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TALIXIMUN 5 MG HARD CAPSULES

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Taliximun 0.5 mg hard capsules
Taliximun 1 mg hard capsules
Taliximun 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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Taliximun is and what it is used for
What you need to know before you take Taliximun
How to take Taliximun
Possible side effects
How to store Taliximun
Contents of the pack and other information

1. What Taliximun is and what it is used for
Taliximun 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.
Taliximun is used to control your body’s immune response enabling your body to accept the
transplanted organ.
Taliximun is often used in combination with other medicines that also suppress the immune system.
You may also be given Taliximun 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.
2. What you need to know before you take Taliximun
Do not take Taliximun
 If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Taliximun.
 If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide
antibiotics (e.g. erythromycin, clarithromycin, josamycin).
Warnings and precautions




You will need to take Taliximun 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 Taliximun 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 Taliximun for you.
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 Taliximun that you need
to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies.



If you have liver problems or have had a disease which may have affected your liver, please tell
your doctor as this may affect the dose of Taliximun that you receive.
 If you have diarrhoea for more than one day, please tell your doctor, because it might be
necessary to adapt the dose of Taliximun that you receive.
 Limit your exposure to sunlight and UV light whilst taking Taliximun by wearing appropriate
protective clothing and using a sunscreen with a high sun protection factor. This is because of the
potential risk of malignant skin changes with immunosuppressive therapy.
If you need to have any vaccinations, please inform your doctor beforehand. Your doctor will advise
you on the best course of action.
Other medicines and Taliximun
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription and herbal preparations.
Taliximun must not be taken with cyclosporine.
Taliximun blood levels can be affected by other medicines you take, and blood levels of other
medicines can be affected by taking Taliximun 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:











antifungal medicines and antibiotics (particularly so-called macrolide antibiotics) used to treat
infectionse.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 used to treat high blood pressure or heart problems (e.g. 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. 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
Taliximun.
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 taking Taliximun.
If you need to have any vaccinations, please inform your doctor in advance.
Taliximun with food, drink and alcohol
You should generally take Taliximun on an empty stomach or at least 1 hour before or 2 to 3 hours
after a meal. Grapefruit and grapefruit juiceshould be avoided while taking Taliximun.
Pregnancy and breast-feeding
If you plan to become pregnant or think that you may be pregnant or you are 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 Taliximun.
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 Taliximun. These effects are more frequently observed if Taliximun is taken in
conjunction with alcohol use.
Taliximun 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 Taliximun
Always take Taliximun exactly as your doctor has told you. You should 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 tacrolimus capsules dose once your
condition has stabilised. Your doctor will tell you exactly how many capsules to take and how often.
Taliximun is taken orally twice daily, usually in the morning and evening. You should generally take
Tacrolimus capsules 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. Take the capsules immediately following
removal from the blister. Avoid grapefruit and grapefruit juice while taking Tacrolimus capsules. Do
not swallow the desiccant contained in the foil wrapper.

If you take more Taliximun than you should
If you have accidentally taken too much Taliximun see your doctor or contact your nearest hospital
emergency department immediately.
If you forget to take Taliximun
Do not take a double dose to make up for forgotten individual doses.
If you have forgotten to take your Taliximun capsules, wait until it is time for the next dose, and then
continue as before.
If you stop taking Taliximun

Stopping your treatment with Taliximun 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, Taliximun can cause side effects, although not everybody gets them.
Taliximun 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 Taliximun you may therefore catch more infections than usual such as infections of the skin,
mouth, stomach and intestines, lungs and urinary tract.
Severe effects may occur, including allergic and anaphylactic reactions. Haemolytic uraemic
syndrome is uncommon: a disease characterised by acute kidney insufficiency, low blood counts of
red cells and platelets. A rare side effect is Thrombotic Thrombocytopenic Purpura (or TTP) that
includes fever and bruising under the skin that may appear as red pinpoint dots, with or without
unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice). Benign and
malignant tumours have been reported following tacrolimus treatment as a result of
immunosuppression.
Possible side effects are listed according to the following categories:
Very common side effects are experienced in more than one in ten patients.
Common side effects are experienced in less than one in ten patients but in more than one per one
hundred patients.
Uncommon side effects are experienced in less than one in one hundred patients but more than one
per one thousand patients.
Rare side effects are experienced in less than one per one thousand patients but more than one per ten
thousand patients.
Very rare side effects are experienced in less than one per ten thousand patients.
Very common side effects







increased blood sugar, diabetes mellitus, increased potassium in the blood
difficulty in sleeping
trembling, headache
increased blood pressure
diarrhoea, nausea
kidney problems

Common side effects







reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell
counts, changes in red blood cell counts
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
anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare,
hallucination, mental disorders
fits, 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
inflammations or ulcers causing abdominal pain or diarrhoea, bleeds in the stomach,
inflammations 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, yellowing of the skin due to liver problems, liver
tissue damage and inflammation of the liver
itching, rash, hair loss, acne, increased sweating
pain in joints, limbs or back, muscle cramps
insufficient function of the kidneys, reduced production of urine, impaired or painful
urination
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 side effects
 changes in blood clotting, reduction in the number of all blood cells
 dehydration, reduced protein or sugar in the blood, increased phosphate in the blood.
 coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language
abnormalities, memory problems
 blurring of the vision due to abnormality in the lens of the eye
 impaired hearing
 irregular heartbeat, skipped heartbeat, 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, shock
 difficulties in breathing, respiratory tract disorders, asthma
 obstruction of the gut, 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
 inability to urinate, painful menstruation and abnormal menstrual bleedings
 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
Rare side effects
 small bleeds in your skin due to blood clots
 increased muscle stiffness
 blindness
 deafness
 collection of fluid around the heart
 acute breathlessness
 cyst formation in your pancreas
 problems with blood flow in the liver
 serious illness with blistering of skin, mouth, eyes and genitals, increased hairiness
 thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Very rare side effects
 muscular weakness
 abnormal heart scan
 liver failure, narrowing of the bile vessel
 painful urination with blood in the urine



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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5. How to store Taliximun
 Keep out of the reach and sight of children.
 Store below 30°C
 Store in the original package (within the foil pouch) in order to protect from moisture & light.
 Do not use Taliximun 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.
 Medicines should not be disposed of via wastewater 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 Taliximun contains
Taliximun 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 Opxide (E-172), Gelatin
Taliximun 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
Taliximun 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.
 Capsule shell: Titanium dioxide (E-171), Red Iron Oxide (E-172), Gelatin
What Taliximun looks like and contents of the pack
Taliximun 0.5 mg hard capsules
Ivory cap and ivory body hard shell capsules with white powder.
Taliximun 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.

Taliximun 1 mg hard capsules
White cap and white body hard shell capsules with white powder.
Taliximun 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.
Taliximun 5 mg hard capsules
Red cap and red body hard shell capsules with white powder.
Taliximun 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.
Taliximun is available in blister packs containing blister strips of 10 capsules each.
30 capsules
50 capsules
60 capsules
90 capsules (for the 5mg tablets only)
100 capsules
Not all pack sizes may be marketed
Marketing Authorization Holder
PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c
170 00 Prague 7
Czech Republic
Manufacturer
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10-Políg Areta 31620 Huarte-Pamplona, Navarra,
Spain
ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Poland
This medicinal product is authorized in the Member States of the EEA under the following
names:

United Kingdom: Taliximun 0.5mg, 1mg, 5mg hard capsules
Poland: Taliximun
Romania: Taliximun 0,5 mg, 1mg, 5mg Capsule
This leaflet was last revised on:

December 2013

Expand Transcript

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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