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CAPEXION 1MG HARD CAPSULES

Active substance(s): TACROLIMUS

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Package leaflet: Information for the patient
Capexion 0.5 mg hard capsules
Capexion 1 mg hard capsules
Capexion 5 mg hard capsules
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 Capexion is and what it is used for
2. What you need to know before you take Capexion
3. How to take Capexion
4. Possible side effects
5. How to store Capexion
6. Contents of the pack and other information

1. What Capexion is and what it is used for
Capexion contains the active substance tacrolimus which is an immunosuppressant. Following
your organ transplant (e.g. liver, kidney, heart), your body’s immune system will try to reject the
new organ.
Capexion is used to control your body’s immune response enabling your body to accept the
transplanted organ.
Capexion is often used in combination with other medicines that also suppress the immune
system.
You may also be given Capexion for an ongoing rejection of your transplanted liver, kidney,
heart or other organ when any previous treatment you were taking was unable to control this
immune response after your transplantation.

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2. What you need to know before you take Capexion
Do not take Capexion
 If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in
section 6)
 If you are allergic to sirolimus or to any macrolide antibiotic (e.g. erythromycin,
clarithromycin, josamycin).

Warnings and precautions
Talk to your doctor or pharmacist before taking Capexion
if you are taking any medicines mentioned below under ‘Other medicines’ and Capexion.
if you have or have had liver problems
if you need to receive any vaccinations
if you or a family member have been diagnosed with heart problems (e.g. congestive
heart failure, bradyarrhythmias)
if you have been diagnosed with a heart condition called “Congenital Long QT
Syndorme” or “QT prolongation”.
Your doctor may need to adjust your dose of Capexion.
During treatment tell your doctor or pharmacist:
 if you have diarrhoea for more than one day
 if you feel strong abdominal pain accompanied with or without other symptoms, such as
chills, fever, feeling sick (nausea) or being sick (vomiting)
 if you have a change of the electrical activity of your heart called “QT prolongation”.

You should keep in regular contact with your doctor. From time to time, your doctor may need to
do blood, urine, heart, eye and neurological tests, to set the right dose of Capexion.
Patients treated with tacrolimus have been reported to have an increased risk of developing
lymphoproliferative disorders (see section 4). Ask your doctor for specific advice on these
disorders.
You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Capexion. This
is because immunosuppressants could increase the risk of skin cancer. Wear appropriate
protective clothing and use a sunscreen with a high sun protection factor.

Other medicines and Capexion
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 preparations.
Capexion must not be taken with ciclosporin.
Capexion blood levels can be affected by other medicines you take, and blood levels of other
medicines can be affected by taking Capexion which may require an increase or decrease in dose.
In particular, you should tell your doctor if you are taking or have recently taken medicines like:

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antifungal medicines and antibiotics, particularly so-called macrolide antibiotics, used to treat
infections, such as ketoconazole, fluconazole, itraconazole, telithromycin, voriconazole,
clotrimazole, erythromycin, clarithromycin, josamycin, rifabutin and rifampicin
HIV medicines ( e.g. ritonavir, nelfinavir, saquinavir), used to treat HIV infection
HCV protease inhibitors (e.g. telaprevir, boceprevir), used to treat hepatitis C infection
medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine)
antiemetics, used to treat nausea and vomiting (e.g. metoclopramide)
cisapride or the antacid magnesium-aluminium-hydroxide, used to treat heartburn
the contraceptive pill or other hormone treatments with ethinylestradiol.
hormone treatments with danazol
medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine,
diltiazem and verapamil)
amiodarone, used to control arrhythmia (uneven beating of the heart)phenytoin, phenobarbital
or carbamazepine, used to treat epilepsy
the corticosteroids prednisolone and methylprednisolone, belonging to the class of
corticosteroids used to treat inflammations or suppress the immune system (e.g. in transplant
rejection)
isoniazid, used to treat tuberculosis
nefazodone, used to treat depression
herbal preparations containing St. John’s wort (Hypericum perforatum) or extracts of
Schisandra sphenanthera.

Tell your doctor if you are taking or need to take ibuprofen, amphotericin B or antivirals (e.g.
ganciclovir, aciclovir). These may worsen kidney or nervous system problems when taken
together with Capexion.
Your doctor also needs to know if you are taking potassium supplements or certain diuretics used
for heart failure, hypertension and kidney disease, (e.g. amiloride, triamterene, or spironolactone),
non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and
pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Capexion.
If you need vaccinations, tell your doctor in advance that you are taking this medicine.
Taking Capexion with food and drink
Avoid grapefruit (also as juice) while on treatment with Capexion since it can affect its levels.
Pregnancy and breast-feeding
If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist
for advice before taking any medicine.
Tacrolimus passes into breast milk. Therefore you should not breast-feed whilst using Capexion.
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 this medicine. These effects are more frequently observed if you also drink
alcohol.

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Capexion contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Capexion
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
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 Capexion dose once
your condition has stabilised. Your doctor will tell you exactly how many capsules to take and
how often.
Capexion is taken orally twice daily, usually in the morning and evening. You should generally
take Capexion on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal. The
capsules should be swallowed whole with a glass of water. Avoid grapefruit and grapefruit juice
while taking Capexion. Do not swallow the desiccant contained in the foil wrapper.
If you take more Capexion than you should
If you have accidentally taken too much see your doctor or contact your nearest hospital
emergency department immediately. Someone who has taken an overdose of Capexion may have
any of these symptoms: shaking, headache, feeling or being sick, itchy rash (hives), feeling tired
and increased infections.
If you forget to take Capexion
Do not take a double dose to make up for forgotten individual doses.
If you have forgotten to take your capsules, wait until it is time for the next dose, and then
continue as before.
If you stop taking Capexion

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Stopping your treatment 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 product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Capexion 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 Capexion you may therefore catch more infections than usual, such as infections of the
skin, mouth, stomach and intestines, lungs and urinary tract.
If you think you may have any of the following side effects, contact your doctor or go to
your nearest hospital emergency room immediately:
Very common (may affect more than 1 in 10 people):
 diabetes mellitus, you may notice increased thirst, needing to urinate more often than
usual and increased hunger
 kidney problems
Common (may affect up to 1 in 10 people):
 yellowing of the skin due to liver problems, liver tissue damage and inflammation of the
liver
 insufficient function of the kidneys with reduced production of urine, impaired or painful
urination
 gastrointestinal perforation, you may have strong abdominal pain accompanied with other
symptoms, such as chills, fever, feeling sick and being sick
 inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach
 fits
Uncommon side effects (may affect up to 1 in 100 people):
 bleeding in the brain, stroke
 difficulties in breathing
 reduction in the number of all types of blood cells
 inflammation of the pancreas
 partial or complete paralysis
 obstruction of the gut
 haemolytic uraemic syndrome, a condition with the following symptoms: low or no urine
output (acute renal failure), extreme tiredness, yellowing of the skin or eyes (jaundice)
and abnormal bruising or bleeding and signs of infection.
 inflammation of the membrane lining of the stomach wall
 severe mental disorder that can cause abnormal thinking and perceptions
 heart attack
 insufficient function of your transplanted organ
 coma, shock
Rare (may affect up to 1 in 1,000 people):

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Thrombotic Thrombocytopenic Purpura, a condition with the following symptoms: fever
and bruising under the skin that may appear as red pinpoint dots, you may feel
unexplained extreme tiredness, confusion, and notice yellowing of the skin or eyes
(jaundice), with symptoms of kidney problems (low or no urine output).
Toxic epidermal necrolysis: erosion and blistering of skin or mucous membranes, red
swollen skin that can detach in large parts of the body.
severe shortness of breath
blindness
collection of fluid around the heart
deafness
problems with blood flow in the liver

Very rare (may affect up to 1 in 10,000 people):
 liver failure
 Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, serious
illness with blistering of skin, mouth, eyes and genitals, hives, tongue swelling, red or
purple skin rash that spreads, skin shedding
 Torsades de Pointes: change in the heart frequency that can be accompanied by
symptoms, such as chest pain (angina), fainting, dizziness or feeling sick (nausea),
palpitations (feeling the heartbeat) and difficulty breathing.
 painful urination with blood in the urine
 abnormal heart scan
 narrowing of the bile vessel
Not known (frequency cannot be estimated from the available data):
 allergic and anaphylactic reactions with the following symptoms: a sudden itchy rash
(hives), swelling of hands, feet, ankle, face, lips, mouth or throat (which may cause
difficulty in swallowing or breathing) and you may feel you are going to faint.
 benign and malignant tumours have been reported following treatment as a result of
immunosuppression
 Posterior Reversible Encephalopathy Syndromes (PRES): headache, altered mental
status, fits, and visual disturbances.
 pure red cell aplasia (a very severe reduction in red blood cell counts) and haemolytic
anaemia (decreased number of red blood cells due to abnormal breakdown accompanied
with tiredness) have been reported. You may have no symptoms or depending on the
severity of the condition, you may notice: fatigue, apathy, abnormal paleness of the skin,
shortness of breath, dizziness, headache, chest pain and coldness in hands and feet.
 agranulocytosis (a severely lowered number of white blood cells accompanied with
ulcers in the mouth, fever and infections). You may have no symptoms or you may feel
sudden fever, chills and sore throat.
Other possible side effects
Very common (may affect more than 1 in 10 people):
• increased blood sugar, increased potassium in the blood
• difficulty in sleeping
• trembling, headache
• diarrhoea, nausea
Common (may affect up to 1 in 10 people):

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• 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 (seen in blood tests)
• anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares,
hallucination, mental disorders
• disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet,
dizziness, impaired writing ability, nervous system disorders
• blurred vision, increased sensitivity to light, eye disorders
• ringing sound in your ears
• reduced blood flow in the heart vessels, faster heartbeat
• bleeding, partial or complete blocking of blood vessels, reduced blood pressure
• shortness in breath, changes in the lung tissue, collection of liquid around the lung,
inflammation of the throat, cough, flu-like symptoms inflammation or ulcers in the mouth,
collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, passing
wind, bloating, loose stools, stomach problems
• changes in liver enzymes and function
• itching, rash, hair loss, acne, increased sweating
• pain in joints, limbs or back, muscle cramps
• general weakness, fever, collection of fluid in your body, pain and discomfort, increase of the
enzyme alkaline phosphatase in your blood, weight gain, feeling feverish
• insufficient function of your transplanted organ.
Uncommon (may affect up to 1 in 100 people):
• changes in blood clotting
• dehydration, reduced protein or sugar in the blood, increased phosphate in the blood
• brain disorder, speech and language abnormalities, memory problems
• clouding of the eyes (cataracts)
• impaired hearing
• irregular heartbeat, skipped heartbeat, reduced performance of your heart, enlargement of the
heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal
• blood clot in a vein of a limb
• respiratory tract disorders, asthma
• increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed
emptying of the stomach
• dermatitis, burning sensation in the sunlight
• joint disorders
• painful menstruation and abnormal menstrual bleedings
• 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.
Rare (may affect up to 1 in 1,000 people):
• increased muscle stiffness
• cyst formation in your pancreas
• increased hairiness
• thirst, fall
• feeling of tightness in your chest
• decreased mobility
• ulcer

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Very rare (may affect up to 1 in 10,000 people):
• muscular weakness
• increase of fat 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 via
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 Capexion
 Keep this medicine out of the sight and reach of children.
 Store below 30C
 Store in the original package (within the foil pouch) in order to protect from moisture and
light.
 Do not use Capexion after the expiry date which is stated on the carton and blister after
{EXP}. Once the foil pouch is opened, the product should be used within 1 year. The
expiry date refers to the last day of that month.
 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.

6. Contents of the pack and other information
What Capexion contains
Capexion 0.5 mg hard capsules The active substance is tacrolimus.
For 0.5mg: Each capsule contains 0.5mg of tacrolimus
The other ingredients are:
 Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous,
Magnesium stearate.
 Capsule shell: Titanium dioxide (E-171), Yellow Iron Oxide (E-172), Gelatin
Capexion 1 mg hard capsules The active substance is tacrolimus.
For 1 mg: Each capsule contains 1mg of tacrolimus
The other ingredients are:
 Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous,
Magnesium stearate.
 Capsule shell: Titanium dioxide (E-171), Gelatin
Capexion 5 mg hard capsules The active substance is tacrolimus.
For 5mg: Each capsule contains 5mg of tacrolimus
The other ingredients are:
 Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous,
Magnesium stearate.

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Capsule shell: Titanium dioxide (E-171), Red Iron Oxide (E-172), Gelatin

What Capexion looks like and contents of the pack
Capexion 0.5 mg hard capsules
Ivory cap and ivory body hard shell capsules with white powder.
Capexion 0.5 mg hard capsules are supplied as blister strips containing 10 capsules within a
protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
Capexion 1 mg hard capsules
White cap and white body hard shell capsules with white powder.
Capexion 1 mg hard capsules are supplied as blister strips containing 10 capsules within a
protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
Capexion 5 mg hard capsules
Red cap and red body hard shell capsules with white powder.
Capexion 5 mg hard capsules are supplied as blister strips containing 10 capsules within a
protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
Capexion is available in blister packs containing blister strips of 10 capsules each.
0.5 mg: 10, 30, 50, 60, 90 and 100 capsules
1 mg: 10, 30, 50, 60, 90 and 100 capsules
5 mg: 10, 30, 50, 60, 90 and 100 capsules
Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10-Políg Areta 31620 Huarte-Pamplona, Navarra,
Spain

This leaflet was last revised in: January 2016

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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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