Perindopril Sandoz

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Perindopril Sandoz 4 mg tablets

Generic medicine
Please read this leaflet carefully before using 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 PERINDOPRIL SANDOZ IS 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 are 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 heart 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 had a heart attack and/or have undergone a procedure to improve blood flow to the heart by widening the blood vessels.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PERINDOPRIL SANDOZ

Do not take Perindopril Sandoz

• if you are allergic to 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, severe itching, skin rashes, dizziness or fainting during previous treatment with ACE inhibitors, or if you have experienced these symptoms in any other circumstances (these are symptoms of a condition called angioedema);
• if you have a hereditary tendency to develop tissue swelling, or if you suffer from unexplained tissue swelling (hereditary or idiopathic angioedema);
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you are more than three months pregnant (Perindopril Sandoz should also be avoided during early pregnancy – see section Pregnancy);
• if you are taking or have recently taken 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, for example in the throat). If you think any of the above situations apply to you, do not take the tablets. Consult your doctor and follow their advice.

Warnings and precautions
Inform your doctor before taking Perindopril Sandoz:

• if you are at risk of excessive drop in blood pressure. This may be the case, for example, if you have heart failure, reduced kidney function, or disturbances in fluid and electrolyte balance, such as due to diuretic use (medicines that increase urine production), a low-salt diet, vomiting, or diarrhoea;
• if you have aortic stenosis (narrowing of the main blood vessels branching from the heart), mitral valve stenosis (narrowing of the heart's mitral valve), hypertrophic cardiomyopathy (a disorder of the heart muscle), or renal artery stenosis (narrowing of the arteries supplying 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 black patients than in patients of other races;
• if you have a heart disorder;
• if you have a liver disorder;
• if you have kidney disorders;
• if you are undergoing dialysis;
• if you have collagen disorders, such as systemic lupus erythematosus or scleroderma;
• if you have been diagnosed with a condition called hypoaldosteronism (reduced levels of the hormone aldosterone in the blood);
• if you are on a low-salt diet or using salt substitutes containing potassium;
• if you have 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 antagonist (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Perindopril Sandoz".
• if you are taking any of the following medicines, which may increase the risk of angioedema (rapid subcutaneous swelling, for example in the throat):
• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs 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 must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Perindopril Sandoz is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child when taken during this period (see section Pregnancy).

Children
Perindopril Sandoz tablets are not recommended for children.

Additionally, inform your doctor or pharmacist that you are taking Perindopril Sandoz:

• if you have suffered from chest pain (angina pectoris);
• if you are due to undergo anaesthesia and/or surgery;
• if you have recently experienced diarrhoea or vomiting;
• if you are about to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings;
• if you are due to undergo LDL apheresis (removal of cholesterol from the blood using a machine);
• if your blood pressure is not sufficiently lowered, due to your ethnicity (particularly in black patients);
• if you suffer from persistent dry cough.

Other medicines and Perindopril Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, to ensure the safe use of Perindopril Sandoz, 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 (e.g. spironolactone, triamterene or amiloride), and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
• 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 (e.g. rheumatoid arthritis) or for post-transplant therapy;
• procainamide, used to treat heart rhythm irregularities;
• 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 (e.g. ephedrine, noradrenaline or adrenaline);
• vasodilators, including nitrates (medicines that widen blood vessels);
• heparin (anticoagulant medicine);
• gold (sodium aurothiomalate), for the treatment of arthritis;
• medicines mainly used to treat diarrhoea (racecadotril);
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions". Your doctor may consider it necessary to adjust your dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take Perindopril Sandoz" and "Warnings and precautions").

If you have any doubts about these medicines, consult your doctor.
Inform your doctor or dentist before undergoing anaesthesia or surgery, as your blood pressure may drop suddenly during anaesthesia.

Perindopril Sandoz with food and drinks
Always take Perindopril Sandoz before a meal, with an adequate amount of liquid (e.g. water), to reduce the influence of food on the medicine's effects.
Foods enriched with potassium or salt substitutes should not be used while taking Perindopril Sandoz, as potassium levels may become too high. Also, a high dietary intake of salt (NaCl) may reduce the antihypertensive effect of Perindopril Sandoz.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Perindopril Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril Sandoz is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Perindopril Sandoz is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies on the effects of Perindopril Sandoz on the ability to drive or use machines have been conducted. However, although Perindopril Sandoz does not affect alertness, some patients may experience side effects such as dizziness or weakness due to lowered blood pressure, especially at the beginning of treatment or after any dose increase. If this applies to you, your ability to drive or use machines 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 prescribed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
Perindopril Sandoz may be used alone or in combination with other medicines intended to lower blood pressure.
The usual dosage is described below.
High blood pressure: the recommended initial and maintenance dose in adults is 4 mg once daily. After one month, the dosage may be increased to 8 mg daily, which is also the maximum recommended dose.
If you are over 65 years of age, the usual starting dose is 2 mg once daily. After one month, the dosage may be increased to 4 mg daily and, if necessary, to 8 mg daily.
Heart failure: treatment should be initiated under close medical supervision at a dose of 2 mg once daily. After two weeks, if necessary, the dosage may be increased to 4 mg daily.
Stable coronary artery disease: the usual initial dose is 4 mg once daily. After two weeks, and if the 4 mg dose is well tolerated, the dosage may be increased to 8 mg once daily.
If you are over 65 years of age, the usual starting dose is 2 mg once daily. After one week, the dosage may be increased to 4 mg once daily, and after another week, to 8 mg once daily.
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 for these conditions is lifelong.
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 start 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, contact the nearest hospital emergency department or inform your doctor immediately. In case of overdose, the most common effect is a drop in blood pressure. If a significant decrease in blood pressure occurs (with symptoms such as dizziness or fainting), lying down with your legs raised may be helpful.
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 it as soon as possible, then continue with your regular dosing schedule. Do not take a double dose to make up for the missed 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 well, you may still need to continue therapy.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Perindopril Sandoz may cause adverse effects, although not everyone experiences them.
Stop taking this medicine and contact 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 symptoms of a serious reaction (angioedema), which can occur with all other medicines of this type (ACE inhibitors) and which must be treated immediately, usually in a hospital. These 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 attacks 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 may cause severe abdominal and back pain accompanied by general malaise (very rare – may affect up to 1 in 10,000 people)
  • skin rash, often starting as itchy red spots on the face, arms or legs, resulting from allergic reactions caused by various 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 (low urine output), which may also occur with high temperature (fever), nausea, fatigue, flank pain, swelling of legs, ankles, feet, face and hands, or blood in the urine. These are due to a serious kidney problem (sudden kidney failure) (very rare, may affect up to 1 in 10,000 people).

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

• cough, shortness of breath
• dizziness caused by low blood pressure (especially at the start of treatment, with any dose increase, and when the medicine is taken together with diuretics)
• headache, dizziness, vertigo, fatigue, tingling, muscle cramps, visual disturbances (e.g. blurred vision, eye pain), tinnitus (sensation of ringing in the ears)
• nausea, vomiting, abdominal pain, taste disturbances, indigestion, diarrhoea, constipation
• skin rashes, itching

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

• mood or sleep disturbances
• bronchospasm (feeling of chest tightness, shortness of breath and difficulty breathing)
• dry mouth
• kidney problems
• impotence
• sweating
• urticaria

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

• worsening of psoriasis

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

• confusion
• eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose)
• changes in blood cell counts: your doctor may decide to perform regular blood tests to monitor your blood values.

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

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

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse 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 packaging after Exp.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via 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 PACKAGE AND OTHER INFORMATION

What Perindopril Sandoz contains
The active substance 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 polacriline,
silicon dioxide, anhydrous colloidal silica, magnesium stearate and hydroxypropyl betadex (contains
cyclodextrin).

Description of the appearance of Perindopril Sandoz and the contents of the pack
Perindopril Sandoz 4 mg tablets are white, round, biconvex tablets with a break line on one side and the number "4" engraved on the other. The tablet can be divided into equal doses.
The tablets are packaged in aluminium/aluminium blisters and placed in cardboard boxes.
Pack sizes: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 100, 112, 120 and 500 tablets.
Not all pack sizes may be marketed.

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

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 EEA Member States under the following names:
Belgium: Perindopril Sandoz 2 mg tabletten
      Perindopril Sandoz 4 mg tabletten
Czech Republic: Perindopril erbumin Sandoz 2 mg tablety
        Perindopril erbumin Sandoz 4 mg tablety
Denmark: Asyntilsan
Finland: Asyntilsan
France: PERINDOPRIL Sandoz 2 mg, comprimé
    PERINDOPRIL Sandoz 4 mg, comprimé sécable
Italy: PERINDOPRIL Sandoz
Netherlands: Perindopril tert-butylamine Sandoz 2 mg, tabletten
      Perindopril tert-butylamine Sandoz 4 mg, tabletten
Poland: Perilan
Portugal: Perindopril Sandoz 2 mg Comprimidos
     Perindopril Sandoz 4 mg Comprimidos
Slovak Republic: Perindopril Sandoz 2 mg tablety
       Perindopril Sandoz 4 mg tablety
Slovenia: Voxin 2 mg tablete
     Voxin 4 mg tablete
United Kingdom: Perindopril 2 mg Tablets
        Perindopril 4 mg Tablets