Ramipril Actavis

Leaflet attached to the packaging: patient information

Ramipril Actavis, 5 mg, tablets

Ramipril Actavis, 10 mg, tablets

Ramipril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ramipril Actavis and what is it used for
• 2. Important information 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 is Ramipril Actavis and what is it 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 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.

Ramipril Actavis can be used to:

• treat high blood pressure (hypertension)
• reduce the risk of heart attack or stroke
• reduce the risk of kidney disease or slow its progression (regardless of whether the patient has diabetes)
• treat heart failure, when the heart is unable to pump enough blood needed by the body
• treat patients with heart failure after a heart attack.

2. Important information before taking Ramipril Actavis

When not to take Ramipril Actavis

• 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 face, lips, tongue, or throat.
• 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, soles of the feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

stopach i w gardle, obrzęk gardła i języka, obrzęki w okolicy oczu i ust, trudności w oddychaniu
i połykaniu.

• If the patient has undergone dialysis or other blood filtration. Depending on the type of device used, Ramipril Actavis 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 assessment should be made by a doctor.
• 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/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

If any of the above situations occur, Ramipril Actavis should not be taken.
In case of doubts about taking the medicine, consult a doctor before starting treatment with Ramipril Actavis.

Warnings and precautions

Before starting treatment with Ramipril Actavis, discuss it 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 (through vomiting, diarrhea, excessive sweating, a low-salt diet, or long-term use of diuretics or dialysis).
• If the patient is to undergo desensitization treatment for bee or wasp stings (allergy shots).
• If the patient is to receive anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Ramipril Actavis one day before the procedure. In case of doubts, consult a doctor.
• If the patient has high potassium levels in the blood (in blood test results).
• If the patient is taking medicines, or has conditions that may lower sodium levels in the blood. The doctor may order regular blood tests, with particular attention to sodium levels in the blood, especially in elderly patients.
• If the patient is black, they may be at higher 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 diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat type 2 diabetes.
• If the patient has collagen disease, such as scleroderma or systemic lupus erythematosus.
• The patient must inform the doctor if they suspect they are pregnant, or plan to become pregnant. It is not recommended to take Ramipril Actavis during the first 3 months of pregnancy, and above the third month of pregnancy, the medicine may have a harmful effect on the fetus, see "Pregnancy and breastfeeding".
• 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.

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 Ramipril Actavis".

Children and adolescents

Ramipril Actavis should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril Actavis in this age group have not been established.
If any of the above situations occur (or there are doubts about them), before starting treatment with Ramipril Actavis, consult a doctor.

Ramipril Actavis and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Ramipril Actavis may affect the action of other medicines. Other medicines may also affect the action of Ramipril Actavis.
Tell your doctor about taking the following medicines. They may reduce the effect of Ramipril Actavis:

• medicines used to relieve 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. Blood pressure monitoring by a doctor will be necessary.

Tell your doctor about taking the following medicines. They may increase the risk of side effects when taken with Ramipril Actavis:

• sacubitril/valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Ramipril Actavis"),
• medicines used to relieve 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 (e.g., furosemide)
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressant used to prevent rejection of a transplanted organ, 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)
• trimethoprim and co-trimoxazole (a medicine used to treat bacterial infections)
• temsirolimus (a medicine used to treat cancer)
• sirolimus, everolimus (medicines used to prevent rejection of a transplanted organ)
• wildagliptin (used to treat type 2 diabetes)
• racecadotril (used to treat diarrhea)
• The doctor may need to change the dose and/or take other precautions if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Ramipril Actavis" and "Warnings and precautions").

Tell your doctor about taking the following medicines. Their action may change when taken with Ramipril Actavis:

• medicines used to treat diabetes, such as oral hypoglycemic agents and insulin. Ramipril Actavis may lower blood sugar levels. Blood sugar levels should be regularly monitored while taking Ramipril Actavis.
• lithium (used to treat mental illnesses). Ramipril Actavis may increase lithium levels in the blood. Lithium levels in the blood should be closely monitored. If any of the above situations occur (or there are doubts about them), before starting treatment with Ramipril Actavis, consult a doctor.

Ramipril Actavis with food and drink
Drinking alcohol while taking Ramipril Actavis may cause dizziness and drowsiness. Consult a doctor if you have any doubts about the amount of alcohol allowed while taking Ramipril Actavis, as well as the possibility of combining the action of blood pressure-lowering medicines and alcohol.
Ramipril Actavis 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 the doctor if they suspect they are pregnant (or plan to become pregnant).
Ramipril Actavis should not be taken during the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as it may harm the fetus. If the patient becomes pregnant while taking Ramipril Actavis, they should inform their doctor immediately. Before planned pregnancy, it is recommended to change the treatment to an alternative.
Breastfeeding
Ramipril Actavis should not be taken during breastfeeding.

Driving and using machines

While taking Ramipril Actavis, dizziness may occur. 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 operate machinery.

Ramipril Actavis contains lactose

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

Ramipril Actavis contains sodium

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

3. How to take Ramipril Actavis

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

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 until blood pressure control is achieved.
• 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 Ramipril Actavis.

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 usual dose is 10 mg once a day.

Reducing or slowing the progression of kidney disease

• 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 usual 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 recommended to take the medicine in two divided doses.

Treatment after a 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 usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients
The initial dose should be lower, and the dose increase should be done slowly.

How to take the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed whole, with at least half a glass of water.
• The tablets should not be chewed or crushed.
• The tablets can be divided into equal doses.

What to do if you take more Ramipril Actavis than you should

Consult a doctor or go to the nearest hospital emergency department.
Do not drive yourself, ask someone to drive you to the hospital or call an ambulance. Take the medicine packaging with you, so the doctor knows what medicine was taken.

What to do if you miss a dose of Ramipril Actavis

If a dose is missed, take the next planned dose.
Do not take a double dose of the medicine to make up for the missed dose.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ramipril Actavis can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Ramipril Actavis and contact a doctor immediately - prompt treatment may be necessary:

• swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, as well as itching and rash. They may be symptoms of a severe allergic reaction to Ramipril Actavis.
• severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If you experience any of the following, tell your doctor promptly:

• 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. They may indicate lung disease.
• 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. They may indicate blood or bone marrow disorders.
• Severe abdominal pain, which may radiate to the back. It may be a symptom of pancreatitis.
• Fever, chills, weakness, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). They may be symptoms of liver disease, such as hepatitis or liver damage.

Other side effects

Tell your 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 of dizziness is higher at the beginning of treatment with Ramipril Actavis 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 persistent cough, sinusitis, or bronchitis, shortness of breath
• abdominal pain or gastrointestinal pain, diarrhea, nausea, or vomiting
• rash with or without itching
• chest pain
• muscle cramps or muscle pain
• high potassium levels in the blood in laboratory 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 may 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. They 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
• laboratory tests showing changes in liver, pancreas, or kidney function.

Rare(may affect up to 1 in 1,000 people)

• feeling of shakiness and disorientation
• red and swollen tongue
• severe peeling and shedding of the skin, itchy papular rash
• nail disorders (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 disorders and 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, consult a doctor immediately.
• difficulty concentrating
• lip pain
• blood tests may show elevated antibody levels
• low blood cell count in blood tests
• low 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.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ramipril Actavis

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, or label after EXP. The expiry date refers to the last day of the month.
Do not store the medicine at temperatures above 30°C.
Blisters: 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 that are no longer needed. This 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, lactose monohydrate, croscarmellose sodium, maize starch, and sodium stearyl fumarate. Additionally, 5 mg tablets contain: Blend PB 24877 Pink: lactose monohydrate, 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, with a dividing line on one side and on the edges of the tablet, and with the inscription R3.
• 10 mg, tablets: capsule-shaped, flat, white, with a dividing line on one side and on the edges of the tablet, and with the inscription R4.

Package sizes
Blisters of OPA/Aluminum/PVC/Aluminum foil: 28, 30, 100 tablets.
Not all package sizes may be marketed.

Marketing authorization 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 more information about this medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Poska Sp.z o.o, ul. Emilii Plater 53, 00-113 Warsaw, Tel (+48 22) 345 93 00

Date of last revision of the leaflet: July 2023

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