VIACORAM 3.5 mg/2.5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Viacoram 3.5 mg/2.5 mg Tablets

perindopril arginine / amlodipine

Read all of this 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Viacoram and what is it used for

Viacoram is a combination of two active substances, perindopril and amlodipine. Both active substances help to control your high blood pressure.

Perindopril is an ACE inhibitor (angiotensin-converting enzyme). Amlodipine is a calcium antagonist (belonging to the dihydropyridine group). Both work together to widen and relax the blood vessels, making it easier for the blood to pass through them, and helping your heart to maintain a normal blood flow.

Viacoram is used to treat high blood pressure (hypertension) in adults.

2. What you need to know before you take Viacoram

Do not take Viacoram

• if you are allergic (hypersensitive) to perindopril or any other ACE inhibitor, or to amlodipine or any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rash with previous treatment with ACE inhibitors, or if you or a member of your family have had these symptoms in any other circumstance (a disorder known as angioedema),
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to pump enough blood to the body),
• if you have very low blood pressure (hypotension),
• if you have heart failure after a heart attack,
• if you are more than 3 months pregnant (it is also best to avoid Viacoram at the start of pregnancy - see section "Pregnancy"),
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren,
• if you are receiving dialysis or any other type of blood filtration. Depending on the machine used, Viacoram may not be suitable for you,
• if you have kidney problems that reduce the amount of blood reaching your kidneys (renal artery stenosis),
• if 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 in an area such as the throat) (see "Warnings and precautions" and "Using Viacoram with other medicines").

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Viacoram if you:

• have hypertrophic cardiomyopathy (a disease of the heart muscle),
• have heart failure,
• have very high blood pressure (hypertensive crises),
• have any other heart problems,
• have liver problems,
• have kidney problems (including kidney transplant),
• have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• have a connective tissue disease such as systemic lupus erythematosus or scleroderma,
• have diabetes,
• are on a low-salt diet or are using salt substitutes that contain potassium (it is essential to have a balanced level of potassium in the blood),
• are an elderly patient and your dose needs to be increased,
• are taking any of the following medicines used to treat 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 monitor your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood periodically.

See also the information under the heading "Do not take Viacoram".

• are of black African origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in patients who are not of black African origin.
• 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 organ rejection and for cancer treatment)
  • sacubitril (available as a fixed-dose combination with valsartan), used to treat long-term heart failure
  • linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class of 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, with difficulty swallowing or breathing) has been reported. This can occur at any time during treatment. If you develop these symptoms, you should stop taking Viacoram and see a doctor immediately. See also Section 4.

You should inform your doctor if you think you are (or might become) pregnant. Viacoram is not recommended at the start 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.

When taking Viacoram, you should inform your doctor or healthcare professional if:

• you are going to have a general anesthetic and/or major surgery
• you have recently had diarrhea or vomiting
• you are going to have an LDL apheresis (removal of cholesterol from your blood using a machine)
• you are going to receive desensitization treatment to reduce allergic effects to bee or wasp stings

Children and adolescents

Viacoram should not be given to children or adolescents.

Using Viacoram with other medicines

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

You should avoid taking Viacoram with:

• lithium (used to treat mania or depression)
• estradiol (used to treat cancer)
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium supplements, or salt substitutes that contain potassium, other medicines that may increase potassium 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 the treatment of infections, and cyclosporine, an immunosuppressive medicine used to prevent organ rejection)
• aliskiren (used to treat high blood pressure) (see also the information under the heading "Do not take Viacoram" and "Warnings and precautions")
• angiotensin II receptor antagonists (ARAs) (used to treat high blood pressure) (e.g., valsartan, telmisartan, irbesartan...)
• dantrolene (perfusion) (used to treat muscle stiffness in diseases such as multiple sclerosis or to treat malignant hyperthermia during anesthesia, including symptoms such as high fever and muscle stiffness)
• sacubitril/valsartan (used to treat long-term heart failure). See sections "Do not take Viacoram" and "Warnings and precautions".

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

• other medicines for high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys)
• medicines used to treat diarrhea (racecadotril) or prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTor inhibitors). See section "Warnings and precautions"
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen) to relieve pain or high doses of aspirin
• medicines for the treatment of diabetes (such as insulin or gliptins)
• medicines for the treatment of mental problems such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics, imipraminic antidepressants, neuroleptics)
• immunosuppressants (medicines that reduce the body's defense mechanisms) used to treat autoimmune disorders or after an organ transplant (e.g., cyclosporine, tacrolimus)
• allopurinol (for the treatment of gout)
• procainamide (for the treatment of irregular heartbeat)
• vasodilators, including nitrates (medicines that dilate blood vessels)
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma)
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis
• certain antibiotics such as rifampicin, erythromycin, clarithromycin (for bacterial infections)
• antiepileptic agents such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• itraconazole, ketoconazole (medicines used to treat fungal infections)
• alpha-blockers used to treat prostate hyperplasia such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin
• amifostine (used to prevent or reduce side effects caused by other medicines or radiation therapy used to treat cancer)
• corticosteroids (used to treat various disorders, including severe asthma and rheumatoid arthritis)
• gold salts, especially when given intravenously (used to treat rheumatoid arthritis)
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat HIV)
• potassium-sparing medicines used in the treatment of heart failure: eplerenone, and spironolactone at doses between 12.5 mg and 50 mg per day
• Hypericum perforatum (St. John's Wort, a medicinal plant used to treat depression)

Taking Viacoram with food and drinks

See section 3.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Viacoram before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Viacoram. Viacoram is not recommended at the start 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

Amlodipine has been shown to pass into breast milk in small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. Viacoram is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if your baby is newborn or premature.

Driving and using machines

Viacoram may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, weak, or tired, or give you a headache, do not drive or use machinery and consult your doctor immediately.

Viacoram contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Viacoram

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one Viacoram 3.5 mg/2.5 mg tablet once a day.

If you have moderate kidney problems, your doctor may advise you to take one Viacoram 3.5 mg/2.5 mg tablet every other day at the start of treatment.

Depending on how you respond to treatment, your doctor may decide to increase the dose after one month of treatment to Viacoram 7 mg/5 mg once a day if necessary.

One Viacoram 7 mg/5 mg tablet once a day is the maximum recommended dose for the treatment of high blood pressure.

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 Viacoram than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

The most common symptom in case of overdose is a decrease in blood pressure. This can cause dizziness or fainting. If this happens, you can help by lying down with your legs raised.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you forget to take Viacoram

It is important to take this medicine every day, as continuous treatment is more effective. However, if you forget to take a dose of Viacoram, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Viacoram

As treatment with Viacoram is usually for life, you should talk to your doctor before stopping this medicine.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stoptreatment with this medicine andgoimmediately to your doctor if you experience any of the following adverse effects that may beserious:

• Sudden whistling when breathing, 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 tongue and throat, causing great difficulty breathing (angioedema) (Uncommon - may affect up to 1 in 100 people),
• Severe skin reactions including intense 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 the mucous membranes (Stevens-Johnson syndrome) (Very rare - may affect up to 1 in 10,000 people), toxic epidermal necrolysis (frequency not known) or other allergic reactions (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),
• Weakness in arms or legs, or speech problems that could 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), unusually fast or abnormal heartbeat (Common - may affect up to 1 in 10 people),
• Pancreatitis that can cause intense abdominal and back pain accompanied by a great feeling of discomfort (Very rare - may affect up to 1 in 10,000 people).
• Yellowing of the skin or eyes (jaundice) that could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people).

The following adverse effectshave been reported with Viacoram. If any of these cause you problems, consult your doctor:

• Common (may affect up to 1 in 10 people): dizziness, cough, edema (fluid retention).
• Uncommon (may affect up to 1 in 100 people): high potassium levels in the blood that can cause an abnormal heart rhythm (hyperkalemia), high blood sugar (hyperglycemia), fatigue.

The following adverse effectshave been reported with perindopril or amlodipine, and either have not been observed with Viacoram or have been observed more frequently with Viacoram. These adverse effects may also occur with Viacoram. If any of these effects cause you problems, consult your doctor:

• Very common adverse effects (may affect more than 1 in 10 people): edema (fluid retention).
• Common adverse effects (may affect up to 1 in 10 people): headache, drowsiness (especially at the beginning of treatment), taste disturbances, numbness or tingling in the limbs, dizziness, vision disturbances (including double vision), tinnitus (ringing in the ears), palpitations (feeling the heartbeat), flushing of the face, difficulty breathing (dyspnea), abdominal pain, nausea, vomiting, dyspepsia or difficulty digesting, alteration of bowel habits, constipation, diarrhea, itching, skin rashes, redness of the skin, pruritus, swelling of the ankles, muscle cramps, fatigue, weakness.
• Uncommon adverse effects (may affect up to 1 in 100 people): increase in the number of some white blood cells (eosinophilia), decrease in sodium levels in the blood (hyponatremia), decrease in blood sugar levels (hypoglycemia), mood changes, anxiety, insomnia, depression, sleep disorders, syncope, loss of pain sensation, tremor, vasculitis (inflammation of blood vessels), rhinitis (congested or runny nose), dry mouth, increased sweating, hair loss, red spots on the skin, skin discoloration, blistering of the skin, sensitivity to light, back pain, muscle or joint pain, urination disorders, increased need to urinate at night, increased frequency of urination, kidney problems, impotence, discomfort or enlargement of the breasts in men, chest pain, feeling of discomfort, pain, weight gain or loss, elevated blood urea, elevated creatinine in the blood, falls, fever.
• Rare adverse effects (may affect up to 1 in 1,000 people): acute renal failure; symptoms of a disease called SIADH (inadequate secretion of antidiuretic hormone): concentrated urine, feeling of discomfort (nausea) or being sick (vomiting), muscle cramps, confusion, and convulsions; decreased or absent diuresis; worsening of psoriasis; high bilirubin levels; increased liver enzyme levels.
• Very rare adverse effects (may affect up to 1 in 10,000 people): changes in blood parameters such as decreased white and red blood cell count, decreased hemoglobin concentration, decreased platelet count, increased muscle tension, nerve disorder that can cause weakness, numbness, or tingling, eosinophilic pneumonia (a rare type of pneumonia), gum inflammation, abdominal swelling (gastritis), yellowing of the skin (jaundice).
• Frequency not known (frequency cannot be estimated from available data): tremor, postural rigidity, facial rigidity similar to a mask, slow movements and imbalance in gait with foot dragging, color change, numbness, and pain in the fingers and toes (Raynaud's phenomenon).

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

Reporting of Adverse Effects

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

5. Storage of Viacoram

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

Do not use this medicine after the expiration date that appears on the box and on the blister pack. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Once opened, Viacoram must be used within the following 10 days for 10-tablet packs, 30 days for 28 or 30-tablet packs, 50 days for 50-tablet packs, and 90 days for 100-tablet packs.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofViacoram

• The active ingredients are perindopril arginine and amlodipine.

One Viacoram 3.5 mg/2.5 mg tablet contains 2.378 mg of perindopril equivalent to 3.5 mg of perindopril arginine and 3.4675 mg of amlodipine besylate equivalent to 2.5 mg of amlodipine.

One Viacoram 7 mg/5 mg tablet contains 4.756 mg of perindopril equivalent to 7 mg of perindopril arginine and 6.935 mg of amlodipine besylate equivalent to 5 mg of amlodipine.

• The other ingredients are: lactose monohydrate, magnesium stearate (E470B), microcrystalline cellulose (E460), and anhydrous colloidal silica (E551).

Appearance of the Product and Package Contents

Viacoram 3.5 mg/2.5 mg tablets are white, round, 5 mm in diameter.

Viacoram 7 mg/5 mg tablets are white, round, 6 mm in diameter, engraved on one side.

Viacoram 3.5 mg/2.5 mg and Viacoram 7 mg/5 mg tablets are available in packs of 10, 28, 30, 60 (2 packs of 30), 84 (3 packs of 28), 90 (3 packs of 30), 100 (2 packs of 50), 100, or 500 (5 packs of 100) tablets.

The desiccant is located in the cap of the tablet 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

Anpharm Przedsiebiorstwo Farmaceutyczne S.A.

Ul. Annopol 6B

03-236 Warsaw – Poland

or

Egis Pharmaceuticals Private Limited Company

Site 3: H-9900, Körmend

Mátyás király u. 65. – Hungary

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

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: July 2022

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