CAPTOPRIL CINFA 50 mg TABLETS

2. What you need to know before you take captopril cinfa

Do not take captopril cinfa

• If you are allergic to captopril or 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 drugs 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 a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant (especially if you are 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 medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g. valsartan, telmisartan, irbesartan), especially 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".

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 experiencing 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 present 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 can manifest as dizziness or fainting, especially when standing up).
• If you have severe or persistent vomiting or diarrhea.
• If you have any heart, liver, kidney, or diabetes disease.
• If you are undergoing desensitization procedures for bee or wasp stings.
• If you are undergoing hemodialysis or apheresis (blood separation procedures) as reactions to the type of membrane used may occur.
• If you have any collagen disease.
• If you are on a low-salt diet.
• If you develop a cough during treatment.
• Excessive sweating and dehydration that can lead to a sudden drop in blood pressure should be avoided.
• If you are going to undergo surgery or receive anesthetics, inform your doctor that you are taking captopril.
• If you are black, as this medicine may be less effective in black patients, as with other medicines used to lower blood pressure.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Elderly patients

Captopril can be used in elderly patients, however, as with other antihypertensive agents, in these patients, treatment should be started 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 medicines and captopril cinfa

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

Certain medicines may interact with captopril. In these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

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

Your doctor may need to modify 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 administered with or without food.

Tell your doctor if you take potassium supplements or have a diet rich in potassium.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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) can cause fetal harm and death. If pregnancy is detected, administration of this medicine should be discontinued as soon as possible.

Breastfeeding

The use of captopril is not recommended during breastfeeding.

Driving and using machines

During treatment for high blood pressure, your ability to drive and use machines may be reduced, especially at the start of treatment, when the dose is changed, or when alcohol is consumed.

Do not drive or use machinery if you observe that this medicine makes you unable to perform these functions.

captopril cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take captopril cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will establish the suitable dose for you and make the necessary adjustments, as the dosage must be individualized.

Adults

Treatment of high blood pressure

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 concomitant administration of other medicines that lower blood pressure.

Treatment of chronic heart failure

The recommended initial dose for chronic heart failure (helping 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 during the first weeks of treatment or when changing the dose.

Heart attack

The usual dose after a heart attack 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 initial dose for the treatment of kidney problems in patients with type 1 diabetes is 75-100 mg per day, administered in several daily doses.

Use in children and adolescents:

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

Elderly patients:

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

Patients with renal impairment:

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

If you think the action of captopril is too strong or too weak, tell your doctor or pharmacist.

Method of administration:

Swallow the tablets with water, independently of food intake.

The tablets can be divided into equal doses.

Remember to take your medicine.

Your doctor will indicate the duration of treatment with captopril. Do not stop treatment before, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

The most frequent symptoms in case of overdose include severe hypotension, shock, stupor, bradycardia (slow heart rate), electrolyte disturbances, and kidney failure.

If you forget to take captopril cinfa

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed:

Common (may affect up to 1 in 10 people): loss of appetite, sleep disorders, taste disturbance, dizziness, headache and tingling sensation, cough and breathing difficulties, nausea, vomiting, gastric irritation, abdominal pain, diarrhea, constipation, dry mouth, stomach 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 (crises of paleness followed by cyanosis and rubor, which occurs in the fingers of the hand), flushing, 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 kidney failure, and changes in urine elimination.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side 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 any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are microcrystalline cellulose (E-460), lactose, cornstarch, stearic acid, and anhydrous colloidal silica.

Appearance of the product and pack contents

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

They are presented in a blister pack 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 last revision of this leaflet:June 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). 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