Prospect: information for the patient

Adoport 0.5 mg hard capsules EFG

Adoport 1 mg hard capsules EFG

Adoport 2 mg hard capsules

Adoport 5 mg hard capsules EFG

tacrolimus

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even ifthey havethe same symptomsas you,as it may harm them.
• If you experience adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospect. See section 4.

6. Contents of the pack and additional information

Adoport belongs to a group of medications calledimmunosuppressants.

After your organ transplant (e.g., liver, kidney, heart), your body's immune system will try to reject the new organ.

Adoport is used to control your body's immune response, allowing you to accept the transplanted organ.

Adoport is often used in combination with other medications that also suppress the immune system.

You may also receive Adoport to treat a rejection that is occurring in your transplanted liver, kidney, heart, or other organ, or if any previous treatment you were following was unable to control this immune response after your transplant.

Do not take Adoport:

• If you are allergic to tacrolimus or any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to any macrolide antibiotics (e.g., erythromycin, clarithromycin, josamycin).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Adoport.

• You will need to take Adoport every day, as long as you require immunosuppression to prevent rejection of your transplanted organ. You should maintain regular contact with your doctor,
• while taking Adoport, your doctor may wish to perform occasional tests (including blood and urine analyses, cardiac function tests, visual and neurological examinations). This is completely normal and will help your doctor decide on the most suitable dose of Adoport for you,
• avoid taking any herbal preparations, e.g.: St. John's Wort (Hypericum perforatum) or any other herbal product as it may affect the efficacy and dose of Adoport you need to receive. If you have doubts, consult your doctor before taking any product or herbal preparation,
• if you have liver problems or have suffered from any disease that may have affected your liver, please inform your doctor as this may affect the dose of Adoport you receive,
• if you have severe abdominal pain accompanied or not by other symptoms, such as chills, fever, nausea or vomiting,
• if you have diarrhea for more than a day, inform your doctor as it may be necessary to adjust the dose of Adoport you receive,
• if you have a heart rhythm disorder called "prolongation of the QT interval",
• limit your exposure to sunlight and UV light using protective clothing and applying high-factor sunscreen. This is due to the potential risk of skin malignancies with immunosuppressive therapy,
• if you need to be vaccinated, please inform your doctor beforehand. He will advise you on the best course of action,
• in patients treated with Adoport, an increased risk of developing lymphoproliferative disorders (see section 4) has been detected. Ask your doctor for more information about these disorders.

Other medications and Adoport

Inform your doctor or pharmacist if you aretaking,havetakenrecentlyor may need to take any other medication, including those purchased without a prescription and herbal medications.

Adoport should not be taken with cyclosporine.

The blood levels of Adoport may be modified due to other medications you are taking, and the blood levels of other medications may be modified by the administration of Adoport, which may require interruption, increase or decrease of the Adoport dose.

In particular, you should inform your doctor if you are taking or have taken recently medications with active substances such as:

• antifungals and antibiotics (especially macrolide antibiotics), used to treat infections, e.g., ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, and isavuconazole, erythromycin, clarithromycin, josamycin, rifampicin, and flucloxacillin
• letermovir, used to prevent diseases caused by CMV (human cytomegalovirus),
• HIV protease inhibitors (e.g., ritonavir, nelfinavir, saquinavir), the pharmacopotentiator cobicistat, and combined tablets, used to treat HIV infection,
• HCV protease inhibitors (e.g., telaprevir, boceprevir, and the combination ombitasvir/paritaprevir/ritonavir, with or without dasabuvir), used in the treatment of hepatitis C,
• nilotinib and imatinib (used to treat certain types of cancer),
• mycophenolic acid, used to suppress the immune system as a transplant rejection prevention,
• medications for the treatment of stomach ulcers and acid reflux (e.g., omeprazole, or lansoprazole or cimetidine),
• antiemetics, used to treat nausea and vomiting (e.g., metoclopramide),
• magnesium or aluminum hydroxide (antacid) used to treat heartburn,
• hormonal treatments with ethinylestradiol (e.g.,: oral contraceptive pill) or danazol,
• medications used to treat hypertension or cardiac problems, such as nifedipine, nicardipine, diltiazem, and verapamil,
• antiarrhythmic medications (amiodarone) used to control arrhythmia (irregular heartbeat),
• statins used to treat high cholesterol and triglycerides,
• antiepileptic medications phenytoin or phenobarbital,
• corticosteroids prednisone and methylprednisolone,
• the antidepressant nefazodone,
• herbal preparations containing St. John's Wort (Hypericum perforatum) or extracts ofShisandra sphenanthera,
• metamizol, a medication used to treat pain and fever.
• cannabidiol (its use includes, among others, the treatment of epilepsy seizures).

Inform your doctor immediately if during treatment you experience:

• vision problems such as blurred vision, changes in color vision, difficulty seeing details, or reduced visual field.

Inform your doctor if you are taking or need to take ibuprofen, amphotericin B, or antivirals (e.g., aciclovir). These may worsen kidney or nervous system problems when administered simultaneously with Adoport.

Inform your doctor if you are taking potassium supplements or diuretics that conserve potassium (e.g., amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim and cotrimoxazole that may increase blood potassium levels, some analgesics (the so-called NSAIDs, e.g., ibuprofen), anticoagulants, or oral medications for diabetes treatment, while taking Adoport.

If you need to be vaccinated, please inform your doctor beforehand.

Adoport with food, drinks, and alcohol

Generally, you should take Adoport on an empty stomach or at least 1 hour before meals or 2 to 3 hours after meals. You should avoid grapefruit or grapefruit juice while taking Adoport.

Pregnancy and breastfeeding

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

Adoport passes into breast milk.Therefore, do not breastfeed while receiving Adoport.

Driving and operating machinery

Do not drive or use tools or machines if you feel dizzy or drowsy or have difficulty seeing clearly after taking Adoport. These effects are more frequent if Adoport is taken with alcohol.

Adoport contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per hard capsule; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

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 twice a day. If the appearance of this medication 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 medication.

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

0.075 mg to 0.30 mg per kilogram of body weight and per day,

depending on the transplanted organ.

Your dose will depend on your overall condition and any other immunosuppressive medication you may be taking. Your doctor will need to perform regular blood tests to determine the correct dose and adjust the dose from time to time. Your doctor will usually reduce your Adoport dose once your condition has stabilized.

Your doctor will tell you exactly how many capsules to take and how often.

-Adoport is taken orally twice a day, usually in the morning and at night. In general, take Adoport on an empty stomach or at least one hour before or 2 to 3 hours after a meal,

-swallow the capsules whole with a glass of water,

-avoid grapefruit and grapefruit juice while taking Adoport,

-take the hard capsules immediately after removing them from the blister,

-do not ingest the desiccant included in the aluminum bag.

If you take more Adoport than you should

If you accidentally take more Adoport than you should, consult your doctor immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Adoport

Do not take a double dose to make up for the missed doses. If you have forgotten to take your capsules, wait until the next scheduled dose and then continue as usual.

If you interrupt treatment with Adoport

Stopping your treatment with Adoport may increase the risk of organ transplant rejection. 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.

Adoport reduces your body's own defense mechanism that allows it to reject the transplanted organ. Consequently, your body will not function as well as usual in fighting off infections. Therefore, if you are taking Adoport, you will be more prone to infections than usual, such as skin, mouth, stomach and intestinal, lung, and urinary tract 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 of weakness or general discomfort.
• 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 those listed below.

Inform your doctor immediately if you suspect or have experienced any of the following severe side effects:

• opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat. Benign and malignant tumors have been reported 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 skin changes such as new colors or changes to existing ones, lesions, or lumps,
• thrombotic thrombocytopenic purpura (or TTP), characterized by fever and skin hemorrhages that may appear as localized red spots, with or without extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure (low or no urine production),
• cases of aplastic anemia (a very severe reduction in the number of red blood cells) and hemolytic anemia (a decrease in the number of red blood cells due to abnormal rupture accompanied by fatigue) and febrile neutropenia (a decrease in the type of white blood cells that fight infection, accompanied by fever). It is not known how often these side effects occur. You may not have symptoms or, depending on the severity of the disease, you may feel fatigued, apathetic, pale skin (pallor), shortness of breath, dizziness, headache, chest pain, and cold hands and feet,
• cases of agranulocytosis (a severe decrease in the number of white blood cells accompanied by mouth sores, fever, or infection(s)). You may not have symptoms or you may feel fever, chills, and sore throat suddenly,
• allergic and anaphylactic reactions with the following symptoms: sudden skin rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and you may feel like you are going to faint,
• posterior reversible encephalopathy syndrome (PRES): headache, altered mental state, seizures, and visual disturbances,
• 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 heartbeats), and difficulty breathing,
• gastrointestinal perforation: severe abdominal pain accompanied or not with other symptoms such as chills, fever, nausea, or vomiting,
• Stevens-Johnson syndrome: inexplicable generalized skin pain, facial swelling, severe disease with blister formation on the skin, mouth, eyes, and genitals, hives, swelling of the tongue, red or purple skin rash that spreads, skin peeling,
• toxic epidermal necrolysis: skin erosion and blister formation on the skin or mucous membranes, red and swollen skin that may be prominent in large areas of the body,
• hemolytic-uremic syndrome with the following symptoms: low or no urine production (acute renal failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and abnormal bleeding or bruising and signs of infection,
• insufficient function of your transplanted organ.

The following side effects may also occur after receiving Adoport.

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,
• diarrhea, nausea,
• kidney problems.

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

• 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 electrolyte changes,
• anxiety symptoms, confusion, and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders,
• seizures, altered consciousness, tingling and numbness (sometimes painful) of hands and feet, dizziness, difficulty writing, nervous system disorders,
• blurred vision, increased sensitivity to light, eye disorders,
• hearing sounds in your ears,
• decreased blood flow in the cardiac vessels, faster 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, pharyngeal inflammation, cough, symptoms like the flu,
• inflammations or ulcers that cause abdominal pain or diarrhea, stomach bleeding, mouth or esophageal inflammation, abdominal fluid retention, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, loose stools, gastrointestinal problems,
• liver enzyme changes and liver function, yellowing of the skin due to liver problems, liver tissue damage, and inflammation,
• itching, rash, hair loss, acne, increased sweating,
• joint pain, extremities, back, and foot pain, muscle spasms,
• kidney function insufficiency, low urine production, difficulty or pain while urinating
• general weakness, fever, fluid retention, pain, and discomfort, increased alkaline phosphatase in the blood, weight gain, altered temperature sensation.

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

• Blood clotting changes, decreased count of all blood cells,
• dehydration, decreased blood proteins or sugar, increased phosphate in the blood,
• coma, cerebral hemorrhage, stroke, paralysis, cerebral disorder, speech and language disorders, memory problems,
• lens opacity,
• hearing difficulties,
• irregular heartbeat, heart stoppage, decreased cardiac function, altered heart muscle, increased heart muscle, faster heart rate, abnormal electrocardiogram, abnormal heart rate and pulse,
• blood clots in a vein of an extremity, shock,
• respiratory difficulties, respiratory tract disorders, asthma,
• intestinal obstructions, increased blood amylase, gastroesophageal reflux, delayed stomach emptying,
• dermatitis, sunburn sensation,
• joint disorders,
• difficulty urinating, painful menstruation, and abnormal menstrual bleeding,
• organ failure, flu-like illness, increased sensitivity to heat and cold, chest pressure sensation, nervousness or strange sensation, increased lactate dehydrogenase in the blood, weight loss.

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

• small skin hemorrhages due to blood clots,
• muscle stiffness,
• blindness,
• hearing loss,
• fluid accumulation around the heart,
• respiratory difficulties,
• pancreatic cyst formation,
• liver blood flow problems,
• hair growth,
• thirst, falls, chest pressure sensation, decreased mobility, ulcer.

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

• optic nerve alteration (optic neuropathy).

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: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the aluminum pouch after CAD/EXP. The expiration date is the last day of the month indicated.

After the first opening of the aluminum pouch containing the blister pack, the capsules must be used within the 12 months that follow. Do not store at a temperature above 25°C after opening the aluminum pouch.

Take the capsules as soon as you remove them from the blister pack.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Adoport 0.5 mg hard capsules

-The active ingredient is tacrolimus. Each capsule contains 0.5 mg of tacrolimus (as monohydrate).

-The other components are:

-Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).

-Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laureate and yellow iron oxide (E172).

Composition of Adoport 1 mg hard capsules

-The active ingredient is tacrolimus. Each capsule contains 1 mg of tacrolimus (as monohydrate).

- Los demás componentes son:

-Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).

-Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laureate, yellow iron oxide (E 172), red iron oxide (E 172) and black iron oxide (E 172).

Composition of Adoport 2 mg hard capsules

• The active ingredient is tacrolimus. Each capsule contains 2 mg of tacrolimus (as monohydrate).
• The other components are:

Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).

Hard gelatin capsule:gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), brilliant blue FCF (E 133), shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525) and black iron oxide (E 172).

Composition of Adoport 5 mg hard capsules

• - The active ingredient is tacrolimus. Each capsule contains 5 mg of tacrolimus (as monohydrate).
• -Losdemás componentes son:

-Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).

-Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laureate and red iron oxide (E 172).

Appearance of the product and contents of the package

Adoport 0.5 mg are hard gelatin capsules, with a white opaque body and a cream-colored cap, containing a white to almost white powder (length: 14.5 mm).

Adoport 1 mg are hard gelatin capsules with a white opaque body and a slightly brown cap, containing a white to almost white powder (length: 14.5 mm).

Adoport 2 mg are dark green opaque hard capsules, printed in black with 2 mg on the cap, containing a white to almost white powder (length: 14.5 mm).

Adoport 5 mg are hard gelatin capsules with a white opaque body and an orange cap, containing a white to almost white powder (length: 15.8 mm).

Adoport is packaged in PVC/PE/PVdC/Aluminum blisters, in an aluminum bag with a desiccant to protect from moisture. The desiccant should not be taken.

Pack sizes of 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.,

Verovskova 57,

1526 Ljubljana,

Slovenia

or

Lek Pharmaceuticals d.d.,

Trimlini 2D,

9220 Lendava,

Slovenia

or

LEK S.A.,

Ul. Domaniewska 50C,

02- 672 Warszawa,

Poland

or

Salutas Pharma GmbH,

Otto- von- Guericke- Allee 1,

D- 39179 Barleben,

Germany

or

S.C. Sandoz S.R.L.,

Str. Livenzeni nr. 7A,

RO- 540472 Targu Mures,

Romania

Last revision date of this leaflet:March 2025.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/