Heart Health

“You can’t beat a healthy heart.”

High Blood Pressure Medication

ACE Inhibitors

Enap-RGB

SCHEDULING STATUS S3

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ENAP 5 mg (tablet)
ENAP 10 mg (tablet)
ENAP 20 mg (tablet)

Please read this patient information leaflet carefully before using ENAP

  • Keep this information. You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

WHAT ENAP CONTAINS

Active ingredients:
Each ENAP 5 mg contains 5 mg enalapril maleate.

Each ENAP 10 mg contains 10 mg enalapril maleate.

Each ENAP 20 mg contains 20 mg enalapril maleate.

WHAT ENAP IS USED FOR

ENAP is used for:

  • Hypertension (high blood pressure of no known cause or high blood pressure caused by the kidneys)
  • Heart failure

Treatment is usually in combination with diuretics (water tablet) and digitalis (stimulation of the heart muscle)

  • Asymptomatic Left Ventricular Dysfunction (one side of the heart does not function properly)

BEFORE YOU USE ENAP

Do not take ENAP:

  • If you are allergic (hypersensitive) to any of the ingredients (see WHAT ENAP CONTAINS)
  • If you have a history of swelling of the face, lips, tongue, extremities or throat when using a similar or other medicine before
  • If you are breastfeeding your baby

Take special care with Enap:

  • If you become pregnant whilst taking ENAP, the medication must be stopped and your doctor will switch your medicine to a different type of tablet
  • Inform your doctor if you plan to become pregnant, before you are given ENAP so that the doctor may prescribe another type of medicine. ENAP may harm your baby and cause deformities especially during the 2nd and 3rd trimesters of your pregnancy
  • Anaphylactoid reactions during Hymenoptera Desensitization (if you receive therapy to stimulate the immune system with insect venom, whilst taking ENAP, you may experience life threatening reactions)
  • If you receive dialysis – your doctor may want to give you a different class of medicine
  • If you have kidney problems, as your doctor may want to adjust your dose
  • If you are scheduled for surgery or anaesthesia
  • If you experience low blood pressure (feeling light headed or dizzy), contact your doctor, as he may want to reduce your dose or change your medication

ENAP should not be given to children.

Taking ENAP with food or drink:
ENAP may be taken with or without food.

Pregnancy and Breastfeeding:
Do not take ENAP if you are preganant, plan to become pregnant, or breastfeed your baby. (see Do not take ENAP and Take special care with ENAP).

Driving and using machinery:
ENAP can cause dizziness in some patients which may affect your ability to drive and use machinery. You are therefore advised not to drive or use machinery until you are sure how ENAP will affect you.

Using other medicines with ENAP:
Consult with your doctor or pharmacist or healthcare professional for advice if you need to take any other medicines. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ENAP with these medicines may cause undesirable interactions.

The following medicine may interact with ENAP:

  • Lithium (used for mood disorders) as ENAP may cause high blood levels of lithium
  • If you are taking other blood pressure medicine with ENAP, such as water tablets (diuretics), ENAP may have a stronger effect.
  • If you have kidney problems and use water tablets such as spironolactone, triamterene, or amiloride, or potassium supplements, your doctor may want to monitor your potassium levels regularly

HOW TO USE ENAP

Hypertension (high blood pressure)
The doctor will decide on the appropriate dosage depending on the degree of your blood pressure. The recommended dosage of ENAP is 10 mg to 20 mg daily. Your doctor will adjust your dose if necessary.

Renovascular hypertension (high blood pressure caused by the kidneys)
A lower starting dose of 5 mg is usually recommended. Your doctor will however decide on the appropriate dosage and adjust your dosage according to your condition.

Heart failure/Asymptomatic Left Ventricular Dysfunction
An initial dose of 2,5 mg should be used. Your blood pressure and kidney function will be closely monitored by your doctor before and after starting your treatment. You may also be requested to have blood tests done to monitor the potassium levels in your blood. Your doctor will adjust the dosage depending on your reaction and tolerance to the usual maintenance dose of 20 mg, given in a single or two divided doses.

If you take more ENAP than you should

In the event of an overdosage, contact your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre as soon as possible. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

Symptoms of overdosage include low blood pressure and a lack of consciousness and commences approximately six hours after the ingestion of ENAP. Treatment may involve inducing vomiting or haemodialysis.

If you forget to take your ENAP

Take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose.

POSSIBLE SIDE-EFFECTS

ENAP may have side effects.

Not all side effects reported for ENAP are included in this leaflet.

Should your general health worsen while taking ENAP, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking ENAP and tell your doctor immediately or go to the casualty department at your nearest hospital: 

  • swelling of the hands, feet ankles, lips, mouth or throat which may cause difficulty in breathing
  • rash or itching
  • jaundice (yellowing of the skin and eyes)

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ENAP. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go the casualty department at your nearest hospital if you notice any of the following:

  • Heart attack, chest pain (angina), irregular or fast heartbeat
  • Feeling dizzy when you get up (orthostatic hypotension)
  • Hypotension (low blood pressure)
  • Stevens Johnson syndrome (a serious skin condition with painful purplish rash and blisters)
  • Confusion
  • Depression and feeling tired
  • Liver failure with symptoms such as swelling of your abdomen, vomiting and yellowing of your skin and eyes or other liver problems
  • Asthma, difficulty in breathing or shortness of breath
  • Inflammation of the pancreas with symptoms such as swollen and tender abdomen, fever, nausea and vomiting
  • Kidney problems, kidney failure, producing less urine than normal

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

  • Dizziness, sleeplessness, nervousness, vertigo, drowsiness
  • Headache, hair loss
  • Nausea, vomiting, diarrhoea, constipation
  • Muscle cramps, abdominal pain
  • Indigestion, anorexia
  • Inflammation of the mouth, tongue
  • Cough, sore throat and hoarseness, runny nose
  • Lung problems such as pneumonia
  • Blurred vision
  • Flushing, sweating
  • Ringing in the ears, taste disturbances
  • Inability to perform sexually
  • A complex of conditions that may include fever, inflammation, arthritis, muscle cramps
  • A feeling of pins and needles
  • Skin conditions (rash, sensitivity to light, pemphigus, urticarial, erythema multiforme, exfoliative dermatitis
  • Abnormal blood tests

STORAGE AND DISPOSAL OF ENAP

  • Store in a dry place below 25 °C.
  • Do not remove tablets from the outer carton until required for use.
  • Protect from light.
  • KEEP OUT OF REACH OF CHILDREN.
  • Do not use after the expiry date printed on the label or carton.
  • Return all unused medicine to your pharmacist.
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).

PRESENTATION OF ENAP

Available in blisters of 28 tablets.

IDENTIFICATION OF ENAP

ENAP 5 mg: A round, white bevelled edge tablet, scored on one side.

ENAP 10 mg: A round, flat, red brown, spotted tablet, with a bevelled edge and scored on one side.

ENAP 20 mg: A round, flat, light orange, spotted tablet, with a bevelled edge and scored on one side.

REGISTRATION NUMBER

ENAP 5 mg: 34/7.1.3/0085

ENAP 10 mg: 34/7.1.3/0086

ENAP 20 mg: 34/7.1.3/0087

NAME AND BUSINESS ADDRESS OF THE APPLICANT

Pharma Dynamics (Pty) Ltd
1st Floor Grapevine House, Steenberg Office Park
Silverwood Close,
Westlake, 7945
Cape Town, South Africa

DATE OF PUBLICATION

7 February 2000

Version: PD9027A

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