Label: information for the user

Enalapril/Hidroclorotiazida TecniGen 20 mg/12.5 mg tablets EFG

Enalapril maleate/Hydrochlorothiazide

Read this label carefully before starting to take this medicine because it contains important information for you

This medication contains enalapril maleate and hidroclorotiazide.

The active ingredient enalapril belongs to a group of medicines called 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 active ingredient hidroclorotiazide belongs to a group of medicines known as thiazide diuretics, which cause the kidneys to eliminate a greater amount of water and salts.

Together, enalapril and hidroclorotiazide help to effectively reduce elevated blood pressure in cases where one of the components has not produced the desired effect.

Your doctor has prescribed Enalapril/Hidroclorotiazida to treat your hypertension (high blood pressure).

Do not take Enalapril/Hidroclorotiazida TecniGen:

• If you are allergic to enalapril, hidroclorotiazida or to any other component of this medication included in section 6.
• If you have been previously treated with a medication from the same group of drugs as enalapril (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing. You should not take Enalapril/Hidroclorotiazida if you have had this type of reaction without a known cause or if you have been diagnosed with idiopathic or hereditary angioedema.
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medications are.
• If you are unable to urinate.
• If you have kidney or liver disease.
• If you are more than 3 months pregnant. (It is best to avoid treatment with Enalapril/Hidroclorotiazida during the first 3 months. See the section on “Pregnancy, breastfeeding and fertility”)
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskirén)
• If you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

If you are unsure, consult with your doctor before starting to take Enalapril/Hidroclorotiazida.

Warnings and precautions:

Consult your doctor, pharmacist or nurse before starting to take Enalapril/Hidroclorotiazida:

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Enalapril/Hidroclorotiazida, seek medical attention immediately

• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• Aliskirén

• If you think you may be pregnant. 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 severe damage to your baby if used at this stage. (See the section on “Pregnancy, breastfeeding and fertility”).

• Inform your doctor about any health problems you have or may have, including allergies.

• If you have heart disease, blood disorders, gout, are undergoing dialysis or are being treated with diuretics or have recently had excessive vomiting or diarrhea.

• If you follow a low-sodium diet, take potassium supplements, medications that conserve potassium (medications that increase the elimination of urine) or salt substitutes that contain potassium.

• If you are over 70 years old

• If you have diabetes or kidney problems (including kidney transplant), as these may cause high levels of potassium in the blood that can be severe. In these cases, your doctor will adjust your Enalapril/Hidroclorotiazida dose and monitor your potassium levels in the blood.

• If you have diabetes and are taking medications to treat diabetes, including insulin, as you may need to adjust your diabetes medication dose, especially during the first month of treatment with Enalapril/Hidroclorotiazida.

• If you have had an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing.

• 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) or 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, may cause a sudden drop in blood pressure (you may notice it as dizziness or fainting, especially when standing up).

• If you are to undergo 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.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly 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 exposure to the sun and UV rays while taking Enalapril/Hidroclorotiazida.

• 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 eye pressure and may occur between hours and weeks after taking Enalapril/Hidroclorotiazida. If left untreated, this may lead to permanent vision loss. You may be at higher risk of developing it if you have had an allergy to penicillin or sulfonamides.

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

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

Older adults:

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

Children and adolescents:

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

Enalapril/Hidroclorotiazida TecniGen with other medications:

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

Enalapril/Hidroclorotiazida can generally be used with other medications. Your doctor may need to adjust your dose and/or take other precautions:

-If you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Enalapril/Hidroclorotiazida TecniGen” and “Warnings and precautions”.

To prescribe the correct dose of Enalapril/Hidroclorotiazida, your doctor needs to know if you are taking other blood pressure-lowering medications, diabetes medications (including oral antidiabetics or insulin), diuretics, potassium-containing medications (including salt substitutes), lithium (a medication used to treat a particular type of depression), tricyclic antidepressants, antipsychotics, sympathomimetic medications, certain pain medications or arthritis treatments, including those containing gold salts, alcohol, anesthetics, non-depolarizing muscle relaxants, barbiturates, narcotics, cholestyramine and colestipol resins, digitalis glycosides, corticosteroids, ACTH, laxatives, cytostatics (such as cyclophosphamide, methotrexate), medications that may prolong the QT interval (such as quinidine, procainamide, amiodarone, sotalol), aspirin, thrombolytics and beta-blockers.

Enalapril/Hidroclorotiazida TecniGen with food, drinks and alcohol:

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

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

You should inform your doctor if you think you may be pregnant.

Generally, your doctor will advise you to stop treatment with Enalapril/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant and take another medication instead of Enalapril/Hidroclorotiazida. Enalapril/Hidroclorotiazida is not recommended at the beginning of pregnancy and should not be used after the third month of pregnancy, as it may cause severe damage to your baby.

Breastfeeding:

You should inform your doctor if you are breastfeeding or plan to do so. Enalapril/Hidroclorotiazida is not recommended during breastfeeding.

Driving and operating machinery:

Individual responses to this medication may vary. Some adverse reactions reported with Enalapril/Hidroclorotiazida may affect some patients' ability to drive or operate machinery (see section 4. Possible adverse reactions).

Enalapril/Hidroclorotiazida contains lactose and sodium:

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 1mmol (23 mg) of sodium per tablet; it is essentially “sodium-free”.

Interference with diagnostic tests:

If you are to undergo any diagnostic tests to evaluate parathyroid gland function, inform your doctor that you are taking Enalapril/Hidroclorotiazida, as it may alter the results.

Use in athletes:

It is reported to athletes that this medication contains a component that may produce a positive result in doping control tests.

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

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

The recommended dose is 1 or 2 tablets taken once a day. They should be taken preferably with water.

The maximum daily dose is 2 tablets.

Take Enalapril/Hidroclorotiazida TecniGen every day, exactly as indicated by your doctor. It is very important to continue taking this medication for the recommended time.

Do not change the prescribed dose and do not stop taking the medication without consulting your doctor.

If you have taken diuretics before starting treatment, or are following a low-sodium diet, your doctor will discontinue the diuretic 2 or 3 days before starting treatment or reduce the initial dose of this medication.

If you take more Enalapril/Hidroclorotiazida TecniGen than you should:

Symptoms :

The most likely symptoms in case of overdose are: a sudden or excessive drop in blood pressure, causing dizziness or vertigo, and/or excessive thirst, disorientation, decreased urine production, and/or rapid heartbeats (tachycardia).

Treatment :

In case of taking an excessive dose, contact your doctor or pharmacist immediately, or the Toxicology Information Service, Phone: 91-562 04 20.

If you forgot to take Enalapril/Hidroclorotiazida TecniGen:

You should take the dose of Enalapril/Hidroclorotiazida indicated by your doctor as soon as possible, but if it is almost time for the next dose, do not take it. Do not take a double dose to compensate for the missed doses.

Resume taking the medication as originally indicated.

If you interrupt treatment with Enalapril/Hidroclorotiazida TecniGen

Do not discontinue treatment with Enalapril/Hidroclorotiazida unless your doctor instructs you to do so.

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

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

The very common side effects are blurred vision, dizziness, cough, discomfort (nausea) and weakness.

The common side effects are hypokalemia, increased cholesterol, increased triglycerides, hyperuricemia, headache, depression, syncope, alteration of taste, hypotension, orthostatic hypotension, changes in heart rhythm, angina, tachycardia, dyspnea, diarrhea, abdominal pain, skin rash, muscle cramps, chest pain, fatigue, hyperkalemia and increased serum creatinine.

The uncommon side effects are anemia (including aplastic and hemolytic anemia), hypoglycemia, hypomagnesemia, gout, confusion, somnolence, insomnia, nervousness, paresthesia, vertigo, decreased libido, tinnitus, flushing, palpitations, myocardial infarction or stroke, possibly secondary to excessive blood pressure decrease in high-risk patients, rhinorrhea, sore throat, hoarseness, bronchospasm/asthma, ileus, pancreatitis, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer, flatulence, sweating, pruritus, urticaria, alopecia, arthralgia, renal insufficiency, renal failure and proteinuria, impotence, general malaise, increased uremia, hyponatremia.

The rare side effects are neutropenia, decrease in hemoglobin, decrease in hematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, leucopenia, pancytopenia, lymphadenopathy and autoimmune diseases, increased blood glucose, abnormal dreams, sleep disorders, paralysis (due to hypokalemia), Raynaud's phenomenon, pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), rhinitis, allergic alveolitis/eosinophilic pneumonia, stomatitis/aphthous ulcers, glossitis, hepatic insufficiency, hepatic necrosis (which can be fatal), hepatocellular or cholestatic hepatitis, jaundice, cholecystitis (particularly in patients with pre-existing cholelithiasis) and multiple edema, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus, erythrodermia, pemphigus, oliguria, interstitial nephritis, gynecomastia, increased hepatic enzymes, increased serum bilirubin.

The very rare side effects are hypercalcemia, interstitial angioedema and acute respiratory distress (the signs include severe respiratory difficulty, fever, weakness and confusion).

The side effects of unknown frequency are syndrome of inappropriate antidiuretic hormone secretion (SIADH), skin and lip cancer (non-melanoma skin cancer) and 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].

Rarely, other side effects may appear and some can be severe. Consult your doctor or pharmacist for more detailed information on side effects.

Stop taking Enalapril/Hidroclorotiazida and immediately contact your doctor in the following cases:

- If you notice swelling of the face, tongue, lips or throat that causes difficulty swallowing or breathing.

- If your hands, feet or ankles swell

- If you have a skin rash (urticaria)

You should be aware that black patients have a higher risk of developing this type of reaction to ACE inhibitors.

The initial dose may cause a greater decrease in blood pressure than will occur after continued treatment. You may notice dizziness or fainting and lying down may help. If this is your case, consult your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use. Website: 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 store at a temperature above 25 °C.

Do not use this medication after the date indicated on the packaging. It is marked as CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of in wastewater or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Tecnigen 20 mg/12.5 mg

The active principles are enalapril maleate and hidroclorotiazida

The other components (excipients) are: microcrystalline cellulose, cornstarch, sodium bicarbonate, magnesium stearate, lactose monohydrate, and sodium starch glycolate

Appearance of the product and contents of the packaging

The Enalapril/Hidroclorotiazida Tecnigen 20 mg/12.5 mg tablets are white, round, and biconvex. Each package contains 10, 28, 30, 60, or 500 tablets in a blister. Some package sizes may only be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Tecnimede España, Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor, Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Madrid. Spain

Responsible for manufacturing:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-228 Sintra, Portugal

This medication is authorized in Portugal under the name Enalapril/Hidroclorotiazida Farmoz 20/12.5 mg tablets.

Date of the last review of this leaflet: May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es/