Enalapril/hydrochlorothiazide Cinfa 20/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

enalapril/hydrochlorothiazide cinfa 20 mg/12.5 mg tablets EFG

enalapril maleate/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 you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What enalapril/hydrochlorothiazide cinfa is and what it is used for
2. What you need to know before taking enalapril/hydrochlorothiazide cinfa
3. How to take enalapril/hydrochlorothiazide cinfa
4. Possible side effects
5. How to store enalapril/hydrochlorothiazide cinfa
6. Contents of the pack and other information

1. What enalapril/hydrochlorothiazide cinfa 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 reduce high blood pressure through different mechanisms.

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 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 enalapril/hydrochlorothiazide to treat your hypertension (high blood pressure) because it is not adequately controlled with enalapril or another ACE inhibitor alone.

2. What you need to know before taking enalapril/hydrochlorothiazide cinfa

Do not take enalapril/hydrochlorothiazide cinfa

• If you are allergic to enalapril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group 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 previously 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 early in pregnancy—see section “Pregnancy and breastfeeding”).
• If you are taking sacubitril/valsartan, a medicine for heart failure.
• If you are unsure whether you should start taking enalapril/hydrochlorothiazide, consult your doctor.

Warnings and precautions

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

• If you have heart disease 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 taking high doses of medicines that increase urine output).

• If you have blood disorders.

• If you have diabetes and are taking antidiabetic medicines, including insulin, as your antidiabetic treatment may require dose adjustment. Diabetes can cause high 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 high blood potassium levels, which can be serious.

• If you are undergoing dialysis.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines (medicines that increase potassium levels), potassium-containing salt substitutes, or other medicines that may increase blood potassium such as heparin (a medicine used to prevent blood clots), trimethoprim-containing medicines, or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat infections).

• If you develop an allergic reaction during treatment with swelling of the face, lips, tongue, and/or throat, accompanied by 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 to undergo desensitization treatment to reduce the effect of an 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 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 and lip cancer. Protect your skin from sun and UV exposure while taking enalapril/hydrochlorothiazide.

• If you are taking a medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), used in patients with heart failure, or racecadotril, used in patients with acute diarrhea. You may have an increased risk of developing an allergic reaction called angioedema.

• Inform your doctor if you are taking any of the following medicines for high blood pressure:

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

• Inform your doctor if you experience vision changes or eye pain, as these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking enalapril/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you previously had an allergy to penicillin or sulfonamide.

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

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

• 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 early in pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents

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

Use in elderly patients

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

Other medicines and enalapril/hydrochlorothiazide cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your dose and/or take other precautions.

It is especially important to inform your doctor if you are taking or have recently taken any of the following medicines:

• An angiotensin II receptor antagonist (ARA-II) or aliskiren (see also “Do not take enalapril/hydrochlorothiazide cinfa” and “Warnings and precautions”).
• Antihypertensive medicines (lower high blood pressure), e.g., vasodilators, beta-blockers, diuretics.
• Potassium-containing medicines (including dietary salt substitutes) or other medicines that may increase blood potassium, such as heparin (a medicine used to prevent blood clots), trimethoprim-containing medicines, or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat infections).
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioid 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), including acetylsalicylic acid, and selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (used in treating 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 and vitamin D salts.
• 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, 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).
• Concomitant use of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan) or racecadotril. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also information in sections “Do not take enalapril/hydrochlorothiazide cinfa” and “Warnings and precautions”.

Taking enalapril/hydrochlorothiazide cinfa with food, drinks, and alcohol

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

Alcohol may enhance the blood pressure-lowering effect (hypotensive 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Usually, your doctor will advise you to stop taking enalapril/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine. enalapril/hydrochlorothiazide is not recommended during pregnancy and must 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 planning to breastfeed. enalapril/hydrochlorothiazide is not recommended for breastfeeding mothers.

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

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 these effects, consult your doctor before engaging in such activities.

enalapril/hydrochlorothiazide cinfa contains lactose

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

enalapril/hydrochlorothiazide cinfa contains sodium

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

Use in athletes

Patients should be informed that this medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

Interference with diagnostic tests

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

3. How to take enalapril/hydrochlorothiazide cinfa

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

Remember to take your medicine.

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

The recommended dose is one or two tablets taken once daily. Take enalapril/hydrochlorothiazide every day exactly as directed by your doctor. It is very important that you continue taking this medicine for as long as your doctor has prescribed it. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than occurs later 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 administered orally.

Take the enalapril/hydrochlorothiazide tablets with a glass of water.

Enalapril/hydrochlorothiazide may be taken before or after meals.

The tablet may be divided into equal doses.

If you take more enalapril/hydrochlorothiazide cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to bring the medicine packaging and leaflet to healthcare personnel.

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 cinfa

You should take enalapril/hydrochlorothiazide as prescribed. 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 cinfa

Your doctor will advise you on the duration of your treatment with enalapril/hydrochlorothiazide. Do not stop treatment early, even if you feel better.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

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).

Benign, malignant 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 (blood cells that carry oxygen).
Rare: reduction in a type of white blood cells (neutrophils), decrease in hemoglobin (the 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 suppression (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: low blood potassium levels, increased cholesterol, increased triglycerides, increased blood uric acid levels.
Uncommon: low blood glucose and magnesium levels, gout*.
Rare: increased blood glucose levels.
Very rare: high blood calcium levels.

Nervous system disorders:

Common: headache, syncope, taste disturbances.
Uncommon: confusion, insomnia, drowsiness, 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: tinnitus (ringing in the ears).

Cardiac and vascular disorders:

Very common: dizziness.
Common: low 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 “Warnings and precautions”).
Rare: color changes in the skin 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 (breathing difficulty) and asthma.
Rare: pulmonary infiltrates, respiratory discomfort (including pneumonia and pulmonary edema), nasal mucosal inflammation, 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: abdominal pain, diarrhea.
Uncommon: vomiting, intestinal obstruction with severe pain, pancreatitis, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence*.
Rare: infection or inflammation of the mouth mucosa, 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 (jaundice), gallbladder inflammation (particularly in patients with pre-existing gallstones 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.

A symptomatic complex has been reported that may include all or some of the following symptoms: fever, serositis, vasculitis, muscle pain/swelling, joint pain/swelling, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis. Skin rash, photosensitivity, or other skin manifestations may also occur.

Musculoskeletal and connective tissue 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: reduced 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: fatigue.

Common: fatigue, chest pain.

Uncommon: malaise, fever.

Investigations:

Common: elevated blood potassium levels, increased serum creatinine.
Uncommon: increased blood urea, low blood sodium levels.
Rare: increased liver enzymes, increased serum bilirubin.

* Observed only 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 this event is "uncommon" and applies to the 6 mg dose of hydrochlorothiazide.

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 enalapril/hydrochlorothiazide cinfa

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, 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 enalapril/hydrochlorothiazide cinfa

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

The other components are: magnesium carbonate (E-504), pregelatinized corn starch, monohydrate lactose, microcrystalline cellulose (E-460), sodium carboxymethyl potato starch (type A), corn starch, glycerol dibehenate, glycerol distearate, hydrogenated castor oil, magnesium stearate (E-470b), anhydrous colloidal silica, talc (E-553b) and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

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

The product is presented in aluminum/aluminum blisters. Each pack contains 28 or 500 tablets (hospital pack).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

or

Rovi Pharma Industrial Services, S.A.

Vía Complutense, 140

28805 Alcalá de Henares (Madrid) - Spain

Date of the most recent review of this leaflet: November 2021.

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65699/P_65699.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65699/P_65699.html