Package Insert: Information for the Patient

Captopril Alter 25 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Captopril Alter is a medication that contains a substance called captopril, which 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 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 when appropriate with digitalis medications and beta-blockers.
• After a myocardial infarction (heart attack).
• Renal problems in patients with type I diabetes.

Do not take Captopril Alter

• If you are allergic to captopril or any of the other ingredients in 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 medications in the same group as captopril.
• If you have idiopathic or hereditary angioedema.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are pregnant (especially 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 chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area with the throat) 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 for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

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

• Supplements of potassium (including salt substitutes) and other medications that may increase the amount of potassium in the blood (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the 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 in the mTOR inhibitor class (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 "sartanes" - e.g., valsartán, telmisartán, irbesartán), especially if you have kidney problems related to diabetes.

-Aliskirén.

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

See also the information under the heading "Do not take Captopril Alter".

Be especially careful with Captopril Alter 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).
• Any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment.
• Low blood pressure (this may manifest as dizziness or fainting, especially when standing up).
• Intense or persistent vomiting or diarrhea.
• Any heart, liver, kidney, or diabetes disease.
• You are undergoing or will be undergoing allergy desensitization treatment for bee or wasp stings.
• You are undergoing hemodialysis or apheresis (blood separation procedures) as you may experience reactions to the type of membrane used.
• You have any collagen disease.
• You are following a low-sodium diet.
• You have a cough.

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

Inform your doctor that you are taking captopril if you are 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 at any time.

Taking Captopril Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 aliskirén (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, you may need to change your dose or discontinue treatment with one of them.

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

• Medications used more frequently to prevent organ transplant rejection (sirolimús, everolimus, and other medications in the mTOR inhibitor class). See the section "Warnings and precautions".
• Supplements of potassium or salt substitutes that contain potassium, diuretics (especially those that are potassium-sparing), other medications that may increase potassium levels in the body (e.g., heparin and cotrimoxazol, also known as trimetoprima/sulfametoxazol).
• Medications that contain potassium.
• Medications that lower blood pressure.
• Antidiabetic medications.
• Anti-inflammatory medications.
• Lithium (a medication used for certain types of depression).
• Tricyclic antidepressants/antipsychotics.

• Sympathomimetics or agents affecting the activity of the sympathetic nervous system.

• Alpha-blockers.
• Alopurinol (a medication used to treat gout attacks).
• Procainamide (a medication used to treat arrhythmias).
• Cytostatic or immunodepressive agents.
• Medications for the treatment of acute myocardial infarction.

Taking Captopril Alter with food and drinks

Captopril can be taken with or without food.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Captopril Alter is not recommended for use 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, ACE inhibitors (the group to which captopril belongs) may cause fetal damage and death.

If pregnancy is detected, the administration of this medication should be discontinued as soon as possible.

Captopril Alter is not recommended for use during breastfeeding.

Driving and operating machinery

During treatment for high blood pressure, your ability to drive and operate machinery may be reduced, especially at the beginning of treatment, when the dose is changed, or when alcohol is consumed. Do not drive or operate machinery if you experience any impairment of these functions.

Captopril Alter contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose 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.

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

Hypertension

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 (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 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 recommended initial dose for the treatment of renal 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 estimate that 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 prematurely, 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 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.

Use in elderly patients

In elderly patients 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 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 (slowing of heart rate), electrolyte imbalances, and renal failure.

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

If you forgot to take Captopril Alter

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 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 (may 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 ulcer, itching with or without skin rash (sometimes with fever, joint pain, and eosinophilia), skin rash, and hair loss.

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

Rare (may 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 (may 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 damage, 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 leaflet. You can also report them directly through the Spanish System of 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.

Store in the original packaging.

Do not store at a temperature above 30°C.

Keep the packaging perfectly closed to protect it from moisture.

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. Deposit the 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 the packaging and medications you no longer need. In this way, you will help protect the environment.

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

Appearance of the product and contents of the packaging

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

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

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: March 2019

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