Package Insert: Information for the Patient

Perindopril/Indapamida Combix 2 mg/0.625 mg Tablets EFG

perindopril terbutilamine/indapamide

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult yourdoctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to others even if they havethe same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist, evenif they are not listed in this package insert. See section 4.

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 angiotensin-converting enzyme (ACE) inhibitors. They 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 Combix

?If you areallergicto perindopril or any other angiotensin-converting enzyme (ACE) inhibitor, indapamida or other sulfonamides, or any of the other components of this medication (listed in section 6),

??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 as angioedema),

?If you havediabetes or kidney insufficiencyand are being treated with a blood pressure medication containing aliskirén.

?If you have aserious liver diseaseor suffer from a condition calledhepatic encephalopathy(degenerative brain disease),

?If you have aserious kidney diseaseor are receiving dialysis,

?If you havelow or high potassium levels in your blood,

?If you suspect you may haveuntreated heart failure(severe fluid retention, difficulty breathing),

?If you aremore than 3 months pregnant(likewise, it is best to avoid perindopril/indapamida at the beginning of pregnancy - see "Pregnancy and breastfeeding"),

?If you are inbreastfeeding(see breastfeeding)

Children and adolescents

DO NOT give this medication tochildren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Perindopril/Indapamida Combix if:

?You haveaortic stenosis(narrowing of the main blood vessel that leaves the heart),

?You havemitral valve stenosis(narrowing of the left heart valve),

?You havehypertrophic cardiomyopathy(heart muscle disease),

?You haverenal artery stenosis(narrowing of the artery that carries blood to the kidney),

?You have any otherheart or kidney problems,

?You haveliver problems,

?You suffer from acollagen disease(skin disease) such as systemic lupus erythematosus or scleroderma,

?You haveatherosclerosis(hardening of the arteries),

?You havehyperparathyroidism(overactivity of the parathyroid gland),

?You havegout,

?You havediabetes,

?You are following alow-sodium dietor using salt substitutes that containpotassium,

?You are takinglithiumorpotassium-sparing diuretics(espironolactona, triamtereno), as simultaneous use with perindopril/indapamida should be avoided (see "Use of other medications"),

?You are taking any of the following medications used to treat high blood pressure (hypertension):

oAn angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.

oAliskirén

Your doctor may 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 Combix".

?You areover 70 years old,

??You think you are (or may become) pregnant. Perindopril/indapamida is not recommended at the beginning of pregnancy, and should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used in this stage of pregnancy (see "Pregnancy").

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

?You are toundergo anesthesiaand/orsurgery,

?You have recently experienceddiarrhea,vomiting, or aredehydrated,

?You have noticed an increase in skin sensitivity tosunlight,

?You havedry coughpersisting,

?You haveabdominal pain with or without nausea or vomiting; these may be symptoms of a serious allergic reaction called intestinal angioedema,

?You are to undergodialysis or LDL apheresis(removal of cholesterol from the blood by a machine),

?You are to receiveallergy desensitizationto reduce the effects of an allergy to bees or wasps, or are 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).

Perindopril/indapamida may be less effective in people of black race.

Use of Perindopril/Indapamida Combix with other medications

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

Avoid taking this medication with:

?Lithium (used to treat depression),

?Potassium-sparing diuretics (espironolactona, triamtereno),

?Salt substitutes containingpotassium.

In particular, consult your doctor before taking this medication if you are taking any of the following, your doctor may need to adjust your dose and/or take other precautions:

?Other medications for the treatment of high blood pressure, including angiotensin II receptor antagonists (ARA), aliskirén (see also the information under the headings "Do not take Perindopril/Indapamida Combix" and "Warnings and precautions"),

?Medications for the treatment of heart rhythm problems (e.g., procainamida, digoxina, hidroquinidina, disopiramida, quinidina, amiodarona, sotalol, difemanilo),

?antihistaminesfor hay fever or allergies such as terfenadina, astemizol, mizolastina,

?bepridil(for angina pectoris),

?benzamidas(for psychiatric disorders such as sultoprida),

?butyrophenones(for psychiatric disorders such as haloperidol),

?cisaprida(intestinal medication),

?erythromycinfor 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),

?Medications for the treatment ofcancer,

?halofantrina(for malaria),

??pentamidina(for pneumonia),

?vincamina(for cognitive impairments in elderly patients),

?baclofeno(for muscle stiffness that occurs in diseases such as multiple sclerosis),

?Medications for the treatment ofdiabetessuch as insulin, metformina, or glimepirida,

?calcio,

?laxatives(e.g., sena),

?Nonsteroidal anti-inflammatory drugs (NSAIDs) forpain reliefor high doses of salicylates (e.g.,aspirina),

?anfotericina Binjectable (for severe fungal diseases),

?Medications for the treatment of mental disorders such as depression, anxiety, schizophrenia (e.g.,tricyclic antidepressants,neuroleptics),

?tetracosactida(for the treatment of Crohn's disease),

?oro(aurotiomalato sódico) injectable (medication for rheumatic disorders).

Consult your doctor if you are unsure about these medications.

Taking Perindopril/Indapamida Combix with food, drinks, and alcohol

Take the tablets with a glass of water, preferably in the morning and before meals. Be especially careful if you are on a low-sodium diet. Consult your doctor before taking the tablets.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

Consult your doctor if you are (or think you may be) pregnant. Generally, your doctor will 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.

Breastfeeding

Do not take perindopril/indapamida if you are breastfeeding. Consult your doctor immediately if you are breastfeeding or plan to start breastfeeding.

Driving and operating machinery

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

Perindopril/Indapamida Combix contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

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

Adults

The usual dose is one tablet once a day.

Older patients

Your doctor will decide on the best dose for you.

Patients with renal insufficiency

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

Use in children and adolescents

This medication is not suitable for use in children.

If you take more Perindopril/Indapamida Combix than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Perindopril/Indapamida Combix

It is essential to take this medication every day, as continuous treatment is more effective. However, if you forget to take a dose of perindopril/indapamida, take the next dose at the usual time. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Perindopril/Indapamida Combix

Since hypertension treatment is usually lifelong, you should discuss with your doctor before stopping this medication.

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

Like all medicines, Perindopril/Indapamida Combix may cause side effects, although not everyone will experience them.

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

swelling of the face, lips, mouth, tongue, eyes, or throat,

? difficulty breathing,

? severe dizziness or fainting,

? blistering of the skin, mouth, eyes, and genitals.

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

? abnormally fast or irregular heartbeat,

? chest pain

Other side effects

Frequent(may affect up to 1 in 10 people)

? constipation,

? dry mouth,

? nausea,

? vomiting,

? stomach discomfort after eating (dyspepsia),

? abdominal pain,

? epigastric pain,

? loss of appetite,

? diarrhea,

? taste disturbances,

? dry cough,

? difficulty breathing,

? vision disturbances,

? ringing or buzzing in the ears,

? muscle cramps,

? feeling of weakness (asthenia),

? low blood pressure and dizziness or fainting when standing up,

? headache,

? feeling of dizziness,

? feeling of prickling, itching, or tingling without apparent cause (paresthesia),

? feeling of dizziness (vertigo),

? skin reactions (rash, hives, itching),

? low potassium levels in the blood.

Less frequent(may affect up to 1 in 100 people)

? red spots on the skin (purpura),

? itchy skin rash (urticaria),

? changes in mood and/or sleep disturbances,

? difficulty breathing with cough or wheezing (bronchospasm),

? swelling of the face, lips, mouth, tongue, eyes, or throat,

? kidney problems (renal insufficiency),

? impotence (inability to achieve or maintain an erection),

? sweating,

? depression.

? low sodium levels in the blood that may cause dehydration and low blood pressure.

If you have systemic lupus erythematosus (a collagen disease), it may worsen.

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

? elevated calcium levels in the blood,

? intestinal angioedema (presented with abdominal pain or with or without nausea or vomiting).

? worsening of psoriasis,

?concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and seizures. These symptoms may be due to a condition called SIADH (inappropriate secretion of antidiuretic hormone),

?decreased or absent diuresis,

?facial flushing,

?acute renal insufficiency.

? low chloride levels in the blood,

? low magnesium levels in the blood.

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

? pancreatitis (inflammation of the pancreas),

??reduction in the number of platelets,

? reduction in the number of white blood cells in the blood, making infections more likely,

? reduction in the number of red blood cells that can cause paleness in the skin and produce weakness or shortness of breath (anemia in patients who have received a kidney transplant or in patients undergoing hemodialysis, aplastic anemia, or hemolytic anemia),

? hepatitis (inflammation of the liver),

? pneumonia,

? nasal congestion or nasal discharge,

? heart problems (slow or abnormally fast heartbeat, chest pain, or heart attack),

? severe skin reactions (manifested as rash, redness of the skin, swelling of the lips, eyes, or mouth, skin peeling with or without fever),

? increased sensitivity of the skin to sunlight,

? confusion.

Unknown(the frequency cannot be estimated from available data)

? in the case of liver failure (liver problems), there is a possibility of brain disorders (change of personality, confusion, stupor, tremors, seizures, confusion, consciousness disorders),

? changes in laboratory parameters studied in blood tests.

? change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease)

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https//: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Perindopril/Indapamida Combix

-The active principles are perindopril terbutilamine and indapamida. Each tablet contains 1,669 mg of perindopril corresponding to 2 mg of perindopril terbutilamine and 0.625 mg of indapamida.

-The other components (excipients) are lactose monohydrate, microcrystalline cellulose (E460i), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

White to off-white elongated, biconvex tablets with a notch on both faces.

OPA/AL/PVC-Aluminium blister in packs of 30 tablets.

PVC/PVDC-Aluminium blister in packs of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: November 2021

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