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CO-AMILOZIDE TABLETS 5/50MG BP

Active substance(s): AMILORIDE HYDROCHLORIDE / HYDROCHLOROTHIAZIDE

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Co-amilozide 5/50mg tablets

(amiloride hydrochloride and 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 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.

Index
1 What Co-amilozide tablets are
and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Co-amilozide tablets are and what they are
used for

Co-amilozide tablets belong to a group of medicines called diuretics
(water tablets). They may be used for:
• high blood pressure
• congestive heart failure
• liver cirrhosis with fluid retention (oedema) and swelling of the
abdomen (ascites).

2 Before you take

Do not take Co-amilozide tablets and tell your doctor if
you are:

• allergic (hypersensitive) to amiloride hydrochloride,
hydrochlorothiazide, other sulphonamide related drugs, or to any
of the other ingredients in Co-amilozide tablets (see section 6).
• under 18 years of age.

or if you have:

• high blood levels of potassium (hyperkalaemia) or other
chemicals such as calcium (hypercalcaemia), urea or creatinine
• difficulty passing water
· severe kidney disease
· severe liver failure
• Addison’s disease
• diabetic neuropathy (diabetic nerve damage causing pain,
weakness or numbness).

Check with your doctor or pharmacist before taking
Co-amilozide tablets if you have:

• liver cirrhosis with swelling of the abdomen (ascites) 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.
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water retention causing swelling (resistant oedema)
severe liver disease
impaired kidney function
had surgery affecting nerves
become pregnant or are breast-feeding
or have had systemic lupus erythematosus (SLE).

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. Especially:
• diuretics such as spironolactone or triamterene
• blood pressure-lowering drugs (antihypertensives) such as
adrenergic blockers and angiotensin II receptor antagonists
• lithium (for some mental illnesses)
• antidiabetic drugs such as insulin or chlorpropramide
• noradrenaline (norepinephrine)
• barbiturates (for sleeping difficulties)
• narcotics e.g. dihydrocodeine
• ACE inhibitors e.g. captopril or enalapril
• corticosteroids e.g. hydrocortisone
• corticotrophin (ACTH)
• tubocurarine (a muscle relaxant)
• non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or
naproxen
• antacids (indigestion remedies)
• nephrotoxic drugs e.g. NSAIDs (non-steroidal anti-inflammatory
drugs) or cisplatin (used in some types of cancer)
• colestyramine (used to reduce cholesterol)
• tetracycline (used to treat bacterial infections)
• ciclosporin and tacrolimus (used to suppress the immune system)
• digoxin (to treat some heart conditions).

Pregnancy and breast-feeding

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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Co-amilozide is not recommended for mothers who are
breast-feeding.

Sugar intolerance

If you have been told you have an intolerance to some sugars,
contact your doctor before taking this medicines, as it contains a
type of sugar called lactose.

Diabetic tests

If you are to be tested for diabetes or need to have other tests
related to diabetes, tell your doctor that you are taking Co-amilozide
tablets. The tablets may need to be stopped at least three days
before the test, as they can interfere with the results.

Continued over page

3 How to take

Always take Co-amilozide tablets exactly as your doctor has told you. If
you are not sure, check with your doctor or pharmacist.
You should not drink alcohol, take potassium supplements or eat foods
with a high potassium content (such as bananas) whilst taking this
medicine.
Swallow the tablets.
Doses:
High blood pressure:
Usually half a tablet a day, which may be increased to one tablet a day,
given as a single or divided dose.
Congestive heart failure:
Initially half a tablet a day, which may be adjusted up to a maximum of
2 tablets a day. Your doctor may change your dose depending on your
response.
Liver cirrhosis with swelling of the abdomen (ascites):
Initially 1 tablet a day as a single dose, which may be adjusted up to
a maximum of 2 tablets a day. Your doctor may change your dose
depending on your response.
Elderly:
The dosage will depend on your kidney function, blood chemical levels
and response to treatment. If you are elderly, it is important to take this
medicine exactly as prescribed.
Children:
Not recommended for children under 18 years old.

If you take more than you should

If you (or someone else) swallow 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. Symptoms of
an overdose include dehydration and changes in the levels of certain
chemicals in the blood.

If you forget to take the tablets

If you forget to take a dose take it as soon as you remember it and then
take the next dose at the right time. Do not take a double dose, to make
up for a forgotten dose.

4 Possible side effects

Like all medicines, Co-amilozide tablets can cause side effects, although
not everybody gets them.
Tell your doctor or pharmacist if you notice any of the following side
effects, they get worse or if you notice anything not listed.
• Altered balance of fluid or chemicals in the body (e.g. sodium,
potassium, chlorine and magnesium) causing a dry mouth, weakness,
tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps,
low blood pressure, difficulty passing water, fast heart rate and feeling
and being sick.
• 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, gout, changes in levels of body chemicals
(increased blood potassium, glucose or uric acid or decreased blood
sodium), glucose in the urine.
• Nervous system: depression, difficulty sleeping or sleepiness,
confusion, nervousness and restlessness, dizziness, pins and needles
or tingling, near unconsciousness including reduced mental
activity and response to stimulation (stupor), feeling of dizziness or
spinning (vertigo), tremors and brain disease (characterised by poor
concentration, confusion and delirium).
• Heart: chest pain (angina), irregular (arrhythmia), fast (tachycardia) or
pounding (palpitation) heart beats, dizziness on standing due to low
blood pressure and inflammation of blood vessels (necrotising angiitis).

• Breathing: cough, difficulty breathing, fluid in the lungs and lung
inflammation (pneumonitis).
• Stomach and intestines: feeling of stomach fullness, cramps, stomach
irritation or pain, activation of stomach ulcers, bleeding in the stomach
or intestines, indigestion, wind, loss or other appetite changes,
constipation or diarrhoea, hiccups, feeling or being sick.
• Liver and pancreas: inflammation of the pancreas (pancreatitis) and
changes in liver function, jaundice (yellow skin or eyes).
• Skin: blood spots, bruising and discolouring to the skin (purpura), loss
of hair, itching, skin rash, pale or red irregular raised patches with severe
itching (hives), flushing, sensitivity of the skin to sunlight or artificial light
(e.g. sunbeds), sweating and swelling of the salivary glands.
• Muscles and joints: joint pain, aching legs and muscle cramps.
• Urinary and genital: pain on passing water, getting up in the night
to pass water, frequent or copious water production, inability to
control bladder movements, bladder pain, impaired kidney function,
kidney failure or inflammation, decreased desire for sex and inability
to maintain an erection. You should consult your doctor if these are
troublesome or continue.
• Senses: bad taste, stuffy nose, ringing in the ears, increased pressure in
the eyes, visual disturbances and yellow vision.
• Other: dry mouth, thirst, allergic (anaphylactic) reactions (rash, swelling,
difficulty breathing), back chest neck and shoulder pain, pain in the
hands and feet, tiredness, a feeling of general discomfort and illness,
weakness, fever, headache and fainting.
Tell your doctor or pharmacist if you notice any of the above side
effects, they get worse or if you notice anything not listed.

5 How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place. Protect from light
Do not use Co-amilozide after the expiry date stated on the label/carton/
bottle. The expiry date refers to the last day of that 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 to protect the environment.

6 Further information

What Co-amilozide tablets contain

• Each tablet contains the active substances (the
ingredients that makes the tablets work) amiloride
hydrochloride (equivalent to 5mg anhydrous amiloride
hydrochloride) and 50mg hydrochlorothiazide.
• The other ingredients are dispersed quinoline yellow
lake (E104), lactose, magnesium stearate, maize starch,
microcrystalline cellulose (102) (E460).

What Co-amilozide tablets look like and contents
of the pack
Co-amilozide tablets are yellow, circular, biconvex, uncoated
tablets.
Pack size is 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in September 2011

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Actavis, Barnstaple, EX32 8NS, UK

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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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