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CO-AMILOZIDE 5/50 TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE / AMILORIDE HYDROCHLORIDE DIHYDRATE / HYDROCHLOROTHIAZIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

CO-AMILOZIDE TABLETS 5/50mg
[amiloride hydrochloride/hydrochlorothiazide]

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 Co-Amilozide Tablets are and what they
are used for
2. Before you take Co-Amilozide Tablets
3. How to take Co-Amilozide Tablets
4. Possible side effects
5. How to store Co-Amilozide Tablets
6. Further information
1. WHAT CO-AMILOZIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
Co-Amilozide is one of a group of medicines
called diuretics. It is used for the treatment of:
 High blood pressure
 Congestive heart failure, heart problems
which can cause shortness of breath or ankle
swelling
 Cirrhosis of the liver disease where the liver is
damaged
2. BEFORE YOU TAKE CO-AMILOZIDE TABLETS
Do not take Co-Amilozide Tablets if you
 Have ever had an allergic reaction to
Co-Amilozide tablets, amiloride,
hydrochlorothiazide 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 not passing water (urine)
due to a condition called anuria
 High levels of potassium in your blood or
are taking potassium supplements or other
potassium containing medicines
 Have high calcium in the blood
 Have severe kidney problems or kidney failure
 Have severe liver failure
 Have Addison’s disease which is a disorder of
the adrenal gland
 Have diabetes or diabetic neuropathy (nerve
damage due to diabetes)
 Are under 18 years of age
Take special care with Co-Amilozide Tablets
Check with your doctor or pharmacist before
taking Co-Amilozide Tablets if you:
 Have low blood sodium, potassium or
magnesium levels.
 Have kidney or liver problems
 Have gout (crystals build up in the joints)
 Have Systemic Lupus Erythematosus
(SLE) which is a chronic condition causing
inflammation of various parts of the body.
 Have any condition which affects urination
(passing water), for example enlarged prostate
gland
 Have low blood pressure
 Have low protein levels in the blood due to
kidney problems
 Are diabetic
 Are taking allopurinol
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
Please tell your doctor before taking this medicine
if you are taking or likely to be taking any of the
following: Ace inhibitors used to treat heart problems
e.g Captopril, Lisinopril

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 Anti-arrhythmics used to treat an irregular
heart beat e.g digoxin, amiodarone
 Drugs used to relieve high blood pressure
including aliskiren and metolazone
 Non-steroidal anti-inflammatory drugs
(NSAIDs) such as ibuprofen and indometacin
which reduce inflammation and pain
 Other anti-inflammatory drugs such as
corticosteroids or carbenoxolone used in
many conditions such as arthritis or asthma
 Medicines to treat severe asthma
 Medicines used to treat depression or
behavioural problems such as lithium,
reboxetine, carbamazepine
 Cisplatin used to treat various cancers
 Antibiotics and antifungals to treat infection
e.g cephalosporin antibiotics and
amphotericin
 Ciclosporin used to prevent organ rejection
after transplant
 Medicines used to treat diabetes such as
insulin and chlorpropramide
 Trilostan used in the treatment of
endometriosis, infertility, prostate cancer
 Pressor amines used for some heart or
blood pressure conditions e.g methoxamine,
adrenalin
 Diuretics used to relieve water retention
e.g spironolactone or triamterene
 Colestipol or colestyramine which are used to
reduce cholesterol levels (fat)
 Taking alcohol, barbituates or narcotics
(Central nervous system depressants)
with thiazide diuretics can lead to low blood
pressure
 Vitamin D, calcium salts or toremifene
 Adrenaline
 Medicines to reduce potassium excretion
e.g. drospirenone, tacrolimus
 Muscle relaxants
 Allopurinol used to treat gout
 Fluconazole used to treat fungal infections.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Pregnancy and breast-feeding
Please tell your doctor if you are pregnant or
you may be pregnant before taking this medicine.
Your doctor will only prescribe Co-Amilozide
tablets if the benefits outweigh the risks to the
unborn child. Breast-feeding is not recommended
whilst taking Co-Amilozide Tablets. Check with
your doctor if you are unsure as breast-feeding
should be discontinued if treatment with
Co-Amilozide is considered essential.
Driving and using machines
Co-Amilozide Tablets may make you feel dizzy,
weak or tired. Make sure you are not affected
before you drive or operate machinery.
Important information about some of the
ingredients of Co-Amilozide tablets
Co-Amilozide Tablets contain lactose. Do not take
these tablets if you have been told by your doctor
that you are lactose intolerant or that you have an
intolerance to some sugars.
Co-Amilozide Tablets also 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-Amilozide Tablets if you
are allergic to sunset yellow.
3. HOW TO TAKE CO-AMILOZIDE TABLETS
Always take Co-Amilozide 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.

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The usual dosage(s) are described below:
For Adult oral use
High blood pressure:
Half a tablet daily increased to one tablet daily if
necessary.
Congestive heart failure:
Half a tablet daily increased to two tablets daily if
necessary.
Cirrhosis of the liver:
One tablet daily increased to two tablets daily if
necessary.
Elderly
The above dosages may sometimes be reduced
especially if you have damaged kidneys.
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-Amilozide 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-Amilozide 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-Amilozide 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 get
any sudden wheeziness, difficulty in breathing,
swelling of the eye lids, face or lips, rash,
reddening of the skin or itching (especially
affecting your whole body). Stop taking this
medication immediately if you experience any
of these symptoms.
Serious side effects:
 Liver problems (yellowing of the skin or whites
of the eyes)
 Problems with the blood cells in your body,
this may show as increased bruising, pale
skin, bleeding from the nose or gums or
regular infections
 Abnormal heart beats; this may be fast, slow
or fluttering or severe chest pain (angina)
 Pancreatitis (inflammation of the pancreas)
this may show as severe stomach pain,
nausea, weight loss and fat in your stools
(foul smelling)
 Serious skin disorders which may give severe
skin rash, this may be blistering, red and very
painful
 Breathing difficulty or breathlessness.
If you experience any of the above side effects,
contact your doctor immediately.
The following side effects may also occur:
 Insomnia (unable to sleep) or somnolence
(over tired), confusion, nervousness and
restlessness, depression (low mood)
 Headaches, dizziness, lethargy (tiredness),
pins and needles, itching, fainting, changes in
taste, tremor, brain disorder

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 Impaired vision, hearing disorders,
eye pressure, yellowing of vision
 Vertigo, ringing in ears
 Low blood pressure (fainting on standing),
flushing (warm red skin), vasculitis
(inflammation of the arteries)
 Cough, nasal congestion or hiccups,
pneumonia, water on the lung
 Feeling sick (nausea), being sick (vomiting),
diarrhoea, constipation, flatulence (wind),
stomach pain or discomfort, stomach
distension and indigestion, changes in
appetite, dry mouth, mouth ulcers, sugar in
urine measured by the doctor
 Rash which can be itchy, blood spots, bruising
and discolouring to the skin (purpural) or
sensitive to sun, increased sweating, hair loss
(alopecia)
 Muscle or joint pain or spasms or tremor
(shaking), pains in arms, legs and neck
 Increased urine production, urination in the
night increased, retention of urine (not passing
water), bladder spasms
 Reduced sex drive (libido) or erectile
dysfunction
 Thirst, general body weakness or feeling of
being unwell, chest pain, back pain, fever
(high temperature).
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-AMILOZIDE 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-Amilozide 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-Amilozide 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-Amilozide Tablets contains
The active substances are amiloride hydrochloride
and hydrochlorothiazide.
The tablets also contain: Lactose monohydrate,
Microcrystalline cellulose, Maize starch,
Magnesium stearate, Purified talc, Sodium starch
glycollate and Sunset yellow aluminium lake E110.
What Co-Amilozide Tablets looks like and
contents of the pack
Description:
A flat, pale peach bevelled edged tablet,
engraved ‘CO breakline AM’ on one side and
plain on the other side.
Contents of pack: Pots of 100 and 500 tablets or
blisters of 28, 50 and 100 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 revised in 06/2015

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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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