Package Leaflet: Information for the User

captopril cinfa 25 mg tablets EFG

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

• Keep this leaflet, as 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

captopril cinfa is a medication that belongs to the group of substances known as angiotensin-converting enzyme inhibitors (ACE inhibitors). Captopril causes relaxation of blood vessels and reduces blood pressure.

captopril cinfa is indicated for:

Do not take captopril cinfa

• If you are allergic to captopril or any of the other ingredients in 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 medications in the same group as captopril.
• If you have idiopathic or hereditary angioedema.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you are pregnant (especially in the second or third trimester of pregnancy).

Warnings and precautions

Consult your doctor or pharmacist before starting to take captopril cinfa.

• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - 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 (such as potassium) at regular intervals.

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

Be especially careful with captopril

• If you experience swelling of the arms, legs, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema) or have a history of angioedema. The risk of developing these symptoms after treatment with captopril is higher in black patients.
• Abdominal pain, with or without nausea or vomiting (potential symptoms of intestinal angioedema).
• When you experience any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment.
• If you experience low blood pressure (this may manifest as dizziness or fainting, especially when standing up).
• If you experience intense or persistent vomiting or diarrhea.
• If you have heart disease, liver disease, kidney disease, or diabetes.
• If you are undergoing or will be undergoing allergy desensitization treatment for bee or wasp stings.
• If you are undergoing hemodialysis or apheresis (blood separation procedures) as you may experience reactions to the type of membrane used.
• If you have any collagen disease.
• If you are following a low-sodium diet.
• If you experience coughing during treatment.
• Avoid excessive sweating and dehydration, which can cause a sudden drop in blood pressure.
• If you are undergoing surgery or receiving anesthesia, inform your doctor that you are taking captopril.
• If you are black, as this medication may be less effective in black patients, similar to other blood pressure medications.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Older patients

Captopril can be used in older patients, however, as with other anti-hypertensive agents, in these patients, treatment should be initiated with lower doses (see "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 medications and captopril cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications may interact with captopril. In these cases, you may need to adjust the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking any of the following medications:

- Diuretics

- Medications containing potassium

- Blood pressure medications

- Antidiabetic medications

- Anti-inflammatory medications

- Lithium (medication used for certain types of depression)

- Tricyclic antidepressants/antipsychotics

- Sympathomimetics or agents affecting the activity of the sympathetic nervous system

- Alpha-blockers

- Allopurinol (medication used to treat gout attacks)

- Procainamide (medication used to treat arrhythmias)

- Cytostatic or immunosuppressive agents

- Medications 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 drinks

Captopril can be taken with or without food.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

If administered during the second and third trimesters of pregnancy, angiotensin-converting enzyme inhibitors (the group to which captopril belongs) may cause fetal damage and death. If pregnancy is detected, administration of this medication should be discontinued as soon as possible.

Breastfeeding

Captopril is not recommended during breastfeeding.

Driving and operating machinery

During high blood pressure treatment, your ability to drive and operate machinery may be reduced, especially at the beginning of treatment, when the dose is changed, or when you consume alcohol.

Do not drive or operate machinery if you experience any impairment due to this medication.

captopril cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Adults

Hypertension treatment

The recommended initial 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 recommend the concurrent administration of other medications that lower blood pressure.

Chronic heart failure treatment

The initial recommended dose for chronic heart failure (to help the heart pump blood properly) is 6.25-12.5 mg two to three times a day. Your doctor may gradually increase the dose up to a maximum of 150 mg per day and will monitor you 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.

Renal problems

The initial recommended dose for the treatment of renal problems in patients with type 1 diabetes is 75-100 mg per day, administered in several daily doses.

Use in children and adolescents:

The initial recommended dose is 0.30 mg/kg of body weight. In children who require special precautions, the starting dose should be 0.15 mg/kg of body weight. The use of this medication in children and adolescents should be initiated under close medical supervision. Your doctor will indicate the number of daily doses.

Older adults:

In older adults with renal function impairment and other organic alterations, lower doses than recommended should be administered.

Patients with renal insufficiency:

In patients with renal impairment, lower doses than recommended should be administered.

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

Administration form:

Swallow the tablets with water, regardless of mealtime.

The tablets can be divided into equal doses.

Remember to take your medication.

Your doctor will indicate the duration of treatment with captopril. Do not discontinue 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The most frequent symptoms in case of overdose include severe hypotension, shock, stupor, bradycardia (slowing of heart rate), electrolyte imbalances, and renal failure.

If you forgot to take captopril cinfa

If you forgot to take the medication, take the dose as soon as you remember on the same day. If you miss a dose, take your normal dose the next day. Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been observed:

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

Infrequent (can affect up to 1 in 100 people): tachycardia or arrhythmia (increased heart rate), chest pain, palpitations, hypotension, Raynaud's syndrome (crises of pallor followed by cyanosis and erythema, which occurs in the fingers of the hand), redness, pallor, swelling of the arms, legs, face, lips, tongue, and/or throat, chest pain, fatigue, discomfort.

Rare (can affect up to 1 in 1,000 people): feeling of sleepiness, mouth lesions, intestinal angioedema, renal function disorders including renal failure, renal insufficiency, and alterations in urine elimination.

Very rare (can affect up to 1 in 10,000 people): alterations in blood cell count, lymph node diseases, autoimmune diseases, changes in blood test results related to potassium and glucose levels, confusion, depression, stroke, blurred vision, cardiac arrest, cardiogenic shock, respiratory disorders, inflammation of the tongue, pancreatitis, liver dysfunction, and yellow skin discoloration, hepatitis (inflammation of the liver) including necrosis, elevated liver enzymes and bilirubin, appearance of blisters accompanied by itching, Stevens-Johnson syndrome, light sensitivity, skin redness, skin peeling, muscle pain, joint pain, nephrotic syndrome, impotence, excessive breast volume in men, fever, alterations in blood cell count, and changes in blood test results.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Captopril cinfa composition

-The active ingredient is captopril. Each tablet contains 25 mg of captopril.

-The other components are microcrystalline cellulose (E-460), lactose, cornstarch, stearic acid, and anhydrous colloidal silica.

Product appearance and packaging contents

Captopril cinfa 25 mg are white, cylindrical, biconvex, bilayered tablets with the inscription C25C on one side.

They are presented in a blister pack consisting of an aluminum layer and a PVC-PVDC layer. Each package contains 60 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:June 2021

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/62304/P_62304.html

QR code to:https://cima.aemps.es/cima/dochtml/p/62304/P_62304.html