Captopril Cinfa 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

captopril cinfa 50 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What captopril cinfa is and what it is used for
2. What you need to know before taking captopril cinfa
3. How to take captopril cinfa
4. Possible side effects
5. How to store captopril cinfa
6. Contents of the pack and other information

1. What captopril cinfa is and what it is used for

Captopril cinfa is a medicine that belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Captopril causes relaxation of the blood vessels and lowers blood pressure.

Captopril cinfa is indicated for:

• Treatment of high blood pressure (hypertension)
• Treatment of chronic heart failure (when the heart does not pump blood properly), in combination with diuretics and, when appropriate, with digitalis medications and beta-blockers
• After a myocardial infarction (heart attack)
• Treatment of kidney problems in patients with type I diabetes (type I diabetic nephropathy).

2. What you need to know before taking captopril cinfa

Do not take captopril cinfa

• If you are allergic to captopril or to any of the other ingredients of this medicine (listed in section 6).
• If you have a history of angioedema (swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing) associated with previous treatment with medicines of the same group as captopril.
• If you have idiopathic or hereditary angioedema.
• If you have diabetes or kidney failure and are being treated with an antihypertensive medicine containing aliskiren.
• If you are pregnant (especially if you are in the second or third trimester of pregnancy).

Warnings and precautions

Talk to your doctor or pharmacist before starting captopril cinfa.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take captopril cinfa”.

Take special care with captopril

• If you experience swelling of the arms, legs, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema), or if you have a history of angioedema. This may occur at any time during treatment. The risk of developing these symptoms with captopril treatment is higher in black patients.
• Abdominal pain, with or without nausea or vomiting (possible symptoms of intestinal angioedema).
• If you develop any signs of infection (such as sore throat or fever) that do not respond quickly to usual treatment.
• If you experience low blood pressure (this may present as dizziness or fainting, especially when standing up).
• If you have severe or persistent vomiting or diarrhea.
• If you have heart, liver, or kidney disease, or diabetes.
• If you are undergoing, or are about to undergo, desensitization procedures for allergy to bee or wasp stings.
• If you are undergoing hemodialysis or plasmapheresis (blood separation procedures), as reactions may occur related to the type of membrane used.
• If you have a collagen disease.
• If you are on a low-salt diet.
• If you develop a cough during treatment.
• Excessive sweating and dehydration should be avoided, as they may lead to a sudden drop in blood pressure.
• If you are scheduled for surgery or will receive anesthetics, inform your doctor that you are taking captopril.
• If you are of black race, as with other medicines used to lower blood pressure, this medicine may be less effective in black patients.

Consult your doctor, even if any of the above circumstances occurred only once.

Elderly patients

Captopril may be used in elderly patients; however, as with other antihypertensive agents, treatment should be initiated with lower doses (see section “How to take”).

Children and adolescents

The efficacy and safety of captopril have not been fully established. The use of captopril in children and adolescents should be initiated under close medical supervision.

Other medicines and captopril cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with captopril. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of them.

It is important that you inform your doctor if you are taking any of the following medicines:

• diuretics
• potassium-containing medicines
• medicines that lower blood pressure
• antidiabetic medicines
• anti-inflammatory medicines
• lithium (a medicine used in some types of depression)
• tricyclic antidepressants/antipsychotics
• sympathomimetics or agents affecting the sympathetic nervous system
• alpha-blockers
• allopurinol (a medicine used to treat gout attacks)
• procainamide (a medicine used for heart rhythm disorders)
• cytostatic or immunosuppressive agents
• medicines for the treatment of acute myocardial infarction.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take captopril cinfa” and “Warnings and precautions”).

Taking captopril cinfa with food and drink

Captopril may be taken with or without food.

Inform your doctor if you are taking potassium supplements or consuming a potassium-rich diet.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Captopril is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy. Inform your doctor immediately if you think you may be pregnant.

Angiotensin-converting enzyme (ACE) inhibitors (the group to which captopril belongs) may cause fetal harm and death if administered during the second and third trimesters of pregnancy. If pregnancy is detected, this medicine must be discontinued as soon as possible.

Breastfeeding

The use of captopril during breastfeeding is not recommended.

Driving and using machines

Treatment of high blood pressure may reduce your ability to drive and use machines, especially at the beginning of treatment, when the dose is changed, or when alcohol is consumed.

Do not drive or operate machinery if you notice that this medicine impairs your ability to perform these tasks.

captopril cinfa contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take captopril cinfa

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose for you and make any adjustments they consider necessary, as dosing must be individualized.

Adults

Treatment of high blood pressure

The recommended starting dose is 25–50 mg per day, administered in two daily doses. Your doctor may gradually increase the dose up to 100–150 mg per day. Your doctor may also recommend concomitant use of other medications that lower blood pressure.

Treatment of chronic heart failure

The recommended starting dose for chronic heart failure (to help the heart pump blood properly) is 6.25–12.5 mg two or three times a day. Your doctor may gradually increase the dose up to a maximum of 150 mg per day and will monitor you closely during the first weeks of treatment or when changing your dose.

Myocardial infarction

The usual dose after a myocardial infarction is a test dose of 6.25 mg. Your doctor may gradually increase the dose up to a maximum of 150 mg per day.

Kidney problems

The recommended starting dose for treating kidney problems in patients with type I diabetes is 75–100 mg per day, administered in several divided doses.

Use in children and adolescents:

The recommended starting dose is 0.30 mg/kg body weight. In children requiring special precautions, the starting dose should be 0.15 mg/kg body weight. Use of this medicine in children and adolescents should be initiated under close medical supervision. Your doctor will advise you on the number of daily doses.

Elderly patients:

In elderly patients with impaired renal function and other organic impairments, lower doses than those recommended should be administered.

Patients with renal impairment:

In patients with kidney problems, doses lower than those recommended should be administered.

If you think that the effect of captopril is too strong or too weak, inform your doctor or pharmacist.

Method of administration:

Swallow the tablets with water, regardless of food intake.

The tablets may be divided into equal doses.

Remember to take your medicine.

Your doctor will tell you how long to continue treatment with captopril. Do not stop treatment prematurely, as only your doctor knows what is best for you.

If you take more captopril cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

The most common symptoms of overdose include severe hypotension, shock, stupor, bradycardia (slowing of the heart rate), electrolyte disturbances, and renal failure.

If you forget to take captopril cinfa

If you forget to take your medicine, take the dose as soon as you remember on the same day. If you miss a dose one day, take your normal dose the next day. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been observed:

Frequent (may affect up to 1 in 10 people): anorexia (loss of appetite), sleep disorders, altered taste, dizziness, headache and tingling sensation, cough and breathing difficulty, nausea, vomiting, gastric irritation, abdominal pain, diarrhea, constipation, dry mouth, gastric ulcer, itching with or without skin rash (sometimes with fever, joint pain, and eosinophilia), skin rash, and hair loss.

Uncommon (may affect up to 1 in 100 people): tachycardia or tachyarrhythmia (increased heart rate), chest pain, palpitations, hypotension, Raynaud's syndrome (episodes of pallor followed by cyanosis and redness, occurring in the fingers), redness, pallor, swelling of the arms, legs, face, lips, tongue, and/or throat, chest pain, fatigue, malaise.

Rare (may affect up to 1 in 1,000 people): drowsiness, mouth lesions, intestinal angioedema, renal function disorders including renal failure, kidney failure, and disturbances in urine elimination.

Very rare (may affect up to 1 in 10,000 people): blood cell count abnormalities, lymph node disorders, autoimmune diseases, changes in blood test results regarding potassium and glucose levels, confusion, depression, stroke, blurred vision, cardiac arrest, cardiogenic shock, respiratory disturbances, tongue inflammation, pancreatitis, hepatic dysfunction and yellowing of the skin, hepatitis (liver inflammation) including necrosis, elevations in liver enzymes and bilirubin, appearance of itchy blisters, Stevens-Johnson syndrome, photosensitivity, skin redness, skin peeling, muscle pain, joint pain, nephrotic syndrome, impotence, excessive breast enlargement in men, fever, blood cell count abnormalities, and changes in blood test results.

Frequency not known (frequency cannot be estimated from available data): Alteration of hormones regulating blood glucose leading to a severe drop in blood sugar levels (insulin autoimmune syndrome).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of captopril cinfa

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of captopril cinfa

• The active substance is captopril. Each tablet contains 50 mg of captopril.
• The other components are microcrystalline cellulose (E-460), lactose, corn starch, stearic acid and anhydrous colloidal silica.

Appearance of the product and contents of the pack

captopril cinfa 50 mg are white, cylindrical, biconvex tablets, scored on one side and marked "C50C" on the other.

The product is presented in blisters consisting of an aluminum layer and a PVC-PVDC layer. Each pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: March 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62305/P_62305.html

QR code to: https://cima.aemps.es/cima/dochtml/p/62305/P_62305.html