Vivace 10 mg

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Vivace 10 mg(Ramipril-ratiopharm), 10 mg, tablets
Ramiprilum
Vivace 10 mg and Ramipril-ratiopharm are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you 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 tell their 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 packaging 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 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 10 mg 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 the heart when it does not pump enough blood to the rest of the body (heart failure)
• treat heart attack complicated by heart failure.

2. Important information before taking Vivace 10 mg

When not to take Vivace 10 mg

• 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". Its symptoms include: itching, hives, red spots on the palms of the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

stop taking the medicine and consult a doctor immediately.

• If the patient has undergone dialysis or another type of blood filtration. Depending on the type of device used, Vivace 10 mg 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 blood pressure is very low or unstable. The doctor will decide whether the patient should take Vivace 10 mg. 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 10 mg should not be taken. In case of doubts about taking the medicine, the patient should consult a doctor before starting to take Vivace 10 mg.

Warnings and precautions

Before starting to take Vivace 10 mg, 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 prolonged use of diuretics).
• If the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings.
• If the patient is to receive medicines used in anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Vivace 10 mg one day before the procedure. In case of doubts, the patient should consult a doctor.
• If the patient has high potassium levels in the blood (as shown by blood tests).
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient must inform the doctor if they suspect or plan to become pregnant. It is not recommended to take Vivace 10 mg 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 used to treat 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 10 mg".

Children and adolescents

Vivace 10 mg should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Vivace 10 mg in this age group have not been established.
If any of the above situations occur (or if there are any doubts), the patient should consult a doctor before starting to take Vivace 10 mg.

Vivace 10 mg 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 10 mg may affect the action of other medicines. Other medicines may also affect the action of Vivace 10 mg.
The patient should inform their doctor about taking the following medicines, as they may reduce the effect of Vivace 10 mg:

• medicines used to treat pain 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 10 mg:

• sacubitril with valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Vivace 10 mg")
• medicines used to treat pain 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; cyclosporine, 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 section "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 10 mg:

• medicines used to treat diabetes, such as oral hypoglycemic agents and insulin. Vivace 10 mg may lower blood sugar levels. During treatment with Vivace 10 mg, blood sugar levels should be regularly monitored.
• lithium (used to treat mental illnesses). Vivace 10 mg may increase lithium levels in the blood.

The patient should be closely monitored for 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 10 mg" and "Warnings and precautions").

If any of the above situations occur (or if there are any doubts), the patient should consult a doctor before starting to take Vivace 10 mg.

Vivace 10 mg with food and drink

• Drinking alcohol while taking Vivace 10 mg may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Vivace 10 mg and the possibility of combining the effects of blood pressure-lowering medicines and alcohol, the patient should consult a doctor.
• Vivace 10 mg 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 a 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 10 mg 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 10 mg, they should immediately inform their doctor. Before planned pregnancy, it is recommended to change the treatment to an alternative.
Breastfeeding
Vivace 10 mg should not be taken during breastfeeding.

Driving and using machines

While taking Vivace 10 mg, dizziness may occur. The risk of dizziness is higher at the beginning of treatment with Vivace 10 mg and after increasing the dose. If dizziness occurs, the patient should not drive vehicles, use tools, or operate machines.

Vivace 10 mg contains lactose monohydrate

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

Vivace 10 mg contains sodium

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

3. How to take Vivace 10 mg

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
The following are available: Vivace 2.5 mg, Vivace 5 mg, Vivace 10 mg.

Dosage

Treatment of high blood pressure

• The recommended initial dose is 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dose of the medicine to achieve blood pressure control.
• The maximum dose is 10 mg once a day.
• In patients taking diuretics (water pills), the 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 initial dose is 2.5 mg once a day.
• The doctor may decide to increase the dose.
• The recommended dose is 10 mg once a day.

Reducing the risk of kidney disease or delaying its progression

• The usual initial dose is 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dose of the medicine.
• The recommended dose is 5 mg or 10 mg once a day.

Treatment of heart failure

• The recommended initial dose is 1.25 mg once a day.
• The doctor may adjust the dose of the medicine.
• The maximum dose is 10 mg per day. It is preferred to administer the medicine in two divided doses.

Treatment after heart attack

• The recommended initial dose is usually 1.25 mg to 2.5 mg once a day.
• The doctor may adjust the dose of the medicine.
• The recommended dose is 10 mg per day. It is preferred to administer the medicine in two divided doses.

Elderly patients
The initial dose should be smaller, and the dose increase should be gradual.

Administration

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

The tablets can be divided into equal doses.

Taking a higher dose of Vivace 10 mg than recommended

The patient should contact a 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 packaging of the medicine with them, so the doctor knows what medicine was taken.

Missing a dose of Vivace 10 mg

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 any further doubts about taking this medicine, the patient should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Vivace 10 mg can cause side effects, although not everybody gets them.

If the patient notices any of the following serious side effects, they should stop taking Vivace 10 mg and contact their doctor immediately - 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 10 mg.
• Severe skin reactions, including rash, mouth ulcers, 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 diseases.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding from the gums), purpura, 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 diseases, 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 10 mg 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 tiring cough, sinusitis, or bronchitis, shortness of breath
• abdominal pain or intestinal cramps, diarrhea, nausea, or vomiting
• rash with or without hives
• chest pain
• muscle cramps or muscle pain
• high potassium levels in the blood, as shown by blood tests.

Uncommon(may affect up to 1 in 100 people)

• balance disorders (dizziness of vestibular 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
• stuffy nose, difficulty breathing, or worsening of asthma
• intestinal edema, which can cause abdominal pain, vomiting, and diarrhea
• heartburn, constipation, or dry mouth
• increased urine production during the day
• kidney function disorders, 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 white blood cell count 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 peeling and shedding of the skin, itchy papular rash
• nail diseases (e.g., loosening or separation of the nail from the nail bed)
• skin rash or tendency to bruise
• spots on the skin and cold extremities
• redness, itching, swelling, and tearing of the eyes
• hearing or ringing in the ears
• weakness
• decreased red blood cell count, white blood cell count, or platelet count, 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 antibody levels in blood tests
• decreased white blood cell count in blood tests
• lower than normal sodium levels in blood tests
• changes in finger color after cooling and a feeling of tingling or pain after warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• burning sensation
• 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, stuffy nose, or runny nose
• 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 this leaflet, they should tell their doctor, pharmacist, or nurse. 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vivace 10 mg

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Do not use Vivace 10 mg after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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.

Translation of some information on the immediate packaging: Ch.-B. und verwendbar bis: see Prägung – batch number and expiry date: see embossing.

6. Contents of the packaging and other information

What Vivace 10 mg contains

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

What Vivace 10 mg looks like and contents of the pack

Appearance of the tablets

White to almost white capsules-shaped tablets, flat, uncoated, 11.0 x 5.5 mm in size, with a score line on one side and on the sides of the tablet, and embossing R4 on the other side. The tablet can be divided into two equal doses.

Pack sizes

30 or 90 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:58548.02.00

Parallel import authorization number: 56/23 Date of approval of the leaflet: 27.03.2023

[Information about the trademark]