Enalapril Durban 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL DURBAN 5 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and you must not give it 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 listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

2 Before you take Enalapril Durban 5 mg tablets

3 How to take Enalapril Durban 5 mg tablets

4 Possible side effects

5 How to store 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 indicated for:

• Treating hypertension (high blood pressure).
• Treating symptomatic heart failure.
• Preventing 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 to any of the components of Enalapril Durban 5 mg tablets.
• If you have previously been treated with a medicine from the same drug class as Enalapril Durban 5 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 angioedema or angioedema of unknown cause.
• 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 5 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 under the skin, particularly in areas such as the throat) is increased.

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

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

In particular, speak with 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 immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

Take special care 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 diarrhoea (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 desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may experience this as 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" – e.g., 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 5 mg tablets”.

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

Inform your doctor if you think you may be pregnant (or could become pregnant). 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 taking or have recently taken any other medicines, including those obtained without a prescription.

Certain medicines may interact with enalapril; in such cases, it may be necessary to change the dose or interrupt treatment with one or more of them. Your doctor may need to adjust 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).
• Potassium-containing medicines (including dietary salt substitutes).
• Lithium (a medicine used to treat certain types of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Anaesthetics.
• 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 may be pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Enalapril Durban 5 mg tablets before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Enalapril Durban 5 mg tablets. 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 onwards.

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended with Enalapril Durban in newborns (first weeks after birth), and especially in premature infants. For older infants, 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 requiring special attention (such as driving 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 them before taking this medicine.

3. How to TAKE Enalapril Durban 5 mg tablets

Follow exactly the instructions for use of Enalapril Durban 5 mg tablets given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will tell you how long to take enalapril. Do not stop treatment early. 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 5 mg tablets based on your condition and whether you are taking other medications.

Hypertension

For most patients, the usual recommended initial 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 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, given in one or two doses.

Precautions 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 5 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

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

4. Possible adverse effects

Like all medicines, Enalapril Durban 5 mg tablets can cause adverse effects, although not everyone experiences 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 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 cell 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 sensation, dizziness.

Rare: sleep disturbances, sleep problems.

Eye disorders:

Very common: blurred vision.

Cardiac and vascular disorders:

Very common: dizziness.

Common: drop in blood pressure (including orthostatic hypotension), fainting, chest pain, irregular heartbeat, angina pectoris, rapid heartbeat.

Uncommon: orthostatic hypotension (decrease 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 impaired blood flow to the heart and/or brain).

Rare: small arteries, usually in the fingers or toes, causing spasms that make the skin pale or mottled blue-red (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 mucous 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 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 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, blisters, skin peeling.

A symptomatic complex has been observed which may include some of the following reactions: fever, inflammation of blood vessels, muscle and joint pain and swelling, blood disorders affecting blood components and usually detected in a blood test, 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: reduced daily urine output.

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, malaise, fever.

Clinical analyses:

Common: high levels of potassium in blood, increased creatinine levels in blood.

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

Rare: increased liver enzymes, increased blood bilirubin levels.

Stop taking Enalapril Durban 5 mg tablets and consult your doctor immediately if you experience any of the following:

• 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 black patients 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 Enalapril Durban 5 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 5 mg tablets after the expiry date stated on the packaging EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or 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 packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Enalapril Durban 5 mg tablets

-The active substance is enalapril (maleate). Each tablet of Enalapril Durban 5 mg 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 contents of the container

Enalapril Durban 5 mg tablets are presented as tablets. Each pack contains 10 or 60 tablets. The tablets are white, oval-shaped and scored on one side.

Marketing Authorisation 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 medicine is available on the website of the

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