Vivace 10 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Vivace 10 mg
10 mg, tablets
Ramiprilum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Vivace 10 mg and what is it used for
2. Important information before taking Vivace 10 mg
3. How to take Vivace 10 mg
4. Possible side effects
5. How to store Vivace 10 mg
6. Contents of the pack and other information

1. What is Vivace 10 mg and what is it used for

Vivace 10 mg contains the active substance ramipril. It belongs to a group of medicines called
ACE inhibitors (angiotensin-converting enzyme inhibitors).
Vivace 10 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 pump blood through the body.

Vivace 10 mg may be used to:

• treat high blood pressure (hypertension)
• reduce the risk of heart attack or stroke
• reduce or delay the progression of 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. Information before taking Vivace 10 mg

When not to take Vivace 10 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 patches on the palms, soles and in the 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 10 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 the patient has very low or unstable blood pressure. The doctor will decide whether the patient should take Vivace 10 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 10 mg if any of the above situations apply.
If in doubt about using this medicine, contact a doctor before starting Vivace 10 mg.
Warnings and precautions
Talk to your doctor or pharmacist before starting Vivace 10 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, 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 10 mg one day before the procedure. If in doubt, contact your doctor.
• If the patient has high potassium levels in the blood (seen 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 10 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 "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.
• Patients of Black African origin have a higher risk of developing angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other ethnicities.
• If the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARBs) (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 diarrhoea;
• medicines used to prevent rejection of transplanted organs 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 10 mg”.
Children and adolescents
Use of Vivace 10 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 doubt), contact a doctor before starting
Vivace 10 mg.
Vivace 10 mg and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, and any medicines
you plan to take.
Vivace 10 mg may affect the action of other medicines. Other medicines may also affect the
action of Vivace 10 mg.
Inform your doctor if you are taking any of the following medicines. They may reduce the
effectiveness of Vivace 10 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 you are taking any of the following medicines. They may increase the risk
of side effects when taken together with Vivace 10 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 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 rejection of transplanted organs; 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 effect may be altered
when taking Vivace 10 mg:

• antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Vivace 10 mg may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Vivace 10 mg;
• lithium (used in psychiatric disorders). Vivace 10 mg may increase lithium levels in the blood. Blood lithium levels should 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 10 mg” and “Warnings and precautions”).

If any of the above situations apply (or if there is any doubt), contact a doctor before starting
Vivace 10 mg.
Vivace 10 mg with food and alcohol

• Drinking alcohol while taking Vivace 10 mg may cause dizziness and drowsiness. If in doubt about how much alcohol is safe to drink while taking Vivace 10 mg, and whether the effects of blood pressure-lowering medicines and alcohol may combine, talk to your doctor.
• Vivace 10 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 a doctor or pharmacist before taking this medicine.
Pregnancy
The patient must inform the doctor if she suspects she is pregnant (or plans to become pregnant). Use of Vivace 10 mg is not recommended during the first 12 weeks of pregnancy and must not be used after the 13th week of pregnancy, as it may harm the unborn child.
If pregnancy occurs while taking Vivace 10 mg, inform the doctor immediately. A change to alternative treatment is recommended before planning a pregnancy.
Breastfeeding
Do not take Vivace 10 mg during breastfeeding.
Driving and using machines
Dizziness may occur while taking Vivace 10 mg. The risk of dizziness is higher at the beginning of treatment with Vivace 10 mg and after dose increases. If dizziness occurs, do not drive, use tools or operate machinery.
Vivace 10 mg contains lactose monohydrate
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
Vivace 10 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 take Vivace 10 mg

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The following 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 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 the diuretic before starting treatment with Vivace 10 mg.

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 recommended starting 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 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 10 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 miss a dose of Vivace 10 mg
If you miss a dose, take the next dose at your usual time.
Do not take a double dose to make up for the 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 experiences them.
If any of the following serious adverse reactions occur,
treatment with Vivace 10 mg must be discontinued immediately and medical advice must be sought urgently –
immediate medical intervention may be required:

• 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 10 mg.
• Severe skin reactions, including rashes, mouth ulcers, worsening of pre-existing skin disorders, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Immediately inform your doctor if any of the following occur:

• Rapid heartbeat, irregular or stronger-than-usual 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), purpuric skin spots, or increased frequency of infections, sore throat, fever, fatigue, weakness, dizziness, or pale skin. These may indicate blood or bone marrow disorders.
• Severe abdominal pain 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 worsen significantly or
persist for more than a few days.
Common (may affect up to 1 in 10 patients)

• Headache or feeling of fatigue
• Dizziness – risk is higher at the beginning of treatment with Vivace 10 mg and after dose increase
• Fainting, hypotension (abnormally low blood pressure), especially when occurring after rapid change to standing or sitting position
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath
• Abdominal pain or intestinal discomfort, diarrhea, indigestion, nausea, or vomiting
• Rash with or without raised lesions
• Chest pain
• Muscle cramps or pain
• Laboratory finding of higher-than-normal blood potassium levels.

Uncommon (may affect up to 1 in 100 patients)

• Balance disorders (vestibular dizziness)
• Itching of the skin and sensory disturbances such as numbness, tingling, pricking, burning, or crawling sensations on the skin (paresthesia)
• Loss or disturbances in taste perception
• Sleep disturbances
• Depression, anxiety, increased nervousness, or restlessness
• Nasal congestion, breathing difficulties, or worsening of asthma
• Intestinal swelling known as "intestinal angioedema," presenting with abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Increased volume of fluid (urine) excreted during the day
• Kidney function disorders, acute kidney failure
• Excessive sweating
• Loss of or reduced appetite (anorexia)
• Rapid or irregular heartbeat
• Swelling of hands and feet. These may be signs of fluid retention in larger-than-normal amounts
• 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)

• Feeling of tremors 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 tearing 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 unknown (cannot be estimated from available data)

• Concentrated urine (dark coloration), nausea, muscle cramps, disorientation, and seizures, which may be caused by inappropriate antidiuretic hormone (ADH) secretion. If these symptoms occur, contact your 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
• Color 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
• Smell disturbances
• 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, nasal congestion, or runny nose
• Red, itchy, or watery eyes.

Uncommon (may affect up to 1 in 100 patients)

• 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 10 mg

Keep this medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Do not use Vivace 10 mg after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must 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 pack and other information

What Vivace 10 mg contains

• The active substance is ramipril. Each tablet contains 10 mg of ramipril.
• Other ingredients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch, sodium stearyl fumarate.

What Vivace 10 mg looks like and contents of the pack
Appearance of the tablets: White or almost white, elongated, flat tablets, with a division line on one side
and along the edges of the tablet, marked with the letter "R" on one side and the digit "4" 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 marketing authorization holder or parallel importer.
Marketing authorization 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., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorization number in Romania, country of export: 9381/2016/02
Parallel import authorization number: 50/21