Ramipril Genoptim

Leaflet accompanying the packaging: patient information

Ramipril Genoptim, 2.5 mg, tablets

Ramipril Genoptim, 5 mg, tablets

Ramipril Genoptim, 10 mg, tablets

Ramipril

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.

Table of contents of the leaflet

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

1. What is Ramipril Genoptim and what is it used for

Ramipril Genoptim contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Ramipril Genoptim works by:

• reducing the production of substances in the body that can increase blood pressure,
• reducing tension and widening blood vessels,
• making it easier for the heart to pump blood throughout the body. Ramipril Genoptim can be used:
• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay kidney function deterioration (in patients with diabetes or without diabetes),
• to treat heart failure, if the heart is not pumping enough blood to meet the body's needs,
• to treat heart failure after a heart attack.

2. Important information before taking Ramipril Genoptim

When not to take Ramipril Genoptim

• If the patient is allergic to ramipril, other ACE inhibitors, 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 lips, face, throat, or tongue.
• If the patient has ever had a severe allergic reaction called angioedema. Its symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient is undergoing dialysis or other types of blood filtration. Depending on the device used, Ramipril Genoptim may not be suitable for the patient.
• If the patient has kidney disease with reduced blood flow to the kidney (renal artery stenosis).
• After the third month of pregnancy (it is also not recommended to take Ramipril Genoptim during the first three months (trimester) - see below "Pregnancy and breastfeeding").
• If blood pressure is very low or unstable - the doctor will assess the patient's condition.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren. If any of the above conditions apply to the patient, they must not take Ramipril Genoptim. In case of doubts, consult a doctor before starting to take Ramipril Genoptim.

Warnings and precautions

Before starting to take Ramipril Genoptim, 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 (due to vomiting, diarrhea, excessive sweating, a low-sodium diet, prolonged use of diuretics, or dialysis).
• If desensitization to bee or wasp venom is planned (desensitization).
• If anesthesia is planned for surgery or dental procedures. It may be necessary to stop taking Ramipril Genoptim the day before the procedure - consult a doctor.
• If the patient has high potassium levels in the blood (detected by blood tests).
• If the patient is taking medicines or has disorders that can cause low sodium levels in the blood - the doctor may recommend regular blood tests, especially to measure sodium levels in the blood, particularly in elderly patients.
• If the patient is taking mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus) or vildagliptin, as there is an increased risk of angioedema (severe allergic reaction).
• If the patient has collagenosis (connective tissue disease), such as scleroderma or systemic lupus erythematosus.
• Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Ramipril Genoptim during the first 3 months of pregnancy, and it must not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
• Inform 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 sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the subsection "When not to take Ramipril Genoptim".

Children and adolescents

Ramipril Genoptim should not be used in children and adolescents under 18 years of age, as the safety and efficacy of ramipril in this age group have not been established.
If any of the above conditions apply to the patient (or if there are any doubts), consult a doctor before starting to take Ramipril Genoptim.

Ramipril Genoptim and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ramipril Genoptim may affect the action of other medicines, and other medicines may affect the action of Ramipril Genoptim.
The 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 subsections "When not to take Ramipril Genoptim" and "Warnings and precautions").

Inform your doctor if you are taking any of the following medicines, as they may reduce the effect of Ramipril Genoptim:

• Pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, or aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline - the doctor will recommend monitoring blood pressure.

Inform your doctor if you are taking any of the following medicines, as they may increase the risk of side effects when taken with Ramipril Genoptim:

• Pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, or aspirin).
• Cancer medicines (chemotherapy).
• Medicines used to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics, such as furosemide.
• Medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim, and trimethoprim in combination with sulfamethoxazole (used to treat infections) and heparin (a medicine that reduces blood clotting).
• Corticosteroid anti-inflammatory medicines, such as prednisolone.
• Allopurinol (used to reduce uric acid levels in the blood).
• Procainamide (used to treat heart rhythm disorders).
• Temsirolimus (used to treat malignant tumors).
• Sirolimus, everolimus (used to prevent organ rejection after transplantation).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat acute diarrhea).

Inform your doctor if you are taking any of the following medicines, as their action may be altered when taken with Ramipril Genoptim:

• Anti-diabetic medicines, such as oral glucose-lowering medicines and insulin. Ramipril Genoptim may lower blood glucose levels. During treatment with Ramipril Genoptim, regular monitoring of blood glucose levels is recommended.
• Lithium (used to treat mental illnesses). Ramipril Genoptim may increase lithium levels in the blood - the doctor will recommend close monitoring of lithium levels in the blood.

If any of the above conditions apply to the patient (or if there are any doubts), consult a doctor before starting to take Ramipril Genoptim.

Ramipril Genoptim with food, drink, or alcohol

• Consuming alcohol while taking Ramipril Genoptim may cause dizziness and fainting. If you have any doubts about the amount of alcohol allowed while taking Ramipril Genoptim, consult your doctor, as blood pressure-lowering medicines and alcohol can enhance each other's effects.
• Ramipril Genoptim can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ramipril Genoptim should not be used during the first 12 weeks of pregnancy and must not be taken from the 13th week of pregnancy, as it may seriously harm the fetus.
If a woman taking Ramipril Genoptim becomes pregnant, she should immediately inform her doctor.
If you plan to become pregnant, your doctor will recommend using a different medicine.
Breastfeeding
Ramipril Genoptim should not be used during breastfeeding.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

While taking Ramipril Genoptim, dizziness may occur. The risk of dizziness is higher at the beginning of treatment with Ramipril Genoptim and after increasing the dose. If dizziness occurs, do not drive, use tools, or operate machines.

Ramipril Genoptim contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Ramipril Genoptim contains sodium

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

3. How to take Ramipril Genoptim

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Dosage

Treatment of high blood pressure
Typically, the initial dose is 1.25 mg or 2.5 mg once daily.

• The doctor will adjust the dose until the desired blood pressure values are achieved.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics, your doctor may recommend stopping them or reducing the dose before starting to take Ramipril Genoptim.

Reducing the risk of heart attack or stroke
Typically, the initial dose is 2.5 mg once daily.
The doctor may then decide to increase the dose.
Typically, the maintenance dose is 10 mg once daily.
Reducing the risk of or delaying kidney function deterioration
Typically, the initial dose is 1.25 mg or 2.5 mg once daily.

• The doctor may modify the dosage of Ramipril Genoptim.
• Typically, the maintenance dose is 5 mg or 10 mg once daily.

Treatment of heart failure
Typically, the initial dose is 1.25 mg once daily.
The doctor may modify the dosage of Ramipril Genoptim.
The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses.
Treatment after a heart attack
Typically, the initial dose is 1.25 mg to 2.5 mg twice daily.
The doctor may modify the dosage of Ramipril Genoptim.

• Typically, the maintenance dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients
The doctor will use a lower initial dose, which will be gradually increased.

Method of administration

• Take the medicine orally, once daily, at the same time.
• Swallow the tablet whole, with water.
• Do not crush or chew the tablets.

Overdose of Ramipril Genoptim

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

Missed dose of Ramipril Genoptim

If a dose is missed, take the next dose at the usual time.
Do not take a double dose of the medicine to make up for the missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Ramipril Genoptim and immediately consult your doctor – you may need urgent medical attention:

Ramipril Genoptim

• Swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ramipril Genoptim.
• Severe skin reactions, including rash, mouth ulcers, worsening of existing skin conditions, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If you experience any of the following symptoms, inform your doctor immediately:

• Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more serious conditions, including heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung disease.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders.
• Severe abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, or yellowing of the skin or eyes (jaundice). These may be symptoms of liver disease, such as inflammation or liver damage.

Other side effects

Inform your doctor if any of the following symptoms worsen or persist for more than a few days.
Frequent(occurring in less than 1 in 10 patients):
headache or feeling tired,

• dizziness - the risk is higher at the beginning of treatment with Ramipril Genoptim and after increasing the dose,
• fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting up from a lying position,
• dry, irritating cough, sinusitis, or bronchitis, shortness of breath,
• stomach or intestinal pain, diarrhea, nausea, or vomiting,
• skin rash, including raised patches,
• chest pain,
• muscle cramps or pain,
• increased potassium levels in the blood, detected by laboratory tests.

Uncommon(occurring in less than 1 in 100 patients):
balance disorders (dizziness of vestibular origin),
itching of the skin and abnormal sensations on the skin, such as numbness, tingling, prickling, burning, or stabbing (paresthesia),
loss of or altered taste,
sleep disorders,
depression, anxiety, nervousness, or restlessness,
nasal congestion, difficulty breathing, or worsening of asthma,
intestinal angioedema, which may cause abdominal pain, vomiting, or diarrhea,
heartburn, constipation, or dryness of the mouth,
increased urine production,
excessive sweating,
loss of or decreased appetite (anorexia),
rapid or irregular heartbeat,
swelling of the hands and feet - may be a sign of fluid retention in the body,
sudden flushing, especially of the face,
blurred vision,
joint pain,
fever,
impotence, decreased libido in men and women,
increased white blood cell count (eosinophilia), detected by blood tests,
liver, pancreas, or kidney function disorders, detected by blood tests.
Rare(occurring in less than 1 in 1000 patients):
feeling of "restlessness" or disorientation,
redness and swelling of the tongue,

• severe, patchy skin peeling, itchy papular rash,
• nail diseases (e.g., nail loosening or separation from the nail bed),
• skin rash or bruising,
• spots on the skin and discoloration of the extremities,
• redness, itching, swelling, and tearing of the eyes,
• hearing or ringing in the ears disorders,
• weakness,
• decreased red blood cell, white blood cell, or platelet count, or hemoglobin level, detected by blood tests.

Very rare(occurring in less than 1 in 10,000 patients):
sensitivity to sunlight.
Frequency not known(frequency cannot be estimated from the available data):
concentration disorders,
swelling of the mouth mucosa,
decreased blood cell count, detected by blood tests,
decreased sodium levels, detected by blood tests,
concentrated urine (dark-colored), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (vasopressin, antidiuretic hormone) secretion - if such symptoms occur, consult a doctor immediately,
change in finger and toe color after cooling and sensation of tingling and pain when exposed to heat (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 side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramipril Genoptim

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from moisture. The HDPE container should be tightly closed to protect from moisture.
Do not use this medicine after the expiry date stated on the label, box, blister, or carton: EXP. The expiry date refers to the last day of the month stated.
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 packaging and other information

What Ramipril Genoptim contains

The active substance of the medicine is ramipril. One tablet contains 2.5 mg, 5 mg, or 10 mg of ramipril.
The other ingredients (excipients) are:
Ramipril Genoptim, 2.5 mg:cornstarch, lactose monohydrate, sodium bicarbonate, sodium carboxymethylcellulose, yellow iron oxide (E172), sodium stearyl fumarate.
Ramipril Genoptim, 5 mg:cornstarch, lactose monohydrate, sodium bicarbonate, sodium carboxymethylcellulose, red iron oxide (E172), sodium stearyl fumarate.
Ramipril Genoptim, 10 mg:cornstarch, lactose monohydrate, sodium bicarbonate, sodium carboxymethylcellulose, sodium stearyl fumarate.

What Ramipril Genoptim looks like and contents of the pack

Tablet
Ramipril Genoptim, 2.5 mg
Yellow to yellowish, flat, round, uncoated tablets with beveled edges, with the symbols "H" and "18" embossed on both sides of the score line on one side of the tablet and smooth on the other side. The tablet can be divided into equal doses.
Ramipril Genoptim, 5 mg
Pale pink, speckled, flat, round, uncoated tablets with beveled edges, with the symbols "H" and "19" embossed on both sides of the score line on one side of the tablet and smooth on the other side. The tablet can be divided into equal doses.
Ramipril Genoptim, 10 mg
White to almost white, flat, round, uncoated tablets with beveled edges, with the symbols "H" and "20" embossed on both sides of the score line on one side of the tablet and smooth on the other side. The tablet can be divided into equal doses.
PVC-Aluminum blister pack in a cardboard box. HDPE container with a PP cap in a cardboard box.
Packaging:
Ramipril Genoptim, 2.5 mg
Blister pack: 20, 28, 30, 50, 60, 90, 98, 100, and 500 tablets
HDPE container: 30 and 1000 (hospital packaging) tablets
Ramipril Genoptim, 5 mg
Blister pack: 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100, and 500 tablets
HDPE container: 30 and 1000 (hospital packaging) tablets
Ramipril Genoptim, 10 mg
Blister pack: 20, 28, 30, 50, 56, 60, 90, 98, 100, and 500 tablets
HDPE container: 30 and 1000 (hospital packaging) tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Importer

APL Swift Services (Malta) Limited
HF26 Hal Far Industrial Estate
Hal Far Birzebbugia
BBG 3000, Malta

Date of last revision of the leaflet: March 2021