CO-AMILOFRUSE 5/40

Active substance: FUROSEMIDE

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Livery: Chatfield

Designer: Shreya

Colours:

Product: Co-Amilofruse
PL Number: 02142/0005 & 6

Text

Design:

leaflet mock up-proposed

Regulatory: C Saxena

Version No: 005
Date MHRA Approved:

Bar Code:

xx/xx/xxxx (Var xx)

Product Code: KAF00025/0005T/LEA005

Contract Manufacturer:

Comments:

company name

Dimensions: A5

Print proof Checked by Regulatory:

Supersedes - Version 004 - 17/12/2004 (variation 17)
Date: 16/10/2006

Chatfield Pharmaceuticals Limited

xx/xx/xxxx
Approved to print:

Artwork submitted with Type II safety
variation following PSUR review

PATIENT INFORMATION LEAFLET

Co-Amilofruse
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING YOUR MEDICINE
IF THERE IS ANYTHING YOU DO NOT UNDERSTAND
ABOUT YOUR TREATMENT, ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF CO-AMILOFRUSE
What is in Co-amilofruse?
Co-amilofruse tablets are available in two strengths, Coamilofruse 2.25/20 and Co-amilofruse 5/40.
One of the active ingredients in this medicine is Furosemide. This
is the new name for Frusemide. This ingredient itself has not
changed.
The active ingredients in Co-amilofruse 2.5/20 tablets are:
Amiloride Hydrochloride Ph. Eur. equivalent to 2.5 mg of the
anhydrous salt and Furosemide BP 20 mg.
Co-amilofruse 2.5/20 tablets also contain the following inactive
ingredients: Microcrystalline cellulose, povidone, crospovidone,
sunset yellow (E110) and magnesium stearate.
The active ingredients in Co-amilofruse 5/40 tablets are:
Amiloride Hydrochloride Ph. Eur. equivalent to 5 mg of the
anhydrous salt and Furosemide BP 40 mg.
Co-amilofruse 5/40 tablets also contain the following inactive
ingredients: Microcrystalline cellulose, povidone, crospovidone,
sunset yellow (E110) and magnesium stearate.
Both strengths of Co-Amilofruse tablets are available in blisterpacks of 28 and 56 tablets and in high density polypropylene
containers of 28, 56, 100 and 500 tablets.

How does Co-Amilofruse work?
Co-Amilofruse is a diuretic (water tablet), helpful in many diseases
by causing you to pass more urine than you normally do.
If you are not sure why you have been prescribed Co-Amilofruse,
then please ask you doctor.
The Manufacturer is:
DDSA Pharmaceuticals Ltd., 310 Old Brompton Road, London
SW5 9JQ.
The Product Licence Holder is:
Chatfield Pharmaceuticals Ltd., Kramer Mews, London SW5 9JL.

What are Co-Amilofruse tablets for?
Co-Amilofruse may be prescribed when excess water in the body
is brought about by the following conditions:
Congestive cardiac failure
Swelling due to fluid retention (oedema)
Kidney disease (nephrosis)
Liver disease (cirrhosis, together with increased fluid in the
abdomen)
Treatment with drugs known as cortico-steroids
Treatment with certain female hormones known as oestrogens.

Check before you take Co-Amilofruse tablets
Before taking this medicine, tell your doctor if you have ever had
any unusual or allergic reactions to the active ingredients of CoAmilofruse, or any of the other ingredients of this tablet.
Tell your doctor if you are taking any other diuretics or medicines,
which contain potassium.
It is important that you tell your doctor if you are pregnant, or likely
to become pregnant.
Also tell your doctor or pharmacist if you are allergic to any other
substances such as foods, preservatives or dyes.

Do not take Co-amilofruse if you have:
Cirrhosis of the liver, which is affecting your level of
consciousness
Kidney failure or are unable to pass water (urine) at all
Heart disease
Addison's disease
Low blood volume or are dehydrated
Low level of potassium in your blood
Low level of sodium in your blood
High level of potassium in your blood
Or are breast-feeding.
Co-amilofruse is not suitable for children. Do not take Coamilofruse if you are under 18 years of age.
The presence of other medical problems may affect the use of
this medicine. Make sure, therefore, to tell your doctor, or
pharmacist, if you have any other medical problems, especially:
Liver or kidney problems
Difficulty in passing urine
Diabetes
Prostate problems
Low blood pressure (dizziness on standing)
Suffer from cramps (electrolyte deficiency - salt imbalance)
Gout
Porphyria
Feel dizzy or dehydrated (e.g., lost water through vomiting,
diarrhoea, excessive urination or are having trouble drinking
or eating)
Or you are going to have a glucose test.
Co-amilofruse tablets also contain sunset yellow dye (E110),
which can cause allergic reactions including asthma. Allergy is
more common in people who are allergic to aspirin.

Use in pregnancy
The safety of Co-Amilofruse during pregnancy and lactation has
not been established.

Can you take Co-Amilofruse with other medicines?
You can take these tablets with other medicines, but there are
some medicines that can interfere with Co-Amilofruse.
It is very important to tell your doctor or pharmacist about all the
medicines, which you are taking, whether or not any medicines
were prescribed by your doctor or bought without a prescription
from the pharmacy or elsewhere.
This includes the following medicines:
Medicines to treat high blood pressure or which can lower
blood pressure, or a heart condition. This is particularly
important for medicines known as ACE inhibitors or
adrenergic neurone blockers or those known as angiotensin
II receptor antagonists. Your doctor may ask you to reduce
the dose or stop taking Co-amilofruse before starting
therapy with these medicines or before increasing their dose
Other diuretics (water tablets)
Corticosteroids
Aminoglutethimide
Methotrexate
Probenecid (to treat gout)
Medicines taken for depression including tricyclic

antidepressants and monoamine oxidase inhibitors (MAOIs)
Non-steroidal anti-inflammatory agents such as Indometacin,
ketorolac and aspirin
Carbamazepine and phenytoin to treat epilepsy
Carbenoxolone to treat ulcer
Amphotericin (treatment of fungal infections)
Liquorice
Medicines for diabetes (e.g. chlorpropamide)
Chloral and triclofos to treat insomnia
Acetazolamide to treat glaucoma
Theophylline and B2 sympathomimetics for breathing
difficulties and asthma
Lithium and reboxetine used to treat excessive mood swings
Medicines for your heart such as ramipril and verapamil
Certain antibiotics (particularly cephaloridine, aminoglycosides,
polymyxins and vancoycin)
Moxisylyte used in Raynaud's syndrome
The Curare-type muscle relaxants baclofen and tizanidine
Ciclosporin and tacrolimus used to prevent transplant rejection
Cisplatin for certain types of cancer
Aldesleukin (drugs affecting the immune response)
Laxatives
Alprostadil used to treat heart defects in babies, and impotence
Potassium salts
Oral contraceptives
Radiocontrast drugs (help doctors view X-rays).
If you are taking sucralfate, you should not take your dose at the
same time as Co-amilofruse. Take your dose at least 2 hours
before or after Co-amilofruse otherwise your medicine may not be
absorbed properly.
If you have limited kidney function associated with lowered
removal of a substance called creatinine from your blood, or Coamilofruse is given in combination with certain other drugs,
frequent checks of the potassium level in your blood will be
necessary.
If you feel sleepy or unwell after taking Co-amilofruse do not drive
or operate dangerous machinery.

When and how to take Co-Amilofruse tablets
Co-Amilofruse tablets are best taken first thing in the morning,
swallowed with a little milk or water, and only in the doses
prescribed by your doctor. Do not take more of it, and do not take
it more often.
Do not stop taking your medicine, or change the dose unless your
doctor tells you to.
You will be prescribed the lowest dose necessary to control your
symptoms.

What to do if too many tablets are taken at the same time
If you accidentally take more tablets than recommended, contact
your doctor or hospital casualty at once.

What if you miss a dose?
If you miss a dose, skip the missed dose and go back to your
regular dosage schedule. Do not double the dose.
(If you feel that this medicine is not working as well after you have
taken it for a short time (1-2 weeks) do not increase the dose,
instead check with your doctor.)

What side effects can Co-Amilofruse have?
In some patients Co-Amilofruse may have some unwanted effects.
These include nausea (feeling of being sick), vomiting, diarrhoea,
stomach upset, constipation, dry mouth, undue tiredness
(malaise), pins and needles, weakness, muscle cramp, headache,
visual changes, sensitivity to light and confusion.
Due to an increase in the amount of urine passed when taking Coamilofruse, this may cause dehydration (increased thirst), or pain
in urinating in some patients with bladder and prostatic problems.

Reduced mental alertness may impair driving or using
machinery, usually occurring only when treatment begins.
Hypersensitivity reactions are rare and usually cause skin
rashes and itching although kidney problems can also occur.
Severe allergic reactions are rare, but may include symptoms of
shock such as difficulty in breathing, cold clammy skin, pale skin
colour and racing heart beat. If these reactions occur stop taking
your Co-amilofruse and immediately tell your doctor.
Also tell your doctor, in the case of any of the following: Buzzing
or ringing in the ears, hearing difficulty, swelling of the joints,
aching joints or dizziness.
The following conditions can also occur on rare occasions: A fall
in blood pressure when rising from sitting or lying down, liver
problems including yellowing of the skin and whites of the eyes
(jaundice), minor psychiatric (mental) disturbances, changes in
behaviour, changes in stomach acidity and low blood pressure.
Inflamed pancreas, which may result in nausea and vomiting
with pain in the abdomen and back, may also occur.
In diabetic patients deterioration in glucose control may develop.
An increase in blood uric acid may occur, on rare occasions
resulting in gout.
Changes in the levels of sodium, calcium, chloride, magnesium,
potassium, sugars, creatinine, urea, cholesterol, triglycerides
and fats found in the blood may occur. Anaemia may also
develop which is marked by unusual tiredness and loss of
colour in the lining of eyes and skin.
Serious bone marrow disorders may also occur but these are
very rare. If affected your doctor may decide to stop your
treatment.
If your doctor sends you for blood tests, then tell the doctor who
is going to do the test that you are taking Co-Amilofruse.
Tell your doctor immediately if you notice any change in
your health while taking Co-Amilofruse.

Storing your medicine
You must keep the medicine in a safe place where children
cannot get at it. Your medicine could harm them.
Keep your medicine in a dry place below 25∞C. Protect from
light. Keep the tablets in the container in which they were given
to you.
If your doctor tells you to stop the treatment, return any
remaining tablets to the pharmacist.
On the carton and blister packs you will find the words "Expiry
Date" followed by numbers indicating the day, month and year.
This is the date when the medicine is no longer fit for use. Do
not use the medicine after this date, but return it to your doctor
or pharmacist.

A reminder
REMEMBER this medicine is for you. Never give it to someone
else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist who have access to
additional information.
Product Licence nos: PL 02142/0005 and PL 02142/0006
This leaflet was revised in September 2006
KAF00025/0005T/LEA005

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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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