Package Insert: Information for the Patient

Enalapril/Hidroclorotiazida Teva-ratiopharm 20 mg/ 12.5 mg Tablets EFG

Enalapril maleate and hydrochlorothiazide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Enalapril/Hidroclorotiazida Teva-ratiopharm belongs to a combination of medications used to treat high blood pressure (hypertension). It contains two active ingredients, enalapril (an ACE inhibitor) and hidroclorotiazida (a diuretic). Enalapril prevents the formation of certain substances in the body that produce an increase in blood pressure, and hidroclorotiazida increases the elimination of water and salts from the body, which also lowers blood pressure.

Enalapril/Hidroclorotiazida Teva-ratiopharm is used in patients whose blood pressure is satisfactorily controlled by taking the same amounts of each active ingredient in the same proportions as when taken separately.

Do not takeEnalapril/Hidroclorotiazida Teva-ratiopharm

• if you are allergic to enalapril maleate, other angiotensin-converting enzyme (ACE) inhibitors, thiazides (diuretics), sulfonamide derivatives (some antibiotics and diabetes medications), or any of the other components of this medication (listed in section 6),
• if you have experienced or a close family member has experienced swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema) at any time,
• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in the neck area) is high
• if you are more than 3 months pregnant. (It is also recommended to avoid using Enalapril/Hidroclorotiazida Teva-ratiopharm during the first months of pregnancy - see pregnancy section),
• if you have severe kidney or liver disease,
• if you are not urinating,
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

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

The doctor who prescribed this medication should know:

• if you are taking diuretics,
• if you are on a low-sodium diet or have had severe diarrhea or vomiting during treatment,
• if you have abnormal levels of water and minerals in your body (electrolyte imbalance),
• if you have heart failure,
• if you have atherosclerosis (narrowing of the arteries) or a cerebrovascular problem (such as a stroke),
• if you have hypertrophic cardiomyopathy (a heart muscle disease), aortic stenosis (narrowing of the aorta), or another type of heart problem called outflow tract obstruction,
• if you are undergoing LDL apheresis (a procedure to remove cholesterol from the blood using a machine),
• if you have kidney problems or narrowing of the veins in your kidneys (renal artery stenosis), or if you have only one functioning kidney or are undergoing dialysis,
• if you have recently had a kidney transplant,
• if you have diabetes,
• if you have a vascular collagen disease such as systemic lupus erythematosus (SLE) or scleroderma, or have been treated with immunosuppressants, allopurinol, or procainamide, or a combination of both,
• if your liver is not functioning properly,
• if you are receiving a treatment to desensitize you to insect venom,
• if you have allergies or asthma,
• if you are undergoing surgery during treatment, as some anesthetics used during surgery may cause excessive lowering of blood pressure when combined with enalapril/hidroclorotiazida,
• if you have high levels of potassium in your blood,
• 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, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may regularly monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.

See also the information under the heading "Do not take Enalapril/Hidroclorotiazida Teva-ratiopharm".

• if you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the neck) is increased:
• sirolimus, everolimus, temsirolimus, and other medications in the class of mTOR inhibitors (used to prevent organ transplant rejection and for cancer);
• racecadotril, a medication used to treat diarrhea;
• vildagliptin, a medication used to treat diabetes.
• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The long-term use of hydrochlorothiazide, particularly 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 Teva-ratiopharm.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to weeks after taking Enalapril/Hidroclorotiazida Teva-ratiopharm. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk.
• 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/Hidroclorotiazida Teva-ratiopharm, seek medical attention immediately.

Inform your doctor if you are pregnant (or suspect you may be). Enalapril/Hidroclorotiazida Teva-ratiopharm is not recommended for use at the beginning of pregnancy and should not be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that point onwards (see pregnancy section).

During treatment, you may experience sudden swelling of the tongue, lips, and face, neck, possibly even hands and feet, or wheezing or hoarseness. This condition is called angioedema. If this occurs, discontinue treatment with Enalapril/Hidroclorotiazida Teva-ratiopharm and consult your doctor. ACE inhibitors cause a higher rate of angioedema in black patients than in patients who are not black.

If you experience dry cough during treatment, consult your doctor, who will decide whether to continue treatment.

Children and adolescents

Do not administer Enalapril/Hidroclorotiazida Teva-ratiopharm to children under 18 years of age. The available information on the safety and efficacy of Enalapril/Hidroclorotiazida Teva-ratiopharm in children is limited.

Kidney

If you have kidney disease (renal insufficiency), it is essential that, during treatment with Enalapril/Hidroclorotiazida Teva-ratiopharm, you do not take potassium supplements or potassium-sparing diuretics, as they may increase your potassium levels excessively.

This medication contains hydrochlorothiazide, which may cause a positive result in doping control tests.

Enalapril/Hidroclorotiazida Teva-ratiopharm with other medications

The administration of Enalapril/Hidroclorotiazida Teva-ratiopharm with other medications may affect the efficacy and safety of this medication. Conversely, Enalapril/Hidroclorotiazida Teva-ratiopharm may affect the efficacy and safety of other medications.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, herbal products, or natural remedies. When prescribed another medication, remember to inform your doctor that you are taking Enalapril/Hidroclorotiazida Teva-ratiopharm or have just finished treatment with Enalapril/Hidroclorotiazida Teva-ratiopharm.

It is especially important to inform your doctor if you are taking any of the following medications:

• potassium-sparing diuretics, such as spironolactone, triamterene, or amiloride), potassium supplements, or calcium supplements, or dietary supplements containing potassium or calcium. This combination may result in dangerously high levels of potassium or calcium in your blood,
• other blood pressure medications or high doses of diuretics. The combination may cause a dangerous drop in your blood pressure,
• angiotensin II receptor antagonists (ARAs) or aliskiren (anti-hypertensive agents): your doctor may need to adjust 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/Hidroclorotiazida Teva-ratiopharm" and "Warnings and precautions").
• allopurinol (a medication for gout), procainamide (a medication for heart rhythm problems), immunosuppressants (such as cyclosporine), or medications that affect the body's immune system (such as azathioprine),
• lithium (a medication used to treat mental health conditions). The combination may cause excessive accumulation of lithium in your body, increasing the risk of adverse effects,
• antipsychotics, some antidepressants (tricyclic antidepressants), or medications that stimulate the central nervous system,
• some anesthetics, barbiturates, or strong painkillers. The combination may make you feel dizzy when standing up,
• other medications that may increase potassium levels in the body (such as heparin, a medication used to thin the blood for preventing clots; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; trimethoprim, an antibiotic for urinary tract infections, and cotrimoxazole, also known as trimethoprim/sulfamethoxazole),
• nonsteroidal anti-inflammatory drugs (NSAIDs),
• carbenoxolone (used to treat ulcers), corticosteroids, corticotropin (ACTH, used to treat epilepsy), or laxatives. The combination may lead to abnormal levels of water and minerals in your body, particularly a lack of potassium,
• digitalis glycosides (such as digoxin) or tubocurarine (a muscle relaxant). The effect of these medications may be enhanced,
• insulin or oral diabetes medications,
• cholestyramine or cholestyramine (cholesterol-lowering medications),
• medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See the section "Warnings and precautions".
• racecadotril (a medication used to treat diarrhea).

Enalapril/Hidroclorotiazida Teva-ratiopharm with food and drinks

Enalapril/Hidroclorotiazida Teva-ratiopharm should be taken with liquids, with or without food.

Be aware that consuming alcohol may enhance the effect of this medication.

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will usually recommend that you stop taking Enalapril/Hidroclorotiazida Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of Enalapril/Hidroclorotiazida Teva-ratiopharm. Enalapril/Hidroclorotiazida Teva-ratiopharm is not recommended for use at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Enalapril/Hidroclorotiazida Teva-ratiopharm is not recommended for use in women who are breastfeeding.

Driving and operating machinery

Enalapril/Hidroclorotiazida Teva-ratiopharm may make you feel tired or dizzy, which may affect your ability to drive or operate machinery that requires special care.

Enalapril/Hidroclorotiazida Teva-ratiopharm contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium per tablet (1 mmol); it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is 1 tablet per day.

Use in children and adolescents

Children should not take this medication, as its effect has not been studied in children.

Older adults

Your doctor will decide the dose you should take. The dose will depend on how well your kidneys are functioning.

Dose in patients with kidney problems

The dose will depend on how well your kidneys are functioning. Follow your doctor's instructions.

Before starting treatment with diuretics

Treatment with other hydrochlorothiazide diuretics should be discontinued 2 or 3 days before starting treatment with Enalapril/Hidroclorotiazida Teva-ratiopharm. Follow your doctor's instructions.

Do not change the dose or stop taking this medication without first consulting your doctor.

If you take moreEnalapril/Hidroclorotiazida Teva-ratiopharmthan you should

If you have taken a higher dose than you should (overdose), contact your doctor or the nearest hospital. An overdose may cause a decrease in blood pressure, a rapid or slow heart rate, palpitations (sensation of a rapid or irregular heartbeat), shock, rapid breathing, coughing, nausea, cramps, dizziness, feeling drowsy and confused or anxious, excessive urination or inability to urinate.

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

If you forget to take Enalapril/Hidroclorotiazida Teva-ratiopharm

Take the next dose at the usual time it is due.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment withEnalapril/Hidroclorotiazida Teva-ratiopharm

Treatment of hypertension is a long-term treatment, and its interruption should be discussed with your doctor. Interruption or suspension of treatment may cause an increase in your blood pressure.

If you have any other questions 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.

Stop taking this medicine and seek immediate medical attention if

• you notice swelling of the hands, feet, ankles, face, lips, or throat that may cause difficulty swallowing or breathing, skin itching, and urticaria. This is a common and serious side effect called angioedema (may affect up to 1 in 10 people).
• you notice red, swollen, or "burned" skin with blisters on the lips, eyes, mouth, nose, and/or genitals. You may also have high fever, gland inflammation, or joint pain. This may be a rare disease called Stevens-Johnson syndrome (may affect up to 1 in 1,000 people).

Either of these symptoms could indicate that you are having an allergic reaction to Enalapril/Hidroclorotiazida Teva-ratiopharm.

Talk to your doctor immediately if you notice any of the following side effects.

Rare (may affect up to 1 in 100 people)

• Sensation of swelling and painful muscle cramps in the stomach (abdomen), feeling dizzy (vomiting), indigestion, heartburn, stomach pain, constipation, loss of appetite, dry mouth. These symptoms may be caused by a blockage or intestinal obstruction (ileus).
• Severe stomach pain that may radiate to the back. May be a symptom of pancreatitis.
• Blood disorders including bone marrow problems and anemia. Symptoms include bruising easily, prolonged bleeding after injuries, bleeding gums or other areas, purple skin spots (caused by damage to small veins), increased risk of infection.
• Lung problems including inflammation of the lungs. You may feel uncomfortable or have no appetite, have a high temperature (fever) for 2-3 days, difficulty breathing, shortness of breath, cough.
• Fever, fatigue, loss of appetite, stomach pain, feeling dizzy, yellow skin and eyes (jaundice). These are symptoms of hepatitis (inflammation of the liver) that may lead to liver failure.
• Disease that may include some or all of the following effects: high temperature, vein inflammation, painful muscle and joint inflammation, blood problems detected by blood tests, skin rash, sensitivity to sunlight, other skin effects.

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

• Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Other possible side effects:

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

• Dizziness
• Blurred vision
• Nausea
• Cough
• Weakness.

Common (may affect up to 1 in 10 people)

• Headache
• Fatigue
• Chest pain
• Fainting
• Irregular heartbeat and/or irregular heart rhythm
• Low blood pressure, including postural hypotension with associated symptoms (dizziness, weakness, blurred vision)
• Diarrhea
• Distortion or decrease of taste
• Abdominal pain
• Rash (eruption)
• Muscle cramps
• Changes in blood potassium levels
• Increased levels of creatinine and fats in the blood
• Excessive levels of acids in urine and blood
• Depression
• Difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• Vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence
• Kidney problems, protein in urine
• Impotence
• Reduction in the number of red blood cells that may cause pale skin and cause weakness or shortness of breath (anemia)
• Palpitations (sensation of rapid or irregular heartbeat)
• Heart attack or stroke ("mini-stroke") (mainly in patients with low blood pressure)
• Confusion, drowsiness, insomnia, nervousness, numbness, itching, and tingling (paresthesia)
• Dizziness (vertigo)
• Joint pain, uncomfortable sensation, fever
• Facial flushing, ear ringing (tinnitus)
• Itching, blisters, hair loss
• Nasal secretion, sore throat, hoarseness, wheezing,
• Excessive sweating
• Gout
• Low sodium and/or magnesium levels in the blood, decreased glucose levels in the blood
• Bile duct inflammation, especially in patients with gallstones.

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

• Changes in blood count, lymph node disease, autoimmune disease, where the body attacks itself
• Stomatitis, glossitis
• Skin allergic reactions (e.g., erythema multiforme, facial flushing, peeling or blisters on the skin, necrolysis epidermal [serious disease with shedding of the superficial layer of the skin], purpura), skin disease with reddish scaly patches on the nose and cheeks (lupus erythematosus)
• Nasal mucosa inflammation causing nasal secretion (rhinitis)
• Reduced urine production
• Interstitial nephritis (inflammation of the kidneys)
• Increased breast size, including men
• Sleep disturbances, sleep disorders
• Muscle movement deterioration (due to low potassium levels in the blood)
• Raynaud's syndrome (symptoms include changes in finger color when exposed to cold or when pressed, pain in the fingers of the hands or feet with cold, tingling or pain when warmed)
• Increased levels of enzymes and waste products produced in the liver.

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

• A disease called "intestinal angioedema". Symptoms are stomach pain with or without dizziness
• Increased calcium levels in the blood.

Frequency not known (cannot be estimated from available data)

• Salivary gland inflammation
• Increased glucose levels in the blood, urine
• Restlessness,
• Headache
• Visual disturbances
• Loss of vision or eye pain due to increased pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage or acute angle-closure glaucoma)
• Vein inflammation
• Anaphylactic reactions (hypersensitivity reaction that develops rapidly, with generalized symptoms)

• Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (symptoms include headache, nausea, vomiting, agitation or confusion and may evolve to seizures and coma if not treated).
• Skin cancer and lip cancer (non-melanoma skin cancer).

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 Pharmacovigilance of Medicines 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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the 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 the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Teva-ratiopharm

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

The other components are lactose monohydrate (lactose), cornstarch, sodium hydrogen carbonate, pregelatinized cornstarch (cornstarch), talc, and magnesium stearate

Appearance of the product and contents of the package

The Enalapril/Hidroclorotiazida Teva-ratiopharm tablets are white, round, with a bisected surface and edges, with a groove on one face and a diameter of8 mm.

The tablets can be divided into equal halves.

They are available in blister packs of 14, 20, 28, 1 x 28, 1 x 30, 56, 60, 98, 1 x 98, 100, 1 x 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11 Edificio Albatros B 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer responsible

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

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

Austria:Enalapril-HCT ratiopharm 20 mg/12.5 mg Tablets

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

Finland:Enalapril comp ratiopharm tablets

Portugal:Enalapril and Hidroclorotiazida-ratiopharm 20 mg and 12.5 mg, tablets

Sweden:Enalapril comp ratiopharm tablets

Last review date of this leaflet: June 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64054/P_64054.html

QR code+ URL