Patient leaflet - Perindopril 8 mg tablets

1. What Perindopril tert-butylamine Tablets are and what they are for.

Perindopril belongs to a group of medicines called ACE inhibitors. These work by widening the blood vessels. This makes it easier for your heart to pump blood through your body.

Perindopril tert-butylamine Tablets are used to:

Treat high blood pressure (hypertension)
Treat heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs). • 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. What you need to know before you take Perindopril tert-butylamine Tablets

Do not take Perindopril:

If you are allergic (hypersensitive) to perindopril or any of the ingredients of Perindopril tert-butylamine
Tablets (listed in section 6)
if you have had symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rash, fainting or feeling dizzy. If you have had these symptoms when you have taken an ACE inhibitor in the past or at any other time, this may be angioedema. If so, do not take Perindopril tert-butylamine Tablets • if you are being treated with sacubitril/valsartan, a medicine for heart failure as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see “Warnings and Precautions” and “other medicines and perindopril tablets”.
if you are more than 3 months pregnant (It is also better to avoid Perindopril tert-butylamine Tablets in early pregnancy – see pregnancy section.).
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, talk to your doctor and do not take Perindopril tert-butylamine Tablets.

Warnings and precautions

Take special care with Perindopril tert-butylamine Tablets

Talk to you doctor before taking Perindopril tert-butylamine Tablets if:

you have narrowing of the heart valves (aortic or mitral stenosis) or heart muscle disease (hypertrophic cardiomyopathy) or narrowing of the artery supplying the kidney with blood (renal artery stenosis) • you have any other heart or liver or kidney problems, or you are having dialysis.
you have abnormally increased levels of a hormone called aldosterone in your blood (primary aldosteronism). • you have diabetes which is not well controlled
you have been told to limit the salt in your diet or to use a salt-substitute containing potassium • you have a collagen disease such as systemic lupus erythematosus or scleroderma • you are taking any of the following medicines, the risk of angioedema is increased:
- racecadotril (used to treat diarrhea)
- sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors
  (used to avoid rejection of transplanted organs)
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 the heading ‘’Do not take Perindopril tert-butylamine Tablets”

Tell your doctor or pharmacist that you are taking Perindopril tert-butylamine Tablets if:

you are about to have an operation or general anaesthetic
you have recently had diarrhoea or vomited
you are going to have treatment to reduce the effects of an allergy to bee or wasp stings • you are going to have cholesterol removed from your blood by a machine (LDL apheresis)

Tell your doctor if any of the situations above have happened to you in the past.

You must tell your doctor if you think you are (or might become) pregnant. Perindopril tert-butylamine 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).

Other medicines and Perindopril tert-butylamine Tablets

Please tell your doctor or pharmacist if you are taking or, have recently taken any other medicines, including medicines obtained without prescription. In particular, talk to your doctor before taking Perindopril tert-butylamine Tablets if you are taking:

medicines for high blood pressure including water tablets (diuretics)
water tablets (diuretics) which affect potassium, such as spironolactone, triamterene or amiloride • medicines to increase your level of potassium
heparin (for thinning the blood) can also affect potassium levels in your blood
medicines for diabetes (insulin or tablets)
baclofen (used to treat muscle stiffness in disease such as multiple sclerosis). • trimethoprim (for the treatment of infections),
estramustine (used in cancer therapy).
gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis). • lithium (for mania or depression)
medicines for mental illness such as depression, anxiety, schizophrenia or other psychosis • allopurinol for gout
medicines to treat auto-immune disorders (such as rheumatoid arthritis) or given after transplant surgery.
These are called immunosuppressants.
procainamide (for irregular heartbeat)
non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac) including aspirin for pain • medicines for low blood pressure, shock or asthma (including ephedrine, noradrenaline or adrenaline) • medicines that make the blood vessels wider (vasodilators, such as nitrates).
If you have been told by your doctor that you have an intolerance to some sugars • medicines most often used to treat diarrhea (e.g. 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”
an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take
Perindopril” and “Warnings and precautions”)

Your doctor may need to change your dose and/or to take other precautions

Ask your doctor if you are not sure what these medicines are. Tell the doctor if you have taken any of the medicines listed above in the past, but have now stopped.

Taking Perindopril tert-butylamine Tablets with food and drink

Take your Perindopril tert-butylamine Tablets in the morning before a meal.

Children and adolescents

Perindopril tert-butylamine is not recommended for use in children and adolescents up to the age of 18 years.

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 tert-butylamine 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 tert-butylamine Tablets. Perindopril tert-butylamine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril tert-butylamine Tablets are not recommended for mothers who are breastfeeding, 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. Ask your doctor or pharmacist for advice before taking any medication.

Driving and using machines

You may feel dizzy or tired when taking Perindopril tert-butylamine Tablets. If this happens, do not drive or use machines. You must talk to your doctor about this.

Important information about some of the ingredients of Perindopril tert-butylamine Tablets

The tablets contain 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.

Information on special patient groups

Perindopril tert-butylamine Tablets should not be given to children.

3.How to take Perindopril tert-butylamine Tablets

Your doctor will decide on the amount of perindopril you should start to take. This may be increased depending on your condition and other medicines you are taking. Always take Perindopril tert-butylamine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not change the amount of medicine you take unless your doctor tells you. Perindopril may be used on its own, or with other medicines which lower blood pressure.

Take Perindopril tert-butylamine Tablets by mouth only.
Take them in the morning, before a meal.
It is best to take your tablet(s) with a glass of water at the same time each day.

The usual dose is:

High blood pressure:

4mg each day
after a month, this may be raised to 8mg each day.
8mg each day is the highest amount normally used.

In older people with high blood pressure the daily amounts are usually:

2mg each day
after a month, this may be raised to 4mg each day
8mg each day is the highest amount normally used.

If you are taking water tablets (diuretics):

your doctor may stop them 2 or 3 days before you start taking Perindopril tert-butylamine Tablets. This is to prevent a fall in your blood pressure.
if needed, you can start taking water tablets again after you have started Perindopril tert-butylamine Tablets. • if it is not possible to stop your water tablets, then you can take 2mg of perindopril as well.
Your doctor or pharmacist will tell you exactly what you should do.

The doctor may start you with 2mg perindopril if:

your blood pressure is very high
you have not enough water in your body (dehydrated)
you have a low level of salt in your blood
you have a heart problem which means that it has difficulty in pumping blood through your body (cardiac decompensation)
you have high blood pressure due to the blood vessels in the kidneys being blocked (constriction of the arteries)

Heart failure:

2mg each day to start
after 2 weeks, this may be raised to 4mg each day

Stable coronary artery disease:

the usual starting dose is 4mg once daily
after 2 weeks, this may be raised to 8mg each day

In older people with stable coronary heart disease the daily amounts are usually: • 2mg each day

after one week, this may be raised to4mg each day
and after a further week to 8mg each day which is the highest amount used.

If you take more Perindopril tert-butylamine Tablets than you should, talk to your doctor or pharmacist straight away. The following effects may happen: Low blood pressure, shock, kidney problems, fast breathing, fast heartbeat, uneven heartbeat (palpitations), slow heartbeat, feeling dizzy or anxious, cough.

If you forget to take Perindopril tert-butylamine Tablets

It is important to take your medicine every day. If you forget to take your tablets, take another as soon as you remember. Then take the normal amount the next day. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Perindopril tert-butylamine Tablets

Do not stop taking Perindopril tert-butylamine Tablets without talking to your doctor. Medicines for high blood pressure or heart failure will normally have to be taken for the rest of your life. If you stop taking Perindopril tert-butylamine Tablets your condition may get worse.

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

4. Possible side effects

Like all medicines Perindopril tert-butylamine Tablets can cause side effects, although not everybody gets them.

If any of the following effects happen, stop taking your tablets and tell your doctor immediately: • swelling of the face, lips, mouth, tongue or throat

difficulty in breathing
feeling dizzy or faint
very fast or uneven heartbeat.
inflamed pancreas (pancreatitis)
inflamed liver (hepatitis)
skin reaction like an allergy (erythema multiforme)
acute renal failure,
uneven heartbeat, chest pain that happens in heart disease (angina), heart attack and stroke (these have happened with ACE inhibitors in people with low blood pressure)
change in blood value such as lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets
Decreased or absent urine output
photosensitivity reaction (increased sensitivity of skin to sun).
formation of blister clusters over the skin (pemphigoid).
Genetic disorder in which abnormal break down of red blood cells (Haemolytic anaemia inpatients with a congenital deficiency of G-6PDH).
The symptoms include paleness (in darker-skinned kids, paleness is sometimes best seen in the mouth, especially on the lips or tongue, extreme tiredness or dizziness, fast heartbeat, fast breathing or shortness of breath, the skin and eyes look yellow etc... (Very rare - may affect up to 1 in 10, 000).

This is a very rare but serious reaction called angioedema, which can happen with all medicines of this type (ACE inhibitors). You must get treatment immediately, usually in hospital

Common (affecting less than 1 person in 10)

cough, shortness of breath
feeling faint due to low blood pressure (especially when you start Perindopril tert-butylamine Tablets, or when the amount is increased, or when you also take water tablets)
headache, feeling dizzy or tired, feeling dizzy with a spinning sensation (vertigo), pins and needles, muscle cramps, blurred vision, sensation of noise in the ears (tinnitus)
feeling or being sick, stomach pain or indigestion, changes in your sense of taste, diarrhoea, constipation • skin rash, itching

Uncommon (affecting less than 1 person in 100)

changes in mood or sleep
tight feeling in the chest, wheezing and short of breath (bronchospasm)
dry mouth
kidney problems
unable to get an erection
excessive sweating
very low blood sugar level
level of potassium
low level of sodium
depression

Rare (may affect up to 1 in 1000 people)

change in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin. • psoriasis worsening
dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion) • flushing

Very rare (affecting less than 1 person in 10,000)

feeling confused
chest infection (eosinophilic pneumonia), blocked up or runny nose (rhinitis)

Frequency not known (cannot be estimated from available data)

Discoloration, numbness and pain in fingers or toes (Raynaud’s phenomenon)

Reporting of side effects

If you get any side effects, talk to your doctor 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicines.

5. How to store Perindopril tert-butylamine Tablets

BLETS

Keep out of the sight and reach of children.
Store below 25°C and in the original package

Use-by date

Do not use Perindopril tert-butylamine Tablets after the expiry date which is stated on the packet after “EXP”. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Content of the pack and other information

What Perindopril tert-butylamine Tablets contain

The active substance is perindopril tert-butylamine. The other ingredients are: lactose monohydrate and magnesium stearate.

What Perindopril tert-butylamine Tablets look like and contents of the pack

Perindopril tert-butylamine 2mg Tablets are white, round biconvex tablets, engraved “PE2” on one side and plain on the other.

Perindopril tert-butylamine 4mg Tablets are white, capsule shaped biconvex tablets, engraved “PE” bisect “4” and plain” on the other. The tablets can be divided into equal halves.

Perindopril tert-butylamine 8mg Tablets are white, capsule shaped tablets, engraved “PE” bisect “8” on one side and plain on the other. The tablets can be divided into equal halves.

Blister pack (Aluminum/PVC/PVAC)

Each strength of Perindopril tert-butylamine Tablets is available in cartons of 4, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 112, 120, 500 tablets

Not all pack sizes may be available.

White HDPE Container with a white polypropylene (PP), child-resistant screw cap

Each strength of Perindopril tert-butylamine Tablets is available in cartons of 120 and 500 tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Steranco Healthcare UK Limited

Unit 2A, Olympic Way,

Sefton Business Park,

Bootle, Merseyside,

L30 1RD, UK

Manufacturer:

Medley Pharma Limited