Herten 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HERTEN 20 mg tablets EFG

Enalapril

Read the entire leaflet carefully before you start taking this medicine,

• 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What HERTEN is and what it is used for
2. Before you take HERTEN
3. How to take HERTEN
4. Possible side effects
5. How to store HERTEN
6. Further information

1. What HERTEN is and what it is used for

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

HERTEN is indicated for:

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

2. Before taking HERTEN

Do not take HERTEN:

• If you are allergic (hypersensitive) to enalapril or to any of the other components of HERTEN.
• If you have previously been treated with a medicine from the same drug class as HERTEN (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.
• If you have been diagnosed with hereditary angioedema or angioedema of unknown cause.

• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is high.

• If you have diabetes or kidney disease and are being treated with an antihypertensive medicine containing aliskiren.

• If you are more than 3 months pregnant. (It is also advisable to avoid HERTEN in early pregnancy – see Pregnancy section).

Take special care with HERTEN:

• If you have heart disease.

• If you have a condition affecting the blood vessels in the brain.

• If you have blood disorders such as low levels or absence of 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 elimination).

• If you have recently experienced excessive vomiting or diarrhea.

• If you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or medicines associated with increased blood potassium levels (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 blood potassium levels, which can be serious.

• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing. Note that black patients are more prone to this type of reaction with ACE inhibitors.

• If you are taking any of the following medicines, the risk of developing angioedema may increase (rapid swelling beneath the skin, such as in the throat):

• Racecadotril (a medicine used to treat diarrhea),

• Medicines used to prevent organ transplant rejection or for cancer treatment (e.g., temsirolimus, sirolimus, everolimus),

• Vildagliptin (a medicine used to treat diabetes).

• 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 experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).
• If you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medicines, or are taking allopurinol, procainamide, or any combination of these.
• If you are taking any of the following medicines for 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 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 should inform your doctor if you think you are pregnant (or could be). HERTEN is not recommended during early 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 at this stage (see Pregnancy section).

Please note that HERTEN is less effective in lowering blood pressure in black patients compared to non-black patients.

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

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking HERTEN, as a sudden drop in blood pressure may occur in association with anesthesia.

Use of other medicines

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

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

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 information under the headings “Do not take HERTEN” and “Take special care with HERTEN”)
• Antihypertensive medicines (reduce high blood pressure)
• Diuretics (medicines that increase urine elimination)
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, 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 drugs (NSAIDs) (medicines to treat pain or certain inflammations, e.g.: acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold therapy
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)

Taking HERTEN with food and drinks:

Food does not affect the absorption of HERTEN.

Alcohol enhances the hypotensive effect (blood pressure lowering) of enalapril; therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking HERTEN before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. HERTEN is not recommended in early 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 onward.

Inform your doctor if you are breastfeeding or planning to breastfeed. While taking HERTEN, breastfeeding is not recommended for newborns (first weeks after birth), and especially for premature infants. For an older infant, your doctor should advise you on the benefits and risks of taking HERTEN compared to other treatments during breastfeeding.

Driving and using machines:

Individual responses to medication may vary.

Since HERTEN may cause dizziness or fatigue, avoid performing tasks that require special attention (such as driving 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 informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take HERTEN

Follow exactly the administration instructions for HERTEN provided by your doctor.

Consult your doctor if you have any doubts.

Remember to take your medication.

Your doctor will determine the duration of your treatment with HERTEN. Do not stop the treatment prematurely. HERTEN may be taken with meals or between meals, together with a glass of water.

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

Hypertension

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

The usual long-term dose is 20 mg once daily.

Heart failure

The recommended initial 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, taken in one or two doses.

Particular caution is required at the beginning of treatment due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you feel that 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 dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take HERTEN:

Continue taking HERTEN as prescribed. Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, HERTEN may produce adverse effects, although not everyone experiences them.

Disorders of the blood and lymphatic system:

Uncommon: anaemia (including aplastic and haemolytic anaemia).

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

Metabolism and nutrition disorders:

Uncommon: low blood glucose levels.

Nervous and psychiatric system disorders:

Frequent: headache, depression.

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

Rare: sleep disturbances, sleep problems.

Eye disorders:

Very frequent: blurred vision.

Cardiac and vascular disorders:

Very frequent: dizziness.

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

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

Rare: small arteries, usually in the fingers or toes, that undergo spasms causing skin colour changes—pale or white turning blue and then red when warmed (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very frequent: cough.

Frequent: difficulty breathing.

Uncommon: runny nasal discharge, throat itching and hoarseness, asthma.

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

Gastrointestinal disorders:

Very frequent: nausea.

Frequent: diarrhoea, abdominal pain, altered taste.

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

Rare: mouth inflammation and ulcers, inflammation of the tongue. Very rare: intestinal angioedema (swelling in the intestine).

Hepatobiliary disorders:

Rare: liver failure, liver inflammation (hepatitis), reduced or obstructed bile flow from the bile duct to the liver (cholestasis including jaundice).

Skin and subcutaneous tissue disorders:

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

Uncommon: sweating, pruritus (itching sensation), urticaria (red, itchy swellings), hair loss.

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

A symptomatic complex has been observed that may include one or more of the following reactions: fever, inflammation of blood vessels, muscle and joint pain and swelling, blood disorders affecting blood components usually detected in a blood test, skin rash, photosensitivity (hypersensitivity to sunlight) and other skin effects.

Renal and urinary disorders:

Uncommon: reduced kidney function or renal failure, presence of protein in urine.

Rare: reduced daily urine output.

Rare: breast enlargement in men.

General disorders:

Very frequent: weakness.
Frequent: fatigue.

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

Clinical laboratory tests:

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

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

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

Stop taking HERTEN and consult your doctor immediately if any of the following occur:

• Swelling of the face, lips, tongue and/or throat causing difficulty breathing or swallowing,
• Swelling of the hands, feet or ankles,
• Appearance of urticaria (itching and redness in certain areas of the body).

Please note that patients of black race are more susceptible to these types of adverse reactions.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 container. Protect from moisture. Expiry:

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

The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of HERTEN

The active substance 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.

Appearance of the product and contents of the pack

HERTEN 20 mg is presented as tablets. Each pack 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
Tel.: 91 486 29 90 Fax: 91 486 29 91

Further information on this medicinal product is available 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es