Perindopril/indapamide Sandoz 4 mg/1.25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Perindopril/Indapamide Sandoz 4 mg/1.25 mg tablets EFG

perindopril erbumine / indapamide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

• Perindopril belongs to a group of medicines known as ACE inhibitors. These work by widening the blood vessels, allowing your heart to pump blood through them more easily.
• Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it produces only 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 taking Perindopril/Indapamida Sandoz

Do not take Perindopril/Indapamida Sandoz

• if you are allergic to 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, facial or tongue swelling, intense itching, or severe skin rashes during previous treatment with ACE inhibitors, or if you or a family member has ever had these symptoms under any circumstances (a condition called angioedema),
• if you have severe liver disease or suffer from a condition known as hepatic encephalopathy (degenerative brain disorder),
• if you have severe kidney disease due to reduced blood flow to your kidneys (renal artery stenosis),
• if you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, perindopril/indapamide may not be suitable for you,
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have low or high levels of potassium in your blood,
• if you suspect you may have untreated decompensated heart failure (severe fluid retention, breathing difficulty),
• if you are more than 3 months pregnant (likewise, it is better to avoid perindopril/indapamide early in pregnancy – see pregnancy section),
• if you are breastfeeding (see breastfeeding),
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, e.g., in the throat) is high.

Warnings and precautions

Talk to your doctor before starting Perindopril/Indapamida Sandoz:

• if you have narrowing of the main blood vessel leaving the heart (aortic stenosis),
• if you have narrowing of the left heart valve (mitral valve stenosis),
• if you have heart muscle disease (hypertrophic cardiomyopathy),
• if you have narrowing of the artery supplying blood to the kidney (renal artery stenosis),
• if you have heart failure or any other heart problems,
• if you have kidney problems, or if you are undergoing dialysis,
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have liver problems,
• if you suffer from a collagen disease (skin disorder) such as systemic lupus erythematosus or scleroderma,
• if you suffer from atherosclerosis (hardening of the arteries),
• if you have hyperparathyroidism (overactive parathyroid gland),
• if you suffer from gout,
• if you have diabetes,
• if you are on a low-salt diet or using salt substitutes containing potassium,
• if you are taking lithium or potassium-sparing diuretics (e.g., spironolactone, triamterene) or potassium supplements, as concomitant use with perindopril/indapamide should be avoided (see “Other medicines and Perindopril/Indapamida Sandoz”),
• if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment. If you develop these symptoms, stop treatment immediately and contact your doctor without delay,
• if you are taking any of the following medicines for high blood pressure:
• angiotensin II receptor antagonists (ARBs) (also known as "sartans" – e.g., 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 information under the heading “Do not take Perindopril/Indapamida Sandoz”,

• if you are a patient undergoing hemodialysis with high-flux membranes,
• if you are taking any of the following medicines, as the risk of angioedema (rapid swelling beneath the skin, e.g., in the throat) may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent organ transplant rejection (e.g., temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of 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 have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure compared to non-Black patients,
• if you think you are (or might become) pregnant. Perindopril/indapamide is not recommended early in pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this stage (see pregnancy section).

You should also inform your doctor or pharmacist that you are taking this medicine:

• if you are about to undergo anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or are dehydrated,
• if you have noticed increased skin sensitivity to sunlight,
• if you have a persistent dry cough,
• if you have abdominal pain with or without nausea or vomiting; these could be symptoms of a serious allergic reaction called intestinal angioedema,
• if you are about to undergo dialysis or LDL apheresis (removal of cholesterol from the blood by a machine),
• if you are to receive desensitization treatment to reduce effects of allergy to bees or wasps,
• if you are to undergo a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays),
• if you experience a decrease in vision or pain in one or both eyes while taking perindopril/indapamide. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye (glaucoma), which may occur within hours to weeks after taking perindopril/indapamide. This can lead to permanent vision loss if untreated. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition. This may be a sign of developing glaucoma, an increase in pressure in your eye(s).
• You must stop treatment with perindopril/indapamide and seek immediate medical attention.

Children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and Perindopril/Indapamida Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Avoid taking this medicine with:

• lithium (used to treat depression),
• potassium supplements (including salt substitutes),
• potassium-sparing diuretics (such as eplerenone, spironolactone, triamterene, amiloride),
• and other medicines that may increase potassium levels in your blood (e.g., trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection, and heparin, a medicine used to thin the blood to prevent clots),
• estramustine (used in cancer treatment).

In particular, before taking this 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 (ARB) or aliskiren (your doctor may need to adjust your dose and/or take other precautions – see also information under “Do not take Perindopril/Indapamida Sandoz” and “Warnings and precautions”), or diuretics (medicines that increase urine production by the kidneys),

• other medicines for treating heart rhythm problems (e.g., procainamide, digoxin, hydroquinidine, disopyramide, quinidine, amiodarone, sotalol, difemethiazole),
• potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
• sacubitril/valsartan (used to treat chronic heart failure). See sections “Do not take Perindopril/Indapamida Sandoz” and “Warnings and precautions”,
• antihistamines for hay fever or allergies such as terfenadine, astemizole, mizolastine,
• bepridil (for angina pectoris),
• benzamides (for psychotic disorders, e.g., sultopride),
• butyrophenones (for psychiatric disorders, e.g., haloperidol),
• anesthetic agents,
• ionized contrast agents,
• cisapride (used to treat gastric and digestive problems),
• erythromycin for injection (an antibiotic),
• moxifloxacin or sparfloxacin (antibiotics),
• methadone (anti-addiction medicine),
• allopurinol (for gout),
• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune disorders or after transplantation to prevent rejection (e.g., cyclosporine, tacrolimus),
• medicines for cancer treatment,
• halofantrine (for malaria),
• pentamidine (for pneumonia),
• vincamine (for symptomatic cognitive disorders in elderly patients),
• baclofen (for muscle stiffness in conditions such as multiple sclerosis),
• medicines for diabetes such as insulin, metformin, glimepiride, vildagliptine, and other gliptins,
• calcium, including calcium supplements,
• stimulant laxatives (e.g., senna),
• non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid),
• amphotericin B by injection (for serious fungal infections),
• medicines for treating mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics),
• tetracosactide (for Crohn's disease treatment),
• gold (sodium aurothiomalate) by injection (medicine for rheumatic disorders),
• vasodilators including nitrates (medicines to widen blood vessels),
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline),
• medicines very commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Consult your doctor if you are unsure whether any of these medicines apply to you.

Taking Perindopril/Indapamida Sandoz with food and drinks and alcohol

Exercise special caution if you are on a salt-restricted diet. Consult your doctor before taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Talk to your doctor if you are (or think you might be) pregnant. Your doctor will usually advise you to stop taking perindopril/indapamide before becoming pregnant or as soon as possible if you are already pregnant, and will recommend an alternative medicine. Perindopril/indapamide is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if used beyond the third month.

Breastfeeding

You must not take perindopril/indapamide while breastfeeding.

Contact your doctor immediately if you are breastfeeding or plan to start breastfeeding.

Driving and using machines

This medicine does not affect alertness. However, due to lowering of blood pressure, you may experience dizziness or weakness, especially at the beginning of treatment or when the dose is increased. If this occurs, your ability to drive or operate machinery may be impaired.

Perindopril/Indapamida Sandoz contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Perindopril/Indapamide Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, 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 daily.

Elderly

Your doctor will decide the most appropriate dose for you.

Patients with renal impairment

Your doctor may decide to adjust the dosage regimen if you have renal impairment.

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 have taken too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. The most common symptom in case of overdose is low blood pressure. If a significant drop in blood pressure occurs (symptoms such as dizziness or fainting), lying down with your legs raised may help.

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

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 missed dose.

If you stop taking Perindopril/Indapamide Sandoz

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

If you have any further questions about 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 everyone will experience them.

If you experience any of the following symptoms, STOP taking this medicine and contact your doctor immediately. These are symptoms of a severe allergic reaction and must be treated immediately, usually in a hospital:

• swelling of the face, eyes, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema) (see section 2 “Warnings and precautions”) (uncommon, may affect up to 1 in 100 people),
• tightness in the chest, wheezing, and shortness of breath (bronchospasm) (uncommon, 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),
• severe skin reactions including erythema multiforme (skin rash often appearing as red, itchy spots on the face, arms, or legs) or severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome), or other allergic reactions (very rare, may affect up to 1 in 10,000 people).

Also contact your doctor immediately if you experience any of the following adverse effects:

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

• liver disorder with severely reduced or absent urine output, which may also occur with increased body temperature (fever), nausea, fatigue, flank pain, swelling of the legs, ankles, feet, face, and hands, or blood in the urine (acute renal failure),
• darkened urine, malaise (nausea), or vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a disorder called SIADH (syndrome of inappropriate antidiuretic hormone secretion).

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

• abnormally rapid or irregular heartbeat,
• chest pain,
• heart attack,
• weakness in arms or legs, or speech problems that may indicate a possible stroke,
• inflamed pancreas which may cause abdominal and back pain accompanied by malaise,
• yellowing of the skin and eyes (jaundice), which 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 disorder (hepatic encephalopathy),
• sudden decrease in vision (myopia),
• decreased vision or eye pain due to elevated pressure (possible sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other adverse effects

Common: may affect up to 1 in 10 people

• constipation,
• nausea,
• vomiting,
• stomach discomfort after eating (dyspepsia),
• abdominal pain,
• diarrhoea,
• taste disturbances,
• dry cough,
• difficulty breathing,
• vision disorders,
• ringing or buzzing in the ears,
• muscle cramps,
• feeling of weakness (asthenia),
• headache,
• dizziness,
• sensation of tingling, itching, or pins and needles without apparent cause (paraesthesia),
• sensation of dizziness (vertigo),
• skin reactions (rash, hives, itching),
• changes in laboratory blood test values: low potassium levels.

Uncommon: may affect up to 1 in 100 people

• red spots on the skin (purpura),
• itchy skin rash (urticaria),
• clusters of blisters,
• mood changes and/or sleep disorders,
• depression,
• kidney disorders (renal failure),
• impotence (inability to achieve or maintain an erection),
• sweating,
• increased eosinophils (a type of white blood cells),
• changes in laboratory parameters: high blood potassium levels (reversible upon discontinuation), low blood sodium levels which may lead to dehydration and low blood pressure,
• somnolence,
• fainting,
• awareness of your own heartbeat (palpitations),
• rapid heartbeat (tachycardia),
• very low blood sugar (hypoglycaemia) in diabetic patients,
• inflammation of blood vessels (vasculitis),
• dry mouth,
• increased sensitivity of the skin to sunlight (photosensitivity reactions),
• joint pain (arthralgia),
• muscle pain (myalgia),
• chest pain,
• malaise,
• peripheral oedema,
• 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 serum bilirubin, low blood chloride levels, low blood magnesium levels,
• reduced 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 which may cause paleness of the skin and lead to weakness or shortness of breath (aplastic anaemia or haemolytic anaemia),
• lower haemoglobin,
• eosinophilic pneumonia (a rare type of pneumonia),
• confusion,
• elevated blood calcium levels,
• abnormal liver function.

Not known: frequency cannot be estimated from available data

• abnormal ECG trace,
• changes in laboratory blood parameters: elevated blood uric acid levels and elevated blood glucose levels,
• blurred vision,
• discoloration, numbness, and pain in fingers and toes (Raynaud's phenomenon),
• if you suffer from systemic lupus erythematosus (a type of collagen disease), this could worsen.

Blood, kidney, liver, or pancreas disorders 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 effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril/Indapamide Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril/Indapamide Sandoz

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

Appearance of the medicinal product and contents of the pack

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

The tablets are presented in Alu/Alu blisters packed in cardboard containers.

Pack sizes:

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

Only certain pack sizes may be commercially available.

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium Perindopril/Indapamide Sandoz 4 mg/1.25 mg tabletten

Bulgaria Daxpamil DUO 4 mg/1.25 mg tablet

Czech Republic Perinalon Combi

Finland Perindopril/Indapamid Sandoz 4 mg/1.25 mg tabletti

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

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

Poland Panoprist

Portugal Perindopril + Indapamida Sandoz

Romania: PANINDORIL 4 mg/1.25 mg comprimate

Slovenia Voxin Combo 4 mg/1.25 mg tablete

Slovakia PERINDASAN 4 mg/1.25 mg tablety

Date of the most recent review of this leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es