Ramipril genoptim

Package leaflet: Information for the patient

Ramipril Genoptim, 2.5 mg, tablets
Ramipril Genoptim, 5 mg, tablets
Ramipril Genoptim, 10 mg, tablets
Ramiprilum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Ramipril Genoptim is and what it is 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 pack and other information

1. What Ramipril Genoptim is and what it is 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 body's production of substances that may increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart pump blood through the body more easily.

Ramipril Genoptim may be used:

• for the treatment of high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening of kidney function (in patients with or without diabetes),
• for the treatment of heart failure (when the heart does not pump enough blood to meet the body's needs),
• for treatment following a heart attack complicated by heart failure.

2. Important information before using Ramipril Genoptim

When not to use 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 experienced a severe allergic reaction called angioedema. Symptoms include: itching, hives, red patches on 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 a kidney disease with reduced blood flow to the kidneys (renal artery stenosis).
• After the third month of pregnancy (Ramipril Genoptim is also not recommended during the first three months (trimester) – see section “Pregnancy and breastfeeding” below).
• If the patient has very low or unstable blood pressure – the doctor will assess the patient's condition.
• If the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, Ramipril Genoptim must not be used. In case of doubt, consult a doctor before starting treatment with Ramipril Genoptim.

Warnings and precautions
Before starting treatment with Ramipril Genoptim, discuss with your doctor or pharmacist if the patient:

• Has heart, liver, or kidney diseases.
• 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).
• Is undergoing desensitization treatment for bee or wasp venom (venom immunotherapy).
• Is scheduled for anesthesia during a surgical or dental procedure. It may be necessary to discontinue Ramipril Genoptim one day before the procedure – consult your doctor.
• Has high potassium levels in the blood (detected by blood tests).
• Is taking medicines or has conditions that may reduce sodium levels in the blood – the doctor may recommend regular blood tests, especially to monitor blood sodium levels, particularly in elderly patients.
• Is taking medicines known as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus) or vildagliptin, as there is an increased risk of angioedema (severe allergic reaction).
• Has collagenosis (connective tissue disease), such as scleroderma or systemic lupus erythematosus.
• Is pregnant, suspects pregnancy, or plans to become pregnant. Ramipril Genoptim is not recommended during the first 3 months of pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy and breastfeeding”).
• Is taking any of the following medicines for high blood pressure:
  • An angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, 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 blood electrolyte levels (e.g., potassium).

See also the section “When not to use Ramipril Genoptim”.

Children and adolescents
Ramipril Genoptim is not recommended for 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 (or if there is any uncertainty), consult a doctor before starting treatment with Ramipril Genoptim.

Ramipril Genoptim and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, 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 dose adjustments and/or additional precautions:

• If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “When not to use Ramipril Genoptim” and “Warnings and precautions”).

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

• Painkillers 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 may recommend monitoring blood pressure.

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

• Painkillers and anti-inflammatory medicines (e.g., NSAIDs such as ibuprofen, indomethacin, or aspirin).
• Medicines used in cancer treatment (chemotherapy).
• Medicines used to prevent organ transplant rejection, such as cyclosporine.
• Diuretics (water pills), such as furosemide.
• Medicines that increase blood potassium levels, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim, 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 blood uric acid levels).
• Procainamide (used for heart rhythm disorders).
• Temsirolimus (used in the treatment of malignant tumors).
• Sirolimus, everolimus (used to prevent rejection of transplanted organs).
• Vildagliptin (used in the treatment of type 2 diabetes).
• Racecadotril (used in the treatment of acute diarrhea).

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

• Antidiabetic medicines, such as oral glucose-lowering agents and insulin. Ramipril Genoptim may reduce blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Ramipril Genoptim.
• Lithium (used in psychiatric disorders). Ramipril Genoptim may increase blood lithium levels – the doctor will recommend close monitoring of blood lithium levels.

If any of the above conditions apply (or if there is any uncertainty), consult a doctor before starting treatment with Ramipril Genoptim.

Ramipril Genoptim with food, drink, or alcohol

• Drinking alcohol while taking Ramipril Genoptim may cause dizziness and drowsiness. If in doubt about the amount of alcohol that may be consumed during treatment with Ramipril Genoptim, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may enhance each other's effects.
• Ramipril Genoptim may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Ramipril Genoptim is not recommended during the first 12 weeks of pregnancy and must not be taken from the 13th week of pregnancy onward, as it may seriously harm the unborn child.
If a woman becomes pregnant while taking Ramipril Genoptim, she should inform her doctor immediately.
If a patient plans pregnancy, the doctor will recommend using an alternative medicine.

Breastfeeding
Ramipril Genoptim must not be used during breastfeeding.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
Dizziness may occur while taking Ramipril Genoptim. 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 machinery.

Ramipril Genoptim contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before using this medicine.

Ramipril Genoptim contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Ramipril Genoptim

This medicine should always be taken exactly as your doctor has instructed. If you are unsure,
you should consult your doctor or pharmacist.
Dosage
Treatment of high blood pressure
The usual starting dose is 1.25 mg or 2.5 mg once daily.

• Your 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 (water tablets), your doctor may recommend stopping or reducing their dose before starting Ramipril Genoptim.

Reduction of the risk of heart attack or stroke
The usual starting dose is 2.5 mg once daily.
Your doctor may then decide to increase the dose.
The usual maintenance dose is 10 mg once daily.
Reduction of the risk or slowing of worsening kidney function
The usual starting dose is 1.25 mg or 2.5 mg once daily.

• Your doctor may modify the dosage of the medicine.
• The usual maintenance dose is 5 mg or 10 mg once daily.

Treatment of heart failure
The usual starting dose is 1.25 mg once daily.
Your doctor may modify the dosage of the medicine.
The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses.
Treatment after heart attack
The usual starting dose is 1.25 mg to 2.5 mg twice daily.
Your doctor may modify the dosage of the medicine.

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

Elderly patients
Your doctor will use a lower starting dose, which will be gradually increased.
Method of administration

• The medicine should be taken orally, at the same time each day.
• The tablet should be swallowed whole with water.
• Tablets must not be crushed or chewed.

Taking more Ramipril Genoptim than prescribed
You should contact your doctor immediately or go to the nearest hospital emergency department.
Do not drive yourself; ask someone to take you to the hospital or call an ambulance.
You should bring the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Ramipril Genoptim
If you miss a dose, take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following serious adverse reactions occur, stop taking Ramipril Genoptim and contact your doctor immediately – you may require urgent medical attention:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with 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 disorders, redness, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following symptoms occur, contact your doctor immediately:

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

Other adverse reactions
Inform your doctor if any of the following symptoms worsen or persist for more than a few days.
Common (occur 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 dose increases,
• fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting up quickly from a lying position,
• dry, irritating cough, sinusitis or bronchitis, shortness of breath,
• stomach or intestinal pain, diarrhoea, indigestion, nausea or vomiting,
• skin rashes, including raised lesions,
• chest pain,
• muscle cramps or muscle pain,
• increased potassium levels in blood, detected in laboratory tests.

Uncommon (occur in less than 1 in 100 patients):
disturbances of balance (vertigo),
itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping sensations (paresthesia),
loss or disturbances of taste,
sleep disturbances,
depression, anxiety, nervousness or restlessness,
nasal congestion, breathing difficulties or worsening of asthma,
intestinal swelling known as angioedema of the intestine, with symptoms such as abdominal pain,
vomiting and diarrhoea,
heartburn, constipation or dryness of the oral mucosa,
increased urination,
excessive sweating,
loss of appetite or reduced appetite (anorexia),
rapid or irregular heartbeat,
swelling of hands and feet – may be a sign of fluid retention,
sudden flushing, especially of the face,
blurred vision,
joint pain,
fever,
impotence, decreased libido in men and women,
increased number of certain white blood cells (eosinophilia), detected in blood tests,
abnormal liver, pancreas or kidney function, detected in blood tests.
Rare (occur in less than 1 in 1000 patients):
feeling "jittery" or disoriented,
redness and swelling of the tongue,

• severe, patchy peeling of the skin, itchy nodular rash,
• nail disorders (e.g. loosening or separation of the nail from the nail bed),
• skin rash or bruising,
• skin spots and cold extremities,
• redness, itching, swelling and watering of the eyes,
• hearing disturbances and tinnitus,
• weakness,
• decreased number of red blood cells, white blood cells, platelets or haemoglobin levels, detected in blood tests.

Very rare (occur in less than 1 in 10,000 patients):
photosensitivity (increased sensitivity to sunlight).
Frequency not known (frequency cannot be estimated from available data):
difficulty concentrating,
swelling of the oral mucosa,
decreased number of blood cells, detected in blood tests,
decreased sodium levels, detected in blood tests,
concentrated urine (dark in colour), nausea or vomiting, muscle cramps, confusion and seizures, which may result from abnormal ADH secretion (antidiuretic hormone, vasopressin) – if these symptoms occur, contact your doctor immediately,
discoloration of fingers and toes upon exposure to cold, with tingling and pain upon warming (Raynaud's phenomenon),
breast enlargement in men,
slowed or impaired reactions,
burning sensation,
smell disturbances,
hair loss.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 below 25°C.
Keep in the original packaging to protect from moisture. The HDPE container should be kept tightly closed to protect from moisture.
Do not use this medicine after the expiry date stated on the label, carton, blister pack after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Ramipril Genoptim Contains
The active substance is ramipril. Each tablet contains 2.5 mg, 5 mg, or 10 mg of ramipril.
The other ingredients (excipients) are:
Ramipril Genoptim, 2.5 mg: maize starch, lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, ferric oxide yellow (E172), sodium stearyl fumarate.
Ramipril Genoptim, 5 mg: maize starch, lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, ferric oxide red (E172), sodium stearyl fumarate.
Ramipril Genoptim, 10 mg: maize starch, lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, sodium stearyl fumarate.

What Ramipril Genoptim Looks Like and Contents of the Pack
Tablet
Ramipril Genoptim, 2.5 mg
Yellowish to yellow, flat, round, uncoated tablets with bevelled edges, marked with the symbols “H” and “18” on either side of the break 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, mottled, flat, round, uncoated tablets with bevelled edges, marked with the symbols “H” and “19” on either side of the break 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 bevelled edges, marked with the symbols “H” and “20” on either side of the break line on one side of the tablet and smooth on the other side. The tablet can be divided into equal doses.

PVC-Aluminium blister pack in a cardboard box. HDPE container with PP cap in a cardboard box.

Pack Sizes:
Ramipril Genoptim, 2.5 mg
Blister: 20, 28, 30, 50, 60, 90, 98, 100 and 500 tablets
HDPE container: 30 and 1000 (hospital pack) tablets

Ramipril Genoptim, 5 mg
Blister: 7, 10, 14, 20, 28, 30, 42, 50, 56, 60, 90, 98, 100 and 500 tablets
HDPE container: 30 and 1000 (hospital pack) tablets

Ramipril Genoptim, 10 mg
Blister: 20, 28, 30, 50, 56, 60, 90, 98, 100 and 500 tablets
HDPE container: 30 and 1000 (hospital pack) tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

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