PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-Amilofruse 2.5/20mg Tablets
Co-Amilofruse 5/40mg Tablets
Co-Amilofruse 10/80mg Tablets
(amiloride hydrochloride and furosemide)
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Co-Amilofruse Tablets are and what are they used for
2. 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. Further information
1. 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 fluid retention due to steroids, oestrogens or cirrhosis of the liver.
2. 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)
- You are 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 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.
Take special care with Co-Amilofruse Tablets if you:
- have difficulty in passing water (urine)
- are prone to gout
- are elderly or seriously ill.
- have liver or kidney problems
- have diabetes
- 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 eating
- are an elderly patient with dementia and are also taking risperidone
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.
You are taking any other water tablets, if you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-Amilofruse Tablets.
Taking other medicines
Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained 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)
- potassium supplements
- other potassium sparing diuretics
- drugs used to control heart rhythm (i.e. digoxin)
- medicines used for arthritis or inflammation (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 difficultly 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. methotrixate)
- 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 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
Pregnancy and breast-feeding
Ask your doctor for advice before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Co-Amilofruse Tablets
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.
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.
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.
You will find that you have the urge to pass water soon after taking your tablets. Because of this it is better to take them first thing in the morning so that you pass any extra water early in the day, leaving you free to go about your usual routine undisturbed. If you work at night, it may be better for you to take your tablets in the evening.
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 leaflet 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 forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-Amilofruse Tablets can cause side effects, although not everybody gets them.
Skin rash or itching suggest 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 in which case you should stop taking the tablets immediately and inform your doctor.
You may experience the following:
- passing a lot of water (urine)
- sickness or vomiting, generally feeling 'unwell'
- stomach upset, diarrhoea or constipation
- imbalance in the levels of potassium and other salts in your blood
- gout or diabetes
- difficulty in passing water if you have prostate problems.
- 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, fits, mood changes
- 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
- 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
Very rarely Co-Amilofruse Tablets have been known to cause loss of hearing or ringing in the ears (tinnitus), this especially affects people who already have problems with their kidneys, minor psychiatric (mental) disturbances, or affect blood cell production (causing tiredness and throat or mouth ulcers) or temporarily alter liver function.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CO-AMILOFRUSE TABLETS
Keep out of the reach and sight 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.
6. FURTHER 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 flat 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 flat 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 flat 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
Odyssey Business Park
West End Road
Odyssey Business Park
West End Road