Captopril jelfa

Package leaflet: Information for the patient

Captopril Jelfa, 12.5 mg, tablets
Captopril Jelfa, 25 mg, tablets
Captopril Jelfa, 50 mg, tablets
Captoprilum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any side effects occur in the patient, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

The active substance in Captopril Jelfa is captopril. It inhibits the angiotensin-converting enzyme, which converts angiotensin I into angiotensin II, a substance with strong vasoconstrictive properties (so-called angiotensin-converting enzyme inhibitor, or ACE inhibitor).
The medicine is used in the treatment of:

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

2. Important information before using Captopril Jelfa

When not to use Captopril Jelfa

• if the patient is allergic to captopril, any other medicine in the ACE inhibitor class, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced angioedema (swelling of any body area, which, if affecting the throat or larynx, may cause difficulty in breathing or swallowing) after taking an ACE inhibitor;
• if the patient has ever been diagnosed with hereditary or idiopathic (of unknown cause) angioedema;
• after the third month of pregnancy (it is also advisable to avoid using Captopril Jelfa in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently using a combination medicine containing sacubitril and valsartan (used in the treatment of certain types of chronic (long-term) heart failure in adults), as this increases the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g. in the throat area).

Warnings and precautions
Before starting treatment with Captopril Jelfa, discuss this with your doctor. Exercise caution if:

• the patient has risk factors for hypotension, e.g. water and electrolyte imbalances (dehydration or fluid overload);
• the patient has severe renin-dependent hypertension or symptomatic heart failure;
• the patient has kidney function disorders, bilateral renal artery stenosis, or stenosis of the artery to the single functioning kidney;
• the patient is undergoing dialysis;
• the patient is undergoing or is planned to undergo desensitization therapy, e.g. to reduce allergic reactions after insect stings;
• the patient is undergoing or is planned to undergo treatment with LDL apheresis (removal of cholesterol from the blood);
• the patient has aortic or mitral valve stenosis (heart valve disorders) or hypertrophic cardiomyopathy (a heart muscle disease);
• the patient has liver function disorders;
• the patient has vasculitis (a connective tissue disease) or is being treated with immunosuppressive medicines, e.g. azathioprine;
• the patient has gout (a disease associated with excess uric acid) and is being treated with allopurinol;
• the patient has cardiac arrhythmia and is being treated with procainamide;
• the patient is scheduled for surgery and/or anaesthesia with medicines that may cause hypotension;
• the patient has diabetes;
• the patient is pregnant, suspects or plans pregnancy – inform the doctor. Use of Captopril Jelfa is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding");
• the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA) (also known as sartans - e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney disorders related to diabetes,
• aliskiren.
• the patient is taking any of the following medicines, as they may increase the risk of angioedema (rapid swelling of tissue, e.g. in the throat area):
• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Captopril Jelfa".
Additionally, exercise particular caution in black patients, due to a higher risk of angioedema and reduced effectiveness of the medicine in lowering blood pressure in these patients.

Captopril Jelfa and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
The doctor may recommend a dose adjustment and/or additional precautions:

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

In particular, inform the doctor if the patient is taking any of the following medicines:

• medicines commonly used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors) – see section "Warnings and precautions";
• potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, amiloride, triamterene), and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots);
• lithium (used to treat mania and depression);
• painkillers, antipyretics, and anti-inflammatory medicines – so-called non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, piroxicam, ibuprofen, acetylsalicylic acid in doses exceeding 3 g per day;
• antihypertensive medicines and vasodilators, such as nitrates;
• antidiabetic medicines;
• thrombolytic medicines (clot-dissolving and vessel-clearing agents), e.g. streptokinase;
• tricyclic antidepressants, antipsychotic medicines;
• vasoconstrictive medicines, so-called sympathomimetics, e.g. adrenaline;
• allopurinol (used to treat gout);
• procainamide (used to treat cardiac arrhythmias);
• cytostatic medicines (used in cancer treatment);
• immunosuppressive medicines.

Captopril may cause a false positive result in urine tests for acetone (which may indicate inadequate diabetes treatment).

Captopril Jelfa with food, drink and alcohol
The medicine may be taken before, during or after meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform the doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. The doctor will usually recommend discontinuing Captopril Jelfa before planned pregnancy or immediately after pregnancy is confirmed, and will advise taking an alternative medicine instead of Captopril Jelfa. Use of Captopril Jelfa is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding
Inform the doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Captopril Jelfa for newborns (first few weeks after birth), especially for premature infants. For older infants, the doctor will inform the patient about the benefits and risks of taking Captopril Jelfa during breastfeeding compared to other medicines.

Driving and using machines
Captopril Jelfa may have a negative effect on the ability to drive and operate machinery, particularly at the beginning of treatment, during dose adjustments, and when alcohol is consumed concurrently. If adverse effects such as dizziness or fatigue occur, contact your doctor.

Captopril Jelfa contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Captopril Jelfa

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist. Your 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, divided into two doses.
Your doctor may gradually increase the dose at intervals of at least two weeks, up to a dose of
100 mg – 150 mg per day, divided into two doses, to achieve the target blood pressure.
Captopril Jelfa may be used as monotherapy or in combination with other antihypertensive medicines,
particularly thiazide diuretics. In combination therapy with antihypertensive medicines such as thiazide
diuretics, once-daily dosing may be appropriate.
For patients with high activity of the renin-angiotensin-aldosterone system (reduced fluid volume in blood vessels,
renovascular hypertension, uncompensated heart failure), your doctor will initiate treatment with a single dose of 6.25 mg or
12.5 mg. Subsequently, your doctor will recommend a dose of 2 times daily. The dose may be gradually
increased up to 50 mg per day, in one or two divided doses, and if necessary up to 100 mg per day in one or two divided doses.

Heart failure:
The recommended initial dose is 6.25 mg to 12.5 mg two or three times daily. Your doctor will recommend
increasing the dose up 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 escalation at intervals of at least two weeks to assess the patient's response. Treatment of heart failure with
Captopril Jelfa must be conducted under strict medical supervision.

Myocardial infarction:

• Short-term treatment: The recommended initial test dose is 6.25 mg, followed by 12.5 mg after 2 hours, and 25 mg after 12 hours. If no adverse hemodynamic effects (circulatory disturbances) are observed in the patient, starting from the next day, 100 mg of Captopril Jelfa should be administered daily in
  two divided doses for a period of 4 weeks. At the end of the four-week treatment, the patient's condition should be
  reassessed before deciding on continued treatment in the post-infarction period. Treatment should be initiated in hospital
  as soon as possible after the onset of subjective (reported by the patient) and/or objective (observed by the physician) symptoms in hemodynamically stable patients.

• Long-term treatment: The recommended initial dose is 6.25 mg, followed by 12.5 mg three times daily for the next 2 days, then 25 mg three times daily, provided no adverse hemodynamic effects occur. The recommended dose to achieve effective cardioprotective action in chronic treatment is 75 mg to 150 mg per day, in two or three divided doses. If treatment has not been initiated within the first 24 hours after an acute myocardial infarction, it is recommended to start treatment between the third and sixteenth day after the infarction, provided the patient's hemodynamic status is stable. Treatment should be initiated in hospital under strict medical supervision (particularly regarding blood pressure monitoring) until the dose of 75 mg is reached. Initial doses should be low, especially in patients with normal or low blood pressure. In case of symptomatic hypotension, e.g., due to heart failure, the dose of diuretics and/or other concurrently administered vasodilating medicines may be reduced to maintain a stable captopril dose. If necessary, the dose should be adjusted according to the patient's clinical response. Captopril Jelfa may be administered in combination with other medicines used in the treatment of myocardial infarction, such as thrombolytics, β-blockers, and acetylsalicylic acid.

Diabetic nephropathy in type I diabetes:
The recommended daily dose in type I diabetic nephropathy is 75 to 100 mg in divided doses. If further reduction of blood pressure is required, other antihypertensive medicines may be added.

Renal impairment:
For patients with impaired kidney function, your doctor will recommend lower doses depending on
the degree of renal impairment (creatinine clearance) or extend the interval between doses. If concomitant diuretic therapy is necessary in patients with severe renal impairment, your doctor may recommend loop diuretics (e.g., furosemide) instead of thiazide diuretics.

Elderly patients:
Your doctor may consider initiating treatment with a lower initial dose (6.25 mg twice daily) in elderly
patients who may have reduced kidney function and other organ impairments, similar to other antihypertensive medicines.
Your doctor will adjust the dose according to achieved blood pressure values, recommending the lowest effective dose.

Use in children and adolescents
The efficacy and safety of Captopril Jelfa have not been fully established in children and adolescents. When initiating treatment in children and adolescents, your 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 impaired kidney function, preterm infants, newborns, and infants is 0.15 mg/kg body weight (kidney function in these patients differs from that in older children and adults). Captopril is usually administered to children three times daily, but the dose and dosing interval will be determined individually by your doctor depending on the patient's response.

The score line on the tablet is only intended to facilitate breaking the tablet for easier swallowing.
If you have any doubts about using this medicine, consult your doctor.

Taking more Captopril Jelfa than recommended
If a patient takes too much medicine or if any amount of the medicine is accidentally ingested by a child,
you should immediately go to the nearest hospital emergency department. You should bring this leaflet and any remaining tablets to show the doctor.
Symptoms of overdose: severe hypotension, shock, stupor, bradycardia,
electrolyte disturbances, and renal failure.
Captopril can be removed from the body by hemodialysis.

Missing a dose of Captopril Jelfa
Do not take a double dose to make up for a missed dose.

Stopping Captopril Jelfa
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the symptoms listed below occur, the medicine should be discontinued immediately and
you should contact your doctor:

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

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

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

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

• tachycardia (fast heartbeat) or tachyarrhythmia (heart rhythm disturbances);
• angina pectoris (chest pain);
• palpitations;
• hypotension;
• Raynaud's syndrome (episodic blanching of fingers or toes triggered by cold or emotional stress);
• sudden flushing;
• pallor, angioneurotic edema;
• fatigue;
• malaise.

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

• anorexia (loss of appetite and weight);
• somnolence;
• headache and paresthesia (pricking, tingling sensations);
• stomatitis/aphthous ulcers;
• renal function disorders, including renal failure, polyuria, oliguria, increased frequency of urination.

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

• neutropenia/agranulocytosis (reduced number or absence of certain types of white blood cells);
• pancytopenia (reduction in all blood cells) – particularly in patients with impaired renal function;
• anaemia (including aplastic and haemolytic anaemia);
• thrombocytopenia (reduced platelet count);
• lymphadenopathy (swollen lymph nodes);
• eosinophilia (increased number of certain types of white blood cells);
• autoimmune disorders and (or) positive antinuclear antibody titre (a type of immune system disorder);
• hyperkalaemia (increased potassium levels);
• hypoglycaemia (reduced serum glucose levels);
• confusion;
• depression;
• cerebrovascular events, including stroke, fainting, blurred vision;
• cardiac arrest;
• cardiogenic shock (acute circulatory failure caused by heart disease);
• bronchospasm;
• rhinitis;
• allergic alveolitis/eosinophilic pneumonia;
• glossitis (inflammation of the tongue);
• peptic ulcer;
• pancreatitis;
• hepatic dysfunction and cholestasis (including jaundice);
• hepatitis, including necrosis, increased liver enzyme activity and bilirubin levels;
• urticaria;
• erythema multiforme, Stevens-Johnson syndrome (diseases characterized by blister formation followed by painful erosions);
• photosensitivity;
• erythrodermia (redness and peeling of the skin);
• skin changes resembling pemphigus and exfoliative dermatitis;
• muscle pain, joint pain;
• nephrotic syndrome (a disease characterized by significant protein loss in urine);
• impotence;
• gynaecomastia (breast enlargement in males);
• fever;
• changes in laboratory test results (proteinuria, eosinophilia, increased serum potassium, decreased serum sodium, increased blood urea nitrogen, increased serum creatinine and bilirubin, decreased haemoglobin, decreased haematocrit, decreased white blood cell and platelet counts, positive antinuclear antibody titre, increased ESR).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the
Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Captopril Jelfa

Keep this medicine out of sight and reach of children.
Store below 25 °C.
Keep in the original packaging.
Do not use this medicine after the expiry date (month and year) stated on the cardboard
box after: {Expiry date (EXP)}. The expiry date refers to the last day of the stated month.
Medicines must 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
Each tablet contains as the active substance 12.5 mg, 25 mg or 50 mg of captopril.
The other ingredients are: microcrystalline cellulose, colloidal anhydrous 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 to facilitate splitting.

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

Available pack sizes:
12.5 mg: 30 tablets
25 mg: 30 or 40 tablets
50 mg: 20 or 30 tablets

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

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland