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CO-AMILOZIDE 2.5/25 TABLETS

Active substance(s): AMILORIDE HYDROCHLORIDE DIHYDRATE / HYDROCHLOROTHIAZIDE

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Co-Amilozide 2.5mg/25mg & 5mg/50mg Tablets
Amiloride Hydrochloride and Hydrochlorothiazide
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
1. What Co-Amilozide Tablets are and what they are
used for
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).
2. Before you take Co-Amilozide Tablets
You should not take Co-Amilozide Tablets if you:
• are allergic (hypersensitive) to amiloride
hydrochloride,hydrochlorothiazide or to any of the other
ingredients inCo-Amilozide Tablets (see section 6)
• have high blood potassium or calcium levels
• have Addison’s disease (an adrenal glands disease)
• have acute kidney failure or are unable to pass water
• have diabetes related kidney disease
• have severe, progressive kidney disease
• have liver failure
• are taking potassium supplements, potassium sparing
diuretics or large amounts of potassium rich foods
• are taking lithium (used to treat manic depression)
• are under 18 years.
Talk to your doctor before taking Co-Amilozide Tablets if
you:
• have diabetes mellitus
• suffer from gout (a condition where too much uric acid in
the body causes joint pains)
• have liver disease
• have severe asthma
• suffer from porphyria (a disease of blood proteins that
effects the skin, gut and nervous system)
• suffer from systemic lupus erythematosus (a disease were
the immune system attacks the tissues of the body)
• are seriously ill or have heart disease or lung disease.
• are due to take a glucose tolerance test (this medicine
should be discontinued for at least three days before).
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. The following medicines can
affect or be affected by treatment with Co-Amilozide Tablets:
• medicines to treat high blood pressure (e.g. prazosin)
• amphotericin and fluconazole, used to treat fungal infections
• carbamazepine, used to treat epilepsy
• quinidine, used to treat abnormal heart rhythms
• anion-exchange resins used to reduce cholesterol

(e.g.colestyramine and colestipol) – these should be
given atleast two hours apart
• medicines to treat depression (e.g. reboxetine, tricyclic
antidepressants and MAOIs)
• medicines used to suppress the immune system following
organ transplant (e.g. ciclosporin and tacrolimus)
• medicines used to treat inflammation (e.g. indometacin)
• carbenoxolone, used to treat stomach ulcers
• medicines called muscle relaxants, such as tizanidine,
used to treat muscle pain, spasms and twitching
• medicines used to treat Parkinson’s disease (e.g.
amantadine)
• acetazolamide, used to treat water retention
• medicines to treat mental illness (e.g. primozide and
sertindole)
• medicines to treat diabetes (e.g. chlorpropamide)
• medicines to maintain blood pressure in severely ill
patients (e.g. adrenaline)
• aprostadil, used to treat impotence
• cisplatin, used to treat some cancers
• allopurinol, used to prevent gout
• terfenadine, an anti-histamine used to treat allergies
• steroids (e.g. cortisone and hydrocortisone)
• hormones or drugs acting on hormones (e.g. trilostane,
toremifene, oestrogens and progestrogens)
• cardiac glycosides medicines used in heart failure
• barbiturates medicines used in sedation and anaesthesia.
Tell your doctor if you are going into hospital for an operation
• potassium, calcium and vitamin supplements.
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.
3. How to take Co-Amilozide Tablets
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 to
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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amilozide 2.5mg/25mg & 5mg/50mg Tablets - 28 Tab
Wockhardt UK
FP2030; FP2031
3rd Party Supplier
(w)170 x (h)240mm
DUMMY
7.5 pt.
Co-amilozide_Leaflet_104104-7.ai
Adobe Illustrator CS5
Arial Regular / Bold
10th February, 2015
R 1st PDF sent on - 19TH FEB. 2015

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • Regulatory text amends

Non-Regulatory



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.
4. Possible side effects
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, seek medical help
immediately:
• inflammation of the pancreas (pancreatitis) which causes
severe pain in the abdomen and back (may be associated
with nausea, vomiting or fever). If you notice these
symptoms talk to your doctor as soon as possible
• yellowing of the skin or whites of the eyes caused by liver
or blood problems (jaundice). If you notice these
symptoms talk to your doctor as soon as possible
• rash, itching, difficulty breathing.
Side effects that have been reported:
• headache
• weakness
• fatigue
• fainting
• fast heartbeat
• dizziness
• vertigo
• chest pain
• rash
• itching
• hives/”nettle rash”
• fever
• difficulty breathing
• loss of appetite
• dehydration
• vomiting
• feeling sick
• constipation
• diarrhoea
• thirst
• stomach pains
• cramps
• dry mouth
• indigestion
• pancreatitis
• nervousness
• bruising
• depression
• confusion
• visual disturbances
• sleepiness
• impotence
• restlessness
• decreased sex drive
• blurred vision
• reduced or altered consciousness
• sensitivity of skin to light
• need to pass water during night
• general feeling of being unwell
• skin tingling and ”pins and needles”
• changes in the way the liver is working, shown by blood tests
• jaundice (yellowing of skin and whites of the eyes)
• a fall in your blood pressure which causes dizziness,
light-headedness or fainting on standing up
• changes in the levels of salts in your blood. Symptoms
include nausea, weakness, feeling confused, loss of






appetite, muscle cramps, muscle twitching and an
abnormal heart beat
anaemia – a condition in which there is a decreased
number of red blood cells (symptoms include
tiredness, headaches, being short of breath when
exercising, dizziness, and looking pale
reduction in the number of white blood cells
(symptoms include frequent infections, fever, severe
chills, sore throat or mouth ulcers)
low blood platelet count (symptoms include bleeding or
bruising more easily than normal. You may also notice
purple or red-brown spots through the skin
yellow vision, a condition where everything you see
appears to have a yellowish tinge
high blood sugar (hyperglycaemia). Symptoms include
feeling thirsty, needing to pass water frequently, feeling tired
and getting infections such as thrush more often than usual
gout, a condition that causes pain, inflammation and
swelling of your joints

FPO

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.

If you experience any side effects or feel that the medicine is
affecting you badly tell your doctor or pharmacist immediately.
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 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.
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 startch, 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:
Product name

Reference number

Co-Amilozide
2.5mg/25mg Tablets

PL 29831/0041

Co-Amilozide
5mg/50mg Tablets

PL 29831/0042

This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in 02/2015.
104104/7

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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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