ENALAPRIL/HYDROCHLOROTHIAZIDE TEVA-RATIOPHARM 20 mg/12.5 mg TABLETS

2. What you need to know before you take Enalapril/Hydrochlorothiazide Teva-ratiopharm

Do not take Enalapril/Hydrochlorothiazide Teva-ratiopharm

• if you are allergic to enalapril maleate, other ACE inhibitors, thiazides (medicines to increase urine output), sulfonamide derivatives (some antibiotics and diabetes medicines) or any of the other ingredients of this medicine (listed in section 6),
• if you have experienced or a close relative has experienced swelling of the limbs, face, lips, throat, tongue (angioedema) under any circumstances,
• 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 the area of the throat) is high
• if you are more than 3 months pregnant. (It is also recommended to avoid the use of Enalapril/Hydrochlorothiazide Teva-ratiopharm during the first months of pregnancy - see section pregnancy),
• if you have severe kidney or liver disease,
• if you do not urinate,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

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

Your doctor who has prescribed this medicine should know:

• if you are taking diuretics,
• if you are on a low-salt diet or if you have had severe diarrhea or vomiting during treatment,
• if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance),
• if you have heart failure,
• if you have narrowing of the arteries (arteriosclerosis) or a cerebrovascular problem (such as a stroke),
• if you have heart muscle disease (hypertrophic cardiomyopathy), narrowing of the main artery that carries blood from the heart (aortic stenosis), or another type of heart problem called outflow tract obstruction,
• if you are undergoing LDL apheresis (removal of cholesterol from the blood by machine),
• if you have kidney problems or narrowing of the veins of your kidneys (renal artery stenosis), or have only one functioning kidney, or if you are on dialysis,
• if you have recently had a kidney transplant,
• if you have diabetes,
• if you have a vascular disease of the collagen such as systemic lupus erythematosus (SLE) or scleroderma or if you have been treated with immunosuppressants, allopurinol, or procainamide, or a combination of both,
• if your liver is not working properly,
• if you are receiving desensitization treatment against insect toxins,
• if you have allergic problems or asthma,
• if you will need surgery during treatment, as some anesthetics used during surgery can cause excessive decrease in blood pressure in combination with enalapril/hydrochlorothiazide,
• if you have high levels of potassium in the blood,
• 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 diabetic-related kidney problems.
• aliskiren.

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

See also the information under the heading “Do not take Enalapril/Hydrochlorothiazide Teva-ratiopharm”.

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• sirolimus, everolimus, temsirolimus, and other medicines of the mTOR inhibitor class (used to prevent organ rejection and for cancer);
• racecadotril, a medicine used to treat diarrhea;
• vildagliptin, a medicine used to treat diabetes.

Tell your doctor if you are pregnant (or think you might be). It is not recommended to use Enalapril/Hydrochlorothiazide Teva-ratiopharm at the start of pregnancy and in no case should it be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that time on (see section pregnancy).

At any time during treatment, sudden swelling of the tongue, lips, and face, neck, possibly even hands and feet, or wheezing or hoarseness may occur. This condition is called angioedema. If this happens, stop treatment with Enalapril/Hydrochlorothiazide Teva-ratiopharm and consult your doctor. ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.

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

Children and adolescents

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

Kidney problems

If you have kidney disease (renal failure), it is important that, during treatment with Enalapril/Hydrochlorothiazide Teva-ratiopharm, you do not take potassium supplements or potassium-sparing diuretics because they can excessively increase potassium levels in your body.

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Enalapril/Hydrochlorothiazide Teva-ratiopharm with other medicines

Taking Enalapril/Hydrochlorothiazide Teva-ratiopharm with other medicines may affect the efficacy and safety of this medicine. On the other hand, Enalapril/Hydrochlorothiazide Teva-ratiopharm may affect the efficacy and safety of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, herbal products, or natural remedies. When you are prescribed another medicine, remember to tell your doctor that you are taking Enalapril/Hydrochlorothiazide Teva-ratiopharm or that you have just finished treatment with Enalapril/Hydrochlorothiazide Teva-ratiopharm.

It is especially important that you tell your doctor if you are taking any of the following medicines:

• potassium-sparing diuretics, such as spironolactone, triamterene, or amiloride), potassium supplements, or calcium supplements, salt supplements, or dietary supplements containing potassium or calcium. This combination may result in dangerously high levels of potassium or calcium in your blood,
• other antihypertensive medicines or high doses of diuretics. The combination may cause a dangerous decrease in your blood pressure,
• angiotensin II receptor blockers (ARAs) or aliskiren (antihypertensive agents): your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor blocker (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril/Hydrochlorothiazide Teva-ratiopharm” and “Warnings and precautions”).
• allopurinol (a medicine used to treat gout), procainamide (a medicine used to treat heart rhythm problems), cytostatic agents (cancer medicines), or medicines that affect the body's immune system (such as cyclosporin),
• lithium (a medicine used to treat mental illnesses). The combination may cause lithium to accumulate in your body, and thus increase the risk of side effects,
• antipsychotic medicines, some medicines used to treat depression (tricyclic antidepressants), or medicines that stimulate the central nervous system,
• certain anesthetics, barbiturates, or strong painkillers. The combination may make you feel dizzy when you stand up,
• other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots; cyclosporin, an immunosuppressive medicine used to prevent organ rejection; trimethoprim, an antibiotic for urinary tract infections, and cotrimoxazole, also known as trimethoprim/sulfamethoxazole),
• non-steroidal anti-inflammatory medicines (NSAIDs),
• carbenoxolone (used to relieve ulcers), corticosteroids, corticotropin (ACTH, used to treat epilepsy), or stimulant laxatives. The combination may lead to abnormal levels of water and minerals in your body, particularly low potassium,
• cardiac glycosides (such as digoxin) or tubocurarine (a muscle relaxant). The effect of these medicines may be enhanced,
• insulin or oral antidiabetic medicines,
• cholestyramine or colestipol (cholesterol-lowering medicines),
• medicines commonly used to prevent organ rejection after transplantation (sirolimus, everolimus, temsirolimus, and other medicines of the mTOR inhibitor class). See section “Warnings and precautions”.
• racecadotril (a medicine used to treat diarrhea).

Enalapril/Hydrochlorothiazide Teva-ratiopharm with food and drinks

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

You should be aware that alcohol consumption may enhance the effect of this medicine.

Pregnancy and breastfeeding

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

Your doctor will generally advise you to stop taking Enalapril/Hydrochlorothiazide Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Enalapril/Hydrochlorothiazide Teva-ratiopharm. It is not recommended to use Enalapril/Hydrochlorothiazide Teva-ratiopharm at the start of pregnancy, and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Enalapril/Hydrochlorothiazide Teva-ratiopharm is not recommended for women who are breastfeeding.

Driving and using machines

Enalapril/Hydrochlorothiazide Teva-ratiopharm may make you feel tired or dizzy, which may affect your ability to drive or use machines that require special care.

Enalapril/Hydrochlorothiazide Teva-ratiopharm contains lactose and sodium

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

3. How to take Enalapril/Hydrochlorothiazide Teva-ratiopharm

Follow exactly the instructions of administration of this medicine given 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 medicine, as its effect has not been studied in children.

Elderly people

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

Dose in patients with kidney problems

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

Before treatment with diuretics

Treatment with other hydrochlorothiazide diuretic medicines should be stopped 2 or 3 days before starting treatment with Enalapril/Hydrochlorothiazide Teva-ratiopharm. Follow your doctor's instructions.

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

If you take more Enalapril/Hydrochlorothiazide Teva-ratiopharm than 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 too fast or slow heart rate, palpitations (feeling of too fast or irregular heartbeat), shock, rapid breathing, cough, feeling sick, 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 Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Enalapril/Hydrochlorothiazide Teva-ratiopharm

Take the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril/Hydrochlorothiazide Teva-ratiopharm

Treatment of high blood pressure is a long-term treatment, and its interruption should be consulted with your doctor. Stopping or suspending treatment may cause your blood pressure to increase.

If you have any further questions on 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 all people suffer from them.

Stop treatment with this medicine and go to your doctor or the nearest hospital immediately if

• you notice swelling of the hands, feet, ankles, face, lips, or throat that may cause difficulty swallowing or breathing, skin itching, and hives. This is a frequent and serious adverse effect called angioedema (it can 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 a high fever, inflammation of the glands, or joint pain. This can be a rare disease called Stevens-Johnson syndrome (it can affect up to 1 in 1,000 people).

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

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

Uncommon or rare (may affect up to 1 in 100 people)

• Feeling of swelling and painful cramps in the stomach (abdomen), feeling nauseous (vomiting), indigestion, acidity, stomach pain, constipation, loss of appetite, dry mouth. These symptoms may be caused by an obstruction or blockage of the intestine (ileus).
• Severe stomach pain that can radiate to the back. It can be a symptom of pancreatitis.
• Blood disorders including bone marrow problems and anemia. Symptoms include a tendency to bruise, longer bleeding after wounds, bleeding gums or other areas, purple spots on the skin (caused by damage to small veins), increased risk of infection.
• Lung problems including inflammation of the lungs. You may feel uncomfortable or lose appetite, have a fever for 2 or 3 days, difficulty breathing, shortness of breath, cough.
• Fever, fatigue, loss of appetite, stomach pain, feeling of dizziness, yellowing of the skin and eyes (jaundice). These are symptoms of hepatitis (liver inflammation) that can lead to liver failure.
• A disorder that can include some or all of the following effects: high temperature, inflammation of the veins, painful inflammation of the muscles and joints, blood problems detected with a blood test, 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 adverse 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
• Altered or irregular heartbeat
• Low blood pressure, including postural hypotension with associated symptoms (dizziness, weakness, blurred vision)
• Diarrhea
• Distortion or decrease in the sense of taste
• Abdominal pain
• Rash (exanthema)
• Muscle cramps
• Changes in potassium levels in the blood
• Increased levels of creatinine and fats in the blood
• Excessive levels of acids in urine and blood
• Depression
• Breathing difficulties

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 the urine
• Impotence
• Reduced number of red blood cells, which can make the skin pale and cause weakness or shortness of breath (anemia)
• Palpitations (feeling of rapid or forceful heartbeat)
• Heart attack or stroke ("mini-stroke") (mainly in patients with low blood pressure)
• Confusion, drowsiness, insomnia, nervousness, tingling sensation, itching, and numbness (paresthesia)
• Dizziness (vertigo)
• Joint pain, uncomfortable feeling, fever
• Facial flushing, ringing in the ears (tinnitus)
• Itching, blisters, hair loss
• Nasal discharge, sore throat, hoarseness, wheezing
• Excessive sweating
• Gout
• Low levels of sodium and/or magnesium in the blood, decreased glucose levels in the blood
• Inflammation of the biliary vesicle, especially in patients with bile stones

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
• Allergic skin reactions (e.g., erythema multiforme, redness, scaling, or blisters on the skin, necrotizing epidermolysis [severe disease with shedding of the outer skin layer], purpura), skin disease with reddish scaly patches on the nose and cheeks (lupus erythematosus)
• Inflammation of the nasal mucosa causing nasal discharge (rhinitis)
• Reduced urine production
• Inflammation of the kidneys (interstitial nephritis)
• Increased breast size, including in men
• Sleep disturbances, sleep disorders
• Worsening of muscle movements (due to low potassium levels in the blood)
• Raynaud's syndrome (symptoms include changes in finger color when exposed to cold or when pressed, finger pain 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 a feeling of dizziness
• Increased calcium levels in the blood

Frequency not known (cannot be estimated from available data)

• Inflammation of the salivary gland
• Increased glucose levels in blood, urine
• Restlessness
• Headache
• Visual disturbances
• Vision loss or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye [choroidal effusion or acute angle-closure glaucoma])
• Inflammation of blood vessels
• Anaphylactic reactions (allergic hypersensitivity that develops rapidly, with generalized symptoms)

• Syndrome of inappropriate secretion of antidiuretic hormone (symptoms include headache, nausea, vomiting, agitation, or confusion, and can evolve into seizures and coma if left untreated)
• Skin and lip cancer (non-melanoma skin cancer)

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 that is not listed in this leaflet. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Enalapril/Hydrochlorothiazide Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril/Hydrochlorothiazide Teva-ratiopharm

The active ingredients are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

The other ingredients are lactose monohydrate (lactose), corn starch, sodium hydrogen carbonate, pregelatinized corn starch (corn starch), talc, and magnesium stearate

Appearance of the Product and Package Contents

Enalapril/Hydrochlorothiazide Teva-ratiopharm tablets are white, round, with a beveled surface and edges, with a score line on one side, and a diameter of 8 mm.

The tablets can be divided into two 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11 Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

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

Finland: Enalapril comp ratiopharm tablets

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

Sweden: Enalapril comp ratiopharm tablets

Date of the Last Revision of this Leaflet: June 2020

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/.

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

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