Acurenal

Package Leaflet: Information for the User

Acurenal, 5 mg, coated tablets

Acurenal, 10 mg, coated tablets

Acurenal, 20 mg, coated tablets

Quinapril

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• You should 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Acurenal is and what it is used for
• 2. Before you take 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 inhibitors (ACE inhibitors). It lowers blood pressure and makes it easier for your heart to pump blood around your body.

Acurenal is used to treat:

• high blood pressure,
• heart failure.

2. Before you take Acurenal

Do not 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 a severe allergic reaction to ACE inhibitors (a type of medicine used to lower blood pressure), which caused swelling of the face, lips, tongue, or throat;
• if you are taking a medicine containing a neprilysin inhibitor (e.g. sacubitril/valsartan) for heart failure;
• if you have hereditary or idiopathic angioedema (a condition that causes swelling of the face, lips, tongue, or throat);
• if you have aortic stenosis (narrowing of the aortic valve) or cardiomyopathy (disease of the heart muscle) with outflow tract obstruction;
• if you have diabetes or kidney problems and are taking aliskiren;
• if you are pregnant after the third month of pregnancy. Acurenal is not recommended during the first three months of pregnancy and should not be taken after the third month, as it may harm the baby.

Warnings and precautions

Before taking Acurenal, tell your doctor:

• if you have ever had a severe allergic reaction to ACE inhibitors, which caused swelling of the face, lips, tongue, or throat;
• if you have kidney problems or are on dialysis;
• if you have heart problems or are taking medicines for heart failure;
• if you have diabetes;
• if you are taking any other medicines, including those for blood pressure, heart problems, or diabetes;
• if you are pregnant, think you may be pregnant, or plan to become pregnant.

Acurenal with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those obtained without a prescription.

• Tetracyclines: the absorption of tetracyclines may be reduced by the magnesium content of Acurenal. It is not recommended to take Acurenal with tetracyclines or other medicines that interact with magnesium.
• Diuretics: if you are taking diuretics, your doctor may need to adjust the dose of Acurenal to avoid excessive lowering of blood pressure.
• Potassium supplements, potassium-sparing diuretics, and other medicines that can increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, an anticoagulant used to prevent blood clots).
• Lithium: taking lithium with quinapril may lead to increased levels of lithium in the blood, which can cause side effects.
• Anesthetics: Acurenal may enhance the effects of anesthetics.
• Non-steroidal anti-inflammatory drugs (NSAIDs): NSAIDs may reduce the effects of ACE inhibitors.
• Allopurinol, cytostatics (used to treat cancer), and immunosuppressants (used after organ transplants), corticosteroids (used to treat inflammation), and procainamide (used to treat irregular heartbeat) may increase the risk of leukopenia (reduced white blood cell count) when taken with ACE inhibitors.
• Alcohol, barbiturates, or narcotics may increase the risk of orthostatic hypotension (low blood pressure when standing up) when taken with quinapril.

Acurenal with food, drink, and alcohol

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

Alcohol may increase the risk of orthostatic hypotension when taken with quinapril.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning 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 during the first three months of pregnancy and should not be taken after the third month, as it may harm the baby.

Breastfeeding:

Tell your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Acurenal, especially in newborns and premature infants.

Driving and using machines

Acurenal may cause dizziness or fatigue, which may affect your ability to drive or operate machinery. If you experience these side effects, do not drive or operate machinery until you feel better.

Acurenal contains lactose. If you have been told by your doctor 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. Check with your doctor or pharmacist if you are not sure.

Adults:

Acurenal can be taken with or without food.

Take Acurenal at the same time every day.

Hypertension

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

Depending on the response, your doctor may 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 control of blood pressure is achieved with Acurenal once daily. Doses of up to 80 mg of quinapril per day have been used.

Heart failure

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

Severe heart failure

Treatment with Acurenal should be initiated under close medical supervision in a hospital setting.

Use in children

Acurenal should not be given to children.

Use in elderly patients or patients with impaired renal function

In elderly patients and patients with a creatinine clearance below 40 ml/min, the recommended initial dose is 2.5 mg. Your doctor will adjust 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

There is limited experience with overdose of quinapril in humans.

The most likely effect of overdose is severe hypotension. In this case, your doctor will advise you to receive intensive hydration through intravenous administration of a saline solution.

Hemodialysis and peritoneal dialysis have a minor effect on the elimination of quinapril and quinaprilat.

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

Missed dose

If you miss a dose, take it as soon as possible. However, if it is almost time for your 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

Do not stop treatment without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine 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, sore throat, runny nose,
• dizziness, headache, insomnia, fatigue, weakness, paresthesia (tingling),
• back pain, muscle pain,
• cough, shortness of breath,
• increased levels of creatinine, urea, and potassium in the blood.

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

• nervousness, drowsiness, depression, dizziness, confusion,
• ringing in the ears, transient ischemic attack,
• itching, 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, palpitations,
• vasodilation,
• dry mouth, dry throat, bloating.

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 1,000 people):

• blurred vision,
• intestinal angioedema, small intestine angioedema,
• psoriasis-like skin rash.

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

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Acurenal

Store in a cool, dry place, below 25°C. Keep the container tightly closed.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Acurenal contains

• The active substance is quinapril hydrochloride.
• The other ingredients are magnesium carbonate, lactose monohydrate, gelatin (E441), crospovidone (E1202), magnesium stearate (E572), and the coating Opadry II 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 Authorisation 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