Enalapril 2,5 mg Tablets

ENALAPRIL UNIMED contains the active substance, enalapril maleate, which belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Enalapril decreases the blood vessel resistance by relaxing the muscles in the blood vessels and that reduces the blood pressure. This also helps improve heart function.

ENALAPRIL UNIMED tablets are used:

• to treat high blood pressure
• to treat heart failure (weakening of heart function)
• to prevent the signs of heart failure (the signs include shortness of breath and swelling of the ankles and feet).

Do not take ENALAPRIL UNIMED:

• If you are allergic (hypersensitive) to enalapril or any of the other ingredients in the formulation of ENALAPRIL UNIMED (listed in section 6).
• If you are pregnant or breastfeeding
• If you have porphyria
• If you take other blood pressure medicines such as those that increase urine formation (water pills)
• If you have a kidney disease
• If you have a history of intolerance of similar medicines
• Any member of your family has had an allergic reaction to these medicines or you have ever had swelling of your face, eyelids, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited
• You have diabetes or impaired kidney function and are treated with a blood pressure lowering medicine containing aliskiren
• If you are taking lithium
• If you have a narrowing of your arteries that carry blood to one or both of your kidneys
• If you have an obstruction of blood flow across the aortic valve in the heart
• If you have moderate to severe renal disorder and you are taking blood pressure medicines called ACE inhibitors like enalapril

Warnings and precautions

Take special care with ENALAPRIL UNIMED:

• Tell your doctor immediately if you are planning to get pregnant or expect that you are pregnant
• If you should become pregnant while taking ENALAPRIL UNIMED tablets. Stop taking the tablets immediately and contact your doctor
• If you have low blood pressure (you may notice this as faintness or dizziness, especially when standing)
• If you have a condition involving the blood vessels in the brain
• If you have a heart problem

Do not share medicines prescribed for you with any other person. Always take ENALAPRIL UNIMED tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Duration of administration

Your doctor will tell you how long your treatment with ENALAPRIL UNIMED will last. Do not stop treatment early. If you have the impression that the effect of ENALAPRIL UNIMED is too strong or too weak, tell your doctor or pharmacist.

Method of administration

The dose of ENALAPRIL UNIMED tablets might be different for different patients. The number of doses you take each day, the time allowed between doses, and the length of time you take this medicine depend on the medical problem for which you are taking ENALAPRIL UNIMED. ENALAPRIL UNIMED, unless otherwise prescribed, should be used as follows: ENALAPRIL UNIMED is to be taken once daily at the same time of the day with a half a glass of liquid.

If you take more ENALAPRIL UNIMED than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. Take this leaflet and the rest of the remaining tablets with you so the doctor will know what you have taken.

If you forget to take ENALAPRIL UNIMED:

Try to take ENALAPRIL UNIMED as prescribed. However, if you forget to take a dose, take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablets at the usual time. Do not take a double dose.

If you stop taking ENALAPRIL UNIMED:

If you interrupt or end treatment early with ENALAPRIL UNIMED, your condition may return.

ENALAPRIL UNIMED can have side effects. Not all side effects reported for ENALAPRIL UNIMED are included in this leaflet. Should your general health worsen while taking ENALAPRIL UNIMED, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• If you begin to itch, develop a raised red skin rash (hives), get short of breath or wheezy and develop swelling of the hands, feet or ankles, face, mouth, lips, tongue or throat, which may cause difficulty in breathing or swallowing
• Fainting (syncope)
• Severe abdominal pain (may be caused by inflammation of the pancreas)
• Jaundice (yellowing of the skin or eyes)
• If you get a rash which looks like targets, blisters, skin peeling off in sheets, which may appear also on the lips, eyes, mouth, nose and/or genitals. You may also have a high temperature or joint pain (erythema multiforme)
• If you get severe skin reaction of which symptoms may be reddening of the skin, skin scaling, blistering or raw sores, detachment of the top layer of the skin from bottom layers (‘Steven-Johnson Syndrome’, 'toxic epidermal necrolysis')

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

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

• Frequent side effects:
• chest pain
• heart attack (myocardial infarction), stroke (cerebrovascular accident)
• angina pectoris (squeezing, heaviness or pain in the chest caused by decreased blood flow to the muscles of the heart)
• difficulty breathing

Store at or below 25 °C. Protect from light. Do not remove blisters from the carton until required for use. Do not use the medication after the expiry date printed on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g., toilets) STORE ALL MEDICINE OUT OF REACH OF CHILDREN.