Viacorlix 7 mg/5 mg/2.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viacorlix 7mg/5mg/2.5mg film-coated tablets

perindopril arginine/amlodipine/indapamide

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Viacorlix is and what it is used for

Viacorlix is a combination of three active substances: perindopril, amlodipine, and indapamide. Viacorlix is an antihypertensive medicine used for the treatment of high blood pressure (hypertension) in adults.

Patients who are already taking perindopril/amlodipine as a fixed-dose combination and indapamide in separate tablets may instead take one tablet of Viacorlix containing the three active substances at the same doses.

Each of the active substances helps lower blood pressure, and together they work to control your blood pressure:

• Perindopril belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. It works by widening blood vessels, allowing your heart to pump blood through them more easily.
• Amlodipine is a calcium channel blocker (belonging to the group of medicines called dihydropyridines). It works by relaxing blood vessels, allowing blood to flow through them more easily.
• Indapamide is a diuretic (belonging to the group of medicines known as sulfonamide-derived with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics in that it produces only a slight increase in the amount of urine formed.

2. What you need to know before taking Viacorlix

Do not take Viacorlix if:

• you are allergic (hypersensitive) to perindopril or any other ACE inhibitor, to amlodipine or any other calcium antagonist, to indapamide or any other sulfonamide, or to any of the other components of this medicine (listed in section 6),
• you have severe kidney disease,
• you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Viacorlix may not be suitable for you,
• you have kidney problems causing reduced blood flow to your kidneys (renal artery stenosis),
• you have taken or are currently taking sacubitril/valsartan, a medicine for heart failure, as this increases the risk of angioedema (rapid swelling under the skin, such as in the throat) (see “Warnings and precautions” and “Use of Viacorlix with other medicines”),
• you have severe liver disease or a condition called hepatic encephalopathy (liver problems affecting the brain and central nervous system),
• you have low levels of potassium in your blood,
• you have previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes with prior treatment with ACE inhibitors, or if you or a family member has ever had these symptoms under any circumstances (a disorder called angioedema),
• you are more than 3 months pregnant (it is also advisable to avoid Viacorlix early in pregnancy – see Pregnancy section),
• you have very low blood pressure (hypotension),
• you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where the heart cannot pump enough blood to the body),
• you have heart failure following a heart attack,
• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Viacorlix if you:

• have previously had photosensitivity reactions,
• have hypertrophic cardiomyopathy (a heart muscle disorder),
• have heart failure or heart rhythm disorders,
• have severe high blood pressure (hypertensive crises),
• have any other heart problems,
• have liver problems,
• have kidney problems (including kidney transplant),
• experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Viacorlix. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this,
• have muscle disorders, including muscle pain, tenderness, weakness, or cramps,
• have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• have a collagen vascular disease (connective tissue disorder) such as systemic lupus erythematosus or scleroderma,
• have diabetes,
• are on a low-salt diet or using salt substitutes containing potassium (a balanced level of potassium in the blood is essential),
• are elderly,
• are taking any of the following medicines for high blood pressure:
  • an “angiotensin II receptor antagonist” (ARA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
  • aliskiren.

Your doctor may periodically monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) in your blood. See also information under the heading “Do not take Viacorlix”.

• 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,
• have gout,
• need to undergo a test to check your parathyroid gland function,
• are taking any of the following medicines, as the risk of angioedema is higher:
  • racecadotril (used to treat diarrhea),
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTor inhibitors (used to prevent rejection of transplanted organs and in cancer treatment),
  • sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure,
  • linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class known as gliptins (used to treat diabetes).

Angioedema:

In patients treated with ACE inhibitors, including perindopril, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, possibly causing difficulty in swallowing or breathing) has been reported. This may occur at any time during treatment. If you develop such symptoms, you must stop taking Viacorlix immediately and seek medical attention. See also section 4.

You should inform your doctor if you think you are (or could become) pregnant. Viacorlix is not recommended during early 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 sections “Pregnancy” and “Breast-feeding”).

While taking Viacorlix, inform your doctor or healthcare professional if you:

• are undergoing general anesthesia and/or major surgery,
• have recently had diarrhea or vomiting,
• are receiving desensitization treatment to reduce allergic reactions to bee or wasp stings,
• are undergoing a medical test requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays).

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

Athletes should be aware that Viacorlix contains an active ingredient (indapamide) that may lead to a positive doping test.

Children and adolescents

Viacorlix must not be given to children or adolescents.

Taking Viacorlix with other medicines

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

You must avoid taking Viacorlix with:

• lithium (used to treat mania or depression),
• estramustine (used to treat cancer),
• potassium-sparing agents (e.g. triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, and other medicines that may increase potassium levels in your body (such as heparin, a medicine used to thin the blood and prevent clots; trimethoprim, and cotrimoxazole also known as trimethoprim/sulfamethoxazole for bacterial infections),
• aliskiren (used to treat high blood pressure) (see also information under “Do not take Viacorlix” and “Warnings and precautions”),
• angiotensin II receptor antagonists (ARA) (used to treat high blood pressure) (e.g. valsartan, telmisartan, irbesartan…),
• dantrolene (infusion) (used to treat muscle stiffness in conditions such as multiple sclerosis or to treat malignant hyperthermia during anesthesia, including symptoms such as high fever and muscle rigidity),
• medicines 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",
• sacubitril/valsartan (used to treat long-term heart failure). See sections “Do not take Viacorlix” and “Warnings and precautions”.

Treatment with Viacorlix may be affected by other medicines. Make sure to inform your doctor if you are taking any of the following medicines, as you may require special monitoring:

• other medicines for high blood pressure, including diuretics (medicines that increase urine production by the kidneys) and angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure),
• medicines for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, cardiac glycosides, bretylium),
• procainamide (for treatment of irregular heart rhythm),
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• antibiotics used to treat bacterial infections (e.g. rifampicin, injectable erythromycin, clarithromycin, sparfloxacin, moxifloxacin),
• bepridil (used to treat angina pectoris, a condition causing chest pain),
• cisapride (used to treat reduced esophageal and stomach motility),
• difemanil (used to treat gastrointestinal problems such as ulcers, excess acid, or hyperactive digestive system),
• injectable vincamine (used to treat symptomatic cognitive disorders in elderly patients including memory loss),
• halofantrine (an antiparasitic medicine used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, astemizole, terfenadine),
• antifungal medicines (e.g. itraconazole, ketoconazole, injectable amphotericin B),
• tetracosactide (for treatment of Crohn's disease),
• stimulant laxatives,
• medicines for diabetes treatment (such as insulin, gliptins, metformin),
• baclofen, used to treat muscle stiffness in conditions such as multiple sclerosis,
• potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day; amiloride, triamterene,
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen) for pain relief or high doses of acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting,
• Hypericum perforatum (St. John’s wort, a herbal remedy used to treat depression),
• vasodilators including nitrates (medicines that dilate blood vessels),
• corticosteroids (used to treat various disorders including severe asthma and rheumatoid arthritis),
• alpha-blockers used to treat prostate enlargement such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (used to prevent or reduce side effects caused by other cancer medicines or radiotherapy),
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat HIV),
• gold salts, especially when administered intravenously (used for symptomatic treatment of rheumatoid arthritis),
• iodinated contrast media (used in X-ray tests),
• calcium tablets or other calcium supplements,
• immunosuppressants (medicines that reduce the body’s defense mechanisms) used to treat autoimmune disorders or after transplantation (e.g. cyclosporine, tacrolimus),
• allopurinol (for treatment of gout),
• antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• trimethoprim (for treatment of infections),
• methadone (used to treat addiction).

Taking Viacorlix with food and drink

See section 3.

People taking Viacorlix must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Viacorlix.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you think you are (or could become) pregnant.

Your doctor will usually advise you to stop taking Viacorlix before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Viacorlix. Viacorlix is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breast-feeding

It has been shown that amlodipine passes into breast milk in small amounts. Inform your doctor if you are breast-feeding or plan to breast-feed. Viacorlix is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Viacorlix may affect your ability to drive or use machines. If the tablets make you feel unwell, dizzy, weak, tired, or cause headache, do not drive or operate machinery and consult your doctor immediately.

Viacorlix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, and is therefore considered essentially “sodium-free”.

3. How to take Viacorlix

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Viacorlix tablet once daily.

Take the tablet preferably at the same time each 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount taken.

The most common symptom in case of overdose is a drop in blood pressure, which may cause dizziness or fainting. If this occurs, lying down with your legs raised may help.

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

You may feel lightheaded, dizzy, or weak. If your blood pressure drops severely, you may go into shock. You may feel your skin becoming cold and clammy, and you may lose consciousness.

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

If you forget to take Viacorlix

It is important to take this medicine every day, as continuous treatment works best. However, if you miss a dose of Viacorlix, 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 Viacorlix

As treatment with Viacorlix is usually lifelong, you must speak with your doctor before stopping 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 experiences them.

Stop treatment with this medicine and seek immediate medical attention if you experience any of the following adverse effects, which may be serious:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon – may affect up to 1 in 100 people),
• Swelling of the eyelids, face or lips (uncommon – may affect up to 1 in 100 people),
• Swelling of the mouth, tongue and throat, causing severe difficulty breathing (angioedema) (uncommon – may affect up to 1 in 100 people),
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching (erythema multiforme) (very rare – may affect up to 1 in 10,000 people), blistering, peeling and inflammation of the skin (exfoliative dermatitis) (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 (common – may affect up to 1 in 10 people), toxic epidermal necrolysis (frequency not known – frequency cannot be estimated from available data),
• Severe dizziness or fainting (common – may affect up to 1 in 10 people),
• Weakness in arms or legs or speech problems that could be signs 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), unusually fast or irregular heartbeat (common – may affect up to 1 in 10 people),
• Inflammation of the pancreas that may cause severe abdominal and back pain accompanied by a strong feeling of illness (very rare – may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (very rare – may affect up to 1 in 10,000 people),
• Brain disease caused by liver disease (hepatic encephalopathy) (frequency not known),
• Muscle weakness, cramps, tenderness or muscle pain, especially if accompanied by feeling unwell or fever, as these may be due to abnormal muscle breakdown (frequency not known).

In decreasing order of frequency, adverse effects may include:

• Very common (may affect more than 1 in 10 people):
  Edema (fluid retention).

• Common (may affect up to 1 in 10 people):
  Low blood potassium levels, headache, numbness or tingling sensations in the limbs, drowsiness (especially at the beginning of treatment), taste disturbances, visual disturbances (including double vision), tinnitus (sensation of ringing in the ears), dizziness, palpitations (awareness of heartbeat), flushing, lightheadedness, cough, difficulty breathing (dyspnea), abdominal pain, constipation, diarrhea, dyspepsia or difficulty digesting, nausea, vomiting, changes in bowel habits, pruritus, allergic reactions such as skin rashes, itching, redness of the skin, muscle cramps, ankle swelling (edema), feeling of fatigue, weakness.

• Uncommon (may affect up to 1 in 100 people):
  Rhinitis (stuffy or runny nose), increased number of certain white blood cells (eosinophilia), low blood sugar (hypoglycemia), high blood potassium levels which may cause abnormal heart rhythm (hyperkalemia), low blood sodium levels (hyponatremia) which may lead to dehydration and low blood pressure, insomnia, mood changes, anxiety, depression, sleep disorders, loss of pain sensation, tremor, fainting, vasculitis (inflammation of blood vessels), dry mouth, hair loss, red spots on the skin (purpura), skin discoloration, increased sweating, photosensitivity reaction (skin changes) after exposure to sunlight or artificial UVA rays, formation of clusters of blisters on the skin, muscle or joint pain, back pain, urinary disorders, increased need to urinate at night, increased frequency of urination, kidney problems, impotence (inability to achieve or maintain an erection), discomfort or enlargement of the breasts in men, chest pain, pain, malaise, fever, weight gain or weight loss, increased blood urea, increased blood creatinine, falls.

• Rare (may affect up to 1 in 1,000 people):
  Low blood chloride levels, low blood magnesium levels, confusion, worsening of psoriasis, high serum bilirubin levels, increased liver enzyme levels, decreased or absent urine output, acute renal failure.

Concentrated urine, feeling of malaise (nausea) or feeling unwell (vomiting), muscle cramps, confusion and seizures. These symptoms may indicate a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).

• Very rare (may affect up to 1 in 10,000 people):
  Changes in blood parameters such as decreased number of white and red blood cells, decreased hemoglobin concentration, reduced platelet count, high blood sugar (hyperglycemia), high blood calcium levels (hypercalcemia), increased muscle tone, nerve disorders that may cause weakness, eosinophilic pneumonia (a rare type of pneumonia), gum inflammation, abdominal swelling (gastritis), yellowing of the skin (jaundice), acute renal failure.

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

• Frequency not known (frequency cannot be estimated from available data):
  Shortness of vision (myopia), blurred vision, reduced vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), worsening of systemic lupus erythematosus (a type of collagen disease), abnormal electrocardiogram, tremor, postural rigidity, facial rigidity resembling a mask, slow movements and unbalanced gait with dragging of the feet, increased uric acid (a substance that may cause or worsen gout – joint pain, especially in the feet), color change, numbness and pain in fingers or toes (Raynaud's phenomenon).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viacorlix

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

Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After opening, Viacorlix should be used within the following time periods: 10 days for bottles containing 10 film-coated tablets, 30 days for bottles containing 30 film-coated tablets, and 100 days for bottles containing 100 film-coated tablets.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Viacorlix

• The active substances are perindopril arginine, amlodipine and indapamide.

One Viacorlix 7 mg/5 mg/2.5 mg film-coated tablet contains 4.75 mg of perindopril equivalent to 7 mg of perindopril arginine, 6.935 mg of amlodipine besilate equivalent to 5 mg of amlodipine, and 2.5 mg of indapamide.

• The other components are:

• Core: calcium carbonate: calcium carbonate 90%, pregelatinized corn starch 10%, microcrystalline cellulose (E460), sodium croscarmellose (E468), magnesium stearate (E470b), anhydrous colloidal silica, pregelatinized corn starch.

• Film coating: glycerol (E422), hypromellose 6cP (E464), macrogol 6000, magnesium stearate (E470b), titanium dioxide (E171).

Appearance of the product and contents of the pack

Viacorlix is a white, elongated film-coated tablet measuring 11.5 mm in length and 6.09 mm in width, with an imprint on one side.

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

For the pack sizes of 10, 30, 60 and 90 film-coated tablets, the desiccant is located in the cap of the tablet bottle.

For the pack size of 100 film-coated tablets, the desiccant is located in the screw cap of the bottle.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer:

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 Warszawa, ul. Annopol 6b
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorios Servier S.L.
Avenida de los Madroños 33
28043 Madrid, Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of last review of this leaflet: November 2022

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