PERINDOPRIL/INDAPAMIDE SANDOZ 4 mg/1.25 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Perindopril/Indapamide Sandoz 4 mg/1.25 mg Tablets EFG

perindopril erbumine / indapamide

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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Perindopril/Indapamide Sandoz and what is it used for

Perindopril/Indapamide is a combination of two active substances, perindopril and indapamide. This medicine is used to treat high blood pressure (hypertension).

• Perindopril belongs to a group of medicines called ACE inhibitors. These work by widening the blood vessels, making it easier for your heart to pump blood through them.
• Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

Each of the active substances lowers blood pressure and they work together to control your blood pressure.

2. What you need to know before you take Perindopril/Indapamide Sandoz

Do not take Perindopril/Indapamide Sandoz

• if you are allergicto perindopril or any other ACE inhibitor, to indapamide or other sulfonamides or to any of the other ingredients of this medicine (listed in section 6 and at the end of section 2),
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rasheswith previous treatment with ACE inhibitors or if you or a member of your family have had these symptoms in any other circumstance (a disorder known as angioedema),
• if you have severe liver diseaseor suffer from a condition called hepatic encephalopathy(a degenerative disease of the brain),
• if you have severe kidney diseasewhere blood flow to your kidneys is reduced (renal artery stenosis),
• if you are receiving dialysis, or any other type of blood filtration. Depending on the machine used, perindopril/indapamide may not be suitable for you,
• if you have diabetes or kidney failureand are being treated with a blood pressure-lowering medicine that contains aliskiren,
• if you have low or high potassium levels in your blood,
• if you suspect you may have untreated heart failure(severe fluid retention, difficulty breathing),
• if you are pregnant for more than 3 months(also, it is best to avoid perindopril/indapamide at the start of pregnancy - see pregnancy section),
• if you are breast-feeding(see breast-feeding section),
• 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 the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Warnings and precautions

Consult your doctor beforestarting to take Perindopril/Indapamide Sandoz:

• if you have narrowing of the main blood vesselthat comes out of the heart (aortic stenosis),
• if you have narrowing of the left valve of the heart(mitral valve stenosis),
• if you have heart muscle disease(cardiomyopathy)
• if you have narrowing of the artery that supplies blood to the kidney(renal artery stenosis),
• if you have heart failure or any other heart problem,
• if you have kidney problems, or if you are receiving dialysis,
• if you have abnormally high levels of a hormone called aldosteronein your blood (primary aldosteronism),
• you have liver problems,
• you suffer from collagen disease(skin disease) such as systemic lupus erythematosus or scleroderma,
• you have atherosclerosis(hardening of the arteries),
• you suffer from hyperparathyroidism(overactivity of the parathyroid gland),
• you suffer from gout,
• you have diabetes,
• you are on a low-salt dietor are using salt substitutes that contain potassium,
• you are taking lithiumor potassium-sparing diuretics(such as eplerenone, spironolactone, triamterene) or potassium supplements, as concurrent use with perindopril/indapamide should be avoided (see "Other medicines and Perindopril/Indapamide Sandoz"),
• if you have a severe allergic reactionwith swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you develop these symptoms, discontinue treatment and contact your doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure:
• a receptor antagonist of angiotensin II (ARA) (also known as "sartans" - e.g. valsartan, telmisartan, irbesartan) - especially if you have diabetes-related kidney problems,
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading "Do not take Perindopril/Indapamide Sandoz",

• if you are a haemodialysis patientwith high-flux membranes.,
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in an area such as the throat) may be increased:
• racecadotril, a medicine used to treat diarrhoea,
• medicines used to prevent organ transplant rejection (e.g. temsirolimus, sirolimus, everolimus and other medicines belonging to the class of medicines called mTOR inhibitors),
• vildagliptin, a medicine used to treat diabetes,
• if you are over 70 years old,
• if you are of black origin, as you may be at higher risk of angioedema and this medicine may be less effective at lowering your blood pressure than in non-black patients,
• if you think you are (or might become) pregnant. Perindopril/indapamide is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used after the third month of pregnancy.

You must also inform your doctor or pharmacist if you are taking or have recently taken any other medicines.

Avoidtaking this medicine with:

• lithium(used to treat depression),
• potassium supplements(including salt substitutes),
• potassium-sparing diuretics(such as eplerenone, spironolactone, triamterene),
• and other medicines that may increase the amount of potassium in your blood (e.g. trimethoprimand co-trimoxazolealso known as trimethoprim/sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent rejection in organ transplants and heparin; a medicine used to thin the blood to prevent clot formation),
• estramustine (used in cancer treatment).

In particular, before takingthis medicine if you are taking any of the following:

• other medicines for treating high blood pressure,

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (your doctor may need to change your dose and/or take other precautions, see also the information under the headings "Do not take Perindopril/Indapamide Sandoz" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys),

• other medicines for treating heart rhythm problems(e.g. procainamide, digoxin, hydroquinidine, disopyramide, quinidine, amiodarone, sotalol, difemanil),
• potassium-sparing medicines used in heart failure treatment:eplerenone and spironolactone at doses between 12.5 mg to 50 mg per day,
• sacubitril/valsartan(used to treat long-term heart failure). See sections "Do not take Perindopril/Indapamide Sandoz" and "Warnings and precautions",
• antihistaminesfor hay fever or allergies such as e.g. terfenadine, astemizole, mizolastine,
• bepridil(for angina),
• benzamides(for psychotic disorders e.g. sultopride),
• butyrophenones(for psychiatric disorders e.g. haloperidol),
• anaesthetic medicines,
• ionized contrast agents,
• cisapride(used to treat stomach and digestive problems),
• erythromycinfor injection (an antibiotic),
• moxifloxacinor esparfloxacin(antibiotics),
• methadone(an anti-addictive medicine),
• allopurinol(for gout),
• corticosteroidsused to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressantsused to treat autoimmune disorders or after a transplant to prevent rejection (e.g. ciclosporin, tacrolimus),
• medicines for treating cancer,
• halofantrine(for malaria),
• pentamidine(for pneumonia),
• vincamine(for cognitive disorders in elderly patients),
• baclofen(for muscle stiffness occurring in diseases such as multiple sclerosis),
• medicinesfor diabetessuch as insulin, metformin, glimepiride, vildagliptin and other gliptins,
• calciumincluding calcium supplements,
• stimulant laxatives(e.g. senna),
• non-steroidal anti-inflammatory medicines (NSAIDs) for pain relief(e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid),
• amphotericin Binjectable (for severe fungal diseases),
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics),
• tetracosactide(for Crohn's disease),
• gold(sodium aurothiomalate) injectable (a medicine for rheumatic disorders),
• vasodilatorsincluding nitrates (medicines that make blood vessels wider),
• medicines used for treating low blood pressure, shock or asthma(e.g. ephedrine, noradrenaline or adrenaline)
• medicines, which are often used to treat diarrhoea(racecadotril) or prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of medicines called mTOR inhibitors). See section "Warnings and precautions".

Consult your doctor if you are not sure what these medicines are.

Taking Perindopril/Indapamide Sandoz with food and drinks and alcohol

Be particularly careful if you are on a low-salt diet. Consult your doctor before taking this medicine.

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 or pharmacist for advice before taking this medicine.

Pregnancy

Ask your doctor for advice if you are pregnant or think you may be pregnant. Your doctor will normally advise you to stop taking perindopril/indapamide before you become pregnant or as soon as possible if you are already pregnant. Perindopril/indapamide is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Do not take perindopril/indapamide if you are breast-feeding.

Consult your doctor immediately if you are breast-feeding or about to start breast-feeding.

Driving and using machines

This medicine does not affect alertness but due to the blood pressure-lowering effect, you may feel dizzy or weak, especially at the beginning of treatment or when increasing the dose. If this happens, your ability to drive or operate machinery may be affected.

Perindopril/Indapamide Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Perindopril/Indapamide Sandoz

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again.

Take the tablets with a glass of water, preferably in the morning and before meals.

Adults

The recommended dose is one tablet once a day.

Elderly

Your doctor will decide the best dose for you.

Patients with kidney problems

Your doctor may decide to adjust the dosage regimen if you have kidney problems.

Use in children and adolescents

This medicine must not be given to children and adolescents (see "Warnings and precautions").

If you take more Perindopril/Indapamide Sandoz than you should

If you ingest too many tablets, contact your doctor or go to the casualty department of your nearest hospital immediately. The most common symptom in case of overdose is low blood pressure. If low blood pressure occurs (symptoms such as dizziness or fainting), it can help to lie down with your legs raised.

If you have taken more Perindopril/Indapamide Sandoz than you should, consult your doctor, pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used.

If you forget to take Perindopril/Indapamide Sandoz

It is important to take this medicine every day as continuous treatment is more effective. However, if you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Perindopril/Indapamide Sandoz

Always consult your doctor if you want to stop treatment with this medicine. Even if you feel well, it may be necessary to continue taking this medicine.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following symptoms, STOP treatment with this medicine and contact your doctor immediately.These are symptoms of a severe allergic reactionand should be treated immediatelyand usually in a hospital:

• swelling of the face, eyes, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema) (see section 2 "Warnings and Precautions") (uncommon, may affect up to 1 in 100 people),
• chest tightness, wheezing, and shortness of breath (bronchospasm) (uncommon, may affect up to 1 in 100 people),
• severe dizziness or fainting, due to low blood pressure (frequent, may affect up to 1 in 10 people),
• severe skin reactions including erythema multiforme (skin rash that often appears with red spots with itching on the face, arms, or legs) or severe skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions (very rare, may affect up to 1 in 10,000 people).

Also, contact your doctor immediatelyif you experience any of the following adverse effects:

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

• liver disorder with severe or absent urine production that can also occur with increased temperature (fever), nausea, fatigue, side pain, swelling of the legs, ankles, feet, face, and hands, or blood in the urine (acute renal failure),
• dark urine, discomfort (nausea) or vomiting, muscle cramps, confusion, and convulsions. These can be symptoms of a disorder called SIHAD (inadequate secretion of antidiuretic hormone).

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

• abnormally fast or irregular heartbeats,
• chest pain,
• heart attack,
• weakness of arms or legs, or speech problems that can be a sign of a possible stroke,
• inflamed pancreas that can cause abdominal and back pain accompanied by discomfort,
• yellowing of the skin and eyes (jaundice) that could be a sign of hepatitis.

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

• potentially life-threatening irregular heartbeat,
• brain disease caused by liver disease (hepatic encephalopathy),
• sudden loss of vision (myopia),
• decreased vision or eye pain due to high pressure (possible sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other adverse effects

Frequent:may affect up to 1 in 10 people

• constipation,
• nausea,
• vomiting,
• stomach discomfort after eating (dyspepsia),
• abdominal pain,
• diarrhea,
• taste disorders,
• dry cough,
• breathing difficulties,
• vision disorders,
• noises or ringing in the ears,
• muscle cramps,
• feeling of weakness (asthenia),
• headache,
• feeling of dizziness,
• tingling, itching, or numbness without apparent cause (paresthesia),
• feeling of dizziness (vertigo),
• skin reactions (rash, hives, itching)
• changes in laboratory values in blood tests: low potassium levels.

.

Uncommon:may affect up to 1 in 100 people

• red spots on the skin (purpura),
• itchy skin rash (urticaria),
• groups of blisters,
• mood changes and/or sleep disorders,
• depression,
• kidney disorders (renal insufficiency),
• impotence (inability to obtain or maintain an erection),
• sweating,
• excess eosinophils (a type of white blood cell),
• changes in laboratory parameters: high potassium levels in blood reversible upon discontinuation, low sodium levels in blood that can lead to dehydration and low blood pressure,
• drowsiness,
• fainting,
• awareness of heartbeats (palpitations),
• fast heartbeats (tachycardia),
• very low blood sugar levels (hypoglycemia) in diabetic patients,
• inflammation of blood vessels (vasculitis),
• dry mouth,
• increased skin sensitivity to sunlight (photosensitivity reactions),
• joint pain (arthralgia),
• muscle pain (myalgia),
• chest pain,
• discomfort,
• peripheral edema,
• fever,
• increased blood urea,
• increased blood creatinine,
• falls.

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

• fatigue,
• worsening of psoriasis,
• changes in laboratory parameters, increased liver enzyme levels, elevated bilirubin levels, low chloride levels in blood, low magnesium levels in blood,
• decreased or absent urine production,
• flushing.

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

• reduction in platelet count,
• reduction in white blood cell count, making infections more likely,
• reduction in red blood cell count that can cause paleness of the skin and produce weakness or shortness of breath (aplastic anemia or hemolytic anemia),
• low hemoglobin,
• eosinophilic pneumonia (a rare type of pneumonia),
• confusion,
• high calcium levels in blood,
• abnormal liver function.

Not known:frequency cannot be estimated from available data

• abnormal ECG tracing,
• changes in laboratory parameters studied in blood tests: high uric acid levels and high blood sugar levels,
• blurred vision,
• discoloration, numbness, and pain in the fingers of the hands and feet (Raynaud's phenomenon),
• if you have systemic lupus erythematosus (a type of collagen disease), this may worsen.

Disorders of the blood, kidneys, liver, or pancreas and changes in laboratory parameters (blood tests) may occur. Your doctor may need to perform blood tests to monitor your condition.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Perindopril/Indapamida Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Alu/Alu Blister

Do not store above 30°C.

Keep in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Perindopril/Indapamida Sandoz

• The active ingredients are perindopril erbumina and indapamida. Each tablet contains 4.00 mg of perindopril erbumina, equivalent to 3.338 mg of perindopril, and 1.25 mg of indapamida.
• The other ingredients are hydroxypropylbetadex, lactose monohydrate, povidone K25, microcrystalline cellulose, silicified colloidal silica, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and packaging contents

White, oblong, biconvex tablets engraved with "PI" on one side.

The tablets are presented in Alu/Alu blister packs packaged in a cardboard box.

Package sizes:

7, 10, 14, 20, 28, 30, 50, 50x1, 60, 90, 100 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

SLO-1526 Ljubljana

Slovenia

or

LEK, S.A.

Ul Domaniewska 50 C

Warszawa, PL 02-672

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

LEK, S.A.

Ul Podlipie, 16

95010 Strykow)

Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium Perindopril/Indapamide Sandoz 4 mg/1.25 mg tablets

Bulgaria Daxpamil DUO 4 mg/1.25 mg tablets

Czech Republic Perinalon Combi

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Finland Perindopril/Indapamid Sandoz 4 mg/1.25 mg tablets

France PERINDOPRIL/ INDAPAMIDE SANDOZ 4 mg/1.25 mg, comprimé

Netherlands Perindopril tert-butylamine/Indapamide Sandoz 4/1.25 mg, tablets

Poland Panoprist

Portugal Perindopril + Indapamida Sandoz

Romania: PANINDORIL 4 mg/1.25 mg tablets

Slovenia Voxin Combo 4 mg/1.25 mg tablets

Slovakia PERINDASAN 4 mg/1.25 mg tablets

Date of last revision of this leaflet: December 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es