Skip to Content



View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

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 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 of the side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See setion 4.
In this leaflet
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. What is and what it is used for
is a combination of Perindopril and Indapamide. They belong to a group of
anti-hypertensive medicines, which are used in the treatment of high blood pressure.
Perindopril belongs to a class of 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. These work by allowing your
kidneys to produce more urine than normal.
Each of the individual medicines work together to lower your blood pressure and control it.
2. What you need to know before you take
DO NOT take
 If you are allergic to perindopril or indapamide or any of the other ingredients of this
medicine (listed in section 6).
 If you are allergic to any other ACE inhibitors or diuretics (Sulphonamides).
 If you have experienced swelling of the face, lips, mouth, tongue or throat which may
cause difficulty in swallowing or breathing, with previous ACE inhibitor therapy. This is a
condition called angioneurotic oedema (Quincke’s oedema)
 Alternatively, if you or any of you family members have had these symptoms tell your
doctor as soon as possible.
 If you have heart problems or are on medication (see “Other medicines and name>”)
 If you are more than 3 months pregnant. (It is also better to avoid in early
pregnancy – see pregnancy section.)
 If you are breastfeeding (see breastfeeding section)

 If you have kidney failure or are receiving dialysis
 If you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren
 If you have serious liver disease or suffer from a condition called hepatic encephalopathy
(which is brain and nervous system impairment caused by severe liver disease)
 If your doctor has told you, that you have low or high blood potassium.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
 If you have bilateral renal artery stenosis (narrowing of the main blood vessel leading to
the kidney) or a single functioning kidney
 If you have diabetes
 If you are on a low salt diet or use salt substitutes, which contain potassium
 If you take lithium or potassium-sparing diuretics (e.g. spironolactone, triamterene)
 If you are taking a medicine which is a combination with a potassium-sparing diuretic
 If you are going to have an operation under general anaesthetic, as you may need to stop
treatment a few days beforehand.
 If you have atherosclerosis (a disease of the arteries in which blood vessel walls thicken
and harden due to cholesterol deposit)
 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 (e.g. bee or wasp sting)
 If you are to undergo a medical test that requires injection of a substance that makes
organs like the kidney or stomach visible on an x-ray (iodinated contrast agent)
 if you have anaemia (a condition when the red blood cells in your body carry less oxygen,
some of the symptoms of anaemia include tiredness, headaches, dizziness)
 If you have gout (a disease where uric acid crystals cause swollen joints)
 If you have a collagen disease such as systemic lupus erythematosus or scleroderma.
 You must tell your doctor if you think you are (or might become) pregnant. name> 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 section).
 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
- aliskiren
 if you are taking any of the following medicines, the risk of angioedema is increased:
- racecadotril (used to treat diarrhoea)
- sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called
mTor inhibitors (used to avoid rejection of transplanted organs)
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
Other medicines and
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
You should avoid with:
 Lithium
 Potassium-sparing diuretics (e.g. spironolactone, triamterene alone or in combination)
potassium salts
 Allopurinol (treatment of gout)


 Procainamide (treatment of irregular heartbeat)
 Systemic corticosteroids (used to treat various conditions including severe asthma and
rheumatoid artheritis)
 Other medicines to treat high blood pressure
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 ” and “Warnings and precautions”)
 Immunosuppressants used for the treatment of auto-immune disorders or following
transplant surgery to prevent rejection (e.g. ciclosporin)
Treatment with can be affected by other medicines. Tell your doctor if you
are taking any of the following medicines as special care may be required:
 Astemizole or terfenadine ( antihistamines for hayfever or allergies)
 Bepridil ( used to treat angina pectoris - an uncomfortable feeling in this chest)
 Erythromycin by injection, moxifloxacin, sparfloxacin (antibiotics)
 Halofantrine ( used to treat certain types ofmalaria)
 Pentamidine (used to treat pneumonia which is a serious lung infection)
 Vincamine (used to treat disorders of the brain in elderly)
 Baclofen ( to treat muscle stiffness occurring in diseases such as multiple sclerosis)
 Medicines to treat diabetes such as insulin, metformin or hypoglycaemic sulphonamides
 Non-Steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g.
acetylsalicylic acid)
 Potassium lowering drugs e.g. amphotericin B (by injection. to treat severe fungal
disease), glucocorticoids and mineralocorticoids (systemic route), or stimulant laxatives
(e.g. senna)
 Potassium-sparing diuretics (amiloride, spironolactone, triamterene)
 Thiazide or loop diuretics
 Medicines to treat irregular heart beat such as quinidine, hydroquinidine, disopyramide,
amiodarone, bretylium, dofetilide, ibutilide and sotalol.
 Medicines to treat mental disorders such as depression, anxiety, schizophrenia (e.g.
tricyclic antidepressants, neuroleptics such as chlorpromazine, cyamemazine,
 Levomepromazine, thioridazine, trifluoperazine, amisulpiride, tiapride, droperidol,
haloperidol, pimozide)
 Cisapride, diphemanil, mizolastine
 Methadone
 Sultopride (used in the treatment ofpsychotic disorders)
 Tetracosactide (used to treat Crohn’s disease)
 Calcium salts
 Medicines, which are most often used to treat diarrhoea (racecadotril) or avoid rejection of
transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the
class of so-called mTor inhibitors). See section “Warnings and precautions”.
with food and drink
It is recommended that are taken in the morning on an empty stomach.
Swallow the tablets with a glass of water.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will
normally advise you to stop taking before you become pregnant or as soon
as you know you are pregnant and will advise you to take another medicine instead of

. 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.
Tell your doctor if you are breast-feeding or about to start breast-feeding.
must not be taken by 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 (see section “Do not take ”).
See your doctor immediately.
Driving and using machines
has minor or moderate influence on the ability to drive and use machines.
This medicine does not affect alertness but reactions related to low blood pressue may occur
in some patients. This can cause dizziness or weakness.If affected your ability to drive or
operate machinery may be impaired therefore caution is advised.
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
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. The dose may be increased depending on your condition and
other medicines you are taking. Take your medicine by mouth only.
The recommended dose is:
High Blood pressure:
It is recommended that one 2 mg/0.625 mg tablet is taken in the morning
before breakfast. If your blood pressure is not controlled then your doctor may increase your
dose to one 4 mg/1.25 mg tablet daily.
In older people with high blood pressure:
It is recommended that one 2 mg/0.625 mg tablet is taken in the morning
before breakfast.
If you take more than you should
If you take more than you should or someone else has taken your medicine
contact your doctor or pharmacist immediately. The most common effect of an overdose is
low blood pressure, the symptoms of this can be dizziness, sleepiness or nausea. It may
help lying down with your legs raised up into the air.
If you forget to take
Take your tablet as soon as you remember unless it is time for your next dose. Take your
next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking
If you stop taking tell your doctor as soon as possible. Normally the
treatment for high blood pressure is long term.
If you have any further questions on the use of this medicines, ask your doctor or pharmacist.
4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These can include:
Common (may affect up to 1 in 10 people):
 Dry cough
 Dry mouth
 Constipation
 Nausea (feeling sick)
 Stomach pain or discomfort
 Loss of appetite
 Taste loss
 Low levels of potassium
Uncommon (may affect up to 1 in 100 people):
 Low blood pressure
 Headache
 Feeling light headed when standing up
 Feelings of dizziness
 Mood swings
 Sleep disturbance
 Hypersensitivity reaction (allergic reaction)
 Cramps
 Paraesthesia (numbness or pins and needles on your hands or feet)
Rare (may affect upt to 1 in 1,000 people):
 Raised levels of calcium in the blood
 Psoriasis worsening
Very rare (may affetc up to 1 in 10,000 people):
 Thrombocytopenia: Low blood platelet count. Symptoms may include bleeding or bruising
more easily than normal.
 Leucopenia or agranulocytosis: lack of white blood cells. Symptoms may include frequent
infections such as fever, severe chills, sore throat or mouth ulcers
 Aplastic anaemia: a rare type of anaemia in which there is a reduction in your red blood
cells, white blood cells and platelets
 Haemolytic anaemia: illness resulting from the destruction of red blood cells
 Anaemia in patients following a kidney transplant or on haemodialysis
 Pancreatitis: inflammation of the pancreas in case of hepatic failure
 Hepatic encephalopathy: brain and nervous system damage related to complicated liver
If you have any blood tests, tell the doctor that you are taking since the
following may be seen:
 Low or high levels of potassium
 Low levels of sodium
 High levels of uric acid and glucose
 Slightly high levels of urea and creatinine.
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 {to be completed


nationally: the national reporting system listed in Appendix V}. By reporting side effects, you
can help provide more information on the safety of this medicine.
5. How to store
Keep this medicine out of the sight and reach of children.
Store in the original package to protect from moisture.
When unopened, this medicinal product does not require any special temperature storage
Once the laminated pouch is opened, blister strips should be stored in the outer box below
30° C. 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. The expiry date
refers to the last day of the 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 protect the
6. Contents of the pack and other information
What contains
 The active substances are Perindopril tert-butylamine and Indapamide
 Each tablet contains 2 mg Perindopril tert-butylamine equivalent to 1.669 mg perindopril
and 0.625 mg Indapamide
 Each tablet contains 4 mg Perindopril tert-butylamine equivalent to 3.338 mg perindopril
and 1.25 mg Indapamide
 The other ingredients are:
Lactose Monohydrate
Magnesium stearate
Silica, hydrophobic colloidal
Cellulose, Microcrystalline
What looks like and contents of the pack
2 mg/0.625 mg 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 doses.
4 mg/1.25 mg 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
30, 90 and 100
*Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
To be completed nationally
This medicinal product is authorised in the Member States of the EEA under the
following names:

Perindoplus STADA 2/0.625mg (4/1.25mg) Tabletten
Perindopril/Indapamide CF2/0,625 mg (4/1,25 mg), tabletten
Perindostad Kombi2 mg/0,625 mg (4 mg/1,25 mg) Tablety
Perindopril/Indapamida STADA 2/0.625mg (4/1.25mg) comprimidos EFG
Perindopril/Indapamide 2mg/0.625mg (4mg/1.25mg) Tablets

This leaflet was last revised in August 2016.


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.