ENALAPRIL TARBIS 20 mg TABLETS

2. What you need to know before you take Enalapril Tarbis 20 mg Tablets

Do not take Enalapril Tarbis

• If you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6)
• If you have been treated with a medicine of the same group as Enalapril Tarbis (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing
• If you have been diagnosed with hereditary or idiopathic angioedema (the development of large hives on the skin surface, especially around the eyes and lips, which can also affect hands, feet, and throat and can also cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing)
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren
• If you are more than 3 months pregnant. (It is also better to avoid Enalapril Tarbis 20 mg 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 high
• 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., temsirolimus, sirolimus, everolimus)
• Vildagliptin, a medicine 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 or absent 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 being treated with diuretics (medicines that increase urine production)
• If you have recently had excessive vomiting or diarrhea
• If you are on a salt-free diet, taking potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium or medicines 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 problems (including kidney transplant), as these may lead to high potassium levels in the blood, which 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 black patients are more sensitive to this type of reaction to ACE inhibitors
• If you are about to undergo a treatment called LDL apheresis or 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 fainting or dizziness, especially in the initial doses and when standing up. In these cases, lying down may help)
• If you have 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 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 diabetes-related kidney problems
  • Aliskiren

Your doctor may monitor 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 Tarbis"

You must inform your doctor if you think you are pregnant (or might be). Enalapril Tarbis is not recommended at the start of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy

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

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

Before undergoing surgery or anesthesia (even at the dentist), inform your doctor or dentist that you are taking Enalapril Tarbis, as there may be a sudden drop in blood pressure associated with anesthesia

Taking Enalapril Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines

Certain medicines may interact with Enalapril Tarbis. Your doctor may need to change your dose and/or take other precautions, such as stopping treatment with one of them

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• 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 anti-hypertensive medicines (lowering high blood pressure)
• Diuretics (medicines that increase urine production)
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• Medicines for diabetes (including oral antidiabetics and insulin)
• Lithium (medicines used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to treat pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold treatment
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain)

Taking Enalapril Tarbis with food, drinks, and alcohol

Food does not affect the absorption of Enalapril Tarbis

Alcohol enhances the blood pressure-lowering effect of enalapril, so inform your doctor if you are taking alcoholic beverages while being treated with this medicine

Pregnancy, breastfeeding, and fertility

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

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril Tarbis 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 Tarbis

Enalapril Tarbis is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. While taking Enalapril Tarbis, breastfeeding is not recommended in newborns (first few weeks after birth), especially in 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 using machines

Individual responses to the medicine may vary

Since Enalapril Tarbis may cause dizziness or fatigue, be careful not to perform tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medicine

3. How to take Enalapril Tarbis 20 mg Tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again

Enalapril Tarbis 20 mg is administered orally

Remember to take your medicine

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

Enalapril Tarbis can be taken with or without food with a glass of water

Your doctor will decide the appropriate dose of Enalapril Tarbis for you to take, depending on your condition and whether you are taking other medicines

The recommended dose is:

Hypertension

For most patients, the initial recommended dose is 5 to 20 mg once daily. Some patients may need a lower initial dose

The usual long-term dose is 20 mg once daily

Heart Failure

The initial recommended dose is usually 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for your case is reached. The usual long-term dose is 20 mg daily in one or two divided doses

At the start of treatment, precautions should be taken due to the possibility of dizziness or vertigo

Inform your doctor immediately if you experience these symptoms

If you think the effect of Enalapril Tarbis 20 mg is too strong or too weak, tell 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 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 medicine and the amount taken

If you forget to take Enalapril Tarbis

You should continue taking Enalapril Tarbis as prescribed. Do not take a double dose to make up for forgotten doses

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible Adverse Effects

Like all medicines, Enalapril Tarbis can cause adverse effects, although not all people suffer from them.

Adverse effects have been classified according to the following frequency definitions:

very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (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:

Infrequent:anemia (decrease in the number of red blood cells) (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 cellular elements in the blood, bone marrow depression (tissue inside the bone that generates blood cells), lymph node disease or abnormal immune response.

Metabolic and Nutritional Disorders:

Infrequent:low blood glucose levels (hypoglycemia).

Nervous System and Mental Disorders:

Frequent:headache, depression.

Infrequent:confusion, drowsiness or inability to sleep, nervousness, tingling or numbness, dizziness.

Rare:sleep disturbances, sleep problems.

Ocular Disorders:

Very frequent:blurred vision.

Cardiac and Vascular Disorders:

Very frequent:dizziness.

Frequent:drop in blood pressure (including orthostatic hypotension), fainting, chest pain, changes in heart rhythm, angina pectoris, rapid heartbeats.

Infrequent:orthostatic hypotension (decrease in blood pressure when sitting or standing), rapid and strong heartbeats, myocardial infarction 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).

Rare:small arteries, usually in the fingers or toes, that produce spasms that make the skin turn pale or a reddish-blue color (Raynaud's phenomenon).

Respiratory, Thoracic, and Mediastinal Disorders:

Very frequent:cough.

Frequent:difficulty breathing.

Infrequent:nasal mucous discharge, throat itching and hoarseness, asthma.

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

Gastrointestinal Disorders:

Very frequent:nausea.

Frequent:diarrhea, abdominal pain, altered taste.

Infrequent: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 failure, liver inflammation (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:

Frequent:skin rash, hypersensitivity or allergic reaction that causes swelling of the face, limbs, lips, tongue, glottis, and larynx.

Infrequent:sweating, pruritus (itching sensation), urticaria (red and itchy hives), hair loss.

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

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

fever, inflammation of blood vessels, pain and inflammation of muscles and joints, blood disorders that affect blood components and are usually detected in a blood test, skin rash, hypersensitivity to sunlight and other skin effects.

Renal and Urinary Disorders

Infrequent:reduced renal function or renal failure, presence of proteins in the urine.

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

Reproductive System and Breast Disorders:

Infrequent:impotence.

Rare:breast enlargement in men.

General Disorders and Administration Site Conditions:

Very frequent:weakness.

Frequent:fatigue.

Infrequent:muscle cramps, flushing, ringing in the ears, general malaise, fever.

Clinical Laboratory Tests:

Frequent:high potassium levels in blood, increased creatinine levels in blood.

Infrequent:increased urea levels in blood, decreased sodium levels in blood.

Rare:increased liver enzymes, increased bilirubin levels in blood.

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

• If your face, lips, tongue, and/or throat swell in a way that makes it difficult to breathe or swallow.
• If your hands, feet, or ankles swell.
• If you experience 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 reactions.

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 them 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. Conservation of Enalapril Tarbis 20 mg Tablets

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 thrown away 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 way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Enalapril Tarbis

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

Appearance of the Product and Packaging Content

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

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

Date of the Last Revision of this Prospectus: May 2019

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/