ADOPORT 0.5 мг Капсулы

Содержание инструкции

1. ADOPORT 0.5 mg hard capsules (equivalent medicine), 0.75 mg hard capsules, 1 mg hard capsules (equivalent medicine), 2 mg hard capsules, 5 mg hard capsules (equivalent medicine)
   1. What ADOPORT is and what it is used for
   2. What you need to know before taking ADOPORT
   3. How to take ADOPORT
   4. Possible side effects
   5. How to store Adoport
   6. Contents of the pack and other information

ADOPORT 0.5 mg hard capsules (equivalent medicine), 0.75 mg hard capsules, 1 mg hard capsules (equivalent medicine), 2 mg hard capsules, 5 mg hard capsules (equivalent medicine)

Tacrolimus

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

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ADOPORT is and what it is used for

ADOPORT belongs to a group of medicines called immunosuppressants.
After an organ transplant (for example of liver, kidney or heart) your immune system will try to
reject the new organ. ADOPORT is used to control the immune response of your body,
allowing it to accept the transplanted organ.
ADOPORT is often used in combination with other medicines, also aimed at suppressing the system
immune.
You may also receive ADOPORT for an ongoing rejection of liver, kidney, heart or another transplanted organ, or
if one of the treatments you were taking was unable to control the immune response after
transplant.

2. What you need to know before taking ADOPORT

Do not take ADOPORT

• If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics (for example erythromycin, clarithromycin, josamycin).

Warnings and precautions
Talk to your doctor or pharmacist before taking ADOPORT.

• You will need to take ADOPORT every day for as long as you need immunosuppression to prevent rejection of the transplanted organ. You should maintain regular contact with your doctor.
• During therapy with ADOPORT, your doctor may decide to prescribe you a series of tests periodically (including blood tests, urine tests, heart function tests and eye and neurological tests). This is a fairly common practice, which allows the doctor to establish the dose of ADOPORT most suitable for your case.
• Avoid taking any herbal products, for example St. John's wort ( Hypericum perforatum) or any other herbal products, as these may compromise the effectiveness of ADOPORT and affect its dose. If you have any doubts, consult your doctor before taking any herbal products or remedies.
• If you have liver problems or if you have suffered from a disease that may have damaged your liver, tell your doctor because this may affect the dose of ADOPORT you need to take.
• If you experience severe abdominal pain accompanied or not by other symptoms, such as chills, fever, nausea and vomiting.
• If you have diarrhea for more than one day, report it to your doctor, as it may be necessary to adjust the dose of ADOPORT.
• If you have an alteration of the electrical activity of the heart, called “QT interval prolongation”.
• Limit exposure to sunlight and UV rays while taking ADOPORT, wearing protective clothing and using a sunscreen with a high protection factor. This is due to the potential risk of malignant skin alterations resulting from immunosuppressive therapy.
• If you need any vaccination, inform your doctor first, who will advise you on what to do.
• It has been reported that patients treated with ADOPORT have an increased risk of developing lymphoproliferative disorders (see section 4). Ask your doctor for specific information about these disorders.

Other medicines and ADOPORT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription and herbal remedies.
ADOPORT must not be taken at the same time as cyclosporine.
The blood levels of ADOPORT may be affected by other medicines and the blood levels of other medicines may in turn be affected by ADOPORT: in these cases it may be necessary to stop, increase or decrease the dose of ADOPORT.

In particular, you should tell your doctor if you are taking or have recently used medicines containing active ingredients such as:

• antifungal and antibiotic medicines, in particular the so-called macrolide antibiotics, used to treat infections, for example ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin and rifampicin
• HIV protease inhibitors (for example ritonavir, nelfinavir, saquinavir), used to treat HIV infections
• HCV protease inhibitors (for example telaprevir, boceprevir), used to treat hepatitis C infections
• medicines for stomach ulcers or acid reflux (for example omeprazole, lansoprazole or cimetidine)
• antiemetic medicines, used to treat nausea and vomiting (for example metoclopramide)
• magnesium-aluminum hydroxide (antacid), used to treat heartburn
• hormonal treatments with ethinylestradiol (for example the contraceptive pill) or danazol
• medicines used to treat high blood pressure or heart problems, such as nifedipine, nicardipine, diltiazem and verapamil
• antiarrhythmic medicines (amiodarone) used to control arrhythmia (irregular heartbeat)
• medicines known as “statins”, used to treat high cholesterol and triglyceride levels
• the anti-epileptic medicines phenytoin or phenobarbital
• the corticosteroids prednisolone and methylprednisolone
• the antidepressant medicine nefazodone
• herbal preparations containing St. John's wort ( Hypericum perforatum) or Schisandra sphenanthera extracts.

Tell your doctor if you are taking or need to take ibuprofen, amphotericin B, antiviral medicines (for example acyclovir). These may worsen kidney or nervous system problems when taken together with ADOPORT.
The doctor will also need to know if you are taking potassium supplements or potassium-sparing diuretics (for example amiloride, triamterene or spironolactone), some painkillers (so-called NSAIDs, for example ibuprofen), anticoagulants or oral medicines for the treatment of diabetes while taking ADOPORT.
If you need to undergo vaccinations, please inform your doctor first.

ADOPORT with food and drink
Generally ADOPORT should be taken on an empty stomach or at least 1 hour before or 2-3 hours after a meal. During treatment with ADOPORT you should avoid consuming grapefruit and grapefruit juice.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• ADOPORT is excreted in breast milk, therefore you should not breastfeed while taking ADOPORT.

Driving and operating machinery
If you feel dizzy or sleepy after taking ADOPORT, or if you have trouble seeing clearly, do not drive vehicles and do not use tools or machinery. These effects are more frequent when ADOPORT is taken with alcoholic beverages.

ADOPORT contains lactose
ADOPORT contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take ADOPORT

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your doctor or pharmacist.
Make sure you receive the same medicine containing tacrolimus each time you present the prescription at the pharmacy,
unless the transplant specialist physician has decided to switch you to a different medicine containing
tacrolimus.
This medicine must be taken twice a day. If the appearance of this medicine does not seem to be the usual one, 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 organ rejection will be established by the doctor and will be calculated based on
your body weight. Generally, initial doses immediately after transplantation are between 0.075 and 0.30
mg per kg of body weight per day, depending on the transplanted organ.
The dose depends on your general condition and which other immunosuppressive medicines you are taking. The
doctor will need to prescribe you regular blood tests, in order to be able to define the most appropriate dose and to
adjust it periodically. Generally, the doctor will reduce the dose of ADOPORT once your condition has stabilized. The
doctor will tell you exactly how many capsules to take and how often.

• ADOPORT must be taken orally twice a day, usually in the morning and evening. Generally, you should take ADOPORT on an empty stomach or at least 1 hour before or 2-3 hours after a meal.
• Swallow the capsules whole, with a glass of water.
• Take the hard capsules immediately after removing them from the blister.
• While undergoing therapy with ADOPORT, avoid consuming grapefruit and grapefruit juice.
• Do not ingest the desiccant contained in the packaging.

If you take more ADOPORT than you should
If you have accidentally taken an excessive dose of ADOPORT, contact your doctor immediately or go to the
emergency room of the nearest hospital.

If you forget to take ADOPORT
Do not take a double dose to make up for a missed single dose.
If you have forgotten to take your ADOPORT capsules, wait until it is time to take the next dose, and then continue as
before.

If you stop taking ADOPORT
Stopping treatment with ADOPORT may increase the risk of organ rejection.
Do not stop treatment unless specifically instructed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
ADOPORT reduces the body's defense mechanisms and prevents them from rejecting the transplanted organ.
Consequently, your body may not be as efficient as usual in fighting infections. Therefore, during therapy with ADOPORT, you may be more susceptible to infections than usual, such as those of the skin, mouth, stomach and intestines, lungs, and urinary tract.
Serious side effects can occur, including those listed below. Immediately ask your doctor if you have or think you have any of the following serious side effects:

• Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
• Tumors, benign and malignant, have been reported following treatment, resulting from immunosuppression.
• Thrombotic thrombocytopenic purpura (TTP), a condition characterized by fever and subcutaneous bruising that may appear as red spots, with or without unjustified extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure (decreased or absent urine output).
• Cases of pure red cell aplasia (a very severe reduction in red blood cell count) and hemolytic anemia (reduced number of red blood cells due to their abnormal destruction accompanied by fatigue) have been reported. You may have no symptoms, or depending on the severity of the condition, you may experience: fatigue, apathy, abnormal paleness of the skin, shortness of breath, dizziness, headache, chest pain, and cooling of the hands and feet.
• Cases of agranulocytosis (a severely reduced number of white blood cells accompanied by mouth ulcers, fever, and infections) have been reported. You may have no symptoms or may experience sudden fever, stiffness, or sore throat.
• Allergic or anaphylactic reactions with the following symptoms: sudden itching (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which can cause difficulty swallowing and breathing) and you may feel weak.
• Posterior reversible encephalopathy syndrome (PRES): headache, altered mental status, seizures, and visual disturbances.
• Torsades de Pointes: change in heart rate that may or may not be accompanied by symptoms such as chest pain (angina), weakness, dizziness or nausea, palpitations (strong perception of your heartbeat) and difficulty breathing.
• Gastrointestinal perforation: severe abdominal pain accompanied or not by other symptoms, such as chills, fever, nausea and vomiting.
• Stevens-Johnson syndrome: widespread unexplained skin pain, facial swelling, severe illness with blister formation on the skin, mouth, eyes, and genitals, hives, tongue swelling, red or purplish skin rash that spreads, skin peeling.
• Toxic epidermal necrolysis: erosion and blister formation on the skin or mucous membranes, reddened and swollen skin that may detach from large areas of the body.
• Hemolytic uremic syndrome, a condition with the following symptoms: decreased or no urine output (acute renal failure), extreme fatigue, yellowing of the skin or eyes (jaundice) and abnormal itching or bleeding and signs of infection.
• Insufficient function of the transplanted organ.

The following side effects may also occur after taking ADOPORT:
Very commonside effects (may affect more than 1 in 10 people):

• increased blood sugar levels, diabetes mellitus, increased potassium levels in the blood
• difficulty sleeping
• tremor, headache
• increased blood pressure
• diarrhea, nausea
• kidney problems

Commonside effects (may affect up to 1 in 10 people):

• reduction in magnesium, phosphate, potassium, calcium, or sodium levels in the blood, fluid overload, increased levels of uric acid or lipids in the blood, decreased appetite, increased blood acidity, other changes in blood salt balance
• anxiety, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders
• seizures, altered consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired ability to write, nervous system disorders
• blurred vision, increased sensitivity to light, eye disorders
• ringing in the ears
• reduced blood flow in the heart vessels, accelerated heartbeat
• bleeding, complete or partial blockage of blood vessels, decreased blood pressure
• shortness of breath, changes in lung tissue, fluid accumulation around the lungs, inflammation of the pharynx, cough, flu-like symptoms
• inflammation or ulcers causing abdominal pain or diarrhea, bleeding in the stomach, ulcers in the mouth, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, excess gas in the intestines (flatulence), bloating, soft stools, stomach disorders
• changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver
• itching, rash, hair loss, acne, increased sweating
• joint, limb, or back pain, muscle spasms
• insufficient kidney function, reduced urine production, impaired or painful urination
• general weakness, fever, fluid accumulation in the body, pain and discomfort, increased alkaline phosphatase levels in the blood, weight gain, altered sensation in temperature perception.

Uncommonside effects (may affect up to 1 in 100 people):

• alterations in blood coagulation, reduction in the count of all blood cells
• dehydration,
• reduction in protein or sugar levels in the blood, increased phosphate levels in the blood
• coma, cerebral hemorrhage, stroke, paralysis, brain disorders, speech and language abnormalities, memory problems
• blurred vision due to an abnormality of the eye's lens
• impaired hearing
• irregular or stopped heartbeat, reduced heart performance, heart muscle disorders, enlargement of the heart muscle, abnormal ECG, abnormalities in heart rate and pulsations
• blood clots (thrombi) in a vein in a limb, shock
• difficulty breathing, respiratory tract disorders, asthma
• intestinal obstruction, increased levels of amylase in the blood, reflux of stomach contents into the esophagus (gastroesophageal), delayed stomach emptying
• dermatitis, burning sensation when exposed to sunlight
• joint disorders
• inability to urinate, painful menstruation and abnormal menstrual bleeding
• insufficiency of some organs, flu-like illness, increased sensitivity to heat and cold, feeling of chest tightness, feeling of extreme nervousness or discomfort, increased lactate dehydrogenase levels in the blood, weight loss.

Rareside effects (may affect up to 1 in 1,000 people):

• small hemorrhages of the skin due to blood clots
• increased muscle stiffness
• blindness
• deafness
• fluid accumulation around the heart
• acute shortness of breath
• cyst formation in the pancreas
• problems with blood flow in the liver
• increased hair growth (hirsutism)
• thirst, fainting, feeling of chest tightness, decreased mobility, ulcer.

Very rareside effects (may affect up to 1 in 10,000 people):

• muscle weakness
• abnormalities in echocardiogram
• liver failure, narrowing of the bile duct
• painful urination with blood in the urine
• increased adipose tissue.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Adoport

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after the wording EXP. The
expiry date refers to the last day of that month.
Use all capsules within 12 months of opening the aluminium wrapper surrounding the blister. Once
the aluminium wrapper is opened, do not store at a temperature above 25°C.
Take the capsules immediately after removing them from the blister.
Do not store at a temperature above 30°C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ADOPORT contains

• The active ingredient is tacrolimus. Each capsule contains 0.5 mg, 0.75 mg, 1 mg, 2 mg or 5 mg of tacrolimus (as monohydrate).
• The other ingredients are: o Capsule content: lactose monohydrate, hypromellose (E464), sodium croscarmellose (E468) and magnesium stearate (E572). Hard gelatin capsuleo ADOPORT 0.5 mg: gelatin, titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate and yellow iron oxide (E172) o ADOPORT 0.75 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), FD&C Blue 1 (E133), shellac (E904), propylene glycol (E1520), potassium hydroxide (E525) and black iron oxide (E172) o ADOPORT 1 mg: gelatin, titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172) o ADOPORT 2 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), FD&C Blue 1 (E133), shellac (E904), propylene glycol (E1520), potassium hydroxide (E525) and black iron oxide (E172) o ADOPORT 5 mg: gelatin, titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate and red iron oxide (E172).

Description of the appearance of ADOPORT and contents of the pack
ADOPORT 0.5 mg is presented in the form of hard capsules with an opaque white body and an ivory cap, containing a powder from white to off-white in color (length: 14.5 mm).
ADOPORT 0.75 mg is presented in the form of hard capsules with an opaque light green body, with “0.75 mg” imprinted in black on the cap, containing a powder from white to off-white in color (length: 14.5 mm).
ADOPORT 1 mg is presented in the form of hard capsules with an opaque white body and a light brown cap, containing a powder from white to off-white in color (length: 14.5 mm).
ADOPORT 2 mg is presented in the form of hard capsules with an opaque dark green body, with “2 mg” imprinted in black on the cap, containing a powder from white to off-white in color (length: 14.5 mm).
ADOPORT 5 mg is presented in the form of hard gelatin capsules with an opaque white body and an orange cap, containing a powder from white to off-white in color (length: 15.8 mm).
ADOPORT is packaged in PVC/PE/PVdC/Aluminum blisters, inserted into an aluminum sachet containing a desiccant that serves to protect the medicine from moisture. The desiccant must not be swallowed.
Packs containing 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sandoz SpA
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers:
Salutas Pharma GmbH, Otto- von- Guericke- Allee 1, D- 39179 Barleben, Germany
Salutas Pharma GmbH, Dieselstrasse 5, D - 70839 Gerlingen, Germany ( only for 0.5 mg, 1 mg, 5 mg hard capsules)
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
S.C. Sandoz S.R.L., Str. Livenzeni nr. 7A, RO - 540472 Targu Mures, Romania
LEK S.A., Ul. Domaniewska 50C, 02- 672 Warsaw, Poland
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the following denominations:
Austria Adport 0.5 mg - Hard capsules
Adport 1 mg - Hard capsules
Adport 5 mg - Hard capsules
Adport 2 mg – Hard capsules
Belgium Adoport 0.5 mg hard capsules
Adoport 1 mg hard capsules
Adoport 5 mg hard capsules
Adoport 2 mg hard capsules
Adoport 0.75 mg hard capsules
Czech Republic Tacrolimus Sandoz 0.5 mg
Tacrolimus Sandoz 1 mg
Tacrolimus Sandoz 5 mg
Tacrolimus Sandoz 2 mg
Tacrolimus Sandoz 0.75 mg
Denmark Adport
Finland Adport 2 mg capsules, hard
Adport 0.75 mg capsules, hard
France ADOPORT 0.5 mg, capsule
ADOPORT 1 mg, capsule
ADOPORT 5 mg, capsule
ADOPORT 2 mg, capsule
Germany Crilomus 0.5 mg Hard capsules
Crilomus 1 mg Hard capsules
Crilomus 5 mg Hard capsules
Crilomus 2 mg Hard capsules
Crilomus 0.75 mg Hard capsules
Hungary Adport 0.5 mg hard capsule
Adport 1 mg hard capsule
Adport 5 mg hard capsule
Italy ADOPORT
Netherlands Adport 0.5 mg, capsules, hard
Adport 1 mg, capsules, hard
Adport 5 mg, capsules, hard
Adport 2 mg, capsules, hard
Adport 0.75 mg, capsules, hard
Poland CIDIMUS
Romania TACROLIMUS SANDOZ 0.5 mg capsule
TACROLIMUS SANDOZ 1 mg capsule
TACROLIMUS SANDOZ 5 mg capsule
Slovenia Adoport 0.5 mg hard capsules
Adoport 1 mg hard capsules
Adoport 5 mg hard capsules
Adoport 2 mg hard capsules
Adoport 0.75 mg hard capsules
Spain Adoport 0.5 mg hard capsules EFG
Adoport 1 mg hard capsules EFG
Adoport 5 mg hard capsules EFG
Adoport 2 mg hard capsules EFG
Sweden Adport, 2 mg capsule, hard
Adport, 0.75 mg capsule, hard
United Kingdom Adoport 0.5 mg Capsules, hard
Adoport 1 mg Capsules, hard
Adoport 5 mg Capsules, hard
Adoport 2 mg Capsules, hard
Adoport 0.75 mg Capsules, hard