Vivace 10 mg

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Vivace 10 mg (Ramipril-ratiopharm), 10 mg, tablets
Ramiprilum
Vivace 10 mg and Ramipril-ratiopharm are different brand names for the same medicine.
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 individual. Do not pass it on to others. The medicine may harm someone else, 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 Vivace 10 mg is and what it is used for
2. What you need to know 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 Vivace 10 mg is and what it is 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 body's production of substances that may increase blood pressure
• reducing tension and widening blood vessels
• helping the heart to pump blood around the body more easily.

Vivace 10 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 10 mg

When not to take Vivace 10 mg

• If the patient is allergic to ramipril, any other 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,
  feet 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 been diagnosed with 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 10 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.

If any of the above situations apply, Vivace 10 mg should not be used. If in doubt about using this medicine, contact your doctor before starting Vivace 10 mg.

Warnings and precautions
Before starting Vivace 10 mg, 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 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 (shown in blood tests).
• 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.
• 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 (Angiotensin Receptor Blockers, ARBs) (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 to treat cancer (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 10 mg have not been established in this age group.
If any of the above situations apply (or if there is any doubt), contact your doctor before starting
Vivace 10 mg.

Vivace 10 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 10 mg may affect the action of other medicines. Likewise, other medicines may affect the action of Vivace 10 mg.

Inform the doctor if the patient is 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. Blood pressure will need to be monitored by the doctor.

Inform the doctor if the patient is taking any of the following medicines. They may increase the risk of
adverse 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 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 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 the doctor if the patient is 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 for psychiatric disorders). Vivace 10 mg may increase lithium levels in the blood.

Lithium levels in the blood 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 10 mg" and "Warnings and precautions").

If any of the above situations apply (or if there is any doubt), contact your doctor before starting
Vivace 10 mg.

Vivace 10 mg with food and alcohol

• Drinking alcohol while taking Vivace 10 mg may cause dizziness and a feeling of lightheadedness. If in doubt about how much alcohol is safe while taking Vivace 10 mg, or about possible combined effects of blood pressure-lowering medicines and alcohol, 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 become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
The patient must inform the doctor if she suspects she is pregnant (or is planning a pregnancy). 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. Alternative treatment should be considered before planning a pregnancy.
Breastfeeding
Vivace 10 mg must not be taken 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 been previously diagnosed with intolerance to certain sugars, the patient should
consult their 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 use Vivace 10 mg

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The following products are available on the market: Vivace 2.5 mg, Vivace 5 mg, 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 the diuretic before starting treatment with Vivace 10 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.

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. It is preferable to administer the medicine in two divided doses.

Treatment following 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, 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 a missed dose.
If you have any further doubts about using 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 10 mg immediately and
contact a doctor straight away – urgent medical attention 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 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:

• Rapid heartbeat, irregular or stronger than normal 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, longer than usual bleeding time, any signs of bleeding (e.g. bleeding gums), purple 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, or 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 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 a rapid change to standing or sitting position
• dry and 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-type 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 in breathing or worsening of asthma
• intestinal swelling known as "intestinal angioedema", with symptoms including abdominal pain, vomiting and diarrhoea
• heartburn, constipation or dry mouth
• increased fluid excretion (urine) during the day
• kidney function disorders, acute kidney failure
• excessive sweating
• loss or decrease in appetite (anorexia)
• rapid or irregular heartbeat
• swelling of hands and feet. These may be symptoms 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 1000 patients)

• sensation of trembling and disorientation
• red and swollen tongue
• severe peeling and shedding of the 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 ringing in the ears (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, disorientation and seizures which may be caused by abnormal secretion of antidiuretic hormone (ADH). If any of these symptoms occur, contact a doctor immediately.
• difficulty in 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, together with 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)

• rapid heartbeat, blocked nose or runny nose
• red, itchy or watery eyes.

Uncommon (may affect up to 1 in 100 patients)

• sensation of trembling, itching of the skin.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also 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 the medicine 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 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 will help protect the
environment.
Translation of some information on the immediate packaging:
Ch.-B. und verwendbar bis: siehe Prägung – batch number and expiry date: see imprint.

6. Contents of the packaging 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, monohydrate lactose, sodium croscarmellose, pregelatinized starch, sodium stearyl fumarate.

What Vivace 10 mg looks like and contents of the pack
Appearance of the tablets
White to almost white, capsule-shaped, flat, uncoated tablets, 11.0 x 5.5 mm in size, with a central dividing groove on one side and along the edges, and the imprint "R4" on the other side. The tablet can be divided into halves.
Pack sizes
30 or 90 tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Germany, 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
German Marketing Authorisation Number (country of export): 58548.02.00
Parallel Import Authorisation Number: 56/23