CO-AMILOFRUSE TABLETS 5/40MG

Active substance: FUROSEMIDE

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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.

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

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



Methotrexate used to treat rheumatoid arthritis



Probencid used to treat gout and kidney stones



Sucralfate (do not take within two hours of co-amilofruse)
or Carbenoxolone used to treat stomach ulcers



In this leaflet:

Medicines used to treat depression or behavioural problems
such as lithium (as additional monitoring of patients on
lithium may be required), amisulpride, atomoxetine,
pimozidesertindole or reboxetine

4. Possible side effects
5. How to store Co-Amilofruse Tablets
6. Further information
1. WHAT ARE CO-AMILOFRUSE TABLETS AND WHAT ARE
THEY USED FOR



Ciclosporin used to prevent organ rejection after transplant



Co-Amilofruse is one of a group of medicines called diuretics.
It is used for the treatment of:

Anti-diabetics, medicines used to treat diabetes such as
insulin and metformin



Antibiotics and antifungals to treat infection including
Vancomycin, Colistin and amphotericin



Heart failure



Nephrosis (kidney disorder)



Fluid retention due to steroids or oestrogen therapy





Cirrhosis of the liver

Cisplatin used to treat various cancers



Corticosteroids used in many conditions such as arthritis
and asthma



2. BEFORE YOU TAKE CO-AMILOFRUSE TABLETS

Theophylline used to treat asthma



Cardiac glycosides used to treat heart conditions e.g. digoxin

Do not take Co-Amilofruse Tablets if you



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

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) 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

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.



Have severe low levels of potassium or sodium in the blood

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



Have severe kidney problems or kidney failure

Pregnancy and breast-feeding



Have cirrhosis of the liver

Pregnancy



Have Addison's disease which is a disorder of the adrenal
gland

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



Are under 18 years of age

Breast feeding



Are breast feeding (see Section Pregnancy and 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.

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 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
sugar disease

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. 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
One or two tablets to be taken in the morning

----- 180 x 300 mm -----

Co-Amilofruse Tablets - 5 & 40 mg Pack Insert (2 pages)
Tuesday, February 07, 2012 9:21:23 AM

FRONT SIDE PRINTING

Elderly

light headed especially on standing)

The above dosages may sometimes be reduced especially
if you have damaged kidneys.

• Inflammation of the blood vessels of the skin (purple spots
or blisters on the skins surface)

Elderly patients will have blood tests to closely monitor sodium,
potassium and urea levels whilst on these tablets.

• Rash which can be itchy, blood spots, bruising and
discolouring to the skin (purpura).

Children under 18 years of age

• Muscle spasms or weakness

Not recommended.

• General body weakness or feeling of being unwell

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

• Increased urine production

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

• Fever (high temperature)
• Urine retention (unable to pass urine), especially in patients
who may already find it difficult to 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.

If you forget to take a tablet take one as soon as you remember,
unless it is nearly time to take the next one.

• Increase in blood cholesterol levels

Do not take a double dose to make up for a forgotten dose.

• Increase in blood creatinine and uric acid levels which may
increase attacks of gout.

Take the remaining doses at the correct time.

• Reduction in blood calcium levels measured by a blood test

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

• Electrolyte imbalances in blood with symptoms of confusion,
cramping, feeling sick, and muscle spasms.
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.
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.

• Vasculitis (inflammation of the veins)
• Erythema multiforme(reddening of the skin)
• Exfoliative dermatitis (itchy red scaly skin).
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)
If you experience any of the above side effects, contact
your doctor immediately.
The following other side effects may also occur:

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.

• Dizziness
• Feeling sick (nausea) or being sick (vomiting)
• Increased chance of blood clotting especially in the elderly

Contents of pack: Pots of 50, 100, 250 and 500 tablets or blisters
of 28 or 56 tablets

• Minor mental disturbances

Marketing Authorisation Holder and Manufacturer

• Glucose intolerance which may due to potential problems
as a diabetic

• Dry mouth

Co-Pharma Limited
Unit 4, Metro Centre,
Tolpits Lane, Watford, Herts.
UK, WD 18 9SS
Tel: 01923 255580
Fax: 01923 255581

• Headaches or feeling of pressure in the head

This leaflet was last amended in 02/2012.

• Diarrhoea or Constipation.
• Stomach pains

• Lack of concentration
• Lethargy (tiredness)
• Pins and needles
• Impaired vision.
• Hearing disorders or tinnitus (ringing in the ears)
• Confusion
• Low blood pressure (reduced in reaction time and feeling

----- 180 x 300 mm -----

Co-Amilofruse Tablets - 5 & 40 mg Pack Insert (2 pages)
Tuesday, February 07, 2012 9:21:23 AM

BACK SIDE PRINTING

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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