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PERIXIS 5 MG HARD CAPSULES

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Tacrolimus

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

3 (Page 1 of 2) (PIQ variation)

Date

14.06.13 (Tacrolimus (PHA V-UK)NEW-PIL)

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Perixis 0.5 mg
Hard Capsules
Perixis 1 mg
Hard Capsules
Perixis 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.
What is in this leaflet:
1. What Perixis is and what it is used for
2. What you need to know before you take Perixis
3. How to take Perixis
4. Possible side effects
5. How to store Perixis
6. Contents of the pack and other information

1. What Perixis is and what it is
used for
Tacrolimus belongs to a group of medicines
called immunosuppressants. Following your
organ transplant (e.g. liver, kidney or heart), your
body's immune system will try to reject the new
organ. Tacrolimus is used to control your body's
immune response enabling your body to accept
the transplanted organ.
Tacrolimus is often used in combination with
other medicines that also suppress the immune
system.
You may also be given Tacrolimus 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 Perixis
Do not take Perixis:
• 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 macrolide
types of antibiotics e.g. erythromycin,
clarithromycin, josamycin.
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Perixis
• You will need to take tacrolimus every day as
long as you need immunosuppression to
prevent rejection of your transplanted organ.
You should keep in regular contact with your
doctor.
• During your treatment period of Perixis, your
doctor may want to carry out a number of tests
(including blood, urine, heart function, visual
and neurological tests) from time to time. These
investigations are normal and will help your
doctor to decide on the most appropriate dose
of Tacrolimus for you.
• Do not take any herbal remedies, e.g. St.
John’s wort (Hypericum perforatum) or other
herbal medicines, as these can influence the
action of tacrolimus and hence the dose you
need to take. If in doubt, contact your doctor
before taking any herbal medicine.
• 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 Perixis that you receive.
• If you have had diarrhoea for more than one
day, please tell your doctor, because it might be
necessary to adjust the dose of Perixis that you
receive.
• Limit your exposure to sunlight and UV light
while you are using Perixis by wearing
protective clothing that gives full coverage and
using sunscreen with a high protection factor.
This is because of the possible risk of
cancerous changes of the skin in
immunosuppressive therapy.
• If you need to have any vaccinations, please
inform your doctor in advance. Your doctor will
advise you on the best course of action.
Other medicines and Perixis:
Please tell your doctor or pharmacist if you are
taking, or have recently taken or might take any
other medicines including medicines obtained
without a prescription and herbal remedies.
Tacrolimus must not be taken with ciclosporin.
Tacrolimus blood levels can be affected by other
medicines you take, and blood levels of other
medicines can be affected by taking Tacrolimus.
Consequently it may be necessary to increase or
reduce the dose of tacrolimus. In particular, you
should tell your doctor if you are taking or have
recently taken medicines with active substances
like.
• antifungal medicines and antibiotics (in
particular those known as macrolide antibiotics)
for the treatment of infections, such as
ketoconazole, fluconazole, itraconazole,
voriconazole, clotrimazole, erythromycin,
clarithromycin, josamycin and rifampicin

• HIV protease inhibitors, for example ritonavir
• Omeprazole or lansoprazole, to treat stomach
ulcers
• hormone treatments with ethinylestradiol (such
as the contraceptive pill) or danazol
• medicines used to treat high blood pressure or
heart problems such as nifedipine, nicardipine,
diltiazem and verapamil
• medicines known as ‘statins’ to treat high
cholesterol and triglyceride levels
• the anti-epilepsy medicines phenobarbital and
phenytoin
• the corticosteroids prednisolone and
methylprednisolone
• the anti-depressant nefadozone
• St John’s wort (Hypericum perforatum)
• antiemetics, used to treat nausea and vomiting
(e.g. metoclopramide)
• cisapride or the antacid magnesium-aluminiumhydroxide, used to treat heartburn
If you need vaccinations, tell your doctor in
advance that you are taking this medicine.
Tell your doctor if you have to use (or are
currently using) ibuprofen, amphotericin B or
anti-viral drugs (such as aciclovir). These
medicines can worsen kidney and nervous
system disorders if they are taken with Perixis.
While you are using Perixis, your doctor must
also be informed if you are taking potassium
supplements or potassium-sparing diuretics
(certain water pill such as amiloride, triamterene
or spironolactone), certain painkillers (known as
NSAIDs, such as ibuprofen), anticoagulants or
oral medicines to treat diabetes.
Perixis with food and drink:
You should generally take Perixis on an empty
stomach or at least 1 hour before or 2 to 3 hours
after a meal. Grapefruit and grapefruit juice must
not be consumed while taking Perixis.
Pregnancy, breast-feeding and fertility:
If you plan to become pregnant or think that you
are pregnant, ask your doctor or pharmacist for
advice before taking any medicine.
Tacrolimus is excreted into breast milk. Therefore
you should not breast-feed whilst receiving
Tacrolimus.
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 Perixis. These effects are
observed more frequently when Perixis is used
together with alcohol.
Perixis contains Lactose monohydrate
Perixis 0.5/1/5 mg contains 0.050/0.102/0.098 g of
lactose monohydrate respectively. When taken
according to the dosage recommendations each
dose supplies 0.050/0.102/0.098 g of lactose
monohydrate respectively. If you have been told by
your doctor that you have intolerance to some
sugars, contact your doctor before taking this
medicinal product. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption
should not take this medicinal product.

3. How to take Perixis
Always take this medicine exactly as your doctor
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 of Perixis to prevent rejection
of your transplanted organ will be decided by
your doctor and will be related to your body
weight. The first dose directly after the transplant
operation will usually be between 0.075 and 0.30
mg per kg body weight per day depending on the
transplanted organ.
Your dose will depend on your general condition
and any other immunosuppressive drugs you are
using. Your doctor should carry out regular blood
tests in order to find the correct dose and
occasionally in order to adjust it. Your doctor will
normally reduce the dose of Perixis when your
condition has stabilised. Your doctor will tell you
exactly how many Perixis you must take and how
often.
Perixis is taken orally twice daily, usually in the
morning and evening. You should generally take
tacrolimus 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 capsule immediately
following removal from the blister. Avoid
grapefruit juice while taking tacrolimus.
If you take more Perixis then you should
If you take too many capsules by accident, see your
doctor immediately or contact the accident and
emergency department of the nearest hospital.
If you forget to take Perixis
Do not take a double dose to make up for
forgotten individual doses.
If you have forgotten to take your Perixis, wait
until it is time to take the next dose, and then
continue as usual.
If you stop taking Perixis
Stopping treatment with Perixis may increase the
risk of rejection of your transplanted organ. Do
not stop the treatment unless your doctor tells
you to do so.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Tacrolimus

Market

UK

Language

English

Size

170 x 550 mm PIL

Min. Font Size

9

Version No.

3 (Page 2 of 2) (PIQ variation)

Date

14.06.13 (Tacrolimus (PHA V-UK)NEW-PIL)

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.
If any of the following happen, stop taking
Perixis and contact a doctor or go to the
nearest hospital straight away, as you may
need urgent medical attention:
• Severe allergic reaction that may include
difficulty in breathing, dizziness and collapse
• Allergic reactions that may include raised lumps
(weals), swelling of the skin and swelling
around the mouth.
• Serious illness with blistering of skin, mouth,
eyes and genitals (Rare)
• Small bleedings in your skin due to blood clots
(Rare)
• Acute breathlessness (Rare)
• Feeling of tightness in your chest (Rare)
• Fits, disturbances in consciousness, tingling
and numbness (sometimes painful) in the
hands and feet (Common)
• Benign and malignant tumours have been
reported following Tacrolimus treatment as a
result of immunosuppression.
Other side effects include:
Very common (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 (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 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, hallucinations, mental disorders
• 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, bleedings 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 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 of temperature disturbed.
• insufficient function of your transplanted organ
Uncommon (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 (may affect up to 1 in 1,000 people):
• increased muscle stiffness
• collection of fluid around the heart
• blindness
• deafness (hearing impaired)
• cyst formation in your pancreas
• problems with blood flow in the liver
• increased hairiness
• thirst
• decreased mobility

• ulcer
• fall
Very rare (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
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.
Immunosuppressant, including tacrolimus,
reduces your body’s own defence mechanisms
to stop you rejecting your transplanted organ.
Consequently your body will not be as good as
normal at fighting infections. So if you are taking
tacrolimus, you may therefore catch more
infections than usual such as infections of the
skin, mouth, stomach and intestines, lungs and
urinary tract.
If you get any side effect, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.

5. How to store Perixis
• 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 carton and blister after
EXP. The expiry date refers to the last day of
that month.
• Store below 25°C. Store in the original package
in order to protect from moisture and light.
• 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 Perixis contains:
The active substance is Tacrolimus.
For 0.5 mg: Each hard capsule contains 0.5 mg
tacrolimus(as tacrolimus monohydrate).
For 1 mg: Each hard capsule contains 1 mg
tacrolimus(as tacrolimus monohydrate).
For 5 mg: Each hard capsule contains 5 mg
tacrolimus(as tacrolimus monohydrate).
The other ingredients for Tacrolimus 0.5 mg, &
1 mg & 5 mg are: lactose monohydrate,
croscarmellose sodium (E468), hypromellose
(E464), magnesium stearate (E 470b).
Capsule Shell composition for Tacrolimus 0.5
mg: Gelatin, titanium dioxide (E 171) iron oxide
yellow (E 172), sodium laurilsulfate.
Capsule Shell composition for Tacrolimus 1 mg:
Gelatin, titanium dioxide (E 171), sodium
laurilsulfate.
Capsule Shell composition for Tacrolimus 5 mg:
Gelatin, titanium dioxide (E 171), iron oxide red
(E 172), sodium laurilsulfate.
Printing ink of capsule shell: Shellac, propylene
glycol, potassium hydroxide, black iron oxide
(E172).
What Perixis looks like and contents of the
pack:
Perixis 0.5 mg: Light yellow / Light yellow hard
gelatin capsules, size "5" imprinted with “TCR”
on cap & “0.5” on body containing white to off
white granular powder.
Perixis 1 mg: White / White hard gelatin
capsules, size "4" imprinted with “TCR” on cap &
“1” on body containing white to off white granular
powder
Perixis 5 mg: Pink/Pink hard gelatin capsules
size “4” imprinted with “TCR” on cap & “5” on
body containing white to off white granular
powder.
Perixis are available in blisters packs of
Tacrolimus 0.5 mg capsules
Packs of 20, 30, 50, 60 and 100 hard capsules.
Tacrolimus 1 mg capsules
Packs of 20, 30, 50, 60, 90 and 100 hard
capsules.
Tacrolimus 5 mg capsules
Packs of 30, 50, 60 and 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex,
HA1 4HF,
United Kingdom
Manufacturer:
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex,
HA1 4HF,
United Kingdom
The leaflet was last revised in 06/2013.

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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