RENITEC®
enalapril maleate
5 mg, 10 mg & 20 mg tablet
What is in this leaflet
This leaflet answers some common questions about RENITEC. It does not contain
all the available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking RENITEC against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What RENITEC is used for
RENITEC lowers high blood pressure, which doctors call hypertension. It is
also used to treat heart failure.
Hypertension
Everyone has blood pressure. This pressure helps get your blood all around
your body. Your blood pressure may be different at different times of the day,
depending on how busy or worried you are. You have hypertension (high blood
pressure) when your blood pressure stays higher than is needed, even when you
are calm and relaxed.
There are usually no symptoms of hypertension. The only way of knowing that
you have hypertension is to have your blood pressure checked on a regular basis.
If high blood pressure is not treated it can lead to serious health problems.
You may feel fine and have no symptoms, but eventually hypertension can cause
stroke, heart disease and kidney failure. RENITEC helps to lower your blood
pressure.
Heart Failure
Heart failure means that the heart muscle cannot pump blood strongly enough
to supply all the blood needed throughout the body. Heart failure is not
the same as heart attack and does not mean that the heart stops working.
Heart failure may start off with no symptoms, but as the condition progresses,
patients may feel short of breath or may get tired easily after light physical
activity such as walking. Some patients may wake up short of breath at night.
Fluid may collect in different parts of the body, often first noticed as swollen
ankles and feet.
RENITEC helps to treat heart failure, whether you have symptoms or not. In
many patients with heart failure who have symptoms,
RENITEC may slow the progression of heart failure and reduce the need to go to
hospital as a result of heart failure. RENITEC may help some of these patients
live longer.
In many patients with heart failure who have no
symptoms, RENITEC may help to stop the heart muscle from getting weaker.
RENITEC may also slow down the development of symptoms, such as shortness of
breath, tiredness after light physical activity, or swelling of the ankles and
feet. These patients may be less likely to have hospital stays due to heart
failure.
By taking RENITEC, heart failure patients may have less chance of having a
heart attack.
When used to treat heart failure, RENITEC is almost always used with other
medicines called diuretics or fluid tablets. These medicines help the kidney get
rid of excess fluid from the body.
How RENITEC works
One of the ways RENITEC helps lower blood pressure and treat heart failure is
that it widens blood vessels. This means that blood is able to pass through them
more easily and the heart doesn't have to pump as hard to move blood around the
body. This also means that when you place extra demands on your heart, such as
during exercise, the heart may cope better so you may not get short of breath as
easily.
RENITEC belongs to a group of medicines called Angiotensin Converting Enzyme
(ACE) inhibitors.
Your doctor may prescribe RENITEC for another reason. Ask your doctor if you
have any questions about why RENITEC has been prescribed for you.
RENITEC is not addictive.
Before you take RENITEC
When you must not take it
Do not take RENITEC if:
- you have taken any other 'ACE inhibitor' medicines for high blood pressure
or heart failure before, which caused your face, lips, tongue, throat, hands
or feet to swell up, or made it hard for you to breathe
If you have had an allergic reaction to an ACE inhibitor before, you may be
allergic to RENITEC. - you have an allergy to RENITEC or any of the ingredients listed at the end
of this leaflet
Symptoms of an. - allergic reaction to RENITEC may include skin rash, itchiness, shortness
of breath, swelling of the face, lips or tongue, muscle pain or tenderness or
joint pain. - you have a history of swelling of the face, lips, tongue, throat, hands or
feet, for no apparent reason. - Do not take RENITEC if you are pregnant or breast-feeding.
Your baby may absorb this medicine in the womb or from breast milk and
therefore there is a possibility of harm to the baby.
Do not take RENITEC if:
- the packaging is torn or shows signs of tampering
- the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work.
If you are not sure whether you should start taking RENITEC, talk to your
doctor.
Before you start to take it
Tell your doctor if:
- you intend to become pregnant or intend to breast-feed
RENITEC should not be used during pregnancy or while breast-feeding. - you have any medical conditions, especially the following:
- heart problems
- if you are undergoing dialysis or are being treated with diuretics
(water tablets) - diabetes or any kidney problems, as these may lead to increased levels
of potassium in the blood which can be serious
- you are following a very low salt diet, are taking potassium supplements,
potassium-sparing agents or potassium-containing salt substitutes - you have had an allergy to any other medicines or any other substances,
such as foods, preservatives or dyes. - you have recently suffered from excessive vomiting or diarrhoea
In these cases, your doctor may need to adjust the dosage of RENITEC or
monitor your blood level of potassium. If you have diabetes and are taking oral
anti-diabetic medicines or insulin, you should closely monitor for low blood
glucose levels, especially during the first month of treatment with RENITEC.
If you have not told your doctor about any of the above, tell them before you
take any RENITEC.
RENITEC has been studied in children. For more information, talk to your
doctor.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines
that you buy without a prescription from your pharmacy, supermarket or health
food shop. Some medicines and RENITEC may interfere with each other. These
include:
- diuretic tablets - also called fluid or water tablets
- drugs for diabetes (including oral anti-diabetic medicines and insulin)
- lithium, a medicine used to treat mood swings and some types of depression
- potassium tablets
- potassium-containing salt substitutes
- non-steroidal anti-inflammatory medicines (including gold therapy), used
to relieve pain, swelling and other symptoms of inflammation and arthritis
These medicines may be affected by RENITEC, or may affect how well it works.
You may need to take different amounts of your medicine, or you may need to take
different medicines.
Your doctor or pharmacist has more information on medicines to avoid while
taking RENITEC.
How to take RENITEC
How much to take
Your doctor will tell you how many tablets you need to take each day. This
depends on your condition and whether you are taking other medicines. Take
RENITEC only when prescribed by your doctor.
For high blood pressure:
For most patients, the usual starting dose is 5 mg taken once a day. Some
patients may need a lower starting dose. The dose may need to be increased
depending on your blood pressure.
For heart failure:
The usual starting dose is 2.5 mg taken once a day. Depending on your
response, this dose may need to be increased up to 20 mg each day. This dose may
be taken once a day or divided into two doses per day.
Follow all directions given to you by your doctor carefully. They may differ
from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or
pharmacist for help.
How to take it
Take your RENITEC at about the same time each day.
Taking your tablet(s) at the same time each day will have the best effect. It
will also help you remember when to take the tablets.
Swallow RENITEC with a glass of water.
It does not matter if you take RENITEC before or after food.
How long to take it
RENITEC helps control your high blood pressure and helps improve your heart
failure, but does not cure it. Therefore RENITEC must be taken every day.
Continue taking RENITEC for as long as your doctor prescribes.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise, take it as soon as you
remember, and then go back to taking your tablet(s) as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or
pharmacist.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for
some hints.
If you take too much (overdose)
Immediately telephone your doctor or National Poisons Centre (telephone 0800
POISON or 0800 764 766), or go to accident and emergency at your nearest
hospital, if you think that you or anyone else may have taken too much RENITEC.
Do this even if there are no signs of discomfort or poisoning.
If you take too many tablets, you will probably feel light-headed or dizzy,
or you may faint.
While you are using RENITEC
Things you must do
Have your blood pressure checked when your doctor says, to make sure RENITEC
is working.
If you feel any light-headedness or dizziness after you take your first dose
of RENITEC or if your dose is increased, tell your doctor immediately. This is
especially important if you are taking RENITEC for heart failure.
If you feel light-headed, dizzy or faint, get up slowly when getting out of
bed or standing up.
You may feel light-headed or dizzy, especially if you are also taking a
diuretic (fluid tablet). This may be because your blood pressure is falling
suddenly. Standing up slowly, especially when you get up from bed or chairs,
will help your body get used to the change in position and blood pressure. If
this problem gets worse or continues, talk to your doctor.
If you become pregnant while taking RENITEC, tell your doctor immediately.
If you are about to be started on any new medicine tell your doctor and
pharmacist that you are taking RENITEC.
If you plan to have surgery (even at the dentist) that needs a general
anaesthetic, tell your doctor or dentist that you are taking RENITEC.
Your blood pressure may drop suddenly.
Make sure you drink enough water during exercise and hot weather when you are
taking RENITEC, especially if you sweat a lot.
If you do not drink enough water while taking RENITEC, you may faint or feel
light-headed or sick. This is because your blood pressure is dropping suddenly.
If you continue to feel unwell, tell your doctor.
If you have excessive vomiting and/or diarrhoea while taking RENITEC, tell
your doctor.
This can also mean that you are losing too much water and salt, and may drop
your blood pressure too much.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do a blood test to check your potassium level in
the blood and to see how your kidneys are working.
Things you must not do
Do not give RENITEC to anyone else, even if they have the same condition as
you.
Things to be careful of
Be careful driving or operating machinery until you know how RENITEC affects
you.
RENITEC may cause dizziness or light-headedness in some people, especially
after the first dose or if the dose is increased. Make sure you know how you
react to RENITEC before you drive a car, operate machinery, or do anything else
that could be dangerous if you are dizzy or light-headed. If you drink alcohol,
dizziness or light-headedness may be worse.
Things that would be helpful for your blood pressure or heart failure
Some self help measures suggested below may help your condition. Talk to your
doctor or pharmacist about these measures and for more information.
- Alcohol - your doctor may advise you to limit your alcohol intake.
- Diet - eat a healthy diet which includes plenty of fresh
vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar. - Exercise - regular exercise helps to reduce blood pressure and
helps the heart get fitter, but it is important not to overdo it. Walking is
good exercise, but try to find a route that is fairly flat. Before starting
any exercise, ask your doctor about the best kind of programme for you. - Salt - your doctor may advise you to watch the amount of salt in
your diet. To reduce your salt intake you should avoid using salt in cooking
or at the table. - Smoking - your doctor may advise you to stop smoking or at least
cut down. - Weight - your doctor may suggest losing some weight to help lower
your blood pressure and help lessen the amount of work your heart has to do.
Some people may need a dietician's help to lose weight.
Adverse Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking RENITEC.
RENITEC helps most people with high blood pressure and heart failure, but it
may have unwanted adverse effects in a few people. All medicines can have
adverse effects. Sometimes they are serious, most of the time they are not. You
may need medical treatment if you get some of the adverse effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- light-headedness or dizziness because blood pressure is too low
- headache
- fatigue
- dry cough
- mild stomach upsets such as feeling sick, diarrhoea, or stomach pains
- muscle cramps
These are usually mild adverse effects of RENITEC, but may be serious.
Tell your doctor immediately if you notice any of the following:
- changes in the way your heart beats, for example, if you notice it beating
faster - fainting
- yellowing of the skin and eyes, also called jaundice
- itchy skin rash or other skin problems
- signs of worrying or frequent infections such as fever, severe chills,
sore throat or mouth ulcers - passing less urine than is normal for you
These may be serious adverse effects. You may need urgent medical attention.
Serious adverse effects are rare.
If any of the following happen, stop taking RENITEC and tell your doctor
immediately or go to accident and emergency at your nearest hospital:
- swelling of the face, lips, mouth or throat which may cause difficulty in
swallowing or breathing - swelling of the hands, feet, or ankles
- pinkish, itchy swellings on the skin, also called hives or nettlerash
- chest pain, angina
- wheeziness due to tightness in the chest
- collapse, numbness or weakness of arms or legs
These are serious adverse effects. You may need urgent medical attention or
hospitalisation.
All of these adverse effects are rare.
Other adverse effects not listed above may also occur in some patients.
Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible adverse effects. You may not
experience any of them.
After using RENITEC
Storage
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack and store them in another
container they will not keep well and they may become soft and crumbly.
Keep it in a cool dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.
Disposal
If your doctor tells you to stop taking RENITEC or the tablets have passed
their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
RENITEC comes in three types of tablets:
- RENITEC 5- white, barrel-shaped tablet with RENITEC marked on one side,
and scored on the other - RENITEC - rust-red, barrel-shaped tablet with RENITEC marked on one side.
- RENITEC 20 - peach coloured, barrel-shaped tablet with MSD714 marked on
one side.
A box of RENITEC contains 30 tablets. .
Ingredients
Active ingredient:
- RENITEC 5 - 5 mg enalapril maleate per tablet
- RENITEC - 10 mg enalapril maleate per tablet
- RENITEC 20 - 20 mg enalapril maleate per tablet
Inactive ingredients:
- lactose
- sodium bicarbonate
- maize starch
- pregelatinised maize starch
- magnesium stearate
- iron oxide red CI77491 (RENITEC and RENITEC 20)
- iron oxide yellow CI77492 (RENITEC 20)
RENITEC does not contain gluten, sucrose, tartrazine or any other azo dyes.