CO-AMILOZIDE TABLETS BP 5/50 MG

Active substance: 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 have a lung disease or heart trouble
• you have difficulty in passing urine
• you suffer from Addison’s disease, gout or diabetes
• you have a condition known as systemic lupus erythematosus
• 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

Children
This medicine is not suitable for children under 18 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:
• 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
• Amiloride hydrochloride
• Hydrochlorothiazide
You should tell any doctor performing a blood test that you are taking or have been taking coamilozide tablets, because they may affect the results.
In addition, if you are going to have an operation, make sure the doctor treating you knows
you are taking Co-amilozide.
Co-amilozide with food and drink

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.
Drinking alcohol while taking this medicine may cause dizziness or light-headedness. Your
doctor will have advised you to keep your alcohol intake to a minimum. Your doctor may need
to carry out simple blood tests while you are taking co-amilozide tablets, to monitor the levels
of salts and a chemical called urea in your body.
Pregnancy, breast-feeding and fertility
The use of diuretics in healthy pregnant women with or without mild oedema is not indicated.
Thiazides cross the placental barrier and appear in cord blood, use where pregnancy is present
or suspected requires that the benefits of the drug be weighed against possible hazards to the
foetus. Although it is not known whether amiloride hydrochloride is excreted in human milk, it
is known that thiazides do appear in breast milk. If amiloride hydrochloride is used during
breast-feeding, doses should be kept as low as possible.
Driving and using machines
If you feel dizzy or tired after taking this medicine you should not drive or operate machinery.

Co-amilozide contains Lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicine.
Your doctor will have advised you to avoid eating potassium rich foods such as bananas, milk
and prunes while taking this medicine. Co-amilozide tablets may also cause an increase in the
amount of cholesterol and triglycerides (fats) in the blood.
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.
The recommended dose is:
Adults
High Blood Pressure: The usual does is half a tablet given once a day. If required, your doctor
may increase the does to a maximum of 1 tablet per day.
Congestive heart failure: The usual starting dose is half a tablet per day. If required, your
doctor may increase the dose to a maximum of 2 tablets per day.
Fluid retention associated with liver disease: The usual starting dose is 1 tablet given once a
day. If required, your doctor may increase the dose to maximum of 2 tablets per day.
All patients, especially elderly patients, should be under regular supervision by their doctor
while taking this medicine.
Children
This medicine is not suitable for children under 18 years of age.
Method of administration
Swallow the tablets with a drink of water.
If you take more Co-amilozide than you should
If you take more Co-amilozide than you should, contact your nearest hospital casualty
department or doctor immediately. You should take this leaflet and any remaining tablets with
you to show the doctor.
If you forget to take Co-amilozide
Keep taking your medicine until the course is finished. If you forget to take a dose, Skip the
missed dose. Take the next dose as normal. Do not take a double dose to make up for the missed
dose.
If you stop taking Co-amilozide
Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking
it just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following tell your doctor IMMEDIATELY.

• Anaphylactic reaction which includes symptoms such as skin rashes, itching for the first time,
wheezing or swelling of the face.
• Bleeding or bruising easily.
• Muscle pains or cramps.
• Yellowing of your skin or the whites of your eyes (Jaundice).
The following side affects are more often mild and may wear off after a few days treatment. If
they are severe or last for more than a few days, tell your doctor.
* Headache, dizziness (including dizziness on standing up)
* Dehydration
* Unresponsive
* Light-headedness due to drop in blood pressure
* Weakness or tiredness, looking pale
* Chest pain or back pain
* Reddish spots on the skin
* Over-sensitivity to light
* Upset stomach such as nausea, indigestion, constipation, bloated feeling, diarrhoea, vomiting,
stomach pain
* Pancreatitis
* Flatulence
* Passing black coloured motions
* Hiccups
* Thirst and a dry mouth
*Sore mouth
* Bad taste
* Difficulty in breathing, cough
* Flushing, sweating
* Leg ache, joint pain
* Cold painful or tingling hands and
feet
* Difficulty sleeping
* Nervousness
* Depression
* Feeling drowsy
* Confusion
* Vertigo (spinning sensation)
* Lack or loss of appetite
* Nasal stuffiness
* Difficulty passing urine
* Excessive urination at night
* Incontinence
* Impotence
* Blurred vision/ yellow vision
* Fatty deposits in the eye
* Irregular/ increased heart beat
* Slow pulse rate
* Restlessness
* Fever
* Urge to urinate
* gastric irritation and bleeding
* Renal Failure
* Increased sensitivity to light
* Inflamed blood vessels
Other side effects that have been reported occasionally are feeling faint, shaking, abnormally
low levels of sodium, chloride, magnesium or potassium or high levels of calcium or uric acid
in the blood, glucose in the urine, kidney problems, which may lead to a reduction in the
amount of urine, passed as well as impaired liver function. Decreased sex drive, severe rash
with blisters and peeling of the skin. There have been isolated cases of hair loss, heart block,
which may cause dizziness, fainting or unusual tiredness, and tinnitus (ringing in the ears)
This medicine may occasionally alter the composition of your blood (causing anaemia,
neutropenia etc.) and your doctor may want to do some blood tests from time to time.
Remember to tell any doctor who does a blood test on you that you are taking this medicine.
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 25oC.
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
(E110).
What Co-amilozide tablets look like and contents of the pack
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, 100, 250, 500 and 1000 tablets.
Marketing Authorisation Holder
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, WA8 0RP.

Marketing authorisation number: PL 20395/0104
POM
Date leaflet last revised: May 2014

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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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