ENALAPRIL KERN PHARMA 20 mg TABLETS

2. What you need to know before you take Enalapril Kern Pharma

Do not take Enalapril Kern Pharma

• If you are allergic (hypersensitive) to enalapril or any of the other ingredients of this medicine (listed in section 6).
• If you have previously been treated with a medicine 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 idiopathic angioedema (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 that contains aliskiren.
• If you are more than 3 months pregnant. It is also better to avoid enalapril at the start of pregnancy (see section Pregnancy).

Warnings and precautions

Consult your doctor or pharmacist before starting to take enalapril:

• If you have a heart condition (that obstructs blood flow from the heart).
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low or lack of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have liver problems.
• If you are undergoing dialysis (a procedure to purify the blood when you have kidney problems).
• If you are receiving treatment with diuretics (medicines that increase urine production).
• If you have recently had excessive vomiting or diarrhea.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium or medicines 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, which 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 desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice it as fainting or dizziness, especially in the initial doses and when standing up. In these cases, lying down could help).
• If you have vascular collagen 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) or aliskiren (see also the information under the headings "Do not take Enalapril Kern Pharma" and "Warnings and precautions").
  • 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 Kern Pharma".

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 can cause serious harm to your baby if used at this stage (see section 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 the medication with 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 this medicine.

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.

Taking Enalapril Kern Pharma with other medicines

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

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

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 Kern Pharma" and "Warnings and precautions").
• Other anti-hypertensive medicines (that reduce 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 (a type of antidepressant).
• Antipsychotics (medicines used in the treatment of psychosis).
• Anesthetics.
• Anti-diabetics (medicines that lower blood glucose levels).
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to treat pain or certain inflammations, e.g., acetylsalicylic acid).
• Sympathomimetics (medicines that increase heart rate and blood pressure or dilate bronchi).
• 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).

Taking Enalapril Kern Pharma with food, drinks, and alcohol

Food does not affect the absorption of enalapril.

Alcohol enhances the blood pressure-lowering effect of enalapril, so it should be used 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Enalapril should not be used in pregnant women.

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. This medicine is not recommended at the start of pregnancy and must not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy onwards.

Tell your doctor if you are breastfeeding or about to start breastfeeding. While taking enalapril, breastfeeding is not recommended in newborns (first weeks after birth), and 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 breastfeeding.

Driving and using machines

Individual responses to the medicine may 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 medicine.

Enalapril Kern Pharma contains lactose, sorbitol, and hydrogenated castor oil

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

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Enalapril Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take enalapril. Do not stop treatment before then.

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

The score line is only to facilitate breaking the tablet if you find it difficult to swallow it whole.

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

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.

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

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 for your case is reached. 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.

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 this medicine is too strong or too weak, tell 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Enalapril Kern Pharma

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

If you stop taking Enalapril Kern Pharma

Do not stop treatment without your doctor's advice.

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

4. Possible Adverse Effects

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

Adverse effects have been coded taking into account the following frequency definitions: very frequent (at least 1 in 10 patients), frequent (at least 1 in 100 patients), infrequent (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:

Infrequent:anemia (decrease in the number of red blood cells) (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:

Infrequent:low blood glucose levels.

Nervous System and Mental Disorders:

Frequent:headache, depression.

Infrequent:confusion, drowsiness or inability to sleep, nervousness, tingling or numbness, vertigo.

Rare:sleep disturbances, sleep problems.

Eyeball Disorders:

Very Frequent:blurred vision.

Cardiac and Vascular Disorders:

Very Frequent:dizziness.

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

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

Rare:narrowing of the arteries, usually in the fingers or toes, which produces spasms that make the skin turn pale or unevenly red to blue (Raynaud's phenomenon).

Respiratory Disorders:

Very Frequent:cough.

Frequent:difficulty breathing.

Infrequent:abundant watery nasal discharge, sore throat 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, taste disturbance.

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

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

Liver 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 causes swelling of the face, limbs, lips, tongue, glottis, and larynx.

Infrequent:sweating, pruritus (itching sensation), urticaria (red and itchy swelling), 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, blood vessel inflammation, 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:

Infrequent: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:

Infrequent:impotence.

Rare:breast enlargement in men.

General Disorders and Administration Site Conditions:

Very Frequent:weakness.

Frequent:fatigue.

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

Clinical Analysis:

Frequent:high blood potassium levels, increased creatinine levels in blood.

Infrequent:increased urea levels in blood, decreased sodium levels in blood.

Rare:increased liver enzymes, increased bilirubin levels in blood.

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

• if your face, lips, tongue, and/or throat swell, making it difficult 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 reactions.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it 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 Kern Pharma

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 25°C.

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 away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

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 castor oil, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the Product and Packaging Content

Enalapril Kern Pharma is presented in the form of tablets.

Each package contains 28 tablets. The tablets are orange, cylindrical, and scored on one side.

The score serves to fractionate and facilitate swallowing but not to divide into equal doses.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: February 2016

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