ENALAPRIL DURBAN 5 mg TABLETS

Introduction

PATIENT INFORMATION LEAFLET

ENALAPRIL DURBAN 5 mg tablets EFG

Read the entire leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1 What Enalapril Durban 5 mg tablets are and what they are used for

2 Before taking Enalapril Durban 5 mg tablets

3 How to take Enalapril Durban 5 mg tablets

4 Possible side effects

5 Storing Enalapril Durban 5 mg tablets

6 Further information

1. What Enalapril Durban 5 mg tablets are and what they are used for

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

Enalapril Durban is used to:

• Treat high blood pressure (hypertension).
• Treat symptomatic heart failure.
• Prevent symptomatic heart failure.

2. Before taking Enalapril Durban 5 mg tablets

Do not take Enalapril Durban 5 mg tablets

• If you are allergic (hypersensitive) to enalapril or any of the other ingredients of Enalapril Durban 5 mg tablets.
• If you have been treated with a medicine of the same group as Enalapril Durban 5 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 (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 problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (It is also recommended to avoid Enalapril Durban at the start of pregnancy – see section Pregnancy).
• 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 an area such as the throat) is high.

• If you are taking any of the following medicines, the risk of angioedema may increase:

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

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

• 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 immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

Be especially careful with Enalapril Durban 5 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.

• If you are on a low-salt diet, take 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 problems (including kidney transplant), as these can lead to high potassium levels in the blood, which can be serious.
• If an allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing occurs during treatment.
• If you are about to undergo a treatment called LDL apheresis or desensitization treatment to reduce the effect of a bee or wasp sting allergy.
• If you have low blood pressure (you may notice this 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):
  • 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 5 mg tablets".

In all these cases, inform your doctor, as you may need a dose adjustment or discontinuation of the medicine with Enalapril Durban 5 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 5 mg tablets. Before undergoing surgery or anesthesia (even at the dentist), inform your doctor or dentist that you are taking Enalapril Durban 5 mg tablets, as there may be a sudden drop in blood pressure associated with anesthesia.

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril Durban 5 mg tablets before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Durban 5 mg tablets. Enalapril Durban 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.

Taking other medicines

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

It is important to 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 Enalapril Durban 5 mg tablets" and "Be especially careful with Enalapril Durban 5 mg tablets").
• Other antihypertensive medicines (reduce high blood pressure).
• Diuretics (medicines that increase urine production).
• Potassium-containing medicines (including dietary salt substitutes).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Antidiabetics.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to treat pain or certain inflammations, 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 enhances the blood pressure-lowering effect of enalapril, so inform

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 Enalapril Durban 5 mg tablets before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril Durban 5 mg tablets. Enalapril Durban 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.

Tell 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 medicine 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 the medicine affects you.

Important information about some of the ingredients of Enalapril Durban

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 Enalapril Durban 5 mg tablets

Follow the administration instructions for Enalapril Durban 5 mg tablets exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with enalapril. Do not stop treatment before then. Enalapril can be taken with or without food, along with a glass of water. Your doctor will decide the appropriate dose of Enalapril Durban 5 mg tablets for you to 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 Enalapril Durban 5 mg tablets is too strong or too weak, tell 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 medicines, Enalapril Durban 5 mg tablets can cause side effects, although not everybody gets them.

The following adverse reactions have been reported for enalapril:

Frequencies are defined as: very common (affects more than 1 in 10 patients); common (affects 1 to 10 in 100 patients); uncommon (affects 1 to 10 in 1,000 patients); rare (affects 1 to 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 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 sugar 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, mental 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 (drop in blood pressure when sitting or standing up), rapid and strong heartbeat, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with coronary or cerebral artery disease).

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

Respiratory, thoracic, and mediastinal disorders:

Very common:cough.

Common:difficulty breathing.

Uncommon:runny nasal 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, mouth ulcers.

Rare:mouth and tongue inflammation, mouth ulcers.

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, limbs, lips, tongue, and/or throat.

Uncommon:sweating, itching, urticaria (hives), 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, blood vessel inflammation, muscle and joint pain, 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 protein in the urine.

Rare:reduced urine production.

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 5 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 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 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 Enalapril Durban 5 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 5 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 pharmacy's SIGRE point. 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 5 mg tablets

-The active ingredient is enalapril (maleate). Each Enalapril Durban 5 mg tablet contains 5 mg of enalapril.

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

Appearance of the product and packaging content

Enalapril Durban 5 mg tablets are presented in tablet form. Each package contains 10 or 60 tablets. The tablets are white, 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.