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PERINDOPRIL / INDAPAMIDE 4MG/1.25MG TABLETS

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SAME SIZE ARTWORK
LEAFLET SIZE: 180 mm x 400 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril/Indapamide 2 mg/0.625 mg and 4 mg/1.25 mg Tablets
Perindopril tert-butylamine 2 mg / Indapamide 0.625 mg
Perindopril tert-butylamine 4 mg / Indapamide 1.25 mg
Read all of this leaflet carefully before you start taking this
medicine.
- 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/Indapamide Tablets is and what it is used
for
2. What you need to know before you take Perindopril/
Indapamide Tablets
3. How to take Perindopril/Indapamide Tablets
4. Possible side effects
5. How to store Perindopril/Indapamide Tablets
6. Contents of the pack and other information
1. What Perindopril/Indapamide Tablets is and what it is
used for
Perindopril/Indapamide Tablets is a combination of two
active ingredients, Perindopril and Indapamide. They belong
to a group of anti-hypertensive medicines, which are used in
the treatment of high blood pressure (hypertension).
Perindopril belongs to a class of medicines called ACE
inhibitors. These work by widening the blood vessels in your
body, which make it easier for your heart to pump blood
around through them.
Indapamide belongs to a group of medicines called diuretics.
Diuretics increase the amount of urine produced by the
kidneys. However, indapamide is different from other
diuretics, as it only causes a slight increase in the amount of
urine produced.
Each of the active ingredients reduces blood pressure and
they work together to control your blood pressure.
2. What you need to know before you take Perindopril/
Indapamide
Do not take Perindopril/Indapamide Tablets
- If you are allergic to perindopril or any other ACE
inhibitor, or to indapamide or any other sulphonamide or
any of the other ingredients of this medicine (listed in
section 6).
- If you have experienced symptoms such as wheezing,
swelling of the face or tongue intense itches 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 severe liver disease or suffer from a condition
called hepatic encephalopathy (degenerative disease of the
brain),
- if you have a severe kidney disease or if you are receiving
dialysis,
- if you have low or high blood potassium,
- if you are suspected of having untreated decompensated
heart failure (severe water retention, difficulty in
breathing),
- If you are more than 3 months pregnant. (It is also better to
avoid Perindopril/Indapamide Tablets in early pregnancy
see ''Pregnancy and Breast-feeding”.)
- If you are breastfeeding
if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.
Warnings and Precautions
If any of the following apply to you please talk to your doctor
before taking Perindopril/Indapamide Tablets:
- 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),
- if you have any other heart problems or problems with your
kidneys,
- if you have liver problems,
- if you suffer from a collagen disease (skin disease) such as
systemic lupus erythematosus or scleroderma,
- if you have atherosclerosis (hardening of the arteries),
- if you suffer from hyperparathyroidism (overactive
parathyroid gland),
- if you suffer from gout,
- If you have diabetes
- If you are on a salt restricted diet or use salt substitutes,
which contain potassium
- If you take lithium or potassium-sparing diuretics
(spironolactone, triamterene) as their use with Perindopril/
Indapamide Tablets should be avoided (see "Other
medicines and Perindopril/Indapamide Tablets").
- If you 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
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 heading “Do not take
Perindopril/Indapamide Tablets”.
When you are taking, you should also inform
your doctor or the medical staff:
- If you are to undergo dialysis or 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 are to undergo a medical test that requires injection
of an iodinated contrast agent ( a substance that makes
organs like kidney or stomach visible on an X-ray)
Athletes should be aware that Perindopril/Indapamide Tablets
contains an active ingredient (indapamide) which may give a
positive reaction in drug tests.
Children and adolescents
Perindopril/Indapamide Tablets should not be given to
children.
Other medicines and Perindopril/Indapamide Tablets
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.
You should avoid Perindopril/Indapamide Tablets with:
- lithium (used to treat depression),
- potassium-sparing diuretics (e.g. spironolactone,
triamterene) potassium salts
Treatment with Perindopril/Indapamide Tablets can be
affected by other medicines. Your doctor may need to change
your dose and/or to take other precuations. Tell your doctor if
you are taking any of the following medicines as special care
may be required:
- other medicines for treating high blood pressure including
angiotensin II receptor blocker (ARB) or aliskiren (see
also information under the headings “Do not take Product
name” and “Warnings and precautions”),,
- procainamide (for the treatment of an irregular heart beat),
- allopurinol (for the treatment of gout),
- terfenadine or astemizole (antihistamines for hay fever or
allergies),
- corticosteroids used to treat various conditions including
severe asthma and rheumatoid arthritis,
- immunosuppressants used for the treatment of auto
immune disorders or following transplant surgery to
prevent rejection (e.g. ciclosporin),
- medicines for the treatment of cancer,
- erythromycin by injection (an antibiotic),
- halofantrine (used to treat certain types of malaria)
- pentamidine (used to treat pneumonia)
- injectable gold (used to treat rheumathoid polyarthritis),
- vincamine (used to treat symptomatic cognitive disorders
in elderly including memory loss
- bepidril (used to treat angina pectoris),
- sultopride (for the treatment of psychoses),
- medicines used for heart rhythm problems (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol),
- digoxin or other cardiac glycosides (for the treatment of
heart problems),
- baclofen (to treat muscle stiffness occurring in diseases
such as multiple sclerosis),
- medicines to treat diabetes such as insulin or metformin,
- calcium including calcium supplements,
- stimulant laxatives (e.g. senna),
- non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or
high dose salicylates (e.g. aspirin),
- amphotericin B by injection (to treat severe fungal
disease),
- medicines to treat mental disorders such as depression,
anxiety, schizophrenia...(e.g. tricyclic antidepressants,
neuroleptics),
- tetracosactide (to treat Crohn's disease)
Perindopril/Indapamide Tablets with food and drink
It is preferable to take Perindopril/Indapamide Tabletsbefore
a meal.
Pregnancy and breast-feeding
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/Indapamide 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/Indapamide
Tablets. Perindopril/Indapamide Tablets is not recommended
in early pregnancy, and must not be taken when you are more
than 3 months pregnant, as it may cause serious harm to your
baby if used after the third month of pregnancy.
Breastfeeding
You must not take Perindopril/Indapamide Tablets if you are
breast-feeding. Tell your doctor if you are breast-feeding or
about to start breast-feeding.
See your doctor immediately
Driving and using machines
Perindopril/Indapamide Tablets usually does not affect
alertness but different reactions such as dizziness or weakness
in relation to the decrease in blood pressure may occur in
certain patients. If affected your ability to drive or operate
machinery may be impaired.
Perindopril/Indapamide Tablets contains lactose
Perindopril/Indapamide Tablets contains lactose. If you have
been told by your doctor that you have an intolerance to some
FONT: Times New Roman
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DATE: 10-02-2016
VERSION: 01 (UK)

SAME SIZE ARTWORK
LEAFLET SIZE: 180 mm x 400 mm

sugars, contact your doctor before taking this medicinal
product.
3. How to take Perindopril/Indapamide Tablets
Always take Perindopril/Indapamide Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is one tablet once a day. Your doctor may
decide to modify the dosage regimen if you suffer from renal
impairment. Take your tablet preferably in the morning and
before a meal. Swallow the tablet with a glass of water.
It is recommended that one Perindopril/Indapamide
2mg/0.625mg tablet is taken in the morning before breakfast.
If your blood pressure is not controlled then your doctor may
increase your dose to one Perindopril/Indapamide
4mg/1.25mg tablet daily.
In older people with high blood pressure:
It is recommended that one Perindopril/Indapamide
2mg/0.625mg tablet is taken in the morning before breakfast.
If you take more Perindopril/Indapamide Tablets than
you should
If you take more too many tablets contact your doctor or
nearest hospital casualty department. The most likely effect in
case of overdose is low blood pressure. If marked low blood
pressure occurs (symptoms such as dizziness,or faitness,
lying down with legs raisedcan help.
If you forget to take Perindopril/Indapamide Tablets
It is important to take your medicine every day as regular
treatment is more effective. However, if you forget to take a
dose of Perindopril/Indapamide 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/Indapamide Tablets
As the treatment for high blood pressure 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 product,
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:
● swelling of the face, lips, mouth, tongue or throat,
difficulty in breathing, severe dizziness or fainting,
cardiovascular disorders (irregular heartbeat, angina, heart
attack).
● severe skin manifestations such as erythema multiforme.
● signs of blood problems (e.g. decreased levels of certain
blood cells which may develop as fever, sore throat,
tiredness, unexplained bruising or bleeding, mouth sores).
● disorders of the blood, kidney, liver or pancreas and
changes in laboratory parameters (blood tests) can occur.
Your doctor may need to give you blood tests to monitor
your condition. In cases of hepatic insufficiency (liver
problems), there is a possibility of onset of hepatic
encephalopathy (degenerative disease in the brain).
In decreasing order of frequency, side effects can include:
Common: may affect up to 1 in 10 people: headache, feelings
of 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, epigastric pain, anorexia,
vomiting, abdominal pain, taste disturbances, dry mouth,
dyspepsia or difficulty of digestion, diarrhoea, constipation),
allergic reactions (such as skin rashes, itching), cramps,
feeling of tiredness,
Uncommon: may affect up to 1 in 100 people: mood swings,
sleep disturbances, bronchospasm (tightening of the chest,
wheezing and shortness of breath), angioedema (symptoms
such as wheezing, swelling of the face or tongue), urticaria,
purpura (red pinpoints on skin), kidney problems, impotence,
sweating
Rare: may affect up to 1 in 1000 people: hypercalcaemia (high
blood levels of calcium).
Very rare: may affect up to 1 in 10,000 people:
- confusion, eosinophilic pneumonia (a rare type of
pneumonia), rhinitis (blocked up or runny nose),. If you
suffer from systemic lupus erythematosus (a type of
collagen disease), this might get worse. Cases of
photosensitivity reactions (change in skin appearance)
after exposure to the sun or artificial UVA have also been
reported.
Not known (frequency cannot be estimated from the available
data): fainting, life-threatening irregular beat (Torsade de
Pointes), abnormal ECG heart tracing, increased levels of
liver enzymes.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
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 Yellow
Card Scheme (Website: www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more information
on the safety of this medicine.

When unopened, this medicinal product does not require any
special temperature storage conditions.
Once the laminated pouch is opened, blister strips should be
stored in the outer box below 30OC.
Any remaining tablets should be discarded two months after
opening the pouch.
Do not use this medicine after the expiry date which is stated
on the label, blister, pouch and carton after EXP. The expiry
date refers to the last day of that month.
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 to protect the
environment.
6. Contents of the pack and other information
What Perindopril/Indapamide Tablets contains
- The active substances are Perindopril tert-butylamine and
Indapamide
- Each tablet contains 2mg Perindopril tert-butylamine
equivalent to 1.669mg perindopril and 0.625mg
Indapamide
- Each tablet contains 4mg Perindopril tert-butylamine
equivalent to 3.338mg perindopril and 1.25mg
Indapamide
- The other ingredients are:
Lactose Monohydrate
Magnesium stearate
Silica, hydrophobic colloidal
Cellulose, Microcrystalline
What Perindopril/Indapamide Tablets looks like and
contents of the pack
Perindopril/Indapamide 2mg/0.625mg Tablet
White, rod shaped tablets engraved with 'P' and 'I' on either
side of the break-line on one side and a break-line on the other
side. The tablet can be broken into equal halves.
Perindopril/Indapamide 4mg/1.25mg Tablet
White rod shaped tablets having 'PI' debossed on one side and
plain on the other.
The tablets are packed in PVC / PVdC ‒ Aluminium blisters
within a protective aluminium pouch, including a desiccant
protecting the tablets from moisture. The desiccant should not
be swallowed.
Pack Sizes
2mg/0.625mg: 20, 30, 90 and 100
4mg/1.25mg: 30, 90 and 100
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue,
Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer (s)
Glenmark Pharmaceuticals S.R.O.
Hvězdova 1716/2b, 140 78 Praha 4,
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium
Perindopril/Indapamide Glenmark
2/0.625mg and 4/1.25mg Tabletten
Denmark
Perindopril tert-butylamin/Indapamid
Glenmark
Germany
Perindopril/Indapamid Glenmark
2mg/0.625mg and 4mg/1.25mg
Tabletten
Greece
Perindopril/Indapamide Glenmark
Italy
Perindopril E Indapamide EG
2/0.625mg and 4/1.25mg
The Netherlands Perindopril tert-butylamine /Indapamide
Glenmark 2/0.625mg and 4/1.25mg
Tabletten
Portugal
Perindopril+Indapamida Labesfal
2+0.625mg and 4+1.25mg
Comprimidos
Spain
Perindopril/Indapamide Viso
Farmaceutica 2/0.625mg and 4/1.25mg
comprimidos
This leaflet was last revised in : 02/2016.

5. How to store Perindopril/Indapamide tablets
Keep out of the sight and reach of children.
Store in the original package to protect from moisture.
FONT: Times New Roman
FONT SIZE: 9 pt
DATE: 10-02-2016
VERSION: 01 (UK)

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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