RANOPRIL 5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. DO NOT USE IN PREGNANT WOMEN
   3. Table of contents of the leaflet
2. What is Ranopril and what is it used for
3. Important information before taking Ranopril
   1. Warnings and precautions
   2. Children and adolescents
   3. Ranopril and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Ranopril contains mannitol
4. How to take Ranopril
   1. Taking a higher dose of Ranopril than recommended
   2. Missing a dose of Ranopril
5. Possible side effects
   1. Reporting side effects
6. How to store Ranopril
7. Package contents and other information
   1. What Ranopril contains
   2. What Ranopril looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Manufacturer

Leaflet attached to the packaging: patient information

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 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, which has a vasoconstrictive effect and increases blood pressure.
The inhibition of angiotensin-converting enzyme leads to a decrease in the concentration of angiotensin II in the blood, a decrease in aldosterone secretion, a decrease in blood pressure in patients with hypertension, and a reduction 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 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 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 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 and concomitant renal complications with microalbuminuria.

2. Important information before taking Ranopril

When not to take Ranopril:

• in pregnant or breastfeeding women;

Warnings and precautions

Before starting treatment with Ranopril, you should discuss it with your doctor, pharmacist, or nurse.
Ranopril should be taken in the doses prescribed by your doctor for the entire treatment period, even if it is very long.
You should not change the dose or way of taking the medicine on your own, without your doctor's recommendation, especially if you are at increased risk of kidney function disorders or have heart failure.
You should 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 "When not to take Ranopril".

You should 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 the rejection of a transplanted organ or in the treatment of cancer), racecadotril - a medicine used to treat diarrhea;
• wildagliptin - a medicine used to treat diabetes.

You should inform your doctor about taking other medicines, including those available without a prescription.
You should inform your doctor, among other things, about taking antidiabetic medicines - oral or insulin, lithium salts (used, among other things, in the treatment of depression), gold salts (used in the treatment of a specific type of pain or arthritis).
Due to the increased risk of hypotension, characterized by dizziness, vision disturbances, fainting, you should inform your doctor about taking diuretics before taking Ranopril.
You should also inform your doctor about any complaints or disorders, especially those related to the kidneys, vomiting, and diarrhea, dialysis, or a salt-free diet.
You should inform your doctor about any hypersensitivity reactions (allergic reactions) that have occurred, especially if they were characterized 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 such a case, you should stop taking the medicine and consult a doctor immediately.
In case of hypotension, characterized by vision disturbances, dizziness, fainting, you should lie down with your legs raised. If the symptoms do not disappear after a few minutes, you should contact your doctor.
You should 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 narrowing of the arteries supplying the brain, excessive lowering of blood pressure may cause myocardial infarction or cerebral hypoperfusion.
In patients taking ACE inhibitors and undergoing dialysis using high-flux dialysis membranes, a pseudoanaphylactic reaction may occur. Before dialysis, you should 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 pseudoanaphylactic reaction may occur. Your doctor will recommend discontinuing the medicine during desensitization or abandoning the desensitization procedure.
You should inform 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, you should lie down with your legs raised, and if the symptoms do not disappear after a few minutes, you should 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 frequent monitoring of electrolyte levels in the serum, especially in patients with increased risk of kidney failure or those taking potassium-sparing diuretics.
In case of symptoms such as fever, lymph node enlargement, pharyngitis, nosebleeds, gum bleeding, or excessive bruising, you should contact your doctor as soon as possible, as they may be related to an excessive decrease in the number of white blood cells or platelets.

Children and adolescents

Ranopril has been studied in children. To obtain additional information, you should consult 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

You should 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, you should 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 the rejection of a transplanted organ or in the treatment of 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, a combination of trimethoprim and sulfamethoxazole - used in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent the rejection of a transplanted organ, and heparin, a medicine used to thin the blood to prevent clots), as the risk of hyperkalemia (high potassium levels in the blood) 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 particularly 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 used with diuretics may enhance the blood pressure-lowering effect.
Indomethacin and other nonsteroidal anti-inflammatory medicines (e.g., acetylsalicylic acid) may weaken 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 serum and, if necessary, recommend lower doses of lithium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Ranopril in pregnant women is contraindicated.
Angiotensin-converting enzyme inhibitors, including Ranopril, may cause harm to or death of the fetus if taken during the second or third trimester of pregnancy (i.e., from the fourth month of pregnancy to birth). If it is discovered during treatment that the woman is pregnant, the medicine should be discontinued, and the doctor should be consulted to change the treatment regimen.
A pregnant woman or a woman planning to become pregnant should inform her 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. The use of Ranopril in breastfeeding women is contraindicated.

Driving and using machines

Individual reactions to the medicine may vary. Some side effects that have been 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

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Ranopril should be taken once a day, every day at the same time.
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 discontinuing 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.
In cases where diuretics cannot be discontinued, in dehydrated patients, with sodium deficiency, in patients with kidney failure, the doctor should recommend a lower dose of lisinopril, adjusted according to the severity of kidney function impairment (creatinine clearance).
Acute phase of myocardial infarction
In the acute phase of myocardial infarction, in hemodynamically stable patients (who have not experienced 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, the same dose (5 mg) should be taken, and after 48 hours from the onset of myocardial infarction, a dose of 10 mg of lisinopril. Then, the medicine should be continued at 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 per day. 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 longer than 1 hour), the doctor should recommend discontinuing Ranopril.
Diabetic nephropathy
In patients with hypertension and type 2 diabetes, the usual single initial daily 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 impaired kidney function, the dose should be adjusted according to the severity of the impairment based on creatinine clearance using the following table.

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 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

In case of taking too much Ranopril, the patient should immediately consult a doctor. Medical supervision is necessary. The most likely symptom of overdose is excessive lowering of blood pressure and related dizziness.

Missing a dose of Ranopril

The medicine should be taken in the dose prescribed by the doctor.
In case of missing a dose at the usual time, you should not take an additional dose.
The next day, you should return to the regular use of the medicine in the dose prescribed by the 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 function disorders, cough, and dizziness related to a sudden drop in blood pressure when standing up quickly (orthostatic symptoms). Other side effects that occur not very often include myocardial infarction or stroke, probably secondary to excessive blood pressure lowering in patients at high risk, palpitations, rapid heart rate (tachycardia), decreased blood flow to the fingers and toes, characterized by a change in their color, accompanied by a feeling of cold or numbness (Raynaud's phenomenon), rhinitis, abdominal pain, nausea, rash, itching, weakness, mood disorders, sleep disorders, paresthesia, impotence, fatigue, dizziness, taste disturbances, increased urea levels in the blood, increased creatinine levels in the serum, increased liver enzyme activity, and hyperkalemia (high potassium levels in the blood).
Other side effects that occur rarely include decreased hemoglobin levels, decreased red blood cell count (decreased hematocrit value), disorientation, dryness of the mucous membranes, 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 serum, 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, oliguria or anuria, and severe abdominal pain. Other side effects that occur very rarely include bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune disease, hypoglycemia, bronchospasm, sinusitis, pancreatitis, intestinal angioedema, hepatitis (hepatocellular or cholestatic), liver failure, excessive sweating, blistering of the skin and mucous membranes, and toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme.
Other side effects have also been reported, but their frequency cannot be determined based on 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 infection, chest pain, flushing, and SIADH (syndrome of inappropriate antidiuretic hormone secretion), blurred vision, back pain, joint pain, muscle cramps, and shoulder pain.
There have been reports of a syndrome including one or more of the following symptoms: fever, vasculitis, muscle pain, joint pain or inflammation, positive antinuclear antibody titer (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia, and leukocytosis, rash, photosensitivity, or other skin symptoms.
For additional information on side effects, you should consult your doctor or pharmacist.
If you experience any side effects or worrying symptoms, you should tell your doctor or pharmacist.
You should discontinue Ranopril and immediately consult a doctor in any of the following cases:

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

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, you should lie down. In case of doubt, you should consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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, 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 gather more information on the safety of the medicine.

5. How to store Ranopril

The medicine should be stored at a temperature below 25 °C. Protect from moisture.
The medicine should be stored 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 stated.
Medicines should not be disposed of via wastewater or household waste. You should 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).

• The other ingredients are: mannitol, calcium hydrogen phosphate anhydrous, corn starch, corn starch pregelatinized, 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 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