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ALTRUDYNT 5 MG HARD CAPSULES

Active substance(s): TACROLIMUS / TACROLIMUS / TACROLIMUS

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SAME SIZE ARTWORK
LEAFLET SIZE: 170 mm x 480 mm

Package leaflet: Information for the user
Altrudyntc 5mg 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 Altrudynt is and what it is used for
2. What you need to know before you take Altrudynt
3. How to take Altrudynt
4. Possible side effects
5. How to store Altrudynt
6. Contents of the pack and other information
1. What Altrudynt is and what it is used for
Altrudynt 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.
Altrudynt is used to control your body's immune
response enabling your body to accept the transplanted
organ.
Altrudynt is often used in combination with other
medicines that also suppress the immune system.
You may also be given Altrudynt for an on-going
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
Altrudynt
Do not take Altrudynt:
● if you are allergic to Altrudynt 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
Altrudynt.
● You will need to take Altrudynt 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 Altrudynt 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 Altrudynt 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 Altrudynt 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 Altrudynt that
you receive.
● If you feel strong abdominal pain accompanied or
not with other symptoms, such as chills, fever,
nausea or vomiting, please tell your doctor.
● If you have diarrhoea for more than one day, please
tell your doctor, because it might be necessary to
adapt the dose of Altrudynt that you receive.
● If you have an alteration of the electrical activity of
your heart called “QT prolongation”. Your doctor
will advise you about this.
● Limit your exposure to sunlight and UV light
whilst taking Altrudynt 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.
● Patients treated with Altrudynt have been reported
to have an increased risk of developing
lymphoproliferative disorders (see section 4). Ask
your doctor for specific advice on these disorders.
Other medicines and Altrudynt
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Altrudynt must not be taken with ciclosporin.
Altrudynt blood levels can be affected by other
medicines you take, and blood levels of other
medicines can be affected by taking Altrudynt, which
may require interruption, an increase or a decrease in
Altrudynt dose. In particular, you should tell your
doctor or pharmacist if you are taking or have recently
taken medicines such as:
● 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
● medicines for stomach ulcer and acid reflux (e.g.
omeprazole, lansoprazole or cimetidine)
● antiemetics, used to treat nausea and vomiting (e.g.
metoclopramide)
● magnesium-aluminium-hydroxide (antacid), used
to treat heartburn
● 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 medicines (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
● 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.
aciclovir). These may worsen kidney or nervous
system problems when taken together with Altrudynt .
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
Altrudynt.
If you need to have any vaccinations, please inform
your doctor beforehand.
Altrudynt with food and drink
You should generally take Altrudynt 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 Altrudynt.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Altrudynt is excreted into breast milk. Therefore you
should not breast-feed whilst receiving Altrudynt.
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 Altrudynt. These effects are more frequently
observed if Altrudynt is taken in conjunction with
alcohol use.
Altrudynt contains lactose
Altrudynt 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 Altrudynt
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 Altrudynt
medicine every time you collect your prescription,
unless your transplant specialist has agreed to change
to a different Altrudynt medicine.
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 Altrudynt dose once your condition has stabilised.
Your doctor will tell you exactly how many capsules to
take and how often.
Altrudynt is taken orally twice daily, usually in the
morning and evening. You should generally take
Altrudynt 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 Altrudynt.
If you take more Altrudynt than you should
If you have accidentally taken too much Altrudynt, see
your doctor or contact your nearest hospital emergency
department immediately.
If you forget to take Altrudynt
Do not take a double dose to make up for a forgotten
dose.
If you have forgotten to take your Altrudynt capsules,
wait until it is time for the next dose, and then continue
as before.
If you stop taking Altrudynt
Stopping your treatment with Altrudynt 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.
Altrudynt 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
Altrudynt, you may catch more infections than usual
such as infections of the skin, mouth, stomach and
intestines, lungs and urinary tract.
Severe side effects may occur, including the ones listed
below. Tell your doctor immediately if you have or
suspect you may have any of the following serious
side effects:
● Opportunistic infections (bacterial, fungal, viral
and protozoal): prolonged diarrhoea, fever and
sore throat.
● Benign and malignant tumours have been
reported following treatment as a result of
immunosuppression.

Date: 10.08.2016
Version: 02 (UK)

SAME SIZE ARTWORK
LEAFLET SIZE: 170 mm x 480 mm

● Thrombotic Thrombocytopenic Purpura (or TTP) a
condition characterised by 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),
with symptoms of acute renal failure (low or no
urine output).
● Cases of 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 feel: fatigue, apathy, abnormal
paleness of the skin (pallor), shortness of breath,
dizziness, headache, chest pain and coldness in
hands and feet.
● Cases of agranulocytosis (a severely lowered
number of white blood cells accompanied with
ulcers in the mouth, fever and infection(s)). You
may have no symptoms or you may feel sudden
fever, rigors and sore throat.
● 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.
● Posterior Reversible Encephalopathy Syndrome
(PRES): headache, altered mental status, seizures,
and visual disturbances.
● Torsades de Pointes: change in the heart frequency
that can be accompanied or not by symptoms, such
as chest pain (angina), faint, vertigo or nausea,
palpitations (feeling the heartbeat) and difficulty
breathing.
● Gastrointestinal perforation: strong abdominal
pain accompanied or not with other symptoms,
such as chills, fever, nausea or vomiting.
● 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.
● Toxic epidermal necrolysis: erosion and blistering
of skin or mucous membranes, red swollen skin
that can detach in large parts of the body.
● 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.
● Insufficient function of your transplanted organ
The side effects listed below may also occur after
receiving Altrudynt:
Very common side effects (may affect more than 1
in 10 people):
● 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 (may affect up to 1 in 10
people):
● 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 pharynx, 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, flatulence, 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 spasms
● 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 of temperature disturbed
Uncommon side effects (may affect up to 1 in 100
people):
● Changes in blood clotting, reduction in all blood
cell counts
● 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, stop of 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 bleeding
● 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 (may affect up to 1 in 1,000
people):
● 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
● Increased hairiness
● Thirst, fall, feeling of tightness in your chest,
decreased mobility, ulcer
Very rare side effects (may affect up to 1 in 10,000
people):
● Muscular weakness
● Echocardiogram abnormal
● Liver failure, narrowing of the bile vessel
● Painful urination with blood in the urine
● 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 Yellow Card Scheme
Website: 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 Altrudynt
Keep this medicine out of the sight and reach of
children.
Take the hard capsules immediately following removal
from the blister.
Do not use this medicine 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 store above 30°C.
Store in the outer packaging (pouch), 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.
6. Contents of the pack and other information
What Altrudynt contains
- The active substance is Tacrolimus (as
monohydrate)
- The other ingredient(s) (excipient(s) are:
Hypromellose 2910 (E464), Crosmellose sodium,
Lactose monohydrate and Magnesium Stearate
(E572).
- Capsule shell of 5 mg contains: Gelatin (E441), Iron
oxide red (E172), Iron oxide black (E172),
Erythrosine (E127), Titanium dioxide (E171) and
Printing ink (White).
- Printing Ink: Shellac (E904), Propylene Glycol,
Potassium Hydroxide and Titanium Dioxide
(E171).
What Altrudynt looks like and contents of the pack
Altrudynt 5 mg Hard Capsules
Size '4' hard gelatin capsule with greyish red cap and
greyish red body, imprinted with “G” on cap and “687”
on body in white ink; filled with white to off-white
granular powder.
Capsules packed in blisters of PVC/PVDC base film
and aluminium lidding foil. Such blisters are packed
along with silica gel desiccant pouch in an aluminium
pouch in cardboard cartons. The desiccant should not
be swallowed.
Packs of 20, 30, 50, 60, 90 and 100 hard capsules in
blisters. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue
Harrow, Middlesex HA3 0BU, United Kingdom
Manufacturers
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom
or
Glenmark Pharmaceuticals s.r.o.
Fibichova 143,
566 17 Vysoké Mýto, Czech Republic
This leaflet was last revised in 08/2016.

Date: 12.08.2016
Version: 03 (UK)

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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