ENALAPRIL DURBAN 20 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL DURBAN 20 mg tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you personally 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 side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

1 What Enalapril Durban 20 mg tablets are and what they are used for

2 Before taking Enalapril Durban 20 mg tablets

3 How to take Enalapril Durban 20 mg tablets

4 Possible side effects

5 Storage of Enalapril Durban 20 mg tablets

6 Additional information

1. What Enalapril Durban 20 mg tablets are and what they are used for

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

Enalapril Durban is indicated for:

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

• Preventing symptomatic heart failure.

2. BEFORE TAKING Enalapril Durban 20 mg tablets

Do not take Enalapril Durban 20 mg tablets

• If you are allergic (hypersensitive) to enalapril or any of the components of Enalapril Durban 20 mg tablets.
• If you have been previously treated with a medication from the same group of drugs as Enalapril Durban 20 mg tablets (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 failure and are being treated with a blood pressure medication containing aliskiren.
• If you are pregnant for more than 3 months. (It is also recommended to avoid Enalapril Durban at the beginning of pregnancy – see section Pregnancy).
• If you have taken or are currently taking sacubitril/valsartan, a medication 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 medications, the risk of suffering from angioedema may increase:

• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

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

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that can increase the amount of potassium in the blood (e.g., trimethoprim and cotrimoxazole 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).

Be especially careful with Enalapril Durban 20 mg tablets

• If you have heart disease.
• If you have blood disorders.
• If you have liver problems.
• If you are undergoing dialysis.

• If you have recently experienced excessive vomiting or diarrhea (which can lead to the elimination of urine).

• If you follow a low-salt diet, take 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 problems (including kidney transplant), as these can lead to high levels of potassium in the blood, which can be serious.
• If during treatment, an allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing appears.
• 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 are taking any of the following medications used to treat high blood pressure (hypertension):
• An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, ibesartan), 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 Enalapril Durban 20 mg tablets".

In all these cases, inform your doctor, as you may need a dose adjustment or discontinuation of the medication with Enalapril Durban 20 mg tablets or monitoring of potassium levels in the blood. 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 Durban 20 mg tablets. Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking Enalapril Durban 20 mg tablets, as there may be a sudden drop in blood pressure associated with anesthesia.

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril Durban 20 mg tablets before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Enalapril Durban 20 mg tablets. Enalapril Durban is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy.

Taking other medications

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

Certain medications may interact with enalapril; in these cases, it may be necessary to change the dose or interrupt treatment with one of them. Your doctor may need to modify your dose and/or take other precautions:

It is essential that you inform your doctor if you are taking or have recently taken any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "do not take Enalapril Durban 5 mg tablets" and "Be especially careful with Enalapril Durban 5 mg tablets").
• Other antihypertensive medications (which reduce high blood pressure).
• Diuretics (medications that increase urine elimination).
• Potassium-containing medications (including dietary salt substitutes).
• Lithium (a medication used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Antidiabetics.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics.
• Certain medications for pain or arthritis, including gold treatment.

Taking Enalapril Durban with food and drinks

Food does not affect the absorption of enalapril.

Alcohol enhances the hypotensive effect (reduction of blood pressure) of enalapril, so inform

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medication.

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril Durban 20 mg tablets before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Enalapril Durban 20 mg tablets. Enalapril Durban is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it can 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 Enalapril Durban, breastfeeding is not recommended in newborns (first few 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 Enalapril Durban compared to other treatments while breastfeeding.

Driving and using machines

Individual responses to the medication may vary.

Since Enalapril Durban 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.

Important information about some of the components of Enalapril Durban

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.

3. HOW TO TAKE Enalapril Durban 20 mg tablets

Follow the administration instructions of Enalapril Durban 20 mg tablets indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with enalapril. Do not suspend treatment before. Enalapril can be taken with or without food, along with a glass of water. Your doctor will decide the appropriate dose of Enalapril Durban 20 mg tablets that 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 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. 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.

At the beginning 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 Durban 20 mg tablets is too strong or too weak, inform your doctor or pharmacist.

The tablets can be divided into equal parts.

If you take more Enalapril Durban than you should

If you take more Enalapril Durban 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 Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Enalapril Durban

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

4. Possible side effects

Like all medications, Enalapril Durban 20 mg tablets can cause side effects, although not everyone will experience them.

The adverse reactions reported for enalapril are listed below.

Frequencies are defined as: very common (affecting more than 1 in 10 patients); common (affecting between 1 and 10 in 100 patients); uncommon (affecting between 1 and 10 in 1,000 patients); rare (affecting between 1 and 10 in 10,000 patients); very rare (affecting less than 1 in 10,000 patients).

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 cell elements, bone marrow depression, 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, somnolence 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 heartbeats.

Uncommon: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 heart and/or brain blood flow).

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

Respiratory, thoracic, and mediastinal disorders:

Very common:cough.

Common:difficulty breathing.

Uncommon:nasal mucous fluid elimination, throat itching 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, alteration of 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 failure, hepatitis (inflammation of the liver), 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, extremities, lips, tongue, and/or throat.

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

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

A symptom 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:

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

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

Reproductive system and breast disorders:

Uncommon:impotence.

Rare:breast enlargement in men.

General disorders and administration site conditions:

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 Enalapril Durban 20 mg tablets 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 experience hives (itching and redness in some areas of the body).

Keep in mind that black patients are more sensitive to these types of adverse reactions.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications:

https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Enalapril Durban 20 mg tablets

Keep out of the reach and sight of children.

Storage conditions

Do not store above 30°C.

Store in the original package to protect from moisture.

Expiry date

Do not use Enalapril Durban 20 mg tablets after the expiry date stated on the packaging CAD. The expiry date is the last day of the month indicated.

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

6. ADDITIONAL INFORMATION

Composition of Enalapril Durban 20 mg tablets

-The active ingredient is enalapril (maleate). Each Enalapril Durban 20 mg tablet contains 20 mg of enalapril.

-The other components (excipients) are: sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, iron oxide (E172) red, iron oxide (E172) yellow, and purified water.

Appearance of the product and packaging content

Enalapril Durban 20 mg tablets are presented in tablet form. Each package contains 28 or 30 tablets. The tablets are peach-colored, oval, and scored on one side.

Marketing authorization holder and manufacturer:

LABORATORIO FRANCISCO DURBÁN, S.A.

Polígono Ind. La Redonda, C/ IX, nº 2

04710 El Ejido (Almería)

This leaflet was approved in April 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.