NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about EDECRIN. 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 EDECRIN 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 EDECRIN is used for
EDECRIN helps to reduce the amount of fluid in the body for people who have:
swelling of the ankles, feet and legs, which is called oedema
fluid accumulation in the lungs, which is called pulmonary oedema
fluid accumulation around the eyes due to kidney disease
fluid accumulation in the stomach area, which is also called ascites, due to liver disease
a heart condition called congestive heart failure.
EDECRIN is also used in children over 2 years old to remove fluid that occurs in some heart and kidney conditions.
EDECRIN belongs to a group of medicines called diuretics or fluid tablets.
It works by making your kidneys pass more water and salt from the body.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
Before you take EDECRIN
When you must not take it
Do not take EDECRIN if you have an allergy to:
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not take this medicine if you are pregnant or intend to become pregnant.
Like most medicines, EDECRIN is not recommended for use during pregnancy.
Do not take this medicine if you are not passing urine.
Do not give this medicine to a child under the age of two years.
Safety and effectiveness in children younger than two years have not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
Tell your doctor if you are breast-feeding or plan to breast-feed.
Like most medicines, EDECRIN is not recommended for use while breast feeding. If it is necessary for you to take EDECRIN, your doctor may ask you to stop breast-feeding.
If you have not told your doctor about any of the above, tell them before you start taking EDECRIN.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and EDECRIN may interfere with each other. These include:
medicines used to treat high blood pressure
certain antibiotics such as aminoglycoside antibiotics and some cephalosporins
warfarin, a medicine used to prevent blood clots
lithium, a medicine used to treat severe mood swings
corticosteroids, such as prednisone and cortisone.
Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.
These medicines may be affected by EDECRIN or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take EDECRIN
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
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.
If you do not understand the instructions on this leaflet, ask your doctor or pharmacist for help.
How much to take
For adults, the usual starting dose is two 25 mg tablets taken once a day. Depending on your response, your doctor may increase this dose. Most people take between 50 mg and 150 mg per day, which is 2 to 6 tablets per day. If you are taking more than two tablets per day, your dose will be divided into two doses per day.
The daily dose should not exceed 16 tablets (400 mg).
For children over 2 years of age, the usual starting dose is one 25 mg tablet taken once a day.
How to take it
Swallow the tablet whole with a full glass of water. Do not split the tablet.
When to take it
If you take EDECRIN once a day, take it immediately after breakfast.
If you take EDECRIN more than once a day, take your first dose immediately after breakfast and take your last dose no later than 6 p.m., unless your doctor tells you otherwise.
EDECRIN may increase the amount of water (urine) you pass and also the number of times you go to the toilet. By taking the last dose no later than 6 p.m., there may be less chance of your sleep being disturbed.
Follow the above instructions even if you don’t take EDECRIN every day.
Your doctor will determine whether or not you need to take EDECRIN every day.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
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 medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 (Australia) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much EDECRIN. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many tablets, you will probably feel light-headed, dizzy, or weak, or you may faint. You may also become very thirsty, confused, have a change in the amount of urine passed, have a fast heartbeat, have muscle cramps or feel a tingling sensation of the skin.
While you are using EDECRIN
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking EDECRIN.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery (even at the dentists), that needs a general anaesthetic, tell the doctor or dentist that you are taking this medicine.
Your blood pressure may drop suddenly.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments and have your blood tests when your doctor asks you to, so that your doctor can check your progress andmake sure your potassium and other electrolytes are at the right level.
EDECRIN may cause a loss of water, potassium, magnesium and other electrolytes from your body. This may cause:
dry mouth or thirst
weakness, tiredness, numbness tingling in the hands and/or feet
muscle pains or cramps
irregular or fast heart beat
passing less urine than normal.
loss of appetite.
Tell your doctor if you get any of these symptoms.
Your doctor may ask you to take a potassium supplement while taking EDECRIN.
Things you must not do
Do not take EDECRIN to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking EDECRIN.
This medicine helps most people with some types of fluid accumulation, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
feeling sick(nausea), vomiting, loss of appetite
generally feeling unwell
stomach upset or pain, diarrhoea or watery diarrhoea
dry mouth or thirst
muscle pains or cramps
passing more or less urine than normal
ringing in the ears
Tell your doctor as soon as possible if you notice any of the following:
yellowing of the skin and eyes, which is called jaundice
difficulty in swallowing
fever or severe chills
bruising more easily than normal
spinning sensation, which is called vertigo
numbness or tingling in the hands and/or feet
feeling anxious or confused
blood in the urine
pain in the small joints (may be a symptom of gout).
These are serious side effects that may require medical attention. Serious side effects are rare.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
irregular or fast heart beat
vomiting blood or material that looks like coffee grounds
bleeding from the back passage, black, sticky bowel motions (stools) or bloody diarrhoea
severe pain or tenderness in any part of the stomach
seizures or fits
irregular heart beat, sweaty, irritable, shaky, anxious and hungry. These may be symptoms of your blood sugar levels being too low.
These are very serious side effects. You may need urgent medical attention or hospitalisation. These very serious side effects are rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using EDECRIN
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store EDECRIN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
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.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
EDECRIN is a white capsule-shaped tablet, scored and engraved “VRX 205” on one side and the other side engraved “EDECRIN”.
EDECRIN tablets are available in plastic bottles with child resistant closures. Each bottle contains 100 tablets.
EDECRIN contains 25 mg of etacrynic acid per tablet as the active ingredient.
colloidal anhydrous silica
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
EDECRIN is supplied in Australia by:
A. Menarini Australia Pty Ltd
Level 8, 67 Albert Avenue
Chatswood NSW 2067
Medical Information: 1800 644 542
Under licence of Bausch Health US, Bridgewater, NJ. USA.
Australian Registration Number: AUST R 96871
This leaflet was revised in December 2019.
For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi
Source: Read Full Article