Label: information for the user

Enalapril Teva-ratiopharm 20 mg tablets EFG

enalapril maleate

Enalapril Teva-ratiopharm belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Enalapril Teva-ratiopharm is indicated for:

• Treating high blood pressure (hypertension).
• Treating symptomatic heart failure.
• Preventing symptomatic heart failure.

This medicine works by widening your blood vessels. This reduces your blood pressure. Normally, the medicine starts to work within one 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

• If you are allergic to enalapril maleate 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 similar medicine to this one, called an 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 hereditary or unknown.
• 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 Enalapril Teva-ratiopharm 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 disease.
• 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).

(including those listed in the section “Adverse reactions”).

• If you have liver problems.
• If you have a kidney problem (including kidney transplant), follow a low-salt diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase blood potassium levels such as heparin (a medicine used to prevent blood clots), trimethoprim or co-trimoxazole (medicines used to treat infections). This may cause high blood potassium levels that can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels. 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 must closely monitor your blood glucose levels,

• especially during the first month of treatment. Your blood potassium levels 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 must be aware that black patients are more sensitive to this type of reaction to ACE inhibitors.
• If you have low blood pressure (you may notice it as dizziness or lightheadedness, especially in the initial doses and when standing.
• If you have vascular collagen disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, are taking alopurinol 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:
• • 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 need to monitor your renal 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 must 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).

You must be aware that this medicine reduces blood pressure in black patients less effectively than in patients who are not black.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take 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 to receive anaesthetics (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 affect how enalapril works. Your doctor may need to modify 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 beta-blockers or diuretics.
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medicines that may increase blood potassium levels (e.g. trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant 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 antidiabetics and insulin).
• Lithium (a medicine used to treat certain types 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”.
• Certain medicines for pain or arthritis, including gold treatment.

• An mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting an organ transplant). See also the information in the 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 drugs (NSAIDs), 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 enalapril.

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

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you may be pregnant (or could be). Normally your doctor will advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of Enalapril Teva-ratiopharm. 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.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking enalapril, 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 an intolerance to certain sugars, consult with him 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 indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Remember to take your medication.

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 recommended dose is:

Hypertension

The initial recommended dose is usually 5 to 20 mg once a day.

Some patients may need a lower initial dose.

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

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

Heart failure

The initial recommended dose is usually 2.5 mg once a day.

Your doctor will gradually increase the dose until the appropriate dose is reached in your case.

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

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

Older patients

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

Use in children

The experience on 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 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 more than 50 kg.

This medication is not recommended in newborns (first weeks after birth) or in pediatric patients with kidney problems.

If you take more Enalapril Teva-ratiopharm than you should

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

Bring the medication packaging with you.

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

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

If you forgot to take Enalapril Teva-ratiopharm

You should continue taking this medication as prescribed.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with 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 immediately:

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

You should be aware that patients of black race have a higher risk of suffering from this type of reaction. If you experience any of the previous reactions, stop taking it and speak with 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 speak with 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):

• lightheadedness due to low blood pressure, chest pain, changes in heart rhythm, angina, rapid heartbeats
• headache, depression
• difficulty breathing
• fatigue (tiredness)
• diarrhea, abdominal pain
• rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing

• elevated potassium levels in the blood, elevated creatinine levels in the blood(usually both are detected in a blood test).

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

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeats (palpitations)
• heart attack or stroke possibly due to excessively low blood pressure in high-risk patients (patients with alterations in blood flow to the heart and/or brain)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness,
• sensation of itching or numbness on your skin
• dizziness (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through yourintestine (ileus), inflammation of the pancreas, vomiting, indigestion, constipation, anorexia
• irritated stomach (gastritis), dry mouth, ulcers

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

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

• “Raynaud's phenomenon” in which your hands and feet may become very cold and white due to low blood flow
• changes in blood values, such as a lower number of white blood cells or red blood cells, lower hemoglobin levels,lower platelet countin the blood
• bone marrow depression,
• inflamed glands in the neck, armpits, or groin.
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid accumulation or other substances in the lungs (as seen in X-rays)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced urine production
• rash 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 rash with peeling or shedding of the skin), pemphigus (small blisters filled with fluid on the skin)

• liver or bile duct problems such as reduced liver function, inflammation of the liver, jaundice (yellow discoloration of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test)
• enlargement of the breasts in men (gynecomastia).

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)

• overproduction of the antidiuretic hormone, which causes 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 the blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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 above30°C. Store in the original packaging.

Do not use this medication after the expiration date indicated 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Enalapril Teva-ratiopharm 20 mg tablets

The active ingredient of this medication is enalapril maleate 20 mg. Each tablet contains 20 mg of enalapril maleate as the active ingredient.

The other components are croscarmelosa sodium, lactose monohydrate, magnesium stearate, pregelatinized cornstarch (from corn), sodium bicarbonate, iron oxide red (E-172), iron oxide yellow (E-172), and cornstarch.

Appearance of the product and contents of the packaging:

Enalapril Teva-ratiopharm 20 mg are circular, flat, scored, light orange tablets. They are presented in packs of 28 tablets.

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:

Teva Pharma, S.L.U.

Polígono Malpica c/C nº4

50016. Zaragoza. Spain.

Date of the last review of this leaflet:February 2022

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

You can access detailed and updated information about this medication 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/66076/P_66076.html