Vivace 10 mg

Leaflet accompanying the packaging: patient information

Vivace 2.5 mg, 2.5 mg, tablets

Vivace 5 mg, 5 mg, tablets

Vivace 10 mg, 10 mg, tablets

Ramipril

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vivace and what is it used for
• 2. Important information before taking Vivace
• 3. How to take Vivace
• 4. Possible side effects
• 5. How to store Vivace
• 6. Package contents and other information

1. What is Vivace and what is it used for

Vivace contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Vivace works by:

• reducing the production of substances in the body that can increase blood pressure
• reducing tension and dilating blood vessels
• making it easier for the heart to pump blood throughout the body.

Vivace can be used to:

• treat high blood pressure (hypertension)
• reduce the risk of heart attack or stroke
• reduce the risk of or delay kidney problems (regardless of whether the patient has diabetes)
• treat heart failure when the heart is not pumping enough blood to the rest of the body
• treat heart failure after a heart attack.

2. Important information before taking Vivace

When not to take Vivace

• If the patient is allergic to ramipril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has ever had a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on the palms, soles, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient has undergone dialysis or another type of blood filtration. Depending on the type of equipment used, Vivace may not be a suitable medicine.
• If the patient has kidney disease related to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see "Pregnancy and breastfeeding").
• If the patient's blood pressure is very low or unstable. The doctor will decide whether the patient should take Vivace.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren
• If the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (long-term) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

If any of the above situations occur, Vivace should not be taken. In case of doubts about taking the medicine, the patient should consult a doctor before starting to take Vivace.

Warnings and precautions

Before starting to take Vivace, the patient should discuss it with their doctor or pharmacist.

• If the patient has heart, liver, or kidney disease.
• If the patient has recently lost a significant amount of electrolytes or fluids (through vomiting, diarrhea, excessive sweating, a low-salt diet, or long-term use of diuretics or dialysis).
• If the patient is to undergo desensitization treatment for bee or wasp stings (allergy shots).
• If the patient is to receive anesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Vivace for one day before the procedure. In case of doubts, the patient should consult their doctor.
• If the patient has high levels of potassium in the blood (as shown by blood tests).
• If the patient has collagen disease, such as scleroderma or systemic lupus erythematosus.
• The patient must inform their doctor if they suspect they are pregnant or plan to become pregnant. It is not recommended to take Vivace during the first three months of pregnancy, and above the third month of pregnancy, the medicine may have a harmful effect on the fetus (see below "Pregnancy and breastfeeding").
• If the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may order regular blood tests, especially to check sodium levels in the blood, particularly in elderly patients.
• In black patients, there is a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races.
• If the patient is taking any of the following medicines for high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• aliskiren.
• If the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat type 2 diabetes. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.

See also the information under the heading "When not to take Vivace".

Children and adolescents

Vivace should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Vivace in this age group have not been established.
If any of the above situations occur (or if there are doubts), the patient should consult a doctor before starting to take Vivace.

Vivace and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Vivace may affect the action of other medicines. Other medicines may also affect the action of Vivace.
The patient should inform their doctor about taking the following medicines, as they may reduce the effect of Vivace:

• medicines used for pain relief and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin)
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as: ephedrine, noradrenaline, or adrenaline. The doctor will need to monitor blood pressure.

The patient should inform their doctor about taking the following medicines, as they may increase the risk of side effects when used with Vivace:

• sacubitril with valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Vivace")
• medicines used for pain relief and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin)
• medicines used to treat cancer (chemotherapy)
• diuretics (such as furosemide)
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots)
• corticosteroids, such as prednisolone
• allopurinol (a medicine used to lower uric acid levels in the blood)
• procainamide (a medicine used to treat irregular heart rhythms)
• temsirolimus (a medicine used to treat cancer)
• medicines used to prevent organ rejection (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See "Warnings and precautions"
• wildagliptin (used to treat type 2 diabetes).
• racecadotril (used to treat diarrhea).

The patient should inform their doctor about taking the following medicines, as their action may be altered when used with Vivace:

• oral hypoglycemic agents, such as metformin, and insulin. Vivace may lower blood sugar levels. Blood sugar levels should be regularly monitored while taking Vivace.
• lithium (used to treat mental illnesses). Vivace may increase lithium levels in the blood.

The patient's doctor should closely monitor lithium levels in the blood.
The doctor may need to adjust the dose and/or take other precautions:

• If the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also "When not to take Vivace" and "Warnings and precautions").

If any of the above situations occur (or if there are doubts), the patient should consult a doctor before starting to take Vivace.

Vivace with food and drink

• Drinking alcohol while taking Vivace may cause dizziness and fainting. In case of doubts about the amount of alcohol allowed while taking Vivace and the possibility of combining the effects of blood pressure-lowering medicines and alcohol, the patient should consult their doctor.
• Vivace can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient must inform their doctor if they suspect they are pregnant (or plan to become pregnant). It is not recommended to take Vivace during the first 12 weeks of pregnancy, and it should not be taken after the 13th week of pregnancy, as it may harm the fetus. If the patient becomes pregnant while taking Vivace, they should immediately inform their doctor. Before planned pregnancy, an alternative treatment should be considered.

• After the 13th week of pregnancy, as it may harm the fetus. If the patient becomes pregnant while taking Vivace, they should immediately inform their doctor. Before planned pregnancy, an alternative treatment should be considered.

Breastfeeding
Vivace should not be taken during breastfeeding.

Driving and using machines

While taking Vivace, dizziness may occur. The risk of dizziness is higher at the beginning of treatment with Vivace and after increasing the dose. If dizziness occurs, the patient should not drive, use tools, or operate machinery.

Vivace contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Vivace contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Vivace

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

Treatment of high blood pressure

• The recommended initial dose is 1.25 mg or 2.5 mg once daily.
• The doctor may adjust the dose to achieve blood pressure control.
• The maximum dose is 10 mg once daily.
• If the patient is taking diuretics (water pills), the doctor may stop or reduce the dose of the diuretic before starting Vivace.

Prevention of heart attack or stroke

• The recommended initial dose is 2.5 mg once daily.
• The doctor may decide to increase the dose.
• The recommended dose is 10 mg once daily.

Reducing the risk of kidney disease or delaying its progression

• The usual initial dose is 1.25 mg or 2.5 mg once daily.
• The doctor may adjust the dose.
• The recommended dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The recommended initial dose is 1.25 mg once daily.
• The doctor may adjust the dose.
• The maximum dose is 10 mg daily. It is preferred to take the medicine in two divided doses.

Treatment after a heart attack

• The recommended initial dose is usually 1.25 mg to 2.5 mg once daily.
• The doctor may adjust the dose.
• The recommended dose is 10 mg daily. It is preferred to take the medicine in two divided doses.

Elderly patients
The initial dose should be lower, and the dose increase should be done slowly.

Taking the medicine

• The medicine should be taken orally, once daily, at the same time.
• The tablets should be swallowed whole with a liquid.

The tablets can be divided into equal doses.

Overdose of Vivace

The patient should contact their doctor or go to the nearest hospital emergency department.
The patient should not drive themselves, but ask someone to drive them to the hospital or call an ambulance. The patient should take the medicine packaging with them so the doctor knows what medicine was taken.

Missed dose of Vivace

If a dose is missed, the patient should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.
In case of further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Vivace can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, the patient should stop taking Vivace and immediately contact their doctor – urgent medical attention may be needed:

• Swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Vivace.
• Severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

The patient should immediately inform their doctor if they experience:

• Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious conditions, including heart attack or stroke.
• Shortness of breath or cough. These may indicate lung disease.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or paleness of the skin. These may indicate blood or bone marrow disorders.
• Severe abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, weakness, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disease, such as hepatitis or liver damage.

Other side effects:

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.
Common(may affect up to 1 in 10 people)

• headache or feeling tired
• dizziness - the risk is higher at the beginning of treatment with Vivace and after increasing the dose
• fainting, hypotension (abnormally low blood pressure), especially if it occurs after a rapid change in position to standing or sitting
• dry and persistent cough, sinusitis, or bronchitis, shortness of breath
• abdominal pain or intestinal cramps, diarrhea, nausea, or vomiting
• rash with or without raised patches
• chest pain
• muscle cramps or muscle pain
• high levels of potassium in the blood (as shown by blood tests).

Uncommon(may affect up to 1 in 100 people)

• balance disorders (dizziness of labyrinthine origin)
• itching of the skin and sensory disturbances, such as: numbness, tingling, prickling, burning, or a feeling of crawling under the skin (paresthesia)
• loss or disturbance of taste
• sleep disorders
• depression, anxiety, increased nervousness, or restlessness
• nasal congestion, difficulty breathing, or worsening of asthma
• intestinal angioedema, which can cause abdominal pain, vomiting, and diarrhea
• heartburn, constipation, or dry mouth
• increased urine production during the day
• kidney problems, acute kidney failure
• excessive sweating
• loss or decreased appetite (anorexia)
• rapid or irregular heartbeat
• swelling of the hands and feet. These may be symptoms of water retention.
• hot flashes
• blurred vision
• joint pain
• fever
• impotence in men, decreased libido in men and women
• increased levels of certain white blood cells (eosinophilia) in blood tests
• blood test results indicating changes in liver, pancreas, or kidney function.

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

• feeling of shaking and disorientation
• red and swollen tongue
• severe skin peeling and shedding, itchy papular rash
• nail diseases (e.g., loosening or separation of the nail from the nail bed)
• skin rash or bruising tendency
• spots on the skin and cold limbs
• redness, itching, swelling, and tearing of the eyes
• hearing disorders and ringing in the ears
• weakness
• decreased levels of red blood cells, white blood cells, or platelets, or hemoglobin levels in blood tests.

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

• increased sensitivity to sunlight. Frequency not known(cannot be estimated from the available data)
• concentrated urine (dark color), nausea, muscle cramps, disorientation, and seizures, which may be caused by abnormal secretion of antidiuretic hormone (ADH). If these symptoms occur, the patient should immediately contact their doctor.
• difficulty concentrating
• mouth pain
• increased levels of antibodies in blood tests
• decreased levels of certain blood cells in blood tests
• decreased sodium levels in blood tests
• changes in finger color upon cooling and a feeling of tingling or pain upon warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• feeling of burning
• smell disorders
• hair loss.

In children, the frequency of the following side effects is higher than in adults:
Common(may affect up to 1 in 10 people)

• rapid heartbeat, blocked nose, or cold
• red, itchy, or tearing eyes.

Uncommon(may affect up to 1 in 100 people)

• feeling of shaking, itching of the skin.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vivace

The medicine should be stored out of sight and reach of children.
Vivace should not be taken after the expiry date stated on the packaging and blister after EXP.
The expiry date refers to the last day of the month stated.
The medicine should not be stored above 25°C.
The medicine should be stored in its original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vivace contains

• The active substance of Vivace is ramipril. Each tablet contains 2.5 mg, 5 mg, or 10 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch (starch 1500), sodium stearyl fumarate. Additionally:
• 2.5 mg tablets contain: yellow iron oxide (E172) and PB 22960 yellow: lactose monohydrate.
• 5 mg tablets contain: PB 24877 pink: lactose monohydrate, yellow iron oxide (E172), red iron oxide (E172).

What Vivace looks like and contents of the pack

Appearance of the tablets

Vivace 2.5 mg
Yellow capsules-shaped, flat, uncoated tablets, 10.0 x 5.0 mm in size, with a score line on one side and on the sides of the tablet, and with the imprint R2 on the other side. The tablet can be divided into two equal doses.
Vivace 5 mg
Pink capsules-shaped, flat, uncoated tablets, 8.8 x 4.4 mm in size, with a score line on one side and on the sides of the tablet, and with the imprint R3 on the other side. The tablet can be divided into two equal doses.
Vivace 10 mg
White to almost white capsules-shaped, flat, uncoated tablets, 11.0 x 5.5 mm in size, with a score line on one side and on the sides of the tablet, and with the imprint R4 on the other side. The tablet can be divided into two equal doses.

Pack sizes

30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

For further information on this medicine and its authorized names in the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:May 2023.