Accupro 10

Leaflet accompanying the packaging: patient information

ACCUPRO 5, 5 mg, coated tablets

ACCUPRO 10, 10 mg, coated tablets

ACCUPRO 20, 20 mg, coated tablets

ACCUPRO 40, 40 mg, coated tablets

Quinapril

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 ACCUPRO and what is it used for
• 2. Important information before taking ACCUPRO
• 3. How to take ACCUPRO
• 4. Possible side effects
• 5. How to store ACCUPRO
• 6. Contents of the packaging and other information

1. What is ACCUPRO and what is it used for

ACCUPRO belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
ACCUPRO is indicated for the treatment of:

• Hypertension (may be used as a single agent or in combination with thiazide diuretics or beta-adrenergic blockers).
• Heart failure (used in combination with diuretics and/or digitalis glycosides).

2. Important information before taking ACCUPRO

When not to take ACCUPRO

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has experienced angioedema (angioedema) in the past during treatment with other ACE inhibitors,
• if the patient or a family member has ever had angioedema (hereditary or of unknown cause),
• if the patient has aortic stenosis or outflow obstruction from the left ventricle,
• after the 3rd month of pregnancy (it is also recommended to avoid taking ACCUPRO in early pregnancy - see "Pregnancy"),
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,

if the patient is taking sacubitril/valsartan (used in heart failure).

Warnings and precautions

Before starting treatment with ACCUPRO, the patient should discuss it with their doctor or pharmacist.
The patient should consult a doctor:

• in case of symptoms such as wheezing, shortness of breath, facial swelling, tongue or larynx swelling (the patient should stop taking ACCUPRO immediately and see a doctor immediately).
• in case of abdominal pain (with or without nausea and vomiting), which may be related to angioedema of the intestines (symptoms resolve after discontinuation of the medicine).
• before desensitization procedures and low-density lipoprotein apheresis (mechanical removal of cholesterol from blood vessels). The patient should inform their doctor about taking ACCUPRO, due to the increased risk of allergic reactions.
• before hemodialysis. The patient should inform their doctor about taking ACCUPRO, due to the increased risk of allergic reactions. In this case, the doctor may recommend a different antihypertensive medicine or use a different dialysis membrane.
• if dehydration or sodium deficiency occurs (e.g., due to diarrhea, vomiting, renin-dependent hypertension), as there is an increased risk of excessive blood pressure lowering,
• in case of heart failure, with a risk of blood pressure lowering. In these patients, the doctor will closely monitor the dosage.
• if the patient has connective tissue disease affecting blood vessels and/or kidney problems, as there is an increased risk of agranulocytosis or neutropenia (excessive reduction of white blood cell count).
• if the patient has kidney problems (creatinine clearance <60 ml min). the doctor will use a lower dose of medicine (see below).< li>
• if the patient has unilateral or bilateral renal artery stenosis. In these patients, the doctor will recommend regular monitoring of kidney function.
• in patients with liver dysfunction, the use of diuretics may cause water and electrolyte imbalance, which can lead to hepatic coma.
• if the patient is taking potassium-sparing diuretics.
• if the patient has diabetes, as hypoglycemia (low blood sugar) may occur,
• if surgery is planned and/or anesthesia is to be administered.
• if 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 kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take ACCUPRO".
• if the patient is taking an mTOR inhibitor (e.g., temsirolimus) or a DPP-IV inhibitor (e.g., wildagliptin) or a neutral endopeptidase inhibitor (NEP) - e.g., racecadotril, as there is an increased risk of angioedema
• in patients taking medicines or having conditions that may decrease sodium levels in the blood.

The patient should inform their doctor:

• about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take ACCUPRO in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy");
• about symptoms such as facial swelling, limb swelling, eyelid swelling, mouth or tongue swelling, difficulty swallowing and breathing, abdominal pain (which may indicate angioedema), throat pain or fever (which may be symptoms of infection with a reduced white blood cell count) and dizziness or fainting. If such symptoms occur, the patient should immediately see a doctor;
• about planned surgery and/or anesthesia.

ACCUPRO and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Particularly, the patient should inform their doctor if they are taking:

• tetracyclines (antibiotics),
• diuretics,
• potassium supplements, salt substitutes containing potassium, medicines that may increase potassium levels (e.g., heparin), potassium-sparing diuretics (spironolactone, triamterene, amiloride) and antibacterial medicines such as sulfamethoxazole and trimethoprim,
• anesthetics,
• lithium, used to treat certain mental illnesses,
• non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors,
• mTOR inhibitors, e.g., temsirolimus (used after organ transplantation and in cancer treatment), DPP-IV inhibitors, e.g., wildagliptin (used in type 2 diabetes treatment) or neutral endopeptidase inhibitors (NEP), e.g., racecadotril, as there is an increased risk of angioedema
• gold preparations (e.g., sodium aurothiomalate),
• other antihypertensive medicines,
• angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take ACCUPRO" and "Warnings and precautions"). The doctor may recommend a dose change and/or take other precautions.

ACCUPRO with food and drink

The absorption of ACCUPRO may be moderately reduced (by about 25-30%) if taken with a fatty meal.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will usually recommend stopping ACCUPRO before becoming pregnant or as soon as pregnancy is confirmed, and will advise on an alternative medicine.
It is not recommended to take ACCUPRO in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or plan to breastfeed.
It is not recommended to breastfeed infants (in the first few weeks after birth), especially premature babies, while taking ACCUPRO. In the case of older infants, the doctor will inform the patient about the potential benefits and risks of taking ACCUPRO during breastfeeding compared to other treatment options.

Driving and using machines

The ability to perform tasks related to driving and operating machinery may be impaired, especially during the initial treatment period.

ACCUPRO contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take ACCUPRO

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will recommend the appropriate dosage of ACCUPRO, depending on the condition and the patient's individual response to treatment.

Hypertension

Monotherapy: The recommended initial dose of ACCUPRO in patients not taking diuretics is 10 mg or 20 mg once daily. Depending on the effectiveness of treatment, the dose may be increased (by doubling) to a maintenance dose of 20 mg or 40 mg once daily, usually given once or twice daily. The doctor may recommend gradual dose increases every few weeks. In most patients, ACCUPRO effectively lowers blood pressure.
Maximum doses of up to 80 mg of ACCUPRO per day have been used in patients.
Taking ACCUPRO with diuretics
In patients who are also taking diuretics, the doctor usually recommends a lower initial dose of ACCUPRO, which is 5 mg. This dose can be increased (as described above) until effective blood pressure control is achieved.

Heart failure

ACCUPRO is used in combination with diuretics and/or digitalis glycosides.
The recommended initial dose in patients with heart failure is 5 mg once or twice daily. After taking ACCUPRO, the doctor will usually recommend monitoring the circulatory system, especially blood pressure. If the initial dose is well tolerated, the doctor will recommend gradual dose increases until the desired effect of the medicine is achieved.

Use in children

ACCUPRO should not be given to children.

Use in the elderly

Age does not appear to affect the efficacy and safety of ACCUPRO. Therefore, the doctor will usually recommend the same doses as for younger patients. The initial dose of ACCUPRO is 10 mg once daily and may be increased until effective blood pressure control is achieved.

Use in patients with kidney problems

The recommended initial dose in patients with a creatinine clearance below 60 ml/min and above 30 ml/min is 5 mg, in patients with a creatinine clearance below 30 ml/min it is 2.5 mg. If the initial dose is well tolerated, ACCUPRO may be given from the next day in a twice-daily regimen. If there are no symptoms of blood pressure lowering or significant kidney function impairment, the dose can be increased at weekly intervals, according to the patient's response to treatment.
In patients with kidney problems, the following dosing of ACCUPRO is proposed:

* Currently, there is a lack of sufficient data to determine specific instructions for the use of ACCUPRO in hemodialysis patients with severe kidney problems.

Use in patients with liver problems

In patients with liver problems or progressive liver disease, ACCUPRO should be used with caution, especially in combination with diuretics.

Method and route of administration

The medicine should be taken orally. The patient should try to take the medicine at the same time(s) every day, regardless of meals.

Overdose of ACCUPRO

In case of overdose of ACCUPRO and symptoms of significant blood pressure lowering (dizziness, fainting), the patient should immediately see a doctor. Depending on the symptoms, the doctor will provide appropriate treatment.

Missed dose of ACCUPRO

The patient should take the missed dose as soon as possible, except when the next dose is approaching. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with ACCUPRO

The patient should not stop treatment without consulting their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ACCUPRO can cause side effects, although not everybody gets them.
The most common side effects include: headache, dizziness, cough, fatigue, runny nose, nausea, vomiting, and muscle pain.
Common(may occur in up to 1 in 10 people)

• pharyngitis, runny nose
• increased potassium levels in the blood
• decreased sodium levels in the blood
• insomnia
• dizziness, headache, paresthesia
• hypotension
• cough, shortness of breath
• nausea, vomiting, diarrhea, indigestion, abdominal pain
• back pain, muscle pain
• chest pain, fatigue, asthenia
• increased creatinine levels in the blood, increased urea levels in the blood

Uncommon(may occur in up to 1 in 100 people)

• bronchitis, upper respiratory tract infection, urinary tract infection, sinusitis
• nervousness, depression, disorientation
• sleepiness, transient ischemic attack (TIA)
• visual impairment in one eye
• tinnitus, vertigo of labyrinthine origin
• palpitations, angina pectoris, tachycardia, myocardial infarction
• vasodilation
• dry throat
• dry mouth or throat, bloating
• pruritus, rash, increased sweating, angioedema
• kidney problems, proteinuria
• impotence
• fever, generalized edema, peripheral edema

Rare(may occur in up to 1 in 1,000 people)

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

Very rare(may occur in up to 1 in 10,000 people)

• visual disturbances
• intestinal obstruction, intestinal angioedema
• psoriasis-like rash

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

• decreased neutrophil count, decreased granulocyte count, hemolytic anemia, thrombocytopenia
• anaphylactic reactions
• dark urine, nausea, vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called inappropriate antidiuretic hormone secretion
• intracranial hemorrhage
• orthostatic hypotension
• bronchospasm
• pancreatitis
• jaundice, hepatitis
• Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia, necrotizing vasculitis, increased sensitivity to light, skin changes, exacerbation of psoriasis symptoms (a skin condition characterized by red patches covered with silver scales)
• decreased hemoglobin, decreased hematocrit and white blood cell count, increased liver enzyme activity and bilirubin levels, single cases of hemolytic anemia in patients with congenital G-6-PDH deficiency

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ACCUPRO

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 patient should ask their pharmacist 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 ACCUPRO contains

• The active substance of ACCUPRO is quinapril in the form of quinapril hydrochloride. 1 coated tablet of ACCUPRO 5 contains 5.416 mg of quinapril hydrochloride (equivalent to 5 mg of quinapril), 1 coated tablet of ACCUPRO 10 contains 10.832 mg of quinapril hydrochloride (equivalent to 10 mg of quinapril), 1 coated tablet of ACCUPRO 20 contains 21.664 mg of quinapril hydrochloride (equivalent to 20 mg of quinapril), 1 coated tablet of ACCUPRO 40 contains 43.328 mg of quinapril hydrochloride (equivalent to 40 mg of quinapril)
• Other ingredients are: Excipients:magnesium carbonate, gelatin, crospovidone, lactose, magnesium stearate. Coating: titanium dioxide, hypromellose, hydroxypropylcellulose, macrogol 400, candelilla wax. The coating of ACCUPRO 40 also contains iron oxide red.

What ACCUPRO looks like and contents of the pack

Accupro 5 are white oval coated tablets marked with the symbol "5" on both sides of the tablet and have a score line that allows the tablet to be divided into two halves.
Accupro 10 are white triangular coated tablets marked with the symbol "10" on one side of the tablet and have a score line that allows the tablet to be divided into two halves.
Accupro 20 are white round coated tablets marked with the symbol "20" on one side of the tablet and have a score line that allows the tablet to be divided into two halves.
Accupro 40 are red oval coated tablets marked with the symbol "40" on one side of the tablet and "PD535" on the other side.
Accupro 5, Accupro 10, Accupro 20:
Blister packs of aluminum foil coated with PVC/PVDC-Polyamide/Al/PVC in a cardboard box containing: 30, 50 or 100 coated tablets
Accupro 40:
Blister packs of aluminum foil coated with PVC/PVDC-Polyamide/Al/PVC in a cardboard box containing: 28 or 56 coated tablets

Marketing authorization holder:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last revision of the leaflet: