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PERINDOPRIL 10 MG FILM-COATED TABLETS

Active substance(s): PERINDOPRIL TOSYLATE

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TEVA UK Ref:

PERINDOPRIL TOSILATE
2.5 mg, 5 mg AND 10 mg
FILM-COATED TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
s Keep this leaflet. You may need
to read it again.
s If you have any further
questions, ask your doctor or
pharmacist.
s 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.
s 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 Perindopril Tosilate
Film-coated Tablets are and what
they are used for
2. What you need to know before
you take Perindopril Tosilate
Film-coated Tablets
3. How to take Perindopril Tosilate
Film-coated Tablets
4. Possible side effects
5. How to store Perindopril Tosilate
Film-coated Tablets
6. Contents of the pack and other
information

1

WHAT PERINDOPRIL
TOSILATE FILM-COATED
TABLETS ARE AND WHAT
THEY ARE USED FOR

Perindopril Tosilate is an
angiotensin converting enzyme
(ACE) inhibitor. These work by
widening the blood vessels, which
makes it easier for your heart to
pump blood through them.
Perindopril Tosilate Film-coated
Tablets are used:
s to treat high blood pressure
(hypertension)
s 2.5 mg and 5 mg strengths to
treat heart failure (a condition
where the heart is unable to
pump enough blood to meet the
body’s needs)
s to reduce the risk of cardiac
events, such as heart attack, in
patients with stable coronary
artery disease (a condition
where the blood supply to the
heart is reduced or blocked) and
who have already had a heart
attack and/or an operation to
improve the blood supply to the
heart by widening the vessels
that supply it.

2

Version:

231-30-40550-D LEA PERINDOPRIL TOSILATE A/S TAB TUK
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
PERINDOPRIL TOSILATE
FILM-COATED TABLETS

Do not take Perindopril Tosilate
Film-coated Tablets
s if you are allergic to perindopril, to
any other ACE inhibitor or any of
the other ingredients of this
medicine (listed in section 6)
s if you are more than 3 months
pregnant. (It is also better to avoid
Perindopril Tosilate in early
pregnancy – see section 2:
Pregnancy, breast-feeding and
fertility).
s if you have experienced symptoms
such as wheezing, swelling of the
face, tongue or throat, intense
itching or severe skin rashes with
previous ACE inhibitor treatment or
if you or a member of your family
have had these symptoms in any
other circumstances (a condition
called angioedema)
s if you have diabetes or impaired
kidney function and you are treated
with a blood pressure lowering
medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking
Perindopril Tosilate if any of the
following apply:
s if you have aortic stenosis
(narrowing of the main blood
vessel leading from the heart) or
hypertrophic cardiomyopathy
(heart muscle disease) or renal
artery stenosis (narrowing of the
artery supplying the kidney with
blood)
s if you have any other heart
problems
s if you have liver problems
s if you have kidney problems or if
you are receiving dialysis
s if you suffer from a collagen
vascular disease (disease of the
connective tissue) such as
systemic lupus erythematosus
or scleroderma
s if you have diabetes
s if you are on a salt restricted diet
or use salt substitutes which
contain potassium
s if you are to undergo anaesthesia
and/or major surgery
s if you are to undergo LDL
apheresis (which is removal of
cholesterol from your blood by a
machine)
s if you are going to have
desensitisation treatment to
reduce the effects of an allergy
to bee or wasp stings
s if you have recently suffered
from diarrhoea or vomiting, or
are dehydrated
s if you have been told by your
doctor that you have an
intolerance to some sugars.

2

09 December 2014

If you are taking any of the
following medicines used to treat
high blood pressure:
s an angiotensin II receptor
blocker (ARBs) (also known as
sartans – for example valsartan,
telmisartan, irbesartan), in
particular if you have
diabetes-related kidney
problems
s aliskiren.
Your doctor may check your kidney
function, blood pressure, and the
amount of electrolytes (e.g.
potassium) in your blood at
regular intervals.
See also information under the
heading ‘Do not take Perindopril
Tosilate’.

operate machinery may be
impaired.

You must tell your doctor if you
think that you are (or might
become) pregnant. Perindopril
Tosilate Film-coated Tablets is not
recommended in early pregnancy,
and must not be taken if you are
more than 3 months pregnant, as
it may cause serious harm to your
baby if used at that stage (see
section 2: Pregnancy,
breast-feeding and fertility).

Swallow your tablet with a glass of
water, preferably at the same time
each day, in the morning, before a
meal. Your doctor will decide on
the correct dose for you.

Children and adolescents
Perindopril Tosilate Film-coated
Tablets is not recommended for
use in children and adolescents.
Other medicines and Perindopril
Tosilate Film-coated Tablets
Tell your doctor or pharmacist if
you are taking, have recently taken
or might take any other medicines,
including medicines obtained
without a prescription.
Treatment with Perindopril Tosilate
Film-coated Tablets can be affected
by other medicines. These include:
s other medicines for high blood
pressure, including diuretics
(medicines which increase the
amount of urine produced by the
kidneys)
s your doctor may need to change
your dose and/or to take other
precautions: If you are taking an
angiotensin II receptor blocker
(ARB) or aliskiren (see also
information under the headings
‘Do not take Perindopril Tosilate’
and ‘Warnings and precautions’)
s potassium-sparing diuretics
(spironolactone, triamterene,
amiloride), potassium
supplements or
potassium-containing salt
substitutes
s lithium for mania or depression
s non-steroidal anti-inflammatory
drugs (e.g. ibuprofen) for pain
relief or high dose aspirin
s medicines to treat diabetes (such
as insulin or metformin)
s medicines to treat mental
disorders such as depression,
anxiety, schizophrenia etc (e.g.
tricyclic antidepressants,
antipsychotics)
s immunosuppressants
(medicines which reduce the
defence mechanism of the body)
used for the treatment of
auto-immune disorders or
following transplant surgery
(e.g. ciclosporin)
s allopurinol (for the treatment of
gout)
s procainamide (for the treatment of
an irregular heart beat)
s vasodilators including nitrates
(products that make the blood
vessels become wider)
s heparin (medicines used to thin
blood)
s medicines used for the treatment
of low blood pressure, shock or
asthma (e.g. ephedrine,
noradrenaline or adrenaline).
Perindopril Tosilate Film-coated
Tablets with food and drink
It is preferable to take Perindopril
Tosilate Film-coated Tablets before
a meal.
Pregnancy, breast-feeding and
fertility
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.
Pregnancy
You must tell your doctor if you
think that you are (or might
become) pregnant. Your doctor will
normally advise you to stop taking
Perindopril Tosilate Film-coated
Tablets before you become
pregnant or as soon as you know
you are pregnant and will advise
you to take another medicine
instead of Perindopril Tosilate
Film-coated Tablets. Perindopril
Tosilate Film-coated Tablets is not
recommended in early pregnancy,
and must not be taken when more
than 3 months pregnant, as it may
cause serious harm to your baby if
used after the third month of
pregnancy.
Breast-feeding
Tell your doctor if you are
breast-feeding or about to start
breast-feeding. Perindopril Tosilate
Film-coated Tablets is not
recommended for mothers who
are breast-feeding, and your
doctor may choose another
treatment for you if you wish to
breast-feed, especially if your baby
is newborn, or was born
prematurely.
Fertility
Effects on fertility by perindopril in
humans are not known.
Driving and using machines
Perindopril Tosilate Film-coated
Tablets usually does not affect
alertness but dizziness or
weakness due to low blood
pressure may occur in certain
patients. If you are affected in this
way, your ability to drive or to

Perindopril Tosilate Film-coated
Tablets 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
PERINDOPRIL TOSILATE
FILM-COATED TABLETS

Always take this medicine exactly
as your doctor has told you. Check
with your doctor or pharmacist if
you are not sure.

The recommended dosages are as
follows:
High blood pressure: the
recommended starting and
maintenance dose is 5 mg once
daily. After one month, this can be
increased to 10 mg once a day if
required. 10 mg a day is the
maximum recommended dose for
high blood pressure.
If you are 65 or older, the
recommended starting dose is
2.5 mg once a day. After a month
this can be increased to
5 mg once a day and then if
necessary to 10 mg once daily.
2.5 mg and 5 mg strengths only Heart failure: the recommended
starting dose is 2.5 mg once daily.
After two weeks, this can be
increased to 5 mg once a day,
which is the maximum
recommended dose for heart
failure.
Stable coronary artery disease: the
recommended starting dose is 5 mg
once daily. After two weeks, this
can be increased to 10 mg once
daily, which is the maximum
recommended dose in this
indication.
If you are 65 or older, the
recommended starting dose is
2.5 mg once a day. After a week
this can be increased to 5 mg once
a day and after a further week to
10 mg once daily.
If you take more Perindopril
Tosilate Film-coated Tablets than
you should
If you take too many tablets,
contact your nearest accident and
emergency department or tell your
doctor immediately. The most
likely effect in case of overdose is
low blood pressure which can
make you feel dizzy or faint. If this
happens, lying down with the legs
raised can help.
If you forget to take Perindopril
Tosilate Film-coated Tablets
It is important to take your medicine
every day as regular treatment
works better. However, if you
forget to take a dose of Perindopril
Tosilate Film-coated Tablets, take
the next dose at the usual time. Do
not take a double dose to make up
for a forgotten dose.
If you stop taking Perindopril
Tosilate Film-coated Tablets
As the treatment with Perindopril
Tosilate Film-coated Tablets is
usually life-long, you should
discuss with your doctor before
stopping this medicinal product.
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 you experience any of the
following, stop taking the
medicinal product at once and tell
your doctor immediately:
s swelling of the face, lips, mouth,
tongue or throat, difficulty in
breathing
s severe dizziness or fainting
s unusual fast or irregular heart
beat.

Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme at:
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
PERINDOPRIL TOSILATE
FILM-COATED TABLETS

Keep this medicine out of the sight
and reach of children.
Once opened use within 100 days.
Do not use this medicine after the
expiry date which is stated on the
carton and bottle after EXP.
The expiry date refers to the last
day of that month.
Keep the container tightly closed in
order to protect from light and
moisture. This medicine does not
require any special temperature
storage conditions.
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 Perindopril Tosilate
Film-coated Tablets contains:
s The active substance is
perindopril tosilate. One
film-coated tablet contains
1.704 mg perindopril
(corresponding to
2.5 mg perindopril tosilate), or
3.408 mg perindopril
(corresponding to 5 mg
perindopril tosilate), or
6.816 mg perindopril
(corresponding to 10 mg
perindopril tosilate).
s The other ingredients are lactose
monohydrate, maize starch,
sodium hydrogen carbonate,
pregelatinized starch, povidone
K30, magnesium stearate,
Poly(vinyl alcohol) - part
hydrolysed, titanium dioxide
E171, macrogol 3350, talc and for
the 5 mg and 10 mg tablets indigo
carmine E132, brilliant blue FCF
E133, iron oxide yellow E172 and
quinoline yellow E104.
What Perindopril Tosilate
Film-coated Tablets look like and
contents of the pack
Perindopril Tosilate 2.5 mg tablets
are white, round, biconvex,
film-coated tablets of approx.
5 mm diameter, debossed “T” on
one side and plain on the other.
Perindopril Tosilate 5 mg tablets
are light-green, capsule-shaped,
biconvex film-coated tablets of
approx. 4 mm width and 8 mm
length, debossed “T” on one side,
plain on the other side with
breaklines on both edges.
Perindopril Tosilate 10 mg tablets
are green, round, biconvex,
film-coated tablets of approx.
8 mm diameter, debossed “10” on
one side and “T” on the other.
5 mg - The tablets are available in
containers of 10, 30, 60, 90, 90
(3x30) or 100 film-coated tablets.
2.5 mg & 10 mg - The tablets are
available in containers of 30, 60,
90, 90 (3x30) or 100 film-coated
tablets.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne,
BN22 9AG, United Kingdom.
Manufacturer
Teva Pharmaceutical Works Private
Limited Company, Pallagi út 13,
4042 Debrecen, Hungary.
This leaflet was last revised in
December 2014.
PL 00289/1693, PL 00289/1694
PL 00289/1695

In decreasing order of frequency,
side effects can include:
s Common (may affect up to 1 in 10
people): headache, dizziness,
vertigo, pins and needles, vision
disturbances, tinnitus (sensation
of noises in the ears),
light-headedness due to low blood
pressure, cough, shortness of
breath, gastrointestinal disorders
(nausea, vomiting, abdominal
pain, taste disturbances,
dyspepsia or difficulty of
digestion, diarrhoea, constipation),
allergic reactions (such as skin
rashes, itching), muscle cramps,
feeling of tiredness
s Uncommon (may affect up to 1
in 100 people): mood swings,
sleep disturbances,
bronchospasm (tightening of the
chest, wheezing and shortness of
breath), dry mouth, angioedema
(symptoms such as wheezing,
swelling of the face, tongue or
throat, intense itching or severe
skin rashes), kidney problems,
impotence, sweating
s Very rare (may affect up to 1 in
10,000 people): confusion,
cardiovascular disorders
(irregular heart beat, angina,
heart attack and stroke),
eosinophilic pneumonia (a rare
type of pneumonia), rhinitis
(blocked up or runny nose),
erythema multiforme, disorders
of the blood, pancreas or liver
s In case of diabetic patients,
hypoglycaemia (very low blood
sugar level) can occur
s Vasculitis (inflammation of blood
vessels) have been reported.
40550-D

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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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