Co-Amilofruse Tablets 5/40mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMILOFRUSE TABLETS 5/40MG
(furosemide/anhydrous amiloride hydrochloride)
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, health care provider 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 are Co-Amilofruse Tablets 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 ARE CO-AMILOFRUSE TABLETS AND WHAT ARE THEYUSEDFOR
Co-Amilofruse is one of a group of medicines called diuretics.
It is used for the treatment of:
• Heartfailure
• Nephrosis (kidney disorder)
• Fluid retention due to steroids or oestrogen therapy
• Cirrhosis of the liver.
2. BEFORE YOU TAKE CO-AMILOFRUSE TABLETS
Do not take Co-Amilofruse Tablets if you
• Have ever had an allergic reaction to Co-Amilofruse Tablets, furosemide, amiloride, sulphonomides or sulphonamide derivatives or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
• Have reduced blood volume (hypovolaemia), are dehydrated or are not passing water (urine) due to a condition called anuria
• Have high levels of potassium in your blood, are taking potassium supplements or other potassium containing medicines. Or
• Have severe low levels of potassium or sodium in the blood
• Have severe kidney problems or kidney failure
• Have cirrhosis of the liver
• Have Addison's disease which is a disorder of the adrenal gland
• Are under 18 years of age
• Are breast-feeding (see Section Pregnancy and breastfeeding)
Take special care with Co-Amilofruse Tablets
Check with your doctor or pharmacist 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 cirrhosis of the liver
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). 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 sugardisease
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.
Taking other medicines
Check with your doctor if you are taking or likely to be taking any of the following medicines
• Medicines used to treat high blood pressure including aliskiren and anti-arrhythmics (irregular heart beat) such as disopyramide, flecainide, quinidine, amiodarone or sotalol
• 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
• Probencid used to treat gout and kidney stones
• Sucralfate (do not take within two hours of co-amilofruse) orcarbenoxolone used to treat stomach ulcers
• Medicines used to treat depression or behavioural problems such as lithium (as additional monitoring of patients on lithium may be required), amisulpride, atomoxetine, pimozide, sertindole or reboxetine
Ciclosporin used to prevent organ rejection after transplant
Anti-diabetics, medicines used to treat diabetes such as u insulin and metformin
Cisplatin used to treat various cancers — o ■
Corticosteroids used in many conditions such as arthritis — ■ and asthma ■ 1
Theophylline used to treat asthma u
Cardiac glycosides used to treat heart conditions e.g. digoxin Diuretics (“water tablets”) used to treat water retention
Laxatives and liquorice preparations used to improve bowel movements (avoid prolonged use)
Medicines called ACE Inhibitors for treatment of heart problems e.g.captopril, or medicines called Angiotensin II receptor antagonists e.g. Losartan
In patients due to go for a glucose tolerance test should tell their doctor and stop taking Co-Amilofruse Tablets. Your doctor will advise you when to start to retake these tables after the test.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withouta prescription.
Pregnancy and breast-feeding Pregnancy
Your doctor will only prescribe Co-Amilofruse Tablets if the benefits to you outweigh the risks to the unborn child.
Breast-feeding
Breast-feeding is not recommended whilst taking Co-Amilofruse Tablets. If the use of this medicine is considered to be essential by your doctor then you will be advised to stop breast feeding your baby. Check with your doctor if you are unsure.
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.
Important information about some of the ingredients of Co-Amilofruse Tablets
Co-Amilofruse Tablets contain the colouring sunset yellow (E110), which can cause hypersensitivity (allergic) reactions including asthma, this is more common in people allergic to aspirin. Do not take Co-Amilofruse Tablets if you are allergic to sunset yellow.
3. HOWTO 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
One or two tablets to be taken in the morning
FRONT SIDE PRINTING
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. If an overdose has been taken there may be signs such as slow or irregular heartbeat, low blood pressure and fainting.
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.
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 have any of the following symptoms:
• Sudden wheeziness, difficulty in breathing, shortness of breath, fever, swelling of the eye lids, facelips 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 orfluttering
• Pancreatitis (inflammation of the pancreas) this may show as severe stomach pain and nausea, weight loss and fat in the stools (foul smelling).
If you experience any of the above side effects, contact your doctor immediately.
The following other side effects may also occur:
• Dizziness
• Feeling sick (nausea) or being sick (vomiting)
• Increased chance of blood clotting especially in the elderly
• Minor mental disturbances
• Glucose intolerance which may due to potential problems as a diabetic
• Diarrhoea or constipation
• Stomach pains
• Dry mouth
• Headaches or feeling of pressure in the head
• Lack of concentration
Lethargy (tiredness)
Pins and needles Impaired vision
Hearing disorders or tinnitus (ringing in the ears), deafness 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
Urine retention (unable to pass urine), especially in patients who may already find itdifficultto pass urine Dehydration and decrease in blood volume (especially in elderly patients) which may result in development of thromboses
Changes in blood cell numbers measured by a blood test There may be changes to your liver these will be seen in blood tests
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.
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.
5. HOWTO STORE CO-AMILOFRUSE TABLETS
Keep out of the sight and reach of children.
Store in the original container below 25°C and protect from light and moisture.
Do not use Co-Amilofruse Tablets after the expiry date which is stated on the label. The expiry refers to the last day of that month.
Do not use Co-Amilofruse Tablets if you notice visible signs of deterioration.
Medicines should not be disposed of via waste water 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 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
Co-Pharma Limited Unit 4, Metro Centre,
Tolpits Lane, Watford, Herts.
UK, WD 18 9SS Tel: 01923 255580 Fax: 01923 255581
This leaflet was last amended in 04/2015.
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BACK SIDE PRINTING