Prospecto:information for the user

Viacorlix7mg/5mg/2,5mg coated tablets

perindopril arginina/amlodipino/indapamida

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you,as it may harm them.

• If you experience adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this prospectus. See section 4.

1.What is Viacorlix and for what it is used

2.What you need to knowbeforestarting totake Viacorlix

3.How to take Viacorlix

4.Possible adverse effects

5Storage of Viacorlix

6.Contents of the package and additional information

Viacorlix is an association of three active principles: perindopril, amlodipine, and indapamide. Viacorlix is an antihypertensive medication used for the treatment of high blood pressure (hypertension) in adults.

Patients already taking perindopril/amlodipine as a fixed-dose combination and indapamide in separate tablets can take instead a Viacorlix tablet containing the three active principles at the same doses.

Each of the active principles lowers blood pressure and all act together to control blood pressure:

-Perindopril belongs to the group of medications called angiotensin-converting enzyme (ACE) inhibitors. It acts by widening blood vessels, making it easier for the heart to pump blood through them.

-Amlodipine is a calcium channel blocker (which belongs to the group of medications called dihydropyridines). It acts by relaxing blood vessels, making it easier for blood to pass through them.

-Indapamide is a diuretic (which belongs to the group of medications called sulfonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only produces a mild increase in urine production.

Do not take Viacorlix if:

• You are allergic (hypersensitive) to perindopril or any other angiotensin-converting enzyme (ACE) inhibitor, amlodipine or any other calcium channel blocker, indapamide or any other sulfonamide, or any of the other components of this medication (listed in section 6),
• You have a severe kidney disease,
• You are receiving dialysis or any other type of blood filtration.
• You have kidney problems that cause a decrease in the amount of blood that reaches your kidneys (renal artery stenosis),
• You have taken or are currently taking sacubitril/valsartan, a medication for heart failure, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat) (see "Warnings and precautions" and "Use of Viacorlix with other medications"),
• You have a severe liver disease or suffer from a condition called hepatic encephalopathy (liver problems that affect the brain and central nervous system),
• You have low potassium levels in your blood,
• You have experienced symptoms such as wheezing, facial or tongue inflammation, intense itching, or severe skin rashes with any previous treatment with ACE inhibitors, or if you or a family member has had these symptoms in any other circumstance (a condition called angioedema),
• You are more than 3 months pregnant (it is also best to avoid Viacorlix during the early stages of pregnancy - see the Pregnancy section),
• You have very low blood pressure (hypotension),
• You have a narrowing of the aortic valve in your heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body),
• You have heart failure after a heart attack,
• You have diabetes or altered renal function and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Viacorlix if you:

• Have had photosensitivity reactions,
• Have hypertrophic cardiomyopathy (heart muscle disease),
• Have heart failure or heart rhythm problems,
• Have severe high blood pressure (hypertensive crises),
• Have any other heart problems,
• Have liver problems,
• Have kidney problems (including kidney transplant),
• Experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and can occur within hours or weeks of taking Viacorlix. If left untreated, this can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this,
• Have muscle disorders, including muscle pain, sensitivity, weakness, or cramps,
• Have abnormally elevated levels of a hormone called aldosterone in your blood (primary aldosteronism),
• Have a vascular disorder of the connective tissue (such as systemic lupus erythematosus or scleroderma),
• Have diabetes,
• Are following a low-sodium diet or using sodium substitutes that contain potassium (it is essential to maintain a balanced level of potassium in your blood),
• Are an elderly patient,
• Are taking any of the following medications used to treat high blood pressure:
• • An angiotensin II receptor antagonist (ARA) (also known as sartans - for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • Aliskiren.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) periodically. See also the information under the heading "Do not take Viacorlix".

• You are of black race, 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 race.
• You have gout,
• You need to undergo a test to check that your parathyroid gland is functioning properly,
• You are taking any of the following medications, as the risk of angioedema is higher:
• • Racecadotril (used to treat diarrhea),
  • Sirolimus, everolimus, temsirolimus, and other medications belonging to the class of inhibitors of mTor (used to prevent organ rejection and for cancer),
  • Sacubitril (available as a fixed-dose combination with valsartan), used to treat heart failure at a long-term stage,
  • Linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medications belonging to the class of gliptins (used to treat diabetes).

Angioedema:

In patients treated with ACE inhibitors, including perindopril, angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing) has been reported. This can occur at any time during treatment. If you develop these symptoms, you should discontinue treatment with Viacorlix and seek medical attention immediately. See also Section 4.

You should inform your doctor if you think you are (or could become) pregnant. Viacorlix is not recommended at the beginning of pregnancy and should not be taken after the third month of pregnancy, as it may cause severe harm to your baby if used during this stage (see the Pregnancy section).

When taking Viacorlix, you should inform your doctor or healthcare staff if you:

• Are to undergo general anesthesia and/or major surgery,
• Have recently experienced diarrhea or vomiting,
• Are to receive a treatment to reduce allergic reactions to bee or wasp stings,
• Are to undergo a medical test that requires the injection of a contrast agent containing iodine.

Your doctor may recommend that you undergo blood tests to check for low sodium or potassium levels or high calcium levels.

Athletes should be aware that Viacorlix contains an active ingredient (indapamide) that may cause a positive result in a doping test.

Children and adolescents

Viacorlix should not be administered to children or adolescents.

Use of Viacorlix with other medications

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

You should avoid taking Viacorlix with:

• Lithium (used to treat mania or depression),
• Estramustine (used to treat cancer),
• Diuretics (medications that increase the amount of urine produced by the kidneys),
• ACE inhibitors (used to treat high blood pressure and heart failure),
• Medications for heart rhythm disorders (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, cardiac glycosides, bretylium),
• Procainamide (for the treatment of irregular heart rhythm),
• Ephedrine, noradrenaline, or adrenaline (medications used to treat low blood pressure, shock, or asthma),
• Medications used to treat mental health disorders such as depression, anxiety, schizophrenia, etc. (such as tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• Antibiotics used to treat bacterial infections (such as rifampicin, injectable erythromycin, clarithromycin, esparfloxacino, moxifloxacino),
• Bepridil (used to treat angina pectoris, a condition that causes chest pain),
• Cisaprida, (used to treat decreased movement of the esophagus and stomach),
• Difemanilo (used to treat gastrointestinal problems such as ulcers, excessive acid, hyperactive digestive system),
• Vincamine injectable (used to treat cognitive impairments in elderly patients, including memory loss),
• Halofantrine (an antiparasitic medication used to treat some types of malaria),
• Pentamidine (used to treat some types of pneumonia),
• Antihistamines used to treat allergic reactions, such as hay fever (such as mizolastina, astemizol, terfenadine),
• Antifungal medications (such as itraconazole, ketoconazole, amphotericin B injectable),
• Tetracosactide (used to treat Crohn's disease),
• Laxatives,
• Medications used to treat diabetes (such as insulin, gliptins, metformin),
• Baclofen used to treat muscle rigidity in diseases such as multiple sclerosis,
• Medications that are used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day; amilorida, triamtereno,
• Nonsteroidal anti-inflammatory drugs (such as ibuprofen) to relieve pain or high doses of acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clotting,,
• Hypericum perforatum(St. John's Wort, a medicinal plant used to treat depression),
• Vasodilators, including nitrates (medications that dilate blood vessels),
• Corticosteroids (used to treat various disorders, including severe asthma and rheumatoid arthritis),
• Alpha blockers used to treat benign prostatic hyperplasia such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• Amifostine (used to prevent or reduce the side effects caused by other medications or radiation therapy used to treat cancer),
• Ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat HIV),
• Gold salts, especially in intravenous administration (used to treat symptomatic rheumatoid arthritis),
• Contrast agent containing iodine (used for X-ray tests),
• Calcium tablets or other calcium supplements,
• Immunosuppressants (medications that reduce the body's defense mechanisms) used to treat autoimmune disorders or after a transplant (such as cyclosporine, tacrolimus),
• Allopurinol (used to treat gout),
• Antiepileptic medications such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• Trimethoprim (used to treat infections),
• Methadone (used to treat addiction).

Use of Viacorlix with food and drinks

See Section 3.

People taking Viacorlix should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can cause an increase in the levels of the active ingredient amlodipine in the blood, which may lead to unpredictable lowering of blood pressure caused by Viacorlix.

Viacorlix contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, making it essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor.This includes consulting your doctor or pharmacist again if you are unsure.

The recommended dose is one Viacorlix tablet once a day.

Take the tablet preferably at the same time every day, in the morning, and before breakfast.

Do not exceed the prescribed dose.

If you take more Viacorlix than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The most common symptom of an overdose is a decrease in blood pressure that may cause dizziness or fainting. If this occurs, lying down with your legs elevated may help.

You may experience nausea (feeling of dizziness), vomiting, cramps, drowsiness, confusion, and changes in the amount of urine produced by the kidneys.

You may feel dizzy, dizzy, or weak. If your blood pressure drop is severe enough, you may experience shock. You may feel your skin cold and wet, and you may lose consciousness.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop within 24-48 hours after ingestion.

If you forget to take Viacorlix

It is essential to take this medication every day as continuous treatment works best. However, if you forget to take a dose of Viacorlix, 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 Viacorlix

Since treatment with Viacorlix is usually lifelong, you should talk to your doctor before stopping this medication.

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

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

Stop treatment with this medicine and seek medical attention immediately if you experience any of the following side effects that may be severe:

• Sudden wheezing while breathing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (rare - may affect up to 1 in 100 people),
• Swelling of the eyelids, face, or lips (rare - may affect up to 1 in 100 people),
• Swelling of the mouth, tongue, and throat, which causes severe difficulty breathing (angioedema) (rare - may affect up to 1 in 100 people),
• Severe skin reactions that include intense skin rash, blisters, skin redness, and intense itching (erythema multiforme) (very rare - may affect up to 1 in 10,000 people), blistering, peeling, and inflammation of the skin (dermatitis exfoliativa) (very rare - may affect up to 1 in 10,000 people), inflammation of mucous membranes (Stevens-Johnson syndrome) (very rare - may affect up to 1 in 10,000 people), or other allergic reactions (frequent - may affect up to 1 in 10 people), toxic epidermal necrolysis (unknown frequency - the frequency cannot be estimated from available data),
• Severe dizziness or fainting (frequent - may affect up to 1 in 10 people),
• Weakness of arms or legs or speech problems that may be a sign of a possible stroke (very rare - may affect up to 1 in 10,000 people),
• Heart attack, chest pain (angina) (very rare - may affect up to 1 in 10,000 people), irregular or abnormal heartbeats (frequent - may affect up to 1 in 10 people),
• Pancreatitis that can cause intense abdominal and back pain accompanied by severe discomfort (very rare - may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) that may be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people),
• Brain disease caused by liver disease (hepatic encephalopathy) (unknown frequency),
• Weakness, muscle cramps, muscle sensitivity or pain, and especially if you feel unwell or have a high temperature, as they may be caused by abnormal muscle breakdown. (Unknown frequency).

In decreasing order of frequency, side effects may include:

• Many frequent (may affect more than 1 in 10 people):

Edema (fluid retention).

• Frequent (may affect up to 1 in 10 people):

Low potassium levels in the blood, headache, numbness or tingling in the extremities, drowsiness (especially at the beginning of treatment), taste alterations, visual disturbances (including double vision), tinnitus (sensation of sounds in the ears), vertigo, palpitations (feeling the heartbeat), flushing, dizziness, cough, shortness of breath (dyspnea), abdominal pain, constipation, diarrhea, indigestion or difficulty digesting, nausea, vomiting, alteration of bowel habits, pruritus, allergic reactions such as skin rash, itching, skin redness, muscle cramps, swelling of the ankles (edema), feeling of fatigue, weakness.

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

Low chloride levels in the blood, low magnesium levels in the blood, confusion, worsening of psoriasis, high bilirubin levels in the blood, increased levels of liver enzymes, decreased or absent diuresis, acute renal insufficiency.

Concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and seizures. These symptoms may be a sign of a disease called SIADH (inadequate secretion of antidiuretic hormone).

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

Changes in blood parameters such as decreased white blood cell count and red blood cell count, decreased hemoglobin concentration, decreased platelet count, high blood sugar (hyperglycemia), high calcium levels in the blood (hypercalcemia), increased muscle tension, nerve disorder that may cause weakness, eosinophilic pneumonia (a rare type of pneumonia), inflammation of the gums, abdominal swelling (gastritis), yellowing of the skin (jaundice), acute renal insufficiency.

If you experience these symptoms, contact your doctor as soon as possible.

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

Myopia (nearsightedness), blurred vision,decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma),if you have systemic lupus erythematosus (a type of collagen disease) it may worsen, abnormal electrocardiogram, tremor, postural rigidity, facial rigidity similar to a mask, slow movements and gait disturbance with foot dragging, increased uric acid levels, a substance that may cause or worsen gout (pain in the joints, especially in the feet),change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease).

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once opened, Viacorlix should be used within the following 10 days for 10film-coated tablets, 30days for 30film-coated tablets, and 100days for 100film-coated tablets.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medications at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacisthow to dispose ofthecontainers and of themedications that you no longerneed. In this way, you will help protect the environment.

Composition of Viacorlix

• The active ingredients are perindopril arginina, amlodipino, and indapamida.

A Viacorlix film-coated tablet 7 mg/5 mg/2.5 mg contains 4.75 mg of perindopril equivalent to 7 mg of perindopril arginina, 6.935 mg of amlodipino besilato equivalent to 5 mg of amlodipino, and 2.5 mg of indapamida.

• The other components are:

• Core: calcium carbonate: calcium carbonate 90%, pregelatinized cornstarch 10%, microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b), anhydrous colloidal silica, pregelatinized cornstarch.
• Coating: glycerol (E422), hypromelose 6cP (E464), macrogol 6000, magnesium stearate (E470b), titanium dioxide (E171).

Appearance of the product and contents of the package

Viacorlix is a white, elongated film-coated tablet measuring 11.5 mm in length and 6.09 mm in width, engraved on one of its faces.

Viacorlix tablets are available in packages of 10, 30, 60 (2 packs of 30 tablets), 90 (3 packs of 30 tablets), or 100 film-coated tablets.

For the 10, 30, 60, and 90 film-coated tablet packages, the desiccant is located in the cap of the tablet container.

For the 100 film-coated tablet package, the desiccant is located in the container's screw cap.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Responsible for manufacturing:

Servier (Ireland) Industries Ltd.

Gorey Road

Arklow - Co. Wicklow – Ireland

or

Les Laboratoires Servier Industrie

905, route de Saran

45520 Gidy

France

or

EGIS Pharmaceuticals PLC

H-9900 Körmend, Mátyás király u.65

Hungary

or

Anpharm Przedsiebiorstwo Farmaceutyczne S.A.

03-236 Warsaw, ul. Annopol 6b

Poland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

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

Last review date of this prospecto: November 2022

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