Enalapril/hidroclorotiazida cinfa 20/12,5 mg comprimidos efg

Leaflet: information for the user

enalapril/hidroclorotiazida cinfa 20 mg/12,5 mg tablets EFG

enalapril maleate/hydrochlorothiazide

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

This medicine contains two active ingredients, 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 medicine 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 (medicines that increase the elimination of urine).

Together, enalapril and hidroclorotiazida help to reduce elevated blood pressure.

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

Do not take enalapril/hidroclorotiazida cinfa

• If you are allergic to enalapril, hidroclorotiazida or any of the other components of this medicine (listed in section 6).
• 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 medicine 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 such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (a condition of the immune system that causes inflammation in the face and airways, and abdominal cramps).
• If you have any severe liver disease.
• If you have any severe kidney disease.
• If you are anuric (do not urinate).
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine 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 section “Pregnancy and breastfeeding”).
• If you are being treated with sacubitrilo/valsartán, a medicine for heart failure.
• If you are unsure whether you should start taking enalapril/hidroclorotiazida, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take enalapril/hidroclorotiazida cinfa. In the following situations, your doctor may need to adjust your enalapril/hidroclorotiazida dose or monitor your blood potassium level:

• If you have a heart disease that is associated with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce blood flow to the left chamber of the heart (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 medicines that increase urine production).
• If you have any blood abnormalities.
• If you have diabetes and are taking medicines to treat diabetes, including insulin, as you may need to adjust the dose of the medicines 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, potassium-sparing medicines (medicines that increase potassium levels), salt substitutes that contain potassium or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimetoprima or cotrimoxazol (medicines used to treat infections).
• If 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 medicine.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove from the blood LDL particles 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 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, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking enalapril/hidroclorotiazida.
• If you are taking a medicine that contains a neprilysin inhibitor such as sacubitrilo (available in a fixed-dose combination with valsartán), used in patients with heart failure, and racecadotrilo, used in patients with acute diarrhea. You may have a higher risk of experiencing an allergic reaction called angioedema.
• Inform your doctor if you are taking any of the following medicines used to treat high blood pressure:
• • 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

• Inform your doctor if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a few hours to a week after taking enalapril/hidroclorotiazida. If left untreated, this can lead to permanent vision loss. You may be at higher risk if you have previously had an allergy to penicillin or sulfonamide.

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

See also “Do not take enalapril/hidroclorotiazida cinfa”.

• Before undergoing surgery or anesthesia (including dental consultation), 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.
• You should 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 taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage - (see section “Pregnancy and breastfeeding”).

Children and adolescents

The safety and efficacy of enalapril/hidroclorotiazida have not been established in this age group, so it is not recommended for use in children.

Use in elderly patients

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

Other medicines and enalapril/hidroclorotiazida cinfa

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Your doctor 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 medicines:

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also “Do not take enalapril/hidroclorotiazida cinfa” and “Warnings and precautions”).
• Anti-hypertensive medicines (reduce elevated blood pressure), for example vasodilators, beta-blockers, diuretics.
• Medicines with potassium (including dietary salt substitutes) or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimetoprima or cotrimoxazol, also known as trimetoprima/sulfametoxazol (medicines used to treat infections).
• Medicines used to treat certain mental disorders such as lithium, antipsychotics or tricyclic antidepressants.
• Anesthetics.
• Opioids (medicines used to treat intense pain).
• Medicines used to treat diabetes such as insulin or oral antidiabetic medicines (e.g. metformin).
• Medicines used to treat pain or certain inflammation, such as non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, including selective COX-2 inhibitors.
• Sympathomimetics (medicines used in the treatment of certain heart and blood vessel disorders and some medicines for colds).
• Amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarina.
• Thrombolytic medicines (that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ionic 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 (medicines that decrease the rate of gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperidina (used in patients with Parkinson's disease).
• Medicines used to treat gout, such as probenecid, sulfinpirazona and allopurinol.
• Antivirals (medicines used to treat viral infections), such as amantadina.
• Cytotoxic medicines (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medicines (used to prevent rejection in organ transplants), such as ciclosporina.
• Antibiotics (medicines used to treat certain infections), such as tetracyclines, amfotericina B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• The simultaneous administration of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medicine that contains a neprilysin inhibitor such as sacubitrilo (available in a fixed-dose combination with valsartán) and racecadotrilo. It may increase the risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). See also the information in the sections “Do not take enalapril/hidroclorotiazida cinfa” and “Warnings and precautions”.

Taking enalapril/hidroclorotiazida cinfa with food, drinks and alcohol

Enalapril/hidroclorotiazida can be taken with or without food. Most people take enalapril/hidroclorotiazida with a glass of water.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Normally, your doctor will advise you to stop taking enalapril/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant and advise you to take another medicine different from enalapril/hidroclorotiazida. Enalapril/hidroclorotiazida is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding:

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Enalapril/hidroclorotiazida is not recommended for mothers who are breastfeeding.

The two active ingredients of enalapril/hidroclorotiazida cinfa, enalapril and hidroclorotiazida, pass into breast milk. If you are breastfeeding or intend to do so, consult your doctor.

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 the treatment of high blood pressure, especially at the beginning. If you experience these effects, you should consult your doctor before engaging in these activities.

Enalapril/hidroclorotiazida cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Enalapril/hidroclorotiazida cinfa contains sodium

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

Use in athletes

You should be warned that this medicine contains hidroclorotiazida, which may produce a positive result in doping control tests.

Interference with diagnostic tests

If you are to undergo any diagnostic test to assess the function of the parathyroid gland, inform your doctor that you are taking enalapril/hidroclorotiazida cinfa, as it may alter the results.

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

Remember to take your medication.

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

The recommended dose is one or two tablets administered once a day. Take enalapril/hidroclorotiazida exactly as indicated by your doctor. It is very important that you continue taking this medication for the time your doctor prescribes. 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 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 administered orally.

Take the enalapril/hidroclorotiazida tablets with the help of a glass of water.

Enalapril/hidroclorotiazida can be taken before or after meals.

The tablet can be split into equal doses.

If you take more enalapril/hidroclorotiazida cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare staff.

The most likely symptoms would be a sensation 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 cinfa

You should take enalapril/hidroclorotiazida as prescribed. 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 the treatment with enalapril/hidroclorotiazida cinfa

Your doctor will indicate the duration of your treatment with enalapril/hidroclorotiazida. Do not stop treatment before, even if you feel better.

Do not stop taking your medication unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Very common (may affect more than 1 in 10 patients).

Common (may affect up to 1 in 10 patients).

Uncommon (may affect up to 1 in 100 patients).

Rare (may affect up to 1 in 1,000 patients).

Very rare (may affect up to 1 in 10,000 patients).

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

Malignant, benign, and unspecified neoplasms (including cysts and polyps):

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

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 platelet count in blood, decrease in hematocrit (proportion of red blood cells in 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:

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

Metabolism and nutrition disorders:

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

Uncommon:low glucose and magnesium levels in blood, gout*.

Rare:increased glucose levels in blood.

Very rare:high calcium levels in blood.

Nervous system disorders:

Common:headache, dizziness, altered taste.

Uncommon:confusion,insomnia, somnolence, paresthesia, 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.

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 hemorrhage) or acute angle-closure glaucoma].

Ear and labyrinth disorders:

Uncommon:tinnitus.

Cardiac and vascular disorders:

Very common:dizziness.

Common:hypotension associated with syncope, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats).

Uncommon:flushing, palpitations (sensation of rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see section“Warnings and precautions”).

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

Respiratory, thoracic, and mediastinal disorders:

Very common:cough.

Common:breathing difficulty.

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

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

Gastrointestinal disorders:

Very common:nausea.

Common:abdominal pain, diarrhea.

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

Rare:mouth and tongue mucosa inflammation.

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

Hepatobiliary disorders:

Rare:hepatic insufficiency, hepatic 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), angioneuritic edema: facial swelling, extremities, lips, tongue, glottis, and/or larynx.

Uncommon:excessive sweating, pruritus, urticaria, hair loss.

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

A complex symptom syndrome has been reported that may include any or all of the following symptoms: fever, serositis, vasculitis, muscle and joint inflammation, positive antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. It may also cause skin rash, sensitivity to sunlight, or other skin manifestations.

Musculoskeletal and connective tissue 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:gynecomastia in men.

General disorders and administration site conditions:

Very common:fatigue.

Common:fatigue, chest pain.

Uncommon:general malaise, fever.

Investigations:

Common:high potassium levels in blood, increases in serum creatinine

Uncommon:increases in blood urea, low sodium levels in blood.

Rare:increases in liver enzymes, increases in serum bilirubin

*Only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in enalapril/hydrochlorothiazide.

†The frequency of muscle cramps as “common” applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in enalapril/hydrochlorothiazide, although the frequency of the event is “uncommon”, and applies to the 6 mg dose of hydrochlorothiazide.

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 Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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.

Do not store at a temperature above 30°C.

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

Composition of enalapril/hidroclorotiazida cinfa

The active principles are enalapril (enalapril maleate) and hidroclorotiazida. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hidroclorotiazida.

The other components are: magnesium carbonate (E-504), pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose (E-460), sodium carboxymethylstarch from potato (type A), cornstarch, dibehenate of glycerol, diestearate of glycerol, hydrogenated ricin oil, magnesium stearate (E-470b), anhydrous colloidal silica, talc (E-553b), and yellow iron oxide (E-172).

Appearance of the product and content of the container

Enalapril/hidroclorotiazida cinfa are yellow-colored, cylindrical, biconvex, scored on one side, and marked with the code “I” on the other.

They are presented in Aluminio/Aluminio blisters. Each container contains 28 or 500 (clinical container) tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - España

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - España

or

Rovi Pharma Industrial Services, S.A.

Vía Complutense, 140

28805 Alcalá de Henares (Madrid) - España

Last review date of this prospectus:November 2021.

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65699/P_65699.html

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