Vivace 5 mg

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Vivace 5 mg (Ramipril Teva Pharma 5 mg Tablets)
5 mg, tablets
Ramiprilum
Vivace 5 mg and Ramipril Teva Pharma 5 mg Tablets are different brand names for the same
medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

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

Table of Contents

1. What Vivace 5 mg is and what it is 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 Vivace 5 mg is and what it is 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 a substance that can raise blood pressure
• reducing tension and widening blood vessels
• helping the heart to pump blood through the body more easily.

Vivace 5 mg may be used:

• to treat high blood pressure (hypertension)
• to reduce the risk of heart attack or stroke
• to reduce the risk of or delay worsening kidney problems (regardless of whether the patient has diabetes)
• to treat heart failure (when the heart cannot pump enough blood to the rest of the body)
• to 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 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 spots 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 disease related to 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 impaired kidney function 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 under 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 Vivace 5 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vivace 5 mg.

• If the patient has heart, liver or kidney disease.
• 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 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 (as shown in blood test results).
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• Female patients must inform their doctor if they suspect they are pregnant or are planning a pregnancy. 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 "Pregnancy 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.
• In patients of Black race, there is a higher risk of angioedema, and this 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 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 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 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 levels of electrolytes (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 5 mg have not been established in this age group.
If any of the above situations apply (or if there is any doubt), contact a doctor before starting Vivace 5 mg.
Vivace 5 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Vivace 5 mg may affect the action of other medicines. Likewise, other medicines may affect the action of Vivace 5 mg.
Inform your doctor if the patient is taking any of the following medicines. They may reduce the effectiveness of Vivace 5 mg:

• 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 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 indomethacin, and aspirin)
• medicines used to treat cancer (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 levels of uric acid)
• 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 the patient is taking any of the following medicines. Their effect may be altered when taking Vivace 5 mg:

• antidiabetic medicines, such as oral glucose-lowering medicines 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 blood lithium levels. Blood lithium levels should 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 doubt), contact a doctor before starting 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, consult your doctor.
• Vivace 5 mg 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 baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The patient must inform her doctor if she suspects she is pregnant (or is planning a 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 your doctor immediately. Alternative treatment should be considered before planning a pregnancy.
Breastfeeding
Do not take Vivace 5 mg while 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 an increase in dose. If dizziness occurs, do not drive, use tools or operate machinery.
Vivace 5 mg contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Vivace 5 mg 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 5 mg

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The following products are available on the market: Vivace 2.5 mg, Vivace 5 mg, and Vivace 10 mg.
Dosage
Treatment of arterial hypertension

• 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 your diuretic before starting treatment with Vivace.

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.
  Reduction of 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. Administration in two divided doses is preferred.

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. Administration in two divided doses is preferred.

Elderly patients
The initial 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 5 mg 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 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 immediately and
contact your doctor right away – urgent medical attention may be required:

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, together with itching and rash. These may be signs 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).

Contact your doctor immediately if any of the following occur:

• Rapid heartbeat, irregular or stronger-than-usual 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, possibly radiating 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 patients)

• headache or feeling tired
• 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 patients)

• balance disorders (vestibular dizziness)
• skin itching and sensory disturbances such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesias)
• loss or disturbances of taste sensation
• sleep disturbances
• depression, anxiety, increased nervousness or restlessness
• nasal congestion, difficulty breathing or worsening of asthma
• intestinal swelling known as "intestinal angioedema", presenting with abdominal pain, vomiting and diarrhoea
• heartburn, constipation or dry mouth
• increased production of urine during the day
• kidney function disorders, acute kidney failure
• excessive sweating
• loss or decreased 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 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 hemoglobin 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, disorientation and seizures, which may be caused by abnormal secretion of antidiuretic hormone (ADH). If any of 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, accompanied by tingling or pain upon warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• burning sensation
• disturbances 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 patients)

• rapid heartbeat, 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 those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vivace 5 mg

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
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. This will help protect the environment.

6. Contents of the pack and other information

What Vivace 5 mg contains

• The active substance is ramipril. One tablet contains 5 mg of ramipril.
• The other ingredients are: pregelatinized maize starch, sodium bicarbonate, monohydrate lactose, sodium croscarmellose, 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, round, biconvex tablets with a division line on one side, 6.5 mm in diameter.
The tablet can be divided into equal doses.
Pack sizes
28 or 84 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Ireland, country of export:
Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Irish Marketing Authorisation number, country of export: PA 749/177/3
Parallel Import Licence number: 102/20