Leaflet: information for the user

Enalapril Kern Pharma 20 mg tablets EFG

Enalapril maleate

Read this leaflet carefully before you start taking this medicine, because 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.

Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). This medicine works by widening your blood vessels. This reduces your blood pressure. This allows your heart to pump blood more easily throughout your body.

Enalapril is indicated for:

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

Do not take Enalapril Kern Pharma

• If you are allergic (hypersensitive) to enalapril or to any of the other components of this medication (listed in section 6).
• If you have previously been 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 with 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 also 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 3 months pregnant. It is also best to avoid enalapril at the beginning of pregnancy (see Pregnancy section).

Warnings and precautions

Consult your doctor or pharmacist before starting to take enalapril:

• If you have heart disease (that blocks the blood flow from the heart).
• 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 liver problems.
• If you are undergoing dialysis (procedure to purify the blood when you have kidney problems).
• If you are receiving diuretic treatment (medications that increase urine elimination).
• If you have recently had excessive vomiting or diarrhea.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications, or salt substitutes containing potassium, or medications associated with elevated potassium levels in the blood (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus (high blood glucose levels) or any kidney problems (including kidney transplant), as these can lead to high potassium levels in the blood that can be serious.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing. You should be aware that black patients 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 at the beginning of treatment 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), particularly if you have kidney problems related to diabetes.
  • Aliskiren.

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

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

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 harm to your baby if used in this stage (see Pregnancy section).

You should be aware that enalapril reduces blood pressure in black patients less effectively than in patients who are not black.

In all these cases, inform your doctor as you may need to adjust your dose 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 this medication.

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

Taking Enalapril Kern Pharma with other medications

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

Certain medications may interact with enalapril. Your doctor may need to adjust your dose and/or take other precautions or discontinue one of them.

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 Kern Pharma” and “Warnings and precautions”).
• Other antihypertensive medications (reduce elevated blood pressure).
• Diuretics (medications that increase urine elimination).
• Potassium medications (including salt substitutes).
• Lithium (medication used to treat certain types of depression).
• Tricyclic antidepressants (a type of antidepressant).
• Antipsychotics (medications used in the treatment of psychosis).
• Anesthetics.
• Antidiabetic medications (medications that lower blood glucose levels).
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications for pain or certain inflammation, e.g., aspirin).
• Sympathomimetics (medications that increase heart rate and blood pressure or dilate the bronchi).
• Certain medications for pain or arthritis, including gold treatment.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and can be used to help you relieve pain).

Taking Enalapril Kern Pharma 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 it should be administered with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Pregnancy and breastfeeding

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

Enalapril should not be used in pregnant women.

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 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 harm to your baby if used in this stage (see Pregnancy section).

You should be aware that enalapril reduces blood pressure in black patients less effectively than in patients who are not black.

In all these cases, inform your doctor as you may need to adjust your dose 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 this medication.

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

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 Kern Pharma contains lactose, sorbitol, and hydrogenated ricin oil

This medication contains lactose and sorbitol as excipients. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

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

Remember to take your medication.

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

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

The groove is only for breaking the tablet if it is difficult to swallow it whole.

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 initial recommended 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.

The maximum long-term dose is 40 mg per day, divided into two doses.

Heart Failure

The initial recommended 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.

The maximum long-term dose is 40 mg per day, divided into 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 this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril Kern Pharma than you should

In case of an overdose, the most likely symptom is a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure.

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.

If you forgot to take Enalapril Kern Pharma

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

If you interrupt treatment with Enalapril Kern Pharma

Do not discontinue treatment without your doctor's indication.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

Side effects have been coded taking into account the following definitions of frequencies: very common (at least 1 in 10 patients), common (at least 1 in 100 patients), uncommon (at least 1 in 1,000 patients), rare (at least 1 in 10,000 patients), and very rare (less than 1 in 10,000 patients).

Blood and lymphatic system disorders:

Uncommon:anemia (decrease in the number of red blood cells in the blood) (including aplastic and hemolytic anemia).

Rare:blood disorders, such as an abnormally low number of neutrophils (a type of blood cell), low hemoglobin levels, reduction or complete absence of granulocytes (a type of blood cell), deficiency of all types of blood cells, bone marrow depression (tissue inside the bone that generates blood cells), lymph node disease or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon:low blood glucose levels.

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:fall in blood pressure (including fall in blood pressure when standing up), fainting, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeats.

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

Rare:arterial narrowing, usually in the fingers of the hands or feet, which produces spasms that make the skin turn pale or red and blue (Raynaud's phenomenon).

Respiratory disorders:

Very common:cough.

Common:difficulty breathing.

Uncommon:excessive nasal mucus, 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.

Hepatic disorders:

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

Dermatological and subcutaneous tissue disorders:

Common:skin rash, hypersensitivity or allergic reaction that causes swelling of the face, extremities, lips, tongue, glottis, and larynx.

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

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

A set of symptoms has been observed that may include some of the following reactions: fever, inflammation of blood vessels, muscle and joint pain, blood disorders that affect blood components and are normally detected in a blood test, skin rash, hypersensitivity to sunlight, and other skin effects.

Renal and urinary disorders:

Uncommon:reduced renal function or renal insufficiency, presence of proteins in the urine.

Rare:reduction in the amount of urine produced per day.

Reproductive and mammary system disorders:

Uncommon:impotence.

Rare:gynecomastia in men.

General disorders and administration site conditions:

Very common:weakness.

Common:fatigue.

Uncommon:muscle cramps, flushing, ear noises, general malaise, fever.

Clinical laboratory tests:

Common:high potassium levels in the blood, increases in creatinine in the blood.

Uncommon:increases in urea in the blood, decrease in sodium levels in the blood.

Rare:increases in liver enzymes, increases in bilirubin in the blood.

Stop taking enalapril and consult your doctor immediately in any of the following cases:

• if your face, lips, tongue, and/or throat swell up, making it difficult to breathe or swallow,
• if your hands, feet, or ankles swell up,
• if you develop 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.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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.

Do not store at a temperature above 25°C.

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 point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril Kern Pharma

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components (excipients) are: magnesium carbonate (E-540i), pregelatinized cornstarch, lactose monohydrate, sorbitol (E-420), hydroxypropylcellulose (E-463), magnesium stearate, hydrogenated ricin oil, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

Enalapril Kern Pharma is presented in the form of tablets.

Each package contains 28 tablets. The tablets are orange, cylindrical in shape, and have a notch on one of the faces.

The notch serves to fraction and facilitate swallowing but not to divide into equal doses.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this prospectus: February 2016

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