Acurenal

Patient Information Leaflet

Acurenal, 40 mg, film-coated tablets
Quinaprilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Acurenal is and what it is 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 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:

• high blood pressure (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 has previously experienced angioedema associated with the use of ACE inhibitors;
• if the patient is currently taking or has previously taken a combination drug containing sacubitril and valsartan (used to treat certain types of chronic heart failure in adults), as this increases the risk of angioedema (rapid swelling of the subcutaneous tissue in areas such as 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 angioedema of the face, tongue, or larynx 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;
• the patient develops jaundice or elevated liver enzyme activity;
• the patient has diabetes and is 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 hemodialysis 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 pregnancy. 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 subcutaneous tissue in areas such as the throat):
  • racecadotril, a medicine used to treat diarrhoea;
  • medicines used to prevent organ transplant rejection and in cancer treatment (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 you are currently taking or have recently taken, as well as any medicines you plan 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 diuretics, initiation of chinapryl therapy may lead to excessive lowering of blood pressure. 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 cotrimoxazole, used in 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, 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 body position from lying to standing).
• Angiotensin II receptor antagonists (AIIRAs), aliskiren: your doctor may recommend dose adjustments and/or additional precautions if you are 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 should be made by your 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 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
This medicine can be taken with or without food, with water. Absorption of Acurenal may be moderately reduced (by about 25–30%) if taken with a high-fat meal.
Alcohol taken concomitantly with chinapryl may worsen orthostatic hypotension (low blood pressure occurring when changing body position from lying to standing).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to have a child, consult your 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 taken after the 3rd month.
Breastfeeding
Inform your doctor if you start or plan to start breastfeeding. Breastfeeding in newborns (first weeks after birth), and especially in preterm infants, is not recommended during treatment with Acurenal.
For older infants, your doctor will discuss the benefits and risks of taking Acurenal during lactation compared to other medicines.

Driving and using machines
Dizziness or tiredness may occur during treatment with Acurenal. If these symptoms 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 you have been previously diagnosed with an intolerance to certain sugars, consult your 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.
Acurenal 40 mg coated tablets are divisible (having a cross-shaped groove on both sides, facilitating division), allowing them to be used both when a dose of 40 mg is required and when 20 mg or 10 mg is needed.
However, when a smaller dose is required, a preparation with a lower content of quinapril 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 for dose adjustment) 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 once-daily administration of Acurenal. Maximum daily doses of quinapril up to 80 mg have been used in patients.
Use of Acurenal together with diuretics: Due to the risk of pronounced hypotension 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. If the initial dose is well tolerated, the doctor will gradually increase the dose to an effective dose (up to 40 mg daily), administered once or divided into two equal doses, in combination with diuretics and (or) digitalis glycosides. In combination therapy, therapeutic effect is usually maintained with doses of 10–20 mg daily.

Severe heart failure
Treatment of severe or unstable congestive heart failure with Acurenal should always be initiated in hospital under close 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 furosemide) or multiple diuretic agents, dehydrated patients, those with hyponatremia (serum sodium concentration less than 130 mEq/L), systolic blood pressure below 90 mmHg, those receiving high doses of vasodilating drugs, 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 than the recommended dose of Acurenal
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 physiological 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, contact your doctor or pharmacist immediately.

Missing a dose of Acurenal
If you miss a dose (e.g., due to forgetfulness), take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and 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 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 they do not occur in everyone.

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

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

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

• nervousness, drowsiness, depression, dizziness, confusion,
• tinnitus, transient ischaemic attack,
• itching, excessive sweating, angioedema, rash,
• generalized oedema, fever, peripheral oedema,
• proteinuria, renal failure,
• erectile dysfunction,
• 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 available data):

• decreased blood cell counts,
• hypersensitivity reactions,
• damage to cerebral vessels,
• orthostatic hypotension (upon changing to upright position),
• 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 symptoms of psoriasis (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 G-6-PDH deficiency, isolated 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 4921301, fax: +48 22 4921309, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Acurenal

Store below 25ºC.
Keep in the original packaging to protect from moisture.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton following: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, gelatin (E441), crospovidone (E1202), magnesium stearate (E572), Opadry II coating type 33G28707 White containing: hypromellose (E464), monohydrate lactose, macrogol 3000, triacetin (E1518), titanium dioxide (E171).

What Acurenal looks like and contents of the pack
White, round, biconvex scored tablets with a cross-score on both sides to facilitate division.
The carton contains 3 blisters with 10 coated tablets each, together with the patient leaflet.
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 Street
35-105 Rzeszów
Poland