PERINDOPRIL 4 mg Коированные Таблетки

Содержание инструкции

1. Perindopril Sandoz 4 mg tablets
   1. WHAT IS PERINDOPRIL SANDOZ AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING PERINDOPRIL SANDOZ
   3. HOW TO TAKE PERINDOPRIL SANDOZ
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PERINDOPRIL SANDOZ
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Perindopril Sandoz 4 mg tablets

Generic medicine
Read this leaflet carefully before using this medicine as 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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS PERINDOPRIL SANDOZ AND WHAT IT IS USED FOR

Perindopril belongs to a class of medicines called ACE inhibitors, which work by widening the blood
vessels, allowing the heart to pump blood more easily.
Perindopril Sandoz tablets is used for:

• the treatment of high blood pressure (hypertension);
• the treatment of heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs);
• reducing the risk of cardiac events, such as heart attacks, in patients with stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked) and in those who have already suffered a heart attack and/or have undergone surgery to improve blood flow to the heart, by widening the blood vessels.

2. WHAT YOU NEED TO KNOW BEFORE TAKING PERINDOPRIL SANDOZ

Do not take Perindopril Sandoz

• if you are allergicto perindopril or to any of the excipients of this medicine (listed in section 6) or to any other ACE inhibitor;
• if you have had symptoms such as shortness of breath, swelling of the face, tongue or throat, intense itching, skin rashes, dizziness or faintingduring previous therapy with ACE inhibitors or if you have experienced these symptoms in any other circumstance (these are symptoms of a condition called angioedema);
• if you have a hereditary tendency to develop tissue swellingor if you suffer from tissue swelling of unknown origin (hereditary or idiopathic angioedema);
• 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 pregnant for more than three months (it is best to avoid Perindopril Sandoz even in the early stages of pregnancy - see section Pregnancy)
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat). If you believe that any of the above situations apply to you, do not take the tablets. Consult your doctor and follow their advice.

Warnings and precautions
Tell your doctor beforetaking Perindopril Sandoz:

• if you are at risk of excessive drop in blood pressure. This could be the case, among other things, if you suffer from heart failure, impaired kidney function or disturbances in the balance of salts and fluids, for example because you are taking diuretic medicines (medicines that increase urine production) or following a low-salt diet or still due to vomiting or diarrhea;
• if you suffer from aortic stenosis (narrowing of the main blood vessels branching from the heart), mitral valve stenosis (narrowing of the mitral valve of the heart), hypertrophic cardiomyopathy (a disorder of the heart muscle), or renal artery stenosis (narrowing of the arteries that supply blood to the kidneys);
• if you develop hypersensitivity reactions or tissue swelling (angioedema) during treatment with perindopril or other ACE inhibitors. Angioedema occurs more frequently in patients of black race compared to patients of other races;
• if you suffer from a heart disorder;
• if you suffer from a liver disorder;
• if you suffer from kidney disorders;
• if you are undergoing dialysis;
• if you suffer from collagen disorders, such as systemic lupus erythematosus or scleroderma;
• if you have been diagnosed with a condition called hypoaldosteronism(decreased levels of aldosterone hormone in the blood)
• if you are following a low-salt dietor using salt substitutes that contain potassium;
• if you suffer from a form of diabetes that is not well controlled;
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 what is reported under “Do not take Perindopril Sandoz”.
• if you are taking any of the following medicines can increase the risk of angioedema (rapid swelling under the skin in areas such as the throat):
• racecadotril, a medicine used to treat diarrhea
• Medicines used to prevent organ rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus) and other medicines belonging to the class of mTOR inhibitors
• Vildagliptin, a medicine used to treat diabetes
• if you are breastfeeding. You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Perindopril Sandoz is not recommended in early pregnancy and must not be

taken if you are pregnant for more than three months, because it can cause serious harm to the baby if taken during this period (see section Pregnancy).
Children
Perindopril Sandoz tablets are not recommended in children.
Also tell your doctor or pharmacist that you are taking Perindopril Sandoz:

• if you have suffered from chest pain (angina pectoris);
• if you are to undergo anesthesia and/or surgery;
• if you have recently suffered from diarrhea or vomiting;
• if you are about to undergo desensitization treatmentto reduce the effects of an allergy to bee or wasp stings;
• if you are to undergo LDL apheresis(removal of cholesterol from the blood using a machine);
• if your blood pressure is not sufficiently low, due to your ethnicity (especially in patients with black skin);
• if you suffer from dry and persistent cough.

Other medicines and Perindopril Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. In particular, in order to ensure the safety of Perindopril Sandoz administration, consult your doctor if you are taking any of the following medicines:

• other medicines for the treatment of high blood pressure, including diuretics;
• Potassium supplements (including salt substitutes)
• potassium-sparing diuretics (for example spironolactone, triamterene or amiloride), and other medicines that can increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood and prevent the formation of clots);
• medicines used for the treatment of diabetes(insulin or tablets), used to lower blood sugar levels;
• lithium, used for the treatment of mania or depression;
• medicines used for the treatment of mental disorders, such as depression, anxiety, schizophrenia or other psychoses;
• allopurinol, used for the treatment of gout;
• immunosuppressants, used for the treatment of autoimmune disorders(for example rheumatoid arthritis) or for therapy following surgical transplants;
• procainamide, used to treat irregular heartbeats;
• non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain, including acetylsalicylic acid (if the dose is greater than or equal to 3 g/day);
• medicines used to treat low blood pressure, shock or asthma(for example ephedrine, norepinephrine or adrenaline);
• vasodilators, including nitrates (medicinal products that widen blood vessels);
• heparin (anticoagulantdrug).
• gold (sodium aurothiomalate), for the treatment of arthritis
• medicines used mainly for the treatment of diarrhea (racecadotril)
• medicines usually used to prevent organ rejection (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported under “Do not take Perindopril Sandoz” and “Warnings and precautions”).

If you have any doubts regarding these medicines, consult your doctor.
Tell your doctor or dentist beforeundergoing anesthesiaor surgery, as your blood pressure may drop suddenly during anesthesia.

Perindopril Sandoz with food and drink
Always take Perindopril Sandoz before a meal, with an adequate amount of liquid (for example water), in order to reduce the influence of food on the effects of the medicine.
Foods supplemented with potassium or salt substitutes should not be used if you are using Perindopril Sandoz. The concentration of potassium may increase too much. Also, a large amount of salt (NaCl) in the diet may reduce the antihypertensive effect of Perindopril Sandoz.

Pregnancy and breastfeeding

Pregnancy
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Perindopril Sandoz before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Perindopril Sandoz. Perindopril Sandoz is not recommended in early pregnancy, and must not be taken if 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 about to start breastfeeding. Perindopril Sandoz is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies have been performed on the effects that Perindopril Sandoz may have on the ability to drive vehicles or use machinery. However, even if Perindopril Sandoz does not affect the level of attention, some patients may experience reactions such as dizziness or weakness, due to the decrease in blood pressure, especially at the beginning of treatment or in connection with each dose increase. If this is your case, your ability to drive or use machinery may be impaired.

Perindopril Sandoz contains cyclodextrin
This medicine contains 11.780 mg of cyclodextrin per tablet

3. HOW TO TAKE PERINDOPRIL SANDOZ

Always take Perindopril Sandoz exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Perindopril Sandoz can be used alone or in combination with other medicines to lower blood pressure.
The normal dosage is described below.

High blood pressure: the recommended initial and maintenance dose in adults is 4 mg once a day. After one month, the dosage may be increased to 8 mg per day, which is also the maximum recommended dose.
If you are over 65 years of age, the normal initial dose is 2 mg once a day. After one month, the dosage may be increased to 4 mg per day and, if necessary, to 8 mg per day.

Heart failure: treatment should be initiated under strict medical supervision with 2 mg once a day. After two weeks, if necessary, the dosage may be increased to 4 mg per day.

Stable coronary artery disease: the normal initial dose is 4 mg once a day. After two weeks, and if the 4 mg dose is well tolerated, the dosage may be increased to 8 mg once a day.
If you are over 65 years of age, the normal initial dose is 2 mg once a day. After one week, the dosage may be increased to 4 mg once a day and after another week to 8 mg once a day.
Before increasing the dose to 8 mg, your doctor may prescribe a blood test to check that your kidneys are functioning properly.
If you have impaired kidney function, your doctor will adjust the dose of Perindopril Sandoz according to your condition.
Generally, treatment of these conditions lasts for life.
Take the tablet(s) with a glass of water, preferably at the same time each day, in the morning before a meal. If you are already taking diuretics, your doctor may decide to reduce or even discontinue them at the beginning of treatment with Perindopril Sandoz.

Use in children
Use in children is not recommended.

If you take more Perindopril Sandoz than you should
If you accidentally take too many tablets, go to the nearest hospital emergency room or inform your doctor immediately. In case of overdose, the most common effect is a lowering of blood pressure. If you experience a significant drop in blood pressure (with symptoms such as dizziness or fainting), it may help to lie down with your legs raised.

If you forget to take Perindopril Sandoz
It is important that you remember to take your dose every day. However, if you forget to take one or more doses, take another as soon as possible, then continue with your normal dosage. Do not take a double dose to make up for the forgotten dose.

If you stop taking Perindopril Sandoz
If you wish to stop treatment, do not do so without first consulting your doctor: even if you feel better, you may need to continue therapy.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Perindopril Sandoz can cause side effects, although not everybody gets them.
manifest.

Stop taking this medicine and consult your doctor immediately if you experience
any of the following side effects as they may be serious.

• swelling of the face, lips, mouth, tongue or throat
• difficulty breathing
• dizziness or fainting
• unusually fast or irregular heartbeat. These are the symptoms of a serious reaction (angioedema), which can occur with all other medicines of

this type (ACE inhibitors) and which needs immediate treatment, usually in hospital. They are not
common (may affect up to 1 in 100 people)

• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people)
• irregular heartbeat, heart attack and stroke (these have been reported with ACE inhibitors in association with low blood pressure), angina pectoris (chest tightness) (uncommon - may affect up to 1 in 100 people)
• inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (very rare - may affect up to 1 in 10,000 people)
• skin rash which often starts with red, itchy patches on the face, arms or legs resulting from allergic reactions caused by multiple factors (erythema multiforme) (very rare - may affect up to 1 in 10,000 people)
• yellowing of the skin or eyes (jaundice) which could be a sign of liver inflammation (hepatitis) (very rare - may affect up to 1 in 10,000 people)
• Not passing urine (decreased urine production) which can also occur with high temperatures (fever), nausea, fatigue, pain in the side, swelling of the legs, ankles, feet, face and hands or blood in the urine. These are due to a serious problem with the kidneys (acute renal failure) (Very rare, may affect up to 1 in 10,000 people).

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

• cough, shortness of breath
• dizziness caused by low blood pressure (especially at the beginning of therapy, with each increase in dose and when the medicine is taken in combination with diuretics)
• headache, dizziness, vertigo, fatigue, tingling, muscle cramps, visual disturbances (e.g. blurred vision, eye pain), tinnitus (ringing in the ears)
• nausea, vomiting, abdominal pain, taste alteration, indigestion, diarrhoea, constipation
• skin rashes, itching. Uncommon(may affect up to 1 in 100 people):
• changes in mood or sleep
• bronchospasm (feeling of tightness in the chest, shortness of breath and wheezing)
• dry mouth
• kidney problems
• impotence
• sweating
• urticaria

Rare(may affect up to 1 in 1,000):

• worsening of psoriasis

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

• confusion
• eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose)
• changes in blood cell counts: your doctor may decide to have you undergo blood tests at regular intervals to monitor your blood levels.

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

• hypoglycaemia (very low blood sugar level)
• vasculitis (inflammation of blood vessels)
• abnormal colour, numbness and pain in the fingers or toes (Raynaud's phenomenon).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any 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 SANDOZ

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 blister and the packaging after Exp.
The expiry date refers to the last day of the month.
Do not store at temperatures above 30°C.
Store in the original packaging, in order to protect the medicine 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Perindopril Sandoz contains
The active ingredient is perindopril erbumine.
Each tablet contains 4 mg of perindopril erbumine, equivalent to 3.338 mg of perindopril.
The excipients are: microcrystalline cellulose, silicified microcrystalline cellulose, potassium polacrilin,
silicon dioxide, anhydrous colloidal silica, magnesium stearate and hydroxypropyl-betadex (contains
cyclodextrin).

Description of the appearance of Perindopril Sandoz and package contents
Perindopril Sandoz 4 mg is presented in the form of round, white, biconvex tablets with a fracture line on one side and the number “4” on the other. The tablet can be divided into equal doses.
The tablets are packaged in aluminum/aluminum blisters and inserted into a cardboard box.
Package sizes: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 100, 112, 120 and 500
Not all package sizes may be marketed

Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni, 1, 21040 Origgio (VA)

Manufacturers
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia
LEK Pharmaceutical d.d.
Trimlini 2D
9220 Lendava
Slovenia
LEK S.A.
ul. Domaniewska 50 C,
02-672 Warszawa
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Salutas Pharma GmbH
Dieselstrasse 5
70839 Gerlingen
Germany

This medicinal product has been authorised in the member states of the EEA under the following
denominations:
Belgium: Perindopril Sandoz 2 mg tablets
Perindopril Sandoz 4 mg tablets
Czech Republic: Perindopril erbumin Sandoz 2 mg tablets
Perindopril erbumin Sandoz 4 mg tablets
Denmark: Asyntilsan
Finland: Asyntilsan
France: PERINDOPRIL Sandoz 2 mg, coated tablet
PERINDOPRIL Sandoz 4 mg, divisible coated tablet
Italy: PERINDOPRIL Sandoz
Netherlands: Perindopril tert-butylamine Sandoz 2 mg, tablets
Perindopril tert-butylamine Sandoz 4 mg, tablets
Poland: Perilan
Portugal: Perindopril Sandoz 2 mg Tablets
Perindopril Sandoz 4 mg Tablets
Slovak Republic: Perindopril Sandoz 2 mg tablets
Perindopril Sandoz 4 mg tablets
Slovenia: Voxin 2 mg tablets
Voxin 4 mg tablets
United Kingdom: Perindopril 2 mg Tablets
Perindopril 4 mg Tablets