Package Insert: Information for the User

Dabonal Plus 20 mg/12.5 mg Tablets

Enalapril/Hydrochlorothiazide

Read this package insert carefully before you start taking the medicine, because 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 medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this package insert, inform your doctor or pharmacist. See section 4.

This medication contains two active ingredients, enalapril and hydrochlorothiazide, which belong to the group of antihypertensives and, through different mechanisms, reduce elevated blood pressure.

The enalapril component of Dabonal Plus is a medication that belongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which acts by dilating blood vessels to make it easier for the heart to pump blood to all parts of the body. The hydrochlorothiazide component of Dabonal Plus belongs to the group of medications known as thiazide diuretics (medications that increase urine elimination). Together, enalapril and hydrochlorothiazide help to decrease elevated blood pressure.

Your doctor has prescribed Dabonal Plus to treat hypertension (high blood pressure) because it is not adequately controlled with enalapril or an ACE inhibitor alone.

Do not take Dabonal Plus

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other components of Dabonal Plus.
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medications are.
• If you have previously been treated with a medication from the same group as Dabonal Plus (ACE inhibitors), and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing.
• If you have had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (a disease that causes inflammation in the face and respiratory tracts, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or renal insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant (It is also best to avoid Dabonal Plus at the beginning of pregnancy - see the section on Pregnancy).

If you are unsure whether you should start taking Dabonal Plus, consult your doctor.

Warning and precautions

Consult your doctor or pharmacist before starting to take Dabonal Plus.

• If you have had skin cancer or if an unexpected skin lesion appears during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Dabonal Plus.
• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Dabonal Plus.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Dabonal Plus, seek medical attention immediately.

Your doctor may need to adjust your dose of Dabonal Plus or monitor your potassium levels in the blood in the following situations:

• If you have heart disease with mitral or aortic valve stenosis or other factors that reduce left ventricular flow (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., intense vomiting, diarrhea, or if you are taking high doses of medications that increase urine elimination).
• If you have any blood abnormalities.
• If you have diabetes and are taking medications to treat diabetes, including insulin, as you may need to adjust the dose of diabetes medications. Diabetes can cause high potassium levels in the blood, which can be severe.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high potassium levels in the blood, which can be severe.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications (medications that increase urine elimination), or salt substitutes containing potassium.
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Note that black patients are more sensitive to this type of medication.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove LDL particles or bad cholesterol from the blood in cases where it is excessively elevated).
• If you are about to undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as the use of Dabonal Plus, especially in the first doses, can cause a sudden drop in blood pressure (you may feel dizzy or lightheaded, especially when standing up).
• 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, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

- aliskiren

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

See also the information under the heading “Do not take Dabonal Plus tablets”.

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

You should inform your doctor if you think you may be pregnant (or could be). Dabonal Plus 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 at this stage (see the section on Pregnancy).

Taking Dabonal Plus with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, or other health-related products, as you may need to interrupt treatment or adjust the dose of one or more of them.

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

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Dabonal Plus” and “Be careful with Dabonal Plus”).

• Antihypertensive medications (reduce elevated blood pressure), such as vasodilators, beta-blockers, diuretics.
• Medications with potassium (including salt substitutes).
• Medications used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medications used to treat intense pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications (e.g., metformin).
• Medications used to treat pain or certain inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, including selective COX-2 inhibitors.
• Sympathomimetic medications (medications used to treat certain heart and blood vessel disorders and some medications for colds).
• Amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ionic exchange resins (medications used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medications (medications used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medications (medications that decrease gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medications used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (medications used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medications (used to prevent rejection in organ transplants), such as cyclosporine.
• Antibiotics (medications used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

Taking Dabonal Plus with food, drinks, and alcohol

Dabonal Plus can be taken before or after meals.

Alcohol can increase the blood pressure-lowering effect of this medication.

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 medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking Dabonal Plus before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Dabonal Plus. Dabonal Plus is not recommended during 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 from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Dabonal Plus is not recommended for mothers who are breastfeeding.

The two active ingredients of Dabonal Plus, enalapril, and hydrochlorothiazide, pass into breast milk. If you are breastfeeding your baby or plan to do so, consult your doctor.

Use in children and adolescents

The safety and efficacy of Dabonal Plus have not been established in this age group, so it is not recommended for use in children.

Use in the elderly

In studies where enalapril and hydrochlorothiazide were taken together, the effect of the medications and tolerability were similar in young and elderly adult patients with high blood pressure.

Use in athletes

Inform athletes that this medication contains a component that can produce a positive result in doping control tests.

Driving and operating machinery

It is unlikely that Dabonal Plus will affect your ability to drive or operate machinery. However, you may occasionally experience dizziness or fatigue during treatment for high blood pressure, especially at the beginning. If you experience these effects, consult your doctor before engaging in these activities.

Dabonal Plus contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, 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”.

Interference with diagnostic tests

If you need to undergo any diagnostic tests to evaluate parathyroid gland function, inform your doctor that you are taking Dabonal Plus, as it may alter the results.

Follow exactly the administration instructions for Dabonal Plus as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will decide on the appropriate dose, depending on your condition and whether you are taking other medications.

The usual dose is one or two tablets administered once a day. Take Dabonal Plus every day, exactly as indicated by your doctor. It is very important to continue taking this medication for the recommended time by your doctor. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than what will occur after continued treatment. You may notice dizziness or fainting and lying down may help. If you are concerned, consult your doctor.

Use in patients with altered kidney function

If you have any kidney disease, your doctor will indicate the most suitable dose.

Administration form

This medication is administered orally.

Take the Dabonal Plus tablets with the help of a glass of water.

Dabonal Plus can be taken before or after meals.

If you take moreDabonal Plusthan you should

If you have taken more Dabonal Plus than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare staff.

The most likely symptoms would be a sensation of dizziness or vertigo due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine production and/or tachycardia.

If you forgot to take Dabonal Plus

You should take Dabonal Plus as indicated by your doctor.

Do not take a double dose to compensate for the missed doses. Limit yourself to taking the next dose in the usual manner.

If you interrupt the treatment with Dabonal Plus

Your doctor will indicate the duration of your treatment with Dabonal Plus. Do not stop treatment before, even if you feel better.

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

Like all medicines, Dabonal Plus can cause side effects, although not everyone will experience them.

The recorded side effects are listed below according to the following frequencies:

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 1000 people)

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

Unknown frequency: (cannot be estimated from available data)

Blood and lymphatic system disorders:

Uncommon: decrease in red blood cells (cells that carry oxygen)

Rare: reduction of a type of white blood cells (neutrophils), decrease in hemoglobin (protein in red blood cells that carries oxygen), decrease in platelets in blood, decrease in hematocrit (proportion of red blood cells in blood), decrease in white blood cells, depression of the bone marrow (decrease in the body's ability to form blood cells), inflammation of lymph nodes, immune system diseases.

Endocrine disorders:

Unknown: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

Common: elevated potassium levels in blood, increased cholesterol, increased triglycerides, increased uric acid in blood

Uncommon: low glucose and magnesium levels in blood, gout

Rare: increased glucose levels in blood

Very rare: elevated calcium levels in blood

Nervous system disorders:

Common: headache, dizziness, alteration of taste

Uncommon: confusion, drowsiness, insomnia, numbness, vertigo

Rare: paralysis (due to low potassium levels)

Mental and behavioural disorders:

Common: depression

Uncommon: nervousness, decreased libido*

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Unknown frequency:decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Ear and labyrinth disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness

Common: hypotension associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats)

Uncommon: flushing, palpitations (sensation of irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see sectionBe careful with Dabonal Plus)

Rare:changes in skin color of fingers, hands, feet, nose, or ears (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very common: cough

Common: difficulty breathing

Uncommon: mucus secretion, sore throat, and hoarseness, bronchospasm (difficulty breathing) and asthma

Rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of the alveolus due to allergy) /eosinophilic pneumonia (disease in which a type of white blood cells, called eosinophils, accumulate in the lungs).

Very rare:acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon: intestinal obstruction with severe pain, pancreatitis, vomiting, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence (gas)*

Rare: infection or inflammation of the mucous membrane of the mouth, inflammation of the tongue

Very rare: intestinal angioedema (inflammation of the intestinal wall).

Hepatobiliary disorders:

Rare: liver insufficiency, liver necrosis (which can be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, inflammation of the gallbladder (particularly in patients with pre-existing formation of stones in the bile ducts).

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

hypersensitivity/angioneurotic edema: swelling of the face, extremities, lips, tongue, glottis, and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: severe skin redness or blistering (Stevens-Johnson syndrome), severe skin rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, severe skin redness, vesicle formation on the skin.

Unknown frequency:skin cancer and lip cancer (non-melanoma skin cancer).

A complex of symptoms has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle or joint inflammation, positive antinuclear antibodies test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. It may also cause skin rash, sensitivity to sunlight, or other skin manifestations.

Musculoskeletal, connective tissue, and bone disorders:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (alteration of kidney function), renal insufficiency, proteinuria

Rare: oliguria (deficient urine secretion), renal cell inflammation.

Reproductive and breast disorders:

Uncommon: impotence

Rare: gynecomastia in men.

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, fatigue

Uncommon: general malaise, fever.

Investigations:

Common: elevated potassium levels in blood, increased creatinine levels

Uncommon: increased urea levels in blood, low sodium levels in blood

Rare: increased liver enzymes, increased bilirubin levels.

* Only observed with doses of 12.5 mg and 25 mg, as found in Dabonal Plus

† The frequency of muscle cramps as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Dabonal Plus, although the frequency of the event is "uncommon".

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 Pharmacovigilance of Medicinal Products 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 out of the reach and sight of children.

Do not use this medicine after the expiration date that appears on the packagingafter 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 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. By doing so, you will help protect the environment.

Composition ofDabonal Plus

The active principles are enalapril, in the form of maleate, and hydrochlorothiazide. Each tablet contains 20 mg of enalapril and 12.5 mg of hydrochlorothiazide.

The other components are lactose monohydrate (lactose), sodium hydrogen carbonate (E-500), cornstarch, pregelatinized cornstarch, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Dabonal Plus is presented in packs of 28 tablets. The tablets are biconvex, elongated, yellow in color, and scored on one of their faces.

The score serves to fraction and facilitate swallowing, but not to divide into equal doses.

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: September 2022

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/