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CO-AMILOFRUSE TABLETS 2.5/20MG

Active substance(s): AMILORIDE HYDROCHLORIDE ANHYDROUS / FUROSEMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amilofruse 2.5/20mg and 5/40mg tablets
(amiloride hydrochloride and furosemide)

If you are prone to large drops in blood
Read all of this leaflet carefully before you start
!
pressure
taking this medicine because it contains
If you are diabetic
!
important information for you.
If you have gout
!
Keep this leaflet. You may need to read it
!
If you have liver disease and also have
!
again.
impaired kidney function
If you have any further questions, ask your
!
If you have been told you have very low levels
!
doctor or pharmacist or nurse.
of protein in your blood
This medicine has been prescribed for you
!
If you are an elderly patient with dementia and
!
only. Do not pass it on to others. It may harm
are also taking Risperidone.
them, even if their signs of illness are the same
as yours.

Your doctor may want to monitor you whilst you
If you get any side effects, talk to your doctor,
!
take this medicine; this may mean having blood or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.

What is in this leaflet:
1. What Co-amilofruse Tablets are and what
they are used for
2. What you need to know before you take Coamilofruse Tablets
3. How to take Co-amilofruse Tablets
4. Possible side effects
5. How to store Co-amilofruse Tablets
6. Contents of the pack and other information

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
!
1. WHAT CO-AMILOFRUSE TABLETS ARE
antagonists used to treat high blood pressure
AND WHAT THEY ARE USED FOR
Medicines used to treat heart problems e.g.
!
amiodarone, disopyramide, flecainide,
Co-amilofruse Tablets contain the active
quinidine, lidocaine, mexiletine or digoxin
ingredients amiloride hydrochloride and
Medicines used after organ transplants e.g.
!
furosemide.
trilostane, ciclosporin or tacrolimus
They are used to treat conditions where there is a
Medicines used to treat diabetes e.g.
!
build-up of fluid in body tissues and potassium
Hypoglycaemic drugs
conservation is required. This includes heart
The antibiotic cephaloridine
!
failure, water retention from some types of kidney
Non Steroidal Anti-inflammatory Drugs
!
disease, treatment with steroids or oestrogens, and
(NSAIDs) used to treat pain and arthritis e.g.
ascites (the accumulation of fluid in the abdomen
indometacin, aspirin
sometimes seen in cirrhosis of the liver).
Polymyxin or vancomycin antibiotics used to
!
treat infections e.g. neomycin
2. WHAT YOU NEED TO KNOW BEFORE YOU
Lithium and reboxetine used to treat
!
TAKE CO-AMILOFRUSE TABLETS
depression
Muscle relaxants e.g. baclofen
!
Medicines used to treat epilepsy e.g
Do not take Co-amilofruse Tablets:
!
carbamazepine, phenytoin
If you are allergic (hypersensitive) to
!
Theophylline used to treat breathing problems
!
furosemide, amiloride hydrochloride,
Medicines used to treat stomach problems e.g.
!
sulphonamides or their derivatives or any of the
sucralfate, carbenoxolone
other ingredients in these tablets (listed in
Cisplatin and aminoglutethimide used to treat
!
section 6)
certain cancers
If you have a low blood volume (hypovolaemia)
!
Corticosteroids used to treat a variety of
!
If you have a disturbance of blood electrolytes
!
conditions
(salts) which may make you feel dehydrated
Liquorice
!
If you have kidney problems
!
Sympathomimetics used to treat a variety of
!
If you have been told you have high potassium
!
conditions
levels in your blood
Laxatives used to treat constipation
!
If you have been told you have very low levels
!
Amphoteracin used to treat fungal infections
!
of potassium in your blood
Probenacid used to treat gout
!
If you have been told you have very low levels
!
Methotrexate used to treat arthritis and certain
!
of sodium in your blood
types of cancer
If you are currently taking any other medicines
!
Risperidone used to treat behavioural
!
that contain potassium (including supplements)
disorders.
If you have Addison's disease
!
If you are breast-feeding
!
If you need to have a blood or urine test you
If you have severe liver problems e.g cirrhosis
!
should tell the doctor or nurse you are taking these
tablets as they may interfere with the results.
associated with a pre-comatose state (or
affecting your state of consciousness)
Pregnancy and breast-feeding
If you have difficulty in urinating (passing
!
If you are pregnant, think you may be pregnant or
water).
become pregnant, you should talk to your doctor
before taking these tablets.
Co-amilofruse Tablets should not be used in
children under the age of 18 years.
If you want to breast-feed your baby you should
talk to your doctor first before taking these tablets.
Warnings and precautions

Talk to your doctor, pharmacist or nurse before
Driving and using machines
taking Co-amilofruse Tablets:
No effects have been established.
If you have prostate problems
!
If you have any problems with passing urine
!
(water) including obstruction of the urinary tract
If you have low blood pressure
!

Co-amilofruse Tablets contain lactose and
sunset yellow (E110)
If you have been told by your doctor that you have
an intolerance to some sugars, you should talk to
your doctor before taking these tablets.

Visual changes (such as sensitivity to
!

These tablets contain orange colouring (sunset
yellow E110) which may cause allergic reactions.

!
Liver disorders including jaundice (a

light)

Ringing in the ears and deafness
!
!
Gout
!
Pancreatitis (abdominal pain, nausea
and vomiting)

3. HOW TO TAKE CO-AMILOFRUSE TABLETS
Always take Co-amilofruse Tablets exactly as your
doctor has told you. If you are not sure you should
check with your doctor or pharmacist before
taking.
Adults:
Normal 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.
Your 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.
If you take too many tablets:
If you 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.
If you forget to take a dose:
If you forget to take your tablet in the morning, but
remember mid-afternoon, take the missed dose
and then continue to take as usual. If you 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.
If you stop taking these tablets:
If you want to stop taking these tablets you should
talk to your doctor first as your original symptoms
may return.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following occur you should STOP
taking this medicine and contact your doctor
immediately:
Allergic reaction: symptoms include skin rash
and itching, increased sensitivity to sunlight,
swelling of face, lips, tongue or throat, difficulty
swallowing or breathing.
Steven-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 of feet. Ulcers can occur in
mucous membranes such as inside the mouth,
nostrils and eyelids (a severe form of
conjunctivitis) but also in genital and anal regions.
Dress syndrome: Symptoms include serious
hypersensitivity reactions (e.g. skin rash, fever and
enlarged lymph nodes.)
Other side effects include:

yellowing of the whites of the eyes
and skin)
!
Feeling tired more easily, aching or
swollen joints, bruising more easily
!
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.
5. HOW TO STORE CO-AMILOFRUSE
TABLETS
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 of via
wastewater of household waste. Ask your
pharmacist how to dispose of unwanted medicines
no longer required. These measures will help
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Co-amilofruse Tablets contain
Co-amilofruse Tablets 2.5/20mg contain 2.5mg of
amiloride hydrochloride and 20mg of furosemide.
Co-amilofruse Tablets 5/40mg contain 5mg of
amiloride hydrochloride and 40mg of furosemide.
The other ingredients are lactose, polyvinylpyrolidone, 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 of 28,
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.

Tiredness
!
Nausea (feeling sick) and vomiting (being sick)
!
MANUFACTURER:
Stomach pain, diarrhoea or constipation
!
Clonmel Healthcare Limited
Pins and needles
!
Waterford Road, Clonmel, County Tipperary,
Low blood pressure, symptoms may include
!
Republic of Ireland

difficulty in concentrating, slowing of your
reactions, feeling lightheaded, a sensation of
This leaflet was last revised in July 2016.
pressure in the head, dizziness, drowsiness,
weakness, visual disturbances, dry mouth and
feeling unwell when standing up.
Skin rashes, itching
!
Changes in your behaviour
!

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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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