Patient leaflet - Co-amilofruse tablets 5/40 mg

1. What are Co-Amilofruse Tablets and what they are used for

Co-Amilofruse Tablets 5mg/40mg is the name of your medicine (called Co-Amilofruse Tablets throughout this leaflet). Co-Amilofruse Tablets contain two different medicines called: furosemide and amiloride hydrochloride. Both belong to a group of medicines called diuretics (water tablets). 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 feeling 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

Have ever had an allergic reaction (hypersensitive) to Co-Amilofruse tablets, furosemide, amiloride hydrochloride, sulphonomides or sulphonamide derivatives (such as sulfadiazine or co-trimoxazole) or any of the ingredients in the tablet (listed in section 6). An allergic reaction may include a rash, itching, difficulty breathing or swallowing, swelling of the face, lips, throat or tongue
Have reduced blood volume (hypovolaemia) or are dehydrated or are not passing water (urine) due to a condition called anuria
Have high levels of potassium in your blood or are taking potassium supplements or other potassium containing medicines. Or
Have too much or too little potassium or sodium in your blood (shown in blood tests)
Have severe kidney problems or kidney failure
Have severe liver problems
Have Addison’s disease which is a disorder of the adrenal gland. This can make you feel tired and weak.
Are under 18 years of age. Co-Amilofruse tablets are not suitable for children
Are breast feeding (see Section Pregnancy and breast feeding).
You are taking other medicines which change the amount of potassium in your blood (see “Taking other medicines” section below).

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 before taking Co-Amilofruse Tablets if you:

Have a condition which affects your urination (passing water)
Have low blood pressure
Have reduced blood volume(hypovolaemia)
Have gout (disease with painful, swollen joint caused by build up of uric acid crystals)
Have low protein levels in the blood due to kidney problems
Have cirrhosis of the liver together with kidney problems
Have diabetes
Are elderly with conditions such as low blood pressure, gout, kidney or liver problems
Have conditions such as kidney problems affecting electrolyte deficiency in the blood (monitored with a blood test) (you may feel dizzy or dehydrate, 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). Or where this medicine is taken in combination with certain other drugs which may lead to increased blood potassium levels
Have been told by your doctor you have a rare hereditary sugar disease
You are an elderly patient with dementia and are also taking risperidone
Are going for a scan or X-ray using contrast material please tell the doctor you are taking Co-Amilofruse
Have systemic lupus erythematosus
Are going to have a glucose tolerance test
Have prostate problems.

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.

If you are not sure if any of the above apply to you,

talk to your doctor or pharmacist before taking Co-Amilofruse Tablets.

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 prescription, including herbal medicines. This is because Co-Amilofruse can affect the way some other medicines work. Also, some medicines can affect the way Co-Amilofruse Tablets work, including the following:

Medicines used to treat high blood pressure including Aliskiren and anti-arrhythmics (irregular heart beat) such as disopyramide, flecainide, quinidine, amiodarone or sotalol
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.
Colestipol or colestyramine which are used to reduce cholesterol levels (fat)
Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, aspirin and indometacin
Phenytoin or Carbamazepine which are used to treat epilepsy
Methotrexate used to treat rheumatoid arthritis, cancers of skin, joint or bowel disease
Probenecid used to treat gout and kidney stones, (used with another HIV medicine)
Sucralfate (do not take within two hours of co-amilofruse) or carbenoxolone used to treat stomach, food pipe (gullet) ulcers
Medicines used to treat depression or behavioural problems such as lithium (as additional monitoring of patients on lithium may be required OR to stop the side effects doctor may need to change the dose of your lithium), amisulpride, atomoxetine, pimozide, sertindole or reboxetine
Ciclosporin used to prevent organ rejection after transplant
Anti-diabetics, medicines used to treat diabetes such as insulin and metformin
Antibiotics and antifungals to treat infection including vancomycin, colistin and amphotericin
Cisplatin used to treat various cancers
Corticosteroids used in many conditions such as arthritis and asthma such as prednisolone
Theophylline used to treat wheezing or difficulty in breathing, asthma
Cardiac glycosides used to treat heart conditions e.g. digoxin
Other Diuretics (“water tablets”) such as bendroflumethiazide used to treat water retention
Laxatives and liquorice preparations used to improve bowel movements (avoid prolonged use) such as bisacodyl or senna
Medicines called ACE Inhibitors for treatment of heart problems e.g.captopril, enalapril, perindopril, ramipril or medicines called Angiotensin II receptor antagonists e.g. Losartan, candesartan, irbesartan. Your doctor may need to change the dose of your tablets or ask you to stop taking them.
Resperidone used to treat schizophrenia, bipolar disorder, and irritability in people with autism
Muscle relaxants (e.g. curare type relaxants)
Medicines for infections such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin or high doses of cephalosporins
Medicines for asthma when given in high doses such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol
Aminoglutethimide used for breast cancer
Medicines used as a general anesthetics for relaxing your muscle during surgery.
Medicines used as injections before X-ray examinations

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding

Pregnancy

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. Your doctor will only prescribe Co-Amilofruse Tablets if the benefits to you outweigh the risks to the unborn child.

Breast-feeding

Do not breast-feed if you are taking Co-Amilofruse Tablets. This is because small amounts may pass into the mothers milk. Talk to your doctor before taking this medicine if you are breast- feeding or planning to breast-feed.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines

Co-Amilofruse Tablets may make you feel dizzy or confused. Make sure you are not affected before you drive or operate machinery.

P3927T

SPACE FOR

PHARMA

CODE

10mmx10mm

5.00 mm

170.00 mm

FRONT

Product:	Co-Amilofruse 5mg/40mg Tablets (Kopran)
	P3927T
	170 x 400 mm
	9pt
	15/04/26
	2
Amendment Date:	10/06/26

Co-Amilofruse Tablets contain Sunset Yellow (E110)

This may cause allergic reactions. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. 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. Follow your doctor’s instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are still unsure ask your pharmacist or doctor. The usual dosage(s) are described below:

For Adult oral use

The usual dose is one or two tablets in the morning. Your doctor will tell you how many tablets to take. Take this medicine by mouth. Swallow the tablets whole with a drink 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. Elderly

The above dosages may sometimes be reduced especially if you have damaged kidneys. Elderly patients will have blood tests to closely monitor sodium, potassium and urea levels whilst on these tablets.

Children under 18 years of age

Not recommended.

Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

If you take more Co-Amilofruse Tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Remember to take with you any medicine that is left so the doctor knows what you have taken. 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 forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

Take the remaining doses at the correct time. If you stop taking Co-Amilofruse Tablets

Keep taking this medicine until your doctor tells you to stop taking it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Amilofruse tablets can cause side effects, although not everybody gets them. Allergic reactions:

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment Frequency not known (cannot be estimated from the available data)

Sudden wheeziness, difficulty in breathing, shortness of breath, fever, swelling of the eye lids, face, lips, tongue or other parts of the body, rash, itching or hives on the skin, (especially affecting your whole body)
Sensitivity to light may occur
Vasculitis (inflammation of the veins)
Erythema multiforme (reddening of the skin)
Exfoliative dermatitis (itchy red scaly skin)
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
Skin eruption with pustules and fever (Acute generalized exanthematous pustulosis) or skin rash accompanied with other symptoms such as fever and changes in the blood.

Serious side effects:

Liver problems (yellowing of the skin or whites of the eyes), hepatic encephaolopathy (liver failure leading to confused state and coma)
Reduction in the numbers of white blood cells and platelets (these can be detected by blood tests. These effects may result in unusual bruising or bleeding or increased risk of infection, fever, severe chills, sore throat or mouth ulcers)
Anaemia (a condition in which there is a decrease in the number of red blood cells). Symptoms include tiredness, headaches, being short of breath when exercising, dizziness and looking pale
Abnormal heart beats; this may be fast, slow or fluttering
Pancreatitis (inflammation of the pancreas) this may show as severe stomach pain and nausea, weight loss and fat in the stools (foul smelling)
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’
Tell your 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). If you experience any of the above side effects, contact your doctor immediately.
The following side effects may also occur: (Frequency Unknown - Cannot be estimated from the available data)
- Dizziness
- Hearing disorders or ringing in the ears (tinnitus)
- Feeling sick (nausea) or being sick (vomiting)
- Minor mental disturbances
- Glucose intolerance which may due to potential problems as diabetic
- Diarrhoea or Constipation.
- Stomach pains
- Dry mouth
- Headaches or feeling of pressure in the head
- Lack of concentration
- Confusion
- Low blood pressure (reduced in reaction time and feeling light headed especially on standing)
- Inflammation of the blood vessels of the skin (purple spots or blisters on the skins surface)
- Rash which can be itchy, blood spots, bruising and discolouring to the skin (purpura)
- Muscle spasms or weakness
- General body weakness or feeling of being unwell
- Fever (high temperature)
- Increased urine production
- People with bladder and prostate problems may have pain when passing water.
- Urine retention (unable to pass urine), especially in patients who may already find it difficult to pass urine
- Changes in blood cell numbers measured by a blood test
- Increase in blood cholesterol levels
- Increase in blood creatinine and uric acid levels which may increase attacks of gout
- Reduction in blood calcium levels measured by a blood test
- Electrolyte imbalances in blood with symptoms of confusion, cramping, feeling sick, and muscle spasms
- Lichenoid reactions, characterized as small, itchy reddish purple, polygon-shaped lesions on the skin, genitals or in the mouth.
- Systemic lupus erythematosus -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.

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.

Store below 25°C. Protect from light.

Do not use this medicine after the expiry date which is stated on the label. The expiry refers to the last day of that month.

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 anhydrous amiloride hydrochloride.

The tablets also contain Mannitol,

Pregelatinised maize starch, Povidone, Maize starch, Colloidal anhydrous silica (aerosil), Purified talc, Magnesium stearate and

Sodium starch glycollate (explotab)

The Film coating contains Opadry orange 8729 composed of: Hydroxypropylmethylcellulose 2910, Titanium dioxide (E171), Polyethylene glycol 400, Sunset yellow aluminium lake (E110), Quinoline yellow aluminium lake (E104), Purified water and Carnauba wax

What Co-Amilofruse Tablets looks like and contents of the pack

Description: Co-Amilofruse tablets 5mg/40mg: pale orange film coated tablets, marked CF with a breakline and 5/40 on one side and G on the reverse. Contents of pack: Pots of 50, 100, 250 and 500 tablets or blisters of 28 or 56 tablets

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Ltd., Key House,

Sarum Hill, Basingstoke, RG21 8SR, UK. This leaflet was last revised in 04/2026. _P3927T