CO-AMILOFRUSE 2.5/20MG TABLETS
Active substance(s): AMILORIDE HYDROCHLORIDE DIHYDRATE / FRUSEMIDE / AMILORIDE HYDROCHLORIDE DIHYDRATE / FRUSEMIDE / AMILORIDE HYDROCHLORIDE DIHYDRATE / FRUSEMIDE
Co-Amilofruse 5/40mg Tablets
Co-Amilofruse 10/80mg Tablets
(amiloride hydrochloride and furosemide)
Read all of this leaet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaet. See section 4.
What is in this leaet:
1. What Co-Amilofruse Tablets are and what are they used for
2. What you need to know before you take Co-Amilofruse Tablets
3. How to take Co-Amilofruse Tablets
4. Possible side effects
5. How to store Co-Amilofruse Tablets
6. Contents of the pack and other information
WHAT CO-AMILOFRUSE TABLETS ARE AND WHAT ARE THEY USED FOR
Co-Amilofruse Tablets contain the active ingredients:
furosemide, belonging to a group of medicines called loop diuretics which remove excess water
but can cause a loss of potassium from the body.
amiloride hydrochloride belongs to a group of medicines known as potassium sparing diuretics
which also remove excess water but prevent excessive loss of potassium from the body.
Co-Amilofruse Tablets are prescribed for adults only for the treatment of heart failure, kidney problems,
or uid retention due to steroids, oestrogens or cirrhosis of the liver.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOFRUSE TABLETS
Do not take Co-Amilofruse Tablets if you:
have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 and end of
Section 2) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
have kidney failure
have a low blood volume or are dehydrated
have high blood potassium levels or any disturbance of other blood electrolytes (salts) which may
make you feel dehydrated.
have cirrhosis of the liver, which is affecting your state of consciousness
have Addison's disease (underactive adrenal glands).
are allergic to sulphonamides such as sulfadiazine or co-trimoxazole
are breast-feeding (see “Pregnancy and breast-feeding” section below)
taking other medicines which change the amount of potassium in your blood (see “Taking other
medicines” section below)
If the person taking the medicine is under 18 years. Co-amilofruse Tablets are not suitable for
Do not take Co-Amilofruse Tablets if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Co-Amilofruse Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Co-Amilofruse Tablets if you:
have difculty in passing water (urine)
are prone to gout
are elderly or seriously ill.
have liver or kidney problems
have low blood pressure or feel dizzy when you stand up
have prostate problems
feel dizzy or dehydrated. This can happen if you have lost a lot of water through being sick, having
diarrhoea or passing water very often. It can also happen if you are having trouble drinking or
are an elderly patient with dementia and are also taking risperidone
are taking any other water tablets
have systemic lupus erythematosus
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pharmacode position may change as per supplier M/C requirement &additional
small pharma code may appear on the front & back panel
are going to have a glucose test
are elderly, or you are on other medications which can cause the drop of the blood pressure
and you have other medical conditions that are risks for the drop of blood pressure.
You will need to have regular blood tests to check your levels of potassium and other electrolytes while
you are taking Co-Amilofruse Tablets. The tablets should be discontinued before a glucose tolerance
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking CoAmilofruse Tablets.
Other medicines and Co-Amilofruse Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken, or might take any other
medicines. This includes medicines you buy without a prescription.
In particular, tell your doctor if you are taking:
medicines called ACE inhibitors (ramipril, enalapril, perindopril) or angiotensin II receptor
antagonists (losartan, candesartan, irbesartan)
other potassium sparing diuretics
drugs used to control heart rhythm (i.e. digoxin)
medicines used for arthritis or inammation (i.e.indomethacin, aspirin, ibuprofen, ketoprofen)
blood sugar lowering drugs
blood pressure lowering drugs
antibiotics (i.e. cephaloridine, aminoglycosides)
drugs used in anaesthesia.
used for mental illness (i.e. lithium)
medicines used for wheezing or difcultly in breathing (i.e. Theophilline)
medicines for epilepsy (i.e. phenytoin, carbamazepine)
medicines for some cancers (i.e. cisplatin)
medicines for breast cancer (i.e. aminoglutethimide)
medicines to stop the rejection of organs after a transplant (i.e. ciclosporin)
medicines for cancers of the skin, joint or bowel diseases (i.e. methotrexate)
medicines for ulcers of the foodpipe (gullet) (i.e. carbrnoxolone)
medicines for depression (i.e.reboxetine)
medicines for fungal infections if used for a long time (i.e. amphotericin)
Liquorice - often used in cough medicines if taken in large amounts
medicines used with another HIV medicine (i.e. probenecid)
medicines used for constipation (laxatives) if used for a long time such as bisacodyl or senna
medicines for asthma when given in high doses such as salbutamol, terbutaline, sulphate,
salmeterol, formoterol or bambuterol
Other water tablets (diuretics) such as bendroumethiazide.Your doctor may need to change the
dose of your medicine
Corticosteroids - used for inammation such as prednisolone
Medicines used as injections before X-ray examinations
Pregnancy and breast-feeding
Do not take Co-Amilofruse Tablets if you are pregnant.
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you
might be pregnant.
Do not breast-feed if you are taking Co-Amilofruse Tablets.
This is because small amounts may pass into the mother's milk. Talk to your doctor before taking this
medicine if you are breastfeeding or planning to breast-feed. Ask your doctor or pharmacist for advice
before taking any medicine if you are pregnant or breastfeeding
Driving and using machines
You may feel dizzy or unwell after taking Co-Amilofruse Tablets. If this happens, do not drive or use any
tools or machines.
Co-Amilofruse Tablets contain Sunset Yellow and Lactose
Lactose - if you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sunset yellow FCF Lake- this colouring may cause allergic reactions.
HOW TO TAKE CO-AMILOFRUSE TABLETS
Always take Co-Amilofruse Tablets exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dose is one or two tablets daily, swallowed with a glass of water.
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but
ask your doctor.
If you are taking sucralfate (a medicine for stomach ulcers)
Do not take sucralfate at the same time as Co-Amilofruse Tablets. Take your dose at least 2 hours
before or after Co-Amilofruse Tablets. This is because it can affect the way your medicine works.
This medicine is not recommended for use in children.
07 02 17
If you take more Co-Amilofruse Tablets than you should
If you accidentally take too many Co-Amilofruse Tablets, you may pass excessive water and become
dehydrated. If you feel dizzy or get muscle cramp, contact your doctor or nearest accident and
emergency department immediately. Always take the box, this leaet and any tablets that are left over
with you, if you can.
The following effects may happen: dry mouth, feeling thirsty, muscle pain or cramps, feeling sick or
being sick (vomiting), weak or uneven heartbeat, feeling dizzy, weak or sleepy.
If you forget to take Co-Amilofruse Tablets
If you miss a dose, take it as soon as you remember and carry on as before. If it is almost time for your
next dose, skip the forgotten dose and continue as usual. Do not take a double dose to make up for a
Your doctor may carry out blood tests to check that the levels of some salts in the blood are at the
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaet. You can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
HOW TO STORE CO-AMILOFRUSE TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package and keep containers tightly closed.
Do not use the tablets after the expiry date is stated on the label.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
POSSIBLE SIDE EFFECTS
Like all medicines, Co-Amilofruse Tablets can cause side effects, although not everybody gets them.
Tell a doctor straight away if you notice any of the following serious side effects – you may need
urgent medical treatment
If you have an allergic reaction. The signs may include inammation of the kidney (nephritis),
swollen ankles or high blood pressure, skin rashes, change in skin colour, severe blistering of the
skin, being more sensitive to the sun than usual, high temperature (fever), and itching
Severe allergic reactions. The signs may include shock such as difculty in breathing, cold clammy
skin, pale skin colour and racing heart beat
Severe stomach or back pain. These could be signs of 'pancreatitis'
Bruising more easily, getting more infections, feeling weak or tired more than usual. Co-Amilofruse
Tablets can affect the number of blood cells, causing serious blood problems
Increased thirst, headache, feeling dizzy or light-headed, fainting, confusion, muscle or joint pains
or weakness, cramps or spasms, stomach upsets or uneven heartbeats. These could be signs of
dehydration or changes in your normal body chemicals. Severe dehydration can also lead to blood
clots or 'gout'
You notice yellowing of your skin or eyes and your urine becomes darker in colour. These could be
signs of a liver problem. In patients who already have liver problems, a more serious liver problem
known as liver encephalopathy may occur. Symptoms include forgetfulness, ts, mood changes
Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, u-like symptoms
and fever. This could be a condition called Stevens-Johnson syndrome.
In a more severe form of the condition called Toxic Epidermal Necrolysis, layers of the skin may peel off
to leave large areas of raw exposed skin all over the body.
Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption), symptoms
include the skin becoming red with swollen areas covered in numerous small pustules
Dizziness, fainting and loss of consciousness
Tell a doctor as soon as possible if you have any of the following side effects:
Uncommon (may affect up to 1 in 100 people)
Deafness (sometimes irreversible)
Frequency not known (cannot be estimated from the available data)
Problems hearing or ringing in the ears (tinnitus). This especially affects people who already have
problems with their kidneys
Tingling or feeling numb on the skin
Small changes in your mood such as feeling agitated or anxious.
Headaches, feeling dizzy or light-headed when standing up quickly. Also loss of concentration,
slower reactions, feeling sleepy or weak, problems with your sight, dry mouth. This could be due to
low blood pressure
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than
a few days, or if you notice any side effects not listed in this leaet
Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and being sick (vomiting) and
People with bladder and prostate problems may notice pain when passing water. This is due to an
increase in the amount of water passed
If you have diabetes you may be less able to control the levels of glucose in your blood
Passing more water (urine) than you usually do. This normally happens 1 or 2 hours after taking
Symptoms vary considerably between patients but the most common are: joint aches and pains,
swollen joints, headaches, increased sensitivity to sunlight, skin rashes, kidney problems, fatigue
and weakness, mouth ulcers, hair loss, anxiety and depression, fevers and night sweats,
abdominal pain, chest pain, shortness of breath, anaemia (Systemic lupus erythematosus)
CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-Amilofruse Tablets contains
The active substances are amiloride hydrochloride and furosemide.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sunset yellow FCF lake
(E110), povidone K30, sodium starch glycollate and magnesium stearate (See Section 2 'Important
information about some of the ingredients of Co-Amilofruse Tablets').
What Co-Amilofruse Tablets look like and contents of the pack
The Co-Amilofruse 2.5/20mg tablets are pale orange, circular and at faced marked with ARD | 20 on
one side and plain on the other side.
The Co-Amilofruse 5/40mg tablets are pale orange, circular and at faced marked with ARD | 40 on one
side and plain on the other side.
The Co-Amilofruse 10/80mg tablets are pale orange, circular and at faced marked with ARD | 80 on
one side and plain on the other side.
The product is available in white blister packs of 28, 30, 56 or 60 tablets as well as in container of 500
tablets (not all pack sizes may be marketed).
Marketing Authorisation Holder
Aurobindo Pharma Limited
Ares ,Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD
This leaet was last revised in 02/2017
Co-Amilofruse Tablets can change the levels of liver enzymes or body fats known as cholesterol and
triglycerides shown up on blood tests.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.