Ramipril Actavis

Package Leaflet: Information for the Patient

Ramipril Actavis, 5 mg, Tablets

Ramipril Actavis, 10 mg, Tablets

Ramipril

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept, as it may be necessary to read it again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 medications 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 medication (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". Symptoms include: itching, hives, red spots on the palms, soles, 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 equipment used, Ramipril Actavis may not be a suitable medication.
• 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 medication containing aliskiren
• If the patient has taken or is currently taking sacubitril/valsartan, a medication 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 in the throat) may increase.

If any of the above situations occur, Ramipril Actavis should not be taken.
In case of doubts about taking the medication, the doctor should be consulted before starting Ramipril Actavis.

Warnings and precautions

Before starting Ramipril Actavis, the doctor or pharmacist should be consulted:

• 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 medications used for anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Ramipril Actavis for one day before the procedure. In case of doubts, the doctor should be consulted.
• If the patient has high potassium levels in the blood (as shown in blood test results).
• If the patient is taking medications 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 of African descent, they may be at higher risk of angioedema and this medication may be less effective in lowering blood pressure compared to patients of other ethnicities.
• If the patient is taking any of the following medications, the risk of angioedema may increase:
• racecadotril, a medication used to treat diarrhea;
• medications used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medication used to treat type 2 diabetes.
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient must inform the doctor if they suspect they are pregnant, plan to become pregnant, or are breastfeeding. Ramipril Actavis is not recommended during the first 12 weeks of pregnancy and should not be used after the 13th week of pregnancy, as it may harm the fetus. If pregnancy occurs while taking Ramipril Actavis, the doctor should be informed immediately. Before planned pregnancy, an alternative treatment should be considered.
• If the patient is taking any of the following medications used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (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 if there are doubts), the doctor should be consulted before starting Ramipril Actavis.

Ramipril Actavis and other medications

The doctor or pharmacist should be informed about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take. Ramipril Actavis may affect the action of other medications. Other medications may also affect the action of Ramipril Actavis.
The doctor should be informed about the use of the following medications, as they may reduce the effect of Ramipril Actavis:

• medications used for pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin)
• medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine. Blood pressure monitoring by the doctor will be necessary.

The doctor should be informed about the use of the following medications, as they may increase the risk of side effects when used with Ramipril Actavis:

• sacubitril/valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Ramipril Actavis"),
• medications used for pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin)
• medications used to treat cancer (chemotherapy)
• diuretics (e.g., furosemide)
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medications that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medication used to prevent transplant rejection; and heparin, a medication used to thin the blood and prevent clots)
• corticosteroids, such as prednisolone
• allopurinol (a medication used to lower uric acid levels in the blood)
• procainamide (a medication used to treat irregular heart rhythms)
• trimethoprim and co-trimoxazole (a medication used to treat bacterial infections)
• temsirolimus (a medication used to treat cancer)
• sirolimus, everolimus (medications used to prevent transplant rejection)
• wildagliptin (used to treat type 2 diabetes)
• racecadotril (used to treat diarrhea)
• The doctor may need to adjust the dose and/or take other precautions if the patient is taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under the heading "When not to take Ramipril Actavis" and "Warnings and precautions").

The doctor should be informed about the use of the following medications, as their action may be affected by Ramipril Actavis:

• medications 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 if there are doubts), the doctor should be consulted before starting Ramipril Actavis.

Ramipril Actavis with food and drink
Drinking alcohol while taking Ramipril Actavis may cause dizziness and fainting.
The patient should discuss this with their doctor if they have doubts about the amount of alcohol allowed while taking Ramipril Actavis and the possibility of additive effects of blood pressure-lowering medications and alcohol.
Ramipril Actavis can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning to have a baby, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
The patient must inform the doctor if they suspect they are pregnant (or plan to become pregnant).
Ramipril Actavis is not recommended during the first 12 weeks of pregnancy and should not be used after the 13th week of pregnancy, as it may harm the fetus. If pregnancy occurs while taking Ramipril Actavis, the doctor should be informed immediately. Before planned pregnancy, an alternative treatment should be considered.

Driving and using machines

While taking Ramipril Actavis, dizziness may occur. The risk of dizziness is higher at the start of treatment with Ramipril Actavis and after dose increases. If dizziness occurs, the patient should not drive or operate machinery.

Ramipril Actavis contains lactose

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

Ramipril Actavis contains sodium

The medication 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 medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

Dosage

Treatment of high blood pressure

• The recommended initial dose is 1.25 mg or 2.5 mg once daily.
• The doctor may adjust the dose to achieve blood pressure control.
• The maximum dose is 10 mg once daily.
• If diuretics (water pills) are being used, the doctor may stop or reduce the dose of the diuretic before starting Ramipril Actavis.

Prevention of heart attack or stroke

• The recommended initial dose is 2.5 mg once daily.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once daily.

Reducing or slowing the progression of kidney disease

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

Treatment of heart failure

• The recommended initial dose is 1.25 mg once daily.
• The doctor may adjust the dose.
• The maximum dose is 10 mg daily. It is preferred to take the medication in two divided doses.

Treatment after a heart attack

• The recommended initial dose is usually 1.25 mg to 2.5 mg once daily.
• The doctor may adjust the dose.
• The usual dose is 10 mg daily. It is preferred to take the medication in two divided doses.

Elderly patients
The initial dose should be lower, and dose increases should be made slowly.

How to take the medication

• The medication should be taken orally, once daily, 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.

Overdose of Ramipril Actavis

The doctor or the nearest hospital emergency department should be contacted.
The patient should not drive themselves, but should ask someone to drive them to the hospital or call an ambulance. The medication packaging should be taken along, so the doctor knows what medication was taken.

Missed dose of Ramipril Actavis

If a dose is missed, the next planned dose should be taken.
A double dose should not be taken to make up for a missed dose.
In case of further doubts about taking this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Ramipril Actavis can cause side effects, although not everyone gets them.

If any of the following serious side effects occur, the patient should stop taking Ramipril Actavis and contact their 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. These 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 the following changes occur, the doctor should be informed promptly:

• rapid heartbeat, irregular heartbeat, 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 disease.
• easy bruising, prolonged bleeding time, 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 disease, such as hepatitis or liver damage.

Other side effects

The doctor should be informed 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 start of treatment with Ramipril Actavis and after dose increases
• fainting, hypotension (abnormally low blood pressure), especially if it occurs after a rapid change in position to standing or sitting
• dry, 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, as shown 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 of or altered sense of taste
• sleep disturbances
• depression, anxiety, increased nervousness, or restlessness
• nasal congestion, 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 of 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 eosinophil 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 trembling 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 or ringing in the ears
• weakness
• decreased red blood cell, white blood cell, 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 inappropriate antidiuretic hormone (ADH) secretion. If these symptoms occur, the doctor should be contacted 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 any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. 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 to gather more information on the safety of this medication.

5. How to store Ramipril Actavis

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the carton, blister, or label after EXP. The expiration date refers to the last day of the month.
The medication should not be stored at temperatures above 30°C.
Blisters: store in the original packaging to protect from moisture.
Medications should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. 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, cornstarch, sodium stearyl fumarate. Additionally, the 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 imprint 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 imprint 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 medication 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 medication. If the patient has any questions or doubts, they should ask their doctor or pharmacist.