ACCUPRO 20 mg Tablets

Warnings and precautions

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

• 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 such cases, the doctor may recommend a different blood pressure-lowering medicine or use a different dialysis membrane.
• in case of heart failure, with a risk of blood pressure lowering. In these patients, the doctor will closely monitor the dosage.
• in patients with liver problems, the use of diuretics may cause water-electrolyte imbalance, which can lead to hepatic coma.
• angiotensin II receptor antagonist (AIIRA), also known as 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".
• 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 swelling of the face, limbs, eyelids, lips, tongue, difficulty swallowing and breathing, abdominal pain (which may indicate angioedema), sore throat, or fever (which may be symptoms of infection with a reduced white blood cell count), as well as dizziness and fainting. If such symptoms occur, the patient should seek medical attention immediately;
• about planned surgery and/or anesthesia.

ACCUPRO and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Especially, 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), DPP-IV inhibitors (e.g. wildagliptin), or neutral endopeptidase inhibitors (NEP), as there is an increased risk of angioedema
• gold preparations (e.g. aurothioglucose),
• other blood pressure-lowering 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 it is 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 pregnancy or as soon as pregnancy is confirmed, and 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 inform 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. For 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 as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The doctor will recommend the appropriate dosage of ACCUPRO, depending on the disease 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 the treatment, the dose may be increased (by doubling) to a maintenance dose of 20 mg or 40 mg once daily, usually taken once or twice a day. 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.
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 a day. After taking ACCUPRO, the doctor will usually monitor the patient's circulatory system, especially blood pressure. If the initial dose is well tolerated, the doctor will recommend gradual dose increases until the desired effect is achieved.

Use in children

ACCUPRO should not be given to children.

Use in elderly patients

Age does not seem 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 creatinine clearance below 60 ml/min and above 30 ml/min is 5 mg, and in patients with 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 problems, 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 recommended:

* Currently, there is a lack of sufficient data to determine specific guidelines 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 an overdose of ACCUPRO and symptoms of significant blood pressure lowering (dizziness, fainting), the patient should seek medical attention immediately. 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 near. 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.
If the patient has any further doubts about taking this medicine, they 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
• low 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
• drowsiness, 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 disturbances, 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)

• neutropenia, agranulocytosis, 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
• intracerebral hemorrhage
• orthostatic hypotension
• bronchospasm
• pancreatitis
• jaundice, hepatitis
• Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia, necrotizing vasculitis, photosensitivity, skin changes, exacerbation of psoriasis (a skin disease 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-PD deficiency

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal 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.
Reporting side effects will help gather more information 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, hydroxypropyl cellulose, 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:
Aluminum/PVC-PVDC-Polyamide/Al/PVC blisters in a cardboard box containing: 30, 50, or 100 coated tablets
Accupro 40:
Aluminum/PVC-PVDC-Polyamide/Al/PVC blisters 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.
phone: 22 335 61 00

Date of last revision of the leaflet: