Patient leaflet - Co-amilofruse tablets 2.5/20 mg
1. WHAT CO-AMILOFRUSE TABLETS ARE AND WHAT THEY ARE USED FOR
Co-amilofruse Tablets contain the active ingredients amiloride hydrochloride and furosemide.
Furosemide belongs 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 fluid retention due to steroids, oestrogen or cirrhosis of the liver.
Co-amilofruse Tablets can be used to stop the build up of extra water in your body. This extra water can cause swollen ankles, shortness of breath and make you feel more tired than usual.
Co-amilofruse Tablets work by helping you to pass more water (urine) than you usually do. If the extra water in your body is not removed, it can put extra strain on the heart, blood vessels, lungs, kidneys or liver.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOFRUSE TABLETS
Do not take Co-amilofruse Tablets:
If you are allergic to furosemide, amiloride hydrochloride, sulfonamides or their derivatives or
any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue · If you have severe problems with your kidneys
- If you have a low blood volume or are dehydrated
If you have too much or too little potassium or sodium in your blood (shown in blood tests) · If you have severe liver problems or cirrhosis of the liver, which is affecting your state of
consciousness
If you have an illness called 'Addison's disease' (underactive adrenal gland). This can make
you feel tired and weak
- If you are not passing any water (urine)
If you are allergic to sulphonamides such as sulfadiazine or co-trimoxazole · If you are breast-feeding (see section "Pregnancy and breast-feeding") · If you are taking other medicines which change the amount of potassium in your blood (see
section "Other medicines and Co-amilofruse Tablets")
- If you are under 18 years of age. Co-amilofruse Tablets are not suitable for children.
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, pharmacist or nurse before taking Co-amilofruse Tablets: · If you have difficulty in passing water (urine)
- If you are prone to gout
- If you are 65 years of age or older
- If you have liver or kidney problems
- If you have been told you have low levels of protein in you blood
- If you have diabetes
- If you have low blood pressure or feel dizzy when you stand up
- If you are prone to large drops in blood pressure
- If you have prostate problems
If you 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 eating
- If you are an elderly patient with dementia and are also taking risperidone · If you are taking any other water tablets
- If you have systemic lupus erythematosus
- If you are going to have a glucose test
If you are taking other medicines which can cause a drop in blood pressure · If you have other medical conditions that put you at greater risk of experiencing a drop in blood
pressure.
Your doctor may want to monitor you whilst you take this medicine; this may mean having blood or urine tests or an ECG to check your heart.
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 test.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-amilofruse Tablets.
Children and adolescents
Co-amilofruse Tablets are not recommended for use in children and adolescents under 18 years of age.
Other medicines and Co-amilofruse Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription including herbal medicines. This is because Co-amilofruse Tablets can affect the way some other medicines work. Also, some medicines can affect the way Co-amilofruse Tablets work.
Your doctor may need to change your dose and/or to take other precautions if you are taking one of the following medicines:
! Aliskiren – used to treat high blood pressure
Do not take this medicine, and tell your doctor, if you are taking:
Medicines which change the amount of potassium in your blood. These include potassium
supplements such as potassium chloride or certain water tablets (diuretics) such as triamterene.
It is also particularly important to tell your doctor if you are taking:
Medicines called ACE inhibitors (ramipril, enalapril, perindopril) or angiotensin II receptor
antagonists (losartan, candesartan, irbesartan) Your doctor may need to change the dose of your tablets or ask you to stop taking them
- Other potassium sparing diuretics
- Medicines used to control heart rhythm (i.e. digoxin)
Non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as
aspirin, ibuprofen, ketoprofen or indometacin
- Blood sugar lowering drugs
- Blood pressure lowering drugs
- Antibiotics (i.e. cephaloridine, aminoglycosides)
- Medicines used in anaesthesia
- Medicines used for mental illness (i.e. lithium)
- Medicines used for wheezing or difficulty in breathing (i.e. theophylline) · 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 food pipe (gullet) (i.e. carbenoxolone)
- Medicines for depression (i.e. reboxetine)
- Medicines for fungal infections if used for a long time (i.e. amphotericin) · Liquorice if taken in large amounts. Often used in cough medicines
- 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 sulfate,
salmeterol, formoterol or bambuterol
Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to change
the dose of your medicine
- Corticosteroids used for inflammation such as prednisolone
- Medicines used as injections before x-ray examinations.
Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramycin,
vancomycin or high doses of cephalosporins
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.
Co-amilofruse Tablets contain lactose and sunset yellow (E110)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Co-amilofruse Tablets contain sunset yellow (E110) which may cause allergic reactions.
Sodium Content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. HOW TO TAKE CO-AMILOFRUSE TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults
The recommended dose is:
One or two 2.5mg/20mg tablets taken in the morning. This can be increased to four tablets daily if required.
Or
One 5mg/40mg tablet taken in the morning. This can be increased to two tablets daily if required.
Your doctor may prescribe a different dose regime. This will depend upon the condition being treated.
Use in the elderly
The dose may be modified by your doctor. This will depend on your reaction to the diuretic.
Use in children and adolescents
Co-amilofruse Tablets are not recommended for use in children and adolescents under 18 years of age.
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 sucralfate can affect the way your medicine works.
If you take more Co-amilofruse Tablets than you should
If you accidently take an extra dose, this should not cause too much concern, although you will pass more urine than usual. You may also feel dizzy and experience muscle cramps.
If you have taken a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Always take the box, this leaflet and any tablets that are left over with you, if you can.
You may also experience the following side effects: 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 forget to take your tablet in the morning, but remember mid-afternoon, take the missed dose and then continue to take as usual. If you take the missed dose later than mid-afternoon you may find that you need to get up in the night to pass urine (water).
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 forgotten dose. If you have trouble remembering when to take your tablets, talk to your doctor.
If you stop taking Co-amilofruse Tablets
If you want to stop taking these tablets you should talk to your doctor first as your original symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Blood tests
Your doctor may carry out blood tests to check that the levels of some salts in the blood are at the correct levels.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur you should STOP taking this medicine and contact your doctor immediately:
Frequency not known (cannot be estimated from the available data)
If you have an allergic reaction. The signs may include inflammation 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 (pruritus)
Severe allergic reactions. The signs may include shock such as difficulty in breathing, cold
clammy skin, pale skin colour and racing heart beat
Severe stomach or back pain. These could be signs of 'pancreatitis' (inflammation of the
pancreas)
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, fits, mood changes and coma
Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-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
- Blisters, lesions and inflammation of the skin (dermatitis bullous lesions) · Kidney failure.
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).
Not known (frequency cannot be estimated from the available data):
- Tingling or feeling numb on the skin
If you have diabetes you may be less able to control the levels of glucose in your blood · Problems hearing or ringing in the ears (tinnitus). This especially affects people who already
have problems with their kidneys
- Passing more water (urine) than you usually do. This normally happens 1 or 2 hours after taking this medicine
- 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
- Small changes in your mood such as feeling agitated or anxious
- People with bladder and prostate problems may notice pain when passing water. This is due to an increase in the amount of water passed
Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and being sick (vomiting)
and constipation.
- Increased levels of creatine, uric acid or urea in the blood
- Low levels of sodium, chloride, potassium, calcium or magnesium in the blood · Inflammation of the blood vessels (vasculitis)
- Lichenoid reactions, characterised as small, itchy reddish-purple, polygon-shaped lesions on the skin, genitals or in the mouth.
- 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)
Changes in liver and kidney function may occur. Your doctor will monitor you carefully for these changes.
Blood tests
Co-amilofruse Tablets can change the levels of liver enzymes or body fats known as cholesterol and triglycerides shown up on blood tests.
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 leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CO-AMILOFRUSE TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-amilofruse Tablets contain
The active substances are furosemide and amiloride hydrochloride.
Co-amilofruse Tablets 2.5/20mg contain 2.5mg of amiloride hydrochloride and 20mg of furosemide.
Co-amilofruse Tablets 5/40mg contain 5mg of amiloride hydrochloride and 40mg of furosemide.
The other ingredients are lactose monohydrate, polyvinylpyrrolidone, sunset yellow E110 FCF, sunset yellow E110 FCF lake, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.
What Co-amilofruse Tablets look like and contents of the pack
Co-amilofruse 2.5/20mg are Orange, Flat, round tablets, 6 mm diameter with break line on one side and C 6 on the other side.
Co-amilofruse 5/40mg are Orange, Flat, round bevel edged tablets with break line on one side and C5 on the other side.
Co-amilofruse Tablets are available in packs of 28, 30, 56, 60, 84, 100, 150, 168 or 200 tablets. Not all pack sizes may be marketed.
The score line is not intended for breaking the tablet.
Marketing Authorization Holder
Ennogen IP Ltd
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer
Ennogen Healthcare International Ltd
Unit G3, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in December 2025.
6 mm