Dabonal Plus 20 mg/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dabonal Plus 20 mg/12.5 mg tablets

Enalapril/Hydrochlorothiazide

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, as it could harm them.

• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Dabonal Plus is and what it is used for
2. What you need to know before taking Dabonal Plus
3. How to take Dabonal Plus
4. Possible side effects
5. How to store 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 the group of antihypertensive agents and reduce high blood pressure through different mechanisms.

The enalapril component of Dabonal Plus is a medicine belonging to a class of medicines known as angiotensin-converting enzyme (ACE) inhibitors, which works by dilating blood vessels to allow the heart to 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 elimination). Together, enalapril and hydrochlorothiazide help lower high 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.

2. What you need to know before taking Dabonal Plus

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 about what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as Dabonal Plus (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by 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 condition causing swelling in the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you suffer from anuria (you do not urinate).
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (Dabonal Plus should also be avoided in early pregnancy – see section Pregnancy).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Dabonal Plus

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Dabonal Plus.
• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure. These may occur within hours to a week after taking Dabonal Plus.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Dabonal Plus, seek medical attention immediately.

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

• If you have heart disease involving narrowing of heart valves (mitral or aortic valve stenosis) or other conditions reducing blood flow from the left side of the heart (obstructive hypertrophic cardiomyopathy).

• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., severe vomiting, diarrhea, or if you are on high-dose diuretic therapy).

• If you have blood disorders.

• If you have diabetes and are taking antidiabetic medications, including insulin, as dose adjustments may be needed. Diabetes can cause elevated blood potassium levels, which may be serious.

• If you have liver problems.

• If you have kidney problems (including kidney transplant), as these may lead to elevated blood potassium levels that could be serious.

• If you are undergoing dialysis.

• If you are on a salt-free diet, taking potassium supplements, potassium-sparing diuretics (medicines that increase urine output), or salt substitutes containing potassium.

• If you develop an allergic reaction during treatment with swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing. Note that black patients are more sensitive to this type of medication.

• If you are about to undergo LDL apheresis (a procedure similar to dialysis used to remove LDL or "bad" cholesterol particles from the blood when levels are excessively high).

• If you are scheduled to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings.

• If you have low blood pressure, as Dabonal Plus, especially during initial doses, may cause a sudden drop in blood pressure (you may feel faint or dizzy, particularly when standing up).

• If you are taking any of the following medicines for high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans", e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• aliskiren

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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

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

Inform your doctor if you think you are pregnant (or could be). Dabonal Plus is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may cause serious harm to your baby if used at this stage (see section Pregnancy and breastfeeding).

Taking Dabonal Plus with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including over-the-counter, homeopathic, herbal remedies, and other health-related products, as it may be necessary to stop or adjust the dose of one or more of these medicines.

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 information under the headings “Do not take Dabonal Plus” and “Take special care with Dabonal Plus”).

• Antihypertensive medicines (reduce 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.

• Opioids (medicines used to treat severe pain).

• 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), like acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.

• Sympathomimetic medicines (used to treat certain heart and blood vessel disorders and some cold remedies).

• Pressor amines, such as noradrenaline.

• Muscle relaxants such as tubocurarine.

• Thrombolytic medicines (prevent blood clot formation).

• Calcium salts and vitamin D.

• Ion-exchange resins (used to lower blood cholesterol), such as cholestyramine and colestipol.

• Antiarrhythmics (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.

• Anticholinergic medicines (reduce gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson’s disease).

• Medicines for gout treatment, such as probenecid, sulfinpyrazone, and allopurinol.

• Antivirals (medicines to treat viral infections), such as amantadine.

• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.

• Immunosuppressants (used to prevent organ transplant rejection), such as cyclosporine.

• Antibiotics (medicines 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 enhance the blood pressure-lowering effect (hypotensive effect) of this medicine.

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 medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Dabonal Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Dabonal Plus is not recommended during pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

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

The two active ingredients in Dabonal Plus, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor.

Use in children and adolescents

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

Use in elderly

In studies combining enalapril and hydrochlorothiazide, the effect and tolerability of the drugs were similar in younger and elderly adult patients with high blood pressure.

Use in athletes

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Driving and using machines

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

Dabonal Plus contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".

Interference with diagnostic tests

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

3. How to take Dabonal Plus

Follow exactly the instructions for administration of Dabonal Plus given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

The usual dose is one or two tablets taken once daily. Take Dabonal Plus every day, exactly as directed by your doctor. It is very important to continue taking this medicine for the length of time recommended by your doctor. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than occurs with continued treatment. You may feel faint or dizzy, and lying down may help. If you are concerned, consult your doctor.

Use in patients with impaired kidney function

If you have any kidney disease, your doctor will determine the most appropriate dose for you.

Method of administration

This medicine is administered orally.

Take the Dabonal Plus tablets with a glass of water.

Dabonal Plus may 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

It is recommended to take the medicine packaging and leaflet to the healthcare professional.

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 output and/or tachycardia.

If you forget to take Dabonal Plus

You should take Dabonal Plus exactly as directed by your doctor.

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

If you stop taking Dabonal Plus

Your doctor will advise you on how long your treatment with Dabonal Plus should last. Do not stop treatment early, even if you feel better.

If you have any further 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 everyone experiences them.

The adverse effects reported 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 1,000 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 (blood cells that carry oxygen)

Rare: reduction in a type of white blood cells (neutrophils), decrease in hemoglobin (a protein in red blood cells that carries oxygen), decrease in the number of platelets in the blood, decrease in hematocrit (proportion of red blood cells in the blood), decrease in the number of white blood cells, bone marrow depression (reduced ability of the body to produce blood cells), lymph node inflammation, immune system disorders.

Endocrine disorders:

Frequency not known: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

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

Uncommon: low blood glucose and magnesium levels, gout

Rare: increased blood glucose

Very rare: high calcium levels in blood

Nervous system disorders:

Common: headache, fainting, taste disturbance

Uncommon: confusion, drowsiness, insomnia, tingling sensation, dizziness

Rare: paralysis (due to low potassium levels)

Psychiatric disorders:

Common: depression

Uncommon: nervousness, decreased libido*

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Frequency not known: decreased vision or eye pain due to increased 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: drop in blood pressure associated with fainting, heart rhythm disorders, angina pectoris, tachycardia (rapid heartbeat)

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

Rare: changes in skin color of fingers, toes, 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 discomfort (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of lung alveoli due to allergy)/eosinophilic pneumonia (a condition in which a type of white blood cells called eosinophils accumulate in the lungs)

Very rare: acute breathing difficulty (symptoms include severe shortness of breath, 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*

Rare: infection or inflammation of the mucosa of the mouth, inflammation of the tongue

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

Hepatobiliary disorders:

Rare: liver failure, hepatic necrosis (which may be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, gallbladder inflammation (particularly in patients with pre-existing gallstone formation in the biliary tract).

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

hypersensitivity/angioneurotic edema: 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 redness/rash with loss of skin and hair, skin peeling, appearance of red spots on the skin, skin disorders, skin redness, blister formation on the skin.

Frequency not known: skin and lip cancer (non-melanoma skin cancer).

A symptomatic complex has been observed which 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, photosensitivity or other skin manifestations may also occur.

Musculoskeletal, connective tissue and bone disorders:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

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

Rare: inadequate urine output, inflammation of kidney cells.

Reproductive system and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: tiredness

Common: chest pain, fatigue

Uncommon: general malaise, fever.

Investigations:

Common: elevated potassium levels in blood, increased serum creatinine

Uncommon: increased blood urea, low sodium levels in blood

Rare: increased liver enzymes, increased serum bilirubin.

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

† The frequency of muscle spasms as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Dabonal Plus, although the actual frequency of this 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabonal Plus

The active substances 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 monohydrate lactose (lactose), sodium hydrogen carbonate (E-500), corn starch, pregelatinized corn starch, magnesium stearate (E-470b), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Dabonal Plus is available in packs of 28 tablets. The tablets are biconvex, elongated, yellow in colour, and scored on one side.

The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide it into equal doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

KeVaRo Group Ltd

9 Tsaritsa Eleonora Str., office 23,

1618 Sofia

Bulgaria

Date of the most recent revision of this leaflet: September 2022

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