ENALAPRIL TEVA-RATIOPHARM 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Teva-ratiopharm 10 mg Tablets

Enalapril Maleate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Enalapril Teva-ratiopharm and what is it used for
2. What you need to know before you take Enalapril Teva-ratiopharm
3. How to take Enalapril Teva-ratiopharm
4. Possible side effects
5. Storage of Enalapril Teva-ratiopharm
6. Contents of the pack and other information

1. What is Enalapril Teva-ratiopharm 10 mg and what is it used for

Enalapril Teva-ratiopharm contains the active substance enalapril maleate. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Teva-ratiopharm is used to:

• Treat high blood pressure (hypertension)
• Treat symptomatic heart failure (weakening of the heart's function). It may reduce the need for hospitalization and may help some patients to live longer.
• Prevent signs of symptomatic heart failure. Signs include: difficulty breathing, tiredness 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 the full effect on blood pressure is seen.

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

Do not take Enalapril Teva-ratiopharm 10 mg

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor,
• if you have ever had swelling of the face, lips, tongue or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary,
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
• if you are more than 3 months pregnant. (It is also better to avoid this medicine at the start of pregnancy - see section Pregnancy).
• If you have taken or are 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 increased.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking 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 or lack of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia) or low red blood cell count (anemia).
• if you have liver problems.
• if you have kidney problems (including kidney transplant), follow a low-salt diet, take potassium supplements, potassium-sparing diuretics 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 cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections). This may cause high levels of potassium in the blood, which can be serious. Your doctor may need to adjust your dose of enalapril 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 recently had severe vomiting (excessive vomiting) or severe diarrhea.
• if you have diabetes. You should monitor your blood for low blood sugar levels, especially during the first month of treatment. Your potassium level 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 black patients have a higher risk of these types of reactions to ACE inhibitors.
• if you have low blood pressure (you may notice this as dizziness or fainting, especially when standing up).
• if you have a disease of the collagen vascular system (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines 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” - e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 Teva-ratiopharm”

You should inform your doctor if you think you are pregnant (or might be pregnant). Enalapril Teva-ratiopharm 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 if used after the third month of pregnancy.

You should be aware that Enalapril Teva-ratiopharm lowers blood pressure in black patients less effectively than in non-black patients.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

If you are about to undergo 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 going to receive anesthetics (even at the dentist),
• a treatment to remove cholesterol from your blood called “LDL apheresis”,
• a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.

If any of the above applies 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 recently taken or might take any other medicines. This includes herbal treatments. This is because enalapril may affect the way other medicines work and certain medicines may affect the way enalapril works. Your doctor may need to change your dose and/or take other precautions.

In particular, 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 beta-blockers or water tablets (diuretics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase potassium levels in the blood (e.g. heparin, trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also the information in the section “Warnings and precautions”.

• Medicines for diabetes (including oral antidiabetics and insulin).
• Lithium (a medicine used to treat a certain type of depression).
• Medicines for depression called “tricyclic antidepressants”.
• Medicines for mental problems called “antipsychotics”.
• Certain medicines for coughs and colds and weight loss medicines that contain a substance called “sympathomimetic medicine”.
• Certain medicines for pain or arthritis, including gold treatment.
• An mTOR inhibitor (e.g. sirolimus, everolimus, temsirolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See section “Warnings and precautions”.
• A medicine that contains sacubitril/valsartan, racecadotril or vildagliptin. It 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 relieve pain).
• Aspirin (acetylsalicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Alcohol

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking 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, breast-feeding and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Normally your doctor will advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of enalapril. This medicine is not recommended during the first trimester 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 after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. While taking this medicine, breast-feeding is not recommended in newborns (first few 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 breast-feeding.

Driving and using 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 an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Enalapril Teva-ratiopharm

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is very important that you continue to take this medicine during the time your doctor prescribes it.

Do not take more tablets than you have been prescribed.

The tablet can be divided into 2 equal doses.

Hypertension

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

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

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

Heart failure

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

The usual long-term dose is 20 mg given daily in one or two divided doses.

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

Patients with kidney problems

Your dose of medicine will change depending on how well your kidneys are working:

• moderate kidney problems - 5 mg to 10 mg per day
• severe kidney problems - 2.5 mg per day
• if you are undergoing dialysis - 2.5 mg per day. On the days when you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Use in children

Your doctor will decide the dose and will be based on the functioning of your kidneys.

Pediatric population

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
• more than 50 kg - 5 mg per day.

The dose can be changed according to the child's needs:

• up to a maximum of 20 mg per day can be used in children who weigh between 20 kg and 50 kg
• up to a maximum of 40 mg per day can be used in children who weigh more than 50 kg.

This medicine is not recommended in newborn babies (first few weeks after birth) or in 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.

Take the medicine package with you.

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Enalapril Teva-ratiopharm

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

Take the next dose as usual.

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

If you stop taking Enalapril Teva-ratiopharm

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

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.

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

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

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

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

Other adverse effects include:

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

• feeling of dizziness, weakness, or vomiting
• cough
• blurred vision

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

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

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

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

• anemia (including aplastic and hemolytic anemia)
• low blood sugar levels (hypoglycemia)
• confusion, drowsiness, or inability to sleep, nervousness
• feeling of itching or numbness in the skin
• vertigo (feeling of dizziness)
• sudden drop in blood pressure
• rapid and arrhythmic heartbeats (palpitations)
• myocardial infarction or stroke (possibly due to very low blood pressure in high-risk patients, even in those with alterations in heart and/or brain blood flow)
• runny nose, sore throat, or hoarseness
• asthma, associated with chest tightness
• slow movement of food through the intestine (ileus), pancreatitis, vomiting, indigestion, constipation, anorexia
• gastric irritation (irritated stomach), dry mouth, ulcer

• increased sweating
• itching or hives
• hair loss
• reduced kidney function, kidney failure
• high levels of protein in the urine (determined in an analysis)
• impotence
• muscle cramps
• flushing
• ringing in the ears (tinnitus)
• malaise (general discomfort), elevated temperature (fever)
• increased urea levels in the blood, decreased sodium levels in the blood
• low blood sugar or sodium levels, high urea levels in the blood (all determined in a blood test).

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, or 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 substance accumulation in the lungs (as seen on X-rays)
• nasal inflammation
• inflammation of the cheeks, gums, tongue, lips, or throat
• target-shaped rash (erythema multiforme)
• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling of the skin, pemphigus (small fluid-filled blisters on the skin)
• reduced amount of urine produced per day
• breast enlargement in men (gynecomastia)
• liver or bile duct problems such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzyme 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(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion
• a symptomatic complex has been observed that may include all or some of the following symptoms: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin manifestations may occur.

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 prospectus. You can also report it 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. Storage of Enalapril Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect it from moisture.

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.

Medicines should not be disposed of through wastewater or household waste. 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 the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril Teva-ratiopharm 10 mg tablets

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

Appearance of the Product and Package Contents

Enalapril Teva-ratiopharm is presented in the form of round, biconvex tablets, reddish-brown in color, 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp.z.o.o.

Mogilska 80

31-546 Cracow

Poland

Date of Last Revision of this Prospectus:September 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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

Place the tablet with the break line facing up on a hard and smooth surface (e.g., a table or plate). Place your index fingers (or thumbs) on both sides of the break line and press briefly and firmly at the same time.

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/63816/P_63816.html