HERTEN 20 mg TABLETS

2. Before taking HERTEN

Do not take HERTEN:

• If you are allergic (hypersensitive) to enalapril or any of the other ingredients of HERTEN.
• If you have been previously treated with a medicine 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 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 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 areas such as the throat) is high.

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

Be especially careful with HERTEN:

• 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 cells (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 (medicines that increase urine production).
• If you have recently experienced excessive vomiting or diarrhea.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing diuretics, 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 problems (including kidney transplant), as these can lead to high levels of potassium 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 taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:

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

• 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).
• 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 this as fainting or dizziness, 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 medicines that suppress your immune system, or 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",
• for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• 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 Herten".

You must inform your doctor if you think you are pregnant (or might be). HERTEN 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 during this stage (see section Pregnancy).

You should be aware that HERTEN 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 medication with HERTEN 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 HERTEN.

Before undergoing surgery or anesthesia (even at the dentist), 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 medicines

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

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

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

• an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Hertén" and "Be especially careful with Herten")
• antihypertensive 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 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 for 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 can be used to help relieve pain).

Taking HERTEN with food and drinks:

Food does not affect the absorption of HERTEN.

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 and breastfeeding

Consult your doctor or pharmacist before using a medicine.

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking HERTEN before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of HERTEN. HERTEN 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.

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

Driving and using machines:

Individual responses to the medicine may vary.

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

Important information about some of the ingredients of HERTEN:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take HERTEN

Follow exactly the administration instructions of HERTEN indicated by your doctor.

Consult your doctor if you have doubts.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with HERTEN. Do not stop treatment before. HERTEN can be taken with or without food, with a glass of water.

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

Hypertension

For most patients, the recommended initial 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 recommended initial 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.

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 HERTEN is too strong or too weak, tell 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 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.

If you forget to take HERTEN:

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

4. Possible side effects

Like all medicines, HERTEN can cause side effects, although not everybody gets them.

Blood and lymphatic system disorders:

Uncommon:anemia (including aplastic and hemolytic anemia).

Rare:blood disorders, such as abnormally low neutrophil count, low hemoglobin levels, reduction or complete absence of granulocytes, deficiency of all cellular elements in the blood, bone marrow depression, lymph node disease, or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon:low blood glucose levels.

Nervous system and mental disorders:

Common:headache, depression.

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

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 (decrease in blood pressure when sitting or standing), rapid and strong heartbeat, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with alterations in heart and/or brain blood flow).

Rare:small arteries, usually in the fingers or toes, that produce spasms that cause skin color changes, pale or white that turns blue and then red when warmed (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

Very common:cough.

Common:difficulty breathing.

Uncommon:nasal mucous fluid elimination, throat irritation 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:mouth ulcers and inflammation, tongue inflammation. 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 jaundice).

Skin and subcutaneous tissue disorders:

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

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

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

A symptom complex has been observed that may include some of the following reactions: fever, blood vessel inflammation, 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:

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

Rare:reduced amount of urine produced per day.

Rare:breast enlargement in men.

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

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

Clinical laboratory tests:

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

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

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

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

• If your face, lips, tongue, and/or throat swell in such a way that it is 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 side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HERTEN

Keep HERTEN out of the sight and reach of children.

Store in the original package. Protect from moisture. Expiry date:

Do not use HERTEN after the expiry date stated on the package after EXP.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the package and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the package and any unused medicines. By doing so, you will help protect the environment.

6. Packaging Content and Additional Information

HERTEN Composition

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, corn starch, pregelatinized potato starch, magnesium stearate.

Product Appearance and Packaging Content

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

The tablets are round, white, and scored.

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR,

S.A. C/ Laguna 66-68-70, 28923 ALCORCÓN

(Madrid) Spain

Phone: 91 486 29 90 Fax: 91 486 29 91

You can request more information about this medication by contacting

the local representative of the marketing authorization holder:

ABABOR PHARMACEUTICALS, S.L

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

Spain

This leaflet was approved in October 2019

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