Leaflet: information for the user

Enalapril STADA 5 mg tablets EFG

Enalapril maleate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What isEnalapril Stadaand what it is used for

2. What you need to know before starting to takeEnalapril Stada

3. How to takeEnalapril Stada

4. Possible side effects

5. Storage ofEnalapril Stada

6. Contents of the pack and additional information

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

Enalapril Stada is indicated for:

•Treating high blood pressure (hypertension)

•Treating symptomatic heart failure.

•Preventing symptomatic heart failure.

Do not take Enalapril Stada:

• If you are allergic to enalapril or any of the other components of this medication (listed in section 6).

• If you have been previously treated with a medication from the same group of drugs as enalapril (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing.

• If you have been diagnosed with hereditary or unknown cause angioedema (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 cause swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing).

• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

• If you are more than three months pregnant. (It is also recommended to avoid enalapril at the beginning of pregnancy – see Pregnancy section).

• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Enalapril Stada.

• If you have heart disease.

• If you have a disease that affects the blood vessels of the brain.

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

• If you have diabetes mellitus or any kidney problem (including kidney transplant), as these can lead to high levels of potassium in the blood that can be serious.

• If you have liver problems.

• If you are undergoing dialysis.

• If you are receiving treatment with diuretics (medications that increase urine production).

• If you have recently had excessive vomiting or diarrhea.

• If you are following a low-sodium diet, taking potassium supplements, medications that save potassium, or salt substitutes that contain potassium, or medications associated with high potassium levels in the blood (e.g., anticoagulants such as heparin). If you are over 70 years old.

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

• 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 feel dizzy or lightheaded, especially in the initial doses and when standing up. In these cases, lying down may help).

• If you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking allopurinol or procainamide, or any combination of these.

• If you are taking any of the following medications used to treat high blood pressure (hypertension):

- An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.

- Aliskiren

• If you are using any of the following medications, the risk of angioedema may increase (rapid swelling under the skin in areas such as the throat):

• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other mTOR inhibitors
• Vildagliptin, a medication used to treat diabetes

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril Stada”.

You should inform your doctor if you think you may be pregnant (or could be). Enalapril is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious damage to your baby if used at this stage (see Pregnancy section).

You should be aware that enalapril is less effective in lowering blood pressure in patients of black race than in patients who are not of black race.

In all these cases, inform your doctor as you may need a dose adjustment or discontinue enalapril or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetic medications or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with enalapril.

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking enalapril, as there may be a sudden drop in blood pressure associated with anesthesia.

Other medications and Enalapril Stada:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with enalapril; in these cases, your doctor may need to adjust 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 medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril Stada” and “Warnings and precautions”)

- Other antihypertensive medications (reduce elevated blood pressure)

- Diuretics (medications that increase urine production)

- Medications with potassium (including salt substitutes)

- Lithium (medication used to treat certain types of depression)

- Tricyclic antidepressants

- Antipsychotics

- Anesthetics

- Diabetes medications (including oral antidiabetic medications and insulin)

- Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications for pain or certain inflammation, e.g., aspirin)

- Sympathomimetics

- Certain medications for pain or arthritis, including gold treatment

- Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and may be used to help you relieve pain).

This applies especially if you are also taking:

- Medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See the section “Warnings and precautions”.

- Potassium supplements (including salt substitutes), diuretics (especially those called potassium-sparing diuretics), and other medications that may increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots).

Taking Enalapril Stada with food, drinks, and alcohol:

Foods do not affect the absorption of enalapril.

Alcohol potentiates the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking beverages that contain alcohol while taking this medication.

Pregnancy, lactation, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant (or could be), or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of enalapril. Enalapril is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious damage to your baby if used at this stage.

Lactation

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking enalapril, it is not recommended to breastfeed newborns (first weeks after birth), and especially premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments while breastfeeding.

Driving and operating machinery:

Individual responses to medication can vary.

Since enalapril can cause dizziness or fatigue, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Enalapril Stada contains lactose and sodium:

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with enalapril. Do not discontinue treatment before.

Enalapril Stada can be taken with meals or between them along with a glass of water.

Your doctor will decide on the appropriate dose of enalapril you should take, 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 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 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 appearing.

Inform your doctor immediately if you experience these symptoms.

If you estimate that the effect of enalapril is too strong or too weak, inform your doctor or pharmacist.

If You Take More Enalapril Stada Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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.

If You Forget to Take Enalapril Stada

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The adverse reactions reported for enalapril are listed below:

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

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 cells, bone marrow depression, lymph node disease, or abnormal immune response.

Metabolism and nutrition disorders

Uncommon: low blood sugar (hypoglycemia).

Nervous system and mental disorders

Common: headache, depression.

Uncommon: confusion, drowsiness or inability to sleep, nervousness, sensation of tingling or numbness, dizziness.

Rare: sleep disturbances, sleep 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 (decrease in blood pressure when standing or sitting), 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 produce spasms causing the skin to become pale or red and blue (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders

Very common: cough.

Common: difficulty breathing.

Uncommon: nasal mucus discharge, 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: diarrhea, abdominal pain, altered taste.

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

Rare: inflammation and ulcers of the mouth, inflammation of the tongue.

Very rare: intestinal angioedema (intestinal swelling)

Hepatobiliary disorders

Rare: liver insufficiency, hepatitis, 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 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, inflammation of blood vessels, muscle and joint pain, blood disorders affecting blood components and normally detected in a blood test, skin rash, photosensitivity, and other skin effects.

Renal and urinary disorders

Uncommon: reduced kidney function or renal insufficiency, presence of proteins in the urine. Rare: reduced urine production per day.

Reproductive 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, ear noises, general malaise, fever.

Investigations

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 STADA and consult your doctor immediately in any of the following cases:

•If your face, lips, tongue, and/or throat become swollen, making it difficult to breathe or swallow.

•If your hands, feet, or ankles become swollen.

•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. If you observe any other reaction not described in this prospectus, consult your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this prospectus. You can also report themdirectlythrough the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use. https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not requirespecial storage conditions.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Enalapril Stada

-The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.

-The other components are lactose monohydrate, sodium hydrogen carbonate, cornstarch and magnesium stearate.

Appearance of the product and contents of the packaging

Enalapril Stada 5 mg is presented in the form of white, round, flat-faced beveled tablets with a groove on one face and the inscription “5” on the other.

The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Each package contains 10, 60 or 500 (clinical package) tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:November 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es