Captopril Alter 50 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Captopril Alter 50 mg tablets EFG
Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Captopril Alter is and what it is used for
- What you need to know before taking Captopril Alter
- How to take Captopril Alter
- Possible side effects
- How to store Captopril Alter
- Contents of the pack and other 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 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 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 kidney failure and are being treated with a blood pressure-lowering 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 beneath 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, talk to 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 potassium levels in the blood (for example, trimethoprim and cotrimoxazole) used for bacterial infections; cyclosporine, an immunosuppressive 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 taking Captopril Alter
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if you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin, such as in the throat) increases:
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sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class (used to prevent rejection of transplanted organs)
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if you are taking any of the following medicines for high blood pressure (hypertension):
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an angiotensin II receptor antagonist (ARA) (also known as "sartans" – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
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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:
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Swelling of the arms, legs, face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema), or 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.
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Abdominal pain, with or without nausea or vomiting (possible symptoms of intestinal angioedema).
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Any signs of infection (such as sore throat or fever) that do not respond quickly to usual treatment.
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Low blood pressure (this may present as dizziness or fainting, especially when standing up).
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Severe or persistent vomiting or diarrhoea.
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Any heart, liver, kidney disease or diabetes.
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Are undergoing, or are about to undergo, desensitisation treatment for allergy to bee or wasp stings.
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Are undergoing haemodialysis or apheresis (blood separation procedures), as reactions may occur related to the type of membrane used.
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Any collagen vascular disease.
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Are on a low-salt diet.
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A persistent 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 scheduled for surgery or to 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 conditions occurred 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 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 discontinue treatment with one of the medicines.
It is important that you inform your doctor if you are taking any of the following medicines:
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medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”
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potassium supplements or salt substitutes containing potassium, diuretics (water tablets, especially potassium-sparing types), other medicines that may increase potassium in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole)
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medicines containing potassium
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medicines that lower blood pressure
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antidiabetic medicines
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anti-inflammatory medicines
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lithium (a medicine used in some types of depression)
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tricyclic antidepressants/antipsychotics
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sympathomimetics or agents affecting the sympathetic nervous system activity
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alpha-blockers
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allopurinol (a medicine used to treat gout attacks)
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procainamide (a medicine used for heart rhythm disorders)
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cytostatic or immunosuppressive agents
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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 are taking potassium supplements or following 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 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.
When administered during the second and third trimesters of pregnancy, angiotensin-converting enzyme (ACE) inhibitors (the class to which captopril belongs) may cause fetal harm and death.
If pregnancy is detected, this medicine should be discontinued 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 use machines, 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 given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Dosage should be individualized, so your doctor will determine the appropriate dose for you and make any necessary adjustments.
High blood pressure
The recommended initial dose for treating 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 also recommend concomitant use 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 daily. 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 treating 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 feel 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 appropriate 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 determine 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 dysfunction, doses lower than the recommended ones should be used.
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 dose, take it 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 one.
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 affecting 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 peeling, 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 Medicines: 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 it from moisture.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. 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 50 mg of captopril.
- The other components are: corn starch, monohydrate lactose, stearic acid.
Appearance of the product and contents of the pack
White, round, flat tablets with a score line on one side.
The tablets are presented in blisters, in packs of 30 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
Date of the most recent review 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/.