Patient Information Leaflet

Tacrólimus Stadafarma 0.5mg prolonged-release hard capsules EFG

Tacrólimus Stadafarma 1mg prolonged-release hard capsules EFG

Tacrólimus Stadafarma 3mg prolonged-release hard capsules EFG

Tacrólimus Stadafarma 5mg prolonged-release hard capsules EFG

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

• Keep this leaflet, aspossibly you will need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1. What isTacrólimus Stadafarmaand what it is used for

2. What you need to know before takingTacrólimus Stadafarma

3. How to takeTacrólimus Stadafarma

4. Possible side effects

5. Storage ofTacrólimus Stadafarma

6. Contents of the pack and additional information

Tacrólimus Stadafarmacontains the active ingredient tacrólimus. It is an immunosuppressant. After organ transplantation (liver, kidney), the immune system of your body will attempt to reject the new organ. Tacrólimus is used to control the immune response of your body, allowing you to accept the transplanted organ.

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

Tacrólimusis used in adults.

Do not take Tacrólimus Stadafarma

-if you are allergic to tacrolimus or any of the other components of this medication (listed in section6).

-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 ingredient tacrolimus. However, tacrolimus prolonged-release capsules are taken once a day, while immediate-release capsules are taken twice a day. This is because tacrolimus capsules allow for prolonged release (slower release over a longer period of time) of tacrolimus.

Tacrolimus prolonged-release capsules and tacrolimus in immediate-release capsulesare not interchangeable.

Inform your doctor if any of the following occur:

• if you are taking any medication (listed below in “Other medications and Tacrólimus Stada”)
• if you have or have had liver problems
• if you have had diarrhea for more than a day
• if you experience severe abdominal pain accompanied or not by other symptoms, such as chills, fever, nausea, or vomiting
• if you have a heart rhythm disorder called “prolongation of the QT interval”.
• if you have or have had small blood vessel injuries, known as microangiopathic hemolytic anemia/thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Inform your doctor if you develop fever, skin hemorrhages (which may appear as red spots), unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine output, vision loss, and seizures (see section 4). When tacrolimus is taken 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).

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

Your doctor may need to adjust your tacrolimus dose.

You should maintain regular contact with your doctor.Occasionally, to establish the appropriate tacrolimus dose, your doctor may need to perform blood and urine tests, cardiac tests, eye tests.

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

Precautions for handling:

Avoid contact with any part of the body, such as the skin or eyes, as well as breathing near 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 18years.

Other medications and Tacrólimus Stada

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

Tacrolimus should not be used with cyclosporine (another medication used to prevent organ transplant rejection).

If you need to visit a doctor other than your transplant specialist, tell the doctor that you are taking tacrolimus.Your doctor may need to consult with your transplant specialist if you need to use another medication that may increase or decrease your tacrolimus blood levels.

Tacrolimus blood levels may be affected by other medications you are taking, and blood levels of other medications may be affected by tacrolimus administration, which may require interruption, increase, or decrease of tacrolimus dose.

Some patients have experienced increased tacrolimus blood levels while taking other medications.This could cause severe adverse effects, such as kidney problems, nervous system problems, and heart rhythm disorders (see section4).

The effect on tacrolimus blood levels can occur very soon after starting another medication, so it may be necessary to monitor tacrolimus blood levels frequently and continuously during the first days of use of another medication and frequently while continuing its use.Some other medications may cause tacrolimus blood levels to decrease, which may increase the risk of organ transplant rejection.Particularly, you should inform your doctor if you are taking or have taken recently medications 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 human cytomegalovirus (CMV)

-protease inhibitors for HIV (e.g., ritonavir, nelfinavir, saquinavir), the pharmacopotentiator cobicistat, and combined tablets, or non-nucleoside reverse transcriptase inhibitors for HIV (efavirenz, etravirine, nevirapine) used to treat HIV infections

-protease inhibitors for HCV (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)

-micophenolic acid, used to suppress the immune system as a transplant rejection prevention

-medications for stomach ulcers and acid reflux (e.g., omeprazole, lansoprazole, or cimetidine)

-antiemetics, used to treat nausea and vomiting (e.g., metoclopramide)

-cisapride or antacids containing magnesium hydroxide and aluminum, used to treat acid reflux

-oral contraceptives or other hormone treatments with ethinylestradiol, hormone treatments with danazol

-medications used to treat high blood pressure or heart problems (e.g., nifedipine, nicardipine, diltiazem, and verapamil)

-antiarrhythmic medications (amiodarone) used to control irregular heartbeats

-statins used to treat high cholesterol and triglycerides

-carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy

-metamizole, used to treat pain and fever

-steroid corticosteroids (prednisolone or methylprednisolone), used to treat inflammation or suppress the immune system (e.g., transplant rejection)

-nefazodone, used to treat depression

-herbal preparations containing St. John's Wort (Hypericum perforatum) or Schisandra sphenanthera extracts.

-cannabidiol (its use includes, among others, the treatment of epilepsy)

Inform your doctor if you are receiving treatment for hepatitis C. The pharmacological treatment for hepatitis C may change your liver function and may affect tacrolimus blood levels. Tacrolimus blood levels may decrease or increase depending on the medications prescribed for hepatitis C. Your doctor may need to closely monitor tacrolimus blood levels and make the necessary adjustments to the tacrolimus dose 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 medications may worsen kidney or nervous system problems when taken with tacrolimus.

Inform your doctor if you are taking sirolimus or everolimus.When tacrolimus is taken with sirolimus or everolimus, the risk of microangiopathic hemolytic anemia, 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 that may increase potassium levels in your blood,nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen) used to treat fever, inflammation, and pain,anticoagulants (which prevent blood clotting), or oral medications for diabetes treatment while taking tacrolimus.

If you plan to be vaccinated, consult your doctor.

Taking Tacrólimus Stada with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

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

Driving and operating machinery

Do not drive and do not operate tools or machines if you feel dizzy or drowsy, or have difficulty seeing clearly after taking tacrolimus. These effects are more frequent if you also take alcohol.

Tacrolimus Stada contains lactose and red iron oxide (E129)

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains red iron oxide (E129).

It may cause allergic reactions.

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

Make sure you receive the same tacrolimus medication every time you pick up your prescription, unless your transplant specialist has agreed to switch to a different tacrolimus medication. This medication should be taken once a day. If the appearance of this medication is not the same as always, or if the dosing instructions have changed, consult your doctor or pharmacist as soon as possible to ensure you have the correct medication.

The initial dose to prevent rejection of your transplanted organ will be set by your doctor, calculated according to your body weight. The initial daily doses shortly after the transplant will generally be within the range of

0.10-0.30mg per kg of body weight per day

depending on the transplanted organ. To treat rejection, the same doses may be used.

Your dose will depend on your overall condition, and any other immunosuppressive medication you may be taking.

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

You will need to taketacrolimusevery day until you no longer need immunosuppression to prevent rejection of your transplanted organ. You should maintain regular contact with your doctor.

Tacrolimus should be taken orally once a day, in the morning. Take tacrolimus with an empty stomach or2 to3hours after a meal.Wait at least one hour before the next meal.

Take the capsules immediately after removing them from the blister pack.The capsules should be swallowedwholewith 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 nearest hospital emergency department.

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 interrupt the treatment with Tacrolimus Stadafarma

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Severe side effects may 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 experiencing any of the following severe side effects:

Severe side effects that are common (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.
• Insufficient function of your transplanted organ.
• Blurred vision.

Severe side effects that are uncommon (may affect up to 1 in 100 people):

• Microangiopathic thrombosis (lesions in smaller 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 abnormal bleeding or bruising, and signs of infection.

Severe side effects that are rare (may affect up to 1 in 1,000 people):

• Purpura thrombocytopenic thrombocytopenia:includes lesions in smaller blood vessels and is characterized by fever and bruises under the skin that may appear as red spots, with or without 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 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.

Severe side effects that are very rare (may affect up to 1 in 10,000 people):

• Stevens-Johnson syndrome: inexplicable generalized skin pain, facial swelling, severe disease with blistering of the skin, mouth, eyes, and genitals, rashes, facial swelling, and peeling of the skin.
• Torsades de Pointes: a change in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness, nausea, palpitations (feeling the heartbeat), and difficulty breathing.

Severe side effects of unknown frequency (the 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.
• Pure red cell aplasia (a very severe reduction in red blood cell count), hemolytic anemia (a decrease in red blood cell count due to abnormal rupture accompanied by fatigue), and febrile neutropenia (a decrease in white blood cell count that fights infections, accompanied by fever). The exact frequency of these side effects is unknown. You may not have symptoms or, depending on the severity of your condition, you may feel: fatigue, apathy, pale skin (pallor), difficulty breathing, dizziness, headache, chest pain, and a feeling of coldness in your hands and feet.
• Agranulocytosis (a significant decrease in white blood cell count accompanied by mouth sores, fever, and infection(s)). You may not have symptoms or may feel fever, chills, and sudden onset of sore throat.
• Allergic reactions and anaphylaxis with the following symptoms: sudden onset of itchy skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), and a feeling of fainting.
• Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood changes, seizures, and visual disturbances. These may be signs of a condition known as posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
• Optic neuropathy (alteration of the optic nerve): vision problems such as blurred vision, changes in color vision, difficulty seeing details, or reduced visual field.

After receivingtacrolimusyou may also experience the following side effects, which can be severe:

Very common side 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
• Abnormal liver function test results
• Diarrhea, nausea
• Renal problems

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

• Reduction in blood cell count (platelets, red blood cells, or white blood cells), increased white blood cell count, changes in red blood cell count (see blood test results)
• 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 electrolytes (see blood test results)
• Anxiety symptoms, confusion, and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders
• Seizures, altered level of consciousness, tingling and numbness (sometimes painful) in hands and feet,migraines, decreased ability to write, nervous system disorders
• Increased sensitivity to light, eye disorders
• Tinnitus in the ears
• Reduced blood flow in heart vessels, faster heart rate
• Bleeding, partial or complete blockage of blood vessels, reduced blood pressure
• Lack of breath, changes in lung tissue, fluid accumulation around the lungs, inflammation of the pharynx, cough, flu-like symptoms
• Inflammations or ulcers that cause abdominal pain or diarrhea, bleeding in the stomach, inflammation or ulcers in the mouth, fluid accumulation in the intestines, vomiting, abdominal pain, indigestion, constipation, flatulence, abdominal swelling, loose stools, gastrointestinal problems
• Bile duct disorders, yellowing of the skin due to liver problems, liver tissue damage, and inflammation
• Itching, rash, hair loss, acne, increased sweating
• Pain in joints, extremities, back, and feet, muscle spasms
• Renal insufficiency, reduced urine production, difficulty or pain while urinating
• General weakness, fever, fluid accumulation in the body, pain and discomfort, increased alkaline phosphatase in the blood, weight gain, altered body temperature sensation

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

• Changes in blood clotting, reduction in all types of blood cells (see blood test results)
• Dehydration
• Reduction in blood sugar or phosphate, increase in blood phosphate
• Coma, cerebral hemorrhage, stroke, cerebral disorders, speech and language disorders, memory problems
• Cloudy cornea
• Decreased hearing
• Irregular heartbeat, cardiac arrest, decreased heart function, cardiac muscle disorders, increased heart muscle size, increased heart rate, abnormal ECG, abnormal heart rate and pulse
• Thrombosis in a vein of a limb, shock
• Difficulty breathing, respiratory tract disorders, asthma
• Intestinal obstruction, increased amylase levels in the blood, gastroesophageal reflux, delayed stomach emptying
• Skin inflammation, sunburn sensation
• Joint disorders
• Inability to urinate, painful menstruation, and abnormal menstrual bleeding
• Multi-organ failure, catarrhal disease, increased sensitivity to heat and cold, chest pressure sensation, restlessness or abnormal sensation, increased lactate dehydrogenase in the blood, weight loss

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

• Small skin bruises due to blood clots
• Increased muscle stiffness
• Deafness
• Fluid accumulation around the heart
• Acute shortness of breath
• Pancreatic cyst formation
• Problems with blood flow in the liver
• Severe disease with vesicle formation in the skin, mouth, eyes, and genitals; increased hair growth
• Thirst, falls, chest stiffness, decreased mobility, ulcer

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

• Muscle weakness
• Abnormal echocardiogram
• Liver insufficiency
• Painful urination, blood in the urine
• Increased body fat

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”.The expiration date is the last day of the month indicated.

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

Store below 30 °C.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Tacrólimus Stadafarma

• The active ingredient is tacrólimus.

Each capsule of Tacrólimus Stadafarma 0.5 mg contains 0.5 mg of tacrólimus (as monohydrate).

Each capsule of Tacrólimus Stadafarma 1 mg contains 1 mg of tacrólimus (as monohydrate).

Each capsule of Tacrólimus Stadafarma 3 mg contains 3 mg of tacrólimus (as monohydrate).

Each capsule of Tacrólimus Stadafarma 5 mg contains 5 mg of tacrólimus (as monohydrate).

• The other components are:

Capule content:ethylcellulose, butylhydroxytoluene, hypromellose, lactose monohydrate, magnesium stearate.

Capule coating: gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

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

Appearance of the product and contents of the package

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

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

The packages of 30, 50 and 100 hard gelatin capsules with prolonged release are available in blisters and 30×1, 50×1 and 100×1 hard gelatin capsules with prolonged release are available in perforated unit dose blisters.

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

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

The packages of 30, 50, 60 and 100 hard gelatin capsules with prolonged release are available in blisters and 30×1, 50×1, 60x1 and 100×1 hard gelatin capsules with prolonged release are available in perforated unit dose blisters.

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

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

The packages of 30, 50 and 100 hard gelatin capsules with prolonged release are available in blisters and 30×1, 50×1 and 100×1 hard gelatin capsules with prolonged release are available in perforated unit dose blisters.

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

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

The packages of 30, 50 and 100 hard gelatin capsules with prolonged release are available in blisters and 30×1, 50×1 and 100×1 hard gelatin capsules with prolonged release are available in perforated unit dose blisters.

Only some package sizes may be commercially available.

Marketing authorization holder andmanufacturer responsible

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Danish:Tacrolimus Stada

German: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

Spanish: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

French: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

Hungarian: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

Italian:Tacrolimus EG

Dutch: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

Polish:Tacrolimus STADA

Last review date of thisleaflet:December 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)