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CO-AMILOZIDE TABLETS BP 5/50 MG

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

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Patient Information Leaflet
CO-AMILOZIDE TABLETS BP 5/50mg
Read all of this leaflet carefully before you start taking Co-amilozide this medicine because it contains
important information for you.
 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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Co-amilozide is and what it is used for
2. What you need to know before you take Co-amilozide
3. How to take Co-amilozide
4. Possible side effects
5. How to store Co-amilozide
6. Contents of the pack and other information
1. WHAT CO-AMILOZIDE IS AND WHAT IT IS USED
FOR
This medicine contains the active ingredients amiloride hydrochloride and hydrochlorothiazide. Both
active ingredients belong to a group of medicines known as diuretics (sometimes described as “water
tablets”). Diuretics work by helping the body to dispose of excess water by urination.
This medicine is prescribed in certain conditions affecting the heart, liver and other organs (e.g.
congestive heart failure, hepatic cirrhosis with ascites) where there is a build-up of excess water in the
body. This medicine is also prescribed for the treatment of high blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-AMILOZIDE
Do not take Co-amilozide if:
 you have previously suffered an allergic reaction to thiazide, a medicine containing amiloride
hydrochloride, hydrochlorothiazide or sulphonamide
 you are allergic to acetazolamide which is a diuretic used to remove fluid from the body and
to treat high pressure in the eye (glaucoma), heart problems and sometimes fits or epilepsy
 you are pregnant, planning to become pregnant or breast feeding
 you have liver or kidney trouble
 you suffer from Addison’s disease or diabetes
 you have been told that you have high levels of urea, creatinine, calcium or potassium in your
blood
 you are taking another potassium-sparing diuretic (e.g. spironolactone, triamterene)you taking
potassium supplements, or medicine containing potassium or you eat potassium-rich foods

Warnings and precautions
Talk to your doctor or pharmacist before taking Co-amilozide if:
 you have been told by your doctor you have high levels of uric acid, cholesterol or
triglycerides (a type of cholesterol) in your blood
 you are taking digitalis such as digoxin – used for heart failure and abnormal heart beat
 you are being given fluids by a tube inserted into one of your veins
 you have recently suffered from severe vomiting or diarrhoea
 you have Systemic Lupus Erythematosus
 you are elderly
 you have gout
If you are not sure talk to your doctor or pharmacist before taking Co-amilozide
Children
This medicine is not suitable for children under l8 years of age.
Other medicines and Co-amilozide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines including medicines obtained without a prescription. This includes herbal medicines. This
is because Co-amilozide can affect the way some other medicines work. Also some other medicines
can affect the way Co-amilozide works.:















Potassium supplements
Non-steroidal anti-inflammatory drugs (NSAIDS e.g. aspirin, ibuprofen).
Medicines used to treat high blood pressure or a heart condition (e.g. captopril, enalapril).
Lithium, a treatment for depression.
Barbiturates or narcotics (painkillers such as codeine, dihydrocodeine, dextropropoxyphene,
diamorphine, morphine, pentazocine and pethidine).
Trilostane, a medicine used to treat Cushing’s syndrome (an adrenal disorder) and breast
cancer.
Ciclosporin and tacrolimus (immunosuppressant drugs used to prevent organ rejection after
transplant surgery).
Medicines for diabetes such as insulin or chlorpropamide.
Colestyramine and colestipol, which are used to reduce the level of fats in the blood.
Corticosteroids which are used to treat a number of conditions, including asthma, skin
disorders and rheumatic diseases (e.g. prednisolone).
ACTH, which is used to test whether your adrenal glands are working properly.
A pressor amine such as adrenaline, which is used to treat serious allergic reactions.
Muscle relaxants (e.g. tubocurarine).
Angiotensin II antagonists, such as Losartan or Olmesartan

Tests while you are taking Co-amilozide
When you are on this medication it may affect some tests on blood or urine samples. Please remind
your doctor you are taking Co-amilozide if he or she wants you to have any tests.

If you have diabetes or your doctor suspects you have diabetes, you may need to have some tests
before receiving treatment with Co-amilozide.
Co-amilozide with food, drink and alcohol
Your doctor may have asked you to change your diet slightly and not to eat certain foods which
contain a lot of potassium. These foods include milk, bananas, raisins and prunes. Your doctor will
tell you what food you should not eat. If you are unsure about what food you should avoid, ask your
doctor before taking Co-amilozide tablets.
Your doctor may have told you that you should keep alcohol intake to a minimum while you are
taking Co-amilozide. Alcohol may increase the effects of Co-amilozide so that you feel dizzy or lightheaded when you stand up quickly.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a
baby. Usually, your doctor will advise you to take another medicine instead of Co-amilozide, as Coamilozide 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.
Driving and using machines
This medicine may make you feel tired or dizzy. Do not drive or operate machinery until you have
discussed this with your doctor or you know if you are affected.
Co-amilozide contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. HOW TO TAKE CO-AMILOZIDE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Swallow the tablets with a drink of water.
The amount you take each day will depend on your illness. The number of tablets to be taken will be
on the label of your medicine.
The recommended doses are:
High blood pressure
• The usual starting dose is half a tablet each day.
• Your doctor may change your dose to one tablet given each day.
• Your doctor may spread out the dose or give it as a single dose.
Heart failure

• The usual starting dose is half a tablet each day.
• Your doctor may change your dose.
• You should not take more than two tablets in a day.
Fluid retention due to cirrhosis
• The usual starting dose is one tablet each day.
• Your doctor may change your dose.
• You should not take more than two tablets in a day.
If you take more Co-amilozide than you should
If you take too much Co-amilozide by mistake, contact your doctor or seek medical help immediately.
If you forget to take Co-amilozide
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-amilozide
Do not stop taking Co-amilozide without speaking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-amilozide can cause side effects, although not everybody gets them. The
following side effects may happen with this medicine:
Stop taking Co-amilozide and see a doctor straight away, if you notice any of the following
serious side effects that may rarely occur. You may need urgent medical treatment:
• allergic reactions - the signs 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 include:
Allergic reactions
• purplish or reddish-brown spots, skin irritation, increased sensitivity to sunlight and a nettle like rash
(urticaria).
Heart and circulation
• irregular heartbeat of your heart that can lead to fainting and dizziness, palpitations
• feeling light headed when you stand quickly
• fast heartbeat, chest pains (angina).
Blood
• anaemia - signs include unusual tiredness or loss of colour in the lining of the eyes and skin around
the eyes
• other blood disorders which can result in high temperature (fever), a sore throat, being unable to stop
bleeding from a cut
• changes in the levels of various chemicals in the blood which are usually detected by blood or urine
tests.

Stomach and gut
• feeling sick (nausea) or being sick (vomiting), indigestion, diarrhoea, constipation, stomach ache
and stomach cramps, wind, bloated feeling, hiccups
• bleeding from your gut - signs may include blood in your faeces or a darker colour of faeces
• liver problems such as jaundice - signs may include yellowing of the skin and/or whites of the eyes
• an inflamed pancreas - signs may include feeling sick (nausea) and being sick (vomiting) with pain
in the stomach area and back
• swelling of the glands that make saliva
• your mouth may become dry
• a bad taste in your mouth
• lack or loss of appetite
• feeling thirsty.
Chest
• difficulty breathing
• blocked nose
• cough.
Nervous system
• feeling dizzy, feeling like you are spinning (vertigo), pins and needles
• feeling sleepy, or sometimes feeling that you cannot sleep
• stupor, a type of brain disorder called encephalopathy
• feeling nervous, confused, depressed or restless
• feeling shaky (tremors)
• headache, blackouts.
Skin and hair
• flushing, sweating
• rash, itching
• hair loss.
Eyes or ears
• an increase in the pressure in the eye which is usually picked up in eye examinations
• changes in vision
• ringing in the ears.
Joints and muscles
• joint pain, pain in the fingers and toes, gout
• neck, shoulder and back pain
• leg ache, muscle cramps.
Urinary
• difficulty or pain urinating, an increase in the amount of urine passed
• contractions of the bladder which can lead to an increase in how often you need to pass urine
• kidney disorders which may lead to a reduced amount of urine being passed
• passing urine at night, incontinence.
Sexual
• lower sex drive
• impotence.

General/Other
• a general feeling of being unwell, feeling tired, weakness, dehydration.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date shown on the pack your medicine came in. Do not store
above 25°C.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Co-amilozide tablets contain: Each tablet contains amiloride hydrochloride equivalent to 5mg
anhydrous amiloride hydrochloride and 50mg of hydrochlorothiazide.
The tablets also contain lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch,
talc, sodium starch glycollate, magnesium stearate and colour, certolake sunset yellow (Ell0).
Co-amilozide tablets 5/50mg are pale peach, circular tablets with the company logo on one face and
the code 237 and a break line on the reverse.
Pack sizes: 28, l00, 250, 500 and l000 tablets.
Marketing Authorisation Holder: Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, WA8
ORP.
Marketing authorisation number: PL 20395/0104
POM
Date leaflet last revised: February 2017

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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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