Adoport 2 Mg Capsules Hard
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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Tacrolimus
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in 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
Adoport belongs to a group of medicines called
immunosuppressants.
Following 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 enabling your body to accept the transplanted organ.
Adoport is often used in combination with other medicines that also suppress the immune system.
You may also be given Adoport for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.
medication for diabetic treatment, while you take Adoport.
Adoport with food and drink
You should generally take Adoport on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. Grapefruit and grapefruit juice should be avoided while taking Adoport.
Pregnancy and breast-feeding:
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Adoport is excreted into breast milk. Therefore you should not breast-feed whilst receiving Adoport.
Driving and using machines:
Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Adoport. These effects are more frequently observed if Adoport is taken in conjunction with alcohol use.
Do not take Adoport:
• If you are allergic (hypersensitive) 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 (e.g. erythromycin, clarithromycin, josamycin).
Adoport contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Warnings and precautions
Talk to your doctor or pharmacist before taking Adoport.
• If you have diarrhoea for more than one day, because it might be necessary to adapt the dose of Adoport that you receive.
• If you have liver problems or have had a disease which may have affected your liver, because this may affect the dose of Adoport that you receive.
• Limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with a high protection factor. This is because of the potential risk of malignant skin changes with immunsuppressive therapy.
• Take Adoport every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor.
• Whilst you are taking Adoport your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time. This is quite normal and will help your doctor to decide on the most appropriate dose of Adoport for you.
• If you need to have any vaccinations, please inform your doctor beforehand. Your doctor will advise you on the best course of action.
• Please avoid taking any herbal remedies, e.g. St. John’s wort (Hypericum perforatum) or any other herbal products as this may affect the effectiveness and the dose of Adoport that you need to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies.
Other medicines and Adoport:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal remedies.
Adoport must not be taken with ciclosporin.
Adoport blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Adoport which may require interruption, an increase or a decrease in Adoport dose.
Take care with the following medicines:
• antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat infections e.g. ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin and rifampicin
• HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), used to treat HIV infection
• HCV protease inhibitors (e.g. telaprevir, boceprevir), used to treat hepatitis C infection
• omeprazole or lansoprazole, used for treating stomach ulcer
• hormone treatments with ethinylestradiol (e.g the oral contraceptive pill) or danazol
• medicines for high blood pressure or heart problems such as nifedipine, nicardipine, diltiazem and verapamil
• anti-arrhythmic drugs (amiodarone) used to control arrhythmia (uneven beating of the heart)
• medicines known as “statins” used to treat elevated cholesterol and triglycerides
• the anti-epileptic medicines phenytoin or phenobarbital
• the corticosteroids prednisolone and methylprednisolone
• the anti-depressant nefazodone
• St. John’s Wort (hypericum perforatum)
Tell 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 taken together with Adoport.
Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g. amiloride, triamterene or spironolactone), certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants or oral
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is as follows:
Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
This medicine should be taken twice a day. If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight. Initial doses just after transplantation will generally be in the range of
0.075-0.30 mg per kg body weight per day depending on the transplanted organ.
Your dose depends on your general condition and on which other immunosuppressive medication you are taking. Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time. Your doctor will usually reduce your Adoport dose once your condition has stabilised. Your doctor will tell you exactly how many capsules to take and how often.
Method and route of administration
• Adoport is taken orally twice daily, usually in the morning and evening. You should generally take Adoport on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal.
• Swallow your capsules whole with a glass of water.
• Avoid grapefruit and grapefruit juice while taking Adoport
• Take the hard capsules immediately following removal from the blister.
• Do not swallow the desiccant contained in the foil wrapper.
If you take more Adoport than you should
If you have accidentally taken too much Adoport or if someone else accidentally takes your medicine, see your doctor or contact your nearest hospital emergency department immediately.
If you forget to take Adoport:
Do not take a double dose to make up for forgotten individual doses.
If you have forgotten to take your Adoport capsules, wait until it is time for the next dose, and then continue as before.
If you stop taking Adoport:
Stopping your treatment with Adoport may increase the risk of rejection of your transplanted organ. Do not stop your treatment unless your doctor tells you to do so.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tacrolimus reduces your body’s own defence mechanism to stop you rejecting your transplanted organ. Consequently, your body will not be as good as usual at fighting infections. So if you are taking Adoport you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.
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Severe effects have been reported, including allergic and anaphylactic reactions. Benign and malignant tumours have been reported following Tacrolimus treatment as a result of immunosuppression.
Serious side effects
If you notice one of the following serious side effects, talk to your doctor or go to a hospital immediately:
• In case of any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding
• Hypersensitivity reactions (anaphylaxis, angioedema): If you develop a swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, or extreme dizziness.
Following serious side-effects are common (may affect up to 1 in 10 people):
• Unusual bruising or bleeding, including vomiting blood or passing blood in your stools
• Fits (convulsions)
• Yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine (signs of inflamed liver).
Following serious side-effects are uncommon (may affect up to 1 in 100 people):
• Coma, stroke, paralysis
• Irregular heartbeat or stop of heartbeat
• Shock
Following serious side-effects are rare (may affect up to 1 in 1,000 people):
• Feeling of tightness in your chest
• Acute breathlessness
• Serious illness with blistering of skin, mouth, eyes and genitals
Following serious side-effects are very rare (may affect up to 1 in 10,000 people):
• Painful urination with blood in the urine
• Severe illness with ulceration of the mouth, lips and skin
These are all serious side effects. You may need urgent medical attention.
Other possible side-effects
Following side-effects are very common (may affect more than 1 in 10 people):
• increased blood pressure
• trembling, headache, difficulty in sleeping
• diarrhoea, nausea
• kidney problems
• increased blood sugar, diabetes mellitus, increased potassium in the blood
Following side-effects are common (may affect up to 1 in 10 people):
• reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts, reduced blood flow in the heart vessels, faster heartbeat, bleeding, partial or complete blocking of blood vessels, reduced blood pressure
• disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders, anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare, hallucination, mental disorders
• blurred vision, increased sensitivity to light, eye disorders
• ringing sound in your ears
• shortness in breath, changes in the lung tissue, collection of liquid around the lung, inflammation of the pharynx, cough, flu-like symptoms
• inflammations or ulcers causing abdominal pain or diarrhoea, inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, flatulence, bloating, loose stools, stomach problems, changes in liver enzymes and function
• itching, rash, hair loss, acne, increased sweating
• insufficient function of the kidneys, reduced production of urine, impaired or painful urination
• pain in joints, limbs or back, muscle cramps
• reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood, other changes in the blood salts
• general weakness, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed, as can happen in patients taking this type of medicine, a very small number of tacrolimus patients have developed cancer of the lymphoid tissues and skin.
• insufficient function of your transplanted organ
Following side-effects are uncommon (may affect up to 1 in 100 people):
• changes in blood clotting, reduction in all blood cell counts, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal, blood clot in a vein of a limb
• bleeding in the brain, brain disorder, speech and language abnormalities, memory problems
• opacity of the lens
• impaired hearing
• difficulties in breathing, respiratory tract disorders, asthma
• obstruction of the gut, peritonitis, severe upper stomach pain, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach
• inability to urinate, painful menstruation and abnormal menstrual bleeding
• dermatitis, burning sensation in the sunlight
• joint disorders
• dehydration, reduced protein or sugar in the blood, increased phosphate in the blood
• failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss
Following side-effects are rare (may affect up to 1 in 1,000 people):
• small bleedings in your skin due to blood clots, collection of fluid around the heart
• increased muscle stiffness
• blindness
• deafness
• acute breathlessness
• partial obstruction of the gut, cyst formation in your pancreas, problems with blood flow in the liver
• increased hairiness
• thirst, fall, decreased mobility, ulcer
Following side-effects are very rare (may affect up to 1 in 10,000 people):
• echocardiogram abnormal
• muscular weakness
• liver failure, narrowing of the bile vessel
• increase of fat tissue
Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells) and haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) have been reported.
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 via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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 EXP. The expiry date refers to the last day of that month.
Use all the capsules within 12 months of opening the aluminium wrapping surrounding the blister. Do not store above 25°C after opening the aluminium wrapping.
Take the capsule immediately after removing from the blister.
Do not store above 30°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Adoport contains
• The active substance is tacrolimus. Each capsule contains 0.75 mg or 2 mg of tacrolimus (as monohydrate).
• The other ingredients are:
- Capsule contents:
lactose monohydrate, hypromellose (E464), croscarmellose sodium (E468) and magnesium stearate (E572).
- Hard gelatin capsule:
Adoport 0.75 mg Capsules, hard: gelatin, titanium dioxide (E 171), yellow iron oxide (E172), FD&C Blue 1 (E133), Shellac (E904), Propylene glycol (E1520), Potassium hydroxide (E525) and Black iron oxide (E172).
Adoport 2 mg Capsules, hard: 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).
What Adoport looks like and contents of the pack
Adoport 0.75 mg Capsules, hard are light green opaque hard capsules, imprinted in black with 0.75 mg on the cap, containing white to off-white powder (length: 14.5 mm).
Adoport 2 mg Capsules, hard are dark green opaque hard capsules, imprinted in black with 2 mg on the cap, containing white to off-white powder (length: 14.5 mm).
Adoport Capsules are packed in PVC/ PE/ PVdC/ Aluminium blisters in Aluminium bag., including a dessicant protecting the capsules from moisture. The dessicant should not be swallowed.
Packs of 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park,
Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke- Allee 1,
D-39179 Barleben, Germany
or
Lek Pharmaceuticals d.d.,
Verovskova 57, 1526 Ljubljana, Slovenia
or
S.C. Sandoz S.R.L.,
Str. Livenzeni nr. 7A,
540472 Targu Mures, Romania
or
LEK S.A.,
Ul. Domaniewska 50C,
02- 672 Warszawa, Poland
or
Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava, Slovenia.
This leaflet was last revised in 06/2014.
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