Enalapril GHS 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril GHS 5 mg tablets

Enalapril

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What ENALAPRIL GHS 5 mg tablets are and what they are used for
2. Before taking ENALAPRIL GHS 5 mg tablets
3. How to take ENALAPRIL GHS 5 mg tablets
4. Possible adverse effects
5. How to store ENALAPRIL GHS 5 mg tablets
6. Contents of the pack and other information

1. What ENALAPRIL GHS 5 mg TABLETS is and what it is used for

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

ENALAPRIL GHS 5 mg tablets are indicated for:

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

2. What you need to know before taking ENALAPRIL GHS 5 mg tablets

Do not take ENALAPRIL GHS 5 mg tablets:

• If you are allergic to enalapril or to 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 as enalapril (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, causing difficulty in 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 may also affect hands, feet, and throat, and may cause swelling of the face, lips, tongue, and/or throat with difficulty in swallowing or breathing).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are pregnant or think you may be pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting enalapril:

Take special care 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 elimination).
• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium, or if you have recently had excessive vomiting or diarrhea.
• If you develop an allergic reaction during treatment, with swelling of the face, lips, tongue, and/or throat, causing difficulty in swallowing or breathing.
• 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 experience fainting or dizziness, especially with initial doses and when standing up. In such 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” – for example, valsartan, telmisartan, irbesartan), particularly 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 require a dose adjustment or discontinuation of treatment with ENALAPRIL GHS 5 mg tablets.

Before undergoing surgery or anesthesia (including at the dentist's), inform the 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, have recently used, or may need to use any other medicine.

Certain medicines may interact with Acetensil; in such cases, your doctor may need to adjust your dose and/or take other precautions, or discontinue treatment with one of the medicines.

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 information under the headings “Do not take ENALAPRIL GHS 5 mg tablets” and “Warnings and precautions”).
• Other antihypertensive medicines (reduce high blood pressure)
• Diuretics (medicines that increase urine elimination)
• Potassium-containing medicines (including dietary salt substitutes)
• Lithium (a medicine used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Antidiabetics
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used 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 hypotensive effect (lowering of blood pressure) of enalapril; therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

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

Breast-feeding:

Consult your doctor or pharmacist before using any medicine.

ENALAPRIL GHS 5 mg tablets pass into breast milk in very small amounts; therefore, breast-feeding must be discontinued during treatment with this medicine.

Driving and using machines:

Individual responses to medication may vary.

Since ENALAPRIL GHS 5 mg tablets may cause dizziness or fatigue, avoid performing tasks requiring special attention (such as 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine may cause allergic reactions as it contains Sunset Yellow FCF (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take ENALAPRIL GHS 5mg TABLETS

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long you should take ENALAPRIL GHS 5 mg tablets. Do not stop treatment earlier than advised.

ENALAPRIL GHS 5 mg tablets may be taken with meals or between meals, together with a glass of water.

Your doctor will decide the appropriate dose of ENALAPRIL GHS 5 mg tablets for you, depending on your condition and whether you are taking other medicines.

Hypertension

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

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

Heart failure

The recommended starting dose is usually 2.5 mg tablets once daily. Your doctor will gradually increase the dose until the appropriate dose for your case is reached. The usual long-term dose is 20 mg daily, taken in one or two doses.

At the beginning of treatment, special caution is required due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think that 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 prescribed, consult your doctor or pharmacist immediately.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: (91) 562-04-20.

If you forget to take ENALAPRIL GHS 5 mg tablets:

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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Blood and lymphatic system disorders:

Uncommon: anaemia (including aplastic and haemolytic anaemia).

Rare: blood disorders such as abnormally low neutrophil count, low haemoglobin levels, reduction or complete absence of granulocytes, deficiency of all blood cellular elements, bone marrow depression, lymph node disease, or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon: low blood glucose levels.

Nervous system and psychiatric disorders:

Frequent: headache, depression.

Uncommon: confusion, drowsiness or inability to sleep, nervousness, tingling or numbness sensations, dizziness.

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, myocardial infarction or stroke, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeat.

Uncommon: rapid and forceful heartbeat.

Rare: small arteries, usually in the fingers of the hands or feet, that produce spasms causing the skin to change color, becoming pale or white, then turning blue and later red when warmed (Raynaud's phenomenon).

Respiratory disorders:

Very frequent: cough.

Frequent: difficulty breathing.

Uncommon: runny nose, sore throat and hoarseness, asthma.

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

Gastrointestinal disorders:

Very frequent: nausea.

Frequent: diarrhoea, 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: liver failure, 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:

Frequent: skin rash, hypersensitivity or allergic reaction causing swelling of the face, limbs, 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 symptomatic complex has been observed that may include some of the following reactions: fever, inflammation of blood vessels, muscle and joint pain and swelling, blood disorders affecting blood components and usually detected in a blood test, skin rash, photosensitivity and other skin effects.

Effects on kidneys and urinary excretion:

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 frequent: weakness. Frequent: fatigue.

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

Clinical laboratory tests:

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

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

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

Stop taking ENALAPRIL GHS 5 mg tablets and consult your doctor immediately if any of the following occur:

• If your face, lips, tongue and/or throat swell so much that it becomes difficult to breathe or swallow,
• If your hands, feet or ankles swell,
• If you develop hives (itching and redness in certain areas of the body).

Please note that black patients are more susceptible to these types of adverse reactions.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other 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 components (excipients) are: sodium bicarbonate (sodium hydrogen carbonate), lactose, gluten-free corn starch, gluten-free pregelatinized potato starch, magnesium stearate, orange-yellow S (E-110) q.s.

Appearance of the medicinal product and contents of the pack

ENALAPRIL GHS 5 mg tablets are presented as tablets. Each pack contains 10 and 60 tablets. The tablets are round, orange in colour and scored.

Marketing Authorisation Holder:

GLOBAL HEALTH SERVICES S.L
Paseo Egiburuberri, 13, Pabellón 0U.
Errentería (Guipúzcoa)

Manufacturer:

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

Date of the most recent revision of this leaflet: February 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es