Pulsaren 20

Package Leaflet: Information for the Patient

PULSAREN 20, 20 mg, Film-Coated Tablets

Quinapril

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

“Medicine absolutely contraindicated in pregnancy.”

Table of Contents of the Package Leaflet

• 1. What is Pulsaren and what is it used for
• 2. Important information before taking Pulsaren
• 3. How to take Pulsaren
• 4. Possible side effects
• 5. How to store Pulsaren
• 6. Contents of the pack and other information

1. What is Pulsaren and what is it used for

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

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

2. Important information before taking Pulsaren

When not to take Pulsaren:

• if you are allergic to quinapril or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had angioedema (a condition that causes swelling of the face, lips, tongue, or throat) during treatment with other ACE inhibitors;
• if you or a member of your family have ever had hereditary or idiopathic angioedema;
• if you have aortic stenosis or hypertrophic cardiomyopathy;
• after the 3rd month of pregnancy (it is also recommended to avoid taking Pulsaren during early pregnancy - see section on pregnancy);
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

When taking Pulsaren, you should be particularly careful:

• if you experience symptoms such as wheezing, shortness of breath, swelling of the face, lips, tongue, or larynx - you should stop taking Pulsaren and contact your doctor immediately;
• if you experience symptoms such as abdominal pain (with or without nausea or vomiting), which may be related to angioedema of the intestine - you should inform your doctor (symptoms resolve after discontinuation of the medicine);
• before undergoing desensitization procedures and low-density lipoprotein apheresis (mechanical removal of cholesterol from blood vessels) - you should inform your doctor about taking Pulsaren, due to the increased risk of allergic reactions;
• before undergoing hemodialysis, you should inform your doctor about taking Pulsaren, due to the increased risk of allergic reactions. Your doctor will then choose another antihypertensive agent or use a different dialysis membrane;
• in patients who are dehydrated or have low sodium levels (e.g., due to diarrhea, vomiting, or renin-dependent hypertension), there is an increased risk of excessive blood pressure lowering;
• in patients with heart failure, with a risk of blood pressure lowering. In these patients, close monitoring of blood pressure is recommended;
• in patients with connective tissue disease affecting blood vessels and/or kidney problems, there is an increased risk of developing agranulocytosis or neutropenia (a decrease in the number of white blood cells);
• in patients with kidney problems, your doctor will usually recommend a lower dose of Pulsaren (see below);
• in patients with unilateral or bilateral renal artery stenosis. In these patients, your doctor will recommend regular monitoring of kidney function;
• in patients with impaired liver function, especially if they are also taking diuretics, as minor disturbances in water and electrolyte balance can lead to hepatic coma;
• in patients taking potassium-sparing diuretics;
• in patients with diabetes, due to the possibility of hypoglycemia (excessive lowering of blood glucose levels);
• in patients undergoing major surgery and/or anesthesia;
• if you are taking any of the following medicines for high blood pressure:
• angiotensin II receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Pulsaren".
You should inform your doctor:

• about pregnancy, suspected pregnancy, or planning pregnancy. It is not recommended to take Pulsaren during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see section on pregnancy);
• about the occurrence of symptoms such as: swelling of the face, limbs, eyelids, lips, tongue, difficulty swallowing and breathing, abdominal pain (which may indicate angioedema), throat pain or fever (as these may be symptoms of infection with a decrease in white blood cell count) and dizziness and fainting. If you experience such symptoms, you should immediately contact your doctor;
• about planned surgery and/or anesthesia.

Children

Pulsaren is not indicated for use in children.

Pulsaren and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Especially, inform your doctor about taking:

• tetracyclines (antibiotics);
• diuretics;
• potassium supplements, potassium-sparing diuretics, or potassium-containing medicines;
• anesthetics;
• lithium used to treat certain mental illnesses;
• anti-inflammatory medicines;
• gold preparations (e.g., gold sodium thiomalate);
• other antihypertensive agents;
• antidiabetic medicines;
• antacids used to treat heartburn or indigestion;
• barbiturates;
• opioids;
• cytostatic and immunosuppressive agents;
• systemic corticosteroids;
• procainamide.

Your doctor may need to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the heading "When not to take Pulsaren" and "Warnings and precautions").

Pulsaren with food and drink

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

Pregnancy and breastfeeding

Pregnancy
Tell your doctor about pregnancy, suspected pregnancy, or planning pregnancy.
Your doctor will usually recommend stopping Pulsaren before becoming pregnant or as soon as pregnancy is detected, and advise taking another medicine instead of Pulsaren.
Pulsaren is not recommended during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not recommended to breastfeed infants (first few weeks after birth), especially premature babies, while taking Pulsaren. For older infants, your doctor will inform you about the potential benefits and risks of taking Pulsaren during breastfeeding compared to other treatment options.

Driving and using machines

Your ability to drive or operate machines may be impaired, especially during the initial treatment period.

Pulsaren contains lactose monohydrate

One tablet contains 145.5 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Pulsaren

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Your doctor will recommend the appropriate dose of Pulsaren, depending on your condition and individual response to treatment.

Hypertension

Monotherapy:
The recommended initial dose of Pulsaren is 10 mg or 20 mg once daily in patients not taking diuretics. 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 daily or in two divided doses. Your doctor may recommend gradual dose increases every four weeks.
Most patients have a satisfactory response to Pulsaren at a dose of 10-40 mg daily given as a single dose or in two divided doses. In some patients, a dose of 80 mg daily has been used.

Chronic heart failure

Pulsaren 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 the first dose of Pulsaren, your doctor will usually monitor blood pressure and signs of congestion, especially in the first few hours. If the initial dose is well tolerated, your doctor will usually recommend gradual dose increases to achieve the desired clinical effect, usually 10 mg to 20 mg twice daily, in combination with the previously used diuretics.

Use of Pulsaren in children

Pulsaren should not be given to children.

Use of Pulsaren in the elderly

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

Use of Pulsaren in patients with renal impairment

The recommended initial dose in patients with a creatinine clearance below 60 ml/min and above 30 ml/min is 5 mg, and in patients with a creatinine clearance below 30 ml/min is 2.5 mg.
If the initial dose is well tolerated, Pulsaren can 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 renal impairment, the following dosing of Pulsaren is recommended:

*

Use of Pulsaren in patients with hepatic impairment

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

Method and route of administration

The medicine should be taken orally. Try to take the medicine at the same time(s) every day, regardless of meals.
Swallow the tablet with water.
The tablet can be divided into two equal doses.

Overdose of Pulsaren

If you have taken more Pulsaren than recommended and experience symptoms indicating significant blood pressure lowering (dizziness, fainting), you should contact your doctor immediately. Your doctor will recommend appropriate symptomatic treatment if necessary.

Missed dose of Pulsaren

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose or take two doses in a short period to make up for the missed dose.

Stopping treatment with Pulsaren

Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pulsaren can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• increased potassium levels in the blood
• insomnia
• dizziness, headache, paresthesia
• hypotension
• cough, pharyngitis, dyspnea, rhinitis
• nausea, vomiting, diarrhea, dyspepsia, abdominal pain
• back pain, muscle pain
• chest pain, fatigue, asthenia
• increased creatinine levels in the blood, increased urea levels in the blood.
• decreased sodium levels in the blood

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

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

Rare side effects (may affect up to 1 in 1,000 people):

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

Very rare side effects (may affect up to 1 in 10,000 people):

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

Additionally, the following side effects have been reported with an unknown frequency (frequency cannot be estimated from the available data):

• neutropenia, agranulocytosis, hemolytic anemia, thrombocytopenia
• anaphylactic reactions
• syncope, cerebral hemorrhage
• orthostatic hypotension
• bronchospasm
• pancreatitis
• jaundice, hepatitis
• Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia, skin necrosis, photosensitivity (skin changes may be accompanied by fever, muscle and joint pain (arthritis), vasculitis, and some changes in laboratory test results (eosinophilia, leukocytosis, and/or increased antinuclear antibody titer, increased ESR))
• decreased hemoglobin, decreased hematocrit, decreased white blood cell count, increased liver enzyme activity, and increased bilirubin; isolated cases of hemolytic anemia in patients with a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD)
• dark urine, nausea, vomiting, muscle cramps, and convulsions; these may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion)
• exacerbation or onset of psoriasis (a skin disease characterized by red patches covered with silvery scales).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pulsaren

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should 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 Pulsaren contains

• The active substance is quinapril (as quinapril hydrochloride). One film-coated tablet of Pulsaren 20 contains 20 mg of quinapril (as quinapril hydrochloride).
• The other ingredients are: lactose monohydrate, magnesium carbonate, crospovidone type A, hypromellose, hydroxypropyl cellulose, magnesium stearate; tablet coating: hypromellose, hydroxypropyl cellulose, talc, titanium dioxide (E 171), macrogol 6000.

What Pulsaren looks like and contents of the pack

Pulsaren 20: white, oval, biconvex film-coated tablets with a score line on one side, without stains and cracks.
The tablet can be divided into two equal doses.
Pulsaren film-coated tablets are packaged in aluminum/aluminum blisters, together with the patient information leaflet, in a cardboard box.
Package size:
30 film-coated tablets (3 blisters of 10 tablets each)

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500

Date of last revision of the package leaflet: