Microsoft word - pentasa tablets june 2011.doc

Ask your doctor if you have
Before you start to take it
any questions about why
this medicine has been
Tell your doctor if you have
prescribed for you. Your
allergies to any other
medicines, foods,
preservatives or dyes.
Consumer Medicine
Tell your doctor if you have
or have had any of the
following medical

What is in this leaflet
Before you take
When you must not take it
Tell your doctor if you are
Do not take PENTASA® if
pregnant or plan to become
you have an allergy to:
pregnant or are breast-
any medicine containing
mesalazine or aspirin-like
any of the ingredients
listed at the end of this
If you have any concerns
about using this medicine,
ask your doctor or
If you have not told your
doctor about any of the
above, tell him/her before
you start using PENTASA®.
What PENTASA® is
Taking other medicines
Tell your doctor or
pharmacist if you are using
any other medicines,
Do not take PENTASA® if
including any that you get
you have a severe kidney or
without a prescription from
liver problem.
your pharmacy, supermarket
or health food shop.
Do not take PENTASA® after
the expiry date printed on
the pack or if the packaging
is torn or shows signs of
How much to take
Continue using your
medicine for as long as your
doctor tells you.
If you forget to take it
urine produced, and tolower blood pressure If you use too much
A child’s dose will beindividualised based on their Immediately telephone your
doctor or the Poisons
Information Centre
How to take it
(telephone 0800 764 766) for
advice, or go to Accident
and Emergency at the
nearest hospital, if you think
that you or anyone else may
have used too much
How to take
PENTASA®. Do this even if
there are no signs of
discomfort or poisoning.
Follow all directions given to
you by your doctor or
pharmacist carefully.
When to take it
While you are taking
time each day. This will helpyou remember when to take it.
If you do not understand the
Things you must do
instructions on the
packaging, ask your doctor
If you are about to be started
or pharmacist for help.
on any new medicine,
How long to take it
remind your doctor and
pharmacist that you are
taking PENTASA®.

Have all blood tests
recommended by your
If you notice any of the
following, tell your doctor
immediately or go to
Accident and Emergency at
Do not be alarmed by the
your nearest hospital:
following lists of side
effects. You may not
experience any of them.
Tell any other doctors,
dentists, and pharmacists
Ask your doctor or
who treat you that you are
pharmacist to answer any
using this medicine.
questions you may have.
limbs, face, lips, mouth,tongue or throat which may If you are going to have
Tell your doctor or
surgery, tell the surgeon or
pharmacist if you notice any
anaesthetist that you are
of the following and they
using this medicine.
worry you:
If you become pregnant
while using this medicine,
tell your doctor immediately.
Things you must not do
Do not take PENTASA® to
treat any other complaints
unless your doctor tells you
Tell your doctor as soon as
possible if you notice any of

Other rare side effects that
Do not give your medicine to
the following:
have been reported with
anyone else, even if they
PENTASA® include:
have the same condition as
Do not stop using your
medicine or lower the
dosage without checking
with your doctor.
Side effects
spreading to the neck andshoulders, or with fever Tell your doctor or
pharmacist as soon as
possible if you do not feel
Tell your doctor or
well while you are taking
pharmacist if you notice
anything that is making you
feel unwell.
people but it may haveunwanted side effects in a few After taking
Keep your PENTASA® in the
packaging until it is time to
take your next dose.

 ethylcellulose microcrystalline cellulose Keep your PENTASA® in a
cool dry place where the

temperature stays below
Do not store PENTASA® or
any other medicine in the
bathroom or near a sink. Do

not leave it on a window sill
or in the car.
Keep PENTASA® where
children cannot reach it.
A locked cupboard at least
one-and-a-half metres abovethe ground is a good place tostore medicines.
If your doctor tells you to
stop taking PENTASA® or
the expiry date has passed,
ask your pharmacist what to
do with any medicine that is
left over.

Product description
What it looks like
PENTASA® 500mg prolongedrelease tablets are white-greyto pale brown, speckled roundtablets with breakmark andmarked: ‘500 mg’ on one side,and ‘PENTASA’ on the otherside. They are supplied inblister packs of 100 tablets.
Each tablet is protected in analuminium foil blister.
PENTASA® tablets contain500mg mesalazine as the


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PHARMACEUTICAL LAW & INDUSTRY ! Reproduced with permission from PharmaceuticalLaw & Industry Report, Vol. 2, No. 7, 02/13/2004. Copyright ஽ 2004 by The Bureau of National Affairs,Inc. (800-372-1033) http://www.bna.comMarket Exclusivity Options Under the FFDCA:Strategic Opportunities for Innovators of Pharmaceutical ProductsBY CAROLYNE R. HATHAWAY AND JOHN R. MANTHEIprotections ha

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