Package Insert: Information for the User
Acetensil20 mg Tablets EFG
Enalapril Maleate
Read this package insert carefully before starting to take the medicine, as it contains important information for you.
Acetensilcontains an active ingredient called enalapril maleate, which belongs to a group of medications called angiotensin-converting enzyme (ACE) inhibitors.
Acetensilis indicated for:
This medication works by widening your blood vessels. This reduces your blood pressure. Normally, the medication starts to work within one hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before observing the greatest effect on their blood pressure.
Do not takeAcetensil
Do not take this medication if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Acetensil:
Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (e.g., potassium) at regular intervals.
See also the information under the heading “Do not take Acetensil”.
You should inform your doctor if you think you may be pregnant (or could be). This medication is not recommendedat the beginning of pregnancyand should not be taken if you are more than 3 months pregnant, as it may causeserious harm to your baby if used in this stage (see the Pregnancy section).
You should be aware that Acetensil reduces blood pressure in black patients less effectively than in patients who are not black.
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medication.
If you are about to undergo a procedure
If you are about to undergo any of the following procedures, inform your doctor that you are taking Acetensil:
If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.
Other medications and Acetensil
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes herbal remedies. This is because Acetensil may affect how other medications work. Other medications may also affect how Acetensil works. Your doctor may need to modify your dose and/or take other precautions.
You should especially inform your doctor or pharmacist if you are taking any of the following medications:
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take Acetensil.
Taking Acetensil with food and drinks
Acetensil can be taken with or without food. Most people take Acetensil with a little water.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant (or could be), or intend to become pregnant, consult your doctor before using this medication. Your doctor will usually advise you to stop taking Acetensil before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medication instead of Acetensil. This medication is not recommendedat the beginning of pregnancyand should not be taken if you are more than 3 months pregnant, as it may causeserious harm to your baby if used in this stage (see the Pregnancy section).
Breastfeeding
Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking this medication, it is not recommended to breastfeed in newborns (first weeks after birth), and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking Acetensil compared to other treatments while breastfeeding.
Driving and operating machinery
You may feel dizzy or drowsy while taking this medication. If this happens, do not drive or use tools or machinery.
Acetensil contains lactose
This medication contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
Acetensil contains sodium
This medication contains less than 1 mmolof sodium (23 mg) per tablet; this is, essentially “sodium-free”.
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Hypertension
Heart failure
Patients with kidney problems
Your medication dose will change depending on how well your kidneys are functioning:
Older patients
Your doctor will decide the dose and will base it on how well your kidneys are functioning.
Use in children
The experience with the use of enalapril in children with hypertension is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual initial doses are:
The dose may be adjusted as needed:
This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.
If you take moreAcetensilthan you should
If you take moreAcetensilthan you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: dizziness or vertigo. This is due to a sudden or excessive drop in blood pressure.
In case of overdose or accidental ingestion, you may also consult your pharmacist or the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication or the amount taken.
If you forgot to takeAcetensil
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, stop taking Acetensil and talk to your doctor immediately:
You should be aware that patients of black race have a higher risk of experiencing this type of reaction. If you experience any of the previous reactions, stop taking Acetensil and talk to your doctor immediately.
When you start taking this medicine, you may feel a loss of consciousness or feel dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue to take the medicine. If you are concerned, please talk to your doctor.
Other side effects include:
Very common(may affect more than 1 in 10 people)
Common(may affect up to 1 in 10 people)
Uncommon(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Very rare(may affect up to 1 in 10,000 people)
Frequency not known(the frequency cannot be estimated from the available data)
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 for the Vigilance 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.
Do not usethis medicationafter the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.
Composition ofAcetensil
Appearance of the product and content of the packaging
Acetensilis presented in the form of tablets. Each package contains 28 tablets.
Holder of the marketing authorization
Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 – Torrejón de Ardoz (Madrid)
Spain
Responsible for manufacturing
Laboratorios Medicamentos Internacionales, S.A.
C/ Solana, 26
28850 Torrejón de Ardoz (Madrid)
Spain
Last review date of this leaflet:11/2023.
The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.
The average price of Acetensil 20 mg comprimidos efg in June, 2025 is around 1.61 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.