Author: Unknown

(enalapril maleate, MSD)

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR TABLETS.
Keep this leaflet. You may want to read it again.

WHAT IS IN YOUR TABLETS? Active ingredients:
The active ingredient in ‘Innovace’ Tablets is enalapril. Four strengths of ‘Innovace’ Tablets are available: white round tablets containing 2.5 mg of enalapril maleate USP, white triangular tablets containing 5 mg of enalapril maleate USP, red triangular tablets containing 10 mg enalapril maleate USP and peach-coloured triangular tablets containing 20 mg enalapril maleate USP.

Other ingredients:
Lactose EP; Magnesium Stearate EP; Maize Starch EP; Pregelatinised Maize Starch BP; Sodium Bicarbonate EP.

In addition the red 10 mg tablets contain red iron oxide E172 and the peach-coloured 20 mg tablets contain red iron oxide E172 and yellow iron oxide E172

‘Innovace’ Tablets are available in calendar packs of 28 or bottles of 50.

HOW DO YOUR TABLETS WORK?
The active ingredient in your tablets is enalapril. This belongs to a group of medicines
work by widening your blood vessels to make it easier for the heart to pump blood through them to all parts of your body. This helps to reduce raised blood pressure. In many patients with heart failure ‘Innovace’ will help your heart to work better.

WHO MAKES YOUR TABLETS?
Your tablets are made by Merck Sharp & Dohme Limited, Shotton Lane. Cramlington, Northumberland for Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire who hold the Product Licence in the UK and Product Authorisation in Ireland.
WHY DO YOU NEED TO TAKE THESE TABLETS?

Your doctor has probably prescribed Innovace for you for one of the following reasons which he will have explained to you:

•	Your blood pressure is too high

•	You have a heart condition sometimes referred to as ‘heart failure’. This means that your heart is not working as well as it used to, in order to pump blood around your body, leading to tiredness after light exercise, breathlessness and swelling of your ankles and legs.

‘Innovace’ may prevent heart failure from getting worse in some patients who have symptoms. These patients may be less likely to go into hospital for treatment of heart failure.

In many patients with early stage heart failure who have no symptoms, including those who have had a heart attack, ‘Innovace’ may help prevent your heart from weakening further (that is, to help prevent you from developing heart failure).

‘Innovace’ may slow down the development of the signs of heart failure such as tiredness after light exercise, breathlessness and swelling of your ankles and feet Such patients may be less likely to have to go into hospital for treatment for heart failure

By taking ‘Innovace’, some heart-failure patients (with or without symptoms) may lessen their risk of heart attack

ARE THERE PATIENTS WHO SHOULD NOT TAKE THESE TABLETS?
Yes, do not take the tablets if:
(1)	You are or think you may be pregnant
(2)	You are planning to become pregnant
(3)	
You are breast-feeding 
(4)	You have suffered from a reaction to ‘Innovace’ or similar medicines in the past or to any of the ingredients and have experienced symptoms such as itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids.
(5)	You have a condition called ‘aortic stenosis’ or ‘outflow obstruction’.

If you think any of these apply to you do not take the tablets. Talk to your doctor first and follow his advice.

WHAT ELSE SHOULD YOU KNOW BEFORE TAKING YOUR TABLETS?

If you have kidney disease or are a dialysis patient, check with your doctor before taking ‘Innovace’. In addition you should tell your doctor if you suffer from excessive vomiting or diarrhoea.

In addition to measuring your blood pressure your doctor may wish to test that your kidneys are working properly before you start taking the tablets and at intervals during your treatment.

If you undergo any surgery or receive anaesthetics (even at the dentist) you should make the doctor or dentist treating you aware that you are taking ‘Innovace’.

It is important to tell your doctor if you suffer from lactose intolerance. Lactose is one of the inactive ingredients in ‘Innovace’ Tablets.

CAN YOU TAKE 'INNOVACE' WITH OTHER MEDICINES?
It is important that you tell your doctor about all of the medicines you are taking particularly others used to treat high blood pressure or heart failure (for example beta-blockers, methyldopa, calcium antagonists, diuretics

continued

(water tablets). and adrenergic blocking drugs such as guanethidine), and a drug called lithium. Also, tell your doctor if you are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents or potassium-containing salt substitutes. Your doctor knows about these and will alter your treatment as needed. Tell your doctor about any medicines you are taking that you obtained without a prescription.

HOW SHOULD YOU TAKE
'INNOVACE'?

You must keep taking ‘Innovace’ as your doctor has told you. The dose you take will depend on your condition and whether you are taking any other treatment.

The usual dosages are as follows:
High blood pressure: Treatment is usually started with 5 mg once a day, and increased gradually up to 10-20 mg once daily. The maximum dose is 40 mg a day. Some patients may start on a lower dose of 2.5 mg once a day.

Heart failure: The usual recommended starting dose is 2.5 mg a day which is gradually increased up to 20 mg a day given either once daily or in 2 doses of 10 mg according to your doctor’s advice.

If you have been given a calendar pack(s), take the tablet(s) marked for that day. This will help you to remember whether you have taken your tablet(s) for that day.

You should take your tablet at the same time each day unless your doctor tells you otherwise. If you are taking 2 tablets a day, take one in the morning and one in the evening unless your doctor has told you otherwise.

If you are unsure or confused about what to do, talk to your doctor or pharmacist.

WHAT IF YOU FORGET TO TAKE A TABLET OR TAKE TOO MANY?
If you miss a dose, just carry on with the next one as normal, but make sure you tell your doctor. Do not take an extra tablet to make up. If you take too many tablets by mistake, contact your doctor IMMEDIATELY.

WHAT UNWANTED EFFECTS COULD YOUR TABLETS HAVE? Like all medicines, ‘Innovace’ may occasionally cause side effects in some patients. It is very important that you stop taking ‘Innovace’ immediately and see your doctor if you have severe dizziness, light-headedness (especially at the start of treatment or when the dose is increased). It is vital to stop taking ‘Innovace’ and seek medical attention immediately if you begin to itch, get short of breath or wheezy and develop swelling of the hands, mouth, throat, face or eyes.

Other general side effects of ‘Innovace’ seen in a few patients are dizziness, headaches, tiredness, weakness, fainting, mild tummy upsets, nausea, diarrhoea, muscle cramps, rash or a cough. ‘Innovace’ may have an effect on the kidneys of a very small number of patients, usually with other conditions. This is recognisable by feeling generally unwell, possible itching of the skin and swelling of the ankles, and a decrease in the amount of urine passed.

There are, in addition, a few other very rare side effects seen only in a very small minority of patients. These include: effects on the heart such as chest pain (which may occur after exercise) and palpitations; effects on the digestive system which can cause abdominal and back pain, heartburn constipation, sore mouth and tongue and taste alteration; effects on the skin such as hair loss and excessive sweating. Other very rare effects are jaundice, stroke, depression, confusion, difficulty in sleeping, nervousness, pins and needles, vertigo, sore throat and hoarseness, sexual inability in men, flushing, runny nose, ringing in the ears, blurred vision, fever and aching joints.

If you notice any of the above effects or if you have any other unusual symptoms or feelings, you should contact your doctor.

HOW SHOULD YOUR TABLETS BE KEPT?
Keep your tablets out of the reach of children. Keep them out of direct sunlight and away from the damp. Do not put them into another container as they might get mixed up. Keep them in the pack in which they are supplied. If you have any tablets left over when your doctor

tells you to stop taking them, then return them to the pharmacist.

Do not take them past the expiry date which is clearly marked on the pack.

REMEMBER, this medicine is for you. Do not share it with anyone else.
It may not suit them.

Date of issue: May 1994.

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT 'INNOVACE'?

This leaflet gives you only some of the most important patient information about ‘Innovace’. Is you have any questions after you have read it ask your doctor or pharmacist who will give you further information

® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

© Merck Sharp & Dohme Limited 1994.
All rights reserved