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.
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.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Adoport.
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 medicines.
Adoport should not be taken with ciclosporin.
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 recently taken medications with active substances such as:
Inform your doctor immediately if during treatment you experience:
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 in advance.
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".
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 Toxicological 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:
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:
The following side effects may also occur after receiving Adoport.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Rare side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Side effects of unknown frequency (cannot be estimated from available data)
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 the Vigilance 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 on 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 trash. Deposit 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 capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laurate 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).
- The other components are:
-Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).
-Hard capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laurate, yellow iron oxide (E 172), red iron oxide (E 172) and black iron oxide (E 172).
Composition of Adoport 2 mg hard capsules
Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).
Hard capsule shell: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
-Capule content: lactose monohydrate, hypromellose (E 464), croscarmellose sodium (E 468) and magnesium stearate (E 572).
-Hard capsule shell: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, sorbitan laurate 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 manufacturer responsible
Marketing authorization holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer responsible
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/
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.