Package Insert: Information for the User

Enalapril GHS 5 mg Tablets

Enalapril

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

ENALAPRIL GHS 5 mg tablets belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

ENALAPRIL GHS 5 mg tablets is indicated for:

- Treating high blood pressure (hypertension).

- Treating symptomatic heart failure.

- Preventing symptomatic heart failure.

Do not take ENALAPRIL GHS 5 mg tablets:

• If you areallergic to enalapril or to 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 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 aliskirén.
• If you arepregnant or think you may be.

Warnings and precautions

Consult your doctor or pharmacist before starting to take enalapril:

Be especially careful with ENALAPRIL GHS 5 mg tablets:

• If you have a heart disease.
• If you have blood disorders.
• If you have diabetes.
• If you have liver problems.
• If you have kidney problems (including kidney transplant).
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medications that increase the elimination of urine).
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications, or salt substitutes that contain potassium, or if you have recently had excessive vomiting or diarrhea.
• If during treatment, an allergic reaction with swelling of the face, lips, tongue, and/or
• throat with difficulty swallowing or breathing appears.
• 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 notice it with dizziness or lightheadedness, especially in the initial doses and when standing up. In these cases, lying down may help).
• 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, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

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

See also the information under the heading “Do not take enalapril GHS 5 mg tablets”.

In all these cases, inform your doctor as you may need a dose adjustment or discontinue the medication with ENALAPRIL GHS 5mg tablets.

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking ENALAPRIL GHS 5 mg tablets, as there may be a sudden drop in blood pressure associated with anesthesia.

Taking ENALAPRIL 5 mg tablets with other medications:

Consult your doctor or pharmacist if you are using or have used recently or would have to use any other medication.

Certain medications may interact withAcetensil; in these cases, your doctor may need to modify your dose and/or take other precautions, or discontinue treatment with 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 aliskirén (see also the information under the headings “Do not take enalapril GHS 5 mg tablets” and “Warnings and precautions”).
• Otheranti-hypertensive medications (reduce elevated blood pressure)
• Diuretics (medications that increase the elimination of urine)
• Medications with potassium (including dietary salt substitutes)
• Lithium (medication used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Antidiabetics
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications to treat pain or certain inflammation, e.g., acetylsalicylic acid)
• Sympathomimetics

Taking ENALAPRIL GHS 5 mg tablets with food and beverages:

Foods do not affect the absorption of ENALAPRIL GHS 5 mg tablets.

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

Pregnancy:

Consult your doctor or pharmacist before using a medication.

ENALAPRIL GHS 5 mg tablets should not be used in pregnant women. If you are pregnant or intend to become pregnant, before starting treatment with ENALAPRIL GHS 5 mg tablets, inform your doctor so that another treatment can be considered.

Lactation:

Consult your doctor or pharmacist before using a medication.

ENALAPRIL GHS 5 mg tablets pass into breast milk in very small amounts, therefore, while undergoing treatment with this medication, breastfeeding should be discontinued.

Driving and operating machinery:

Individual responses to medication can vary.

Since ENALAPRIL GHS 5 mg tablets may cause dizziness or fatigue, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Important information about some of the components of ENALAPRIL GHS 5 mg tablets:

This medication contains Lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause allergic reactions because it contains Yellow Orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

Your doctor will inform you of the duration of your treatment with ENALAPRIL GHS 5 mg tablets. Do not discontinue treatment before.

ENALAPRIL GHS 5 mg tablets can be taken with meals or between them along with a glass of water.

Your doctor will decide on the appropriate dose of ENALAPRIL GHS 5 mg tablets for you to 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 tablets 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 action of ENALAPRIL GHS 5 mg tablets is too strong or weak, inform your doctor or pharmacist.

If you take more ENALAPRIL GHS 5 mg tablets than you should:

If you take more ENALAPRIL GHS 5 mg tablets than you should, consult your doctor or pharmacist immediately.

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.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: (91) 562-04-20.

If you forget to take ENALAPRIL GHS 5 mg tablets:

You should continue taking ENALAPRIL GHS 5 mg tablets as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with ENALAPRIL GHS 5 mg tablets:

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, ENALAPRIL GHS 5mg tablets can cause side effects, although not everyone will experience them.

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 levels.

Nervous system and mental disorders:

Common:headache, depression.

Uncommon:confusion, drowsiness or inability to sleep, nervousness, 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, myocardial infarction or stroke, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeats.

Uncommon:rapid and strong heartbeats.

Rare:small arteries, usually in the fingers or toes, that produce spasms causing skin changes, pale or white that turns blue and then red when warmed up (Raynaud's phenomenon).

Respiratory disorders:

Very common:cough.

Common:breathing difficulties.

Uncommon:nasal mucous discharge, sore throat, hoarseness, asthma.

Rare:fluid in the lungs, inflammation of the nasal mucosa, 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, inflammation of the liver, 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 swelling of the face, extremities, lips, tongue, glottis, and larynx.

Uncommon:sweating, pruritus, urticaria, hair loss.

Rare:severe skin reaction, including excessive redness of the skin, 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, 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:reduced urine production per day.

Reproductive and mammary system disorders:

Uncommon:impotence.

Rare:breast enlargement in men.

General disorders:

Very common:weakness.Common:fatigue.

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

Clinical laboratory tests:

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 GHS 5 mg tablets 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 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 leaflet. You can also report them directly through the Spanish System for the Vigilance 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 use this medication after the expiration date that appears on the packaging. 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ENALAPRIL GHS 5 mg tablets

The active ingredient is Enalapril in the form of maleate. Each tablet contains 5 mg of enalapril.

The other components (excipients) are: sodium bicarbonate (sodium hydrogen carbonate), lactose, cornstarch without gluten, pregelatinized potato starch without gluten, magnesium stearate, yellow orange S (E-110) c.s.

Appearance of the product and content of the packaging

ENALAPRIL GHS 5 mg tablets 5 mg tablets are presented in the form of tablets. Each package contains 10 and 60 tablets. The tablets are round, orange, and scored.

Holder of the marketing authorization:

GLOBAL HEALTH SERVICES S.L

Paseo Egiburuberri, 13, Pabellón 0U.

Errentería ( Guipúzkoa)

Responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A. C/ Laguna 66-68-70, 28923 ALCORCÓN (Madrid)

Last review date of this leaflet: February 2016

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es