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RETICUTAN 20MG SOFT CAPSULES.

Active substance(s): ISOTRETINOIN

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!
if you are allergic to isotretinoin,
Prescriptions are limited to 30
Afterwards you will receive a new
during your treatment, particularly
Reticutan 20 mg treatment. If you
Children and adolescents
timing of this pregnancy test
days treatment for women of
prescription covering your needs for
if you have diabetes, are
experience any problems with your
soya, peanut or any of the other
The use of Isotretinoin 20 mg in
If you are a girl or women of
should reflect your sexual
childbearing potential.
another 30 days.
overweight, or are an alcoholic.
sight, please inform your doctor
ingredients of this medicine
children under the age of 12 is not
childbearing age you can only
activity and should be
Continuation of treatment requires a
!
Use a skin moisturising
immediately, as your Reticutan 20
(listed in section 6)
recommended. This is because it is
receive Reticutan 20 mg treatment
undertaken approximately 3
new prescription, and each
Five weeks after the end of
ointment or cream and a lip
mg may need to be stopped and
!
if you have liver disease
not known if it is safe or effective in
if:
weeks after you had
Reticutan 20 mg soft capsules
prescription is only valid for seven
treatment with Reticutan 20 mg
balm during treatment as you may
your sight monitored.
!
if you have very high levels of
this age group. Use in adolescents
!
you have severe acne (such as
unprotected sexual intercourse.
contains the active ingredient
days.
another medically supervised
experience skin and/or lip dryness
blood fats (e.g. high cholesterol
over 12 years of age only after
nodular or conglobate acne or
!
you understand and accept
pregnancy test must be carried
during Reticutan 20 mg therapy.
Stop treatment immediately and
isotretinoin. This is a vitamin A
or triglycerides)
puberty.
acne at risk of permanent scarring)
the need for monthly follow
Pregnancy tests
out, because it takes about 1 month
contact your doctor as soon as
derivative, belonging to the retinoid
!
if you have very high levels of
which has not got better after other
up visits and maybe further
before the active substance
Contact your doctor
possible
Isotretinoin
class of medicines. Reticutan 20 mg
vitamin A in your body
Other medicines and Reticutan 20
anti-acne treatments, including
pregnancy tests as decided by
Your doctor will provide you with
contained in Reticutan 20 mg is
!
If you have any kind of mental
is used to treat severe forms of
(hypervitaminosis A)
mg
oral antibiotics.
your doctor. You may then have
information
brochures
that
you
completely
eliminated
from
the
body.
problems,
or,
if
you
think
you
have
!
If
you
experience
an
allergic
acne (such as nodular or conglobate
THIS MEDICINAL
!
if you are taking tetracyclines (a
Tell your doctor or pharmacist if you
!
your doctor has explained the
a pregnancy test 5 weeks after
must read carefully and may
This test will exclude the possibility
signs of depression while taking
reaction (skin redness, itching) or
acne, or acne at risk of permanent
type of antibiotic medicine).
are taking, have recently taken or
PRODUCT IS STRONGLY
teratogenic risk of isotretinoin,
stopping your therapy with
refer
you
to
a
gynaecologist,
who
will
of
a
pregnancy
during
this
period.
Reticutan
20
mg
such
as
feeling
a
serious
anaphylactic
reaction.
scarring) which has not got better
might take any other medicines.
and you understand why you must
Reticutan 20 mg. You must not
TERATOGENIC
explain about contraception and
very sad for no reason, crying
!
If you experience a persistent
after other anti-acne treatments,
Due to the high risk that a child with
not get pregnant and how to
become pregnant at any time
recommend
the
contraceptive
Male
patients
spells,
difficulty
concentrating
or
headache,
nausea,
vomiting
and
including oral antibiotics.
Please see the brochures on
Do not take vitamin A
congenital defects will result if
prevent pregnancy.
during treatment or for one
methods suitable for you. Your
You must remember not to share
you become withdrawn from your
blurred vision. Reticutan 20 mg
supplements or tetracyclines (a
the contraceptive programme
pregnancy occurs you should only
!
you are using effective birth
month after treatment ends.
doctor or gynaecologist will carry
your medication with anyone,
friends or family. Your doctor may
has been very rarely associated
type of antibiotic) during therapy with
take Isotretinoin 20 mg if all the
and the information you are
2. WHAT YOU NEED TO
out a medically supervised
particularly not females.
refer you for appropriate treatment
with a condition called benign
control (contraception) without
!
your doctor may ask you (or
Isotretinoin 20 mg because the risk
conditions of the pregnancy
pregnancy test before you start to
if necessary. Stopping therapy with
intracranial hypertension.
interruption:
your guardian) to sign an
given in this patient leaflet in
KNOW BEFORE YOU
of getting side effects may increase.
prevention
programme
are
met.
use
the
contraception
(during
the
Treatment
with
Reticutan
20
mg
Reticutan
20
mg
may
not
be
!
If
you
experience
severe
1.
your
doctor
will
discuss
this
acknowledgment
form
where
section 2 under the heading
TAKE RETICUTAN
first
3
days
of
your
menstrual
cycle)
does
not
appear
to
damage
sperm.
enough
and
you
may
require
haemorrhagic
diarrhoea
(e.g.
Please
talk
about
these
issues
with
with you and give you
you confirm that you have been
"Pregnancy Prevention
20 MG
Do not use any skin treatments for
in order to exclude the possibility that
Isotretinoin and its metabolites are
further psychiatric or psychological
blood in your stool). Reticutan 20
your doctor.
information on pregnancy
informed about the risks of
Programme".
acne during treatment with
you
might
already
be
pregnant.
If
present
in
very
low
levels
in
your
help.
Rare
cases
of
depression,
mg
has
on
very
rare
occasions
prevention including a
Reticutan 20 mg treatment and
Isotretinoin 20 mg because local
Reticutan should only be
you do not have a regular period the
semen. These levels are considered
worsening depression, anxiety,
been associated with inflammatory
Warnings and precautions
brochure on contraception
that you accept the necessary
test
should
be
carried
out
about
3
too
low
to
harm
the
unborn
baby
of
mood
changes,
psychotic
bowel
disease.
irritation may increase. It is fine to
prescribed by or under the
Talk to your doctor or pharmacist
explaining the different
precautionary measures.
weeks after the last unprotected
your female partner.
symptoms and very rarely suicidal
use moisturisers and emollients (skin
supervision of a dermatologist (a
Read all of this leaflet carefully
before taking Reticutan 20 mg.
methods. Your doctor may
sexual intercourse. The test must
thoughts, suicide attempts and
What to avoid when taking
creams or preparations that prevent
doctor specialised in the treatment of
before you start taking this
refer you to a specialist for
If you become pregnant while
have a minimum sensitivity of 25
Other precautions
suicide have been reported.
Reticutan 20 mg
water loss and have a softening
skin problems) with understanding of
medicine because it contains
Pregnancy Prevention Programme
contraceptive advice.
on Reticutan 20 mg
mIU/mL. Your doctor will document
!
Reticutan 20 mg may increase
!
Severe skin reactions (e.g.
effect on the skin).
the risks of Reticutan therapy and
important information for you.
2. you must agree to use at
therapy or during the month after
the date and result of this pregnancy
the levels of fats such as
erythema multiforme (EM),
!
Avoid too much sun and do not
monitoring requirements.
!
Keep this leaflet. You may need
least one and preferably two
treatment has stopped,
Important
test.
triglycerides or cholesterol in
Stevens-Johnsons syndrome
use a sun-lamp or sun-bed. Your
Avoid the use of topical
to read it again.
effective methods of
immediately stop taking the
your
blood.
Your
doctor
will
do
(SJS)
and
toxic
epidermal
skin
may become more sensitive
keratolytic or exfoliative anti-acne
Your
doctor
will
inform
you
about
!
If you have any further
contraception
including
a
medicine
and
contact
your
Isotretinoin is teratogenic. That
If the first pregnancy test is
some blood tests in order to
necrolysis (TEN)) have been
to sunlight during Reticutan 20 mg
agents during treatment with
the precautions you have to fulfil
questions, ask your doctor or
barrier method (i.e. the pill
doctor. Your doctor may refer you
means it is likely to damage an
negative, you must start using an
monitor these levels before, during
reported with the use of
therapy. Before going out in the
Isotretinoin 20 mg.
when you take Reticutan 20 mg.
pharmacist.
and
condoms)
for
one
month
to
a
specialist
for
evaluation
and
unborn baby. These deformities
effective contraceptive method.
and at the end of your Reticutan
Isotretinoin. The rash may
sun apply a sun-protection product
Additionally, you should receive
!
This medicine has been
before Reticutan 20 mg
advice.
A second medically supervised
20 mg treatment. Tell your doctor if
progress to widespread blistering
with a high protection factor of at
include central nervous system and
Pregnancy and breast-feeding
information materials from your
prescribed for you only. Do not
treatment, during treatment
pregnancy test must be carried out
you already have high levels of
or peeling of the skin. You should
least SPF 15.
cardiovascular abnormalities and
doctor. If not, ask your doctor for this
pass it on to others. It may harm
one month after starting a consistent
these substances in your blood or
also look for ulcers in the mouth,
!
Cosmetic procedures such as
and for one month after
Written information on this
cleft palate. There is also an
Pregnancy
information. If your doctor has not
them, even if their signs of illness
and effective contraceptive method
if you have diabetes, are
throat, nose, genitals and
dermabrasion or laser treatments
treatment ends. Before you
subject is available from your
increased incidence of
explained the precautionary
are the same as yours.
and before starting the treatment,
overweight, or are an alcoholic, as
conjunctivitis (red and swollen
(removing horny skin or scars) and
start treatment your doctor will
doctor. If you haven't received
spontaneous abortion.
Reticutan 20 mg must not be
measures or you have not
!
If you get any side effects, talk to
and not more than 3 days before the
you may need to have blood tests
eyes).
wax epilation should be avoided
ask you to take a pregnancy
this material please contact
taken during pregnancy, as
understood them, please contact
your doctor or pharmacist. This
visit
to
the
prescribing
doctor.
If
the
more
frequently.
!
If
you
suffer
from
kidney
failure.
during
and
for
at
least
6
months
test which must be negative.
your doctor.
The percentage of deformities is
Isotretinoin the active compound
your doctor before you start taking
includes any possible side
result of this second pregnancy test
!
Reticutan 20 mg may increase
In this case therapy has to begin
after treatment; Reticutan 20 mg
3. you must use contraception
high even if Isotretinoin was taken
of Reticutan 20 mg is highly
Reticutan 20 mg.
is
negative,
your
doctor
will
issue
your
liver
enzyme
levels.
Your
with
a
lower
dose.
may
make
your
skin
more
fragile
effects not listed in this leaflet.
even if you do not have
only for a short period during
teratogenic. If pregnancy does
your first prescription for Reticutan
doctor will do some blood tests
!
Reticutan 20 mg therapy may
and this could cause scarring or
See section 4.
periods or are not currently
occur in spite of the described
pregnancy or when you get pregnant
20 mg. This prescription is limited to
before, during and at the end of
affect your night vision. You may
irritation of the skin.
Do not take Reticutan 20 mg
sexually active, unless your
precautions (Pregnancy
within 4 weeks following the end of
30
days
of
treatment.
your
Reticutan
20
mg
treatment
to
develop
dry
eyes
or
sight
problems
!
Reduce
intensive
physical
!
if you are pregnant or think you
prevention programme) during
doctor decides this is not
treatment.
In this leaflet:
check your liver values. In cases
during Reticutan 20 mg therapy
activity during Reticutan 20 mg
may be pregnant
treatment or in the month
necessary.
1. What Reticutan 20 mg is and
After
this
you
must
see
your
where
liver
enzyme
values
remain
which
normally
returns
to
normal
therapy,
because
muscle
and
joint
!
if you are breast-feeding
following, there is a great risk of
!
you accept that a medically
You must not take Reticutan 20
what it is used for
doctor at regular 28 days
high your doctor may reduce your
once treatment is stopped. Always
pain have been observed during
!
if you are able to become
very severe and serious damage
supervised
pregnancy
test
will
be
mg
if
you
are
pregnant
or
may
2. What you need to know before
intervals.
dose or stop your Reticutan 20 mg
be cautious when driving or
Reticutan 20 mg treatment.
pregnant but are unable or
to the unborn baby.
performed in the first 3 days of
become pregnant at any time
you take Reticutan 20 mg
As
a
rule
further
medically
therapy.
operating
machinery
at
night
!
Do
not
donate
blood
either
unwilling to follow the
your
menstrual
cycle
prior
to
during
treatment
and
for
one
3. How to take Reticutan 20 mg
supervised pregnancy tests must be
!
Reticutan 20 mg may increase
because these sight changes can
during or for one month after
necessary pregnancy
starting therapy.
month after treatment has
4. Possible side effects
carried out monthly on the day of the
your blood sugar levels and in
happen quite suddenly. If you wear
Reticutan 20 mg treatment. If
prevention measures that are
If you have unregular menses, the
stopped.
prescribing visit or in the 3 days
rare cases diabetes mellitus has
contact lenses and experience dry
someone who is pregnant receives
5. How to store Reticutan 20 mg
listed in the Pregnancy
before the visit throughout the
been diagnosed. Your doctor may
eyes you may need to wear
your donated blood, her baby may
6. Contents of the pack and other
Prevention Programme
course of treatment.
monitor your blood sugar levels
glasses for the duration of
be born with serious birth defects.
information

Driving and using machines
Your night vision may get worse
during your treatment. This can
happen suddenly. In rare cases this
has continued after the treatment
has stopped. You should therefore
be cautious when driving or
operating machines.
Breast-feeding
You should not take Reticutan 20
mg if you are breast-feeding,
because isotretinoin is likely to pass
into the milk and may harm the baby.
If pregnancy occurs or might be
likely in a woman treated with
isotretinoin, treatment must be
stopped immediately and the
patient should contact her doctor
without delay.
The foetal deformities associated
with exposure to isotretinoin include
central nervous system
abnormalities (hydrocephalus,
cerebellar malformation/
abnormalities, microcephaly), facial
dysmorphia, cleft palate, external
ear abnormalities (absence of
external ear, small or absent
external auditory canals), eye
abnormalities (microphthalmia),
cardiovascular abnormalities
(conotruncal malformations such as
tetralogy of Fallot, transposition of
great vessels, septal defects),
thymus gland abnormality and
parathyroid gland abnormalities.
There is also an increased incidence
of spontaneous abortion.
(continued...)

2. WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE RETICUTAN 20 MG

Reticutan
20 mg soft
capsules

1. WHAT RETICUTAN 20 MG
IS AND WHAT IT IS USED
FOR

Drowsiness, dizziness and visual
disturbances have been reported
very rarely. If you experience any of
these effects, you should not drive,

PACKAGE LEAFLET:
INFORMATION FOR THE USER

!
Dry throat
(triglyceride) increased
!
Benign intracranial hypertension
necrolysis), which are potentially
harm them even if their symptoms
your doctor may adjust your dose.
operate machinery or take part in
6. CONTENTS OF THE PACK AND
Unknown frequency (frequency
!
Pancreatitis (see section 2. Before
!
HDL-cholesterol (high density
!
Oedema of the optic disc
life-threatening and require
appear similar to yours.
This will depend on how you are
any other activities where these
OTHER INFORMATION
cannot be estimated from available
you take Isotretinoin 20 mg)
lipoprotein) decreased
(papilloedema, as sign of benign
immediate medical attention.
getting on with your medicine. For
symptoms could put either yourself
data)
!
Severe acne (acne fulminans)
!
Deficiency of red blood cells
intracranial hypertension)
These appear initially as circular
If you take more Reticutan 20 mg
most patients the dose will be
or others at risk.
What Reticutan 20 mg contains
!
Dark or cola-coloured urine
!
Worsening of acne (acne flare)
!
Red blood cell sedimentation rate
!
Blurred vision
patches often with central blisters
than you should
between 0.5 and 1.0 mg/kg/day.
The active substance is isotretinoin.
!
Problems getting or maintaining an
!
Skin redness, particulalrly on the
increased
!
Clouding of the surface of the eye
usually on arms and hands or
The following symptoms are
Reticutan 20 mg contains soya oil,
Each capsule contains 20 mg of
erection
face
!
Number of blood plates increased
(cataract)
legs and feet, more severe rashes
possible: severe headache, nausea
If you have the impression that the
sorbitol and Ponceau 4R (E124).
isotretinoin.
!
Lower libido.
!
Skin rash
or decreased
!
Colour blindness (colour vision
may include blistering of the chest
or vomiting, somnolence, irritability
effect of Reticutan 20 mg is too
If you are allergic to peanut or soya,
!
Hair disorders
!
Inflammation of lips
deficiencies)
and back
and itching. If you take too many
strong or too weak, talk to your
do not use this medicinal product.
The other ingredients are Soya-bean
Reporting of side effects:
!
Increased levels of body hair
!
Inflammation of the skin
!
Decreased night vision
!
Additional symptoms such as
capsules or someone else
doctor or pharmacist.
oil (see section 2), DL-alphaIf you get any side effects, talk to
!
Changes in the nails, infections of
!
Dryness of skin
!
Eye inflammation
infection of the eye (conjunctivis)
accidentally takes your medicine,
If you have been told by your doctor
tocopherol, disodium edetate,
your doctor, pharmacist or nurse.
the tissue around the base of the
!
Localised shedding of layers of
!
Visual disturbances.
or ulcers of the mouth, throat or
contact your doctor, pharmacist
Patients with severe renal
that you have an intolerance to some
butylhydroxyanisole, soya-bean oil
This includes any possible side
nails
skin
nose may occur
or nearest hospital immediately.
insufficiency
sugars, contact your doctor before
(partly) hydrogenated (see section 2),
effects not listed in this leaflet. You
!
Sensitivity to light
!
Itching
Contact your doctor straight away
!
Severe forms of rash may
If you have severe kidney problems,
taking this medicinal product.
beeswax yellow and vegetable oil
can also report side effects directly
!
Pus forming swellings (pyogenic
!
Rash with redness
if you get any of the following
progress to widespread peeling of
If you forget to take Reticutan 20
Reticutan 20 mg should be started at
hydrogenated. The capsule shell
via the Yellow Card Scheme at:
granuloma)
!
Skin fragility (risk of frictional
symptoms. Your doctor may tell you
the skin which can be life
mg
a lower dose such as 10 mg/day and
Ponceau 4R (E124) may cause
contains gelatin, glycerol, sorbitol
www.mhra.gov.uk/yellowcard or
!
Increased pigmentation of the skin
trauma)
to stop taking Reticutan 20 mg.
threatening. These serious skin
If you miss a dose, take it as soon
then increased up to the highest
allergic reactions.
solution 70% (non-crystallising) (see
search for MHRA Yellow Card in the
!
Sweating increased
!
Joint pain
rashes are often preceded by
as possible. However if it is nearly
tolerated dose.
section 2), Ponceau 4R (E124) (see
Google Play or Apple App Store. By
!
Lymph node disease
!
Muscle pain
Rare (may affect up to 1 in every
headache, fever, body aches (flutime for your next dose, skip the
3. HOW TO TAKE
section 2), titanium dioxide, water
reporting side effects you can help
(lymphadenopathy)
!
Back pain (particularly in children
1000 people)
like symptoms). If you develop a
missed dose and carry on as before.
Children
RETICUTAN 20 MG
purified, and Indigotine Lacquer
provide more information on the
!
Contact lens intolerance
and adolescent patients)
Depression
rash or these skin symptoms, stop !
Do not take a double dose to make
The use of Reticutan 20 mg in
(E132).
safety of this medicine.
!
Corneal opacity
!
Increase in the level of liver
!
Worsening of depression
taking Reticutan 20 mg and
up for a forgotten dose.
children under the age of 12 is not
Always take this medicine exactly as
!
Intolerance to light
enzymes (see Section 2: Before
!
Aggressive behaviour
contact your doctor immediately.
recommended. This is because it is
your doctor has told you. Check with
What Reticutan 20 mg looks like
5.
HOW
TO
STORE
RETICUTAN
!
Hearing
impaired
Reticutan
20
mg
you
take
).
!
Anxiety
If
you
have
any
further
questions
on
not
known
if
it
is
safe
or
effective
in
your doctor or pharmacist if you are
and contents of the pack
20 MG
!
Narrowing of the airways
!
Mood alterations.
Rare (may affect up to 1 in every
the use of this medicine, ask your
this age group. Use in adolescents
not sure.
(bronchospasm),
particularly
in
Common
(may
affect
up
to
1
in
1000
people)
doctor
or
pharmacist.
over
12
years
of
age
only
after
!
The capsules should be taken
The soft-gelatin capsules are maroon
Keep
this
medicine
out
of
the
sight
patients
with
asthma
every
10
people)
Very
rare
(may
affect
up
to
1
in
every
!
Allergic
skin
reaction
(symptoms
puberty.
with food once or twice daily.
coloured with the markings Iso 20.
and reach of children.
!
Hoarseness
!
Headache
10,000 people)
include reddening of the skin,
4. POSSIBLE SIDE EFFECTS
!
Swallow the capsules whole, do
!
Increase
in
blood
sugar
levels
!
Neutrophilic
leucozytes
decreased
!
Abnormal
behavoiur
rash,
itching)
Patients
with
intolerance
not chew or suck them.
The capsules come in blister packs
Do
not
use
this
medicine
after
the
(diabetes
mellitus)
(a
kind
of
white
blood
cells)
!
Psychotic
disorder
!
Severe
allergic
response
Like
all
medicines,
this
medicine
can
If
you
cannot
tolerate
the
of 28, 30, 56 or 60 capsules.
expiry date which is stated on the
!
Increase in uric acid blood levels
!
Nosebleed
!
Suicidal thoughts
(anaphylactic reactions), which
cause side effects, although not
recommended dose, your doctor
Occasionally your acne may get
[Not all pack sizes may be marketed.]
carton. The expiry date refers to the
!
Inflammation of joints
!
Nasal dryness
!
Suicidal attempt
may cause shock (symptoms
everybody gets them.
may continue your treatment at a
worse during the first weeks of
last day of that month.
!
Calcifications in soft tissues
!
Inflammation of the nasal mucosa,
!
Suicide.
include, difficulty in breathing or
lower dose with the consequence of
treatment. It should improve with
Marketing Authorisation Holder and
(ligaments and tendons)
respectively pharyngeal mucosa
swallowing, sudden swelling of
Some of the side effects associated
a longer therapy duration and a
continued treatment.
Manufacturer
Do
not
store
above
30°C.
Store
in
the
!
Prematurely
ending
of
growing
!
Blood
cholesterol
increased
The
following
symptoms
are
the
most
the
throat,
face,
lips
and
tongue,
with
the
use
of
isotretinoin
are
dosehigher
risk
of
relapse.
Ennogen Healthcare Limited
original container. Keep the container
bones
!
Blood sugar levels (blood glucose)
commonly reported undesirable
reddening of the skin and
related. The side effects are
Dosage
Unit G4, Riverside Industrial Estate,
stored in the outer carton.
!
Formation of excessive bony
increased
effects with isotretinoin: dryness of
dizziness)
generally reversible after altering the
Duration of treatment
Your doctor will prescribe an
Riverside Way, Dartford, DA1 5BS,
tissue
(exostosis/hypertosis)
!
Blood
in
the
urine
the
skin,
dryness
of
the
mucosa
e.g.
!
Hypersensitivity
(symptoms
dose
or
discontinuation
of
treatment;
A
course
of
treatment
usually
individual dose in accordance
UK.
Important! Please return any
!
Reduced bone density
!
Excretion of protein in the urine.
of the lips, the nasal mucosa, and the
include reddening of the skin,
however some may persist after
lasts for 16 to 24 weeks. Your acne
with your body weight and other
unused capsules to your
!
Tendonitis
eyes.
rash,
itching).
treatment
has
stopped.
may
continue
to
improve
for
up
to
8
clinical parameters like renal
pharmacist at the end of treatment. This leaf let was last revised in
!
Blood
creatine
phosphokinase
Rare
(may
affect
up
to
1
in
every
weeks
after
the
treatment
finishes.
insufficiency, etc.
Only keep it if your doctor tells you to. 10/2017
increased
1000 people)
Also the following side effects may
Stop taking Reticutan 20 mg and
Go to a doctor straight away and
Therefore, a further course of
!
Bacterial infections of the skin and
!
Loss of hair.
occur:
contact your doctor if any of the
stop taking Reticutan 20 mg if any
treatment should not be started until
The specific individual doses might
Do not throw away any medicines via
mucous membranes
following side effects occur.
of the following side effects
at least this period has elapsed.
be better matched by other available
wastewater or household waste. Ask
!
Blood vessel infiammation (for
Very rare (may affect up to 1 in
Very common (may affect more than
occur.
Most patients only need a single
strengths.
your pharmacist how to throw away
example Wegener's
every 10,000 people)
1 in every 10 people)
Very rare (may affect up to 1 in
course of treatment.
medicines you no longer use. These
granulomatosis, allergic vasculitis)
!
Liver inflammation
!
Inflammation of the eyelid area
every 10,000 people)
Unknown frequency (frequency
305808
measures will help protect the
!
Increased formation of tissue,
!
Convulsions, drowsiness,
!
Eye inflammation
!
Gastric and intestinal bleeding,
cannot be estimated from the
environment.
which may cause thickened
dizziness
!
Dry eye
haemorrhagic diarrhoea,
available data)
scarring after surgical
!
Inflammation of the colon mucosa
!
Eye irritation
inflammatory bowel disease and
!
Serious skin rashes (erythema
interventions
and intestinal mucosa
!
Blood levels of fat like substances
nausea
multiforme, Stevens-Johnson
!
Malaise.
!
Kidney inflammation
syndrome and toxic epidermal

Adults including adolescents and
the elderly
The usual starting dose is 0.5 mg
per kilogram body weight per day
(0.5 mg/kg/day). After a few weeks

Remember this medicine is for
you
Only a doctor can prescribe it for
you. Never give it to others. It may

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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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