Package Insert: Information for the Patient

Viacoram 3.5 mg/2.5 mg Tablets

perindopril arginina / amlodipino

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 your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What is Viacoram and for what it is used

2.What you need to know before starting to take Viacoram

3.How to take Viacoram

4.Possible adverse effects

5.Storage of Viacoram

6.Contents of the package and additional information

Viacoram is an association of two active principles, perindopril and amlodipine. Both active principles help control your high blood pressure.

Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (belonging to the group of medications called dihydropyridines). Both act in combination by widening and relaxing blood vessels, allowing blood to pass more easily through them and enabling your heart to maintain a suitable blood flow.

Viacoram is used for the treatment of high blood pressure (hypertension) in adults.

Do not takeViacoram

• if you are allergic (hypersensitive) to perindoprilor to any other angiotensin-converting enzyme (ACE) inhibitor, or to amlodipine or to any other calcium channel blocker, or to any of the other components ofthis medication (listed in section 6),
• if you have severe kidney disease,
• if you have experienced symptoms such as shortness of breath, facial or tongue swelling, 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),
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which 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 recommended to avoid Viacoram at the beginning of pregnancy - see section “Pregnancy”),
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure 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 cause a decrease in the amount of blood that reaches your kidneys (renal artery stenosis),
• if you have taken or are currently taking sacubitril/valsartan, a medication for heart failure,since 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 Viacoram with other medications”).

Warnings and precautions

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

• have hypertrophic cardiomyopathy (heart muscle disease),
• have heart failure,
• have very high blood pressure (hypertensive crisis),
• have any other heart problem,
• 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 vascular disease of the connective tissue (such as systemic lupus erythematosus or scleroderma),
• have diabetes,
• are following a low-sodium diet or using salt substitutes that contain potassium (it is essential to maintain 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 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 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 race, as you may have a higher risk of angioedemaand this medication may be less effective in lowering your blood pressure than in patients who are not of black race.
• 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 over a long period,
  • 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 stop taking Viacoram and see your doctor immediately. See also Section 4.

You should informyour doctorif you think you are (or could become) pregnant.Viacoramis not recommended at the beginning of pregnancy and should not be taken after the third month of pregnancy,as it may cause serious harm to your child if used in this stage(see section “Pregnancy”).

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

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

Children and adolescents

Viacoram should not be administered to children or adolescents.

Use ofViacoramwith other medications

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

You should avoid takingViacoramwith:

• lithium (used to treat mania or depression),
• estramustine (used to treat cancer),
• potassium-sparing diuretics (such as triamterene, amiloride), potassium supplements or salt substitutes that contain potassium, other medications that can increase potassium levels in your body (such as heparin, a medication used to thin the blood and prevent clots, trimethoprim, and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, for the treatment of infectionsandciclosporina, an immunosuppressant medication 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 (ARA) (used to treat high blood pressure) (for example valsartan, telmisartan, irbesartan…),
• dantrolene (infusion) (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 heart failure over a long period). See sections “Do not take Viacoram” and “Warnings and precautions”.

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

• other medications for high blood pressure, including diuretics (medications that increase the amount of urine produced by the kidneys),
• medications,that are commonly used to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the class of inhibitors of mTor). See section "Warnings and precautions",
• nonsteroidal anti-inflammatory drugs (such as ibuprofen) to relieve pain or high doses of aspirin,
• medications for the treatment of diabetes (such as insulin or gliptins),
• medications for treating mental health conditions such as depression, anxiety, schizophrenia, etc (such as tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressants (medications that reduce the body's defense mechanisms) used to treat autoimmune disorders or after a transplant (such as ciclosporina, tacrolimus),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of irregular heartbeat),
• vasodilators including nitrates (medications that dilate blood vessels),
• ephedrine, noradrenaline, or adrenaline (medications used to treat low blood pressure, shock, or asthma),
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis,
• some antibiotics such as rifampicin, erythromycin, clarithromycin (for bacterial infections),
• antiepileptic agents such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medications used to treat fungal infections),
• alfa blockers used to treat benign prostatic hyperplasia such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (used to prevent or reduce the effects caused by other medications or by radiation therapy used to treat cancer),
• corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis),
• gold salts, especially in intravenous administration (used to treat symptomatic rheumatoid arthritis),
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat HIV),
• potassium-sparing diuretics 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).

Administration ofViacoramwith food and beverages

See section 3.

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

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you think you are (or could become) pregnant. Your doctor will generally advise you to stop taking Viacoram before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Viacoram. Viacoram is not recommended at the beginning of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your child if used in this stage

Breastfeeding

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

Driving and operating machinery

Viacoram may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, weak, or tired, or cause headaches, do not drive or operate machinery and consult your doctor immediately.

Viacoram contains lactose monohydrate

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 two days at the beginning 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 every day, in the morning, and before breakfast.

Do not exceed the prescribed dose.

If you take moreViacoramthan you should

If you taketoo many tablets, contact your doctor immediately or go to the emergency service of your nearest hospital.

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

The most common symptom in case of overdose is a decrease in blood pressure. You may experience dizziness or fainting. If this occurs, you can help by lying down with your legs elevated.

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

If you forget to takeViacoram

It is essential to take this medication every day since 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 compensate for the missed dose.

If you interrupt treatment withViacoram

Since treatment with Viacoram is usually lifelong, you should talk to your doctorbefore 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 can 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 tongue and throat, which causes great difficulty breathing (angioedema) (Rare - may affect up to 1 in 100 people),
• severe skin reactions that include intense skin rash, blisters, skin redness 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 (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),toxic epidermal necrolysis (unknown frequency)or other allergic reactions (Rare - 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 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 heart rhythm (Common - may affect up to 1 in 10 people),
• inflammation of the pancreas that can cause intense abdominal and back painaccompanied by great 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 to1 in 10,000people).

The following side effects have 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).
• Rare (may affect up to 1 in 100 people): high levels of potassium in the blood that can cause an abnormal heart rhythm (hyperkalemia), high blood sugar (hyperglycemia), fatigue.

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

• Side effects very common (may affect more than 1 in 10 people): edema (fluid retention).
• Side effects common (may affect up to 1 in 10 people): headache,sleepiness (especially at the beginning of treatment),alterations in taste,numbness or tingling in the extremities, dizziness,vision changes (including double vision), tinnitus (sensation of sounds in the ears),palpitations (feeling the heartbeat), facial redness ,difficulty breathing(dyspnea),abdominal pain,nausea, vomiting, indigestion or difficulty digesting,alteration of bowel habits,constipation, diarrhea, itching, skin rash, skin redness, pruritus, swelling of ankles,muscle cramps, fatigue,weakness.
• Side effects rare (may affect up to 1 in 1,000 people):acute renal insufficiency; symptoms of a disease called SIADH (inadequate secretion of antidiuretic hormone): concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps,confusionand convulsions; decreased or absent diuresis;psoriasis worsening; high bilirubin serum levels; increased levels of liver enzymes.
• Side effects very rare (may affect up to 1 in 10,000 people):changes in blood parameters such as decreased white blood cell count and decreased hemoglobin concentration, decreased platelet count,muscle tension, nerve disorder that can cause weakness,tingling or numbness,eosinophilic pneumonia (a rare type of pneumonia),gingivitis (inflammation of the gums),abdominal swelling (gastritis), yellowing of the skin (jaundice).
• Unknown frequency (frequency cannot be estimated from available data):shaking, postural rigidity, facial rigidity similar to a mask, slow movements and gait disturbance with foot dragging,color change, numbness and pain in the fingers of the hands and feet (Raynaud's phenomenon).

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

Reporting of side effects

If you experience any type of side effect,consult your doctor, even if it is a possible side effect that does notappear in this prospectus. You can also report them directly through
the Spanish Systemof Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information onthe 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 box and on the bottle of tablets. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once opened, Viacoram must be used within the following 10 days for bottles of 10 tablets, 30 days for bottles of 28 or 30 tablets, 50 days for bottles of 50 tablets and 90 days for bottles of 100 tablets.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofViacoram

• The active principles are perindopril arginina and amlodipino.

A tablet ofViacoram 3,5 mg/2,5 mgcontains2,378 mg of perindopril equivalent to 3,5 mg of perindopril arginina and 3,4675 mg of amlodipino besilato equivalent to 2,5 mg of amlodipino.

A tablet ofViacoram 7 mg/5 mgcontains 4,756 mg of perindopril equivalent to 7 mg of perindopril arginina and 6,935 mg of amlodipino besilato equivalent to 5 mg of amlodipino.

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

Appearance of the product and contents of the package

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 packages of10, 28, 30, 60 (2 bottles of 30), 84 (3 bottles of 28), 90 (3 bottles of 30), 100 (2 bottles of 50), 100 or 500 (5 bottles of 100) tablets.

The desiccant is located in the bottle cap.

Only some 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

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 medication by contacting the local representative of the holder of the marketing authorization:

Laboratorios Servier S.L.

Avenida de los Madroños 33

28043 Madrid

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

Last review date of this leaflet: July 2022

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