Captopril Ielfa

Leaflet attached to the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist or nurse.
• This medicine has been prescribed to you specifically. 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 or nurse. 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 packaging 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 (stimulating heart function) 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): 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 the patient is allergic to captopril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a history of angioedema (swelling of any part of the body, which in the case of the throat or larynx can cause difficulty breathing or swallowing) after taking an ACE inhibitor;
• if the patient has 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 "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is 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, you should discuss it with your doctor. You should be careful if:

• the patient has risk factors for hypotension, such as water and electrolyte disorders (dehydration or overhydration), severe renin-dependent hypertension, or symptomatic heart failure;
• the patient has kidney problems, bilateral renal artery stenosis, or stenosis of the artery of a single functioning kidney;
• the patient is undergoing dialysis;
• the patient is undergoing desensitization treatment, e.g. to reduce the allergic reaction to insect stings;
• the patient is undergoing treatment with low-density lipoprotein apheresis (removal of cholesterol from the blood);
• the patient has aortic or mitral stenosis (heart valve narrowing) or hypertrophic cardiomyopathy (heart muscle disease);
• the patient has liver problems;
• the patient has collagen vascular disease or is being treated with immunosuppressive drugs, e.g. azathioprine;
• the patient has gout and is being treated with allopurinol;
• the patient has arrhythmias and is being treated with procainamide;
• surgery is planned and/or anesthesia is to be administered using hypotensive agents;
• the patient has diabetes;
• the patient is pregnant, suspects she is pregnant, or plans to become pregnant - she should inform her doctor. It is not recommended to take Captopril Jelfa in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding");
• the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin II receptor antagonist (AIIRA) (also known as sartan - e.g. valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney problems,
• aliskiren.
• the patient is 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 organ rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

The 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, special caution should be exercised in patients of black race, 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The doctor may recommend changing the dose and/or taking other precautions:

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

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

• medicines commonly used to prevent organ 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 organ 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 medicines and vasodilators, 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 test for acetone in the urine (may indicate inadequate treatment of diabetes).

Captopril Jelfa with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks she may be pregnant or plans to have a baby, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Captopril Jelfa before planned pregnancy or immediately after confirming pregnancy, and recommend taking another medicine instead of Captopril Jelfa. It is not recommended to take Captopril Jelfa in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should inform the doctor about breastfeeding or intending 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, the doctor will inform the patient 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 when drinking alcohol. If side effects such as dizziness or fatigue occur, the patient should contact their doctor.

Captopril Jelfa contains lactose

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

Captopril Jelfa contains sodium

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

3. How to take Captopril Jelfa

This medicine should always be taken as directed by the doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist. The doctor will determine the dose 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. The 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 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), the doctor will start treatment with a single dose of 6.25 mg or 12.5 mg. Then, the doctor will recommend taking this dose twice 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 twice or three times a day. The 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. The doctor will recommend gradually increasing the dose, 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), from the next day on, 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 re-evaluated before deciding on treatment after myocardial infarction. Treatment with the medicine should be started in a hospital 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 three times a day for 2 days, and then 25 mg three 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, 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 vasodilator medicines taken at the same time can be reduced to maintain a constant dose of captopril. If necessary, the dose can 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 the case of diabetic nephropathy is 75 to 100 mg in divided doses. If further reduction of blood pressure is required, other antihypertensive medicines can be added.
Renal impairment:
In patients with kidney problems, the 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 at the same time in patients with severe kidney impairment, the doctor may recommend using loop diuretics (e.g. furosemide) instead of thiazide diuretics.
Elderly patients:
The doctor will consider starting treatment with a lower initial dose (6.25 mg twice a day) in elderly patients with possible kidney impairment and disorders affecting other organs, as with other antihypertensive medicines. The 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 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 three 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 to make it easier to swallow. If you have any doubts about taking the medicine, you should consult a doctor.

Overdose of Captopril Jelfa

In the event of taking too much of the medicine, or if a child has taken any amount of the medicine, you should immediately go to the emergency room of the nearest hospital. You should take this leaflet and any remaining tablets with you to show the doctor.
Overdose symptoms: severe hypotension, shock, stupor, bradycardia, electrolyte disturbances, and kidney failure.
Captopril can be removed from the body by hemodialysis.

Missed dose of Captopril Jelfa

You should 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, you should consult a 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, you should stop taking the medicine and contact your doctor:

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

Frequent (in at least 1 patient in 100, but less than 1 in 10)

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

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

• tachycardia (rapid heart rate) or tachyarrhythmia (heart rhythm disorders);
• angina pectoris (chest pain);
• palpitations;
• hypotension;
• Raynaud's syndrome (episodic 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 patient in 10,000, 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 patient in 10,000)

• 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 titers (a type of immune system disorder);
• hyperkalemia (increased potassium levels);
• hypoglycemia (decreased blood sugar levels);
• confusion;
• depression;
• cerebrovascular incidents, including stroke, syncope, blurred vision;
• cardiac arrest;
• cardiogenic shock (acute circulatory failure due to heart disease);
• bronchospasm;
• 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;
• hives;
• 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 levels in the blood, increased creatinine and bilirubin levels in the blood, decreased hemoglobin levels, decreased hematocrit values, decreased white blood cell and platelet counts, positive antinuclear antibody titers, accelerated ESR).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist or nurse.
Side effects can be reported directly to the
Department of Monitoring of Adverse Reactions to Medicinal Products
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 gather more information on the safety of the medicine.

5. How to store Captopril Jelfa

The medicine should be stored out of 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 stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 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 what the pack contains

Captopril Jelfa, 12.5 mg – white or almost white, round, biconvex tablets with a dividing line on one side.
Captopril Jelfa, 25 mg – white or almost white, oval, biconvex tablets with a dividing line on one side and the marking "CTP 25" on the other side.
Captopril Jelfa, 50 mg – white or almost white, oval, biconvex tablets with a dividing line on one side and the marking "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

Przedsiębiorstwo Farmaceutyczne Jelfa SA
Wincentego Pola 21
58-500 Jelenia Góra

Date of last revision of the leaflet: 03/2025