ENALAPRIL/HYDROCHLOROTHIAZIDE NORMON 20 mg/12.5 mg TABLETS

2. What you need to know before you take 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 medication
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are not sure what sulfonamide-derived medications are.
• If you have been previously treated with a medication from the same group as enalapril/hydrochlorothiazide (ACE inhibitors), and you 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 (an immune system disorder that causes inflammation of 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 blood pressure medication that contains aliskiren.
• If you are pregnant for more than 3 months (It is also best to avoid Enalapril/Hydrochlorothiazide at the beginning of pregnancy - see section Pregnancy).

If you are not sure if 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 the dose of enalapril/hydrochlorothiazide or monitor your potassium blood level:

• If you have a heart condition that involves 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 medications to treat diabetes, including insulin, as it may be necessary to adjust the dose of the medications used to treat diabetes. Diabetes can cause high potassium levels in the blood, which 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, which can be serious.
• If you are undergoing dialysis.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medications (medications that increase urine elimination), or salt substitutes that contain potassium.
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing during treatment. You should be aware 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 or bad cholesterol from the blood in cases where it is excessively elevated).
• 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 enalapril/hydrochlorothiazide, 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 medications 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

• If you have had skin cancer or if you 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Enalapril/Hydrochlorothiazide.
• 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 they 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 been allergic to penicillin or sulfonamide, you may be at greater risk of developing it.
• 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 Enalapril/Hydrochlorothiazide Normon, go to the doctor 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 (even at the dentist's office), inform your doctor or dentist that you are taking enalapril/hydrochlorothiazide, as you may experience a sudden drop in blood pressure due to anesthesia.

You should inform your doctor if you think you are pregnant (or might be). Enalapril/hydrochlorothiazide 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 from the third month of pregnancy onwards.

Taking Enalapril/Hydrochlorothiazide Normon with other medications

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

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

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril/Hydrochlorothiazide Normon" and "Warnings and precautions").
• Blood pressure medications (e.g., vasodilators, beta-blockers, diuretics).
• Potassium-containing medications (including dietary salt substitutes).
• Medications used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Narcotics (medications used to treat severe pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medications used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medications (medications used to treat certain heart and blood vessel disorders and some cold medications).
• Pressor amines, such as norepinephrine.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (which prevent blood clot formation).
• Calcium salts and vitamin D.
• Ion 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.
• Antiviral medications (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 organ rejection in 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 Enalapril/Hydrochlorothiazide Normon with food and drinks:

This medication can be taken before or after meals.

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

Pregnancy and Breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Pregnancy:

You should inform your doctor if you think you are pregnant (or might be).

Generally, your doctor will advise you to stop 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 instead of enalapril/hydrochlorothiazide. Enalapril/Hydrochlorothiazide 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 onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use this medication if you are breastfeeding.

The two active ingredients of this medication, 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 this medication have not been established in this population, 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 medications and tolerability were similar in young adult and elderly patients with high blood pressure.

Use in Athletes:

Athletes are informed that this medication contains a component that may produce a positive result in doping tests.

Driving and Using Machines:

It is unlikely that enalapril/hydrochlorothiazide 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 these effects, you should consult your doctor before performing these activities.

Enalapril/Hydrochlorothiazide 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 them before taking this medication.

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

Interference with Diagnostic Tests:

If you are going to undergo any diagnostic tests to evaluate parathyroid gland function, inform your doctor that you are being treated with enalapril/hydrochlorothiazide, as it may alter the results.

3. How to Take Enalapril/Hydrochlorothiazide Normon

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medication.

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

The normal 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 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 what 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 impaired kidney function: If you have kidney disease, your doctor will indicate the most suitable dose.

Method of administration:

This medication is taken orally.

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

This medication can be taken before or after meals.

• If you take more Enalapril/HydrochlorothiazideNormonthan you should:

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

It is recommended to take the medication package 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 production, and/or tachycardia.

• If you forget to take Enalapril/HydrochlorothiazideNormon:

You should take this medication 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 Enalapril/HydrochlorothiazideNormon:

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 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 all people suffer from them.

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

Very frequent: occur in at least 1 in 10.

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

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

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

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

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 cells (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 diseases.

Endocrine disorders:

Not known: 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

Frequency not known: 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 sensation), myocardial infarction or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients (see section Take special care with Enalapril/Hydrochlorothiazide Normon tablets)

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 pulmonary alveolus due to allergy)/eosinophilic pneumonia (disease in which a type of white blood cells, called eosinophils, accumulate in the lungs)

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 (particularly in patients with pre-existing bile duct stone formation).

Skin and subcutaneous tissue disorders:

Frequent: 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 rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, skin redness, blistering 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, sun sensitivity, or other skin manifestations may also occur.

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

Musculoskeletal, connective tissue, and bone disorders:

Frequent: muscle cramps†

Uncommon: joint pain

Renal and urinary disorders:

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

Rare: inadequate urine secretion, kidney cell inflammation.

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

Respiratory, thoracic, and mediastinal disorders

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

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 leaflet. 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 Enalapril/Hydrochlorothiazide Normon

Keep out of sight and reach of children.

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

Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point (or any other pharmaceutical waste collection system) at the pharmacy. If in doubt, 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 of Enalapril/Hydrochlorothiazide Normon:

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

Appearance of the product and package contents:

Enalapril/Hydrochlorothiazide 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 line is to facilitate breaking and swallowing but not to divide into equal doses.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

(SPAIN)

This leaflethas been approved:August 2022.

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