Package Leaflet: Information for the User

Enalapril Tarbis 20 mg Tablets EFG

Enalapril Maleate

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 leaflet. See section 4.

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

Enalapril Tarbis is indicated for:

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

Do not take Enalapril Tarbis

• If you are allergic to enalapril or any of the other components of this medication (including those listed in section 6).
• If you have previously been treated with a medication from the same group of drugs as Enalapril Tarbis (angiotensin-converting enzyme inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing.
• If you have been diagnosed with hereditary or unknown cause angioedema (the development of large hives on the surface of the skin, especially around the eyes and lips, which can also affect hands, feet, and throat, and can cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant. (It is also recommended to avoid Enalapril 20 mg Tarbis at the beginning of pregnancy - see Pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.
• If you are taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Tarbis

• If you have 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).
• If you have liver problems.
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medications that increase urine elimination)
• If you have recently had excessive vomiting or diarrhea.
• If you are following a low-sodium diet, taking potassium supplements, medications that conserve potassium, or salt substitutes that contain potassium, or medications associated with elevated potassium levels in the blood (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus or any kidney problem (including kidney transplant), as these can lead to high potassium levels in the blood that can be serious.
• 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 are more sensitive to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis, or a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice it as dizziness or lightheadedness, especially in the initial doses and when standing up. In these cases, lying down may help).
• If you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking allopurinol or procainamide, or any combination of these.
• 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 "sartans" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren

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

See also the information under the heading “Do not take Enalapril Tarbis”.

You should inform your doctor if you think you may be pregnant (or could be). Enalapril Tarbis is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used in this stage (see Pregnancy section).

You should be aware that Enalapril Tarbis reduces blood pressure in black patients less effectively than in patients who are not black.

In all these cases, inform your doctor as you may need a dose adjustment or discontinue Enalapril Tarbis or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetic medications or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with Enalapril Tarbis.

Inform your doctor or dentist before undergoing surgery or anesthesia (even at the dentist's office), as there may be a sudden drop in blood pressure associated with anesthesia.

Taking Enalapril Tarbis with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with Enalapril Tarbis. Your doctor may need to adjust your dose and/or take other precautions, such as discontinuing one of them.

Particularly, talk to your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril Tarbis” and “Warnings and precautions”).
• Other antihypertensive medications (reduce elevated blood pressure)
• Diuretics (medications that increase urine elimination)
• Potassium supplements (including salt substitutes), diuretics that conserve potassium, and other medications that can increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots).
• Diabetes medications (including oral antidiabetic medications and insulin)
• Lithium (medications used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications for pain or certain inflammation, e.g., aspirin)
• Sympathomimetics
• Certain medications for pain or arthritis, including gold treatment
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and can be used to help you relieve pain).

Taking Enalapril Tarbis with food, drinks, and alcohol

Food does not affect the absorption of Enalapril Tarbis.

Alcohol potentiates the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking beverages that contain alcohol while taking this medication.

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 medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Enalapril Tarbis is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used in this stage (see Pregnancy section).

Breastfeeding

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

Driving and operating machinery

Individual responses to medication can vary.

Since Enalapril Tarbis can cause dizziness or fatigue, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Enalapril Tarbis 20 mg is administered orally.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Enalapril Tarbis. Do not discontinue treatment before.

Enalapril Tarbis can be taken with meals or between them along with a glass of water.

Your doctor will decide on the appropriate dose of Enalapril Tarbis you should take, depending on your condition and if you are taking other medications.

The recommended dose is:

Hypertension

For most patients, 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.

Heart Failure

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

Caution should be exercised at the beginning of treatment due to the possibility of dizziness or vertigo appearing.

Inform your doctor immediately if you experience these symptoms.

If you estimate that the action of Enalapril Tarbis 20 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril Tarbis than you should

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

In case of an 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Enalapril Tarbis

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Enalapril Tarbis may cause side effects, although not everyone will experience them.

Side effects have been classified according to the following definitions of frequencies:

Very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

Blood and lymphatic system disorders:

Uncommon:anemia (decrease in the number of red blood cells in the blood) (including aplastic and hemolytic anemia).

Rare:blood disorders, such as an abnormally low number of neutrophils (a type of blood cell), low hemoglobin levels, reduction or complete absence of granulocytes (a type of blood cell), deficiency of all blood cells, bone marrow depression (tissue inside the bone that generates blood cells), lymph node disease or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon:low blood glucose levels (hypoglycemia).

Nervous system and mental disorders:

Common:headache, depression.

Uncommon:confusion, drowsiness or inability to sleep, nervousness, sensation of tingling or numbness, dizziness.

Rare:sleep disturbances, sleep disorders.

Eye disorders:

Very common:blurred vision.

Cardiac and vascular disorders:

Very common:dizziness.

Common:fall in blood pressure (including orthostatic hypotension), fainting, chest pain, cardiac rhythm disturbances, angina pectoris, rapid heartbeats.

Uncommon:orthostatic hypotension (decrease in blood pressure when sitting or standing), rapid and strong heartbeats, possible myocardial infarction or stroke due to excessively low blood pressure in high-risk patients (patients with alterations in blood flow to the heart and/or brain).

Rare:small arteries, usually in the fingers or toes, that produce spasms causing the skin to become pale or red and blue (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very common:cough.

Common:difficulty breathing.

Uncommon:nasal mucus discharge, sore throat and hoarseness, asthma.

Rare:fluid in the lungs, inflammation of the nasal mucosa membrane, allergic inflammation of the lungs.

Gastrointestinal disorders:

Very common:nausea.

Common:diarrhea, abdominal pain, altered taste.

Uncommon:intestinal obstruction, pancreatitis, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer.

Rare:inflammation and ulcers of the mouth, inflammation of the tongue.

Very rare:intestinal angioedema (swelling in the intestine).

Hepatobiliary disorders:

Rare:liver insufficiency, hepatitis, reduction or obstruction of bile flow from the bile duct to the liver (cholestasis) including yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders:

Common:skin rash, hypersensitivity or allergic reaction causing swelling of the face, extremities, lips, tongue, glottis, and larynx.

Uncommon:sweating, pruritus (itching), urticaria (hives), hair loss.

Rare:severe skin reaction, including excessive redness of the skin, blisters, skin peeling.

A complex of symptoms has been observed that may include some of the following reactions:

fever, inflammation of blood vessels, muscle and joint pain, blood disorders affecting blood components and normally detected in a blood test, skin rash, hypersensitivity to sunlight and other skin effects.

Renal and urinary disorders:

Uncommon:reduced kidney function or renal insufficiency, presence of proteins in the urine.

Rare:reduction in the amount of urine produced per day.

Reproductive and mammary disorders:

Uncommon:impotence.

Rare:breast enlargement in men.

General disorders and administration site conditions:

Very common:weakness.

Common:fatigue.

Uncommon:muscle cramps, flushing, ear noises, general malaise, fever.

Investigations:

Common:high potassium levels in the blood, increases in creatinine in the blood.

Uncommon:increases in urea in the blood, decrease in sodium levels in the blood.

Rare:increases in liver enzymes, increases in bilirubin in the blood.

Stop taking Enalapril Tarbis and consult your doctor immediately in any of the following cases:

• If your face, lips, tongue, and/or throat become swollen, making it difficult to breathe or swallow.
• If your hands, feet, or ankles become swollen.
• If you develop urticaria (itching and redness in some areas of the body).

You should be aware that black patients are more sensitive to this type of adverse reaction.

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 the Vigilance 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 Enalapril Tarbis 20 mg out of sight and reach of children.

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

No special storage conditions are required.

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

Composition of Enalapril Tarbis

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components (excipients) are: pregelatinized cornstarch, microcrystalline cellulose (E-460i), silicon dioxide (E-551), sodium bicarbonate, and magnesium stearate.

Appearance of the product and contents of the packaging

Enalapril Tarbis is presented in the form of white, biconvex, scored tablets. Each package contains 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Responsible manufacturer:

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26

28850 Torrejón de Ardoz (Madrid), Spain

or

FERRER INTERNACIONAL, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona), Spain

Last review date of this leaflet: May 2019

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/