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ADOPORT 5MG CAPSULES HARD

Active substance(s): TACROLIMUS

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Ref: 1501/080115/1/F

®

Adoport 5mg Capsules, hard
(tacrolimus)
Patient Information Leaflet
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.
Your medicine is called Adoport 5mg Capsules, hard and will be referred to
as Adoport throughout the leaflet.
Please note that the leaflet also contains information about other strengths
of the medicine, Adoport 0.5mg Capsules, hard and Adoport 1mg Capsules,
hard.
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

* medicines known as “statins” used to treat elevated cholesterol and
*
*
*
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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 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 contains lactose monohydrate.
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
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.

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.

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

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.

Ref: 1501/080115/1/B

®

Adoport 5mg Capsules, hard
(tacrolimus)
Patient Information Leaflet
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.

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.
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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5

How to store Adoport

Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.

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

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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.

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 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.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via waterwaste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. 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 5mg of tacrolimus
(as monohydrate).
The other ingredients are:
Capsule content: lactose monohydrate, hypromellose, croscarmellose
sodium and magnesium stearate.
Hard gelatin capsule: gelatin, titanium dioxide (E 171), sodium lauryl sulfate,
sorbitan laurate and red iron oxide (E172).
What Adoport looks like and contents of the pack
Adoport 5mg 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.
Available in packs of 30 hard capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Lek Pharmaceuticals d.d., Verovskova 57,
1526 Ljubljana, Slovenia and is procured from within the EU and repackaged
by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire, B98 0RE, UK.

POM

PL 15184/1501

Adoport 5mg Capsules, hard

Adoport is a registered trademark of Novartis AG.
Revision date: 08/01/2015

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414
for help.

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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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