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CO-AMILOFRUSE TABLETS 2.5/20MG

Active substance(s): AMILORIDE HYDROCHLORIDE ANHYDROUS / FUROSEMIDE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

250313/3

Colours Used

Customer

Ennogen

Black

Description

Co-amilofruse Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

1

Date

25-03-13

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

If you are an elderly patient with dementia and
Read all of this leaflet carefully before you start
!
are also taking Risperidone.
taking this medicine.
!
Keep this leaflet. You may need to read it
Your doctor may want to monitor you whilst you
again.
!
take this medicine; this may mean having blood or
If you have any further questions, ask your
urine tests or an ECG to check your heart.
doctor or pharmacist
!
This medicine has been prescribed for you. Do
If you need to have a glucose tolerance test you
not pass it on to others. It may harm them,
should stop taking these tablets before you have
even if their symptoms are the same as yours.
!
the test. Talk to your doctor about this.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
Using other medicines
please tell your doctor or pharmacist.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
In this leaflet:
including those bought without a prescription.
1. What Co-amilofruse Tablets are and what
This is particularly important if you are taking any
they are used for
of the following:
2. Before you take Co-amilofruse Tablets
Potassium supplements
3. How to take Co-amilofruse Tablets
!
Other diuretics (water tablets) e.g. furosemide
4. Possible side effects
!
ACE inhibitors and Angiotensin II receptor
5. Storing Co-amilofruse Tablets
!
antagonists used to treat high blood pressure
6. Further information
Medicines used to treat heart problems e.g.
!
1. WHAT CO-AMILOFRUSE TABLETS ARE
Amiodarone, Disopyramide, Flecainide,
AND WHAT THEY ARE USED FOR
Quinidine, Lidocaine, Mexiletine or digoxin
Medicines used after organ transplants e.g.
!
Trilostane, Ciclosporin or tacrolimus
Co-amilofruse Tablets contain the active
Medicines used to treat diabetes e.g.
ingredients amiloride hydrochloride and
!
Hypoglycaemic drugs
furosemide.
The antibiotic Cephaloridine
They are used to treat conditions where there is a
!
Non Steroidal Anti-inflammatory Drugs
build-up of fluid in body tissues and potassium
!
(NSAIDs) used to treat pain and arthritis e.g.
conservation is required. This includes heart
indometacin, aspirin
failure, water retention from some types of kidney
Polymyxin or Vancomycin antibiotics used to
disease, treatment with steroids or oestrogens, and
!
treat infections e.g. neomycin
ascites (the accumulation of fluid in the abdomen
Lithium and Reboxetine used to treat
sometimes seen in cirrhosis of the liver).
!
depression
Muscle relaxants e.g. baclofen
2. BEFORE YOU TAKE CO-AMILOFRUSE
!
Medicines used to treat epilepsy e.g
TABLETS
!
Carbamazepine, phenytoin
Theophylline used to treat breathing problems
Do not take Co-amilofruse Tablets:
!
Medicines used to treat stomach problems e.g.
!
If you are allergic (hypersensitive) to
!
Sucralfate, Carbenoxolone
furosemide, amiloride hydrochloride,
Cisplatin and Aminoglutethimide used to treat
sulphonamides or their derivatives or any of the
!
certain cancers
other ingredients in these tablets
Corticosteroids used to treat a variety of
!
If you have a low blood volume (hypovolaemia)
!
conditions
!
If you are 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 bhavioral disorders.
that contain potassium (including supplements)
!
!
If you have Addison's disease
If you need to have a blood or urine test you
!
If you are breast-feeding
should tell the doctor or nurse you are taking these
!
If you have severe liver problems e.g cirrhosis
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.
Take special care with Co-amilofruse Tablets
!
If you have prostate problems
Driving and using machines
!
If you have any problems with passing urine
No effects have been established.
(water) including obstruction of the urinary tract
!
If you have low blood pressure
Important information about one of the
!
If you are prone to large drops in blood
ingredients in these tablets
pressure
These tablets contain lactose. If you have been
!
If you are diabetic
told by your doctor that you have an intolerance to
!
If you have gout
some sugars, you should talk to your doctor before
!
If you have liver disease and have also have
taking these tablets.
impaired kidney function
!
if you have been told you have very low levels
of protein in your blood

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

310112/2

Colours Used

Customer

Ennogen

Black

Description

Co-amilofruse Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

5

Date

25-03-13

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

These tablets contain orange colouring (sunset
yellow E110) which may cause allergic reactions.
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, Co-amilofruse Tablets 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.)

Quality Control (QC)

Production

!
Skin rashes, itching
!
Changes in your behaviour
!
Visual changes (such as sensitivity to
light)

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

!
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
!
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: Also you can help
make sure that medicines remain as safe as
possible by reporting any unwanted side effects via
the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100
3352(available from 10 a.m. to 2 p.m. Mondays to
Fridays) or fill in a paper form available from your
local pharmacy.
5. STORING CO-AMILOFRUSE TABLETS
Keep out of the reach and sight 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. 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
Other Side effects include:
Unit G4, Riverside Industrial Estate,
!
Tiredness
Riverside Way, Dartford, DA1 5BS, UK.
!
Nausea (feeling sick) and vomiting (being sick)
!
Stomach pain, diarrhoea or constipation
MANUFACTURER:
!
Pins and needles
Clonmel Healthcare Limited
!
Low blood pressure, symptoms may include
Waterford Road, Clonmel, County Tipperary,
Republic of Ireland
difficulty in concentrating, slowing of your
reactions, feeling lightheaded, a sensation of
This leaflet was last revised in March 2013
pressure in the head, dizziness, drowsiness,
weakness, visual disturbances, dry mouth and
feeling unwell when standing up.

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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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