Ranopril

Leaflet attached to the packaging: patient information

Ranopril, 5 mg, tablets
Ranopril, 10 mg, tablets
Ranopril, 20 mg, tablets
Lisinoprilum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 side effects not listed in this leaflet, they should tell their 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. Package contents 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.
Inhibiting angiotensin-converting enzyme reduces the concentration of angiotensin II in the blood, reduces aldosterone secretion, lowers blood pressure in patients with hypertension, and reduces 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 concentration in serum 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 cause 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 use in 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-hour) phase of myocardial infarction to prevent the development of left ventricular dysfunction and heart failure;
• patients with diabetes and hypertension, as well as concomitant kidney damage with microalbuminuria.

2. Important information before taking Ranopril

When not to take Ranopril:

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

Warnings and precautions

Before starting Ranopril, discuss it with your doctor, pharmacist, or nurse.
Ranopril should be taken in the prescribed doses by the doctor for the entire treatment period, even if it is very long.
Do not change the dose or method of taking the medicine without consulting your doctor, especially in patients with increased risk of kidney problems or 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). See also "When not to take Ranopril".

Tell your doctor if you are taking any of the following medicines, as the risk of angioedema may increase:

• mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus - medicines 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 about taking antidiabetic medicines - oral or insulin, lithium salts (used to treat depression), gold salts (used to treat a specific type of pain or arthritis).
Due to the increased risk of hypotension, characterized 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 characterized by swelling of the face, lips, tongue, and/or throat, difficulty breathing or swallowing.
While taking Ranopril or another ACE inhibitor, angioedema may occur (swelling of the face, limbs, lips, tongue, larynx, and/or throat). In this case, stop taking the medicine and consult a doctor.
If hypotension occurs, characterized 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 cautious 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 decrease in blood pressure may occur, characterized by a feeling of 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.
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, consult your doctor.
Ranopril is not recommended for children under 6 years of age or children with severe kidney problems.

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 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,
• 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), as the risk of hyperkalemia increases. 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 "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, 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 reduce 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 child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Taking Ranopril during pregnancy is contraindicated.
ACE inhibitors, including Ranopril, may cause fetal harm or death when taken in the second or third trimester of pregnancy (i.e., from the fourth month of pregnancy to birth). If pregnancy occurs during treatment, stop taking the medicine, consult your doctor, and change the treatment according to your doctor's recommendation.
Women of childbearing age taking lisinopril should use effective contraception.
Breastfeeding
It is not known whether lisinopril passes into breast milk. Taking Ranopril during breastfeeding 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

Take this medicine always as directed by your doctor. If you are unsure, consult 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 per day, and the maintenance dose is 20 mg per day. 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 per day. The doctor may then recommend a higher dose of the medicine.
Heart failure
In heart failure, the initial dose is 2.5 mg per day, and the maintenance dose is 5-20 mg per day.
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 start 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 start of treatment and for the next three days should take a lower dose - 2.5 mg of lisinopril per day. If hypotension occurs (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, and the maintenance dose should be adjusted to lower diastolic blood pressure to the currently recommended values in these patients.
Kidney failure
In patients with kidney problems, the dose should be adjusted according to the severity of the problems 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 6-16 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- <50 kg, the recommended initial dose is 2.5 mg once a day.
For children with a body weight ≥ 50 kg, the recommended initial dose is 5 mg once a day.

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 extra 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, vomiting, kidney problems, cough, and dizziness related to a sudden drop in blood pressure 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 patients at high risk.

Other side effects that occur less frequently include a feeling of rapid heartbeat, rapid heart rate, decreased blood flow to the fingers and toes, characterized by a change in their color, accompanied by a feeling of coldness or numbness (Raynaud's phenomenon), nasal congestion, abdominal pain, nausea, rash, itching, weakness, mood disturbances, sleep disturbances, tingling, numbness, or a feeling of burning (paresthesia), impotence, fatigue, dizziness, taste disturbances, increased urea levels in the blood, increased creatinine levels in the serum, increased liver enzyme activity, and high potassium levels in the blood (hyperkalemia).
Other side effects that occur rarely include decreased hemoglobin levels, decreased red blood cell count (decreased hematocrit), disorientation, dry mouth, hypersensitivity/angioedema (swelling of the face, limbs, lips, tongue, larynx, and/or throat), hives, hair loss, high levels of 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 serum, low sodium levels in the blood (hyponatremia).
Other side effects may occur very rarely, and some of them may be serious. Examples of such side effects include jaundice, oliguria, or anuria, and severe abdominal pain. Other side effects that occur very rarely include bone marrow suppression, anemia, low platelet count, decreased white blood cell count, low neutrophil count, significant decrease in granulocyte count, hemolytic anemia, lymphadenopathy, autoimmune disease, low blood sugar (hypoglycemia), bronchospasm, sinusitis, pancreatitis, angioedema of the intestine, liver disease (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of the skin and mucous membranes, and toxic epidermal necrolysis.
A syndrome has been reported that includes one or more of the following symptoms: fever, vasculitis, muscle pain, joint pain, positive antinuclear antibody titer, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis, rash, photosensitivity, or other skin symptoms.
For more information on side effects, consult 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 Ranopril, a greater decrease in blood pressure may occur than after subsequent doses. This may be accompanied by fainting or dizziness. If this happens, lie down. If you are unsure, contact your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell 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, phone: 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 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. Package contents 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 package contents

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 package 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