DABONAL PLUS 20 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dabonal Plus 20 mg/12.5 mg Tablets

Enalapril/Hydrochlorothiazide

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.

• Keep this leaflet, as 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 Dabonal Plus is and what it is used for
2. What you need to know before you take Dabonal Plus
3. How to take Dabonal Plus
4. Possible side effects
5. Storage of Dabonal Plus
6. Contents of the pack and other information

1. What Dabonal Plus is and what it is used for

This medicine contains two active substances, enalapril and hydrochlorothiazide, which belong to a group of medicines called antihypertensives, and which, through different mechanisms, reduce high blood pressure.

The enalapril component of Dabonal Plus is a medicine that belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which acts by dilating blood vessels to make the heart pump blood more easily to all parts of the body. The hydrochlorothiazide component of Dabonal Plus belongs to a group of medicines known as thiazide diuretics (medicines that increase urine production). Together, enalapril and hydrochlorothiazide help to decrease high blood pressure.

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

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

Do not take Dabonal Plus

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other ingredients of Dabonal Plus.
• If you are allergic to sulphonamide-derived substances. Ask your doctor if you are not sure what sulphonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as Dabonal Plus (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 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 tract, and abdominal colic).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskiren.
• If you are pregnant for more than 3 months (It is also best to avoid Dabonal Plus at the beginning of pregnancy - see section Pregnancy and Breastfeeding)

If you are not sure if you should start taking Dabonal Plus, consult your doctor.

Warnings 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. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Dabonal Plus.
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and 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 shortness of breath or severe difficulty breathing after taking Dabonal Plus, go to the doctor immediately.

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

• If you have heart disease with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce left ventricular outflow (hypertrophic obstructive cardiomyopathy).
• If you have disorders that reduce fluid volume or sodium levels in the body (e.g., severe vomiting, diarrhea, or if you are being treated with high doses of diuretics).
• If you have any blood disorders.
• If you have diabetes and are taking medicines to treat diabetes, including insulin, as it may be necessary to adjust the dose of the medicines used to treat diabetes. Diabetes can cause high potassium levels in the blood that can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as they can cause high potassium levels in the blood that can be serious.
• If you are undergoing dialysis.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medicines (medicines that increase urine production), or salt substitutes that contain potassium.
• If an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing occurs during treatment. You should be aware that black patients are more sensitive to this type of medicine.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove LDL or bad cholesterol from the blood in cases where it is excessively high).
• If you are going 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 notice dizziness or fainting, especially when standing up).
• 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 need to check 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 Plus tablets”.

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

You must inform your doctor if you think you are pregnant (or might be). Dabonal Plus is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used during this period (see section Pregnancy and Breastfeeding).

Taking Dabonal Plus with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

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

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

• Antihypertensive medicines (lower high blood pressure), e.g., vasodilators, beta-blockers, diuretics.
• Potassium-containing medicines (including dietary salt substitutes).
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Narcotics (pain-relieving medicines).
• Medicines used to treat diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medicines used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), e.g., acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (medicines used to treat certain heart and blood vessel disorders and some cold medicines).
• Pressor amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medicines (which prevent blood clot formation).
• Calcium salts and vitamin D.
• Ion exchange resins (medicines used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medicines (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (which slow down gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for the treatment of gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medicines (used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medicines (used to prevent organ rejection in transplants), such as cyclosporine.
• Antibiotics (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 may increase the blood pressure-lowering effect of this medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 Plus before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Dabonal Plus. Dabonal Plus is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

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

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

Use in Children and Adolescents

The safety and efficacy of Dabonal Plus in this population have not been established, so its use is not recommended in children.

Use in the Elderly

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

Use in Athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

Driving and Using Machines

It is unlikely that Dabonal Plus will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment of high blood pressure, especially at the beginning. If you experience such effects, you should consult your doctor before performing these activities.

Dabonal Plus contains lactose and sodium

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

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

Interference with Diagnostic Tests

If you are to undergo any diagnostic tests to assess parathyroid gland function, inform your doctor that you are being treated with Dabonal Plus, as it may alter the results.

3. How to Take Dabonal Plus

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

Remember to take your medicine.

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

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

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

Use in Patients with Renal Impairment

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

Method of Administration

This medicine 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 more Dabonal Plus than you should

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

It is recommended to take the package and the package leaflet of the medicine to the healthcare personnel.

The most likely symptoms would be 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 forget to take Dabonal Plus

You should take Dabonal Plus exactly as your doctor has indicated.

Do not take a double dose to make up for forgotten doses. Just take the next dose as usual.

If you stop taking 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Dabonal Plus can cause adverse effects, although not all people suffer from them.

The recorded adverse effects are detailed below according to the following frequencies:

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

Frequent(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)

Frequency not known: (cannot be estimated from available data)

Blood and lymphatic system disorders:

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

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

Endocrine disorders:

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

Metabolic and nutritional disorders:

Frequent: high potassium levels in the blood, increased cholesterol, increased triglycerides, increased uric acid in the blood

Uncommon: low glucose and magnesium levels in the blood, gout

Rare: increased glucose in the blood

Very rare: high calcium levels in the blood

Nervous system disorders:

Frequent: headache, syncope, altered taste

Uncommon: confusion, somnolence, insomnia, tingling sensation, vertigo

Rare: paralysis (due to low potassium levels)

Psychiatric disorders:

Frequent: depression

Uncommon: nervousness, decreased libido*

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very frequent: 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 frequent: dizziness

Frequent: low blood pressure associated with fainting, heart rhythm disorders, chest pain, tachycardia (rapid heartbeats)

Uncommon: flushing, palpitations (rapid and irregular heartbeat), myocardial infarction or stroke, possibly secondary to excessive decrease in blood pressure in high-risk patients (see section Take special care withDabonal Plus)

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

Respiratory, thoracic, and mediastinal disorders:

Very frequent: cough

Frequent: 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 the nasal mucosa, allergic alveolitis (inflammation of the lung alveoli due to allergy) / eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).

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

Gastrointestinal disorders:

Very frequent: nausea

Frequent: 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 mouth mucosa, tongue inflammation

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Frequent: skin rash (exanthema)

Hypersensitivity/angioedema: swelling of the face, limbs, lips, tongue, glottis, and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

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

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

A symptomatic complex has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle inflammation/pain, joint inflammation/pain, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. Skin rash, sun sensitivity, or other skin manifestations may also occur.

Musculoskeletal and connective tissue disorders:

Frequent: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (alteration of kidney function), renal failure, presence of protein in the urine

Rare: inadequate urine secretion, inflammation of kidney cells.

Reproductive system and breast disorders:

Uncommon: impotence

Rare: increased breast size in men.

General disorders and administration site conditions:

Very frequent: fatigue

Frequent: chest pain, fatigue

Uncommon: general malaise, fever.

Investigations:

Frequent: high potassium levels in the blood, increased serum creatinine

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

Rare: increased liver enzymes, increased serum bilirubin.

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

† The frequency of muscle spasms as "frequent" 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 adverse effects:If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dabonal Plus

Keep out of the reach and sight of children.

Do not use this medicine after the expiration date stated 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 via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofDabonal Plus

The active ingredients 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), corn starch, pregelatinized corn starch, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Product Appearance and Package Contents

Dabonal Plus is presented in packages of 28 tablets. The tablets are biconvex, elongated, yellow, and scored on one side.

The score line is used to facilitate breaking and swallowing, but not to divide into equal doses.

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 prospectus: September 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/