CAPTOPRIL ALTER 25 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Captopril Alter 25 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Captopril Alter and what is it used for
2. What you need to know before taking Captopril Alter
3. How to take Captopril Alter
4. Possible side effects
5. Storage of Captopril Alter
6. Package Contents and Additional Information

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

Captopril Alter is a medication that contains a substance called captopril, which belongs to the group of so-called angiotensin-converting enzyme inhibitors (ACE inhibitors). Captopril produces a relaxation of blood vessels and reduces blood pressure.

Captopril Alter is indicated for the treatment of:

• High blood pressure (hypertension).
• Chronic heart failure (when the heart does not pump blood properly), in combination with diuretics and, if appropriate, with digitalis and beta-blockers.
• After a heart attack (myocardial infarction).
• Kidney problems in patients with type 1 diabetes.

2. What you need to know before taking Captopril Alter

Do not take Captopril Alter

• If you are allergic to captopril or any of the other components of this medication (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 medication that contains 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 medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in the throat area) is high.
• If you are taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole) for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin blood to prevent clots.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Captopril Alter

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

• sirolimus, everolimus, and other medications that belong to the category of mTOR inhibitors (used to prevent organ transplant rejection)

• 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 "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 headings "Do not take Captopril Alter" and "Warnings and Precautions".

Be especially careful with Captopril Alter if you have:

• Swelling of the arms, legs, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema), or 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).
• Any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment.
• Low blood pressure (which can manifest as dizziness or fainting, especially when standing).
• Severe or persistent vomiting or diarrhea.
• Any heart, liver, kidney, or diabetes disease.
• You are undergoing, or will undergo, desensitization procedures for bee or wasp stings.
• You are undergoing hemodialysis or apheresis (blood separation procedures), as reactions to the type of membrane used may occur.
• Any collagen disease.
• You follow a low-salt diet.
• Cough.

Excessive sweating and dehydration that can lead to a sudden drop in blood pressure should be avoided.

Inform your doctor that you are taking captopril if you are going to undergo surgery or receive anesthetics.

As with other medications used to lower blood pressure, this medication 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 medications

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

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 medications may interact with Captopril Alter. In these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

• medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitor class medications). See section "Warnings and Precautions"
• potassium supplements or salt substitutes that contain potassium, diuretics (especially potassium-sparing ones), other medications that can increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole)
• medications that contain potassium
• medications that lower blood pressure
• antidiabetics
• anti-inflammatory medications
• lithium (a medication 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 medication used to treat gout attacks)
• procainamide (a medication used to treat heart rhythm disorders)
• cytostatic agents or immunodepressants
• medications for the treatment of acute myocardial infarction

Taking Captopril Alter with food and drinks

Captopril can be administered with or without food.

Inform your doctor if you take potassium supplements or follow a potassium-rich diet.

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 medication.

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

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 medication should be discontinued as soon as possible.

The use of Captopril Alter 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 beginning of treatment, when the dose is changed, or when you consume alcohol. Do not drive or use machinery if you observe that this medication causes you any disability to perform these functions.

Captopril Alter contains lactose

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

3. How to take Captopril Alter

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

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 the concurrent administration of other medications that lower blood pressure.

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.

Myocardial infarction

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.

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

Remember to take your medication.

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

Your doctor will indicate the duration of treatment with captopril. Do not stop treatment before then, as only your doctor knows what is best for you.

Use in children

The recommended initial dose is 0.30 mg/kg of body weight. In children who require special precautions, the initial 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.

Use in 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 take more Captopril Alter than you should

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

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 915 620 420.

If you forget to take Captopril Alter

If you forget to take the medication, 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects have been observed:

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

Very rare (may affect up to 1 in 10,000 people): changes in blood cell counts, lymph node disorders, autoimmune diseases, changes in blood tests related to potassium and glucose, confusion, depression, stroke, blurred vision, cardiac arrest, cardiogenic shock, respiratory disorders, tongue inflammation, pancreatitis, liver disorders, and yellowing of the skin.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Captopril Alter

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

Store in the original package.

Do not store above 30°C.

Keep the package tightly closed to protect it from moisture.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Captopril Alter Composition

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

Product Appearance and Package Contents

White, round, flat tablets with a cross-shaped notch.

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

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last revision of this package leaflet: March 2019

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