ADOPORT 1 MG CAPSULES HARD

Active substance: TACROLIMUS

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Adoport 0.5 mg Capsules, hard
Adoport 1 mg Capsules, hard
Adoport 5 mg Capsules, hard

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.

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

1

What Adoport is and what it is
used for

Adoport belongs to a group of medicines called
immunosuppressants.

Following your organ transplant (e.g. liver, kidney,
heart), your bodyʼs immune system will try to
reject the new organ. Adoport is used to control
your bodyʼs 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.

2

What you need to know before you
take Adoport

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).

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 immunosuppressive
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. Johnʼs 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 an increase or decrease in
Adoport dose.

Take care with the following medicines:
• antifungal medicines and antibiotics, particularly
so-called macrolide antibiotics, e.g.
ketoconazole, fluconazole, itraconazole,
voriconazole, clotrimazole, erythromycin,
clarithromycin, josamycin and rifampicin
• HIV protease inhibitors e.g. ritonavir
• omeprazole or lansoprazole, used for treating
stomach ulcers
• 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
• 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. Johnʼs Wort (hypericum perforatum).
Tell your doctor if you are taking or need to take
ibuprofen, amphotericin B, 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
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 any
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.

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.

3

How to take Adoport

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.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Tacrolimus reduces your bodyʼs 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.
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.

Continued on the next page >>

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.

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.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. However, do not
stop taking your medicine unless you have
discussed this with your doctor first.

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 EXP. The expiry
date refers to the last day of that month.

Do not store above 30°C. Store in the original
package in order to protect from moisture.

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 throw away medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

6

Contents of the pack and other
information

What Adoport contains
• The active substance is tacrolimus. Each
capsule contains 0.5 mg, 1 mg or 5 mg of
tacrolimus (as monohydrate).
• The other ingredients are:
- Capsule contents: lactose monohydrate,
hypromellose, croscarmellose sodium and
magnesium stearate.
- Hard gelatin capsule:
Adoport 0.5 mg Capsules, hard: gelatin,
titanium dioxide (E171), sodium laurilsulfate,
sorbitan laureate and yellow iron oxide
(E172).
Adoport 1 mg Capsules, hard: gelatin,
titanium dioxide (E171), sodium laurilsulfate,
sorbitan laureate, yellow iron oxide (E172),
red iron oxide (E172) and black iron oxide
(E172).
Adoport 5 mg Capsules, hard: gelatin,
titanium dioxide (E171), sodium laurilsulfate,
sorbitan laureate and red iron oxide (E172).

What Adoport looks like and contents of the
pack
Adoport 0.5 mg Capsules, hard are hard capsules
with white coloured opaque body and ivory
coloured cap containing white to off-white powder.

Adoport 1 mg Capsules, hard are hard capsules
with white coloured opaque body and light brown
coloured cap containing white to off-white powder.

Adoport 5 mg Capsules, hard are hard capsules
with white coloured opaque body and orange
coloured cap containing white to off-white powder.
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, UK.

Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, D-39179 Barleben,
Germany
or

Salutas Pharma GmbH,
Dieselstrasse 5, D-70839 Gerlingen,
Germany
or

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia
or

S.C. Sandoz S.R.L.,
Str. Livenzeni nr. 7A, RO-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 08/2012.

Following side-effects are rare (may affect up to 1
in 1,000 people):
• small areas of bleeding 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.

SZ00000LT000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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