Ramipril actavis

Patient Information Leaflet

Ramipril Actavis, 5 mg, tablets
Ramipril Actavis, 10 mg, tablets
ramiprilum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Ramipril Actavis is and what it is used for
2. What you need to know before taking Ramipril Actavis
3. How to take Ramipril Actavis
4. Possible side effects
5. How to store Ramipril Actavis
6. Contents of the pack and other information

1. What Ramipril Actavis is and what it is used for

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

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

Ramipril Actavis may be used:

• to treat high blood pressure (hypertension)
• to reduce the risk of heart attack or stroke
• to reduce the risk of kidney disease or to slow down its progression (regardless of whether the patient has diabetes)
• to treat heart failure (when the heart is unable to pump sufficient blood to meet the body's needs)
• in the treatment of patients with heart failure following a heart attack.

2. Information before taking Ramipril Actavis

When not to take Ramipril Actavis

• If the patient is allergic to ramipril, to another medicine in the class of ACE inhibitors, or to 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 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, Ramipril Actavis may not be suitable.

• If the patient has kidney disease 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's blood pressure is very low or unstable. This assessment should be made by a physician.

• If the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

• If the patient has taken or is currently using 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 Ramipril Actavis if any of the above situations apply.
If in doubt about using this medicine, contact your doctor before starting
treatment with Ramipril Actavis.
Warnings and precautions
Before starting treatment with Ramipril Actavis, discuss this with your 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 (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 Ramipril Actavis 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 is taking medicines, or suffers from conditions, that may reduce sodium levels in the blood. Your doctor may recommend regular blood tests, particularly monitoring sodium levels, especially in elderly patients.
• If the patient is of Black race, they may be at 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, 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.
• If the patient has collagenosis such as scleroderma or systemic lupus erythematosus.
• The patient must inform the doctor if she suspects she is pregnant or if she plans to become pregnant. Use of Ramipril Actavis is not recommended during the first 3 months of pregnancy, and after the third month of pregnancy the medicine may seriously harm the unborn baby – see section "Pregnancy and breastfeeding".
• 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 dysfunction related to diabetes.
• aliskiren.

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 Ramipril Actavis”.
Children and adolescents
Ramipril Actavis is not recommended for use in children and adolescents under 18 years of age, as
the safety and efficacy of Ramipril Actavis 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
treatment with Ramipril Actavis.
Ramipril Actavis and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, and any medicines the patient plans to take. Ramipril Actavis may
affect the action of other medicines. Other medicines may also affect the action of Ramipril
Actavis.
Tell your doctor if the patient is taking any of the following medicines. They may reduce the effectiveness of
Ramipril Actavis:

• 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 should be monitored by the doctor.

Tell your doctor if the patient is taking any of the following medicines. They may increase the risk of
side effects when taken together with Ramipril Actavis:

• sacubitril/valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 “When not to take Ramipril Actavis”),
• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as: ibuprofen or indomethacin and aspirin)
• anticancer medicines (chemotherapy)
• diuretics (water tablets), such as furosemide
• potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride, 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)
• trimethoprim and co-trimoxazole (medicines used to treat bacterial infections)
• temsirolimus (a medicine used to treat cancer)
• sirolimus, everolimus (medicines used to prevent transplant rejection)
• vildagliptin (used to treat type II diabetes)
• racecadotril (used to treat diarrhoea)
• 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 information under the headings “When not to take Ramipril Actavis” and “Warnings and precautions”).

Tell your doctor if the patient is taking any of the following medicines. Their effects may be altered
by taking Ramipril Actavis:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Ramipril Actavis may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Ramipril Actavis.
• lithium (used for psychiatric disorders). Ramipril Actavis may increase lithium levels in the blood. Lithium levels in the blood should be closely monitored. If any of the above situations apply (or if there is any doubt), contact your doctor before starting treatment with Ramipril Actavis.

Ramipril Actavis with food and alcohol
Drinking alcohol while taking Ramipril Actavis may cause dizziness
and drowsiness. Discuss this with your doctor if the patient has any concerns about the amount
of alcohol allowed while taking Ramipril Actavis and about the possible combined effects of blood pressure-lowering medicines and alcohol.
Ramipril Actavis may be taken during or independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, 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 plans to become pregnant).
Use of Ramipril Actavis 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 baby. If pregnancy occurs while taking Ramipril Actavis, inform the doctor immediately. Alternative treatment should be considered before planning a pregnancy.
Breast-feeding
Ramipril Actavis must not be taken during breast-feeding.
Driving and operating machinery
Dizziness may occur while taking Ramipril Actavis. The risk of dizziness is higher at the beginning of treatment with Ramipril Actavis and after increasing the dose. If dizziness occurs, do not drive or use tools or operate machinery.
Ramipril Actavis contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should
consult their doctor before taking this medicine.
Ramipril Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to use Ramipril Actavis

This medicine should always be taken exactly as your doctor or pharmacist has advised. If you are unsure,
you should consult your doctor or pharmacist.
Dosage
Hypertension treatment

• 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 pills), your doctor may stop or reduce the dose of your diuretic before starting Ramipril Actavis.

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 usual dose is 10 mg once daily.

Reducing or delaying the worsening of kidney function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor may adjust the dosage.
• The usual dose is 5 mg or 10 mg once daily.

Heart failure treatment

• 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 administer the medicine in two divided doses.

Post-heart attack treatment

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

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 at least half a glass of water.
• Do not chew or crush the tablets.
• Tablets may be divided into equal doses.

Taking more Ramipril Actavis 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 Ramipril Actavis
If you miss a dose, take the next scheduled dose as planned.
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 or pharmacist.

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, treatment with Ramipril Actavis must be
discontinued immediately and medical advice must be sought without delay – prompt
treatment may be necessary:

• 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 Ramipril Actavis.
• 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).

If any of the following symptoms occur, contact your doctor promptly:

• Rapid heartbeat, irregular or stronger-than-normal heartbeats (palpitations), chest pain, sensation 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), purple spots on the skin, 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 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 patients)

• headache or feeling of fatigue
• dizziness. The risk is higher at the beginning of treatment with Ramipril Actavis and after dose increase
• fainting, hypotension (abnormally low blood pressure), especially when occurring after a rapid change to a 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
• elevated potassium levels in blood tests.

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 (paraesthesiae)
• loss or disturbances in taste sensation
• sleep disturbances
• depression, anxiety, increased nervousness or restlessness
• sensation of nasal congestion, difficulty breathing or worsening of asthma
• intestinal swelling known as "intestinal angioedema", with symptoms of 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 reduced appetite (anorexia)
• rapid or irregular heartbeat. Swelling of hands and feet. These may be signs of increased 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 tremor 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 concentration 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 colouration), nausea, muscle cramps, disorientation and seizures, which may be caused by inappropriate antidiuretic hormone (ADH) secretion. If any of these symptoms occur, contact your doctor immediately.
• difficulty concentrating
• lip pain
• blood tests may show elevated levels of antibodies
• 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 exposure to cold, with tingling or pain upon warming (Raynaud's phenomenon)
• breast enlargement in men
• slowed or impaired reactions
• burning sensation
• disturbances in smell
• hair loss.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ramipril Actavis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister or label following EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Blister packs: store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ramipril Actavis contains

• The active substance is ramipril.
• Each tablet contains 5 mg or 10 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose, pregelatinized corn starch, magnesium stearate. Additionally, the 5 mg tablets contain: colouring agent Blend PB 24877 Pink: monohydrate lactose, yellow iron oxide (E172), red iron oxide (E172).

What Ramipril Actavis looks like and contents of the pack

• 5 mg tablets: capsule-shaped, flat, pink tablets, with a dividing groove on one side and along the sides of the tablet, and embossed with R3.
• 10 mg tablets: capsule-shaped, flat, white tablets, with a dividing groove on one side and along the sides of the tablet, and embossed with R4.

Pack sizes
Aluminum blisters made of OPA/Aluminium/PVC/Aluminium: 28, 30, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Actavis Ltd.
BLB0015-016
Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

For further information about this medicinal product and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Tel (+48 22) 345 93 00

This leaflet does not contain all the information about this medicine. If you have any questions or doubts, please consult your doctor or pharmacist.