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PERINDOPRIL ERBUMINE 8 MG TABLETS

Active substance(s): PERINDOPRIL TERT-BUTYLAMINE

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TBC

Perindopril Erbumine
8 mg Tablets
(perindopril tert-butylamine)
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 Perindopril Erbumine is and what
it is used for
2. What you need to know before you take
Perindopril Erbumine
3. H
 ow to take Perindopril Erbumine
4. Possible side effects
5. How to store Perindopril Erbumine
6. C
 ontents of the pack and other
information

1. What Perindopril Erbumine is
and what it is used for
Perindopril Erbumine Tablets contain the
active substance perindopril erbumine
which belongs to a group of medicines
known as angiotensin converting enzyme
(ACE) inhibitors. These work by making
your blood vessels wider, which makes
it easier for your heart to pump blood
through them.
Perindopril Erbumine is used:
• to treat high blood pressure
(hypertension)
• 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 blood vessels
supplying it.

2. What you need to know before
you take Perindopril Erbumine
Do not take Perindopril Erbumine:

• if you are allergic to perindopril, to any
other ACE inhibitor or to any of the other
ingredients of this medicine (listed in
section 6),
• if you are more than 3 months pregnant
(it is also better to avoid perindopril in
early pregnancy - see pregnancy section),
• 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).
• 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 or pharmacist before
taking Perindopril Erbumine 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),
• have any other heart problems,
• have liver problems,
• have kidney problems or if you are
receiving dialysis,
• suffer from a collagen vascular disease
(disease of the connective tissue)
such as systemic lupus erythematosus
or scleroderma,
• have diabetes, and are taking
antidiabetic medicines, including insulin
to control your diabetes (your blood
should be monitored for low blood
glucose levels, especially during the first
month of treatment)
• are on a salt restricted diet or use salt
substitutes which contain potassium,
• have recently suffered from diarrhoea or
vomiting, or are dehydrated,
• are of black origin since you may have
a higher risk of angioedema and this
medicine may be less effective in
lowering your blood pressure than in
non-black patients.
• are taking any of the following medicines
used to treat high blood pressure:
* an angiotensin II receptor blocker
(ARBs) (also known as sartans - for
example valsartan, telmisartan,
irbesartan), in particular if you have
diabetes-related kidney problems.
* aliskiren

Perindopril erbumine is not recommended
for use in children and adolescents less
than 18 years old.

Other medicines and Perindopril
Erbumine

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Perindopril erbumine can affect the way
some other medicines work and some
medicines can have an effect on Perindopril
Erbumine. In particular, tell your doctor
if you are using any of the following
medicines:
• other medicines for high blood pressure,
including diuretics (medicines which
increase the amount of urine produced
by the kidneys),
• potassium-sparing medicines (e.g.
triamterene, amiloride), potassium
supplements or potassium-containing
salt substitutes,
• potassium-sparing medicines used
in the treatment of heart failure (e.g.
eplerenone, spironolactone at doses
between 12.5 mg and 50 mg per day),
• lithium (a medicine for mental health
problems such as mania or depression)
• non-steroidal anti-inflammatory drugs
(e.g. ibuprofen, diclofenac) for pain relief
or high dose aspirin,
• medicines to treat diabetes (such as
gliptins, insulin or metformin),
• baclofen (used to treat muscle stiffness in
diseases such as multiple sclerosis)
• medicines to treat mental disorders such
as depression, anxiety or schizophrenia
(e.g. tricyclic antidepressants,
antipsychotics),
• 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,
tacrolimus),
• trimethoprim (used for the treatment
of infections)
• estramustine (used in cancer therapy)
• medicines for the treatment of gout (e.g.
allopurinol),
• medicines for the treatment of an
irregular heart beat (e.g. procainamide),
• medicines that make the blood vessels
become wider (i.e. vasodilators, including
nitroglycerin and other nitrates),
• medicines used to thin blood
(e.g. heparin),
• medicines used for the treatment of low
blood pressure, shock or asthma (e.g.
ephedrine, noradrenaline or adrenaline).
• gold salts, especially with intravenous
administration (used to treat symptoms
of arthritis)
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 Erbumine” and
“Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you maybe 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
you are (or might become) pregnant.
Your doctor will normally advise you to
stop taking Perindopril Erbumine before
you become pregnant or as soon as you
know you are pregnant and will advise
you to take another medicine instead
of Perindopril Erbumine. Perindopril
Erbumine 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

Your doctor may check your kidney
function, blood pressure, and the amount
of electrolytes (e.g. potassium) in your
blood at regular intervals.

Angioedema

Driving and using machines

See also information under the heading
“Do not take Perindopril Erbumine”

Description Perindopril Erbumine 8 mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 714655

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 714655
MA No. 04569/1350

Supplier Code N/A

Children and adolescents

Tell your doctor if you are breast-feeding
or about to start breast-feeding.
Perindopril Erbumine 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.

Angioedema (a severe allergic reaction
with swelling of the face, lips, tongue or
throat with difficulty in swallowing or
breathing) has been reported in patients
treated with ACE inhibitors, including
perindopril erbumine. This may occur at
any time during treatment. If you develop
such symptoms you should stop taking
Perindopril Erbumine and see a doctor
immediately. See also section 4.

Packing Site/Printer N/A

During treatment tell your doctor
or pharmacist:
• if you develop signs of an infection (e.g.
sore throat, fever)
• if you develop yellowing of the skin or
whites of the eyes (jaundice)
• if you are to undergo anaesthesia and/or
major surgery,
• if you are to undergo LDL apheresis
(which is removal of cholesterol from
your blood by a machine),
• if you are going to have desensitisation
treatment to reduce the effects of an
allergy to bee or wasp stings,
• if you think that you are (or might
become) pregnant. Perindopril Erbumine
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 Pregnancy and breast-feeding
section).

Vendor Job No. 263811
Trackwise Proof No. 2
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

TBC

Package leaflet: Information for the patient

Perindopril erbumine 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 operate
machinery may be impaired.

Perindopril Erbumine contains Lactose

Perindopril Erbumine contains lactose. If
you have been told by your doctor that
you have an intolerance to some sugars,
such as lactose, contact your doctor before
taking this medicine.

Date: 17 Nov 2015

Time: 11:26
Page Count 1/2

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3. How to take Perindopril
Erbumine
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
Swallow your tablet with a glass of water,
preferably at the same time each day,
in the morning and before a meal. Your
doctor will decide on the correct dose for
you. The 4 mg tablet can be divided into
equal doses.
The recommended dose for Perindopril
Erbumine is:
High blood pressure:
The recommended starting and
maintenance dose is 4 mg once daily.
After one month, this can be increased to
8 mg once a day if required. The maximum
recommended dose for high blood
pressure is 8 mg a day.
Elderly patients with high blood pressure:
If you are 65 years old or older, the
recommended starting dose is 2 mg once
a day. After a month this can be increased
to 4 mg once a day and then, if necessary,
to 8 mg once daily.
Stable coronary artery disease:
The recommended starting dose is 4 mg
once daily. After two weeks, this can be
increased to 8 mg once a day, which is the
maximum recommended dose for this
indication.
Elderly patients with stable coronary artery
disease:
If you are 65 years old or older, the
recommended starting dose is 2 mg once
a day. After a week this can be increased to
4 mg once a day and after a further week,
to 8 mg once daily.
Patients with kidney problems:
If you have kidney problems, your doctor
will alter the dose depending on how well
your kidneys are working.

If you take more Perindopril Erbumine
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. Other
side effects may include: kidney failure,
shock, imbalance of minerals in the body,
rapid or deep breathing, increase in heart
rate, irregular heart beat, slowing of heart
rate, anxiety and cough.

If you forget to take Perindopril
Erbumine

It is important to take your medicine every
day as regular treatment works better.
However, if you forget to take a dose of
Perindopril Erbumine, take the next dose
at the usual time. Do not take a double
dose to make up for a forgotten dose.
As the treatment with perindopril
erbumine is usually life-long, you should
discuss with your doctor before stopping
this medicine.

Rare (may affect up to 1 in 1000 people):
• increased level of liver enzymes, high
level of serum bilirubin. This may show
up in blood tests.
Very rare (may affect up to 1 in
10,000 people):
• confusion,
• rhinitis (blocked up or runny nose),
• disorders of the blood such as a
lower number of red blood cells,
lower haemoglobin, lower number of
blood platelets.

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 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
Erbumine
Keep this medicine out of the sight and
reach of children.

4. Possible Side Effects

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.

If you experience any of the following
side effects, stop taking this medicine
at once and tell your doctor or go
to the nearest hospital casualty
department immediately:
Common (may affect up to 1 in 10 people):
• severe dizziness or fainting due to low
blood pressure
Uncommon (may affect up to 1 in
100 people):
• swelling of the face, lips, mouth,
tongue or throat, difficulty in breathing
(angioedema),
• tightening of the chest, wheezing and
shortness of breath (bronchospasm),
• intense itching or severe skin rash,
formation of blister clusters over the skin
(pemphigoid)
• producing little or no urine, cloudy
urine, pain when passing urine or lower
back pain (these may be signs of serious
problems with your kidneys)
Very rare (may affect up to 1 in
10,000 people):
• unusual fast or irregular heart beat., chest
pain (angina) or heart attack
• weakness of arms or legs, or problems
speaking which could be sign of a
possible stroke
• inflamed pancreas which may cause
severe abdominal and back pain
accompanied with feeling very unwell
• yellowing of the skin or eyes (jaundice)
which could be a sign of liver problems
• skin rash which often starts with red
itchy patches on your face, arms or legs
(erythema multiforme)
• disorders of the blood, such as decreased
number of all or certain blood cell
types – you may notice a pale skin colour,
headache, an increase in infections such
as sore throat, mouth ulcers etc. with
fever, an increase in unexpected bruising
or bleeding, or feel tired, dizzy, breathless
and weak.
• eosinophilic pneumonia (a rare type
of pneumonia).You may develop cough,
high temperature and have difficulty
breathing.

Description Perindopril Erbumine 8 mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 714655

SAP No. N/A

Superceded Affiliate Item Code N/A
TrackWise PR No. 714655
MA No. 04569/1350

Supplier Code N/A

Uncommon (may affect up to 1 in
100 people):
• mood swings
• fast heart rate, thump in the chest
• sleep disturbances,
• dry mouth,
• impotence,
• excessive sweating
• excess of eosinophils in the blood (a type
of white blood cell). This may show up in
blood tests.
• somnolence
• fainting
• vasculitis (inflammation of blood vessels)
• photosensitivity reaction (increased
sensitivity of the skin to sun)
• arthralgia (joint pain), myalgia (muscle
pain)
• chest pain
• peripheral oedema (swelling of the
hands or feet/ankles)
• fever
• fall
• high level of potassium in the blood
(reversible on discontinuation)
• low level of sodium in the blood
• hypoglycaemia (very low blood sugar
level). This is important in case of diabetic
patients.
• increased blood urea, and increased
blood creatinine.
These may show up in blood tests.

If you have any further questions on
the use of this product, ask your doctor
or pharmacist.

Like all medicines, this medicine can
cause side effects, although not everybody
gets them.

Packing Site/Printer N/A

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,
• gastro-intestinal disorders (nausea
(feeling sick), vomiting (being sick),
abdominal pain, taste disturbances,
indigestion, diarrhoea, constipation),
• allergic reactions (such as skin rashes,
itching),
• muscle cramps,
• feeling of weakness or tiredness.

Vendor Job No. 263811
Trackwise Proof No. 2
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

Do not store above 25 °C.

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 Erbumine contains

The active substance is perindopril
tert-butylamine.
One 8 mg tablet contains 8 mg of
perindopril tert-butylamine, equivalent to
6.676 mg of perindopril.
The other ingredients are:
Lactose anhydrous, magnesium stearate,
silica, hydrophobic colloidal, cellulose,
microcrystalline, sodium hydrogen
carbonate, aluminium lake of sodium
copper chlorophyllin E141.

What Perindopril Erbumine looks like
and contents of the pack

Perindopril Erbumine 8 mg tablets are
green mottled, round, tablets debossed
with “PT8” on one side of the tablet and “M”
on the other side.
Perindopril Erbumine is available in blisters
of 14, 30, 60, 90 and 100 tablets. Not all
pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan,
Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Manufacturer:

Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Generics [UK] Limited,
Station Close, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Mylan Hungary Kft,
H-2900 Komarom, Mylan utca 1, Hungary.
This leaflet was last revised in 12/2015.

TBC

TBC

If you stop taking Perindopril Erbumine

Other possible side effects:

Code No.: MH/DRUGS/25/NKD/89

Date: 17 Nov 2015

714655

Time: 11:26
Page Count 2/2

No. of colours 1
Colours

Black

Non-Print
Colours

Codes

Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 130 x 480mm

Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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