Acurenal

Leaflet accompanying the packaging: information for the user

Acurenal, 5 mg, film-coated tablets

Acurenal, 10 mg, film-coated tablets

Acurenal, 20 mg, film-coated tablets

Quinapril

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

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 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 packaging and other information

1. What is Acurenal and what is it used for

Acurenal contains quinapril, which belongs to a group of angiotensin-converting enzyme inhibitors (ACE inhibitors). It lowers blood pressure and widens blood vessels, making it easier for blood to flow and reducing the workload on the heart.
Acurenal is used to treat:

• high blood pressure,
• heart failure.

2. Important information before taking Acurenal

When not to take Acurenal

• if the patient is allergic to quinapril or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced angioedema associated with ACE inhibitors;
• if the patient is taking or has recently taken 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 the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• in pregnant women after the third month of pregnancy (Acurenal should also be avoided in early pregnancy - see section "Pregnancy").

Warnings and precautions

Before starting treatment with Acurenal, the doctor, pharmacist, or nurse should be consulted.
The doctor should be informed if, before or during treatment with Acurenal:

• a wheezing sound or angioedema of the face, tongue, or larynx occurs (Acurenal should be discontinued immediately and the doctor consulted);
• abdominal pain occurs (with or without nausea or vomiting), as this symptom may indicate intestinal angioedema;
• the patient is to undergo LDL apheresis with dextran sulfate (mechanical removal of cholesterol from blood vessels);
• the patient is undergoing desensitization treatment with bee or wasp venom;
• the patient is being dialyzed;
• the patient has collagen vascular disease and/or kidney disease;
• jaundice develops or liver enzyme activity increases;
• the patient has diabetes and is being treated with insulin or oral antidiabetic medicines;
• the patient is to undergo major surgery or anesthesia with agents that cause hypotension;
• the patient has severe or unstable congestive heart failure;
• the patient is being hemodialyzed due to severe kidney failure;
• the patient has recently undergone kidney transplantation;
• a persistent dry cough occurs, which may be associated with taking Acurenal;
• the patient has primary hyperaldosteronism (increased production of a hormone called aldosterone by the adrenal cortex);
• the patient is pregnant, suspects she may be pregnant, or plans 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 fetus;
• the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has diabetic kidney disease;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Acurenal".
• •the patient is taking any of the following medicines, as there is an increased risk of angioedema (rapid swelling of the skin and mucous membranes in areas such as the throat):
• 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.

The doctor should be consulted, even if the above warnings relate to past situations.

Acurenal and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans 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 these medicines, the introduction of quinapril may cause excessive blood pressure lowering. To prevent this, the doctor may recommend discontinuing 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 the 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 (cancer medicines), and immunosuppressive 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 position from lying to standing).
• Angiotensin II receptor antagonists (AIIRA), aliskiren: the doctor may recommend a dose change and/or take other precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "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 the absorption of Acurenal.
• Oral antidiabetic medicines: their dosage may need to be adjusted by the doctor when taken with quinapril.
• Gold: in patients treated with gold injections and ACE inhibitors, rare cases of reactions similar to those caused by nitrates (flushing of the face, nausea, vomiting, hypotension) have been reported.
• Medicines commonly used to prevent transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See the section "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. The absorption of Acurenal 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 position from lying to standing).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
Pregnancy
The doctor should be told about the pregnancy or suspected pregnancy. The doctor will advise stopping the medicine. Acurenal is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The doctor should be informed about breastfeeding or the intention to breastfeed. Breastfeeding newborns (in the first weeks after birth), especially premature babies, is not recommended while taking Acurenal.
In the case of breastfeeding older infants, the doctor will inform about the benefits and risks associated with taking Acurenal during lactation, compared to other medicines.

Driving and using machines

During treatment with Acurenal, dizziness or fatigue may occur. If these symptoms occur, the patient should not drive or operate machinery. The patient should exercise caution when driving or operating machinery until they are sure how the medicine affects them.
Acurenal contains lactose.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Acurenal

This medicine should always be taken exactly as advised by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Adults:
Acurenal can be taken with or without food.
Acurenal should be taken regularly at the same time every day.

Hypertension

Monotherapy: the recommended initial dose of Acurenal is 10 mg once daily.
Depending on the patient's response, the 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 daily, taken once or divided into two doses. In most patients, long-term blood pressure control is achieved with Acurenal taken 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. The 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, the doctor will gradually increase the dose to an effective dose (up to 40 mg daily), given once 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 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 patients, those with hyponatremia (sodium level in the blood less than 130 mEq/l), or those 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 renal impairment/elderly patients

In elderly patients and those with a creatinine clearance below 40 ml/min, the recommended initial dose is 2.5 mg. The doctor will then increase the dose according to the therapeutic effect.
If the patient feels that the effect of Acurenal is too strong or too weak, they should consult their doctor.

Overdose of Acurenal

The symptoms of quinapril overdose in humans are not known.
The most likely consequence of overdose may be symptoms of severe hypotension. In such a case, the 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.
In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missed dose of Acurenal

If a dose is missed (e.g., forgotten), it should be taken as soon as possible. However, if it is close to the time for the next dose, the next dose should be taken at the scheduled time.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Acurenal

Treatment should not be stopped without consulting the doctor.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

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 100 people):

• chest pain, hypotension,
• decreased 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, and potassium levels in the blood.

Uncommon side effects (may affect up to 1 in 1000 people):

• nervousness, drowsiness, depression, dizziness, confusion,
• tinnitus, transient ischemic attack,
• pruritus, excessive sweating, angioedema, rash,
• generalized edema, fever, peripheral edema,
• proteinuria, renal 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, bloating.

Rare side effects (may affect up to 1 in 10,000 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, small intestine angioedema,
• psoriasis-like skin inflammation.

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

• decreased blood cell count,
• pseudoallergic reactions,
• cerebrovascular damage,
• orthostatic hypotension (when changing position from lying to standing),
• bronchospasm,
• pancreatitis, hepatitis, jaundice due to bile flow obstruction,
• dark urine, nausea, vomiting, muscle cramps, confusion, and seizures. 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 symptoms (a skin disease characterized by red patches covered with silver scales),
• decreased hemoglobin, decreased hematocrit, decreased hematocrit and WBC, abnormal liver test results. In patients with congenital G-6-PD deficiency, single cases of hemolytic anemia have been reported.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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 the medicine.

5. How to store Acurenal

Store in a temperature below 25°C, in the original packaging.
The medicine should be kept out of 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Acurenal contains

• The active substance of the medicine is quinapril in the form of quinapril hydrochloride.
• The other ingredients of the medicine are: heavy magnesium carbonate, lactose monohydrate, gelatin (E441), crospovidone (E1202), magnesium stearate (E572), and Opadry II coating type 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, film-coated tablets are white. The tablets are round, biconvex.
Acurenal, 10 mg, film-coated tablets are white. The tablets are round, biconvex.
Both sides of the tablets have a score line to facilitate breaking.
Acurenal, 20 mg, film-coated tablets are white. The tablets are round, biconvex.
Both sides of the tablets have a cross score line to facilitate breaking.
3 blisters containing 10 film-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