Co-Amilofruse Tablets 2.5/20mg
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Read all ofthis leaflet carefully before you start jtaking this medicine because it contains important information for you.
I* Keep this leaflet. You may need to read it again.
I doctor or pharmacist or nurse.
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only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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I pharmacist or nurse. This includes any possible | side effects not listed in this leaflet. See section 4.
What is in this leaflet:
ll. What Co-amilofruse Tablets are and what , they are 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 b. Contents of the pack and other information
1. WHAT CO-AMILOFRUSE TABLETS ARE AND WHAT THEY ARE USED FOR
|Co-amilofruse Tablets contain the active ingredients amiloride hydrochloride and furosemide.
They are used to treat conditions where there is a build-up of fluid in body tissues and potassium ponservation is required. This includes heart failure, water retention from some types of kidney disease, treatment with steroids or oestrogens, and ascites (the accumulation of fluid in the abdomen sometimes seen in cirrhosis of the liver).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOFRUSE TABLETS
bo not take Co-amilofruse Tablets:
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I furosemide, amiloride hydrochloride,
sulphonamides or their derivatives or any of the other ingredients in these tablets (listed in section 6)
I (salts) which may make you feel dehydrated
levels in your blood of potassium in your blood
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I of sodium in your blood L If you are currently taking any other medicines that contain potassium (including supplements)
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associated with a pre-comatose state (or I affecting your state of consciousness)
| water).
ICo-amilofruse Tablets should not be used in phildren under the age of 18 years.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before faking Co-amilofruse Tablets:
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, (water) including obstruction of the urinary tract
• If you are prone to large drops in blood pressure
• If you are diabetic
• If you have gout
• If you have liver disease and also have impaired kidney function
• If you have been told you have very low levels of protein in your blood
• If you are an elderly patient with dementia and are also taking Risperidone.
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 need to have a glucose tolerance test you should stop taking these tablets before you have the test. Talk to your doctor about this.
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 is particularly important if you are taking any of the following:
• Potassium supplements
• Other diuretics (water tablets) e.g. furosemide
• ACE inhibitors and Angiotensin II receptor antagonists used to treat high blood pressure
• Medicines used to treat heart problems e.g. amiodarone, disopyramide, flecainide, quinidine, lidocaine, mexiletine ordigoxin
• Medicines used after organ transplants e.g. trilostane, ciclosporin or tacrolimus
• Medicines used to treat diabetes e.g. Hypoglycaemic drugs
• The antibiotic cephaloridine
• Non Steroidal Anti-inflammatory Drugs (NSAIDs) used to treat pain and arthritis e.g. indometacin, aspirin
• Polymyxin orvancomycin antibiotics used to treat infections e.g. neomycin
• Lithium and reboxetine used to treat depression
• Muscle relaxants e.g. baclofen
• Medicines used to treat epilepsy e.g carbamazepine, phenytoin
• Theophylline used to treat breathing problems
• Medicines used to treat stomach problems e.g. sucralfate, carbenoxolone
• Cisplatin and aminoglutethimide used to treat certain cancers
• Corticosteroids used to treat a variety of conditions
• Liquorice
• Sympathomimetics used to treat a variety of conditions
• Laxatives used to treat constipation
• Amphoteracin used to treat fungal infections
• Probenacid used to treat gout
• Methotrexate used to treat arthritis and certain types of cancer
• Risperidone used to treat behavioural disorders.
If you need to have a blood or urine test you should tell the doctor or nurse you are taking these tablets as they may interfere with the results.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or become pregnant, you should talk to your doctor before taking these tablets.
If you want to breast-feed your baby you should talk to your doctor first before taking these tablets.
Driving and using machines
No effects have been established.
feo-amilofruse Tablets contain lactose and sunset yellow (E110)
Ifyou have been told by your doctor that you have an intolerance to some sugars, you should talk to your doctor before taking these tablets.
^These tablets contain orange colouring (sunset fellow E110) which may cause allergic reactions.
Always take Co-amilofruse Tablets exactly as your doctor has told you. If you are not sure you should bheck with your doctor or pharmacist before taking.
Adults:
iNormal 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.
Vour doctor may prescribe a different dose regime. |This will depend upon the condition he is treating you for.
^Elderly:
[The dose may be modified by your doctor. This will depend upon your body's reaction to the diuretic.
Children:
[This product should not be used in children.
Ilfyou take too many tablets:
Ifyou 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.
ifyou forget to take a dose:
jlfyou forget to take your tablet in the morning, but remember mid-afternoon, take the missed dose ^nd then continue to take as usual. Ifyou 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 you have trouble remembering when to |take your tablets talk to your doctor.
Ilfyou stop taking these tablets:
Ifyou want to stop taking these tablets you should talk to your doctor first as your original symptoms may return.
• Visual changes (such as sensitivity to | light)
• Ringing in the ears and deafness
• Gout
• Pancreatitis (abdominal pain, nausea | and vomiting)
• Liver disorders including jaundice (a | yellowing of the whites of the eyes and skin)
• Feeling tired more easily, aching or swollen joints, bruising more easily L
• Changes in serum calcium levels
• Changes in serum cholesterol and triglyceride
• Changes in the level of salts in your body. Symptoms may include increased thirst, headache, low blood pressure, confusion, muscle cramps and weakness, changes in the heart rhythm and stomach disturbances
Changes in your types and numbers of blood cells may occur. Your doctor will monitor this with regular blood tests
Changes in liver and kidney function may occur. Your doctor will monitor you carefully for these changes.
If any of the side effects gets worse, or if you notice any side effects not mentioned in this leaflet, please inform 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 leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not take Co-amilofruse Tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed ofvia wastewater of household waste. Ask your pharmacist how to dispose of unwanted medicines no longer required. These measures will help protect the environment.
Like all medicines, this medicine can cause side effects, although not everybody gets them, ilf any of the following occur you should STOP taking this medicine and contact your doctor limmediately:
Allergic reaction: symptoms include skin rash pnd itching, increased sensitivity to sunlight, swelling offace, lips, tongue or throat, difficulty ^wallowing or breathing.
^teven-Johnson syndrome: Symptoms may include, sore throat, fatigue, intense skin rash and |lesions which may occur on the face, upper body, arms, legs and soles offeet. Ulcers can occur in Imucous membranes such as inside the mouth, nostrils and eyelids (a severe form of bonjunctivitis) but also in genital and anal regions.
bress syndrome: Symptoms include serious hypersensitivity reactions (e.g. skin rash, fever and enlarged lymph nodes.)
bther side effects include:
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difficulty in concentrating, slowing ofyour reactions, feeling lightheaded, a sensation of pressure in the head, dizziness, drowsiness, weakness, visual disturbances, dry mouth and feeling unwell when standing up.
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What Co-amilofruse Tablets contain
Co-amilofruse Tablets 2.5/20mg contain 2.5mg of amiloride hydrochloride and 20mg offurosemide. Co-amilofruse Tablets 5/40mg contain 5mg of amiloride hydrochloride and 40mg offurosemide. The other ingredients are lactose, polyvinyl-pyrolidone, Orange (sunset yellow E110), microcrystalline cellulose (E460), sodium starch glycollate and magnesium stearate.
What Co-amilofruse Tablets look like and contents of the pack
Co-amilofruse 2.5/20mg-Orange, flat, round tablets, 6mm diameter, scored one side.
Co-amilofruse 5/40mg - Orange, flat, bevel edged tablets with the following markings: 5 breakline 40 on one side. CO-AF on the other side.
Co-amilofruse Tablets are available in packs of28, 30, 56, 60, 84, 100, 168 and 200 tablets.
MARKETING AUTHORISATION HOLDER:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
MANUFACTURER:
Clonmel Healthcare Limited
Waterford Road, Clonmel, County Tipperary,
Republic of Ireland