Enalapril Belmac 10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enalapril Belmac 10 mg tablets

enalapril maleate

Package leaflet contents

1. What Enalapril Belmac is and what it is used for
2. What you need to know before taking Enalapril Belmac
3. How to take Enalapril Belmac
4. Possible side effects
5. Storage of Enalapril Belmac

Pack contents and additional information

1. What Enalapril Belmac is and what it is used for

Enalapril Belmac belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors.

Enalapril Belmac is indicated for:

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

This medicine works by widening your blood vessels, thereby lowering your blood pressure. The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the maximum effect on blood pressure is observed.

2. What you need to know before taking Enalapril Belmac

Do not take Enalapril Belmac

• If you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor.
• If you have ever had swelling of the face, lips, mouth, tongue or throat causing difficulty swallowing or breathing (angioedema) when the cause was hereditary or unknown.
• If you have diabetes or kidney failure 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 this medicine during early pregnancy—see Pregnancy section.)
• If you are taking or have recently taken sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high.

Do not take this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril Belmac

• If you have heart disease.

• If you have a condition affecting the blood vessels in the brain.

• If you have blood disorders such as low levels or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).

• If you have liver problems.

• If you have kidney problems (including kidney transplant), are on a salt-free diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood—for example, heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may lead to high potassium levels in the blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels. See also information under the heading “Taking Enalapril Belmac with other medicines”.

• If you are undergoing dialysis.

• If you have experienced excessive vomiting or severe diarrhoea recently.

• If you have diabetes. You should closely monitor your blood glucose levels,

especially during the first month of treatment. Your blood potassium level may also be higher.

• If you have ever had an allergic reaction with swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing. Please note that black patients are more sensitive to this type of reaction to ACE inhibitors.

• If you have low blood pressure (you may experience fainting or dizziness, especially with initial doses and when standing up).

• If you have a vascular collagen disease (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are being treated with medicines that suppress your immune system, are taking allopurinol or procainamide, or any combination of these.

• 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. sirolimus, everolimus, temsirolimus).

• vildagliptin, a medicine used to treat diabetes.

• If you are taking any of the following medicines used to treat high blood pressure:

• 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 information under the heading “Do not take Enalapril Belmac”.

You should inform your doctor if you think you are pregnant (or could be). This medicine is not recommended during 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 at this stage (see Pregnancy section).

Please note that this medicine is less effective in lowering blood pressure in black patients than in non-black patients.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medicine.

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• any surgery or if you are to receive anaesthetics (including at the dentist’s),
• a treatment to remove cholesterol from your blood called “LDL apheresis”,
• a desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.

If any of the above apply to you, consult your doctor or dentist before starting the procedure.

Taking Enalapril Belmac with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies. This is because enalapril may affect how other medicines work, and certain medicines may affect how enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril Belmac” and “Warnings and precautions”).
• Other blood pressure-lowering medicines such as beta-blockers or diuretics (“water tablets”).
• 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; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also information in the section “Warnings and precautions”.
• Medicines for diabetes (including oral antidiabetics and insulin).
• Lithium (a medicine used to treat certain types of depression).
• Medicines for depression (“tricyclic antidepressants”).
• Medicines for mental disorders (“antipsychotics”).
• Certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic agent”.
• Certain medicines for pain or arthritis, including gold therapy.
• An mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See also information in the section “Warnings and precautions”.
• A medicine containing sacubitril/valsartan, racecadotril or vildagliptin. These may increase the risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). See also “Do not take Enalapril Belmac” and “Warnings and precautions”.
• Non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).
• Aspirin (acetylsalicylic acid).
• Medicines used to dissolve blood clots (thrombolytics).
• Alcohol.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting to take enalapril.

Taking Enalapril Belmac with food, drinks and alcohol

Enalapril may be taken with or without food. Most people take enalapril with a little water.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Enalapril Belmac. Enalapril Belmac is not recommended during 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.

Breast-feeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Breastfeeding is not recommended in newborns (first weeks after birth) while taking enalapril, and especially in premature infants. For an older infant, your doctor should advise you on the benefits and risks of taking enalapril versus other treatments while breastfeeding.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this occurs, do not drive or operate tools or machinery.

Enalapril Belmac contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Enalapril Belmac

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

It is very important that you continue taking this medicine for as long as your doctor prescribes it.

Do not take more tablets than prescribed.

The recommended dose is:

Hypertension

The 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.

The maximum long-term dose is 40 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 you is reached.

The usual long-term dose is 20 mg daily, taken in one or two divided doses.
The maximum long-term dose is 40 mg once daily, divided into two doses.

Patients with kidney problems

Your dose will depend on how well your kidneys are functioning:

• moderate kidney problems – 5 mg to 10 mg daily
• severe kidney problems – 2.5 mg daily
• if undergoing dialysis – 2.5 mg daily. On days when you are not undergoing dialysis, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

Your doctor will decide the dose based on kidney function.

Use in children

Experience with enalapril in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. Usual initial doses are:

• between 20 kg and 50 kg – 2.5 mg daily
• over 50 kg – 5 mg daily.

The dose may be adjusted according to the child's needs:

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg daily may be used in children weighing over 50 kg.

This medicine is not recommended in newborn infants (first weeks after birth) or in pediatric patients with kidney problems.

If you take more Enalapril Belmac than you should

If you take more enalapril than prescribed, contact your doctor or pharmacist immediately.

Take the medicine pack with you.

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, indicating the medicine and the amount taken.

If you forget to take Enalapril Belmac

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

If you stop taking Enalapril Belmac

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following symptoms, stop taking this medicine and consult your doctor immediately:

• swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing,
• swelling of the hands, feet or ankles,
• if you develop a red rash on the skin with swelling (hives).

Please be aware that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking this medicine and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, lying down may help. This is due to a drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

Other adverse effects include:

Very common (may affect more than 1 in 10 people):

• dizziness, weakness or vomiting
• cough
• blurred vision

Common (may affect up to 1 in 10 people):

• headache, depression, fainting (syncope), altered taste
• dizziness due to low blood pressure, chest pain, changes in heart rhythm, angina, rapid heartbeat
• difficulty breathing
• tiredness (fatigue)
• diarrhoea, abdominal pain
• rash, allergic reactions with swelling of the face, limbs, lips, tongue or throat with difficulty swallowing or breathing
• elevated potassium levels in blood, elevated creatinine levels in blood (both are usually detected in a blood test)

Uncommon (may affect up to 1 in 100 people):

• flushing
• sudden drop in blood pressure
• anaemia (including aplastic and haemolytic anaemia)
• confusion, drowsiness or inability to sleep, nervousness
• sensation of itching or numbness in the skin
• vertigo (sensation of dizziness)
• rapid and irregular heartbeat (palpitations)
• myocardial infarction or stroke (possibly due to excessively low blood pressure in high-risk patients, even in those with impaired blood flow to the heart and/or brain)
• runny nose, sore throat or hoarseness
• asthma – associated with chest tightness
• slow movement of food through the intestine (ileus), inflammation of the pancreas
• vomiting, indigestion, constipation, anorexia
• gastric irritation (irritated stomach), dry mouth, peptic ulcer
• increased sweating
• itching or urticaria
• hair loss
• reduced kidney function, kidney failure
• elevated protein levels in urine (detected in a urine test)
• impotence
• muscle cramps
• ringing in the ears (tinnitus)
• malaise (general discomfort), elevated temperature (fever)
• low blood sugar or sodium levels, elevated blood urea levels (all detected in a blood test)

Rare (may affect up to 1 in 1,000 people):

• “Raynaud’s phenomenon” in which your hands and feet may become very cold and turn white due to reduced blood flow
• changes in blood values, such as lower numbers of white or red blood cells, reduced haemoglobin, lower platelet count
• bone marrow depression
• swollen glands in the neck, armpits or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• accumulation of fluid or other substances in the lungs (as seen on X-rays)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonitis)
• inflammation of the cheeks, gums, tongue, lips, throat
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin disorder in which you have red, peeling skin, blistering or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• reduced amount of urine produced per day
• breast enlargement in men (gynaecomastia)
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood test)

Very rare (may affect up to 1 in 10,000 people):

• Intestinal angioedema (swelling in the intestine)

Frequency not known (frequency cannot be estimated from the available data):

• excessive production of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue or confusion

A symptomatic complex has been observed which may include all or some of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other skin manifestations may occur.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Belmac

Keep this medicine out of sight and reach of children.

Do not store above 30 °C. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after 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 Point of your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Belmac 10 mg tablets

The active substance in this medicine is enalapril maleate 10 mg. Each tablet contains 10 mg of enalapril maleate as the active substance.

The other components (excipients) are: croscarmellose sodium, lactose, magnesium stearate, pregelatinized maize starch (derived from corn), sodium bicarbonate, iron oxide red (E-172), iron oxide yellow (E-172), and maize starch.

Appearance of the product and pack contents

Enalapril Belmac 10 mg are circular, flat, scored* tablets, peach-colored. They are available in packs of 28 or 56 tablets.

*The score line is intended only to facilitate breaking and swallowing, and is not intended to divide the tablet into equal doses.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

Alcobendas, 28108 Madrid (Spain).

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica c/C nº4

50016 Zaragoza. Spain.

Date of the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/