CAPTOPRIL 25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
2. What is Captopril Jelfa and what is it used for
3. Important information before taking Captopril Jelfa
   1. When not to take Captopril Jelfa
   2. Warnings and precautions
   3. Captopril Jelfa and other medicines
   4. Captopril Jelfa with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Captopril Jelfa contains lactose
   8. Captopril Jelfa contains sodium
4. How to take Captopril Jelfa
   1. Use in children and adolescents
   2. Overdose of Captopril Jelfa
   3. Missed dose of Captopril Jelfa
   4. Stopping treatment with Captopril Jelfa
5. Possible side effects
   1. Reporting side effects
6. How to store Captopril Jelfa
7. Contents of the pack and other information
   1. What Captopril Jelfa contains
   2. What Captopril Jelfa looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet: 03/2025

Package Leaflet: Information for the Patient

Captopril Jelfa, 12.5 mg, tablets
Captopril Jelfa, 25 mg, tablets
Captopril Jelfa, 50 mg, tablets
Captopril

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

The active substance of Captopril Jelfa is captopril. It inhibits the enzyme that converts angiotensin I to angiotensin II, a substance with strong vasoconstrictive properties (so-called angiotensin-converting enzyme inhibitor, also known as ACE inhibitor).
The medicine is used to treat:

• hypertension;
• chronic heart failure with impaired contractile function of the ventricles, in combination with diuretics and, if appropriate, with digitalis glycosides (which stimulate the heart) and beta-adrenergic blockers (used to treat hypertension);
• myocardial infarction:
• - short-term treatment (4 weeks):the drug is recommended for all patients in a stable clinical condition, within 24 hours of myocardial infarction;
• - long-term prophylaxis of symptomatic heart failure:the drug is recommended for patients in a stable clinical condition, with asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%);
• diabetic nephropathy (kidney disease in diabetes): treatment of diabetic nephropathy with proteinuria in patients with type 1 diabetes.

2. Important information before taking Captopril Jelfa

When not to take Captopril Jelfa

• if you are allergic to captopril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had angioedema (swelling of any part of the body, which in the case of swelling of the throat or larynx can cause difficulty breathing or swallowing) after taking an ACE inhibitor;
• if you have ever had hereditary or idiopathic (of unknown cause) angioedema;
• after the third month of pregnancy (it is also recommended to avoid taking Captopril Jelfa in early pregnancy - see section "Pregnancy and breastfeeding");
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan (used to treat a certain type of chronic heart failure in adults), as the risk of angioedema (rapid swelling of the subcutaneous tissue, in areas such as the throat) increases.

Warnings and precautions

Before starting treatment with Captopril Jelfa, discuss it with your doctor. Be cautious if:

• you have risk factors for hypotension, such as water and electrolyte disorders (dehydration or overhydration), severe renin-dependent hypertension, or symptomatic heart failure;
• you have kidney problems, bilateral renal artery stenosis, or stenosis of the artery of a single functioning kidney;
• you are undergoing dialysis;
• you are undergoing desensitization treatment, e.g., to reduce the allergic reaction to insect stings;
• you are undergoing treatment with low-density lipoprotein apheresis (removal of cholesterol from the blood);
• you have aortic or mitral stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease of the heart muscle);
• you have liver problems;
• you have collagen vascular disease or are taking immunosuppressive drugs, such as azathioprine;
• you have gout and are taking allopurinol;
• you have arrhythmias and are taking procainamide;
• surgery is planned and (or) anesthesia with drugs that cause hypotension is to be administered;
• you have diabetes;
• you are pregnant, suspect you may be pregnant, or plan to become pregnant - you should inform your doctor. It is not recommended to take Captopril Jelfa in early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the fetus (see section "Pregnancy and breastfeeding");
• you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA) (also known as sartan - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney problems,
• aliskiren.
• you are taking any of the following medicines, as the risk of angioedema (sudden swelling of tissue, e.g., in the throat) increases:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the section "When not to take Captopril Jelfa".
In addition, be particularly cautious in black patients, due to the increased risk of angioedema and lower efficacy of the medicine in lowering blood pressure in these patients.

Captopril Jelfa and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Your doctor may recommend changing the dose and (or) taking other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "When not to take Captopril Jelfa" and "Warnings and precautions").

Especially, inform your doctor about taking any of the following medicines:

• medicines commonly used to prevent transplant rejection (sirolimus, everolimus, and other mTOR inhibitors) - see the section "Warnings and precautions";
• potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, amiloride, triamterene), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• lithium (used to treat mania and depression);
• medicines with analgesic, antipyretic, and anti-inflammatory effects - so-called non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac, piroxicam, ibuprofen, acetylsalicylic acid, in a dose greater than 3 g per day;
• antihypertensive and vasodilating medicines, such as nitrates;
• antidiabetic medicines;
• thrombolytic medicines (dissolving blood clots and opening blood vessels), e.g., streptokinase;
• tricyclic antidepressants, antipsychotic medicines;
• vasoconstrictor medicines, so-called sympathomimetics, e.g., adrenaline;
• allopurinol (used to treat gout);
• procainamide (used to treat arrhythmias);
• cytostatics (medicines used to treat cancer);
• immunosuppressive medicines.

Captopril may cause a false-positive result in the acetone test (may indicate inadequate diabetes treatment) in urine.

Captopril Jelfa with food, drink, and alcohol

The medicine can be taken before, during, or after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Captopril Jelfa before planned pregnancy or as soon as possible after confirming pregnancy, and will recommend taking another medicine instead of Captopril Jelfa. It is not recommended to take Captopril Jelfa in early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed. During treatment with Captopril Jelfa, it is not recommended to breastfeed a newborn (in the first few weeks after birth), especially a premature baby. In the case of an older infant, your doctor will inform you about the benefits and risks of taking Captopril Jelfa during breastfeeding, compared to using other medicines.

Driving and using machines

Captopril Jelfa may have a negative effect on the ability to drive and operate machinery, especially at the beginning of treatment or when changing the dose, and in the case of concurrent alcohol consumption. If you experience side effects such as dizziness or fatigue, contact your doctor.

Captopril Jelfa contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Captopril Jelfa contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Captopril Jelfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The dose of the medicine will be determined by your doctor, individually, depending on the diagnosis and the patient's response to treatment. The maximum daily dose is 150 mg per day.
Hypertension:
The recommended initial dose is 25 mg to 50 mg per day, in two divided doses. Your doctor may gradually increase the dose, at intervals of at least two weeks, to a dose of 100 mg - 150 mg per day in two divided doses, to achieve the target blood pressure. Captopril Jelfa can be used as a single medicine, or with other antihypertensive medicines, especially with thiazide diuretics. In the case of combination therapy with antihypertensive medicines, such as thiazide diuretics, it may be appropriate to take the medicine once a day.
In patients with high activity of the renin-angiotensin-aldosterone system (decreased fluid volume in blood vessels, renovascular hypertension, uncontrolled heart failure) your doctor will start treatment with a single dose of 6.25 mg or 12.5 mg. Then, your doctor will recommend taking this dose 2 times a day. The dose may be gradually increased to 50 mg per day, in one or two divided doses, and if necessary to 100 mg in one or two divided doses.
Heart failure:
The recommended initial dose is 6.25 mg to 12.5 mg two or three times a day. Your doctor will recommend increasing the dose to 75 mg - 150 mg per day, depending on the patient's response, clinical condition, and tolerance to the medicine. The maximum dose is 150 mg per day in divided doses. Your doctor will recommend gradual dose increases, at intervals of at least two weeks, to assess the patient's response. Treatment of heart failure with Captopril Jelfa is carried out under close medical supervision.
Myocardial infarction:

• - short-term treatment:The recommended initial test dose is 6.25 mg, after 2 hours 12.5 mg, and after 12 hours 25 mg. If the patient does not experience any undesirable hemodynamic effects (blood circulation disorders), starting from the next day, 100 mg of Captopril Jelfa should be taken per day in two divided doses for a period of 4 weeks. At the end of the 4-week treatment, the patient's condition should be reassessed before deciding on treatment after myocardial infarction. Treatment with the medicine should be started in a hospital setting as soon as possible after the onset of subjective (reported by the patient) and (or) objective (observed by the doctor) symptoms in hemodynamically stable patients.

- long-term treatment:The recommended initial dose is 6.25 mg, then 12.5 mg 3 times a day for 2 days, and then 25 mg 3 times a day, provided that no undesirable hemodynamic effects are observed. The recommended dose for effective cardioprotective action in chronic treatment is 75 mg to 150 mg per day in two or three divided doses. If treatment with the medicine was not started within the first 24 hours of acute myocardial infarction, it is recommended to start treatment between the third and sixteenth day after the infarction, provided that the patient's hemodynamic status is stable. Treatment should be started in a hospital setting, under close medical supervision (especially regarding blood pressure control), to achieve a dose of 75 mg. The initial dose must be small, especially in patients with normal or low blood pressure. In the case of symptomatic hypotension, e.g., due to heart failure, the dose of diuretics and (or) other vasodilating medicines taken concurrently can be reduced to maintain a constant dose of captopril. If necessary, the dose should be adjusted according to the patient's clinical response. Captopril Jelfa can be taken in combination with other medicines used to treat myocardial infarction, such as thrombolytic medicines, beta-blockers, and acetylsalicylic acid.

Diabetic nephropathy:
The recommended daily dose in diabetic nephropathy is 75 to 100 mg in divided doses. If further reduction in blood pressure is required, other antihypertensive medicines can be added.
Renal impairment:
In patients with kidney problems, your doctor will recommend lower doses of the medicine, depending on the degree of kidney impairment (creatinine clearance) or will prolong the interval between doses. If it is necessary to take diuretics concurrently in patients with severe kidney impairment, your doctor may recommend using loop diuretics (e.g., furosemide) instead of thiazide diuretics.
Elderly patients:
Your doctor will consider starting treatment with a lower initial dose (6.25 mg 2 times a day) in elderly patients with possible kidney impairment and other organ disorders, as with other antihypertensive medicines. Your doctor will adjust the dose according to the achieved blood pressure values, recommending the smallest effective dose.

Use in children and adolescents

The efficacy and safety of Captopril Jelfa in children and adolescents have not been fully evaluated. When starting treatment with the medicine in children and adolescents, the doctor will closely monitor the treatment process. The recommended initial dose in children and adolescents is 0.3 mg/kg body weight. The recommended initial dose in children with kidney problems, premature babies, newborns, and infants is 0.15 mg/kg body weight (kidney function is different in these patients than in older children and adults). Usually, captopril is given to children 3 times a day, but the dose and interval between doses will be determined by the doctor, individually, depending on the patient's response. The dividing line on the tablet is only to facilitate breaking it for easier swallowing. If you have any doubts about taking the medicine, ask your doctor.

Overdose of Captopril Jelfa

If you have taken too much of the medicine or if a child has taken any amount of the medicine, go to the emergency room of the nearest hospital immediately. Bring this leaflet and any remaining tablets to show the doctor.
Symptoms of overdose: severe hypotension, shock, stupor, bradycardia, electrolyte disturbances, and kidney failure.
Captopril can be removed from the body by hemodialysis.

Missed dose of Captopril Jelfa

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

Stopping treatment with Captopril Jelfa

If you have any further doubts about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking the medicine and contact your doctor:

• swelling of the face, tongue, and larynx;
• difficulty swallowing;
• skin reactions with blistering, ulcers, and urticaria;
• breathing difficulties;
• feeling of fainting.

Common (in at least 1 in 100 patients, but less than 1 in 10)

• sleep disturbances;
• taste disturbances;
• dizziness;
• dry, persistent cough and shortness of breath;
• nausea, vomiting;
• irritation of the gastric mucosa;
• abdominal pain, diarrhea, constipation;
• dryness of the mucous membranes of the mouth;
• itching with or without rash;
• rash and hair loss.

Uncommon (in at least 1 in 1000 patients, but less than 1 in 100)

• tachycardia (rapid heart rate) or tachyarrhythmia (heart rhythm disorders);
• angina pectoris (chest pain);
• palpitations;
• hypotension;
• Raynaud's syndrome (sudden pallor of the fingers of the hands or feet under the influence of cold or emotions);
• sudden flushing;
• pallor, angioedema;
• fatigue;
• malaise.

Rare (in at least 1 in 10,000 patients, but less than 1 in 1000)

• anorexia (loss of appetite and weight);
• drowsiness;
• headaches and paresthesia (tingling sensation);
• stomatitis/oral ulcers;
• kidney problems, including kidney failure, polyuria, oliguria, increased frequency of urination.

Very rare (in less than 1 in 10,000 patients)

• neutropenia/agranulocytosis (decreased number/absence of a certain type of white blood cell);
• pancytopenia (decreased number of all blood cells) - especially in patients with kidney problems;
• anemia (including aplastic and hemolytic anemia);
• thrombocytopenia (decreased platelet count);
• lymphadenopathy (enlargement of lymph nodes);
• eosinophilia (increased number of a certain type of white blood cell);
• autoimmune disorders and (or) positive antinuclear antibody titer (a type of immune system disorder);
• hyperkalemia (elevated potassium levels);
• hypoglycemia (low blood sugar levels);
• confusion;
• depression;
• cerebrovascular incidents, including stroke, syncope, blurred vision;
• cardiac arrest;
• cardiogenic shock (acute circulatory failure due to heart disease);
• bronchospasm;
• rhinitis;
• allergic alveolitis/pulmonary eosinophilia;
• glossitis (inflammation of the tongue);
• peptic ulcer;
• pancreatitis;
• liver problems and bile stasis (including jaundice);
• hepatitis, including necrosis, increased liver enzyme activity, and bilirubin levels;
• urticaria;
• erythema multiforme, Stevens-Johnson syndrome (diseases characterized by blistering and subsequent painful ulcers);
• photosensitivity;
• erythroderma (redness and peeling of the skin);
• skin changes similar to pemphigus and exfoliative dermatitis;
• muscle pain, joint pain;
• nephrotic syndrome (a disease characterized by significant protein loss in the urine);
• impotence;
• gynecomastia (breast enlargement in men);
• fever;
• changes in laboratory test results (proteinuria, eosinophilia, increased potassium levels in the blood, decreased sodium levels in the blood, increased urea nitrogen and creatinine levels in the blood, increased bilirubin levels in the blood, decreased hemoglobin levels, decreased hematocrit values, decreased white blood cell and platelet counts, positive antinuclear antibody titer, accelerated ESR).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the
Department of Drug Safety Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Captopril Jelfa

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging.
Do not use this medicine after the expiry date (month and year) stated on the carton after {Expiry Date (EXP)}. The expiry date refers to the last day of the month stated.
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 Jelfa contains

One tablet contains 12.5 mg, 25 mg, or 50 mg of captopril as the active substance.
The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, lactose monohydrate, stearic acid, sodium croscarmellose.

What Captopril Jelfa looks like and contents of the pack

Captopril Jelfa, 12.5 mg – white or almost white, round, biconvex tablets with a score line on one side.
Captopril Jelfa, 25 mg – white or almost white, oval, biconvex tablets with a score line on one side and marked "CTP 25" on the other side.
Captopril Jelfa, 50 mg – white or almost white, oval, biconvex tablets with a score line on one side and marked "CTP 50" on the other side.
Available packs:
12.5 mg: 30 tablets
25 mg: 30 or 40 tablets
50 mg: 20 or 30 tablets

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Jelfa Pharmaceutical Works SA
Wincentego Pola 21
58-500 Jelenia Góra

Date of last revision of the leaflet: 03/2025