Hypace 5 mg Tablets

HYPACE is a medication that belongs to the group of medicines called angiotensin converting enzyme inhibitors, (ACE inhibitors). Your doctor has prescribed HYPACE to treat your hypertension (high blood pressure) or heart failure (weakening of heart function). HYPACE is also used for the prevention of symptomatic heart failure in patients with decreased heart function. HYPACE works by widening your blood vessels to make it easier for the heart to pump blood to all parts of your body.

Do not take HYPACE if you:

• Are allergic to enalapril maleate or any of the other ingredients of HYPACE (see “WHAT HYPACE CONTAINS”)
• Have previously been treated with a medication in the same group of medicines as HYPACE (ACE Inhibitors) or angiotensin receptor blockers (ARBs) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty in swallowing or breathing. You should not take HYPACE if you have had these types of reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angio-oedema
• If you have hypertrophic obstructive cardiomyopathy, a heart disorder in which the walls of the ventricles (lower heart chambers) thicken (hypertrophy) and become stiff and the thickened muscle blocks the flow of blood out of the heart.
• If you have severe kidney disease.
• If you have narrowing of the blood vessels to both kidneys or to a single kidney.
• If you have aortic stenosis, a narrowing of the aortic valve opening between the left ventricle (large pumping chamber of the heart) and the aorta (the main artery leading away from the heart).
• If you are taking diuretics (water pills) that cause your body to retain potassium such as spironolactone, triamterene and amiloride.
• Porphyria
• Lithium therapy: Using at the same time with HYPACE may lead to toxic blood concentrations of lithium
• Are pregnant and breastfeeding (see Pregnancy and Breastfeeding)

If you are not sure whether you should start taking HYPACE, contact your doctor.

Take special care with HYPACE

Tell your doctor about any medical problems you have or have had, and about any allergies. Tell your doctor if you have a heart condition, are undergoing dialysis or are being treated with diuretics (water tablets) or if you have recently suffered from excessive vomiting or diarrhoea. Also tell your doctor if you are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents or potassium-containing salt substitutes, have diabetes or any kidney problems, as these may lead to increased levels of potassium in the blood which can be serious. In these cases, your doctor may need to adjust the dosage of HYPACE or monitor your blood level of potassium. If you have diabetes and are taking oral antidiabetic medicines or insulin, you should closely monitor for low blood glucose levels, especially during the first month of treatment with HYPACE. Tell your doctor if you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty in swallowing or breathing. Tell your doctor if you suffer from low blood pressure (you may notice this as faintness or dizziness, especially when standing). Before surgery and anaesthesia (even at the dentist's office), tell the doctor or dentist that you are taking HYPACE as there may be a sudden fall in blood pressure associated with anaesthesia.

Do not share medicines prescribed for you with any other person. HYPACE may be taken with or between meals. Most people take HYPACE tablets with a drink of water. Your doctor will decide on the appropriate dose of HYPACE, depending on your condition and whether you are taking other medicines. Always take HYPACE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. It is very important to continue taking HYPACE for as long as your doctor prescribes it. Do not take more tablets than the prescribed dosage. If you have the impression that the effect of HYPACE is too strong or too weak, talk to your doctor or pharmacist.

High Blood Pressure

For most patients, the usual recommended starting dose is 10 to 20 mg in tablet formulation taken once a day. Some patients may need a lower starting dose. The usual long term dose is a 20 mg tablet taken once a day.

Heart Failure

The usual recommended starting dose is a 2,5 mg tablet taken once a day. Your doctor will increase this amount step by step until the dose that is right for you has been achieved. The usual long term dose is a 20 mg tablet per day taken in one or two doses. Be especially careful when you take your first dose or if your dose is increased. Let your doctor know immediately if you feel any light headedness or dizziness.

If you take more HYPACE than you should: In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. The most likely symptom would be a feeling of light-headedness or dizziness due to a sudden or excessive drop in blood pressure. If you forget to take HYPACE: You should take HYPACE as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

HYPACE can have side effects. Not all side effects reported for HYPACE are included in this leaflet. Should your general health worsen while taking HYPACE, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happens, stop taking HYPACE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• If you develop swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing
• If you experience swelling of the hands, feet or ankles
• If you develop hives.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to HYPACE. You may need urgent medical attention or hospitalisation. Tell your doctor or pharmacist promptly about any of these or any other unusual symptoms: The following are frequent side effects: Headache, dizziness or light-headedness due to a drop in blood pressure when standing up quickly, fainting, cough, nausea, diarrhoea, rash, weakness, tiredness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

HOW LONG SHOULD I KEEP MY MEDICINE? Do not use this medicine after the month and year following EXPIRES/VERVAL on the container.

HOW SHOULD I STORE HYPACE? Store in a dry place at or below 25°C. Protect from light. Keep all medicines out of reach and sight of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).