Acurenal

Package Leaflet: Information for the User

Acurenal, 5 mg, coated tablets

Acurenal, 10 mg, coated tablets

Acurenal, 20 mg, coated tablets

Quinapril

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Acurenal and what is it used for

Acurenal contains quinapril, which belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It lowers blood pressure and widens the blood vessels, making it easier for the heart to pump blood.

Acurenal is used to treat:

• high blood pressure,
• heart failure.

2. Important information before taking Acurenal

When not to take Acurenal

• if you are allergic to quinapril or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had angioedema (swelling of the face, lips, tongue, or throat) associated with ACE inhibitors;
• if you are taking a medicine containing sacubitril and valsartan (used to treat a certain type of long-term (chronic) heart failure in adults), as the risk of angioedema (rapid swelling of the skin and mucous membranes) increases;
• in patients with hereditary or idiopathic angioedema;
• in patients with impaired blood flow from the left ventricle of the heart;
• if you have diabetes or kidney problems and are taking aliskiren, a medicine used to lower blood pressure;
• in pregnant women after the third month of pregnancy (see also "Pregnancy").

Warnings and precautions

Before taking Acurenal, discuss with your doctor, pharmacist, or nurse.

Tell your doctor if, before or during treatment with Acurenal, you:

• experience throat swelling or angioedema of the face, tongue, or glottis (stop taking Acurenal and see a doctor immediately);
• experience abdominal pain (with or without nausea or vomiting), as this may indicate angioedema of the intestine;
• are to undergo LDL apheresis with dextran sulfate (mechanical removal of cholesterol from blood vessels);
• are undergoing desensitization therapy with bee or wasp venom;
• are on dialysis;
• have collagen vascular disease and/or kidney disease;
• develop jaundice or elevated liver enzymes;
• have diabetes and are treated with insulin or oral antidiabetic medicines;
• are to undergo major surgery or anesthesia with agents that cause hypotension;
• have severe or unstable congestive heart failure;
• are on hemodialysis due to severe kidney failure;
• have recently undergone kidney transplantation;
• experience persistent dry cough, which may be associated with Acurenal;
• have primary hyperaldosteronism (increased production of a hormone called aldosterone by the adrenal cortex);
• are pregnant, think you may be pregnant, or plan to become pregnant. Acurenal is not recommended in early pregnancy and is contraindicated after the third month of pregnancy, as it may seriously harm the baby;
• are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as sartan - e.g., valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also "When not to take Acurenal" and "Warnings and precautions".
• •are taking any of the following medicines, as there is an increased risk of angioedema (rapid swelling of the skin and mucous membranes):
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

Consult your doctor, even if the above warnings apply to situations that have occurred in the past.

Acurenal with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Tetracyclines: due to the magnesium carbonate content in Acurenal, tetracycline absorption is reduced. It is not recommended to take Acurenal with tetracyclines or other medicines that interact with magnesium.
• Diuretics: in patients taking diuretics, the introduction of quinapril may cause excessive blood pressure lowering. To prevent this, your doctor may recommend stopping diuretics for a few days or increasing salt intake before starting Acurenal.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin blood and prevent clots).
• Lithium taken with quinapril may lead to lithium toxicity.
• General anesthetics may enhance the blood pressure-lowering effect of quinapril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) that reduce prostaglandin synthesis (e.g., ibuprofen) may weaken the effect of ACE inhibitors.
• Allopurinol, cytostatics (medicines used to treat cancer), and immunosuppressive medicines (medicines used after transplants), corticosteroids used systemically or procainamide (a medicine used to treat heart rhythm disorders) taken with ACE inhibitors may cause leukopenia (reduced white blood cell count).
• Alcohol, barbiturates, or narcotics taken with quinapril may enhance orthostatic hypotension (low blood pressure when changing body position from lying to standing).
• Angiotensin II receptor antagonists (AIIRAs), aliskiren: your doctor may recommend a dose change and/or take other precautions if you are taking an AIIRA or aliskiren (see also "When not to take Acurenal" and "Warnings and precautions").
• Other blood pressure-lowering medicines taken with quinapril may enhance its blood pressure-lowering effect.
• Antacids used to treat heartburn or indigestion may reduce Acurenal absorption.
• Oral antidiabetic medicines: their dosage may need to be adjusted by your doctor when taken with quinapril.
• Gold: in patients treated with gold injections and ACE inhibitors, rare cases of reactions similar to those caused by nitrate administration (flushing of the face, nausea, vomiting, low blood pressure) have been reported.
• Medicines commonly used to prevent transplant rejection (e.g., sirolimus, everolimus, and other mTOR inhibitors). See "Warnings and precautions".
• Racecadotril, a medicine used to treat diarrhea.
• Wildagliptin, a medicine used to treat diabetes.

Acurenal with food, drink, and alcohol

The medicine can be taken with or without food, with a glass of water. Acurenal absorption may be moderately reduced (by about 25-30%) if taken with a fatty meal.

Alcohol taken with quinapril may enhance orthostatic hypotension (low blood pressure when changing body position from lying to standing).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will advise you to stop taking Acurenal. Acurenal is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding of newborns (first weeks after birth), especially premature babies, is not recommended during treatment with Acurenal.

For breastfeeding older infants, your doctor will inform you about the benefits and risks of taking Acurenal during lactation compared to other medicines.

Driving and using machines

While taking Acurenal, dizziness or fatigue may occur. If this happens, do not drive or operate machinery. Be careful when driving or operating machinery until you know how Acurenal affects you.

Acurenal contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Acurenal

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults:

Acurenal can be taken with or without food.

Take Acurenal regularly at the same time every day.

High blood pressure

Monotherapy: the recommended initial dose of Acurenal is 10 mg once daily.

Depending on the patient's response, your doctor will gradually increase the dose (by doubling, taking into account the time required to adjust the dose) to a maintenance dose of 20-40 mg once daily, taken as a single dose or divided into two doses. In most patients, long-term blood pressure control is achieved with Acurenal once daily. Patients have been treated with quinapril doses up to 80 mg daily.

Taking Acurenal with diuretics: due to the possibility of excessive blood pressure lowering, the recommended initial dose of quinapril is 2.5 mg. Your doctor will then gradually increase the dose (as described above) until effective blood pressure control is achieved.

Heart failure

The recommended initial dose is 2.5 mg once daily. If the initial dose is well tolerated, your doctor will gradually increase the dose to an effective dose (up to 40 mg once daily), given as a single dose or divided into two equal doses, in combination with diuretics and/or digitalis glycosides. Usually, in combination therapy, the therapeutic effect is maintained with doses of 10-20 mg once daily.

Severe heart failure

In the treatment of severe or unstable congestive heart failure, Acurenal should always be initiated in a hospital, under close medical supervision.

Other patients at high risk, who should start treatment in a hospital, include those taking high doses of loop diuretics (e.g., more than 80 mg of furosemide) or multiple diuretics, dehydrated, hyponatremic (serum sodium level less than 130 mEq/l), or with systolic blood pressure less than 90 mmHg, taking high doses of vasodilators, with serum creatinine levels greater than 150 µmol/l, and patients aged 70 or older.

Use in children

Acurenal should not be given to children.

Patients with kidney problems/elderly patients

In elderly patients and patients with a creatinine clearance below 40 ml/min, the recommended initial dose is 2.5 mg. Your doctor will then increase the dose according to the therapeutic effect.

If you feel that the effect of Acurenal is too strong or too weak, talk to your doctor.

Overdose of Acurenal

There is no experience of quinapril overdose in humans.

The most likely effect of overdose is severe hypotension. In this case, your doctor will recommend intensive hydration of the patient through intravenous administration of a saline solution.

It has been found that hemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat.

If you have taken more than the recommended dose of Acurenal, contact your doctor or pharmacist immediately.

Missed dose of Acurenal

If you miss a dose (e.g., forget), take it as soon as possible. However, if it is almost time for the next dose, take the next dose at the scheduled time.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Acurenal

Do not stop treatment without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people):

• chest pain, low blood pressure,
• low sodium levels in the blood,
• nausea, vomiting, diarrhea, indigestion, abdominal pain, pharyngitis, rhinitis,
• dizziness, headache, insomnia, fatigue, weakness, paresthesia (tingling),
• back pain, muscle pain,
• cough, dyspnea,
• increased creatinine, urea, potassium levels in the blood.

Uncommon side effects (may affect up to 1 in 100 people):

• anxiety, somnolence, depression, dizziness, confusion,
• tinnitus, transient ischemic attack,
• pruritus, excessive sweating, angioedema, rash,
• generalized edema, fever, peripheral edema,
• proteinuria, kidney failure,
• erectile dysfunction,
• blurred vision,
• bronchitis, upper respiratory tract infection, urinary tract infection, sinusitis,
• myocardial infarction, angina pectoris, tachycardia (rapid heart rate), palpitations,
• vasodilation,
• dry throat, dry mouth, flatulence.

Rare side effects (may affect up to 1 in 1,000 people):

• balance disorders, fainting,
• eosinophilic pneumonia,
• laryngitis, constipation, taste disturbances,
• erythema multiforme, pemphigus, urticaria.

Very rare side effects (may affect less than 1 in 10,000 people):

• blurred vision,
• enteritis, angioedema of the small intestine,
• psoriasis-like skin inflammation.

Frequency not known (frequency cannot be estimated from the available data):

• reduced blood cell count,
• pseudoallergic reactions,
• cerebrovascular disorders,
• orthostatic hypotension (when changing body position from lying to standing),
• bronchospasm,
• pancreatitis, liver inflammation, jaundice due to bile duct obstruction,
• dark urine, nausea, vomiting, muscle cramps, confusion, and convulsions. These may be symptoms of a condition called inappropriate antidiuretic hormone secretion.
• Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, alopecia, photosensitivity,
• onset or exacerbation of psoriasis (a skin disease characterized by red patches covered with silver scales),
• reduced hemoglobin, reduced hematocrit, reduced hematocrit and WBC, abnormal liver function tests. In patients with congenital G-6-PD deficiency, single cases of hemolytic anemia have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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 Acurenal

Store in a temperature below 25°C, in the original packaging.

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. 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 Acurenal contains

• The active substance is quinapril in the form of quinapril hydrochloride.
• The other ingredients are: heavy magnesium carbonate, lactose monohydrate, gelatin (E441), crospovidone (E1202), magnesium stearate (E572), and Opadry II coating 33G28707 White, which contains hypromellose, lactose monohydrate, macrogol 3000, triacetin, and titanium dioxide (E171).

What Acurenal looks like and contents of the pack

Acurenal, 5 mg, coated tablets are white, round, biconvex, and have a score line on both sides.

Acurenal, 10 mg, coated tablets are white, round, biconvex, and have a score line on both sides.

Acurenal, 20 mg, coated tablets are white, round, biconvex, and have a cross-score line on both sides.

3 blisters containing 10 coated tablets in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

ICN Polfa Rzeszów S.A.

ul. Przemysłowa 2, 35-959 Rzeszów

Bausch Health Poland sp. z o.o.

ul. Przemysłowa 2

35-959 Rzeszów

Date of last revision of the leaflet:February 2022