ENALAPRIL STADA 5 mg TABLETS

2. What you need to know before you take Enalapril Stada

Do not take Enalapril Stada:

• if you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6)
• if you have been treated with a medicine of the same group as enalapril (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 (a condition characterized by the 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 better to avoid enalapril 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 areas such as the throat) is high

Warnings and precautions

Talk to 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 in the brain
• if you have blood disorders such as low or absent white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia)
• if you have diabetes mellitus or any kidney problems (including kidney transplant), as these can lead to high levels of potassium in the blood, which can be serious
• if you have liver problems
• if you are undergoing dialysis
• if you are receiving treatment with diuretics (medicines that increase urine production)
• if you have recently had excessive vomiting or diarrhea
• if you are on a low-salt diet, taking potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium, or medications associated with increased potassium levels in the blood (e.g., anticoagulants such as heparin), or 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 black patients are more sensitive to these types of reactions to ACE inhibitors
• if you are about to undergo a treatment called LDL apheresis or desensitization treatment to reduce the effect of an allergy to bee or wasp stings
• if you have low blood pressure (you may notice this as fainting or dizziness, especially in the initial doses and when standing up; in these cases, lying down may help)
• if you have collagen vascular disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines allopurinol or procainamide, or any combination of these
• 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), especially if you have kidney problems related to diabetes
  • aliskiren
• if you are using any of the following medicines, the risk of angioedema may increase (rapid swelling under the skin in areas such as the throat):
  • racecadotril, a medicine used to treat diarrhea

• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other medicines of the mTOR inhibitor class
• vildagliptin, a medicine used to treat diabetes

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 Stada”.

You must inform your doctor if you think you are pregnant (or might be). Enalapril 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 after the third month of pregnancy.

You should be aware that enalapril lowers blood pressure in black patients less effectively than in non-black patients.

In all these cases, inform your doctor, as you may need a dose adjustment or discontinuation of enalapril or monitoring of your potassium blood level. 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.

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

Other medicines and Enalapril Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Certain medicines may interact with enalapril; in these cases, 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 Stada” and “Warnings and precautions”)

• Other anti-hypertensive medicines (lowering 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
• Medicines for diabetes (including oral antidiabetics and insulin)
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to treat pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold treatment
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and can be used to help relieve pain)

This applies especially if you are also taking:

• Medicines used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitor class medicines); see section “Warnings and precautions”
• Potassium supplements (including salt substitutes), diuretics (especially potassium-sparing diuretics), and other medicines that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)

Taking Enalapril Stada with food, drinks, and alcohol

Food does not affect the absorption of enalapril.

Alcohol enhances the blood pressure-lowering effect of enalapril; therefore, inform your doctor if you are consuming alcoholic beverages while being treated with this medicine.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking enalapril before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of enalapril. Enalapril 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 after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. While taking enalapril, breast-feeding is not recommended in newborns (first few weeks after birth), especially in 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 breast-feeding.

Driving and using machines

Individual responses to the medicine may vary.

Since enalapril can cause dizziness or fatigue, do not perform tasks that require special attention (driving vehicles or operating machinery) until you know how the medicine affects you.

Enalapril Stada contains lactose and sodium

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

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

3. How to take Enalapril Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will decide the duration of your treatment with enalapril. Do not stop treatment before.

Enalapril Stada can be taken with or without food, with a glass of water.

Your doctor will decide the appropriate dose of enalapril for you to take, depending on your condition and whether you are taking other medicines.

Hypertension

For most patients, the initial recommended dose is 5 to 20 mg once daily. Some patients may need a lower initial dose.

The usual long-term dose is 20 mg once daily.

Heart Failure

The initial recommended dose is usually 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 per day in one or two divided 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 is too strong or too weak, tell 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

In case of overdose, the most likely symptom is a feeling 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 make up for forgotten doses.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse reactions reported for enalapril are detailed below:

Frequencies are defined as: very frequent (affecting more than 1 in 10 people); frequent (affecting between 1 and 10 in 100 people); uncommon (affecting between 1 and 10 in 1,000 people); rare (affecting between 1 and 10 in 10,000 people); very rare (affecting 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 cellular elements in the blood, bone marrow depression, lymph node disease or abnormal immune response.

Metabolism and Nutrition Disorders

Uncommon: low blood glucose levels (hypoglycemia).

Nervous System and Mental Disorders

Frequent: headache, depression.

Uncommon: confusion, somnolence or inability to sleep, nervousness, sensation of tingling or numbness, vertigo.

Rare: sleep disturbances, sleep problems.

Eye Disorders

Very frequent: blurred vision.

Cardiac and Vascular Disorders

Very frequent: dizziness.

Frequent: drop in blood pressure (including orthostatic hypotension), fainting, chest pain, changes in heart rhythm, angina pectoris, rapid heartbeat.

Uncommon: orthostatic hypotension (decrease in blood pressure when sitting or standing), rapid and strong heartbeat, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with alterations in blood flow to the heart and/or brain).

Rare: small arteries, usually in the fingers or toes, that produce spasms that make the skin turn pale or a reddish-blue color (Raynaud's phenomenon).

Respiratory, Thoracic, and Mediastinal Disorders

Very frequent: cough.

Frequent: difficulty breathing.

Uncommon: nasal mucous discharge, throat irritation and hoarseness, asthma.

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

Gastrointestinal Disorders

Very frequent: nausea.

Frequent: diarrhea, abdominal pain, alteration of 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 (swelling of the intestine)

Hepatobiliary Disorders

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

Skin and Subcutaneous Tissue Disorders

Frequent: skin rash, hypersensitivity or allergic reaction that produces swelling of the face, limbs, lips, tongue, glottis, and larynx.

Uncommon: sweating, pruritus (itching sensation), urticaria (red and itchy hives), hair loss.

Rare: severe skin reaction, including excessive redness of the skin, blisters, skin peeling.

A symptomatic complex has been observed that may include some of the following reactions: fever, inflammation of blood vessels, pain and inflammation of muscles and joints, 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 renal function or renal failure, presence of proteins in the urine. Rare: reduction 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 frequent: weakness.

Frequent: fatigue.

Uncommon: muscle cramps, flushing, ringing in the ears, general malaise, fever.

Clinical Laboratory Tests

Frequent: 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 swell in a way that makes it difficult for you to breathe or swallow.
• If your hands, feet, or ankles swell.
• If you experience urticaria (itching and redness in some areas of the body).

You should 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 Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Enalapril Stada

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

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 Packaging Contents

Enalapril Stada 5 mg is presented in the form of white, round, flat-faced tablets with a notch on one side and the inscription "5" on the other.

The notch is only for fractionation and to facilitate swallowing, but not for dividing into equal doses.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Prospectus:November 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