Acurenal

Package Leaflet: Information for the User

Acurenal, 40 mg, Film-Coated Tablets

Quinapril

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, the doctor or pharmacist should be informed. 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 Package 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 of 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 other ingredient of this medication (listed in section 6);
• if the patient has previously experienced angioedema associated with ACE inhibitors;
• if the patient is taking or has taken a combination medication 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 medication 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 to take 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 angioedema of the intestines;
• 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 undergoing dialysis;
• the patient has collagen vascular disease and/or kidney disease;
• the patient develops jaundice or has elevated liver enzyme levels;
• the patient has diabetes and is being treated with insulin or oral antidiabetic medications;
• 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 undergoing hemodialysis due to severe kidney failure;
• the patient has recently undergone kidney transplantation;
• the patient experiences persistent dry cough, 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 medications 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). See also section "When Not to Take Acurenal".
• the patient is taking any of the following medications, as there is an increased risk of angioedema (rapid swelling of the skin and mucous membranes):
• racecadotril, a medication used to treat diarrhea;
• medications used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medication used to treat diabetes.

The doctor should be consulted, even if the above warnings refer to situations that have occurred in the past.

Acurenal and Other Medications

The doctor or pharmacist should be informed about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.

• Tetracyclines: due to the presence of magnesium carbonate in Acurenal, the absorption of tetracyclines is reduced. It is not recommended to take Acurenal with tetracyclines or other medications that interact with magnesium.
• Diuretics: in patients taking these medications, 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 medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medication used to prevent transplant rejection, and heparin, a medication used to thin the blood and prevent clots).
• Lithium taken with quinapril may lead to the development of lithium toxicity.
• General anesthetics may enhance the blood pressure-lowering effect of quinapril.
• Nonsteroidal anti-inflammatory medications that reduce prostaglandin synthesis (e.g., ibuprofen) may weaken the effect of ACE inhibitors.
• Allopurinol, cytostatics (medications used to treat cancer), and immunosuppressive medications (medications used after transplants), corticosteroids used systemically or procainamide (a medication 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 that occurs when changing position from lying down to standing).
• Angiotensin II receptor antagonists (AIIRA), aliskiren: the doctor may recommend changing the dose and/or taking other precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When Not to Take Acurenal" and "Warnings and Precautions").
• Other blood pressure-lowering medications taken with quinapril may enhance its antihypertensive effect.
• Antacids used to treat heartburn or indigestion may reduce the absorption of Acurenal.
• Antidiabetic medications: 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, low blood pressure) have been reported.
• Medications commonly used to prevent transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and Precautions".
• Racecadotril, a medication used to treat diarrhea.
• Wildagliptin, a medication used to treat diabetes.

Acurenal with Food, Drink, and Alcohol

The medication 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 that occurs when changing position from lying down to standing).

Pregnancy and Breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before taking this medication.
Pregnancy
The doctor should be informed about pregnancy or suspected pregnancy. The doctor will recommend discontinuing the medication. 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 during treatment with 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 medications.

Driving and Operating Machines

During treatment with Acurenal, dizziness or fatigue may occur. If these symptoms occur, the patient should not drive or operate machines. The patient should exercise caution when driving or operating machines until they are sure how the medication 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 medication.

3. How to Take Acurenal

This medication should always be taken as directed 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.
The 40 mg film-coated tablets of Acurenal are divisible (with a cross-score on both sides, making it easier to divide), so they can be used when a dose of 40 mg, 20 mg, or 10 mg is needed.
However, when a smaller dose is needed, a medication with a lower quinapril content should be used.

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 mg to 40 mg per day, taken once or divided into two doses. In most patients, long-term blood pressure control is achieved by taking Acurenal once daily. In some patients, doses of quinapril up to 80 mg per day have been used.
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 per day), taken once or divided into two equal doses, in combination with diuretics and/or digitalis glycosides. Usually, in combination therapy, the therapeutic effect is maintained during treatment with doses of 10 mg to 20 mg per day.

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 over 70 years old.

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 based on 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 this 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 doctor or pharmacist should be consulted immediately.

Missed Dose of Acurenal

If a dose is missed (e.g., forgotten), it should be taken as soon as possible. However, if it is almost 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.

Discontinuation of Acurenal

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

4. Possible Side Effects

Like all medications, Acurenal can cause side effects, although not everybody gets them.
Common side effects (may occur in more than 1 in 100 people):

• chest pain, low blood pressure,
• reduced 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 levels of creatinine, urea, potassium in the blood.

Uncommon side effects (may occur in more than 1 in 1000 people):

• nervousness, 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, bloating.

Rare side effects (may occur in more than 1 in 10,000 people):

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

Very rare side effects (may occur in 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 damage,
• orthostatic hypotension (when changing position from lying down to standing),
• bronchospasm,
• pancreatitis, hepatitis, jaundice due to bile duct 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),
• reduced hemoglobin levels, reduced hematocrit, reduced hematocrit and WCXC, 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 not listed in this 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 this medication.

5. How to Store Acurenal

Store in a temperature below 25°C.
Store in the original package to protect from moisture.
The medication should be kept out of sight and reach of children.
Do not use this medication after the expiration date stated on the package after: EXP. The expiration date refers to the last day of the month.
Medications should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the Package and Other Information

What Acurenal Contains

• The active substance of the medication is quinapril in the form of quinapril hydrochloride.
• The other ingredients of the medication are: magnesium carbonate, lactose monohydrate, gelatin (E441), crospovidone (E1202), magnesium stearate (E572), and the coating Opadry II type 33G28707 White, which contains: hypromellose (E464), lactose monohydrate, macrogol 3000, triacetin (E1518), and titanium dioxide (E171).

What Acurenal Looks Like and What the Package Contains

White, round, biconvex film-coated tablets with a cross-score on both sides, making them easier to divide.
The package contains 3 blisters of 10 tablets each, along with a patient information leaflet.

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
Poland
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Poland
Date of Last Revision of the Leaflet:February 2022