Aporami

Package Leaflet: Information for the Patient

ApoRami, 1.25 mg, Tablets

ApoRami, 2.5 mg, Tablets

ApoRami, 5 mg, Tablets

ApoRami, 10 mg, Tablets

Ramipril

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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. Package Contents 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 medications called ACE inhibitors (angiotensin-converting enzyme inhibitors). ApoRami works by:

• Reducing the production of substances that may 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 is not pumping 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". 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 medication used to treat 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 another type of blood filtration. Depending on the type of device used, ApoRami may not be a suitable medication.
• 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 medication containing aliskiren.
• If the patient is taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea;
• Medications used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• Wildagliptin, a medication used to treat type 2 diabetes.

If any of the above situations occur, do not take ApoRami. In case of doubts about taking the medication, consult a doctor before starting to take ApoRami.

Warnings and Precautions

Before starting to take ApoRami, discuss it with a doctor or pharmacist

• If the patient has heart, liver, or kidney disease.
• If the patient has recently experienced significant loss of electrolytes or fluids due to: vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics (water pills) or dialysis.
• In case of planned desensitization to bee or wasp venom (desensitization)
• If the patient is to undergo anesthesia. Such medications are administered before surgical or dental procedures. It may be necessary to stop taking ApoRami the day before the procedure, in case of doubts, consult a doctor.
• If the patient has been diagnosed with high potassium levels in the blood (based on blood tests).
• If the patient is taking any of the following medications, which may increase the risk of angioedema (rapid swelling of the skin and mucous membranes):
• Sirolimus, everolimus, and other mTOR inhibitors (used to prevent the 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.
• Women should inform their doctor if they think they are pregnant or plan to become pregnant. ApoRami is not recommended during 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 inform her doctor immediately. Before becoming pregnant, it is recommended to switch to a different medication suitable for use during pregnancy.
• If the patient is taking any of the following medications used to treat high blood pressure:
• Angiotensin receptor blockers (ARBs), also known as sartans, e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to 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), consult a doctor before starting to take ApoRami.

Other Medications and ApoRami

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

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

Inform the doctor about taking the following medications, as they may increase the risk of side effects when used with ApoRami:

• Sacubitril/valsartan - used to treat chronic heart failure in adults (see section 2 "When Not to Take ApoRami")
• Pain and anti-inflammatory medications (e.g., NSAIDs, such as ibuprofen or indomethacin and aspirin)
• Cancer medications (chemotherapy)
• Medications used to prevent organ rejection after transplantation, such as cyclosporine
• Diuretics (water pills), such as furosemide
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole in bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ rejection; and heparin, a medication used to thin blood to prevent clot formation)
• Steroidal anti-inflammatory medications, 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)
• Medications commonly used to prevent the rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See "Warnings and Precautions".
• Wildagliptin (used to treat type 2 diabetes)
• Racecadotril (used to treat diarrhea)
• If the patient is taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under the headings "When Not to Take ApoRami" and "Warnings and Precautions")

Inform the doctor about taking the following medications, as their action may be altered when used with ApoRami:

• Antidiabetic medications, such as oral glucose-lowering medications 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), consult a doctor before starting to take ApoRami.

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 ApoRami treatment, consult a doctor, as alcohol may enhance the effect of blood pressure-lowering medications.
• 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 child, they should consult a doctor or pharmacist before taking this medication.
Pregnancy
Inform the doctor if the patient thinks they are pregnant (or plan to become pregnant). ApoRami is not recommended during 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 inform her doctor immediately. Before becoming pregnant, it is recommended to switch to a different medication suitable for use during pregnancy.
Breastfeeding
ApoRami should not be used during breastfeeding.
Before taking any medication, consult a doctor or pharmacist.

Driving and Operating Machinery

While taking ApoRami, dizziness may occur. The risk of dizziness is higher at the beginning of ApoRami treatment and after increasing the dose. If dizziness occurs, do not drive vehicles or operate machinery.
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 medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to Take ApoRami

This medication should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Dosage

Treating 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 case of diuretic (water pill) use, the doctor may discontinue or reduce the dose of the diuretic before starting ApoRami.

Preventing 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 Problems

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

Treating Heart Failure

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

Treating Heart Failure After a Heart Attack

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

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

Taking the Medication

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

Taking a Higher Than Recommended Dose of ApoRami
Consult a doctor or immediately go to the nearest hospital emergency department. Do not drive yourself. Ask someone to drive you to the hospital or call an ambulance. Bring the medication packaging with you, so the doctor knows what medication was taken.
Missing a Dose of ApoRami

• In case of a missed dose, take the next dose at the usual time.
• Do not take a double dose of the medication to make up for the missed dose.

In case of doubts about taking the medication, consult a doctor or pharmacist.

4. Possible Side Effects

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

In Case of Any of the Following Serious Side Effects, Stop Taking ApoRami and Immediately Consult a Doctor – Immediate Medical Attention May Be Necessary:

• 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 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, Immediately Inform a Doctor:

• Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more serious side effects, such as a heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung-related side effects.
• 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, 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

Inform a 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 ApoRami treatment and after increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially if the patient is standing or has recently changed position from lying down 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 walking on air (paresthesia).
• Loss or disturbance of taste.
• Sleep disturbances.
• Depression, anxiety, nervousness, or restlessness.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal angioedema, characterized by abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urination during the day.
• Excessive sweating.
• Loss or decreased appetite (anorexia).
• Rapid 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 white blood cell count in the blood (eosinophilia).
• Abnormal liver, pancreas, or kidney function test results.

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

• Tremors or disorientation.
• Redness and swelling of the tongue.
• Flaking skin, itchy papular rash.
• Nail diseases (e.g., reduced 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 disturbances and ringing in the ears.
• Weakness.
• Abnormal blood test results: decreased red blood cell count, white blood cell count, platelet count, or hemoglobin level.

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

• Sensitivity to sunlight.

Other Reported Side Effects:

Inform a doctor if any of the following symptoms worsen 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 actual illness, muscle cramps, confusion, and seizures, which may be caused by inappropriate antidiuretic hormone (ADH) secretion. If the patient experiences any of these symptoms, they should consult a doctor as soon as possible.
• Change in finger color upon 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 disturbances.
• Hair loss.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, inform a 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.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store ApoRami

Store the medication 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 medication after the expiration date stated on the carton, blister, and label after EXP. The expiration date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist what to do with unused medications. This will help protect the environment.

6. Package Contents 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.
Other ingredients are: cornstarch, lactose monohydrate, sodium bicarbonate, 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 What the Package Contains

Tablet.
1.25 mg:
White or almost white, flat, with beveled edges, rounded [5.0 mm in diameter], uncoated tablet with "H" and "17" embossed on one side and smooth on the other side.
2.5 mg:
Light yellow to yellow, with beveled edges, rounded [5.0 mm in diameter], uncoated tablet with "H" and "18" embossed on one side and smooth on the other side. The tablet can be divided into equal doses.
5 mg:
Pink, speckled, flat, with beveled edges, rounded [6.0 mm in diameter], uncoated tablet with "H" and "19" embossed on one side, with a score line, and smooth on the other side. The tablet can be divided into equal doses.
10 mg:
White or almost white, flat, with beveled edges, rounded [8.0 mm in diameter], uncoated tablet with "H" and "20" embossed on one side, with a score line, and smooth on the other side. The tablet can be divided into equal doses.
ApoRami tablets are available in:
PVC/Aluminum blisters.
HDPE bottle containing a desiccant, 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