Patient Information Leaflet

Enalapril/Hydrochlorothiazide Teva 20 mg/12.5 mg

Tablets EFG

Enalapril maleate/hydrochlorothiazide (HCT)

Read this leaflet carefully before you start taking this medicine, as 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, and you must 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.

Contents of the pack and additional information

• Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors) and lowers blood pressure by widening blood vessels.
• Hidroclorotiazida belongs to a group of medicines called diuretics and lowers blood pressure by increasing urine production.
• Enalapril/Hidroclorotiazida Teva contains a combination of enalapril and hidroclorotiazida and is used as a treatment for high blood pressure when treatment with enalapril alone has been shown to be ineffective.

Your doctor may also prescribe enalapril/hidroclorotiazida instead of separate tablets of the same doses of enalapril and hidroclorotiazida.

This fixed-dose combination is not suitable as initial therapy.

Do not take Enalapril/Hidroclorotiazida Teva

• If you are allergic to enalapril, hidroclorotiazida, or any of the other components of this medication (listed in section 6).
• If you are allergic to other angiotensin-converting enzyme (ACE) inhibitors, for example ramipril, or to medications derived from sulfonamides (most antibiotics, for example sulfamethoxazole).
• If you have previously experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema) when treated with other medications belonging to the group of medications called ACE inhibitors (such as ramipril).
• If you have taken or are currently taking sacubitrilo/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 the area of the throat) is increased.
• If you have previously experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema) under any other circumstances.
• If a member of your family has previously experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema).
• If you have severe kidney problems.
• If you are unable to urinate.
• If you have severe liver problems or a neurological disorder as a result of severe liver disease (hepatic encephalopathy).
• If you are more than 3 months pregnant (it is better to avoid taking Enalapril/Hidroclorotiazida at the beginning of your pregnancy – see section 2: Pregnancy, breastfeeding, and fertility).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril/Hidroclorotiazida Teva.

• If you have atherosclerosis, cerebrovascular problems such as a stroke or transient ischemic attack (TIA, a "mini-stroke").
• If you have heart failure.
• If you have low blood pressure, follow a low-sodium diet or are taking diuretics.
• If you have abnormal levels of water and minerals in your body (electrolyte imbalance).
• If you have hypertrophic cardiomyopathy, aortic stenosis, or another type of cardiac problem called outflow tract obstruction.
• If you are undergoing LDL apheresis (blood cholesterol removal using a machine).
• If you are undergoing desensitization treatment for insect venom, such as bee or wasp sting.
• If you have diabetes.
• If you have gout, elevated uric acid levels in your blood, or are being treated with allopurinol.
• If you need to undergo anesthesia.
• If you have recently experienced severe vomiting, prolonged, and/or severe diarrhea.
• If you are about to undergo a parathyroid function test.
• If you have or have had kidney or liver problems, or have renal artery stenosis, or have only one functioning kidney, or are undergoing dialysis.
• If you have a vascular collagen disease such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin eruptions, joint pain, and fever.
• If you have allergies or asthma.
• If you are taking lithium, used to treat certain psychiatric disorders.
• 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

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

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

• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• Sirolimus, everolimus, temsirolimus, and other medications in the class of mTOR inhibitors (used to prevent organ transplant rejection);
• Racecadotril, a medication used to treat diarrhea;
• Vildagliptina, a medication used to treat diabetes
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Enalapril/Hidroclorotiazida Teva.
• If you experience a decrease in visual acuity, it could be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within a few hours to weeks after taking Enalapril/Hidroclorotiazida Teva. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing it.
• 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 Teva, seek medical attention immediately

You must inform your doctor if you think you are (or may be) pregnant. Enalapril/Hidroclorotiazida Teva is generally not recommended if the following occurs, so consult your doctor before starting to take this medication:

• If you have recently undergone a kidney transplant.
• If you have high potassium levels in your blood.

See the section “Other medications and Enalapril/Hidroclorotiazida Teva” below.

Inform your doctor if you are a competitive athlete who is subject to doping control, as enalapril/hidroclorotiazida contains an active ingredient that may produce positive results in a doping test.

Older patients or malnourished patients should exercise caution when using enalapril/hidroclorotiazida.

Enalapril/hidroclorotiazida may be less effective in black people.

This medication is not recommended for use in children.

While taking enalapril/hidroclorotiazida:

If you develop any of the following symptoms, inform your doctor immediately:

• You feel dizzy after the first dose. Some people react to their first dose or when their dose is increased, feeling dizzy, lightheaded, and unwell.
• Swelling of the lips, face, and neck, possibly also hands and feet, accompanied by a hissing sound during breathing or snoring. This condition is called angioedema. This can occur at any time during treatment. ACE inhibitors produce a higher rate of angioedema in black patients than in non-black patients.
• Elevated temperature, sore throat, or mouth ulcers (these may be symptoms of infection caused by a decrease in white blood cell count).
• Yellowing of the skin and white of the eyes (jaundice) that may be a sign of liver disease.
• Persistent dry cough. A dry cough has been observed with the use of ACE inhibitors, but it may also be a symptom of another upper respiratory tract disease.

Other medications and Enalapril/Hidroclorotiazida Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, herbs, or natural products.

• Potassium supplements or salt substitutes that contain potassium or calcium.
• Diuretics used to treat high blood pressure, including potassium-sparing diuretics, such as spironolactone, triamterene, or amiloride.
• Other medications that decrease potassium levels in your body (such as laxatives, amphotericin B).
• Other medications that may increase potassium levels in your body (such as heparin, tacrolimus, cyclosporine, and cotrimoxazole, also known as trimethoprim/sulfamethoxazole).
• Other medications used to treat high blood pressure

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 Teva” and “Warnings and precautions”).

• Anesthetics and medications for treating mental disorders or depression, medications for treating psychotic disorders, tricyclic antidepressants, or sedatives.
• Lithium (a medication used to treat certain mental disorders).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) as they may prevent your blood pressure from being well-controlled and may increase the level of potassium in your blood.
• Gold injections (aurintrimalate of sodium) a medication for injecting against rheumatoid arthritis.
• A medication for treating prostate cancer (estradiol).
• Medications such as ephedrine used for cough and cold, or noradrenaline or adrenaline used to reduce blood pressure, shock, heart failure, asthma, or allergies.
• Medications that decrease blood sugar levels, such as insulin or those taken orally.
• Cholestyramine and colestipol, active principles that decrease lipid levels in the blood.
• Corticosteroids, substances such as anti-inflammatory hormones
• Corticotropin (ACTH) used mainly to analyze if the adrenal glands function correctly.
• Muscle relaxants (e.g. tubocurarine chloride, medications to relax muscles used in operations).
• Medications for treating cancer, such as cyclophosphamide or methotrexate.
• Medications for treating epilepsy (carbamazepine, oxcarbazepine)
• Contrast agents containing iodine
• Cardiac glycosides (e.g. digoxin, medications to strengthen the heart).
• Medications that, as an adverse effect, cause abnormalities in the conduction of stimuli in the heart, such as medications for treating arrhythmias (e.g. quinidine, procainamide, amiodarone, sotalol).
• Medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section “Warnings and precautions”.

• Racecadotril (a medication used to treat diarrhea).

Enalapril/Hidroclorotiazida Teva with food, drinks, and alcohol

Enalapril/Hidroclorotiazida Teva can be taken without regard to meals.

Drinking alcohol with this medication may increase the blood pressure-lowering effect (and may cause dizziness when standing up, among other things).

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 must inform your doctor if you think you are (or may be) pregnant. In general, your doctor will advise you to stop taking Enalapril/Hidroclorotiazida Tevabefore becoming pregnant or as soon as you know you are pregnant, and will recommend taking another antihypertensive medication instead. Enalapril/Hidroclorotiazida Teva is not recommended during pregnancy, and it should not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding.

Enalapril/Hidroclorotiazida is not recommended for mothers who are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Dizziness and fatigue have been reported in people taking enalapril/hidroclorotiazida; if you experience any of these symptoms, do not drive a car or operate machinery (see section 4. “Possible side effects”).

Enalapril/Hidroclorotiazida Teva contains lactose and sodium

Patients with lactose intolerance should be aware that this medication contains a small amount of 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 mmolof sodium (23 mg); it is essentially “sodium-free”.

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

Adults

The recommended dose is one tablet once a day.

Senior patients

Your doctor may adjust the dose of enalapril and hidroclorotiazida carefully.

Patients with kidney problems

Your doctor will adjust the dose of enalapril and hidroclorotiazida carefully.

Administration form

The tablets should be swallowed with a glass of water. Enalapril/hidroclorotiazida can be taken with food or on an empty stomach.

If you take more Enalapril/Hidroclorotiazida Teva than you should

If you (or someone) ingest many tablets together, or if you think a child has swallowed some tablets, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. A overdose may cause decreased blood pressure, an excessively fast or slow heartbeat, palpitations (sensation of an excessively fast or irregular heartbeat), shock, rapid breathing, cough, nausea, and vomiting, muscle cramps, dizziness, numbness, confusion, or anxiety, excessive urination, or inability to urinate. Please bring this leaflet, the remaining tablets, and the packaging to the hospital or to your doctor so they know which tablets you are taking.

If you forget to take Enalapril/Hidroclorotiazida Teva

Do not take a double dose to make up for the missed doses, take the next dose at the usual time.

If you interrupt the treatment with Enalapril/Hidroclorotiazida Teva

The treatment of hypertension is a long-term treatment and interrupting this treatment should be discussed with your doctor. Stopping or suspending your treatment may cause an increase in blood pressure.

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

Like all medicines, Enalapril/Hidroclorotiazida Teva can cause side effects, although not everyone will experience them:

If you experience any of the following, stop taking Enalapril/Hidroclorotiazida and immediately inform your doctor or go to the nearest hospital emergency room:

• A severe allergic reaction called angioedema (hives, itching, swelling of the extremities, face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious and frequent side effect. You may need urgent medical attention or hospitalization.

• Jaundice (yellowing of the skin and white of the eyes).

This is a potentially serious but rare side effect indicative of liver inflammation. You may need urgent medical attention or hospitalization.

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion). This is a serious but very rare side effect.

Enalapril/Hidroclorotiazida frequently causes a decrease in blood pressure that may be associated with dizziness and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, you should contact your doctor immediately.

Enalapril/Hidroclorotiazida can cause a reduction in the number of white blood cells and may decrease your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, you should see your doctor immediately. They will perform a blood test to check for possible reduction of white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

A very frequent side effect has been reported, a dry cough, which may persist for a long time with the use of Enalapril/Hidroclorotiazida and other ACE inhibitors, but may also be a symptom of another upper respiratory tract disease. You should contact your doctor if this symptom appears.

The following side effects have also been reported:

Very frequent (may affect more than 1 in 10 people)

• Blurred vision
• Dizziness
• Cough
• Nausea
• Drowsiness

Frequent (may affect up to 1 in 10 people)

• Headache, depression, low blood pressure
• Fainting, chest pain, abnormal heart rhythm, angina, rapid heartbeat (tachycardia)
• Heart attack or stroke (“mini-stroke”) (mainly in patients with low blood pressure)
• Shortness of breath
• Diarrhea, abdominal pain, distorted sense of taste, changes in taste, fluid retention (edema)
• Rash, hypersensitivity/angioneuritic edema: angioneuritic edema of the face, extremities, lips, tongue, glottis, and/or larynx has been reported
• Fatigue
• Muscle cramps
• Elevated potassium levels in the blood, which may cause abnormal heart rhythm; increased creatinine levels in the blood, low potassium levels in the blood, elevated cholesterol levels, increased triglyceride levels, elevated uric acid levels in the blood

Rare (may affect up to 1 in 100 people)

• Reduction in the number of red blood cells, which may cause pale skin and produce weakness or difficulty breathing (anemia)
• Hypoglycemia (low blood sugar) (see “Warnings and precautions”)
• Confusion, drowsiness, insomnia, nervousness, numbness or tingling, vertigo
• Low blood pressure associated with changes in posture (such as feeling dizzy or weak when standing up after lying down), palpitations (a feeling of rapid or irregular heartbeat), heart attack or stroke (in high-risk patients)
• Runny nose, sore throat, hoarseness, difficulty breathing, whistling sound during breathing
• Intestinal obstruction, pancreatitis (inflammation of the pancreas that causes severe abdominal and back pain), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence, gout
• Sweating, itching, urticaria, hair loss
• Renal problems, protein in the urine
• Joint pain
• Impotence, decreased libido
• Muscle cramps, flushing, ringing in the ears, feeling unwell, fever
• Low magnesium levels in the blood (hypomagnesemia)
• Low sodium levels in the blood, which may cause fatigue and confusion, muscle cramps, seizures, or coma, also leading to dehydration and low blood pressure that makes you feel dizzy when standing up; increased urea levels in the blood

Rare (may affect up to 1 in 1,000 people)

• Reduction in the number of white blood cells, making infections more frequent, reduction in the number of other blood cells, changes in blood composition, reduced bone marrow production, lymph node disease, autoimmune disease, in which the body attacks itself
• Strange dreams, sleep disorders
• Raynaud's syndrome, a blood vessel disorder that causes numbness in the fingers and toes and they turn pale, then blue, and then red
• Pulmonary problems that include pneumonia, difficulty breathing (including inflammation (pneumonitis) and fluid accumulation in the lungs (pulmonary edema)), allergic reaction in the lungs (allergic alveolitis), eosinophilic pneumonitis (a lung disease)
• Ulcers in the mouth, inflammation of the tongue
• Liver problems
• Skin rash, severe blisters, skin redness, Stevens-Johnson syndrome (blisters on the skin, mouth, eyes, and genitals), Lyell syndrome (the skin appears as if it has been burned and exfoliated), pemphigus (a disease that produces blisters and lesions that usually start in the mouth, urticaria, hair loss, and itching), skin sensitivity to light, skin disease with scaly, red patches on the nose and cheeks (lupus erythematosus). This disease may worsen in patients who already have severe allergic reactions. Sometimes, skin problems may be accompanied by fever, severe inflammation, inflammation of blood vessels, muscle pain, and/or joint pain, changes in blood composition, and an increase in the sedimentation rate (a blood test is used to detect inflammation)
• Reduced urine production, interstitial nephritis (inflammation of the kidneys)
• Increased breast tissue in men
• Increased levels of liver enzymes and waste products, increased blood glucose levels
• Muscle weakness, sometimes due to low potassium levels

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

• Intestinal inflammation
• Elevated calcium levels in the blood

Frequency unknown (cannot be estimated from available data)

• Adrenocorticotropic hormone (ACTH) secretion disorder. Increased levels of sugar, fat, or uric acid in the blood, glucose in urine; low potassium levels in the blood, which may cause muscle weakness, cramps, or abnormal heart rhythm; elevated calcium levels in the blood that cause abdominal pain, nausea, and vomiting, constipation, loss of appetite, excessive thirst, excessive urination, fatigue, weakness, and weight loss.

• Skin cancer and lip cancer (non-melanoma skin cancer).
• Loss of 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).

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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 medication.

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 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 drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Teva 20 mg/12.5 mg tablets

• The active principles are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other components (excipients) are lactose monohydrate, cornstarch (gluten-free), pregelatinized cornstarch, sodium hydrogen carbonate, magnesium stearate.

Appearance and contents of the packaging

• Enalapril/Hidroclorotiazida Teva 20 mg/12.5 mg tablets are white, round, slightly arched, marked with “EL”, “20” and a notch on one side and flat on the other side. The tablet can be divided into two equal halves.

Enalapril/Hidroclorotiazida Teva 20 mg/12.5 mg tablets are available in packaging sizes of 14, 20, 28, 28 (4x7), 30, 49, 49 (49x1), 50, 56, 60, 90, 98, 98 (14x7) and 100 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Pharmachemie B.V

Swensweg 5

Postbus 552

2003 RN Haarlem

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: Enalapril Hydrochlorthiazid “Teva”, tabletter

Spain: Enalapril/ Hidroclorotiazida Teva 20mg/12.5 mg tablets EFG

France: Enalapril/hydrochlorothiazide teva 20 mg/12.5 mg, comprimé sécable

Netherlands: Enalaprilmaleaat/HCT 20/12.5 mg Teva, tabletten

Last reviewed date of this leaflet: July 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /