Viacoram 3.5 mg/2.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Viacoram 3.5 mg/2.5 mg tablets

perindopril arginine / amlodipine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor, pharmacist or nurse.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Viacoram is and what it is used for

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

Perindopril is an ACE inhibitor (angiotensin-converting enzyme inhibitor). Amlodipine is a calcium antagonist (belonging to the group of medicines known as dihydropyridines). Both work together by widening and relaxing the blood vessels, allowing blood to flow through them more easily and helping your heart to maintain adequate blood flow.

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

2. What you need to know before taking 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 components of this medicine (listed in section 6),
• if you have severe kidney disease,
• if you have previously experienced symptoms such as wheezing, facial or tongue swelling, severe itching, or serious skin rashes while taking an ACE inhibitor, or if you or a family member has ever had these symptoms under any circumstances (a condition called angioedema),
• if you have aortic valve stenosis (narrowing of the heart valve) 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 following a heart attack,
• if you are more than 3 months pregnant (Viacoram should also be avoided in early pregnancy – see section “Pregnancy”),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you are undergoing 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 causing reduced blood flow to 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, for example in the throat) (see “Warnings and precautions” and “Use of Viacoram with other medicines”).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Viacoram if you:

• have hypertrophic cardiomyopathy (a heart muscle disorder),
• have heart failure,
• have very high blood pressure (hypertensive crisis),
• 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 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 and your dose needs to be increased,
• 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 levels of electrolytes (e.g. potassium) in your blood.

See also the information under the heading “Do not take Viacoram”.

• are of Black African or Afro-Caribbean descent, 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.
• are taking any of the following medicines, as the risk of angioedema is increased:
  • racecadotril (used to treat diarrhoea),
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the class known as mTor inhibitors (used to prevent rejection of transplanted organs and in cancer treatment),
  • sacubitril (available in 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:

Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, possibly causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This may occur at any time during treatment. If you develop such symptoms, you must stop taking Viacoram immediately and seek medical help without delay. See also Section 4.

You must inform your doctor if you think you are (or might become) pregnant. Viacoram 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 unborn child if used during this period (see section “Pregnancy”).

While taking Viacoram, inform your doctor or healthcare provider if:

• you are undergoing general anaesthesia and/or major surgery,
• you have recently had diarrhoea or vomiting,
• you are scheduled to undergo LDL apheresis (removal of cholesterol from your blood using a machine),
• you are due to receive desensitisation treatment to reduce allergic reactions to bee or wasp stings.

Children and adolescents

Viacoram must not be given to children or adolescents.

Use of Viacoram with other medicines

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

You must avoid taking Viacoram with:

• lithium (used to treat mania or depression),
• estramustine (used in cancer treatment),
• 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, used to treat infections; and cyclosporine, an immunosuppressant used to prevent organ transplant rejection),
• aliskiren (used to treat high blood pressure) (see also information under “Do not take Viacoram” and “Warnings and precautions”),
• angiotensin II receptor antagonists (ARA) (used to treat high blood pressure) (e.g. valsartan, telmisartan, irbesartan…),
• dantrolene (intravenous) (used to treat muscle stiffness in conditions such as multiple sclerosis or to treat malignant hyperthermia during anaesthesia, including symptoms such as high fever and muscle rigidity),
• 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 require special monitoring:

• other medicines for high blood pressure, including diuretics (medicines that increase urine production by the kidneys),
• medicines commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class known as mTor inhibitors). See section "Warnings and precautions",
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high-dose aspirin,
• medicines for diabetes (such as insulin or gliptins),
• medicines used to treat mental health conditions such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressants (medicines that reduce the body’s immune defences) used to treat autoimmune disorders or after organ transplantation (e.g. cyclosporine, tacrolimus),
• allopurinol (used to treat gout),
• procainamide (used to treat 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 conditions 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 enlargement, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (used to prevent or reduce side effects caused by other medicines or radiotherapy in cancer treatment),
• corticosteroids (used to treat various disorders including severe asthma and rheumatoid arthritis),
• gold salts, especially when administered intravenously (used for symptomatic treatment of rheumatoid arthritis),
• ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat HIV),
• potassium-sparing agents used in heart failure treatment: eplerenone, and spironolactone at doses between 12.5 mg and 50 mg daily,
• Hypericum perforatum (St. John’s wort, a herbal remedy used to treat depression).

Taking Viacoram with food and drink

See section 3.

People taking Viacoram must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active ingredient amlodipine, which may lead to 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Viacoram before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Viacoram 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 unborn child if used after this time.

Breastfeeding

It has been shown that amlodipine passes 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 an alternative treatment if you wish to breastfeed, particularly if your baby is a newborn or premature.

Driving and using machines

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

Viacoram contains lactose monohydrate

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Viacoram

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

The recommended dose is one tablet of Viacoram 3.5 mg/2.5 mg once daily.

If you have moderate renal problems, your doctor may advise you to initially take one tablet of Viacoram 3.5 mg/2.5 mg every two days at the beginning of treatment.

Depending on your response to treatment, your doctor may decide, after one month of treatment, to increase the dose to Viacoram 7 mg/5 mg once daily, if necessary.

One tablet of Viacoram 7 mg/5 mg once daily 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 immediately or go to the nearest hospital emergency department.

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

The most common symptom in case of overdose is a drop in blood pressure. This may cause you to feel dizzy or faint. If this occurs, lying down with your legs raised may help.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 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 miss a dose of Viacoram, 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 Viacoram

Since treatment with Viacoram is usually lifelong, you should 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 will experience them.

Stop treatment with this medicine and contact your doctor immediately 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 tongue and throat, causing severe breathing difficulty (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, severe 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), 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 which 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 which 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).

The following adverse 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, oedema (fluid retention).
• Uncommon (may affect up to 1 in 100 people): high levels of potassium in the blood which may cause an abnormal heart rhythm (hyperkalaemia), high blood sugar (hyperglycaemia), fatigue.

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

• Very common adverse effects (may affect more than 1 in 10 people): oedema (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 sensations in the extremities, dizziness, visual disturbances (including double vision), tinnitus (sensation of ringing in the ears), palpitations (awareness of heartbeat), facial flushing, difficulty breathing (dyspnoea), abdominal pain, nausea, vomiting, dyspepsia or difficulty digesting, changes in bowel habits, constipation, diarrhoea, itching, skin rashes, redness of the skin, pruritus, ankle swelling, muscle cramps, fatigue, weakness.
• Uncommon adverse effects (may affect up to 1 in 100 people): increased number of certain white blood cells (eosinophilia), low blood sodium levels (hyponatraemia), low blood sugar levels (hypoglycaemia), mood changes, anxiety, insomnia, depression, sleep disorders, fainting (syncope), loss of pain sensation, tremor, vasculitis (inflammation of blood vessels), rhinitis (stuffy or runny nose), dry mouth, increased sweating, hair loss, red spots on the skin, skin discoloration, blistering of the skin, photosensitivity, back pain, muscle or joint pain, urinary disorders, increased need to urinate at night, increased frequency of urination, kidney problems, impotence, discomfort or enlargement of breasts in men, chest pain, feeling unwell, pain, weight changes (increase or decrease), elevated blood urea, elevated blood creatinine, falls, fever.
• Rare adverse effects (may affect up to 1 in 1,000 people): acute renal failure; symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion): concentrated urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and seizures; reduced or absent urine output; worsening of psoriasis; high serum bilirubin levels; increased liver enzymes.
• Very rare adverse effects (may affect up to 1 in 10,000 people): changes in blood parameters such as decreased number of white and red blood cells, decreased haemoglobin concentration, decreased platelet count, increased muscle tone, nerve disorders that may cause weakness, tingling or numbness, eosinophilic pneumonia (a rare type of pneumonia), inflammation of the gums, abdominal swelling (gastritis), yellowing of the skin (jaundice).
• Frequency not known (frequency cannot be estimated from available data): tremor, postural rigidity, facial rigidity resembling a mask, slow movements and gait imbalance with shuffling steps, changes in colour, numbness and pain in fingers and toes (Raynaud's phenomenon).

If you experience any of 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viacoram

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Once opened, Viacoram should be used within the following time periods: 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 must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Viacoram

• The active substances are perindopril arginine and amlodipine.

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

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

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

Appearance of the product and contents of the pack

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

Viacoram 7 mg/5 mg tablets are white, round tablets, 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 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 cap of the tablet bottle.

Only certain 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

Further information on this medicinal product is available from 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 the most recent review of this leaflet: July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.