Enalapril/hydrochlorothiazide Normon 20 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril/Hydrochlorothiazide Normon 20 mg/12.5 mg tablets EFG

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 only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Enalapril/Hydrochlorothiazide Normon is and what it is used for

2. What you need to know before taking Enalapril/Hydrochlorothiazide Normon

3. How to take Enalapril/Hydrochlorothiazide Normon

4. Possible adverse effects

5. How to store Enalapril/Hydrochlorothiazide Normon

6. Contents of the pack and other information

1. What Enalapril/Hydrochlorothiazide Normon is and what it is used for

This medicine contains two active substances, enalapril and hydrochlorothiazide, which belong to the group of antihypertensive drugs and which, through different mechanisms, reduce elevated blood pressure.

The component enalapril is a medicine that belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which works by dilating blood vessels to allow the heart to pump blood more easily to all parts of the body. The component hydrochlorothiazide belongs to the 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 this medicine 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 starting Enalapril/Hydrochlorothiazide Normon

Do not take Enalapril/Hydrochlorothiazide Normon

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other components of this medicine
• 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 in the same class as enalapril/hydrochlorothiazide (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 (an immune system disorder causing swelling of 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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (Enalapril/Hydrochlorothiazide should also be avoided in early pregnancy—see Pregnancy section).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine. In the following situations, your doctor may need to adjust your dose of enalapril/hydrochlorothiazide or monitor your blood potassium levels:

• If you have a heart condition involving narrowing of heart valves (mitral or aortic stenosis) or other factors reducing blood flow from the left chamber 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 doses of diuretic medicines that increase urine output).

• If you have blood disorders.

• If you have diabetes and are taking medicines for diabetes, including insulin, as dosage adjustments of your diabetes medicines may be needed. Diabetes can lead to high blood potassium levels, which may be serious.

• If you have liver problems.

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

• If you undergo dialysis.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines (diuretics), 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 patients of Black race are more sensitive to this type of medicine.

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

• If you are scheduled for desensitization therapy to reduce the effects of allergy to bee or wasp stings.

• If you have low blood pressure, as enalapril/hydrochlorothiazide, especially during initial doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, 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

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV radiation while taking Enalapril/Hydrochlorothiazide.

• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased intraocular pressure, occurring within hours to a week after taking this medicine. This may lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.

• If you have had respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe breathing difficulty after taking Enalapril/Hydrochlorothiazide Normon, seek medical attention immediately.

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 Enalapril/Hydrochlorothiazide Normon”.

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking enalapril/hydrochlorothiazide, as you may experience a sudden drop in blood pressure due to anesthesia.

Inform your doctor if you think you are pregnant (or could be). Enalapril/hydrochlorothiazide is not recommended in early pregnancy and must not be used after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy and Lactation section).

Taking Enalapril/Hydrochlorothiazide Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter, homeopathic, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of them. Your doctor may need to modify your dose and/or take other precautions.

It is especially important to 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 Enalapril/Hydrochlorothiazide Normon” and “Warnings and precautions”).
• Antihypertensive medicines (lower elevated 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.
• Opioid medicines (used to treat severe pain).
• Medicines for diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medicines used for pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, and 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 (used 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 (used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

Taking Enalapril/Hydrochlorothiazide Normon with food and drinks:

This medicine can be taken before or after meals.

Alcohol may enhance the blood pressure-lowering (hypotensive) effect of this medicine.

Pregnancy and Lactation:

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

Inform your doctor if you think you are pregnant (or could be).

Generally, your doctor will advise stopping treatment with this medicine before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative to enalapril/hydrochlorothiazide. Enalapril/Hydrochlorothiazide 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.

Lactation

Inform your doctor if you are breastfeeding or about to start breastfeeding. This medicine is not recommended during breastfeeding.

The two active ingredients of this medicine, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor.

Use in children and adolescents:

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

Use in the elderly:

In studies combining enalapril and hydrochlorothiazide, the drug effects and tolerability were similar in younger and older adult patients with high blood pressure.

Use in athletes:

Athletes are advised 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 enalapril/hydrochlorothiazide 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 such effects, consult your doctor before engaging in these activities.

Enalapril/Hydrochlorothiazide Normon contains lactose and sodium

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

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

Interference with diagnostic tests:

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

3. How to take Enalapril/Hydrochlorothiazide Normon

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Remember to take your medicine.

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

The usual dose is one or two tablets taken once daily. Take this medicine 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 during 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 taken orally.

Take the Enalapril/Hydrochlorothiazide tablets with a glass of water.

This medicine may be taken before or after meals.

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

If you have taken more enalapril/hydrochlorothiazide than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to bring the medicine's 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 Enalapril/Hydrochlorothiazide Normon:

You should take this medicine 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 Enalapril/Hydrochlorothiazide Normon:

Your doctor will determine how long you should take this medicine. Do not stop treatment earlier, 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, Enalapril/Hydrochlorothiazide may produce adverse effects, although not everyone experiences them.

The adverse effects reported are listed below according to the following frequencies:

Very common: occurs in at least 1 in 10 people.

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

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

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

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

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

Blood and lymphatic system disorders:

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

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

Endocrine disorders:

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

Metabolism and nutrition disorders:

Common: elevated 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: elevated calcium levels in blood

Nervous system disorders:

Common: headache, syncope, taste disturbance

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

Rare: paralysis (due to low potassium levels)

Psychiatric disorders:

Common: depression

Uncommon: restlessness, decreased libido*

Rare: abnormal dreams, sleep disorders

Eye disorders:

Very common: blurred vision

Frequency not known: decreased vision or eye pain due to elevated 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 or irregular heartbeat sensation), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section "Take special care with Enalapril/Hydrochlorothiazide Normon tablets")

Rare: changes in skin coloration 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 the lung alveoli due to allergy)/eosinophilic pneumonia (a condition in which a type of white blood cells called eosinophils accumulate in the lungs)

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 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 bile ducts)

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 hair and skin loss, skin peeling, appearance of red spots on the skin, skin disorders, skin redness, blister formation on the skin, Stevens-Johnson syndrome.

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, photosensitivity, or other skin manifestations may also occur.

Frequency not known: 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 (impaired kidney function), renal failure, presence of protein in urine

Rare: inadequate urine output, inflammation of kidney cells

Reproductive system and breast disorders:

Uncommon: impotence

Rare: enlargement of the breasts in men

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, tiredness

Uncommon: malaise, fever

Additional 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

Respiratory, thoracic and mediastinal disorders

Very rare: acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Reporting of adverse effects:

If you experience any adverse effect, talk to 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 Enalapril/Hydrochlorothiazide Normon

Keep out of the sight and reach of children.

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

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Hydrochlorothiazide Normon:

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

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

Appearance of the product and contents of the pack:

Enalapril/Hydrochlorothiazide Normon 20 mg/12.5 mg is presented as yellow, round, scored tablets. Each pack contains 28 or 30 tablets.

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

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

(SPAIN)

This patient information leaflet was approved: August 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es