PERINDOPRIL 4 mg Tabletki Powlekane

Treść ulotki

1. Perindopril Sun 4 mg tablets
   1. What is Perindopril Sun and what it is used for
   2. What you need to know before taking Perindopril Sun
   3. How to take Perindopril Sun
   4. Possible side effects
   5. How to store Perindopril Sun
   6. Contents of the pack and other information

Perindopril Sun 4 mg tablets

(perindopril tert-butylamine)

Generic medicine
Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this

Contents of this leaflet:

• 1. What Perindopril Sun is and what it is used for
• 2. What you need to know before you take Perindopril Sun
• 3. How to take Perindopril Sun
• 4. Possible side effects
• 5. How to store Perindopril Sun
• 6. Contents of the pack and other information

1. What is Perindopril Sun and what it is used for

Perindopril Sun belongs to a group of medicines called “Angiotensin Converting Enzyme Inhibitors” (ACE). ACE inhibitors work by widening blood vessels and making it easier for the heart to pump blood through them.

Perindopril Sun is used for:

• treating high blood pressure(hypertension)
• treating heart failure(a condition where the heart cannot pump blood with enough force to meet the body's needs).
• reducing the risk of cardiac events, such as a heart attack, in patients with stable coronary artery disease(a condition in which the blood supply to the heart is reduced or blocked due to narrowing of the blood vessels) and who have previously had a heart attack and/or surgery to improve blood supply to the heart.

2. What you need to know before taking Perindopril Sun

Do not take Perindopril Sun:

• If you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor,
• if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member have experienced such symptoms in any other circumstance (a condition called angioedema).
• If you are pregnant for more than three months. (It is also best to avoid Perindopril Sun at the beginning of pregnancy, see section “Pregnancy ”).
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• If you are undergoing dialysis or are undergoing any other type of blood filtration. Depending on the type of machinery used, Perindopril Sun may not be suitable for you.
• If you have kidney problems due to insufficient blood supply to the kidneys (renal artery stenosis)
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Perindopril Sun:

• if you have aortic stenosis (narrowing of the main blood vessel leading to the heart), hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys)
• if you suffer from other heart problems
• if you have liver problems
• if you have kidney problems or are undergoing hemodialysis.
• if you have a high abnormal concentration of the hormone aldosterone in the blood (primary aldosteronism)
• if you suffer from a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma
• if you have diabetes and are taking antidiabetic medicines including insulin to control diabetes (blood must be monitored for low glucose levels, especially during the first month of treatment)
• if you are following a strictly salt-free or low-salt diet or if you are taking salt substitutes containing potassium,.
• if you have recently had episodes of diarrhea and/or vomiting or are dehydrated.
• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-black patients.
• If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARB) [also known as sartans, for example valsartan, telmisartan, irbesartan], especially if you have kidney problems related to diabetes.
• aliskiren.
• If you are taking any of the following medicines, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhea.
• medicines used to prevent organ rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• vildagliptin, a medicine used to treat diabetes.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.
Angioedema
Angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril tert-butylamine. This can occur at any time during treatment. If you develop such symptoms, you should stop taking Perindopril Sun and consult a doctor immediately. See also section 4.
See also what is reported in the section “Do not take Perindopril Sun”.
During treatment, inform your doctor or pharmacist:

• if you develop signs of an infection (e.g. sore throat, fever)
• if you develop jaundice (yellowing of the skin or whites of the eyes)
• If you are to undergo anesthesia and/or major surgery;
• If you are to undergo a treatment called LDL apheresis (a procedure in which cholesterol is removed from the blood using a special machine).
• If you are to undergo a desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• if you think you are (or might be) pregnant. Perindopril Sun is not recommended at the beginning of pregnancy and should not be taken if you are pregnant for more than 3 months as it can cause serious harm to the baby (see section “Pregnancy ”)

Children and adolescents
The use of perindopril tert-butylamine is not recommended in children and adolescents under the age of 18 years..

Other medicines and Perindopril Sun
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Perindopril Sun can affect the way other medicines work and some medicines can have an effect on Perindopril Sun. In particular, tell your doctor if you are taking any of the following medicines:

• other medicines used to treat high blood pressure such as diuretics;
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium;
• 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), other medicines that can increase potassium in the body (e.g. co-trimoxazole also known as trimethoprim/sulfamethoxazole);
• lithium (used to treat manic-depressive disorders).
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen or diclofenac), for pain relief or high doses of aspirin
• Medicines used to treat diabetes (such as gliptins, insulin or metformin)
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis).
• Medicines used to treat mental illnesses, such as depression, anxiety, psychosis or schizophrenia (e.g. tricyclic antidepressants, antipsychotics).
• immunosuppressants (medicines that reduce the body's defense mechanism), used for the treatment of autoimmune diseases or following organ transplant surgery (e.g. cyclosporine, tacrolimus);
• trimethoprim (used for the treatment of infections);
• estramustine (used in cancer therapy);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm problems);
• vasodilators such as nitrates (medicines that widen blood vessels, such as nitroglycerin and other nitrates);
• medicines used to thin the blood (e.g. heparin);
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline);
• injectable gold (used for the treatment of arthritis);

Treatment with Prindopril Sun may be affected by other medicines. Your doctor may need to adjust the dose and/or take other precautions. These include:

• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also what is reported under “Do not take Prindopril Sun” and “Warnings and precautions”).
• medicines more often used to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See the section “Warnings and precautions”.
• sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, see also the section “Do not take Prindopril Sun”

Perindopril Sun with food and drink
Perindopril Sun should be taken before meals.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.
Pregnancy
You must tell your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Perindopril Sun tablets before starting a pregnancy or as soon as you confirm you are pregnant and will advise you on another medicine instead of Perindopril Sun. Perindopril Sun is not recommended at the beginning of pregnancy and should not be taken when you are pregnant for more than three months as it can cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are starting to breastfeed. Perindopril Sun is not recommended for mothers who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newly born or premature.

Driving and using machines
Perindopril Sun usually does not affect alertness, but in some patients dizziness or weakness may occur due to low blood pressure and this may affect the ability to drive or operate machinery. You must be sure how you react to Perindopril Sun before driving or operating machinery or starting any other activity that may be dangerous if you are not alert.

Perindopril Sun tablets 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.

3. How to take Perindopril Sun

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Take the tablet by swallowing it with a glass of water, preferably every day at the same
time, in the morning, before a meal. Your doctor will decide the appropriate dose for you.

Dose
The following information relates to the usual dose of Perindopril Sun. Your doctor may
occasionally change your dose to make sure you get the best results from this
medicine. Follow your doctor's instructions.
The recommended dose is:

High blood pressure:
the usual starting dose of Perindopril Sun is one 4 mg tablet once a day, in the morning. According to
your response to treatment, after one month, your doctor may decide to increase the dose to 8
mg once a day. The maximum recommended dose for the treatment of high blood pressure is 8 mg
per day.

Elderly patients with high blood pressure:
If you are over 65 years old, the usual starting dose is 2 mg once a day. After one month this dose
may be increased to 4 mg once a day and then, if necessary, to 8 mg once a day.

Heart failure:the usual starting dose is 2 mg once a day. After two weeks,
this dose may be increased to 4 mg once a day, which is the maximum
recommended dose for heart failure.

Stable coronary artery disease:the usual starting dose is 4 mg once a day. After two weeks,
this dose may 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 over 65 years old, the usual starting dose is 2 mg once a day. After one week this
dose may be increased to 4 mg once a day and after another week to 8 mg once a day.

Patients with kidney problems:
If you have kidney problems, your doctor will adjust the dose depending on how well your kidneys are working.

If you take more Perindopril Sun than you should
If you have taken too many tablets, consult your doctor or go immediately to the nearest emergency
room. The most likely effect of an overdose is a lowering of blood pressure
which may cause dizziness or fainting. In this case, lying down with your legs raised may be
helpful. Other side effects may include: kidney failure, shock, imbalance of minerals in the
body, rapid or deep breathing, increased heart rate, irregular heartbeat,
slowed heart rate, anxiety and cough.

If you forget to take Perindopril Sun
It is important to take the medicine every day, as regular treatment gives better results. If
you forget to take the tablet, take the forgotten tablet as soon as you remember. However,
if it is almost time to take your next dose, skip the forgotten dose and return to your regular schedule. Do
not take a double dose to make up for a forgotten dose.

If you stop taking Perindopril Sun
Because treatment with Perindopril Sun usually lasts for a long period of your life, you should talk to
your doctor before stopping taking this medicine.
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 side effects, stop taking Perindopril Sun and contact your
doctor immediately or go to the emergency room of the nearest hospital.
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 breathing (angioedema)
• sudden shortness of breath, chest pain, wheezing or difficulty breathing (bronchospasm)
• intense itching or severe skin rash, formation of blisters on the skin (pemphigoid);
• decreased or absent urine production, cloudy urine, pain during urination or lower back pain (these may be signs of serious kidney problems).

Very rare (may affect up to 1 in 10,000 people):

• unusually fast or irregular heartbeat, chest pain (angina) or heart attack
• weakness of the arms or legs or speech problems, which could be a sign of a possible stroke
• inflamed pancreas that can cause severe abdominal pain and back pain accompanied by feelings of severe discomfort
• yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis
• skin rashes that often start with red, itchy spots on the face, arms or legs (erythema multiforme)).
• blood disorders, such as a decrease in the number of all or some types of blood cells - you may notice paleness of the skin, headache, an increase in infections such as sore throat, mouth ulcers, etc. with fever, an increase in unexplained bruising or bleeding, or feeling tired, dizzy, short of breath and weak;
• eosinophilic pneumonia (a rare type of pneumonia). You may develop a cough, high fever and difficulty breathing.

Other possible side effects:
Common (may affect up to 1 in 10 people):

• headache, dizziness, vertigo (a sensation of spinning) and tingling,
• vision disturbances,
• tinnitus (ringing in the ears),
• dizziness due to low blood pressure
• cough, shortness of breath,
• gastrointestinal disorders (nausea (feeling sick), vomiting, abdominal pain, altered taste, indigestion or difficulty digesting, diarrhea, constipation),
• allergic reaction (e.g. skin rash, itching),
• muscle cramps,
• feeling weak or tired.

Uncommon (may affect up to 1 in 100 people):

• mood swings;
• depression;
• fast heartbeat, palpitations;
• sleep disturbances;
• dry mouth;
• impotence;
• excessive sweating;
• increased eosinophils in the blood (a type of white blood cells). This can be revealed by blood tests;
• drowsiness;
• fainting;
• vasculitis (inflammation of blood vessels);
• photosensitivity reactions (increased sensitivity of the skin to sunlight);
• arthralgia (joint pain), and myalgia (muscle pain);
• chest pain;
• peripheral edema (swelling of the hands or feet/ankles);
• fever;
• falls;
• high potassium levels in the blood (reversible upon discontinuation of treatment);
• low sodium levels in the blood;
• hypoglycemia (very low blood sugar levels). This is important in patients with diabetes;
• increased urea and creatinine in the blood. These can be detected in blood tests Rare (may affect up to 1 in 1000):
• increased levels of liver enzymes, high serum bilirubin levels. This can be found in blood tests;
• worsening of psoriasis;
• dark urine, feeling sick (nausea) or feeling unwell (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion);
• decreased or absent urine production;
• flushing;
• acute renal failure (sudden inability of the kidneys to function properly).

Very rare (may affect up to 1 in 10,000 people):

• confusion,
• rhinitis (stuffy or runny nose),
• changes in blood values such as low numbers of white and red blood cells, hemoglobin and platelets.

Frequency not known (the frequency cannot be estimated from the available data):

• discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

If you experience these symptoms, contact your doctor as soon as possible.

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 through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store Perindopril Sun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril Sun contains
The active ingredient is perindopril tert-butylamine. Each tablet contains 4 mg of perindopril tert-
butylamine.
The other ingredients are:
Lactose monohydrate
microcrystalline cellulose (E460)
magnesium stearate (E470b)
anhydrous colloidal silica (E551)

Description of the appearance of Perindopril Sun and contents of the pack
Perindopril Sun 4 mg tablets; white to off-white round tablets with ‘ P’
and ‘ 5’engraved on both sides of the score line on one side and a score line on the other side.
Dimensions - Diameter: 5.1 mm, Thickness: 2.15 mm (1.9 mm – 2.4 mm)
The tablets can be divided into equal doses.
Perindopril Sun 4 mg tablets are available in blisters containing 14, 30, 60 and 90 tablets.
A hospital pack of 1x500 tablets is also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sun Pharmaceutical Industries (Europe) B.V.
Polaris Avenue 87
2132 JH
B.V. 1441408 Netherlands

Local Representative:
Sun Pharma Italia S.r.l. - Viale Giulio Richard, 3 - 20143 Milan
Manufacturers
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands
Terapia S.A.
124 Fabricii Str.
400 362 Cluji-Napoca
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Italy: Perindopril Sun 4 mg tablets
Netherlands: Perindopril tert-butylamine SUN 4 mg tablets
Spain: Perindopril 4mg comprimidos SUN