Package Insert: Information for the User

HERTEN 20 mg Tablets EFG

Enalapril

Read this package insert carefully before starting to use the medication,

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist. See section 4.

1. What HERTEN is and for what it is used

2. Before taking HERTEN

3. How to take HERTEN

4. Possible adverse effects

5. Storage of HERTEN

6. Additional informationl

HERTEN belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors).

HERTEN is indicated for:

- Treating high blood pressure (hypertension).

- Treating symptomatic heart failure.

- Preventing symptomatic heart failure.

Do not take HERTEN:

• If you are allergic (hypersensitive) to enalapril or to any of the other components of HERTEN.

• If you have been previously treated with a medication from the same group of drugs as HERTEN (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 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 also cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).

• 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 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 best to avoid HERTEN at the beginning of pregnancy - see Pregnancy section).

Be especially careful with HERTEN:

- If you have heart disease.

- If you have a disease that affects the blood vessels of 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 diuretic treatment (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, potassium-sparing medications, 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 black patients are more sensitive to this type of reaction with ACE inhibitors.

- If you are taking any of the following medications, the risk of angioedema may

increase (rapid swelling under the skin in areas such as the throat):

− 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).

- If you are about to undergo a treatment called LDL apheresis, or a treatment for desensitization 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 alopurinol 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 "sartanes"

- for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

- aliskirén

Your doctor may monitor your renal 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 Herten”.

You should inform your doctor if you think you are pregnant (or may be). HERTEN 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 damage to your baby if used from the third month of pregnancy.

You should be aware that HERTEN 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 to adjust the dose or discontinue HERTEN 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 HERTEN.

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Certain medications may interact with HERTEN; in these cases, your doctor may need to modify your dose and/or take other precautions, or discontinue one of them.

It is especially important to inform your doctor if you are taking or have recently taken any of the following medications:

- an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Hertén” and “Be especially careful with Herten”)

- Anti-hypertensive medications (reduce elevated blood pressure)

- Diuretics (medications that increase urine elimination)

- Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medications that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to dilute 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

- Non-steroidal anti-inflammatory drugs (NSAIDs) (medications for pain or certain inflammation, e.g. acetylsalicylic acid)

- Sympathomimetics

- Certain medications for pain or arthritis, including gold treatment

- Anti-inflammatory non-steroidal medications (AINEs), including COX-2 inhibitors (medications that reduce inflammation and may be used to help you alleviate pain).

Taking HERTEN with food and drinks:

Food does not affect the absorption of HERTEN.

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 and breastfeeding

Consult your doctor or pharmacist before using a medication.

You should inform your doctor if you think you are pregnant (or may be). HERTEN 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 damage to your baby if used from the third month of pregnancy.

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

You should inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking HERTEN, 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 HERTEN, compared to other treatments, while breastfeeding.

Driving and operating machinery:

Individual responses to medication can vary.

Since HERTEN may cause dizziness or fatigue, be careful not toperform tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Important information about some of the components of HERTEN:

This medication contains Lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for HERTEN as indicated by your doctor.

Consult your doctor if you have any doubts.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with HERTEN. Do not discontinue treatment before. HERTEN can be taken with meals or between them along with a glass of water.

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

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. Your doctor will gradually increase the dose until the appropriate dose is reached for 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 HERTEN is too strong or too weak, inform your doctor or pharmacist.

If you take more HERTEN than you should:

If you take more HERTEN 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 the Toxicological Information Service. Phone: 91 562 04 20.

If you forgot to take HERTEN:

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

Like all medicines, HERTEN can cause side effects, although not everyone will experience them.

Blood and lymphatic system disorders:

Uncommon:anemia (including aplastic and hemolytic anemia).

Rare:blood disorders, such as an abnormally low number of neutrophils, low hemoglobin levels, reduction or complete absence of granulocytes, deficiency of all blood cells, bone marrow depression, lymph node disease or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon:low blood sugar levels.

Nervous system and mental disorders:

Common:headache, depression.

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

Rare:sleep disturbances, sleep problems.

Eye disorders:

Very common:

blurred vision

Cardiac and vascular disorders:

Very common:dizziness.

Common:low blood pressure (including orthostatic hypotension), fainting, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeat.

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

Rare:small arteries, usually in the fingers or toes, that produce spasms causing skin changes, pale or white that turns blue and then red when warmed up (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, 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:hepatic insufficiency, inflammation of the liver (hepatitis), reduction or obstruction of bile flow from the bile duct to the liver (cholestasis including jaundice).

Skin and subcutaneous tissue disorders:

Common:skin rash, hypersensitivity or allergic reaction causing facial, limb, lip, tongue, glottis and larynx swelling.

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

Rare:severe skin reaction, including excessive skin redness, 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:reduced urine production per day.

Rare:breast enlargement in men.

General disorders:Very common:weakness.Common:fatigue.

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

Clinical laboratory tests:

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

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

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

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

• If your face, lips, tongue and/or throat swell, making it difficult to breathe or swallow,

• If your hands, feet or ankles swell,

• 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 adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. 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 reactions, you can contribute to providing more information on the safety of this medicine.

Keep HERTEN out of sight and reach of children.

Store in the original packaging. Store protected from moisture. Expiration Date:

Do not use HERTEN after the expiration date appearing on the packaging after CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or trash. Deposit empty packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Composition of HERTEN

The active ingredient is Enalapril in the form of maleate. Each tablet contains 20 mg of enalapril.

The other components (excipients) are: sodium bicarbonate (sodium hydrogen carbonate), lactose, cornstarch, pregelatinized potato starch, magnesium stearate.

Appearance of the product and contents of the packaging

HERTEN 20 mg is presented in the form of tablets. Each package contains 28 or 30 tablets.

The tablets are round, white, and scored.

Holder of the marketing authorization and responsible for manufacturing

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, 28923 ALCORCÓN

(Madrid) Spain

Tel.: 91 486 29 90 Fax: 91 486 29 91

You can request more information about this medication by contacting

the local representative of the holder of the marketing authorization:

ABABOR PHARMACEUTICALS, S.L

C/ Chile 4, building 1, office 1, Las Matas, 28290, Las Rozas, Madrid.

Spain

This prospectus was approved in October 2019

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