Package leaflet: Information for the user

Acurenal, 5 mg, film-coated tablets
Acurenal, 10 mg, film-coated tablets
Acurenal, 20 mg, film-coated tablets
Quinapril
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Acurenal is and what it is used for
What you need to know before taking Acurenal
How to take Acurenal
Possible side effects
How to store Acurenal
Contents of the pack and other information

1. What Acurenal is and what it is used for

Acurenal contains quinapril, which belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It lowers blood pressure and dilates peripheral blood vessels, thereby improving blood flow and reducing the workload of the heart.
Acurenal is used to treat:

arterial hypertension,
heart failure.

2. Important information before using Acurenal

When not to use Acurenal

if the patient is allergic to chinapryl or any of the other ingredients of this medicine (listed in section 6);
if the patient previously experienced angioedema (vascular oedema) associated with the use of ACE inhibitors;
if the patient has taken or is currently taking a medicine containing sacubitril and valsartan (used to treat certain types of chronic (long-term) heart failure in adults), as this increases the risk of angioedema (rapid swelling of tissue beneath the skin, such as in the throat);
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 dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren;
in pregnant women beyond the 3rd month of pregnancy (Acurenal should also be avoided during early pregnancy – see section “Pregnancy”).

Warnings and precautions
Before starting treatment with Acurenal, discuss this with your doctor, pharmacist, or nurse.
Inform your doctor if, before or during treatment with Acurenal:

hoarseness or facial, tongue, or laryngeal angioedema occurs (discontinue Acurenal immediately and contact your doctor);
abdominal pain occurs (with or without nausea or vomiting), as this symptom may indicate intestinal angioedema;
the patient is scheduled to undergo LDL apheresis with dextran sulfate (mechanical removal of cholesterol from blood vessels);
the patient is undergoing venom immunotherapy for bee or wasp stings;
the patient is undergoing dialysis;
the patient has vasculitis and/or kidney disease;
jaundice develops or increased liver enzyme activity is detected;
the patient has diabetes and is being treated with insulin or oral antidiabetic medicines;
the patient is scheduled for major surgery or anaesthesia with agents that may cause hypotension;
the patient has severe or unstable congestive heart failure;
the patient is undergoing haemodialysis due to severe kidney failure;
the patient has recently undergone kidney transplantation;
the patient develops a persistent dry cough, which may be related to taking Acurenal;
the patient has primary hyperaldosteronism (excessive production of the hormone aldosterone by the adrenal cortex);
the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. Acurenal is not recommended during early pregnancy and is contraindicated beyond the 3rd month of pregnancy, as it may seriously harm the unborn child;
the patient is taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney impairment related to diabetes;
- aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section “When not to use Acurenal”.
the patient is taking any of the following medicines, as there is an increased risk of angioedema (rapid swelling of tissue beneath the skin, such as in the throat):
- racecadotril, a medicine used to treat diarrhoea;
- medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Acurenal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Tetracyclines: due to the presence of magnesium carbonate in Acurenal, absorption of tetracyclines may be reduced. Concomitant use of Acurenal with tetracyclines or other medicines interacting with magnesium is not recommended.
Diuretics: in patients taking these medicines, excessive lowering of blood pressure may occur when chinapryl is added to therapy. To prevent this, your 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 co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, an anticoagulant used to prevent blood clots).
Lithium taken concomitantly with chinapryl may lead to symptoms of lithium toxicity due to increased blood lithium levels.
General anaesthetics may enhance the blood pressure-lowering effect of chinapryl.
Non-steroidal anti-inflammatory drugs (NSAIDs) that reduce prostaglandin synthesis (e.g. ibuprofen) may reduce the effectiveness of ACE inhibitors.
Allopurinol, cytostatic agents (medicines used in cancer treatment), immunosuppressants (medicines used after transplantation), corticosteroids used systemically, or procainamide (a medicine used for cardiac arrhythmias), when used concomitantly with ACE inhibitors, may cause leukopenia (reduced number of white blood cells in peripheral blood).
Alcohol, barbiturates, or narcotics taken together with chinapryl may worsen orthostatic hypotension (low blood pressure occurring when changing position from lying to standing).
Angiotensin II receptor antagonists (AIIRAs), aliskiren: your doctor may recommend dose adjustments and/or additional precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “When not to use Acurenal” and “Warnings and precautions”).
Other blood pressure-lowering medicines taken concomitantly with chinapryl may enhance its antihypertensive effect.
Antacids used to treat heartburn or indigestion may reduce the absorption of Acurenal.
Antidiabetic medicines: dosage adjustments may be required by the doctor when used concomitantly with chinapryl.
Gold: in patients treated with injectable gold preparations and ACE inhibitors, rare cases of reactions similar to those seen with nitrates (flushing, nausea, vomiting, hypotension) have been reported.
Medicines commonly used to prevent organ transplant rejection (sirolimus, everolimus, and other so-called mTOR inhibitors). See section “Warnings and precautions”.
Racecadotril, a medicine used to treat diarrhoea.
Vildagliptin, a medicine used to treat diabetes.

Acurenal with food, drink, and alcohol
The medicine can be taken independently of meals, with water. Absorption of Acurenal may be moderately reduced (approximately 25–30%) if taken with a high-fat meal.
Alcohol taken concomitantly with chinapryl may worsen orthostatic hypotension (low blood pressure occurring when changing position from lying to standing).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Pregnancy
Inform your doctor if you are pregnant or suspect pregnancy. Your doctor will advise you to stop taking the medicine. Acurenal is not recommended during early pregnancy and must not be used beyond the 3rd month of pregnancy, as it may seriously harm the unborn child if administered after the 3rd month of pregnancy.
Breastfeeding
Inform your doctor if you start or intend to start breastfeeding. Breastfeeding in newborns (first weeks after birth), and especially in premature infants, is not recommended during treatment with Acurenal.
For older infants, your doctor will advise you on the benefits and risks associated with taking Acurenal during lactation compared to other medicines.

Driving and operating machinery
Dizziness or fatigue may occur during treatment with Acurenal. If these occur, do not drive or operate machinery. Exercise caution when driving or operating machinery until you are certain how this medicine affects you.

Acurenal contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Acurenal

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Adults:
Acurenal may be taken regardless of meals.
Acurenal should be taken regularly at the same time each 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 for dose adjustment) to a maintenance dose of 20 mg to 40 mg
per day, taken once or divided into two doses. Most patients achieve long-term blood pressure
control with once-daily administration of Acurenal. Maximum doses of quinapril up to 80 mg per
day have been used in patients.
Concomitant use of Acurenal with diuretic medicines: due to the possibility of a marked drop in
blood pressure in patients treated with diuretics, 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. Then, if the initial dose is well tolerated, the
doctor will gradually increase the dose to an effective dose (up to 40 mg per day), administered once
daily or divided into two equal doses, in combination with diuretics and (or) digitalis glycosides. In
combination therapy, therapeutic effect is usually maintained with doses ranging from 10 mg to
20 mg per day.
Severe heart failure
Treatment of severe or unstable congestive heart failure with Acurenal should always be initiated in
hospital under strict medical supervision.
Other high-risk patients in whom treatment should be initiated in hospital include those receiving
high doses of loop diuretics (e.g. more than 80 mg of furosemide) or multiple diuretics, those who
are dehydrated, have hyponatremia (serum sodium concentration less than 130 mEq/l), systolic
blood pressure less than 90 mmHg, those receiving high doses of vasodilating medicines, those
with serum creatinine concentration greater than 150 µmol/l, and patients aged 70 years or older.
Use in children
Acurenal should not be given to children.
Patients with renal impairment/elderly patients
In elderly patients and patients with creatinine clearance below 40 ml/min, the recommended
initial dose is 2.5 mg. The doctor will then increase the dose according to therapeutic response.
If you feel that the effect of Acurenal is too strong or too weak, consult your doctor.
Taking more Acurenal than recommended
Symptoms of quinapril overdose in humans are not known.
The most likely consequence of overdose would be symptoms of severe hypotension. In such a case,
the doctor will recommend intensive rehydration of the patient by intravenous administration of
normal saline solution.
Hemodialysis and peritoneal dialysis have been shown to have minimal effect on the elimination of
quinapril and quinaprilat.
If you have taken more than the recommended dose of this medicine, seek medical advice immediately from your doctor or pharmacist.
Missing a dose of Acurenal
If you miss a dose (e.g. because you forgot), take it as soon as possible. However, if it is almost time
for your next dose, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping Acurenal
Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Common adverse reactions (may occur in more than 1 in 100 people):

chest pain, hypotension,
decreased sodium concentration in blood,
nausea, vomiting, diarrhoea, indigestion, abdominal pain, sore throat, catarrh,
dizziness, headache, insomnia, fatigue, weakness, paraesthesia (tingling sensations),
back pain, muscle pain,
cough, dyspnoea,
increased concentration of creatinine, urea, potassium in blood.

Uncommon adverse reactions (may occur in more than 1 in 1,000 people):

nervousness, somnolence, depression, dizziness, confusion,
tinnitus, transient ischaemic attack,
itching, excessive sweating, angioedema, rash,
generalized oedema, fever, peripheral oedema,
proteinuria, renal failure,
erectile disorders,
visual impairment,
bronchitis, upper respiratory tract infection, urinary tract infection, sinusitis,
myocardial infarction, angina pectoris, tachycardia (rapid heartbeat), palpitations,
vasodilation,
dry throat, dry mouth, bloating.

Rare adverse reactions (may occur in more than 1 in 10,000 people):

disturbances of balance, fainting,
eosinophilic pneumonia,
laryngitis, constipation, taste disturbances,
erythema multiforme, bullous eruption, urticaria.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

blurred vision,
enteritis, angioedema of the small intestine,
psoriasiform dermatitis.

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

decreased number of blood cells,
hypersensitivity reactions,
damage to cerebral vessels,
orthostatic hypotension (upon changing body position to upright),
bronchospasm,
pancreatitis, hepatitis, cholestatic jaundice,
dark urine, nausea, vomiting, muscle cramps, confusion and convulsions. These may be symptoms of a condition called syndrome of inappropriate antidiuretic hormone secretion.
Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, alopecia, photosensitivity,
occurrence or worsening of psoriasis symptoms (a skin disease characterized by red patches covered with silvery scales),
decreased haemoglobin concentration, decreased haematocrit, decreased haematocrit and WCXC, abnormal liver function tests. In patients with congenital deficiency of G-6-PDH, single cases of haemolytic anaemia have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Acurenal

Store 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 stated month.
Medicines must 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 chinapryl in the form of chinapryl hydrochloride.
The other ingredients are: heavy magnesium carbonate, monohydrate lactose, gelatine (E441), crospovidone (E1202), magnesium stearate (E572), Opadry II coating type 33G28707 White containing: hypromellose, monohydrate lactose, polyethylene glycol 3000, triacetin, titanium dioxide (E171).

What Acurenal looks like and contents of the pack
Acurenal 5 mg film-coated tablets are white in colour. The tablets are round, biconvex.
Acurenal 10 mg film-coated tablets are white in colour. The tablets are round, biconvex.
On both sides, the tablets have a score line to facilitate division.
Acurenal 20 mg film-coated tablets are white in colour. The tablets are round, biconvex.
On both sides, the tablets have a cross-score line to facilitate division.
3 blisters containing 10 film-coated tablets each in a cardboard box.
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-105 Rzeszów
Poland