Vivace 5 mg

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Vivace 5 mg
5 mg, tablets
Ramipril
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What is Vivace 5 mg and what is it used for

Vivace 5 mg contains the active substance ramipril. It belongs to a group of medicines called
ACE inhibitors (angiotensin-converting enzyme inhibitors).
Vivace 5 mg works by:

• reducing the production in the body of substances that may increase blood pressure
• reducing tension and widening blood vessels
• helping the heart to pump blood around the body.

Vivace 5 mg 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 5 mg

When not to take Vivace 5 mg

• 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 hands, feet, 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 5 mg 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 blood pressure is very low or unstable. The doctor will decide whether the patient should take Vivace 5 mg.
• If the patient has diabetes or kidney function disorders 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 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 5 mg if any of the above situations apply.
If in doubt about using this medicine, contact a doctor before starting
treatment with Vivace 5 mg.
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Vivace 5 mg.

• 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, prolonged use of diuretics (water tablets), or dialysis).
• If the patient is due to undergo treatment to reduce allergic reactions to bee or wasp venom (desensitisation).
• If the patient is to receive medicines used in anaesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Vivace 5 mg one day before the procedure. If in doubt, contact your doctor.
• If the patient has high potassium levels in the blood (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 5 mg 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 recommend regular blood tests, particularly to check blood sodium levels, especially in elderly patients.
• Patients of Black race have a higher risk of developing 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 – for example, valsartan, telmisartan, irbesartan), especially 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 5 mg".
Children and adolescents
Use of Vivace 5 mg is not recommended 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 apply (or if there is any uncertainty), contact a doctor before starting
treatment with Vivace.
Vivace 5 mg and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, and any medicines
you plan to take. Vivace 5 mg may affect the action of other medicines. Other medicines may also
affect the action of Vivace 5 mg.
Inform your doctor if you are taking any of the following medicines. They may reduce the effect
of Vivace 5 mg:

• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and aspirin)
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as: ephedrine, noradrenaline, or adrenaline. Blood pressure will need to be monitored by the doctor.

Inform your doctor if you are taking any of the following medicines. They may increase the risk
of adverse effects when used together with Vivace 5 mg:

• 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 indometacin, 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 immunosuppressant 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 uric acid levels in the blood)
• 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 class of mTOR inhibitors). See section "Warnings and precautions".
• vildagliptin (used to treat type 2 diabetes)
• racecadotril (used to treat diarrhoea).

Inform your doctor if you are taking any of the following medicines. Their effects may be altered
when taking Vivace 5 mg:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Vivace 5 mg may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Vivace 5 mg;
• lithium (used for psychiatric disorders). Vivace 5 mg 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 other
precautions:

• If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also "When not to take Vivace 5 mg" and "Warnings and precautions").

If any of the above situations apply (or if there is any uncertainty), contact a doctor before
starting treatment with Vivace 5 mg.
Vivace 5 mg with food and alcohol

• Drinking alcohol while taking Vivace 5 mg may cause dizziness and drowsiness. If in doubt about how much alcohol is safe while taking Vivace 5 mg, or about possible combined effects of blood pressure-lowering medicines and alcohol, talk to your doctor.
• Vivace 5 mg can be taken during or independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The patient must inform the doctor if she suspects she is pregnant (or plans pregnancy). Use of
Vivace 5 mg is not recommended during the first 12 weeks of pregnancy, and must not be used
after week 13 of pregnancy, as it may harm the unborn child.
If pregnancy occurs while taking Vivace 5 mg, inform the doctor immediately. Before planning
pregnancy, alternative treatment should be considered.
Breastfeeding
Do not take Vivace 5 mg during breastfeeding.
Driving and using machines
Dizziness may occur while taking Vivace 5 mg. The risk of dizziness is higher at the beginning of
treatment with Vivace 5 mg and after dose increases. If dizziness occurs, do not drive, use tools, or
operate machinery.
Vivace 5 mg contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should
consult a doctor before taking this medicine.
Vivace 5 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Vivace 5 mg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The following products are available on the market: Vivace 2.5 mg (2.5 mg), Vivace 5 mg (5 mg), Vivace 10 mg (10 mg).
Dosage
Treatment of high blood pressure

• The recommended initial 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 pills), your doctor may discontinue or reduce the dose of the diuretic before starting treatment with Vivace 5 mg.

Prevention of heart attack or stroke

• The recommended initial 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 initial 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 initial 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 administer the medicine in two divided doses.

Treatment after heart attack

• The recommended initial dose is usually between 1.25 mg and 2.5 mg once daily.
• Your doctor may adjust the dosage.
• The recommended dose is 10 mg per day. It is preferable to administer the medicine in two divided doses.

Elderly patients
The initial dose should be lower, and dose escalation should be performed gradually.
How to take the medicine

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

Tablets may be divided into equal doses.
Taking more Vivace 5 mg than recommended
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 forget to take a dose of Vivace 5 mg
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 5 mg and contact a doctor immediately – urgent medical help may be needed:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe allergic reaction to Vivace 5 mg.
• 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).

Inform your doctor immediately if any of the following occur:

• Rapid heartbeat, irregular or stronger heartbeats (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 become severe or persist for more than a few days.
Common (may affect up to 1 in 10 people)

• Headache or feeling of fatigue
• Dizziness – risk is higher at the beginning of treatment with Vivace 5 mg 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 people)

• Balance disorders (vestibular dizziness)
• Itching of the skin and sensory disturbances such as numbness, tingling, pricking, burning or crawling sensations on the skin (paraesthesia)
• Loss or disturbances in taste sensation
• Sleep disturbances
• Depression, anxiety, increased nervousness or restlessness
• Nasal congestion, difficulty breathing or worsening of asthma
• Intestinal angioedema, presenting with abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Increased volume of fluid (urine) passed during the day
• Kidney function disorders, acute kidney failure
• Excessive sweating
• Loss of appetite or reduced appetite (anorexia)
• Rapid or irregular heartbeat
• Swelling of hands and feet. These may be signs of 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 1000 people)

• Feeling of tremor and disorientation
• Red and swollen tongue
• Severe skin peeling and desquamation, 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 concentration 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 available data)

• Concentrated urine (dark colour), nausea, muscle cramps, disorientation and seizures, which may be caused by abnormal secretion of antidiuretic hormone (ADH). If these symptoms occur, contact your doctor immediately.
• Difficulty concentrating
• Mouth pain
• Detection of increased levels of antibodies 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
• Disorders of 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 people)

• Rapid heartbeat, blocked nose or runny nose
• Red, itchy or watery eyes.

Uncommon (may affect up to 1 in 100 people)

• Feeling 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, 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vivace 5 mg

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use Vivace 5 mg after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the Package and Other Information

What Vivace 5 mg Contains

• The active substance is ramipril. Each tablet contains 5 mg of ramipril.
• The other components are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose, pregelatinized starch, sodium stearyl fumarate, yellow iron oxide (E 172), red iron oxide (E 172).

What Vivace 5 mg Looks Like and Contents of the Pack
Appearance of the tablets: Pink, flat, elongated tablets, with a division line on one side and along the edges, marked with the letter “R” on one side and the number “3” on the other side of the line. The tablet can be divided into equal doses.
Pack sizes: 28 or 84 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Manufacturer:
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Actavis hf., Reykjavikurvegur 76-78, IS–220 Hafnarfjörður, Iceland
Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Romania, country of export: 9380/2016/02
Parallel Import Authorisation Number: 52/21