DABONAL 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dabonal 20 mg Tablets

Enalapril Maleate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dabonal and what is it used for
2. What you need to know before you take Dabonal
3. How to take Dabonal
4. Possible side effects
5. Storing Dabonal
6. Contents of the pack and other information

1. What is Dabonal and what is it used for

Dabonal belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Dabonal is indicated for:

• Treating high blood pressure (hypertension)
• Treating symptomatic heart failure.
• Preventing symptomatic heart failure.

2. What you need to know before taking Dabonal

Do not take Dabonal:

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

• If you have been previously treated with a medicine from the same group of medicines as Dabonal (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing.

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

• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Dabonal

• If you have heart disease.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low or lack of white blood cells (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 (medicines that increase urine production).
• If you have recently had excessive vomiting or diarrhea.
• If you are on a low-salt diet, taking potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium.
• If you are over 70 years old.
• If you have diabetes mellitus or any kidney problems (including kidney transplant), as these may lead to high levels of potassium in the blood, which can be serious.
• 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 desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice this as fainting or dizziness, especially when standing up. In these cases, lying down may help).
• If you have a disease of the collagen vascular system (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking the medicines allopurinol or procainamide, or any combination of these.

• If you are taking any of the following medicines 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 heading “Do not take Dabonal”.

In all these cases, inform your doctor as you may need to have your dose adjusted or the medicine discontinued or your potassium level monitored. If you have diabetes and are taking oral antidiabetics 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), 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 lowers blood pressure in black patients less effectively than in non-black patients.

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Dabonal before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Dabonal. Dabonal is not recommended at the start of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Taking Dabonal with other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Certain medicines may interact with Dabonal; your doctor may need to change your dose and/or take other precautions or stop treatment with one of them.

It is especially important that you tell your doctor if you are taking or have recently taken any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Dabonal” and “Be careful with Dabonal”.
• Other medicines to lower blood pressure, such as beta-blockers or water pills (diuretics)
• Potassium-containing medicines (including dietary salt substitutes)
• Medicines for diabetes (including oral antibiotics and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to treat pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold treatment.
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain).

Taking Dabonal with food, drinks, and alcohol:

Food does not affect the absorption of Dabonal.

Alcohol enhances the blood pressure-lowering effect of enalapril, so inform your doctor if you are taking alcoholic beverages while being treated with this medicine.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Dabonal before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Dabonal. Dabonal is not recommended at the start of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

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

While taking Dabonal, breastfeeding is not recommended in newborns (first few 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 Dabonal, compared to other treatments, while breastfeeding.

Driving and using machines:

Individual responses to the medicine may 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 medicine.

Dabonal contains lactose and sodium

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

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

3. How to take Dabonal

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long to take Dabonal. Do not stop treatment before.

Dabonal can be taken with or without food, with a glass of water.

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

Hypertension

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

The usual long-term dose is 20 mg once daily.

Heart failure

The recommended initial dose is 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose is reached in your case. The usual long-term dose is 20 mg daily in one or two divided doses.

At the start of treatment, precautions should be taken due to the possibility of dizziness or lightheadedness.

Inform your doctor immediately if you experience these symptoms.

If you think the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.

If you take more Dabonal than you should

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

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

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

If you forget to take Dabonal

Continue taking Dabonal as prescribed. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dabonal can cause side effects, although not everybody gets 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 can cause difficulty swallowing or breathing
• Swelling of your hands, feet, or ankles
• If you develop a red rash on the skin with swelling (hives).

You should be aware that black patients 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 medicine, you may feel faint or dizzy. If this happens, lying down may help. This is due to a drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, talk to your doctor.

The following side effects have been reported:

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

• Feeling dizzy, weak, or sick
• Blurred vision
• Cough.

Common(may affect up to 1 in 10 people)

• Dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina, or chest pain
• Headache, depression, fainting (syncope), taste disturbance
• Difficulty breathing
• Diarrhea, abdominal pain
• Fatigue
• Rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing
• High levels of potassium in the blood, high levels of creatinine in the blood (both usually detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• Flushing
• Sudden drop in blood pressure
• Rapid or irregular heartbeat (palpitations)
• Heart attack (possibly due to very low blood pressure in certain high-risk patients, even those with changes in blood flow to the heart or brain)
• Stroke (possibly due to very low blood pressure in high-risk patients)
• Anemia (including aplastic anemia and hemolytic anemia)
• Confusion, drowsiness, or inability to sleep, nervousness
• Feeling of itching or numbness in your skin
• Dizziness (feeling of spinning)
• Ringing in the ears (tinnitus)
• Runny nose, sore throat, or hoarseness
• Asthma-associated chest tightness
• Slow movement of food through your intestine (ileus), pancreatitis
• Vomiting, indigestion, constipation, anorexia
• Irritated stomach (gastric irritation), dry mouth, ulcer
• Muscle cramps
• Reduced kidney function, kidney failure
• Increased sweating
• Itching or hives
• Hair loss
• Malaise (general feeling of being unwell), fever
• Impotence
• High levels of protein in your urine (determined in a test), low blood sugar or sodium levels, high levels of urea in the blood (all determined in a blood test).

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

• “Raynaud's phenomenon” where your hands and feet can become very cold and white due to low blood flow
• Changes in blood values such as low white or red blood cell count, low hemoglobin, low platelet count in the blood
• Depression of the bone marrow
• Inflamed glands in the neck, armpits, or groin
• Autoimmune diseases
• Sleep disturbances or sleep problems
• Fluid accumulation or other substances in the lungs (as seen on X-rays)
• Inflammation of the nose
• Inflammation of the lungs causing difficulty breathing (pneumonia)
• Inflammation of the cheeks, gums, tongue, lips, throat
• Reduced amount of urine produced
• Rash with a target-like shape (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder where you have red and scaly skin, blisters, or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small blisters filled with fluid on the skin)
• Liver or bile problems such as reduced liver function, liver inflammation, yellowing of the skin or eyes (jaundice), high levels of liver enzymes or bilirubin (determined in a test)
• 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 not known(frequency cannot be estimated from the available data)

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

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dabonal

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Content and Additional Information

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), corn starch, magnesium stearate (E470b), and red iron oxide (E172).

Appearance of the Product and Packaging Content

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

DABONAL 20 mg tablets are presented in packages containing 28 tablets and a clinical package with 500 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 SANT JOAN DESPÍ (Barcelona)

Spain

Date of the Last Revision of this Leaflet: March 2021

Detailed 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/