Patient Information Leaflet

Perindopril/Indapamida Sandoz 2 mg/0.625 mg Tablets EFG

perindopril erbumina/indapamida.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Perindopril/Indapamida Sandoz

4. Possible side effects

5. Storage of Perindopril/Indapamida Sandoz

6. Contents of the pack and additional information

Perindopril/Indapamida is an association of two active principles, perindopril and indapamida. This medicationis used for the treatment of high blood pressure (hypertension).

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

Each of the active principles reduces blood pressure and acts in conjunction to control blood pressure.

Do not take Perindopril/Indapamida Sandoz

• if you areallergicto perindopril or any other angiotensin-converting enzyme (ACE) inhibitor, to indapamida or other sulfonamides, or to any of the other components of this medication (listed in section 6 and at the end of section 2),
• if you have experienced symptoms such asdifficulty breathing with wheezing, facial or tongue swelling, intense itching, or severe skin eruptionswith previous treatment with ACE inhibitors or if you or a family member has had these symptoms in any other circumstance (a condition known asangioedema),
• if you have asevere liver diseaseor suffer from a condition calledhepatic encephalopathy(a degenerative brain disease),
• if you have asevere kidney diseasedue to decreased blood flow to your kidneys (renal artery stenosis),
• ifyou are receiving dialysis, or any other type of blood filtration.
• ifyou havediabetes or kidney insufficiencyand are being treated with a medication to lower blood pressure that containsaliskirén,
• if you havelow or high potassium levels in your blood,
• if you suspect that you may haveuntreated heart failure(severe fluid retention, difficulty breathing),
• if you aremore than 3 months pregnant(equally, it is best to avoid perindopril/indapamida at the beginning of pregnancy - see pregnancy section),
• if you are inlactation(see lactation section),
• if you have taken or are currently takingsacubitril/valsartán, a medication used to treat a type of 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 doctorbeforestarting to take Perindopril/Indapamida Sandoz:

• if you haveaortic stenosis(narrowing of the main blood vessel that leaves the heart),
• if you havemitral valve stenosis(narrowing of the left heart valve),
• if you havehypertrophic cardiomyopathy(heart muscle disease),
• if you haverenal artery stenosis(narrowing of the artery that carries blood to the kidney),
• if you haveheart failure or any otherheart problem,
• if you have kidney problems, or if you are receiving dialysis,
• if you haveabnormally high levels of a hormone called aldosteronein your blood (primary aldosteronism),
• if you haveliver problems,
• if you suffer from acollagen disease(skin disease) such as systemic lupus erythematosus or scleroderma,
• if you haveatherosclerosis(hardening of the arteries),
• if you suffer fromhyperparathyroidism(overactivity of the parathyroid gland),
• if you havegout,
• if you havediabetes,
• if you are following alow-sodium dietor using salt substitutes that containpotassium,
• if you are takinglitioorpotassium-sparing diuretics(such as eplerenone, spironolactone, triamterene) or potassium supplements, as simultaneous use with perindopril/indapamida should be avoided (see “Other medications and Perindopril/Indapamida Sandoz”),
• if you have asevere allergic reactionwith facial, lip, mouth, tongue, or throat inflammation 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,
• ifyou aretakingany of the following medications used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartan, telmisartan, irbesartan) - particularly if you have kidney problems related to diabetes,
• aliskirén.

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

See also the information under the heading “Do not take Perindopril/Indapamida Sandoz”,

• if you are ahemodialysis patient with high-flow membranes.,
• if you are taking any of the following medications, the risk ofangioedema (rapid swelling under the skin in an area such as the throat)may be increased:
• racecadotrilo, a medication used to treat diarrhea,
• medications used to prevent organ transplant rejection (e.g., temsirolimus, sirolimus, everolimus, and other medications belonging to the class of medications called mTOR inhibitors),
• vildagliptina, a medication used to treat diabetes,
• ifyou areover70 years old,
• if you are of black origin, as you may have a higher risk of angioedema and this medication may be less effective in lowering your blood pressure than in patients who are not of black origin,
• if you suspect that you may be (or could become)pregnant. Perindopril/indapamida is not recommended at the beginning of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used at this stage of pregnancy (see pregnancy section).

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

• if you areabout to undergo anesthesiaand/orsurgery,
• if you have recently experienceddiarrheaorvomiting, or aredehydrated,
• if you have noticed an increase in skin sensitivity tosunlight,
• if you havedry coughpersistently,
• if you haveabdominal pain with or without nausea or vomiting; these may be symptoms of a severe allergic reaction called angioedema intestinal,
• if you are about to undergodialysisorLDL apheresis(blood filtration to remove cholesterol),
• if you are about to receiveallergy desensitizationto reduce the effects of an allergy to bees or wasps,
• if you are about to undergo a medical examination that requires the injection of acontrast agent containing iodine(a substance that makes organs such as the kidney or stomach visible with X-rays),
• if you experiencea decrease in vision or eye painwhile taking perindopril/indapamida. These may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure (glaucoma) and can occur within hours to a week after taking perindopril/indapamida. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this.

You should discontinue treatment with perindopril/indapamida and seek medical attention.

Children and adolescents

Do not give this medication to children and adolescents.

Other medications and Perindopril/Indapamida Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Avoidtaking this medication with:

• litio(used to treat depression),
• potassium supplements(including salt substitutes),
• potassium-sparing diuretics(such as eplerenone, spironolactone, triamterene),
• and other medications that can increase the amount of potassium in your blood (e.g.trimetoprimandcotrimoxazolalso known as trimetoprim/sulfamethoxazole for bacterial infections;ciclosporina, an immunosuppressant medication used to prevent organ rejection in transplant patients andheparina; a medication used to thin the blood to prevent clot formation),
• estramustina (used in cancer treatment).

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

• other medications for the treatment ofhigh blood pressure,

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

• other medications for treatingheart rhythm problems(e.g., procainamide, digoxin, hydroquinidine, disopyramide, quinidine, amiodarone, sotalol, difemanil),
• potassium-sparing diuretics used inheart failure treatment:eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• sacubitril/valsartán(used to treat chronic heart failure). See sections “Do not take Perindopril/Indapamida Sandoz” and “Warnings and precautions”,
• antihistaminesfor hay fever or allergies such as p. e., terfenadine, astemizol, mizolastina,
• bepridil(for angina pectoris),
• benzamidas(for psychiatric disorders p. e., sultoprida),
• butyrophenones(for psychiatric disorders p.ej., haloperidol),
• anesthetics,
• ionized contrast agents,
• cisaprida(used to treat gastrointestinal and digestive problems),
• eritromicinafor injection (an antibiotic),
• moxifloxacinooresparfloxacino(antibiotics),
• metadona(anti-addictive medication),
• alopurinol(for gout),
• corticoesteroidesused to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressorsused to treat autoimmune disorders or after a transplant to prevent rejection (e.g., ciclosporina, tacrolimus),
• medications for cancer treatment,
• halofantrina(for malaria),
• pentamidina(for pneumonia),
• vincamina(for cognitive impairment symptoms in elderly patients),
• baclofeno(for muscle stiffness that occurs in diseases such as multiple sclerosis),
• medicationsfor diabetes such as insulin, metformin, glimepiride, vildagliptin, and other gliptins,
• calcioincluding calcium supplements,
• laxatives(e.g., senna),
• nonsteroidal anti-inflammatory drugs (NSAIDs) forpain relief(e.g., ibuprofen)or high doses of salicylates (e.g.,aspirin),
• anfotericina Binjectable (for severe fungal infections),
• medications for treating mental disorders such as depression, anxiety, schizophrenia (e.g.tricyclic antidepressants,neuroleptics),
• tetracosactida(for Crohn's disease treatment),
• oro(sodium aurothiomalate) injectable (medication for rheumatic disorders),
• vasodilatorsincluding nitrates (medications that make blood vessels wider),
• medications used forlow blood pressure treatment, shock, or asthma(e.g., ephedrine, noradrenaline, or adrenaline)
• medications that are often used to treat diarrhea (racecadotrilo) or prevent organ rejection after transplant (sirolimus, everolimus, temsirolimus, and other medications belonging to the class of medications called mTOR inhibitors). See section “Warnings and precautions”.

Consult your doctor if you are unsure about these medications.

Perindopril/Indapamida Sandoz with food and drinks and alcohol

Be especially careful if you are on a low-sodium diet. Consult your doctor before taking this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor if you are (or think you may be) pregnant. Your doctor will usually advise you to stop taking perindopril/indapamida before becoming pregnant or as soon as possible if you are pregnant and recommend taking another medication instead of perindopril/indapamida. Perindopril/indapamida is not recommended in the first months of pregnancy and should 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.

Lactation

You should not take perindopril/indapamida if you are breastfeeding.

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

Driving and operating machines

This medication does not affect your alertness, but due to the decrease in blood pressure, you may feel dizzy or weak, especially at the beginning of treatment or when increasing the dose. If this occurs, it may affect your ability to drive and operate machines.

Perindopril/Indapamida Sandoz contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated 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 a day. Your doctor may decide to increase the dose to 2 tablets a day.

Advanced age

Your doctor will decide what is the best dose for you. Occasionally, your doctor may start treatment with one tablet of perindopril/indapamida once a day.

Patients with renal insufficiency

Your doctor may decide to modify the dosing regimen if you suffer from renal insufficiency.

Use in children and adolescents

This medication should not be administered to children and adolescents (see “Warnings and precautions”).

If you take more Perindopril/Indapamida Sandoz than you should

If you ingest too many tablets, contact your doctor immediately or go to the emergency department of your nearest hospital. The most frequent symptom in case of overdose is a decrease in blood pressure. If a significant decrease in blood pressure occurs (symptoms such as dizziness or fainting), it may help to lie down with your legs elevated.

If you have taken more Perindopril/Indapamida Sandoz than you should, consult your doctor, your pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Perindopril/Indapamida Sandoz

It is essential to take this medication every day since continuous treatment is more effective. However, if you forgot to take a dose, take the next dose at the usual time. Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Perindopril/Indapamida Sandoz

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, INTERRUPT treatment with this medicine and contact your doctor immediately.These are symptoms of asevere allergic reactionand should be treatedimmediatelyand usually in ahospital:

• swelling of the face, eyes, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema) (see section 2 “Warnings and precautions”) (infrequent, may affect up to 1 in 100 people),
• chest tightness, wheezing, and shortness of breath (bronchospasm) (infrequent, 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 patches with itching on the face, arms, or legs) or intense skin rash, urticaria, skin redness 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 immediatelyif you experience any of the following side effects:

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

• liver disorder with severe or absent urine production that may also be accompanied by fever, nausea, fatigue, side pain, swelling of the legs, ankles, feet, face, and hands, or blood in the urine (acute renal failure),
• dark urine, nausea, or vomiting, muscle cramps, confusion, and seizures. This may be a sign of a condition called SIHAD (inadequate secretion of antidiuretic hormone).

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

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

Unknown frequency(frequency cannot be estimated from available data):

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

Other side effects

Frequent:may affect up to 1 in 10 people

• constipation,
• nausea,
• vomiting,
• discomfort after eating (dyspepsia),
• abdominal pain,
• diarrhea,
• gastrointestinal disturbances,
• dry cough,
• difficulty breathing,
• vision disturbances,
• ringing or buzzing 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)
• laboratory value changes: low potassium levels.

Infrequent:may affect up to 1 in 100 people

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

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

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

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

• reduction in the number of platelets,
• reduction in the number of white blood cells in the blood, which makes infections more likely,
• reduction in the number of red blood cells that may cause pale skin and produce weakness or shortness of breath (aplastic anemia or hemolytic anemia),
• low hemoglobin levels,
• eosinophilic pneumonia (a rare type of pneumonia),
• confusion,
• high calcium levels in the blood,
• abnormal liver function.

Unknown frequency(frequency cannot be estimated from available data)

• abnormal ECG tracing,
• laboratory parameter changes studied in blood analysis: elevated uric acid levels and elevated 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.

May occur blood disorders, kidney, liver, or pancreas problems and changes in laboratory parameters (blood analysis). Your doctor may need to perform blood tests to monitor your condition.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears 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.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Perindopril/Indapamida Sandoz

• The active ingredients are perindopril erbumina and indapamida. Each tablet contains 2 mg of perindopril erbumina, equivalent to 1,669 mg of perindopril, and 0.625 mg of indapamida.
• The other components are: hydroxypropylbetadex, lactose monohydrate, povidone K25, microcrystalline cellulose, colloidal anhydrous silica, hydrated colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

White, oblong, biconvex, scored, and engraved with “PI” on one face (score between the P and the I).

The score should not be used to break the tablet.

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.

Only some package 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

95 010 Strykow

Poland

or

Lek Pharmaceuticals, d.d.

Trimlini 2D

9220 Lendava

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica

Perindopril/Indapamide Sandoz 2 mg/0.625 mg tabletten

Francia

PERINDOPRIL/ INDAPAMIDE Sandoz 2 mg/0,625 mg, comprimé

Polonia

Panoprist

Portugal

Perindopril + Indapamida Sandoz

Eslovenia

Voxim Combo 2 mg/0.625 mg tablete

Eslovaquia

PERINDASAN 2 mg/0,625 mg tablety

Last review date of this leaflet: December 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es