ENALAPRIL/HYDROCHLOROTHIAZIDE TECNIGEN 20/12.5 mg TABLETS

2. What you need to know before you take Enalapril/Hydrochlorothiazide TecniGen

Do not take Enalapril/Hydrochlorothiazide TecniGen:

• If you are allergic to enalapril, hydrochlorothiazide or any other component of this medicine listed in section 6.
• If you have been previously treated with a medicine from the same group of medicines 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/Hydrochlorothiazide 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 sulphonamide-derived substances. Ask your doctor if you are not sure what sulphonamide-derived medicines are.
• If you are unable to urinate.
• If you have kidney or liver disease.
• If you are more than 3 months pregnant. (It is recommended that you avoid treatment with Enalapril/Hydrochlorothiazide during the first 3 months. See the section on “Pregnancy, breastfeeding and fertility”)
• If you have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren)
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 not sure, consult your doctor before taking Enalapril/Hydrochlorothiazide.

Warnings and precautions

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

• 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 severe shortness of breath or difficulty breathing after taking Enalapril/Hydrochlorothiazide, seek medical attention immediately

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g. valsartan, telmisartan, irbesartan), particularly if you have diabetes-related kidney problems.
• aliskiren

• If you think you may be pregnant (or may become pregnant). Enalapril/Hydrochlorothiazide is not recommended at the start of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby. (See the section on “Pregnancy, breastfeeding and fertility”)

• Tell your doctor about any health problems you have or may have, and about any allergies you have.

• 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-salt diet, take potassium supplements, potassium-sparing medicines (medicines that increase urine elimination) 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, which can be serious. In these cases, your doctor will adjust the dose of Enalapril/Hydrochlorothiazide and monitor your potassium levels in the blood.

• If you have diabetes and are taking medicines to treat diabetes, including insulin, as it may be necessary to adjust the dose of the medicines used to treat diabetes, especially during the first month of treatment with Enalapril/Hydrochlorothiazide.

• If you have had any 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 LDL or bad cholesterol particles from the blood in cases where it is excessively high) or if you are going to undergo desensitization treatment to reduce the effect of a bee or wasp sting allergy.

• If you have low blood pressure, as the use of Enalapril/Hydrochlorothiazide, 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 need to undergo 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 the anesthesia.

• 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 can occur between hours and weeks after taking Enalapril/Hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be more likely to develop it if you have had an allergy to penicillin or sulphonamides.

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

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

Elderly people

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

Children and adolescents

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

Taking Enalapril/Hydrochlorothiazide TecniGen with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In general, Enalapril/Hydrochlorothiazide can be used with other medicines. Your doctor may need to change your dose and/or take other precautions:

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

To prescribe the correct dose of Enalapril/Hydrochlorothiazide, your doctor needs to know if you are taking other medicines to lower blood pressure, medicines to treat diabetes (including oral antidiabetics or insulin), diuretics, potassium-containing medicines (including dietary salt substitutes), lithium (a medicine used to treat a particular type of depression), tricyclic antidepressants, antipsychotics, sympathomimetic medicines, some medicines used to treat pain or certain types of arthritis, including treatments that contain gold salts, alcohol, anesthetics, non-depolarizing muscle relaxants, barbiturates, narcotics, colestyramine and colestipol resins, digitalis glycosides, corticosteroids, ACTH, laxatives, cytostatics (such as cyclophosphamide, methotrexate), medicines that can increase the QT interval (such as quinidine, procainamide, amiodarone, sotalol), acetylsalicylic acid, thrombolytics and beta-blockers.

Taking Enalapril/Hydrochlorothiazide TecniGen with food, drinks and alcohol:

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

Pregnancy, breastfeeding and fertility:

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

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

As a general rule, your doctor will advise you to stop treatment with Enalapril/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and take another medicine instead of Enalapril/Hydrochlorothiazide. Enalapril/Hydrochlorothiazide is not recommended at the start of pregnancy and should not be used after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding:

You should tell your doctor if you are breastfeeding or plan to breastfeed. Enalapril/Hydrochlorothiazide is not recommended during breastfeeding.

Driving and using machines:

Individual responses to this medicine may vary. Some side effects reported with Enalapril/Hydrochlorothiazide may affect some patients' ability to drive or operate machinery (see section 4. Possible side effects).

Enalapril/Hydrochlorothiazide contains lactose and sodium:

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

Interference with diagnostic tests:

If you are to undergo any diagnostic test to assess parathyroid gland function, inform your doctor that you are being treated with Enalapril/Hydrochlorothiazide, as it may alter the results.

Use in athletes:

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

3. How to take Enalapril/Hydrochlorothiazide TecniGen 20/12.5 mg tablets

Follow exactly the administration instructions indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

The maximum daily dose is 2 tablets.

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

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

If you have been taking diuretics before starting treatment, or follow a low-salt diet, your doctor will stop the diuretic 2 or 3 days before starting treatment or reduce the initial dose of this medicine.

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

Symptoms:

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

Treatment:

In case of overdose, contact your doctor or pharmacist, or the Toxicology Information Service, Telephone: 91-562 04 20, immediately.

If you forget to take Enalapril/Hydrochlorothiazide TecniGen:

You should take the dose of Enalapril/Hydrochlorothiazide 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 make up for forgotten doses.

Restart taking the medicine as originally indicated.

If you stop taking Enalapril/Hydrochlorothiazide TecniGen

Do not stop treatment with Enalapril/Hydrochlorothiazide unless your doctor tells you to.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

The frequent adverse effects are hypokalemia, increased cholesterol, increased triglycerides, hyperuricemia, headache, depression, syncope, altered 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 infrequent adverse 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 cerebrovascular accident, possibly secondary to excessive blood pressure reduction in high-risk patients, rhinorrhea, throat irritation, hoarseness, bronchospasm/asthma, ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer, flatulence, sweating, pruritus, urticaria, alopecia, arthralgia, renal failure, and proteinuria, impotence, general malaise, fever, increased uremia, hyponatremia.

The rare adverse effects are neutropenia, decreased hemoglobin, decreased 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/apthous ulcers, glossitis, hepatic failure, hepatic necrosis (which can be fatal), hepatocellular or cholestatic hepatitis, jaundice, cholecystitis (especially in patients with pre-existing cholelithiasis) multiforme edema, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus, erythroderma, pemphigus, oliguria, interstitial nephritis, gynecomastia, increased liver enzymes, increased serum bilirubin.

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

The adverse effects of unknown frequency are syndrome of inadequate 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 effusion) or acute angle-closure glaucoma].

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

Stop taking Enalapril/Hydrochlorothiazide and contact your doctor immediately 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 skin rashes (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 drop in blood pressure than will occur after continued treatment. You may feel faint or dizzy and lying down may help. If this is your case, consult your doctor.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Enalapril/Hydrochlorothiazide TecniGen

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25 °C.

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

Medicines should not be thrown into wastewater or trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril/Hydrochlorothiazide Tecnigen 20 mg/12.5 mg

The active ingredients are enalapril maleate and hydrochlorothiazide

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

Appearance of the Product and Package Contents

The Enalapril/Hydrochlorothiazide Tecnigen 20 mg/12.5 mg tablets are white, round and biconvex. Each package contains 10, 28, 30, 60 or 500 tablets in blister packs. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tecnimede España, Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Madrid. Spain

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

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

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

Date of the Last Revision of this Prospectus: May 2023

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/