Aporami

Leaflet attached to the packaging: patient information

ApoRami, 1.25 mg, tablets

ApoRami, 2.5 mg, tablets

ApoRami, 5 mg, tablets

ApoRami, 10 mg, tablets

Ramipril

You should carefully read the contents of the leaflet before taking 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.

Table of contents of the leaflet:

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

1. What is ApoRami and what is it used for

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

• Reducing the production of substances in the body that can increase blood pressure
• Reducing tension and dilating blood vessels
• Making it easier for the heart to pump blood throughout the body

ApoRami can be used to:

• Treat high blood pressure (hypertension)
• Reduce the risk of heart attack or stroke
• Reduce the risk of or delay the onset of kidney problems (regardless of whether the patient has diabetes)
• Treat heart failure (when the heart does not pump enough blood needed by the body)
• Treat heart failure after a heart attack.

2. Important information before taking ApoRami

When not to take ApoRami:

• If the patient has been diagnosed with an allergy (hypersensitivity) to ramipril, another ACE inhibitor, or any of the other ingredients of ApoRami 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". Its symptoms include: itching, hives, red spots on the palms, soles, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient is taking or has recently taken sacubitril/valsartan, a medicine used to treat long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of the skin and mucous membranes) is increased.
• If the patient is undergoing dialysis or other blood filtration treatment. Depending on the type of device used, ApoRami may not be a suitable medicine.
• If the patient has been diagnosed with a disease characterized by reduced blood flow to the kidney (renal artery stenosis).
• In pregnancy over the third month (see "Pregnancy and breastfeeding").
• If blood pressure is very low or unstable. The assessment should be made by a doctor.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of the skin and mucous membranes) may increase:
• Racecadotril, a medicine used to treat diarrhea;
• Medicines used to prevent rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• Wildagliptin, a medicine used to treat type 2 diabetes.

If any of the above situations occur, ApoRami should not be taken. In case of doubts about taking the medicine, you should consult a doctor before starting to take ApoRami.

Warnings and precautions

Before starting to take ApoRami, you should 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-salt diet, or prolonged use of diuretics (water pills) or dialysis.
• In the case of planned desensitization to bee or wasp venom (desensitization)
• If the patient is to undergo anesthesia. Such measures are administered before surgical or dental procedures. It may be necessary to stop treatment with ApoRami the day before the procedure, in case of doubts, you should consult a doctor.
• If the patient has been diagnosed with high levels of potassium in the blood (based on blood tests).
• If the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of the skin and mucous membranes) may increase:
• Sirolimus, everolimus, and other mTOR inhibitors (used to prevent rejection of transplanted organs) or wildagliptin or neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 "When not to take ApoRami".
• If the patient has been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient should inform the doctor if they think they are pregnant or plan to become pregnant. ApoRami is not recommended in early pregnancy. It should not be taken after the 13th week of pregnancy, as it may cause serious harm to the fetus. If a woman taking ApoRami becomes pregnant, she should immediately tell her doctor. Before becoming pregnant, it is recommended to change the medicine to one suitable for use during pregnancy.
• If the patient is taking any of the following medicines used to treat high blood pressure:
• Angiotensin receptor antagonist (ARB), also known as sartans, e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems associated with diabetes.
• Aliskiren.

The doctor may regularly check kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the information under the heading "When not to take ApoRami". Children and adolescentsApoRami should not be used in children and adolescents under 18 years of age, as the safety and efficacy of ApoRami in this patient group have not been established. If any of the above situations occur (or are uncertain), before starting to take ApoRami, you should consult a doctor.

Other medicines and ApoRami

The patient should inform the doctor or pharmacist about all medicines taken recently, including those available without a prescription (including herbal medicines). ApoRami may affect the action of other medicines, and other medicines may affect the action of ApoRami. The patient should inform the doctor about taking the following medicines, as they may reduce the effectiveness of ApoRami:

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

The patient should inform the doctor about taking the following medicines, as they may increase the risk of side effects when used with ApoRami:

• Sacubitril/valsartan - used to treat long-term (chronic) heart failure in adults (see section 2 "When not to take ApoRami")
• Pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin and aspirin)
• Cancer medicines (chemotherapy)
• Medicines used to prevent rejection of transplanted organs, such as cyclosporine
• Diuretics (water pills), such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood to prevent clot formation)
• Steroidal anti-inflammatory medicines, such as prednisolone
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (used to treat heart rhythm disorders)
• Temsirolimus (used to treat cancer)
• Medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See "Warnings and precautions" section.
• Wildagliptin (used to treat type 2 diabetes)
• Racecadotril (used against diarrhea)
• If the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the headings "When not to take ApoRami" and "Warnings and precautions")

The patient should inform the doctor about taking the following medicines, as their action may be altered when used with ApoRami:

• Antidiabetic medicines, such as oral glucose-lowering medicines and insulin. ApoRami may lower blood glucose levels. During treatment with ApoRami, blood glucose levels should be regularly monitored.
• Lithium (used to treat mental illnesses). ApoRami may increase lithium levels in the blood. Lithium levels in the blood should be closely monitored.

If any of the above situations occur (or are uncertain), before starting to take ApoRami, you should consult a doctor.

ApoRami with food and drink or alcohol

• Consuming alcohol while taking ApoRami may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed during treatment with ApoRami, you should discuss it with your doctor, as alcohol may enhance the effect of blood pressure-lowering medicines.
• ApoRami can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. PregnancyThe patient should inform the doctor if they think they are pregnant (or plan to become pregnant). ApoRami is not recommended in the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as it may cause serious harm to the fetus. If a woman taking ApoRami becomes pregnant, she should immediately tell her doctor. Before becoming pregnant, it is recommended to change the medicine to one suitable for use during pregnancy. BreastfeedingApoRami should not be used during breastfeeding.

Driving and using machines

While taking ApoRami, dizziness may occur. The risk of dizziness is higher at the beginning of treatment with ApoRami and after increasing the dose. If dizziness occurs, the patient should not drive vehicles or use tools and machines. ApoRami contains lactose monohydrate.If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is "essentially sodium-free".

3. How to take ApoRami

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

Treatment of high blood pressure

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The dose should be gradually increased until the desired blood pressure values are achieved.
• The maximum dose is 10 mg once a day.
• In the case of diuretic (water pill) use, the doctor may discontinue or reduce the dose of the diuretic before starting ApoRami.

Prevention of heart attack or stroke

• The initial dose is usually 2.5 mg once a day.
• The doctor may decide to increase the dose.
• Usually, a dose of 10 mg once a day is used.

Reducing or delaying kidney function deterioration

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dose of ApoRami.
• Usually, a dose of 5 mg or 10 mg once a day is used.

Treatment of heart failure

• The initial dose is usually 1.25 mg once a day.
• The doctor may adjust the dose of ApoRami.
• The maximum dose is 10 mg per day. It is recommended to administer the medicine in two divided doses.

Treatment after a heart attack

• The initial dose is usually 1.25 mg to 2.5 mg once a day.
• The doctor may adjust the dose of ApoRami.
• Usually, a dose of 10 mg per day is used. It is recommended to administer the medicine in two divided doses.

Elderly patientsThe initial dose should be lower, and the dose increase should be slower.

Taking the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be taken whole, with a liquid.
• The tablets should not be crushed or chewed.

Overdose of ApoRamiThe patient should consult a doctor or immediately go to the nearest hospital emergency department. The patient should not drive themselves. They should ask someone to drive them to the hospital or call an ambulance. The patient should take the medicine packaging with them, so the doctor knows what medicine was taken. Missed dose of ApoRami

• In case of a missed dose, the patient should take the next dose at the usual time.
• The patient should not take a double dose of the medicine to make up for the missed dose.

In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of any of the following serious side effects, the patient should stop taking ApoRami and immediately consult a doctor – immediate medical attention may be required:

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

In case of the following changes, the patient should immediately inform their doctor:

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

Other side effects

The patient should inform their doctor if any of the following symptoms worsen significantly 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 ApoRami treatment and after increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially if the patient is standing or after quickly changing position from lying to sitting or standing.
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
• Abdominal pain, diarrhea, nausea, or vomiting.
• Skin rash, including elevated rash.
• Chest pain.
• Muscle cramps or pain.
• Higher than usual potassium levels in the blood in laboratory tests.

Uncommon:occur in less than 1 in 100 patients

• Balance disorders (dizziness).
• Itching of the skin and sensory disturbances, such as numbness, tingling, prickling, burning, or a feeling of crawling under the skin (paresthesia).
• Loss or disturbance of taste.
• Sleep disorders.
• Depression, anxiety, nervousness, or restlessness.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal edema, called "angioedema of the intestine", whose symptoms are abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urine production during the day.
• Excessive sweating.
• Loss or decreased appetite (anorexia).
• Accelerated or irregular heartbeat. Swelling of the hands and feet. These may be symptoms of excessive water retention.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased levels of certain white blood cells in the blood (eosinophilia).
• Blood test results indicating changes in liver, pancreas, or kidney function.

Rare:occur in less than 1 in 1,000 patients

• Tremors or disorientation.
• Redness and swelling of the tongue.
• Flaking of the skin, itchy papular rash.
• Nail diseases (e.g., decreased nail adhesion or separation of the nail from its bed).
• Rash or bruising on the skin.
• Spots on the skin and discoloration of the extremities.
• Redness, itching, swelling, and tearing of the eyes.
• Hearing disorders and ringing in the ears.
• Weakness.
• Blood tests showing decreased red blood cell count, white blood cell count, platelet count, or hemoglobin levels.

Very rare:occur in less than 1 in 10,000 patients

• Sensitivity to sunlight.

Other reported side effects:

The patient should inform their doctor if any of the following symptoms worsen significantly or persist for more than a few days.

• Difficulty concentrating.
• Swelling of the lips.
• Low blood cell count in blood tests.
• Lower than usual sodium levels in blood tests.
• Concentrated urine (dark color), feeling unwell or actually being ill, muscle cramps, confusion, and seizures, which may be caused by inappropriate ADH (antidiuretic hormone) secretion. If the patient has these symptoms, they should consult their doctor as soon as possible.
• Change in finger color after cooling and a feeling of tingling or pain in response to heat (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disorders.
• Hair loss.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, 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, 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, more information can be collected on the safety of the medicine.

5. How to store ApoRami

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C Store in the original packaging to protect from moisture. Store the HDPE bottle tightly closed to protect from moisture. Do not use the medicine after the expiry date stated on the carton, blister, and label after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What ApoRami contains

The active substance is ramipril. One tablet contains 1.25 mg, 2.5 mg, 5 mg, or 10 mg of ramipril. The other ingredients are: maize starch, lactose monohydrate, sodium hydrogen carbonate, croscarmellose sodium, yellow iron oxide (E172) (only 2.5 mg dose), red iron oxide (E172) (only 5 mg dose), sodium stearyl fumarate.

What ApoRami looks like and contents of the pack

Tablet. 1.25 mg:White or almost white, flat, with beveled edges, rounded [diameter 5.0 mm], uncoated tablet with the inscription "H" and "17" on one side and smooth on the other. 2.5 mg:Light yellow to yellow with beveled edges, rounded [diameter 5.0 mm], uncoated tablet with the inscription "H" and "18" on one side and smooth on the other. The tablet can be divided into equal doses. 5 mg:Light pink, speckled, flat with beveled edges, rounded [diameter 6.0 mm], uncoated tablet with the inscription "H" and "19" and a dividing line on one side and smooth on the other. The tablet can be divided into equal doses. 10 mg:White or almost white, flat with beveled edges, rounded [diameter 8.0 mm], uncoated tablet with the inscription "H" and "20" and a dividing line on one side and smooth on the other. The tablet can be divided into equal doses. ApoRami tablets are available in: PVC/Aluminum blister packs. HDPE bottle containing a cotton plug, with a PP cap and a seal, in a cardboard box. Packaging:Blister: 14, 28, 30, 56, and 98 tablets HDPE bottle: 250 tablets Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lok. 27 01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal

This medicinal product is registered in the EEA Member States under the following names:

Belgium Ramipril AB 2.5 mg / 5 mg/10 mg, tablets Czech Republic Rampiril Aurovitas 2.5 mg / 5 mg / 10 mg tablets Netherlands Ramipril Aurobindo 1.25 mg / 2.5 mg, tablets Poland ApoRami Portugal Ramipril Aurovitas Spain RAMIPRIL AUROVITAS 5 mg / 10 mg comprimidos EFG

Date of last revision of the leaflet: 04/2022