Leaflet: information for the user

Dabonal 20 mg tablets

Enalapril Maleate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Dabonal is and for what it is used

2. What you need to know before starting to take Dabonal

3. How to take Dabonal

4. Possible side effects

5. Storage of Dabonal

6. Contents of the pack and additional information

Dabonal belongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors).

Dabonal is indicated for:

Do not take Dabonal:

• If you are allergic (hypersensitive) to enalapril or any of the components of Dabonal.

• If you have been previously treated with a medication from the same group of drugs as Dabonal (angiotensin-converting enzyme inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing.

• If you have been diagnosed with hereditary or unknown cause angioedema (the development of large hives on the surface of the skin, especially around the eyes and lips, which can also affect hands, feet, and throat, and can cause swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing).

• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

• If you are more than 3 months pregnant. (It is also recommended to avoid Dabonal at the beginning of pregnancy. See Pregnancy section).

Warning and precautions

Consult your doctor or pharmacist before starting to take Dabonal.

• If you have heart disease.
• If you have a disease that affects the blood vessels of the brain.
• If you have blood disorders such as low white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have liver problems.
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medications that increase urine elimination).
• If you have recently had excessive vomiting or diarrhea.
• If you are on a low-sodium diet, taking potassium supplements, medications that conserve potassium, or salt substitutes that contain potassium, or medications associated with elevated potassium levels in the blood (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus or any kidney problem (including kidney transplant), as these can lead to high potassium levels in the blood that can be severe.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing. You should be aware that black patients are more sensitive to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis or a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may feel dizzy or lightheaded, especially at the beginning of treatment and when standing up. In these cases, lying down may help).
• If you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking allopurinol or procainamide, or any combination of these.

• 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" - for example, valsartán, telmisartán, irbesartán), particularly 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 Dabonal”.

In all these cases, inform your doctor as you may need to adjust your dose or discontinue Dabonal or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetic medications or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with Dabonal.

Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking Dabonal, as there may be a sudden drop in blood pressure associated with anesthesia.

You should be aware that Dabonal reduces blood pressure in black patients less effectively than in patients who are not black.

Inform your doctor if you think you may be pregnant. Dabonal is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it can cause severe damage to your baby if used during this period (see Pregnancy section).

Taking Dabonal with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Certain medications may interact with Dabonal; your doctor may need to adjust your dose and/or take other precautions, or discontinue one of them.

It is especially important to inform your doctor if you are taking or have recently taken any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Dabonal” and “Be careful with Dabonal”.
• Other medications to reduce blood pressure, such as beta-blockers or diuretics.
• Medications with potassium (including salt substitutes).
• Medications for diabetes (including oral antibiotics and insulin).
• Lithium (a medication used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications to treat pain or certain inflammation, e.g., aspirin).
• Sympathomimetics.
• Certain medications for pain or arthritis, including gold treatment.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and can be used to help you relieve pain).

Taking Dabonal with food, drinks, and alcohol:

Foods do not affect the absorption of Dabonal.

Alcohol potentiates the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking beverages that contain alcohol while taking this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

Inform your doctor if you think you may be pregnant. Normally, your doctor will advise you to stop taking Dabonal before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Dabonal. Dabonal is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause severe damage to your baby if used during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding.

While taking Dabonal, it is not recommended to breastfeed newborns (first weeks after birth), and especially premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking Dabonal compared to other treatments while breastfeeding.

Driving and operating machinery:

Individual responses to medication can vary.

Since Dabonal can cause dizziness or fatigue, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Dabonal contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Dabonal. Do not discontinue treatment before.

Dabonal can be taken with meals or between them along with a glass of water.

Your doctor will decide on the appropriate dose of Dabonal for you, depending on your condition and if you are taking other medications.

Hypertension

For most patients, the recommended initial dose is usually 5 to 20 mg once a day. Some patients may need a lower initial dose.

The usual long-term dose is 20 mg once a day.

Heart Failure

The recommended initial dose is usually 2.5 mg once a day. The doctor will gradually increase the dose until the appropriate dose is reached for your case. The usual long-term dose is 20 mg per day in one or two doses.

Caution should be exercised at the beginning of treatment due to the possibility of dizziness or vertigo appearing.

Immediately inform your doctor if you experience these symptoms.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Dabonal than you should

If you take more Dabonal than you should, consult your doctor or pharmacist immediately.

In case of an overdose, the most likely symptom is a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562-0420.

If you forgot to take Dabonal:

You should continue taking Dabonal as prescribed. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Dabonal may have side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking Dabonal and talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that may cause difficulty swallowing or breathing
• swelling of your hands, feet, or ankles
• if you develop a red rash on your skin with swelling (hives).

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 above reactions, stop taking Dabonal and talk to your doctor immediately.

When you start taking this medication, 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 medication. If you are concerned, please talk to your doctor.

The reported side effects are detailed below according to frequency:

Very common(may affect more than 1 in 10 people)

• dizziness, weakness, or vomiting
• blurred vision
• cough.

Common(may affect up to 1 in 10 people)

• lightheadedness due to low blood pressure, changes in heart rhythm, rapid heartbeat, chest pain, or chest discomfort
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (weakness)
• eruption, allergic reactions with swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing
• high levels of potassium in the blood, high levels of creatinine in the blood (usually both are detected in an analysis).

Rare(may affect up to 1 in 100 people)

• rubefaction
• sudden drop in blood pressure
• rapid and irregular heartbeat (palpitations)
• heart attack (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• sensation of itching or numbness in your skin
• dizziness (sensation of spinning)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-related chest tightness
• slow movement of food through your intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastritis), dry mouth, ulcers
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of illness, elevated temperature (fever)
• impotence
• high levels of protein in your urine (determined in an analysis)
• low levels of sugar or sodium in the blood, high levels of urea in the blood (all determined in a blood analysis).

Rare(may affect up to 1 in 1,000 people)

• “Raynaud's phenomenon” in which your hands and feet may become very cold and white due to low blood flow
• changes in blood values such as a lower number of white blood cells or red blood cells, lower hemoglobin levels, lower platelet count in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or other substance accumulation in the lungs (as seen in X-rays)
• inflamed nose
• inflamed lungs causing difficulty breathing (pneumonia)
• inflamed cheeks, gums, tongue, lips, throat
• reduced urine production
• eruption in the shape of a target (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red, peeling skin, ulcers with vesicles, or open ulcers), dermatitis exfoliativa/erythroderma (severe skin eruption with peeling or shedding of the skin), pemphigus (small blisters filled with fluid on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in an analysis)
• enlargement of the breasts in men (gynecomastia).

Very rare(may affect up to 1 in 10,000 people)

• swelling in your intestine (intestinal angioedema)

Frequency unknown(the frequency cannot be estimated from the available data)

• excessive production of the antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion
• a set of symptoms that may include some or all of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

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 prospectus. You can also report them directly through the Spanish System for the 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 medication.

Keep out of sight and reach of children.

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.

This medicationdoes not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition ofDabonal

The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.

The other components are:Sodium hydrogen carbonate (E500), lactose monohydrate (lactose), cornstarch, magnesium stearate (E470b) and iron oxide red (E172).

Appearance of the product and content of the container

Dabonal 20 mgtablets,are presented in the form of tablets.The tablets are cylindrical, flat-faced, pink in color, with a notch on one face and the inscription “20”on the other.

DABONAL 20 mg tablets are presented in containers containing 28 tablets and aclinical container with 500 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 SANT JOAN DESPÍ (Barcelona)

Spain

Last review date of this leaflet: March 2021

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