Package Insert: Information for the User

Enalapril Teva-ratiopharm 10 mg Tablets

Enalapril maleate

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

Enalapril Teva-ratiopharmcontains an active ingredient called enalapril maleate.It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Teva-ratiopharm is used for:

• Treating high blood pressure (hypertension)
• Treating symptomatic heart failure(weakening of the heart function). It may reduce the need for hospitalization and may help some patients live longer.
• Preventing symptoms of symptomatic heart failure.The symptoms include: difficulty breathing, fatigue after light physical activity such as walking or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This reduces your blood pressure. Normally, the medicine starts to work within an hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before they notice the greatest effect on their blood pressure.

Do not take Enalapril Teva-ratiopharm 10 mg

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6),
• if you have ever been treated for an allergic reaction to a similar medicine, called an angiotensin-converting enzyme (ACE) inhibitor,
• if you have ever had swelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you are more than 3 months pregnant. (It is also best to avoid this medicine at the beginning of pregnancy - see Pregnancy section).
• 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.

Do not take this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

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

• if you have a heart problem.
• if you have a disease that affects the blood vessels in the brain.
• if you have blood disorders such as low white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• if you have a liver problem.
• if you have a liver problem.
• if you have kidney problems (including kidney transplant), follow a low-salt diet, take potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim, or co-trimoxazole (a medicine used to treat infections). This can cause high levels of potassium in the blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels in the blood. See also the information under the heading “Taking Enalapril Teva-ratiopharm with other medicines”.
• if you are undergoing dialysis.
• if you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently.
• if you have diabetes. You should monitor your blood sugar levels to see if you have low blood sugar levels, especially during the first month of treatment. Your potassium levels in the blood may also be higher.
• if you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing. You should be aware that patients of black race have a higher risk of suffering this type of reaction to ACE inhibitors.
• if you have low blood pressure (you may feel dizzy or faint, especially at the beginning of treatment and when standing up).
• if you have a disease called collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking allopurinol or procainamide, or any combination of these.
• if you are taking any of the following medicines, the risk of angioedema may increase:
• • racecadotril, a medicine used to treat diarrhea.
  • medicines used to prevent organ transplant rejection and for cancer (e.g., sirolimus, everolimus, temsirolimus)
  • vildagliptin, a medicine used to treat diabetes.
• 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”-for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

- aliskiren

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (e.g. potassium) at regular intervals.

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

You should inform your doctor if you think you may be pregnant (or could be). Enalapril Teva-ratiopharm 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 serious harm to your baby if used in this stage (see Pregnancy section).

Before undergoing a procedure

if you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• any surgery or if you are to receive anesthetics (even at the dentist's consultation),
• a treatment to remove cholesterol from your blood called “apheresis of LDL”,
• a desensitization treatment to reduce the effect of an allergy to a bee or wasp sting.

if any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Taking Enalapril Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes herbal remedies. This is because enalapril may affect how other medicines work and certain medicines may also affect how enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

Especially, inform your doctor or pharmacist if you are taking any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril Teva-ratiopharm” and “Warnings and precautions”.
• Other medicines to reduce blood pressure, such as blockers or diuretics.
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medicines that may increase potassium levels in the blood (e.g. heparin, trimethoprim, and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to prevent blood clots). See also the information in the section “Warnings and precautions”.

• Medicines for diabetes (including oral antidiabetic medicines and insulin).
• Lithium (a medicine used to treat a certain type of depression).
• Medicines for depression called “tricyclic antidepressants”.
• Medicines for mental health called “antipsychotics”.
• Certain medicines for coughs and colds and weight loss medicines that contain a substance called “sympathomimetic”.
• Certain medicines for pain or arthritis, including gold treatment.
• An mTOR inhibitor(e.g. sirolimus, everolimus, temsirolimus; medicines used to treat certain types ofcancer or to prevent the immune system from rejecting an organ transplant). See section “Warnings and precautions”.
• A medicine that contains sacubitril/valsartan, racecadotril, or vildagliptin. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also “Do not take Enalapril Teva-ratiopharm” and “Warnings and precautions”.
• Non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help you relieve pain).
• Aspirin (acetylsalicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Alcohol

if you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medicine.

Taking Enalapril Teva-ratiopharm with food, drinks, and alcohol

Enalapril can be taken with or without food. Most people take enalapril with a little water.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of enalapril. This medicine 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 serious harm to your baby if used in this stage (see Pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking this medicine, breastfeeding is not recommended in newborns (first weeks after birth), and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments, while breastfeeding.

Driving and operating machines

You may feel dizzy or drowsy while taking this medicine. If this happens, do not drive or use tools or machines.

Enalapril Teva-ratiopharm contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is very important that you continue taking this medication for the time your doctor prescribes.

Do not take more tablets than those prescribed to you.

The tablet can be divided into 2 equal doses.

Hypertension

The usual initial dose varies between 5 to 20 mg, administered once a day. Some patients may need a lower initial dose.

The usual long-term dose is 20 mg administered once a day.

The maximum long-term dose is 40 mg administered once a day.

Heart failure

The usual initial dose is 2.5 mg administered once a day. Your doctor will increase the dose gradually until the appropriate dose is reached for your case.

The usual long-term dose is 20 mg administered once a day in one or two doses.

The maximum long-term dose is 40 mg, divided into two doses.

Patients with kidney problems

Your medication dose will change depending on how well your kidneys are functioning:

• Moderate kidney problems - 5 mg to 10 mg per day
• Severe kidney problems - 2.5 mg per day
• On dialysis - 2.5 mg per day. On non-dialysis days, your dose may change depending on your low blood pressure.

Use in children

Your doctor will decide the dose and will base it on your kidney function.

Pediatric population

The experience with the use of enalapril in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual initial doses are:

- between 20 kg and 50 kg - 2.5 mg per day

- over 50 kg - 5 mg per day.

The dose can be adjusted as needed:

- a maximum of 20 mg per day can be used in children weighing between 20 kg and 50 kg

- a maximum of 40 mg per day can be used in children weighing over 50 kg.

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

If you take more Enalapril Teva-ratiopharm than you should

If you take more enalapril than you should, consult your doctor or pharmacist immediately.

Bring the medication packaging with you.

In case of overdose, the most likely symptom is dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Enalapril Teva-ratiopharm

If you forget to take a tablet, do not take the missed dose.

Take the next dose as usual.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Enalapril Teva-ratiopharm

Do not stop taking your medication unless your doctor tells you to.

If you have any other doubts 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.

If you experience any of the following symptoms, stop taking this medicine and consult your doctor:

• swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.that may cause difficulty breathing or swallowing.
• swelling of your hands, feet, or ankles.
• if you develop a red rash on your skin with swelling (hives)

You should be aware that patients of black race have a higher risk of experiencing this type of reaction. If you experience any of the reactions mentioned above, stop taking it and talk to your doctor immediately.

When you start taking this medicine, you may feel a loss of consciousness or feel dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue to take the medicine. If you are concerned, please talk to your doctor.

Other side effects include:

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

• feeling dizzy, weakness, or vomiting
• cough
• blurred vision

Common(may affect up to 1 in 10 people):

• headache, depression, fainting (syncope), alteration of taste
• low blood pressure dizziness, chest pain, changes in heart rhythm, angina, or chest pain
• difficulty breathing
• fatigue (tiredness)
• diarrhea, abdominal pain
• eruption, allergic reactions with swelling of the face, extremities, lips, tongue, or throat with difficulty breathing or swallowing

• elevated potassium levels in the blood, elevated creatinine levels in the blood (usually both are detected in an analysis)

Uncommon(may affect up to 1 in 100 people):

• anemia (including aplastic and hemolytic anemia)
• low blood sugar (hypoglycemia)
• confusion, drowsiness, or inability to sleep, nervousness
• tingling or numbness in your skin
• vertigo (dizziness)
• sudden drop in blood pressure
• rapid and irregular heartbeats (palpitations)
• heart attack or stroke (possibly due to very low blood pressure in high-risk patients, even in those patients with alterations in blood flow to the heart and/or brain)
• sore throat, cough, or hoarseness
• asthma, associated with chest tightness
• slow movement of food through your intestines (ileus), pancreatitis, vomiting, indigestion, constipation, anorexia
• irritated stomach (stomach irritation), dry mouth, ulcers

• increased sweating
• itching or urticaria
• hair loss
• reduced kidney function, kidney failure
• elevated protein levels in the urine (determined in an analysis)
• impotence
• muscle cramps
• rubefaction
• ringing in the ears (tinnitus)
• general feeling of being unwell, elevated temperature (fever)
• elevated urea levels in the blood, decreased sodium levels in the blood
• low blood sugar or sodium levels, elevated urea levels in the blood, (all determined in a blood analysis).

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

• changes in blood values, such as a lower number of white or red blood cells, lower hemoglobin levels, lower platelet count in the blood
• bone marrow depression,
• lymph node disease or abnormal immune response
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• “Raynaud's phenomenon”in which your hands and feet may become very cold and white due to low blood flow
• fluid or other substance accumulation in the lungs(as seen in X-rays)
• inflamed nose
• inflamedcheeks, gums, tongue, lips, throat
• eruption in the shape of a target (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red, peeling skin, ulcers with vesicles or open ulcers), dermatitis exfoliativa/erythroderma (severe skin eruption with peeling or shedding of the skin,pellagra (small blisters filled with fluid on the skin)
• reduced urine production per day
• enlargement of the breasts in men (gynecomastia)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in an analysis).

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

• intestinal angioedema (swelling in the intestine)

Frequency not known(the frequency cannot be estimated from the available data)

• excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion
• a complex symptom syndrome that may include any or all of the following symptoms: fever, inflammation of blood vessels(serositis, vasculitis), muscle pain (mialgia, miositis), joint pain (arthritis/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

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 prospectus. You can also report them directly through the Spanish System for the 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. Store in the original packaging to protect it from moisture.

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.

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 of 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 Teva-ratiopharm 10 mg tablets

• The active ingredient is enalapril (maleate). Each tablet contains 10 mg of enalapril (maleate).
• The other components are lactose monohydrate (lactose), cornstarch, talc, hydrogenated sodium carbonate, red iron oxide (E-172), and magnesium stearate

Appearance of the product and contents of the package

Enalapril Teva-ratiopharm is presented in the form of round, biconvex, brownish-red tablets, scored. The tablet can be divided into 2 equal doses.

Each package contains 10, 28, 60, or 500 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp.z.o.o.

Mogilska 80

31-546 Cracovia

Poland

Last review date of this leaflet:September 2024

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

If your treatment with Enalapril Teva-ratiopharm 10 mg requires dividing the tablet, this is the best way to do it.

Place the tablet with the score line facing upwards on a hard, flat surface (such as a table or a plate). Place your index fingers (or thumbs) on either side of the score line and press simultaneously briefly and firmly.

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/63816/P_63816.html