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, you may need to read it again.
• Ask your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 around 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 hypersensitivity (allergy) 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 in 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 section "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 doubt, consult a doctor before starting treatment with the medicine.

Warnings and precautions

Before starting treatment with 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 long-term use of diuretics or dialysis).
• If the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings.
• If the patient is to receive medicines used in anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop treatment with Apoauronarami the day before the procedure; consult a doctor.
• If the patient has high levels of potassium 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 your doctor if you are 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 section "Pregnancy and breastfeeding").
• If the patient is taking any of the following medicines used to treat high blood pressure:
• 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 should not be used in 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 doubt), before starting treatment with Apoauronarami, consult a doctor.

Apoauronarami and other medicines

Inform your 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 your doctor about taking 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 your doctor about taking 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 section 2 "When not to take Apoauronarami").
• 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 (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, 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 adjust the dose and/or take other precautions:

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

Inform your doctor about taking the following medicines. Their action may be altered when used with Apoauronarami:

• Antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Apoauronarami may lower blood glucose levels. When taking Apoauronarami, blood glucose levels should be regularly monitored.
• 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 doubt), before starting treatment with Apoauronarami, consult a doctor.

Apoauronarami with food, drink and alcohol

• Drinking alcohol while taking Apoauronarami may cause dizziness and drowsiness. In case of doubt about the amount of alcohol allowed while taking Apoauronarami, consult a doctor about the possibility of combining the effects of blood pressure-lowering medicines and alcohol.
• Apoauronarami can be taken with or without food.

Pregnancy, breastfeeding and fertility

Pregnancy
If the patient is pregnant or planning to become pregnant, she should inform her doctor.
Apoauronarami should not be used during the first 12 weeks of pregnancy.
Apoauronarami should not be used from the 13th week of pregnancy, as it may harm the fetus.
If the patient becomes pregnant while taking Apoauronarami, she should inform her doctor immediately. It is recommended to change the treatment 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 beginning of treatment with Apoauronarami and after increasing the dose. 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 that the medicine is considered "sodium-free".

3. How to take Apoauronarami

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

How to take the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed whole, with a drink of water.
• 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 of the medicine.
• The maximum dose is 10 mg once a day.
• In patients taking diuretics (water pills), the doctor may discontinue or reduce the dose of the diuretic before introducing Apoauronarami into the 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 of the medicine.
• 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 of the medicine.
• The maximum dose is 10 mg per day. It is recommended 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 of the medicine.
• The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

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

Overdose of Apoauronarami

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. Take the medicine packaging with you so that 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 that makes swallowing or breathing difficult, as well as itching and rash. They 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 changes, tell your doctor promptly:

• 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. They may indicate lung disease.
• 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. They may indicate blood or bone marrow disorders.
• Severe abdominal pain that may radiate to the back. It 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). They 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 beginning of treatment with Apoauronarami and after increasing the dose.
• Fainting, hypotension (abnormally low blood pressure), especially when changing position from lying down or sitting to standing.
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
• Abdominal pain, diarrhea, indigestion, nausea or vomiting.
• Rash with or without hives.
• Chest pain.
• Muscle cramps or 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 crawling under the skin (paresthesia).
• Loss or disturbance of taste.
• Sleep disorders.
• Depression, anxiety, agitation or restlessness.
• Stuffy nose, 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).
• Rapid or irregular heartbeat.
• Swelling of the hands and feet. They may be a sign 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 peeling of the skin, itchy papular rash.
• Nail diseases (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 disorders and ringing in the ears.
• Weakness.
• Decreased red blood cell count, white blood cell count 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 actual illness, muscle cramps, confusion and seizures, which may be caused by inappropriate ADH (antidiuretic hormone) secretion. If the patient has these symptoms, they should contact their doctor as soon as possible.
• Change in finger color when cold and feeling of tingling or pain when warmed (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: [email protected].
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 Apoauronarami

• Store 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 use 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 required. 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 bicarbonate, 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, it 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, it 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 packs contain 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.