Vivace 2.5 mg

Patient Information Leaflet

Vivace 2.5 mg, 2.5 mg, tablets
Vivace 5 mg, 5 mg, tablets
Vivace 10 mg, 10 mg, tablets
Ramipril
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Vivace is and what it is 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 in the body of a substance that can raise blood pressure
• reducing tension and widening blood vessels
• helping the heart to pump blood around the body.

Vivace may be used to:

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

2. Important information before taking Vivace

When not to take Vivace

• If the patient is allergic to ramipril, another medicine in the ACE inhibitor class, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic (hypersensitivity) reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches 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 suitable.
• If the patient has kidney diseases associated with reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section "Pregnancy and breastfeeding").
• If the patient has very low or unstable blood pressure. The doctor will decide whether the patient should take Vivace.
• If the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently using sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) increases.

Do not take Vivace if any of the above situations apply. In case of
doubt regarding the use of this medicine, consult your doctor before
starting Vivace.
Warnings and precautions
Before starting Vivace, discuss this with your doctor or pharmacist.

• If the patient has heart, liver, or kidney diseases.
• If the patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics (water tablets), or dialysis).
• If the patient is scheduled for treatment to reduce allergic reactions to bee or wasp venom (desensitisation).
• If the patient is to receive medicines used in anaesthesia. These may be administered during surgical or dental procedures. It may be necessary to stop taking Vivace one day before the procedure. In case of doubt, consult your doctor.
• If the patient has high potassium levels in the blood (as shown in blood test results).
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient must inform the doctor if pregnancy is suspected or planned. Use of Vivace is not recommended during the first three months of pregnancy, and after the third month of pregnancy, the medicine may seriously harm the unborn child (see section "Pregnacy and breastfeeding" below).
• If the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may order regular blood tests, particularly to check blood sodium levels, especially in elderly patients.
• In black patients, there is an increased risk of angioedema, and this medicine may be less effective in lowering blood pressure compared to patients of other races.
• If the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if the patient has kidney disorders 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 diarrhoea;
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the heading "When not to take Vivace".
Children and adolescents
Use of Vivace is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Vivace have not been established in this age group.
If any of the above situations apply (or if there is any doubt), consult your doctor before starting Vivace.
Vivace with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Vivace may affect the action of other medicines, and other medicines may affect the action of Vivace.

Inform your doctor if the patient is taking any of the following medicines. They may reduce the effectiveness of Vivace:

• painkillers and anti-inflammatory medicines (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.

Inform your doctor if the patient is taking any of the following medicines. They may increase the risk of
adverse effects when taken together with Vivace:

• sacubitril in combination with valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Vivace")
• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin)
• medicines used in cancer treatment (chemotherapy)
• diuretics (water tablets), 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 for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• corticosteroid anti-inflammatory medicines, such as prednisolone
• allopurinol (a medicine used to lower blood uric acid levels)
• procainamide (a medicine used for heart rhythm disorders)
• temsirolimus (a medicine used to treat cancer)
• medicines used to prevent organ transplant rejection (sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class). See section "Warnings and precautions"
• vildagliptin (used to treat type 2 diabetes)
• racecadotril (used to treat diarrhoea)

Inform your doctor if the patient is taking any of the following medicines. Their effects may be altered
when taken with Vivace:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Vivace may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Vivace.
• lithium (used in psychiatric disorders). Vivace may increase lithium levels in the blood.

Blood lithium levels must be closely monitored.
The treating doctor may need to adjust the dose and/or take additional
precautions:

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

If any of the above situations apply (or if there is any doubt), consult your doctor before starting Vivace.
Vivace with food and alcohol

• Drinking alcohol while taking Vivace may cause dizziness and a feeling of lightheadedness. If in doubt about the amount of alcohol allowed while taking Vivace, or about possible combined effects of blood pressure-lowering medicines and alcohol, discuss with your doctor.
• Vivace may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The patient must inform the doctor if she suspects she is pregnant (or is planning a pregnancy). Use of Vivace is not recommended during the first 12 weeks of pregnancy, and the medicine must not be used after
the 13th week of pregnancy, as it may harm the unborn child. If pregnancy occurs while taking Vivace, inform the doctor immediately. Before planning a pregnancy, a change to an alternative treatment is recommended.

Breastfeeding
Do not take Vivace during breastfeeding.
Driving and operating machinery
Dizziness may occur while taking Vivace. The risk of dizziness is higher at the beginning of treatment with Vivace and after dose increases. If dizziness occurs, do not drive, use tools, or operate machinery.
Vivace contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult the doctor before taking this medicine.
Vivace contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Vivace

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dosage
Treatment of high blood pressure

• The recommended starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor may adjust the dose until blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water tablets), your doctor may discontinue or reduce the dose of your diuretic before starting Vivace treatment.

Prevention of heart attack or stroke

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

Reducing the risk of kidney disease or slowing its progression

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

Treatment of heart failure

• The recommended starting dose is 1.25 mg once daily.
• Your doctor may adjust the dosage.
• The maximum dose is 10 mg per day. It is preferable to divide the dose into two administrations.

Treatment after heart attack

• The usual recommended starting dose is 1.25 mg to 2.5 mg once daily.
• Your doctor may adjust the dosage.
• The recommended dose is 10 mg per day. It is preferable to divide the dose into two administrations.

Elderly patients
The starting dose should be lower, and dose escalation should be gradual.
How to take the medicine

• Take the medicine orally, at the same time each day.
• Swallow the tablets whole with liquid.

Tablets may be divided into equal doses.
Taking more Vivace than prescribed
Contact your doctor or go to the nearest hospital emergency department immediately.
Do not drive yourself—ask someone to take you to the hospital or call an ambulance. Bring the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Vivace
If you miss a dose, take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Vivace and
contact a doctor immediately – urgent medical care may be required:

• Swelling of the face, lips or throat causing difficulty swallowing or breathing, together with itching and rash. These may be symptoms of a severe hypersensitivity reaction to Vivace.
• Severe skin reactions, including rashes, mouth ulcers, worsening of pre-existing skin disorders, redness, blisters or peeling of the skin (such as: Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact a doctor immediately if any of the following occur:

• Increased heart rate, irregular or forceful 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 disorders.
• Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purplish spots on the skin, or more frequent infections, sore throat and fever, fatigue, weakness, dizziness or pale 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 disorders such as hepatitis or liver damage.

Other adverse reactions:
Inform your doctor if any of the following symptoms worsen significantly or persist for more than a few days.
Common (may affect up to 1 in 10 patients)

• headache or feeling tired
• dizziness – risk is higher at the beginning of Vivace treatment and after dose increase
• fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly
• dry, persistent cough, sinusitis or bronchitis, shortness of breath
• abdominal pain or intestinal discomfort, diarrhoea, indigestion, nausea or vomiting
• rash with or without raised lesions
• chest pain
• muscle cramps or muscle pain
• laboratory finding of higher than normal potassium levels in blood.

Uncommon (may affect up to 1 in 100 patients)

• balance disorders (vertigo)
• itching of the skin and sensory disturbances such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesia)
• loss or disturbance of taste sensation
• sleep disturbances
• depression, anxiety, increased nervousness or restlessness
• stuffy nose, breathing difficulties or worsening of asthma
• intestinal swelling known as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhoea
• heartburn, constipation or dry mouth
• increased production of urine (polyuria)
• kidney function disorders, acute kidney failure
• excessive sweating
• loss or decrease of appetite (anorexia)
• rapid or irregular heartbeat
• swelling of hands and feet. These may be symptoms of increased fluid retention
• hot flushes
• blurred vision
• joint pain
• fever
• impotence in men, decreased libido in men and women
• increased number 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 patients)

• sensation of trembling and disorientation
• red and swollen tongue
• severe peeling and shedding of skin, itchy nodular rash
• nail disorders (e.g. loosening or separation of the nail from the nail bed)
• skin rash or tendency to bruise
• skin spots and cold extremities
• redness, itching, swelling and watering of the eyes
• hearing disturbances and tinnitus
• weakness
• decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin levels in blood tests.

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

• increased sensitivity to sunlight. Frequency not known (cannot be estimated from available data)
• concentrated urine (dark colour), nausea, muscle cramps, confusion and seizures, which may be caused by abnormal secretion of antidiuretic hormone (ADH). If any of these symptoms occur, contact a doctor immediately.
• difficulty concentrating
• mouth pain
• detection of increased antibody levels in blood tests
• detection of abnormally low blood cell counts in blood tests
• detection of lower than normal sodium levels in blood tests
• colour changes in fingers upon cold exposure and tingling or pain upon warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• burning sensation
• disturbances in smell
• hair loss.

In children, the frequency of the following adverse reactions is higher than in adults:
Common (may affect up to 1 in 10 patients)

• increased heart rate, blocked nose or runny nose
• red, itchy or watery eyes.

Uncommon (may affect up to 1 in 100 patients)

• sensation of trembling, skin itching.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vivace tablets

Keep this medicine out of sight and reach of children.
Do not use Vivace after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vivace contains

• The active substance is ramipril. Each tablet contains 2.5 mg, 5 mg, or 10 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose, pregelatinized starch (starch 1500), magnesium stearate. Additionally:
• 2.5 mg tablets contain: colouring PB 22960 yellow: monohydrate lactose, yellow iron oxide (E172).
• 5 mg tablets contain: colouring PB 24877 pink: monohydrate lactose, 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, capsule-shaped, flat, uncoated tablets of size 10.0 x 5.0 mm, with a dividing groove on one side and along the sides of the tablet, and an imprint "R2" on the other side. The tablet can be divided into halves.
Vivace 5 mg
Pink, capsule-shaped, flat, uncoated tablets of size 8.8 x 4.4 mm, with a dividing groove on one side and along the sides of the tablet, and an imprint "R3" on the other side. The tablet can be divided into halves.
Vivace 10 mg
White to almost white, capsule-shaped, flat, uncoated tablets of size 11.0 x 5.5 mm, with a dividing groove on one side and along the sides of the tablet, and an imprint "R4" on the other side. The tablet can be divided into halves.
Pack sizes
30 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 about this medicinal product and its names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.