Captopril Alter 25 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Captopril Alter 25 mg Tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Leaflet Contents

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

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

Captopril Alter is a medicine that contains a substance called captopril, which belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors). Captopril causes relaxation of blood vessels and lowers blood pressure.

Captopril Alter is indicated for the treatment of:

• High blood pressure (hypertension).
• Chronic heart failure (when the heart does not pump blood effectively), in combination with diuretics and, when appropriate, with digitalis medications and beta-blockers.
• After a myocardial infarction (heart attack).
• Kidney problems in patients with type I diabetes.

2. What you need to know before taking Captopril Alter

Do not take Captopril Alter

• If you are allergic to captopril or to any of the other components 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 class as captopril.
• If you have idiopathic or hereditary angioedema.
• If you have diabetes or renal impairment 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).
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, including in the throat area) is high.
• If you are taking any of the following medicines, the risk of developing angioedema may increase:
• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

In particular, speak with your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (for example, trimethoprim and cotrimoxazole) used to treat bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots.

Warnings and precautions

Talk to your doctor or pharmacist before starting Captopril Alter

• if you are using any of the following medicines, the risk of angioedema (rapid swelling under the skin, such as in the throat) increases:

• sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs)

• 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 Alter”.

Take special care with Captopril Alter if you have:

• Swelling of the arms, legs, face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema), or have a history of angioedema. This may occur at any time during treatment. The risk of these symptoms with captopril treatment is higher in black patients.

• Abdominal pain, with or without nausea or vomiting (possible symptoms of intestinal angioedema).

• Any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment.

• Low blood pressure (this may present as dizziness or fainting, especially when standing up).

• Severe or persistent vomiting or diarrhoea.

• Any heart, liver, kidney disease or diabetes.

• You are undergoing, or are about to undergo, desensitisation procedures for allergy to bee or wasp stings.

• You are undergoing haemodialysis or apheresis (blood separation procedures), as reactions may occur related to the type of membrane used.

• Any collagen disease.

• You are on a low-salt diet.

• Cough.

Excessive sweating and dehydration should be avoided, as they may lead to a sudden drop in blood pressure.

Inform your doctor that you are taking captopril if you are due to have surgery or receive anaesthetics.

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 have occurred to you in the past.

Taking Captopril Alter with other medicines

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

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 Alter” and “Warnings and precautions”).

Certain medicines may interact with Captopril Alter. In such cases, it may be necessary to change the dose or temporarily stop treatment with one of the medicines.

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

• medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”

• potassium supplements or salt substitutes containing potassium, diuretics (water tablets, especially potassium-sparing diuretics), other medicines that may increase potassium in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole)

• medicines containing potassium

• 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 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 or immunosuppressive agents

• medicines for the treatment of acute myocardial infarction

Taking Captopril Alter with food and drinks

Captopril may be taken with or without food.

Inform your doctor if you take potassium supplements or follow a diet high in potassium.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Captopril Alter is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy.

ACE inhibitors (the class to which captopril belongs) administered during the second and third trimesters of pregnancy may cause fetal harm or death.

If pregnancy occurs, treatment with this medicine should be stopped as soon as possible.

The use of Captopril Alter during breastfeeding is not recommended.

Driving and using machines

Treatment for high blood pressure may reduce your ability to drive and operate machinery, 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 Alter contains lactose

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

3. How to take Captopril Alter

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

The dosage must be individualized, so your doctor will determine the appropriate dose for you and will make any adjustments considered necessary.

High blood pressure

The recommended initial dose for the treatment of high blood pressure 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 concomitant administration of other medicines that lower blood pressure.

Chronic heart failure

The recommended initial 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 an initial 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 I diabetes is 75–100 mg per day, administered in several divided doses.

The tablets should be swallowed with water and may be taken with or without food.

Remember to take your medicine.

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

Your doctor will determine how long you should take captopril. Do not stop treatment prematurely, as only your doctor knows what is best for you.

Use in children

The recommended initial dose is 0.30 mg/kg body weight. In children requiring special precautions, the starting 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 advise you on the number of daily doses.

Use in elderly patients

In elderly patients with impaired renal function and other organ impairments, doses lower than the recommended ones should be administered.

Patients with renal impairment

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

If you take more Captopril Alter than you should

If you have taken more Captopril Alter than you should, contact your doctor or pharmacist immediately.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.

If you forget to take Captopril Alter

If you forget to take your medicine, take the missed 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 a missed dose.

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 can 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, taste disturbances, dizziness, headache and tingling sensation, cough and breathing difficulty, nausea, vomiting, gastric irritation, abdominal pain, diarrhoea, 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 blisters accompanied by itching, Stevens-Johnson syndrome, photosensitivity, skin redness, skin desquamation, 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): disturbance of hormones regulating blood glucose leading to a marked decrease 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Captopril Alter

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

Store in the original container.

Do not store above 30°C.

Keep the container tightly closed to protect from moisture.

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 medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Captopril Alter

• The active substance is captopril. Each tablet contains 25 mg of captopril.
• The other components are: corn starch, monohydrate lactose and stearic acid.

Appearance of the product and contents of the pack

White, round, flat tablets with a cross-shaped score line.

The tablets are presented in blisters, in packs of 60 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

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