Ranopril

Package Leaflet: Information for the Patient

Ranopril, 5 mg, tablets
Ranopril, 10 mg, tablets
Ranopril, 20 mg, tablets
Lisinopril

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

DO NOT USE IN PREGNANT WOMEN

Table of Contents of the Leaflet

• 1. What is Ranopril and what is it used for
• 2. Important information before taking Ranopril
• 3. How to take Ranopril
• 4. Possible side effects
• 5. How to store Ranopril
• 6. Contents of the pack and other information

1. What is Ranopril and what is it used for

Ranopril contains lisinopril (an angiotensin-converting enzyme inhibitor - ACE), which inhibits the activity of the enzyme that converts angiotensin I into angiotensin II, a vasoconstrictor that increases blood pressure.
Inhibition of angiotensin-converting enzyme leads to a decrease in angiotensin II levels in the blood, a decrease in aldosterone secretion, a decrease in blood pressure in patients with hypertension, and a decrease in symptoms of heart failure. Lisinopril is absorbed orally at about 25%, and the presence of food does not affect the absorption of the medicine. The maximum serum concentration occurs after 6-8 hours. The half-life of the medicine is about 12 hours. Long-term administration of therapeutic doses of Ranopril does not lead to its accumulation in the blood. In the body, it does not undergo metabolic transformations and is excreted in the urine in an unchanged form.
Ranopril is indicated for the treatment of:

• essential and renovascular hypertension, both as monotherapy and in combination with other antihypertensive agents;
• heart failure, in monotherapy or in combination with diuretics and digitalis glycosides;
• hemodynamically stable patients in the early (24 hours) phase of myocardial infarction to prevent the development of left ventricular dysfunction and heart failure;
• patients with diabetes and hypertension and concomitant renal complications with microalbuminuria.

2. Important information before taking Ranopril

When not to take Ranopril:

• if you are allergic to lisinopril or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had angioedema (a condition characterized by swelling of the face, lips, tongue, and/or throat, difficulty swallowing, or breathing difficulties) while taking ACE inhibitors;
• if you have hereditary or idiopathic angioedema;
• in pregnant or breastfeeding women;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are taking or have taken a combination product containing sacubitril and valsartan (used to treat chronic heart failure in adults), as the risk of angioedema (rapid swelling of the subcutaneous tissue, in areas such as the throat) increases.

Warnings and precautions

Before starting treatment with Ranopril, discuss it with your doctor, pharmacist, or nurse.
Ranopril should be taken in the doses prescribed by your doctor throughout the treatment period, even if it is very long.
Do not change the dose or method of taking the medicine on your own without consulting your doctor, especially if you are at increased risk of kidney function disorders or have heart failure.
Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Ranopril".

Tell your doctor if you are taking any of the following medicines, as the risk of angioedema may increase (sudden swelling of the subcutaneous tissue, in areas such as the throat):

• mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus - medicines most commonly used to prevent organ rejection or treat cancer), racecadotril - a medicine used to treat diarrhea;
• wildagliptin - a medicine used to treat diabetes.

Tell your doctor about taking other medicines, including those available without a prescription.
Tell your doctor, among other things, about taking antidiabetic medicines - oral or insulin, lithium salts (used, among other things, to treat depression), gold salts (used to treat a specific type of pain or arthritis).
Due to the increased risk of hypotension, manifested by dizziness, vision disturbances, fainting, tell your doctor about taking diuretics before taking Ranopril.
Also, inform your doctor about any complaints or disorders, especially those related to the kidneys, vomiting, and diarrhea, dialysis, or a salt-free diet.
Tell your doctor about any allergic reactions that have occurred, especially if they were manifested by swelling of the face, lips, tongue, and/or throat, difficulty breathing or swallowing.
During treatment with Ranopril or another ACE inhibitor, angioedema (swelling of the face, limbs, lips, tongue, larynx, and/or throat) may occur. In this case, stop taking the medicine and consult a doctor.
If hypotension occurs, manifested by vision disturbances, dizziness, fainting, lie down with your legs raised. If the symptoms do not disappear after a few minutes, contact your doctor.
Be careful when taking potassium-containing preparations (including dietary supplements) and potassium-sparing diuretics during therapy with Ranopril.
In patients with coronary artery disease or significant stenosis of the arteries supplying the brain, excessive blood pressure reduction may cause myocardial infarction or cerebral hypoperfusion.
In patients taking ACE inhibitors and undergoing dialysis using high-flux dialysis membranes, a pseudo-anaphylactic reaction may occur. Before dialysis, inform your doctor about taking lisinopril. Similar reactions have occurred during low-density lipoprotein apheresis using dextran sulfate. This method should not be used in patients taking ACE inhibitors.
In patients taking lisinopril and desensitized to hymenoptera venom, a life-threatening pseudo-anaphylactic reaction may occur. The doctor will recommend stopping the medicine during desensitization or abandoning the desensitization procedure.
Tell your doctor about taking Ranopril before undergoing general anesthesia for surgical procedures.
At the beginning of treatment with Ranopril, a transient hypotensive effect may occur, which usually disappears during continued treatment, manifested by excessive fatigue and dizziness. If such symptoms occur, lie down with your legs raised, and if the symptoms do not disappear after a few minutes, contact your doctor.
To assess the effectiveness of treatment and determine the smallest effective dose, your doctor may recommend frequent blood pressure measurements, especially at the beginning of treatment and after changing the dose of the medicine.
Your doctor may recommend regular monitoring of electrolyte levels in the blood, especially in patients with increased risk of kidney failure or those taking potassium-sparing diuretics.
If symptoms such as fever, lymph node enlargement, pharyngitis, nosebleeds, or excessive bruising occur, contact your doctor immediately, as they may be related to a decrease in white blood cell or platelet count.

Children and adolescents

Ranopril has been studied in children. For more information, contact your doctor.
Ranopril is not recommended for use in children under 6 years of age or in children with severe kidney function disorders.

Ranopril and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Ranopril may affect the action of other medicines, and other medicines may affect the action of Ranopril.
Especially, tell your doctor if you are taking any of the following medicines:

• mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus - medicines most commonly used to prevent organ rejection or treat cancer), racecadotril (used to treat diarrhea), or wildagliptin (used to treat diabetes), as the risk of angioedema may increase (sudden swelling of the subcutaneous tissue, in areas such as the throat),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, 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). Your doctor may recommend changing the dose and/or taking other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "When not to take Ranopril" and "Warnings and precautions").

To determine the appropriate dose of Ranopril, it is especially important for your doctor to know about the use of:

• other blood pressure-lowering medicines, diuretics (water pills), potassium-containing preparations (including salt substitutes), diabetes medicines (including oral antidiabetic medicines or insulin), lithium (a medicine used to treat certain types of depression), and some medicines used to treat pain and arthritis.

Ranopril may enhance the blood pressure-lowering effect of diuretics.
Indomethacin and other nonsteroidal anti-inflammatory medicines (e.g., acetylsalicylic acid) may reduce the antihypertensive effect of Ranopril.
Concomitant administration of Ranopril and lithium may lead to decreased lithium excretion. Your doctor will recommend regular monitoring of lithium levels in the blood and, if necessary, reduce the dose of lithium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Using Ranopril in pregnant women is contraindicated.
ACE inhibitors, including Ranopril, may cause harm or death to the fetus if taken during the second or third trimester of pregnancy (i.e., from the fourth month of pregnancy to birth). If pregnancy is detected during treatment, stop taking the medicine, contact your doctor, and change the treatment according to the doctor's recommendation.
Pregnant women or those planning to become pregnant should inform their doctor before starting treatment with Ranopril.
Women of childbearing age taking lisinopril should use effective contraception.
Breastfeeding
It is not known whether lisinopril passes into breast milk. Using Ranopril in breastfeeding women is contraindicated.

Driving and using machines

Individual reactions to the medicine may vary. Some side effects reported during treatment with Ranopril may affect the ability to drive or operate machinery (see section 4).

Ranopril contains mannitol

Mannitol may have a mild laxative effect.

3. How to take Ranopril

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Ranopril should be taken once a day, at the same time every day.
The tablets can be taken before meals, during meals, or after meals. Food does not affect the action of the medicine.
Essential hypertension
In essential hypertension, the usual initial dose is 10 mg once daily, and the maintenance dose is 20 mg once daily. The maximum single daily dose is 80 mg.
In patients treated with diuretics, the doctor usually recommends stopping or reducing the dose of the diuretic 2-3 days before starting treatment with Ranopril. The recommended initial dose is 5 mg.
Reno-vascular hypertension
In patients with reno-vascular hypertension, patients with bilateral renal artery stenosis, or stenosis of a single kidney artery, the initial dose is 2.5-5 mg once daily. The doctor may then recommend a higher dose of the medicine.
Heart failure
In heart failure, the initial dose is 2.5 mg once daily, and the maintenance dose is 5-20 mg once daily.
If diuretics cannot be stopped, in dehydrated patients, with sodium deficiency, in patients with kidney failure, the doctor should recommend a lower dose of lisinopril, adjusting it according to the severity of kidney failure (creatinine clearance).
Acute phase of myocardial infarction
In the acute phase of myocardial infarction, in hemodynamically stable patients (without cardiogenic shock), within 24 hours of the onset of myocardial infarction, the doctor should recommend an initial dose of 5 mg. After another 24 hours, take the same dose (5 mg), and after 48 hours from the onset of myocardial infarction, take a dose of 10 mg of lisinopril. Then, continue taking the medicine in a single daily dose of 10 mg for 6 weeks.
If there are no contraindications, the doctor will also recommend taking other medicines usually used to treat myocardial infarction (anticoagulants, antiplatelet agents, and beta-blockers).
Patients with low systolic blood pressure (≤ 120 mmHg) at the beginning of treatment and for the next three days should take a lower dose - 2.5 mg of lisinopril once daily. In case of hypotension (systolic blood pressure below 100 mmHg), the doctor may recommend reducing the maintenance dose to 5 mg or 2.5 mg. If prolonged hypotension occurs (systolic blood pressure below 90 mmHg lasting more than 1 hour), the doctor should recommend stopping Ranopril.
Diabetic nephropathy
In patients with hypertension and type 2 diabetes, the usual initial dose of Ranopril is 10 mg once daily, and the maintenance dose should be adjusted to reduce diastolic blood pressure to the currently recommended values in these patients.
Kidney failure
In patients with kidney function disorders, the dose should be adjusted according to the severity of the disorders based on creatinine clearance using the following table.

Then, the doctor usually recommends gradually increasing the dose. The maximum single daily dose of lisinopril is 40 mg.
Use in children aged 6 to 16 years with hypertension
The doctor will determine the dose suitable for the child, depending on their body weight.
For children with a body weight of 20 to <50 kg, the recommended initial dose is 2.5 mg once daily.
For children with a body weight ≥ 50 kg, the recommended initial dose is 5 mg once daily.

Taking a higher dose of Ranopril than recommended

If you have taken too much Ranopril, contact your doctor immediately. Medical supervision is necessary. The most likely symptom of overdose is excessive blood pressure reduction and related dizziness.

Missing a dose of Ranopril

Take the medicine in the dose prescribed by your doctor.
If you miss a dose, do not take an additional dose.
The next day, return to your regular schedule and take the medicine in the dose prescribed by your doctor.

4. Possible side effects

Like all medicines, Ranopril can cause side effects, although not everybody gets them.
Ranopril is generally well-tolerated. Common side effects include dizziness, headache, diarrhea, nausea, vomiting, kidney function disorders, cough, and dizziness related to sudden blood pressure reduction when standing up quickly (orthostatic symptoms). Other side effects that occur less frequently include myocardial infarction or stroke, probably secondary to excessive blood pressure reduction in high-risk patients, palpitations (rapid heart rate), tachycardia (rapid heart rate), decreased blood flow to the fingers and toes, manifested by a change in their color, accompanied by a feeling of coldness or numbness (Raynaud's phenomenon), rhinitis, abdominal pain, nausea, rash, itching, weakness (fatigue), mood disorders, sleep disorders, paresthesia (tingling, prickling, or burning sensation), impotence, fatigue, dizziness, taste disturbances, increased urea levels in the blood, increased creatinine levels in the blood, increased liver enzyme activity, hyperkalemia (high potassium levels in the blood).
Other side effects that occur rarely include decreased hemoglobin levels, decreased hematocrit value, disorientation, dry mouth, hypersensitivity/angioedema (swelling of the face, limbs, lips, tongue, larynx, and/or throat), hives, hair loss (alopecia), increased urea, creatinine, and other nitrogenous end products of protein and amino acid metabolism in the blood (uremia), acute kidney failure, gynecomastia, increased bilirubin levels in the blood, hyponatremia (low sodium levels in the blood).
Other side effects may occur very rarely, and some of them may be serious. Examples of such side effects include jaundice (yellowing of the skin and/or eyes) and severe abdominal pain. Other side effects that occur very rarely include bone marrow suppression, anemia, thrombocytopenia (low platelet count), leukopenia (low white blood cell count), neutropenia (low neutrophil count), agranulocytosis (significant reduction in granulocyte count), hemolytic anemia, lymphadenopathy (enlargement of the lymph nodes), autoimmune disease, hypoglycemia (low blood sugar), bronchospasm (constriction of the airways), sinusitis, pancreatitis, intestinal angioedema, hepatitis (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of the skin and mucous membranes, and toxic epidermal necrolysis (a condition characterized by blistering and peeling of the skin), Stevens-Johnson syndrome, and erythema multiforme.
Other side effects have also been reported, but their frequency cannot be determined from the available data (frequency unknown): gout, decreased libido, depression, somnolence, stroke, fainting, angina pectoris, arrhythmias, shortness of breath, pulmonary infiltrates, laryngitis, bronchitis, nasal congestion, sore throat, anorexia, constipation, bloating, photosensitivity, pseudolymphoma, urinary tract infections, chest pain, flushing, and SIADH (syndrome of inappropriate antidiuretic hormone secretion), blurred vision, back pain, joint pain, muscle cramps, and shoulder pain.
Reports have been made of a syndrome that includes one or more of the following symptoms: fever, vasculitis, muscle pain, joint pain or inflammation, positive antinuclear antibody (ANA) titer, increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis, rash, photosensitivity, or other skin symptoms.
For more information on side effects, contact your doctor or pharmacist.
If you experience any side effects or worrying symptoms, tell your doctor or pharmacist.
Stop taking Ranopril and contact your doctor immediately in any of the following cases:

• if swelling of the face, lips, tongue, larynx, and/or throat occurs, which may cause difficulty breathing or swallowing

if swelling of the hands, ankles, or feet occurs

• if hives occur

After taking the first dose of the medicine, a greater decrease in blood pressure may occur than after subsequent doses. This may be manifested by fainting or dizziness. If this happens, lie down. In case of doubt, contact your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 the medicine.

5. How to store Ranopril

Store the medicine at a temperature below 25 °C. Protect from moisture.
Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Ranopril contains

The active substance of the medicine is lisinopril (in the form of lisinopril dihydrate). One tablet of Ranopril contains 5 mg, 10 mg, or 20 mg of lisinopril (in the form of lisinopril dihydrate).

• Other ingredients are: mannitol, calcium hydrogen phosphate anhydrous, maize starch, maize starch pregelatinised, magnesium stearate, yellow iron oxide, red iron oxide (Ranopril, 20 mg).

What Ranopril looks like and contents of the pack

Ranopril, 5 mg tablets
Light yellow, capsule-shaped, biconvex, uncoated tablets with "5" embossed on one side of the score line and a deep score line on the other side of the tablet.
Ranopril, 10 mg tablets
Light yellow, capsule-shaped, biconvex, uncoated tablets, with "1" and "0" embossed on one side of the score line and a deep score line on the other side of the tablet.
Ranopril, 20 mg tablets
Light orange, capsule-shaped, biconvex, uncoated tablets with "2" and "0" embossed on one side of the score line and a deep score line on the other side of the tablet.
The pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
Netherlands
Date of last revision of the leaflet: May 2023