PATIENT INFORMATION LEAFLET

ENALAPRIL DURBAN 20 mg tablets EFG

Read this leaflet carefully before you start taking the 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 personally and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

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

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

Enalapril Durbán is indicated for:

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

• Preventing symptomatic heart failure.

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 previously been treated with a medicine 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 unknown cause angioedema (it is 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 diabetes or kidney failure 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 Enalapril Durbán 20 mg tablets at the beginning of pregnancy – see Pregnancy section).

• If you have taken or are currently taking sacubitril/valsartan, a medicine 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 are taking any of the following medicines, the risk of suffering 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.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medicines:

• Supplements of potassium (including salt substitutes) and other medicines that may increase the amount of potassium in the blood (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to dilute 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 had vomiting or excessive diarrhea. This can affect the removal of urine).

• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medicines, 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 problem (including kidney transplant), as these may lead to high levels of potassium in the blood that can be serious.

• If during treatment, an allergic reaction occurs with swelling of the hands, feet, ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing.

• 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 notice it as dizziness or lightheadedness, especially in the initial doses and when standing up. In these cases, lying down may help).• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• Angiotensin II receptor antagonist (ARA) (also known as "sartanes" – for example, valsartán, telmisartán, ibesartán), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may need to monitor your kidney 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 Enalapril Durbán 20 mg tablets".

In all these cases, inform your doctor as you may need to adjust the dose or discontinue the medication with Enalapril Durban 20 mg tablets or monitor the level of potassium in the blood. If you have diabetes and are taking oral antidiabetic drugs or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with Enalapril Durbán 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 may be pregnant (or may be). Enalapril Durbán is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause serious damage to your baby if used in this stage (see Pregnancy section).

Taking other medicines

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

Certain medicines may interact with enalapril; in these cases, you may need to change the dose or discontinue treatment with one of them.You may need to modify your dose and/or take other precautions:

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

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings "Do not take Enalapril Durbán 5 mg tablets" and "Be especially careful with Enalapril Durban 5 mg tablets").

• Other antihypertensive medicines (reduce elevated blood pressure).

• Diuretics (medicines that increase urine elimination).

• Potassium-containing medicines (including salt substitutes).

• Lithium (medicine used to treat certain types of depression).

• Tricyclic antidepressants.

• Antipsychotics.

• Anesthetics.

• Antidiabetic medicines.

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

• Sympathomimetics.

• Certain medicines for pain or arthritis, including gold treatment.

Taking Enalapril Durban with food and drinks

Food does not affect the absorption of enalapril.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medicine.

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

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking Enalapril Durbán, it is not recommended to breastfeed 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 Enalapril Durbán compared to other treatments while breastfeeding.

Driving and operating machinery

Individual responses to medication can vary.

Since Enalapril Durban may 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 components of Enalapril Durban

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

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

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with enalapril. Do not discontinue treatment prematurely. Enalapril can be taken with meals or between meals along with a glass of water. Your doctor will decide on the appropriate dose of Enalapril Durban 20 mg tablets for you, depending on your condition and if 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 require 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 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. Inform your doctor immediately if you experience these symptoms.

If you estimate that the action 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

Consult your doctor or pharmacist immediately if you take more Enalapril Durban than you should.

In case of an overdose, the most likely symptom is a sensation 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 forget to take Enalapril Durban

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

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

The adverse reactions reported for enalapril are detailed below.

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

Blood and lymphatic system disorders:

Uncommon:anemia (including aplastic and hemolytic anemia).

Rare:blood disorders, such as abnormally low neutrophil counts, 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 glucose levels (hypoglycemia).

Nervous system and mental disorders:

Common:headache, depression.

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

Rare:sleep disturbances, sleep disorders.

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 strong heartbeat, possible myocardial infarction or stroke due to excessively low blood pressure in high-risk patients (patients with heart or brain blood flow abnormalities).

Rare:small arteries, usually in the fingers or toes, that cause spasms and make the skin pale or turn red and blue (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

Very common:cough.

Common:shortness of breath.

Uncommon:nasal mucus discharge, sore throat, and hoarseness, asthma.

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

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 and tongue inflammation, mouth and tongue ulcers.

Very rare:intestinal angioedema (intestinal swelling).

Hepatobiliary disorders:

Rare:liver insufficiency, hepatitis, reduced or obstructed 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 (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, blood vessel inflammation, 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, proteinuria.

Rare:reduced urine production per day.

Reproductive and breast disorders:

Uncommon:impotence.

Rare:gynecomastia in men.

General disorders and administration site conditions:

Very common:weakness.

Common:fatigue.

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

Investigations:

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 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 develop urticaria (itching and redness in some areas of the body).

Be aware that black patients are more sensitive to this type of adverse reaction.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish Medicines Vigilance System:

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

Keep out of reach and sight of children.

Storage Conditions

Do not store above 30º C.

Store in the original packaging to protect it from moisture.

Expiration Date

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

Medicines should not be disposed of through drains or trash.Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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, cornstarch, pregelatinized cornstarch, magnesium stearate, iron oxide (E172) red, iron oxide (E172) yellow, and purified water.

Appearance of the product and contents of the package

Enalapril Durban 20 mg tablets are presented in the form of tablets. Each package contains 28 or 30 tablets. The tablets are orange in color, oval, and scored on one side.

Manufacturer and Responsible for Manufacturing:

LABORATORIO FRANCISCO DURBÁN, S.A.

Industrial Park La Redonda, C/ IX, nº 2

04710 El Ejido (Almería)

This prospectus was approved in April 2019

The detailed and updated information on this medication is available on the website of the

Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.