Leaflet: information for the user

Enalapril/Hidroclorotiazida Normon 20 mg/12,5 mg tablets EFG

Enalapril/Hidroclorotiazida

Read this leaflet carefully before you start taking this medicinebecause 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 it may harm them.
• If you experienceside effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

6. Contents of the pack andadditional information

This medication contains two active principles, enalapril and hidroclorotiazida, which belong to the group of anti-hypertensive drugs and, through different mechanisms, reduce elevated blood pressure.

The enalapril component is a medication that belongs to a group of drugs 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 hidroclorotiazida component belongs to a group of drugs known as thiazide diuretics (medications that increase urine elimination). Together, enalapril and hidroclorotiazida help to reduce elevated blood pressure.

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

Do not take Enalapril/Hidroclorotiazida Normon

• If you are allergic (hypersensitive) to enalapril, hidroclorotiazida or to any of the other components of this medication
• If you are allergic to sulfonamide derivatives. Ask your doctor if you are unsure what sulfonamide derivatives are
• If you have previously been treated with a medication from the same group as enalapril/hidroclorotiazida (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 this type of allergic reaction without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (a disease of the immune system that causes inflammation of the face and respiratory tract, 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 kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén
• If you are more than 3 months pregnant (Also, it is best to avoid Enalapril/Hidroclorotiazida at the beginning of pregnancy - see Pregnancy section)

If you are unsure whether you should start taking this medication, consult your doctor

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.In the following situations, your doctor may need to adjust your dose of enalapril/hidroclorotiazida or monitor your potassium levels in the blood:

• If you have a heart disease that is associated with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce the flow of the left heart chamber (hypertrophic obstructive cardiomyopathy)
• If you have conditions that reduce the volume of fluids or the level of sodium in the body (for example: intense vomiting, diarrhea or if you are being treated with 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 the medications used to treat diabetes. Diabetes can cause high levels of potassium in the blood that can be serious
• If you have liver problems
• If you have kidney problems (including kidney transplant), as these can cause high levels of potassium in the blood that can be serious
• If you are undergoing dialysis
• If you are following a low-sodium diet, taking potassium supplements, medications that conserve potassium (medications that increase urine elimination) or salt substitutes that contain potassium
• If during treatment you experience an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing. Note that patients of black race 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 from the blood the particles of LDL or bad cholesterol in cases where it is excessively elevated)
• If you are about to undergo a desensitization treatment to reduce the effect of an allergy to bee or wasp stings
• If you have low blood pressure, as the use of enalapril/hidroclorotiazida, 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, valsartán, telmisartán, irbesartán), especially if you have kidney problems related to diabetes
  • Aliskirén

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, especially its long-term use at high doses, can increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Enalapril/Hidroclorotiazida
• 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 this medication. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Enalapril/Hidroclorotiazida Normon, go to your doctor immediately

Your doctor may need to monitor your renal function, blood pressure and electrolyte levels in the blood (such as potassium) at regular intervals

See also the information under the heading “Do not take Enalapril/Hidroclorotiazida Normon”

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

Inform your doctor if you think you may be pregnant (or could be). Enalapril/hidroclorotiazida 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 serious damage to your baby if used in this stage (see Pregnancy and Breastfeeding section)

Taking Enalapril/Hidroclorotiazida Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription, homeopathic, herbal and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.You may need to adjust your dose and/or take other precautions

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

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Enalapril/Hidroclorotiazida Normon” and “Warnings and precautions”)
• Antihypertensive medications (reduce elevated blood pressure), for example 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 (for example, metformin)
• Medications used to treat pain or certain inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, including selective COX-2 inhibitors
• Sympathomimetics (medications used in the treatment of certain heart and blood vessel disorders and some medications for colds)
• Amines pressors, such as noradrenaline
• Muscle relaxants such as tubocurarina
• Thrombolytic medications (that prevent blood clot formation)
• Calcium salts and vitamin D
• Ionic exchange resins (medications used to reduce 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 reduce gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperidino (used in patients with Parkinson's disease)
• Medications used to treat gout, such as probenecid, sulfinpirazona and allopurinol
• Antivirals (medications used to treat viral infections), such as amantadita
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate
• Immunosuppressive medications (used to prevent rejection in organ transplants), such as cyclosporina
• Antibiotics (medications used to treat certain infections), such as tetracyclines, amphotericin B
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis)

Taking Enalapril/Hidroclorotiazida Normon with food and drinks:

This medication can be taken before or after meals

Alcohol can increase the hypotensive effect of 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 (or could be)

Generally, your doctor will advise you to interrupt treatment with this medication before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication other than enalapril/hidroclorotiazida. Enalapril/Hidroclorotiazida is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious 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 breastfeedingNo Enalapril/Hidroclorotiazida is recommended if you are breastfeeding

The two active principles of this medication, enalapril and hidroclorotiazida, 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 this medication 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 hidroclorotiazida were taken together, the effect of the medications and tolerability were similar in young adult patients and elderly 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 enalapril/hidroclorotiazida 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

Enalapril/Hidroclorotiazida Normon contains lactose and sodium

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

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

Interference with diagnostic tests:

If you need to undergo any diagnostic test to evaluate the function of the parathyroid gland, inform your doctor that you are being treated with enalapril/hidroclorotiazida, as it may alter the results

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubts, consult your doctor or pharmacist.

Remember to take your medication.

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

The usual dose is one or two tablets administered once a day. Take this medication 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 taken orally.

Take the Enalapril/Hidroclorotiazida tablets with the help of a glass of water.

This medication can be taken before or after meals.

• If you take more Enalapril/Hidroclorotiazida Normon than you should:

If you have taken more enalapril/hidroclorotiazida than you should, consult your doctor, pharmacist, 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 professional.

The most likely symptoms would be a feeling 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 Enalapril/Hidroclorotiazida Normon:

You should take this medication 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 treatment with Enalapril/Hidroclorotiazida Normon:

Your doctor will indicate the duration of treatment with this medication. 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, Enalapril/Hidroclorotiazida may cause side effects, although not everyone will experience them.

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

Very common: occur in at least 1 in 10.

Common: occur in at least 1 in 100 and less than 1 in 10 patients treated.

Uncommon: occur in at least 1 in 1,000 and less than 1 in 100 patients treated.

Rare: occur in at least 1 in 10,000 and less than 1 in 1,000 patients treated.

Very rare: occur in less than 1 in 10,000 patients treated.

Frequency unknown: (cannot be estimated from available data).

Blood and lymphatic system disorders:

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

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

Endocrine disorders:

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

Metabolism and nutrition disorders:

Common: elevated 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 levels in the blood

Very rare: elevated calcium levels in the blood

Nervous system disorders:

Common: headache, dizziness, altered taste

Uncommon: confusion, drowsiness, insomnia, numbness, vertigo

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

Unknown: decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) 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 (rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see section Be careful with Enalapril/Hidroclorotiazida Normon tablets)

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

Respiratory, thoracic, and mediastinal disorders:

Very common: cough

Common: shortness of breath

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

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

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

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

Rare: mouth or tongue inflammation

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, gallbladder inflammation (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: facial swelling, extremities, lips, tongue, glottis, and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

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

A complex of symptoms has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle and 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.

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

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, renal cell inflammation.

Reproductive and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, fatigue

Uncommon: general malaise, fever

Complementary examinations:

Common: elevated potassium levels in the blood, increased creatinine levels

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

Rare: increased liver enzymes, increased bilirubin levels

Respiratory, thoracic, and mediastinal disorders

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

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 Vigilance of Medicines for Human Use:https://www.notificaram.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Normon:

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

The other components are: lactose monohydrate, sodium hydrogen carbonate, sodium croscarmellose, magnesium stearate, and yellow iron oxide (E-172).

Appearance of the product and content of the packaging:

Enalapril/Hidroclorotiazida Normon 20 mg/12.5 mg is presented in the form of yellow, round, and scored tablets. Each package contains 28 or 30 tablets.

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

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

(SPAIN)

This prospectushas been approved:August 2022.

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