CAPTOPRIL 25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Captopril Polfarmex 12.5 mg, tablets
3. Captopril Polfarmex 25 mg, tablets
4. Captopril Polfarmex 50 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Captopril Polfarmex and what is it used for
6. Important information before taking Captopril Polfarmex
   1. When not to take Captopril Polfarmex:
   2. Warnings and precautions
   3. Before starting Captopril Polfarmex, discuss it with your doctor or pharmacist.
   4. Captopril Polfarmex and other medicines
   5. Clinical chemistry (medical analysis):
   6. Pregnancy and breastfeeding
   7. Driving and using machines:
   8. Captopril Polfarmex contains lactose and sodium
7. How to take Captopril Polfarmex
   1. Hypertension:
   2. Heart failure:
   3. Myocardial infarction:
   4. Diabetic nephropathy type I:
   5. Renal impairment:
   6. Elderly patients
   7. Use in children and adolescents
   8. Overdose of Captopril Polfarmex
   9. Missed dose of Captopril Polfarmex
8. Possible side effects
   1. Blood and lymphatic system disorders:
   2. Metabolism and nutrition disorders:
   3. Psychiatric disorders:
   4. Nervous system disorders:
   5. Eye disorders:
   6. Cardiac disorders:
   7. Vascular disorders:
   8. Respiratory, thoracic, and mediastinal disorders:
   9. Gastrointestinal disorders:
   10. Hepatobiliary disorders:
   11. Skin and subcutaneous tissue disorders:
   12. Musculoskeletal and connective tissue disorders:
   13. Renal and urinary disorders:
   14. Reproductive system and breast disorders:
   15. General disorders:
   16. Investigations:
   17. Reporting side effects
9. How to store Captopril Polfarmex
10. Contents of the pack and other information
    1. What Captopril Polfarmex contains
    2. What Captopril Polfarmex looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Captopril Polfarmex 12.5 mg, tablets

Captopril Polfarmex 25 mg, tablets

Captopril Polfarmex 50 mg, tablets

(Captoprilum)

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

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Captopril Polfarmex and what is it used for

DO NOT USE IN PREGNANT WOMEN
Captopril is an angiotensin-converting enzyme (ACE) inhibitor. It blocks the conversion of inactive angiotensin I to active angiotensin II. In patients with hypertension, blocking the synthesis of angiotensin II causes a decrease in blood pressure, and inhibiting tissue renin-angiotensin systems reduces left ventricular hypertrophy.
In heart failure, due to decreased peripheral resistance, captopril reduces the heart's workload and improves the patient's condition.
In diabetic nephropathy, it reduces proteinuria.
Captopril Polfarmex is indicated for use in:

• hypertension,
• chronic heart failure with impaired left ventricular function, in combination with diuretics and, if appropriate, digitalis glycosides and beta-adrenergic blockers,
• asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%) after myocardial infarction in patients with stable clinical condition,
• diabetic nephropathy.

2. Important information before taking Captopril Polfarmex

When not to take Captopril Polfarmex:

• if the patient is hypersensitive (allergic) to captopril or any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6),
• angioedema caused by ACE inhibitor treatment,
• hereditary or idiopathic angioedema,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren,
• second and third trimester of pregnancy,
• breastfeeding.

Warnings and precautions

Before starting Captopril Polfarmex, discuss it with your doctor or pharmacist.

• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic nephropathy.
• aliskiren,
• if the patient has low blood pressure,
• in patients with heart failure,
• in patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney,
• in case of impaired renal function (creatinine clearance ≤ 40 ml/min),
• if during the first week of treatment, angioedema of the extremities, face, lips, mucous membranes, tongue, glottis, or larynx occurred. Angioedema of the tongue, glottis, or larynx may be fatal,
• if a cough occurred,
• if jaundice developed or liver enzyme levels increased,
• in patients with renal failure,
• in patients with diabetes,
• in patients taking potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels,
• in patients taking lithium,
• if the patient has been desensitized with hymenoptera venom,
• in patients undergoing hemodialysis using high-flux membranes or low-density lipoprotein apheresis,
• in patients undergoing surgical procedures or anesthesia with agents that cause hypotension,
• in patients with congenital galactosemia, glucose-galactose malabsorption, or lactase deficiency,
• if the patient is black. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

Captopril Polfarmex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Your doctor may need to change the dose and/or take other precautions:

• if you are taking an angiotensin receptor antagonist (ARB) or aliskiren (see also "When not to take Captopril Polfarmex" and "Warnings and precautions"). Captopril Polfarmex should be used with caution if:
• you are taking potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium,
• you have been treated with high doses of diuretics (thiazides or loop diuretics),
• you are taking nitroglycerin and other nitrates or other vasodilators,
• you are taking lithium,
• you are being treated with tricyclic antidepressants/antipsychotics,
• you are taking allopurinol, procainamide, cytostatics, and immunosuppressants,
• non-steroidal anti-inflammatory drugs (NSAIDs) are taken concurrently,
• you are taking sympathomimetic agents,
• you are taking antidiabetic drugs.

Captopril can be used safely with:

• common antihypertensive drugs (e.g., beta-blockers and long-acting calcium channel blockers), aspirin (in cardiac doses), thrombolytics, beta-blockers, and/or nitrates in patients with myocardial infarction.

Clinical chemistry (medical analysis):

• Captopril may cause a false-positive test result for acetone in the urine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Captopril Polfarmex is not recommended during the first trimester of pregnancy. When pregnancy is planned or confirmed, an alternative treatment should be used as soon as possible.
The medicine should not be used during the second and third trimesters of pregnancy. Prolonged exposure to captopril during the second and third trimesters of pregnancy is toxic to the fetus (renal dysfunction, oligohydramnios, delayed bone ossification) and the newborn (renal failure, hypotension, hyperkalemia).
Captopril Polfarmex should not be used during breastfeeding.

Driving and using machines:

The ability to drive vehicles and operate machinery may be impaired, especially during the initial treatment period, after changing the dose, and after combining the medicine with alcohol. This depends on individual patient susceptibility.

Captopril Polfarmex contains lactose and sodium

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. Captopril Polfarmex 12.5 mg contains 0.01785 g of lactose (0.008925 g glucose and 0.008925 g galactose), Captopril Polfarmex 25 mg - 0.0357 g of lactose (0.01785 g glucose and 0.01785 g galactose), Captopril Polfarmex 50 mg - 0.0714 g of lactose (0.0357 g glucose and 0.0357 g galactose) per tablet.
This should be taken into account in patients with diabetes.
Captopril Polfarmex contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Captopril Polfarmex

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The recommended maximum daily dose is 150 mg per day.
The medicine can be taken before, during, and after meals.

Hypertension:

The recommended initial dose is 25-50 mg, given twice daily. The dose may be gradually increased, at intervals of at least two weeks, to a dose of 100-150 mg/day in two divided doses to achieve the target blood pressure. Captopril may be used as monotherapy or in combination with other antihypertensive drugs, such as thiazides.
A once-daily dose of captopril may be used in combination with antihypertensive agents such as thiazide diuretics.
In patients with high activity of the renin-angiotensin-aldosterone system (hypervolemia, renovascular hypertension, cardiac decompensation), it is recommended to start treatment with a dose of 6.25 mg or 12.5 mg given once daily. The start of treatment should be closely monitored. Subsequent doses are given twice daily. The dose may be gradually increased to 50 mg or 100 mg per day and given in one or two divided doses.

Heart failure:

Treatment of heart failure with captopril should be closely monitored by a doctor.
Dosing usually starts with 6.25 mg to 12.5 mg given two or three times daily.
Transition from a maintenance dose to a maximum dose of 150 mg per day in divided doses should be done based on the patient's clinical response. The dose should be increased gradually, at intervals of at least 2 weeks, as long as the patient tolerates it.

Myocardial infarction:

Short-term treatment:treatment with Captopril Polfarmex should start in the hospital as soon as possible, while the patient is stable.
The initial dose is 6.25 mg, followed by 12.5 mg after 2 hours and 25 mg after 12 hours.
Then, 100 mg of captopril should be given in two divided doses for 4 weeks, provided that no adverse hemodynamic reactions have occurred.
At the end of the 4-week treatment period, before deciding to start post-infarction treatment, the patient's condition should be assessed.
Long-term treatment:if captopril treatment was not started within 24 hours of a severe myocardial infarction, it is recommended to start treatment between 3 and 16 days after the event, provided that the necessary conditions are met (stable hemodynamics, complete diagnosis of residual ischemia). Treatment should start in the hospital under close medical supervision until a dose of 75 mg is reached. The initial dose must be small, especially if the patient has normal or low blood pressure during the initial treatment phase. Treatment should start with a dose of 6.25 mg to 12.5 mg given three times daily for 2 days, then 25 mg given three times daily, provided that no adverse hemodynamic changes have occurred. To achieve a cardioprotective effect during long-term treatment, a dose of 75 mg to 150 mg per day in two or three divided doses is recommended. In the case of symptomatic hypotension, as occurs in heart failure, the dose of diuretics and/or other vasodilating medications may be reduced in relation to the fixed dose of captopril.
Captopril may be used in combination with other medications used in heart failure, such as thrombolytics, beta-blockers, or aspirin.

Diabetic nephropathy type I:

The recommended dose is 75 mg to 100 mg in divided doses.
If additional blood pressure reduction is indicated, an antihypertensive agent may be used.

Renal impairment:

Given that captopril is primarily excreted by the kidneys, dosing should be reduced or dosing intervals increased in patients with impaired renal function. If concomitant diuretic therapy is necessary in patients with severe renal impairment, loop diuretics (e.g., furosemide) are preferred over thiazide diuretics.
In patients with renal impairment, the daily dose may be adjusted to avoid captopril accumulation.

Elderly patients

As with other antihypertensive agents, therapy should start with the lowest initial dose (6.25 mg twice daily) in elderly patients with possible impaired renal function and dysfunction of other organs.
The dose should be adjusted based on the patient's blood pressure and should be used as the lowest maintenance dose.

Use in children and adolescents

The efficacy and safety of captopril have not been fully evaluated. Use of this medicine in children and adolescents should be under close medical supervision. The initial dose should be 0.3 mg/kg body weight. For patients requiring special attention (children with impaired renal function, premature infants, newborns, and infants, as their renal function is different from that of older children and adults), the initial dose should be 0.15 mg/kg body weight. Captopril is usually given to children three times daily, but the dose and dosing intervals should be individualized based on the patient's condition.

Overdose of Captopril Polfarmex

Overdose symptoms: severe hypotension, shock, stupor, bradycardia, electrolyte disturbances, renal failure.
If an overdose occurs, absorption of the medicine should be prevented (e.g., by performing gastric lavage, administering adsorbents and sodium sulfate within 30 minutes of taking the medicine). Immediately after the overdose, the medicine should be rapidly eliminated.
In case of hypotension, the patient should be placed in a shock position and quickly given a saline infusion. Administration of angiotensin II should also be considered. In case of bradycardia or adverse vagal reactions, atropine should be given. A pacemaker may also be considered.
Captopril can be removed from the body by hemodialysis.

Missed dose of Captopril Polfarmex

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Captopril Polfarmex can cause side effects, although not everybody gets them.
Side effects reported after taking captopril and/or ACE inhibitors:

Blood and lymphatic system disorders:

Very rare: neutropenia/agranulocytosis, pancytopenia - especially in patients with impaired renal function, anemia (including aplastic anemia and hemolytic anemia), thrombocytopenia, lymphadenopathy, eosinophilia, autoimmune diseases, and/or positive ANA test result.

Metabolism and nutrition disorders:

Rare: anorexia.
Very rare: hyperkalemia (high potassium levels in the blood), hypoglycemia (low blood sugar levels).

Psychiatric disorders:

Common: sleep disturbances.
Very rare: disorientation, depression.

Nervous system disorders:

Common: taste disturbances, dizziness.
Rare: somnolence, headaches, and paresthesias.
Very rare: cerebrovascular incidents, such as stroke, syncope.

Eye disorders:

Very rare: blurred vision.

Cardiac disorders:

Uncommon: tachycardia or tachyarrhythmia, angina pectoris, palpitations.
Very rare: cardiac arrest, cardiogenic shock.

Vascular disorders:

Uncommon: hypotension, Raynaud's syndrome, flushing, pallor.

Respiratory, thoracic, and mediastinal disorders:

Common: dry, irritating (non-productive) cough, dyspnea.
Very rare: bronchospasm, nasal congestion, allergic alveolitis/pulmonary eosinophilia.

Gastrointestinal disorders:

Common: nausea, vomiting, gastrointestinal irritation, abdominal pain, diarrhea, constipation, dry mouth.
Rare: oral/pharyngeal ulceration.
Very rare: tongue inflammation, peptic ulcer, pancreatitis.

Hepatobiliary disorders:

Very rare: liver dysfunction and cholestasis (including jaundice), hepatitis (including necrosis), increased liver enzymes and bilirubin levels.

Skin and subcutaneous tissue disorders:

Common: itching with or without rash, rash, and alopecia.
Uncommon: angioedema.
Very rare: urticaria, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid (autoimmune skin disease with blisters and rashes), and exfoliative dermatitis.

Musculoskeletal and connective tissue disorders:

Very rare: muscle pain, joint pain.

Renal and urinary disorders:

Rare: renal function disorders, including renal failure, polyuria, oliguria, increased frequency of urination.
Very rare: nephrotic syndrome.

Reproductive system and breast disorders:

Very rare: impotence, gynecomastia (breast enlargement in men).

General disorders:

Uncommon: chest pain, fatigue, malaise.
Very rare: fever.

Investigations:

Very rare: proteinuria, eosinophilia, increased potassium levels in the blood, decreased sodium levels in the blood, increased BUN (blood urea nitrogen), increased creatinine and bilirubin levels in the blood, decreased hemoglobin, leukocytes, thrombocytes, decreased hematocrit, positive ANA test result, increased ESR.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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,
tel: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Captopril Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
Store in a temperature below 25°C.
Store in the original package.
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 Captopril Polfarmex contains

• The active substance is captopril. One tablet contains 12.5 mg, 25 mg, or 50 mg of captopril.
• The other ingredients are: microcrystalline cellulose (type 102), lactose monohydrate, sodium carmellose, magnesium stearate, anhydrous colloidal silica.

What Captopril Polfarmex looks like and contents of the pack

Captopril Polfarmex is a tablet.
12.5 mg tablets - 30 tablets in a pack.
25 mg or 50 mg tablets - 30, 40, 90 tablets in a pack.
OPA/Al/PVC//Al blisters in a carton box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]
Date of last revision of the leaflet:November 2021