Apoauronarami

PATIENT INFORMATION LEAFLET: USER INFORMATION

Apoauronarami, 2.5 mg, tablets
Apoauronarami, 5 mg, tablets
Apoauronarami, 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.
• Consult a doctor or pharmacist if you have any doubts.
• 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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Apoauronarami and what is it used for

Apoauronarami is available in tablet form. The tablets are available in three strengths containing 2.5 mg, 5 mg, or 10 mg of ramipril.
Apoauronarami contains the active substance ramipril. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Apoauronarami works by:

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

Apoauronarami can be used to:

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

2. Important information before taking Apoauronarami

When not to take Apoauronarami:

• If the patient has been diagnosed with an allergy (hypersensitivity) to ramipril, another ACE inhibitor, or any of the other ingredients of Apoauronarami 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". 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 has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.
• If the patient has undergone dialysis or another type of blood filtration. Depending on the type of device used, Apoauronarami may not be a suitable medicine.
• If the patient has kidney disease related to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy(see "Pregnancy and breastfeeding").
• If blood pressure is very low or unstable. The doctor should assess blood pressure.
• 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 situations occur, do not take Apoauronarami. In case of doubts, consult a doctor before starting treatment.

Warnings and precautions

Before starting Apoauronarami, consult a 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 (through vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics or dialysis).
• If the patient is to undergo desensitization treatment for bee or wasp stings.
• If the patient is to receive anesthesia. These may be used during surgical or dental procedures. It may be necessary to stop Apoauronarami treatment the day before the procedure; consult a doctor.
• If the patient has high potassium levels in the blood (in blood test results).
• If the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may recommend regular blood tests, especially to monitor sodium levels in the blood, especially in the elderly.
• If the patient is taking any of the following medicines, the risk of angioedema 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 the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• Inform the doctor if the patient is pregnant or planning to become pregnant. Apoauronarami is not recommended during the first 12 weeks of pregnancy, and above the third month of pregnancy, the medicine may harm the fetus (see "Pregnancy and breastfeeding").
• If the patient is taking any of the following medicines used to treat high blood pressure:
• An angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• Aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Apoauronarami".
Children and adolescents
Apoauronarami is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established in children.
If any of the above situations occur (or in case of doubts), before starting Apoauronarami, consult a doctor.

Apoauronarami and other medicines

Inform the doctor or pharmacist about all medicines taken recently, including those available without a prescription (including herbal medicines). Ramipril may affect the action of other medicines, and other medicines may affect the action of Apoauronarami.
Inform the doctor about taking any of the following medicines. They may reduce the effect of Apoauronarami:

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

Inform the doctor about taking any of the following medicines. They may increase the risk of side effects if taken with Apoauronarami:

• Sacubitril/valsartan - used to treat chronic heart failure in adults (see "When not to take Apoauronarami" and "Warnings and precautions").
• Pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and acetylsalicylic acid).
• Cancer medicines (chemotherapy).
• Medicines used to prevent organ rejection, such as cyclosporine.
• Diuretics (e.g., 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, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots).
• Corticosteroids, 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).
• Sirolimus, everolimus (medicines used to prevent organ rejection).
• Wildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhea).

The doctor may need to change the dose and/or take other precautions:

• If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also "When not to take Apoauronarami" and "Warnings and precautions").

Inform the doctor about taking any of the following medicines. Their effect may be altered when taken with Apoauronarami:

• Antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Apoauronarami may lower blood glucose levels. Blood glucose levels should be regularly monitored while taking Apoauronarami.
• Lithium (used to treat psychiatric disorders). Apoauronarami may increase lithium levels in the blood. Lithium levels in the blood should be closely monitored.

If any of the above situations occur (or in case of doubts), before starting Apoauronarami, consult a doctor.

Apoauronarami with food, drink, and alcohol

• Consuming alcohol while taking Apoauronarami may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Apoauronarami, consult a doctor about the potential interaction between blood pressure-lowering medicines and alcohol.
• Apoauronarami can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient suspects she is pregnant (or plans to become pregnant), she should inform her doctor.
Apoauronarami is not recommended during the first 12 weeks of pregnancy.
Apoauronarami should not be taken after the 13th week of pregnancy, as it may harm the fetus.
If the patient becomes pregnant while taking Apoauronarami, she should immediately inform her doctor. A change in treatment is recommended before planned pregnancy.
Breastfeeding
Apoauronarami should not be taken during breastfeeding.
Consult a doctor or pharmacist before taking any medicines.

Driving and using machines

While taking Apoauronarami, dizziness may occur. The risk of dizziness is higher at the start of Apoauronarami treatment and after dose increases. If dizziness occurs, do not drive vehicles or operate machinery.

Apoauronarami 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 Apoauronarami

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

Taking the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed whole, with a liquid.
• Do not crush or chew the tablets.

Recommended dose:

Treatment of high blood pressure

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• Based on blood pressure control, the doctor may adjust the dose.
• The maximum dose is 10 mg once a day.
• If diuretics (water pills) are being taken, the doctor may stop or reduce the dose of the diuretic before starting Apoauronarami treatment.

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.
• The usual dose is 10 mg once a day.

Reducing or delaying kidney disease

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dose.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

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

Treatment after a heart attack

• The initial dose is usually 1.25 mg once a day to 2.5 mg twice a day.
• The doctor may adjust the dose.
• The usual dose is 10 mg per day. It is preferred to take the medicine in two divided doses.

Elderly patients
The initial dose should be lower, and dose increases should be more gradual.

Taking a higher dose of Apoauronarami than recommended

Consult a doctor or 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 medicine packaging with you, so the doctor knows what medicine was taken.

Missing a dose of Apoauronarami

If a dose is missed, take the next planned dose.
Do not take a double dose of the medicine to make up for the missed dose.
In case of further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Apoauronarami and consult a doctor immediately - prompt treatment may be necessary:

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

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

• Rapid heartbeat, irregular heartbeat, chest pain, tightness in the chest, or more severe heart conditions, including heart attack or stroke.
• Shortness of breath or cough. These may indicate lung disease.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding 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 disease, such as inflammation or liver damage.

Other side effects

Tell your doctor if any of the following symptoms worsen or persist for more than a few days.
Common(occurring in less than 1 in 10 patients)

• Headache or feeling tired.
• Dizziness. The risk of dizziness is higher at the start of Apoauronarami treatment and after dose increases.
• Fainting, hypotension (abnormally low blood pressure), especially when changing position from lying down or sitting.
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
• Abdominal pain, diarrhea, indigestion, nausea, or vomiting.
• Rash with or without raised patches.
• Chest pain.
• Muscle cramps or muscle pain.
• Higher than usual potassium levels in blood tests.

Uncommon(occurring 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 pins and needles (paresthesia).
• Loss of or altered sense of taste.
• Sleep disturbances.
• Depression, anxiety, agitation, or restlessness.
• Stuffy nose, difficulty breathing, or worsening of asthma.
• Intestinal angioedema, whose symptoms are abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urine production during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Rapid or irregular heartbeat.
• Swelling of the hands and feet. These may be symptoms of excessive fluid retention in the body.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men and women.
• Increased levels of certain white blood cells (eosinophilia) in blood tests.
• Blood test results indicating changes in the liver, pancreas, or kidneys.

Rare(occurring in less than 1 in 1000 patients)

• Feeling of uncertainty, confusion, disorientation.
• Red, swollen tongue.
• Severe skin peeling, itchy papular rash.
• Nail disorders (e.g., loosening or separation of the nail from the nail bed).
• Rash or bruising of the skin.
• Spots on the skin and cold extremities.
• Redness, itching, swelling, and tearing of the eyes.
• Hearing or ringing in the ears.
• Weakness.
• Decreased red blood cell, white blood cell, or platelet count, or hemoglobin levels in blood tests.

Very rare(occurring in less than 1 in 10,000 patients)

• Sensitivity to sunlight.

Other reported side effects:

Tell your 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 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 a doctor as soon as possible.
• Change in finger color upon cooling and feeling of burning or pain upon warming (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 possible side effects not listed in this leaflet, tell 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, e-mail: ndl@urpl.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 medicine.

5. How to store Apoauronarami

• Keep the medicine out of sight and reach of children.
• Do not store above 25°C.
• Store in the original packaging to protect from moisture.

Do not take Apoauronarami after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Apoauronarami contains

• The active substance is ramipril.
• Other ingredients are: microcrystalline cellulose, maize starch, low-substituted hydroxypropylcellulose, sodium hydrogen carbonate, magnesium stearate, yellow iron oxide (E 172) (2.5 mg tablets) or red iron oxide (E 172) (5 mg and 10 mg tablets).

What Apoauronarami looks like and contents of the pack

Apoauronarami, 2.5 mg: yellow, elongated, biconvex tablets with a dividing line. The tablet can be divided into two equal parts.
Apoauronarami, 5 mg: pink, elongated, biconvex tablets with a dividing line. The dividing line is only to facilitate breaking the tablet to make it easier to swallow and does not allow the tablet to be divided into two equal doses.
Apoauronarami, 10 mg: pink, round, biconvex tablets with a dividing line. The dividing line is only to facilitate breaking the tablet to make it easier to swallow and does not allow the tablet to be divided into two equal doses.
The tablets are in aluminum-OPA-PVC/aluminum blisters in a cardboard box.
The packaging contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturer:

Laboratorios Normon S.A.

Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Apotex Nederland B.V.

Archimedesweg 2
2333 CN Leiden
Netherlands

Date of last revision of the leaflet: 10.2021

This leaflet does not contain all the information about the medicine. If you have any questions or doubts, consult a doctor or pharmacist.