Skip to Content

UK Edition. Click here for US version.

CO-AMILOZIDE 5/50 TABLETS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

artwork.leicester@multipkg.com
Profile

9pt (main body) / 6.5pt (variables)

128 X 390mm

Use uploaded cutter

Measure bar should be 150mm at 100% scale

Size

UK

Wockhardt UK Limited

Min. Point Size

English

Customer

Market

Co-amilozide tablet leaflet common

Language

matt.pirie-scott

Description

Proof By

2

104104-8

Proof No.

28/10/2015

Item Code

Date

Process Black

Colours Used

Keylines

You should not take Co-Amilozide
Tablets if you:
• are allergic (hypersensitive) to amiloride
hydrochloride, hydrochlorothiazide or to
any of the other ingredients in
Co-Amilozide Tablets (see section 6)
• are allergic to a type of antibiotic
called sulphonamides, such as
sulphamethoxazole
• have been told by your doctor that you
have high levels of potassium, calcium,
urea or creatinine in your blood
• have kidney failure or disease or you
are unable to pass water
• have severe liver failure
• are taking potassium supplements or
medicines containing potassium or you
eat large amounts of potassium rich
foods
• you are taking potassium sparing
diuretics such as spironolactone or
triamterene
• are taking lithium (used to treat manic
depression)
• have diabetes (high blood sugar level)
• have Addison’s disease (an adrenal
glands disease)
• you are pregnant or think you may be
pregnant or are breastfeeding
• are under 18 years.
Talk to your doctor before taking
Co-Amilozide Tablets if you:
• are elderly or seriously ill
• have recently suffered from severe
vomiting or diarrhoea
• have liver cirrhosis and abnormally
high levels of alkalinity in the body
(metabolic alkalosis)
• or have had high levels of acid in the
body (metabolic or respiratory acidosis)
caused by heart disease or poorly
controlled diabetes.
• have water retention causing swelling
(resistant oedema)
• severe liver disease
• impaired kidney function
• you are taking digitalis such as digoxin
- used for heart failure and abnormal
heart beat
• suffer from gout (a condition where too
much uric acid in the body causes joint
pains)
• are due to take a glucose tolerance test
(this medicine should be discontinued
for at least three days before).
• have been told by your doctor you have
high levels of uric acid, cholesterol or
triglycerides (a type of cholesterol) in
your blood
• have severe asthma
• suffer from systemic lupus erythematosus
(a disease were the immune system
attacks the tissues of the body).
Taking other medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including medicines
obtained without a prescription.

N/A

2. Before you take Co-Amilozide Tablets

Pharma
Code

The name of your medicine is Co-Amilozide
Tablets. This medicine contains two active
ingredients, amiloride hydrochloride
and hydrochlorothiazide. Amiloride
hydrochloride removes excess water and
prevents a reduction in potassium levels.
Hydrochlorothiazide removes excess
water from the body.
Co-Amilozide Tablets comes in two
strengths and is used in the treatment
heart failure, high blood pressure and
fluid retention due to liver disease
(especially when it is important to
maintain potassium levels).

605346

1. W
 hat Co-Amilozide Tablets are and
what they are used for

The following medicines can affect or be
affected by treatment with Co-Amilozide
Tablets:
• medicines used to treat cancer of the
kidney such as aldesleukin
• non-steroidal anti-inflammatory drugs
(NSAIDs), such as aspirin or ibuprofen
- used to reduce high temperature
(fever), pain or for arthritis
• painkillers such as codeine,
dihydrocodeine, dextropropoxyphene,
diamorphine, morphine, pentazocine
and pethidine
• anion-exchange resins used to reduce
cholesterol (e.g.colestyramine and
colestipol) – these should be given at
least two hours apart
• anti-arrhythmic medicines used to treat
abnormal heart rhythms e.g. quinidine
• medicines used to treat bacterial
infections such as trimethoprim
• medicines to treat depression
(e.g. reboxetine, tricyclic
antidepressants and MAOIs)
• medicines to treat diabetes
(e.g. chlorpropamide)
• carbamazepine, used to treat epilepsy
• amphotericin and fluconazole, used to
treat fungal infections
• allopurinol, used to prevent gout
• anti-histamine drugs used to treat
allergies e.g. astemizole and terfenadine
• angiotensin converting enzyme
inhibitors (ACE inhibitors) such as
enalapril used to treat high blood
pressure or heart problems
• angiotensin II receptor antagonists
such as losartan - used to treat high
blood pressure or diabetics with kidney
damage
• other medicines used to treat high blood
pressure (e.g. proazosin, hydralazine,
diazoxide)
• medicines used to treat malaria, such as
halofantrine
• medicines to treat mental illness
(e.g. primozide and sertindole)
• potassium, calcium and vitamin
supplements.
• cardiac glycoside medicines used in
heart failure (e.g. digoxin)
• steroids (e.g. cortisone and
hydrocortisone)
• diuretics such as spironolactone,
triamterene or acetazolamide.
• medicines used to treat Parkinson’s
disease (e.g. Amantadine, levodopa)
• hormones or drugs acting on hormones
(e.g. trilostane, toremifene, oestrogens)
• medicines used to suppress the immune
system following organ transplant
(e.g. ciclosporin and tacrolimus)
• lithium - used for depression
• barbiturates used in sedation and
anaesthesia
• ‘non-depolarising’ muscle relaxants
such as tubocurarine used in surgery.
Tell your doctor if you are going into
hospital for an operation
• nitrates, to treat angina
• carbenoxolone, used to treat stomach
ulcers
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including medicines
obtained without a prescription.
Taking Co-Amilozide Tablets with food
and drink
If you feel dizzy while taking this medicine
then alcohol may make the effects worse.
Pregnancy
You must tell your doctor if you are
pregnant or if you think that you are.
Usually, your doctor will advise you to take
another medicine instead of co-amilozide,
as co-amilozide is not recommended
during pregnancy. This is because
co-amilozide crosses the placenta and
its use after the third month of pregnancy
may cause potentially harmful foetal and
neonatal effects.
Breastfeeding
Tell your doctor if you are breast-feeding or
about to start breast-feeding. Co-amilozide
is not recommended for mothers who are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
Driving and using machinery
This medicine can make you feel dizzy,
reduce alertness or impair your vision.
Do not drive or operate machinery if
affected.
Important information about some of
the ingredients in Co-Amilozide Tablets
This medicine contains lactose, if you have
been told by your doctor that you have an
intolerance to some sugars contact your
doctor before taking this medicine.

Artwork No.

Read all of this leaflet carefully before
you start to take this medicine.
- Keep this leaflet. You may need to read
it again.
- If you have any further questions,
please ask your doctor 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 get 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

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-Amilozide 2.5mg/25mg & 5mg/50mg Tablets
Amiloride Hydrochloride and Hydrochlorothiazide

3. How to take Co-Amilozide Tablets

128 X 390mm

Use uploaded cutter

Measure bar should be 150mm at 100% scale

Profile

9pt (main body) / 6.5pt (variables)

Wockhardt UK Limited

Size

UK

Customer

Min. Point Size

English

Co-amilozide tablet leaflet common

Market

Description

Language

matt.pirie-scott

104104-8

Proof By

2

Process Black

Colours Used

Keylines

104104/8

Item Code

Proof No.

28/10/2015

This is a service provided by the
Royal National Institute of Blind People.
This leaflet was last revised in 10/2015

N/A

Product Name
Reference Number
PL 29831/0041
Co-Amilozide
2.5mg/25mg Tablets
Co-Amilozide
5mg/50mg Tablets PL 29831/0042

Pharma
Code

6. Further information
What Co-Amilozide Tablets contains
The active ingredients are: amiloride
hydrochloride (2.5mg or 5mg) and
hydrochlorothiazide (25mg or 50mg).
The other ingredients are: lactose,
calcium phosphate dibasic, maize starch,
pregelatinised maize starch, magnesium
stearate, purified water.
What Co-Amilozide Tablets looks like
and the contents of the pack:
Co-Amilozide tablets are cream coloured
tablets contained in opaque blister packs
or in polyethylene plastic containers.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following
information:

artwork.leicester@multipkg.com

Date

5. How to store Co-Amilozide Tablets
Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the
original container and do not transfer to
another container.
• Do not take after the expiry date on the
label; the expiry date refers to the last
day of the month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help protect the environment.

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

605346

Like all medicines, Co-Amilozide Tablets
can cause side effects, although not
everybody gets them. As can happen with
any medicine, a few people may develop
an allergic reaction.
If you experience any of the following,
stop taking Co-Amilozide tablets and
see a doctor straight away:
 erious adverse reaction – signs
• S
may include inflamed blood vessels,
difficulties breathing or swallowing,
collapse, redness, blisters, peeling skin,
muscle pains, chills, a general feeling
of being unwell, ulcers in your mouth,
eyes or genitals.
Other side effects that have been
reported:
 ltered balance of fluid or
• A
chemicals in the body (e.g. sodium,
potassium, chlorine and magnesium)
that may cause feeling of or being
sick, weakness, tiredness, irritability,
restlessness, confusion and muscle
cramps.
• Blood: altered numbers and types of
blood cells causing increased bruising,
nosebleeds, sore throats, infections,
excessive tiredness, breathlessness on
exertion or abnormal paleness of the
skin (you may need a blood test).
• Metabolism: dehydration, changes
in appetite, gout, changes in levels
of body chemicals (increased blood
potassium, glucose or uric acid or
decreased blood sodium), glucose in
the urine.
• N
 ervous system: difficulty sleeping,
sleepiness, confusion, reduced
response to stimulation (stupor),
unconsciousness, nervousness,
depression, headaches, dizziness
(vertigo), pins and needles,
tremors, restlessness, brain disease
(characterised by loss of cognitive
function, ability to concentrate and
subtle personality changes).
• Senses: changes in vision such as
blurred and yellow vision, bad taste,
ringing in the ears (tinnitus) and an
increase in pressure in the eye.
• H
 eart: chest pain (angina), irregular
(arrhythmia), fast (tachycardia) or
pounding (palpitation) heart beats,
dizziness on standing due to low blood
pressure, inflammation of blood vessels
(necrotising angiitis),
• Skin: rash, irregular raised bumps
with severe itching (hives) excessing
sweating, hair loss, flushing, sensitivity
of the skin to sunlight or artificial
light (e.g. sunbeds), bruising and
discolouring to the skin (purpura).
• Breathing: difficulty breathing,
hiccups, nasal congestion, cough,
fluid in the lungs and lung inflammation
(pneumonitis).

Artwork No.

4. Possible side effects

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Always take Co-Amilozide Tablets as
your doctor has told you. Your doctor will
decide the right dose for you. This will be
on the pharmacist’s label. This medicine
should be swallowed whole. The usual
starting dose is:
Treatment of high blood pressure:
• one tablet taken once a day. Your doctor
may decide to increase your dose up to
two tablets a day.
Treatment of heart failure:
• one tablet taken once a day. Your doctor
may decide tom increase your dose up
to four tablets a day.
Treatment of water retention in liver
disease:
• two tablets taken once a day. Your doctor
may decide to increase your dose up to
four tablets a day.
Your doctor may want to monitor your salt
levels with regular blood tests, especially
if you are elderly or unwell, to check for
any possible imbalances.
Children
• This medicine is not recommended for
use in children under the age of 18.
If you take more Co-Amilozide Tablets
than you should
If you (or anybody else, including a child),
takes more Co-Amilozide Tablets than
you should then you should contact your
nearest hospital casualty department
or doctor immediately. Always take the
container and this leaflet with you.
If you forget to take Co-Amilozide Tablets
If you forget a dose, take another as
soon as you remember. If it is almost time
for your next dose, then do not take the
missed dose at all. NEVER take a double
dose to make up for the one missed.

• Stomach and intestines:
Feeling of sickness or being
sick, diarrhoea, constipation,
abdominal pain and feeling
of fullness, passing wind,
activation of stomach ulcers,
stomach cramps, bleeding in
the stomach, inflammation of
the salivary glands, and dry
mouth
• Liver and pancreas: inflammation of
the pancreas (pancreatitis), changes in
liver function and jaundice (yellow skin
or eyes).
• Muscles and joints: muscle cramps,
leg ache, back pain, joint pain, neck
and shoulder ache.
• Urinary and genital: getting up
in the night to pass water, pain on
passing water, frequent or copious
water production, inability to control
bladder movements, bladder pain,
impaired kidney function, kidney failure
or inflammation, inability to gain or
maintain an erection and a decreased
interest in sex.
• Other: chest pain, fatigue, feeling
unwell, weakness, thirst and fever.
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.

Expand Transcript

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.

Hide