blood vessels, reduced blood pressure
Shortness of breath, changes in lung tissue, fluid accumulation around the lungs, inflammation of the pharynx, cough, flu-like symptoms
Inflammations or ulcers causing abdominal pain or diarrhoea, stomach bleeding, mouth ulcers or inflammation, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, abdominal swelling, loose stools, stomach problems
Biliary tract disorders, yellowing of the skin due to liver problems, liver tissue damage and liver inflammation
Itching, rash, hair loss, acne, increased sweating
Joint, limb, back and foot pain, muscle spasms
Inadequate kidney function, reduced urine production, difficulty or pain when urinating
General weakness, fever, fluid accumulation in the body, pain and discomfort, increased blood alkaline phosphatase enzyme, weight gain, sensation of altered temperature

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

Changes in blood clotting, reduction in all types of blood cells (see blood tests)
Dehydration
Reduction in blood proteins or blood sugar, increased blood phosphate
Coma, brain haemorrhage, stroke, paralysis, brain disorders, speech and language abnormalities, memory problems
Clouding of the lens
Hearing deterioration
Irregular heartbeat, cardiac arrest, reduced heart performance, disorders of heart muscle, enlargement of heart muscle, stronger heartbeat, abnormal ECG, abnormal heart rate and pulse
Blood clot in a vein of a limb, shock
Breathing difficulties, respiratory tract disorders, asthma
Intestinal obstruction, increased blood level of amylase enzyme, reflux of stomach contents into the throat, delayed stomach emptying
Skin inflammation, burning sensation in sunlight
Joint disorders
Inability to urinate, painful menstruation and abnormal menstrual bleeding
Multi-organ failure, catarrhal-type illness, increased sensitivity to heat and cold, chest pressure sensation, restlessness or abnormal sensation, increased blood lactate dehydrogenase enzyme, weight loss

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

Small skin bleeds due to blood clots
Increased muscle stiffness
Deafness
Fluid accumulation around the heart
Acute shortness of breath
Cyst formation in the pancreas
Problems with blood flow in the liver
Serious illness with blister formation on the skin, mouth, eyes and genitals; increased hairiness

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

Muscle weakness
Abnormal echocardiogram
Liver failure
Pain when urinating, blood in the urine
Increase in fatty tissue

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tacrolimus Stadafarma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack following “EXP”. The expiry date refers to the last day of the month indicated.

Use all prolonged-release hard capsules within one year after opening the aluminium wrapper.

Store below 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tacrolimus Stadafarma

The active substance is tacrolimus.

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

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

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

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

The other components are:

Capsule contents: ethylcellulose, butylated hydroxytoluene, hypromellose, lactose monohydrate, magnesium stearate.

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

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

Appearance of the product and contents of the pack

Tacrolimus Stadafarma 0.5 mg are prolonged-release hard gelatin capsules, with an opaque yellow body and an opaque orange cap, 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-aluminium foil blisters or in single-dose perforated blisters, wrapped in an aluminium pouch, including a desiccant incorporated into the film layer.

Pack sizes of 30, 50 and 100 prolonged-release hard capsules are available in blisters, and 30×1, 50×1 and 100×1 prolonged-release hard capsules are available in single-dose perforated blisters.

Tacrolimus Stadafarma 1 mg are prolonged-release hard gelatin capsules, with an opaque white body and an opaque orange cap, 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-aluminium foil blisters or in single-dose perforated blisters, wrapped in an aluminium pouch, including a desiccant incorporated into the film layer.

Pack sizes of 30, 50, 60 and 100 prolonged-release hard capsules are available in blisters, and 30×1, 50×1, 60×1 and 100×1 prolonged-release hard capsules are available in single-dose perforated blisters.

Tacrolimus Stadafarma 3 mg are prolonged-release hard gelatin capsules, with an opaque orange body and an opaque orange cap, 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-aluminium foil blisters or in single-dose perforated blisters, wrapped in an aluminium pouch, including a desiccant incorporated into the film layer.

Pack sizes of 30, 50 and 100 prolonged-release hard capsules are available in blisters and 30×1, 50×1 and 100×1 prolonged-release hard capsules are available in single-dose perforated blisters.

Tacrolimus Stadafarma 5 mg are prolonged-release hard gelatin capsules, with an opaque greyish-red body and an opaque orange cap, 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-aluminium foil blisters or in single-dose perforated blisters, wrapped in an aluminium pouch, including a desiccant incorporated into the film layer.

Pack sizes of 30, 50 and 100 prolonged-release hard capsules are available in blisters and 30×1, 50×1 and 100×1 prolonged-release hard capsules are available in single-dose perforated blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Pharmathen SA

6 Dervenakion Str.

Pallini, Attiki

15351 Greece

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Centrafarm Services B.V.

Van de Reijtstraat 31 D

4814NE Breda

Netherlands

This medicinal product is authorised 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
Tacrolimus Stadafarma 1 mg cápsulas de liberación prolongada EFG
Tacrolimus Stadafarma 3 mg cápsulas de liberación prolongada EFG
Tacrolimus 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 most recent review of this summary: May 2025

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