ENALAPRIL GHS 5 mg TABLETS

2. What you need to know before you take ENALAPRIL GHS 5 mg TABLETS

Do not take ENALAPRIL GHS 5 mg TABLETS:

• 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 angioedema (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) of hereditary or unknown origin.
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant or think you may be pregnant.

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 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 (medicines that increase urine production).
• If you are on a low-salt diet, taking potassium supplements, potassium-sparing medicines, 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 desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice fainting or dizziness, especially in the initial doses and when standing up. In these cases, lying down may help).
• 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.

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 GHS 5 mg tablets".

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

Before undergoing surgery or anesthesia (even at the dentist's office), 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 medicines:

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

Certain medicines may interact with Enalapril; in these cases, your doctor may need to modify your dose and/or take other precautions or interrupt 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 GHS 5 mg tablets" 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
• Antipsychotics
• Anesthetics
• Anti-diabetic medicines
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines to treat pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics

Taking ENALAPRIL GHS 5 mg tablets with food and drinks:

Food does not affect the absorption of ENALAPRIL GHS 5 mg tablets.

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

Pregnancy:

Consult your doctor or pharmacist before using a medicine.

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

Breast-feeding:

Consult your doctor or pharmacist before using a medicine.

ENALAPRIL GHS 5 mg tablets passes into breast milk in very small amounts, so while being treated with this medicine, breast-feeding should be discontinued.

Driving and using machines:

Individual responses to the medicine may vary.

Since ENALAPRIL GHS 5 mg tablets 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.

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

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

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

3. How to take ENALAPRIL GHS 5mg TABLETS

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with ENALAPRIL GHS 5 mg tablets. Do not stop treatment before.

ENALAPRIL GHS 5 mg tablets can be taken with or without food, with a glass of water.

Your doctor will decide the appropriate dose of ENALAPRIL GHS 5 mg tablets that you should take, 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.

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 in your case. The usual long-term dose is 20 mg per day in one or 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 ENALAPRIL GHS 5 mg tablets is too strong or too weak, tell 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 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 the Toxicology 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 make up for forgotten doses.

If you stop taking ENALAPRIL GHS 5 mg TABLETS:

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

4. Possible side effects

Like all medicines, ENALAPRIL GHS 5mg tablets can cause side effects, although not everybody gets them.

Blood and lymphatic system disorders:

Uncommon:anemia (including aplastic anemia and hemolytic anemia).

Rare:blood disorders, such as abnormally low neutrophil count, 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 sugar levels.

Nervous system and mental disorders:

Common:headache, depression.

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

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, arrhythmias, angina pectoris, rapid heartbeat.

Uncommon:rapid and strong heartbeat.

Rare:small arteries, usually in the fingers of the hands or feet, that produce spasms that cause skin color changes, pale or white that turns blue and then red when warmed (Raynaud's phenomenon).

Respiratory disorders:

Very common:cough.

Common:difficulty breathing.

Uncommon:runny 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 common:nausea.

Common:diarrhea, abdominal pain, altered taste.

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

Rare:mouth ulcers and inflammation, tongue inflammation.

Liver disorders:

Rare:liver failure, liver inflammation, 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 that causes swelling of the face, limbs, lips, tongue, glottis, and larynx.

Uncommon:sweating, itching, urticaria, hair loss.

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

A symptom complex has been observed that may include some of the following reactions: fever, inflammation of the blood vessels, pain and inflammation of muscles and joints, blood disorders that affect the components of the blood and are usually detected in a blood test, skin rash, hypersensitivity to sunlight, and other skin effects.

Kidney and urinary disorders:

Uncommon:reduced kidney function or kidney failure, presence of protein 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:

Very common:weakness. Common:fatigue.

Uncommon:muscle cramps, flushing, ringing in the ears, 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 in such a way that it is difficult to breathe or swallow,
• If your hands, feet, or ankles swell,
• If you develop hives (itching and redness in some areas of the body)

Keep in mind that black patients are more sensitive to these types of adverse reactions.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing ENALAPRIL GHS 5 mg TABLETS

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

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of ENALAPRIL GHS 5 mg TABLETS

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

The other ingredients (excipients) are: sodium bicarbonate (sodium hydrogen carbonate), lactose, cornstarch, pregelatinized potato starch, magnesium stearate, Orange Yellow S (E-110) c.s.

Appearance of the product and pack contents

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

Marketing Authorization Holder:

GLOBAL HEALTH SERVICES S.L

Paseo Egiburuberri, 13, Pabellón 0U.

Errentería (Guipúzkoa)

Manufacturer:

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

Date of last revision of this leaflet: February 2016

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