Enalapril Durban 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL DURBAN 20 mg tablets EFG

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 personally and must not be given to other people, 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 listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

2 Before you take Enalapril Durban 20 mg tablets

3 How to take Enalapril Durban 20 mg tablets

4 Possible side effects

5 How to store Enalapril Durban 20 mg tablets

6 Further information

1. What Enalapril Durban 20 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 indicated for:

• Treating hypertension (high blood pressure).

• 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 to any of the components of Enalapril Durban 20 mg tablets.
• If you have previously been treated with a medicine from the same drug class as Enalapril Durban 20 mg tablets (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 or idiopathic angioedema (a condition characterized by the development of large hives on the skin surface, especially around the eyes and lips, which may also affect the hands, feet, and throat, and may cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (It is also advisable to avoid Enalapril Durban 20 mg tablets in early pregnancy – see Pregnancy section).
• If you are currently taking or have recently taken 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 are taking any of the following medicines, your risk of developing 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.

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

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (for example, trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

Take special care 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 may reduce urine output).

• If you are on a salt-free diet, take 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, during treatment, you develop an allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue, and/or throat, accompanied by 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 experience fainting or dizziness, especially with initial doses and when standing up. In such 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” – 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 Enalapril Durban 20 mg tablets”.

In all these cases, inform your doctor, as you may require a dose adjustment, discontinuation of Enalapril Durban 20 mg tablets, or monitoring of 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 Enalapril Durban 20 mg tablets. Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking Enalapril Durban 20 mg tablets, as a sudden drop in blood pressure may occur in association with anesthesia.

Inform your doctor if you think you are pregnant (or might be). Enalapril Durban is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

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

It is 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 Enalapril Durban 5 mg tablets” and “Take special care with Enalapril Durban 5 mg tablets”).
• Other antihypertensive medicines (reduce high blood pressure).
• Diuretics (medicines that increase urine output).
• Medicines containing potassium (including dietary salt substitutes).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anesthetics.
• Antidiabetics.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g.: acetylsalicylic acid).
• Sympathomimetics.
• Certain medicines for pain or arthritis, including gold therapy.

Taking Enalapril Durban with food and drinks

Food does not affect the absorption of enalapril.

Alcohol enhances the hypotensive effect (blood pressure lowering) of enalapril; therefore, inform your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 recommend an alternative medicine. Enalapril Durban 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.

Inform your doctor if you are breastfeeding or planning to breastfeed. While taking Enalapril Durban, breastfeeding is not recommended in newborns (first weeks after birth), and especially in premature infants. For an older infant, 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 medication may vary.

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

3. How to TAKE Enalapril Durban 20 mg tablets

Follow exactly the instructions for use of Enalapril Durban 20 mg tablets as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long you should take enalapril. Do not stop treatment prematurely. Enalapril may be taken with meals or between meals, together with a glass of water. Your doctor will decide the appropriate dose of Enalapril Durban 20 mg tablets based on your condition and whether you are taking other medicines.

Hypertension

For most patients, the usual recommended starting dose is 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 starting dose is normally 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for your condition is reached. The usual long-term dose is 20 mg daily, taken in one or two doses.

Extreme caution should be taken at the beginning of treatment due to the possibility of dizziness or vertigo. Inform your doctor immediately if you experience these symptoms.

If you think that the effect of Enalapril Durban 20 mg tablets is too strong or too weak, tell your doctor or pharmacist.

The tablets may be divided into equal parts.

If you take more Enalapril Durban than you should

If you take more Enalapril Durban than you should, contact 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 Enalapril Durban

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

4. Possible adverse effects

Like all medicines, Enalapril Durban 20 mg tablets can cause adverse effects, although not everyone experiences them.

The adverse reactions reported for enalapril are listed below.

Frequencies are defined as follows: 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 fewer than 1 in 10,000 patients).

Blood and lymphatic system disorders:

Uncommon: Anaemia (including aplastic and haemolytic anaemia).

Rare: Blood disorders such as abnormally low neutrophil count, low haemoglobin levels, reduction 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 (hypoglycaemia).

Nervous system and psychiatric disorders:

Common: Headache, depression.

Uncommon: Confusion, drowsiness or inability to sleep, nervousness, tingling or numbness sensations, dizziness.

Rare: Sleep disturbances, sleep disorders.

Eye disorders:

Very common: Blurred vision.

Cardiac and vascular disorders:

Very common: Dizziness.

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

Uncommon: Orthostatic hypotension (decrease in blood pressure upon sitting or standing), rapid and forceful 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 of the hands or feet, that undergo spasms causing the skin to become pale or mottled red to blue (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very common: Cough.

Common: Difficulty breathing.

Uncommon: Runny nose, sore throat and hoarseness, asthma.

Rare: Fluid in the lungs, inflammation of the nasal mucosa membrane, allergic inflammation of the lungs.

Gastrointestinal disorders:

Very common: Nausea.

Common: Diarrhoea, abdominal pain, taste disturbances.

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

Rare: Mouth inflammation and ulcers, tongue inflammation.

Very rare: Intestinal angioedema (swelling in the intestine).

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Common: 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 reddening of the skin, blisters, skin peeling.

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

Renal and urinary disorders:

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

Rare: Decrease 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, tinnitus (ringing in the ears), general malaise, fever.

Clinical laboratory findings:

Common: High blood potassium levels, increased blood creatinine levels.

Uncommon: Increased blood urea levels, decreased blood sodium levels.

Rare: Increased liver enzymes, increased blood bilirubin levels.

Stop taking Enalapril Durban 20 mg tablets and consult your doctor immediately if any of the following occur:

• If your face, lips, tongue and/or throat swell so that you have difficulty breathing or swallowing,
• If your hands, feet or ankles swell,
• If you develop urticaria (itching and redness in 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 can 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 Enalapril Durban 20 mg tablets

Keep out of the reach and sight of children.

Storage conditions

Do not store above 30°C.

Keep in the original packaging to protect from moisture.

Expiry

Do not use Enalapril Durban 20 mg tablets after the expiry date stated on the container 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 unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Enalapril Durban 20 mg tablets

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

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

Appearance of the product and contents of the pack

Enalapril Durban 20 mg tablets are supplied as tablets. Each pack contains 28 or 30 tablets. The tablets are peach-colored, oval-shaped, 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.