CO-AMILOZIDE 5/50 TABLETS

Active substance: HYDROCHLOROTHIAZIDE

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By jarmand at 11:35 am, 6/13/06
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Please read all of this leaflet carefully before you start taking this medicine.
Keep the 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 personally and you should not pass it on to others.
It may harm others even if their symptoms are the same as yours.

This medicine may cause some patients to feel weak, tired, dizzy or drowsy. DO NOT drive or operate machinery if it has this
effect on you.
HOW TO TAKE YOUR MEDICINE
Make sure you take the tablets exactly as directed by your doctor. The tablets should be swallowed with a drink of water.

The name of this medicine is

For the treatment of high blood pressure: Initially take half a tablet daily. Your doctor may increase your dose up to one tablet
daily, if necessary.

CO-AMILOZIDE 5/50 TABLETS
WHAT IS THIS MEDICINE?
The tablets contain 5 mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide (together known as Co-amilozide).
These are the two active ingredients in this medicine. The tablets also contain lactose monohydrate, microcrystalline cellulose,
maize starch, magnesium stearate, purified talc, sodium starch glycollate and sunset yellow (E110).

For the treatment of heart failure: Initially take half a tablet daily. Your doctor may increase your dose up to two tablets daily,
if necessary. The dose may then be reduced by your doctor once initial improvement has occurred.
For the treatment of hepatic cirrhosis: Initially take one tablet daily. Your doctor may increase your dose up to two tablets daily,
if necessary. The dose may then be reduced by your doctor once your weight has been stabilised.

Product Licence holder and Manufacturer: Co-pharma Ltd., Unit 4, Metro Centre, Tolpits Lane, Watford, Herts WD1 8SS.
Co-amilozide belongs to a group of medicines called diuretics. The medicine works by increasing the amount of urine passed
by your kidneys to reduce blood pressure or remove excess water from the body.
The tablets are pale, peach coloured with a breakline and the tablet markings “CO-AM” on one side and the Co-pharma pestle
and mortar logo on the other side.
The tablets are supplied to your pharmacist in packs containing 28, 50, 100 or 500 tablets, who will then provide you with the
required number of tablets as prescribed by your doctor (not all pack sizes may be marketed).
WHAT IS THE MEDICINE FOR?
Co-amilozide is used for treatment of high blood pressure and to treat heart failure due to fluid retention. It is also used to treat
a liver disease called hepatic cirrhosis which causes a build up of fluid in the body.
WHAT DO YOU NEED TO KNOW BEFORE TAKING THIS MEDICINE?
If the answer to any of the following questions is YES, DO NOT take this medicine without checking with your doctor:
- Have you taken Co-amilozide tablets before (or any medicines containing amiloride or hydrochlorothiazide) and had an
allergic reaction (rash, itching, shortness of breath)?
- Are you allergic to any of the other tablet ingredients? The tablet colouring contains sunset yellow (E110) which can
sometimes cause allergic- type reactions including asthma, this is more common in those people who are allergic to aspirin.
- Are you allergic to medicines called sulphonamides (for the treatment of infections)?
- Do you suffer from kidney or liver disease or failure, or suffer from the condition anuria (unable to urinate or very little
urine output)?
- Do you suffer from diabetes or an underactive adrenal gland (Addison’s disease)?
- Have you been told you have a high level of potassium or calcium in your blood?
- Are you under 18 years of age?
- Are you taking other diuretic medicines (water tablets), lithium (a treatment for depression) or potassium supplements?
- Are you pregnant, planning to become pregnant or breastfeeding?
- Do you suffer from gout or systemic lupus erythematosus (SLE)?
- Do you have or have you ever had a stomach or intestinal ulcer?
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine, as it contains lactose.
ARE YOU TAKING OTHER MEDICINES?
- Other medicines used for the treatment of high blood pressure (e.g. an “ACE” inhibitor, thiazide diuretic, “Beta-blocker”
or “Alpha-blocker”)?
- Allopurinol (for the treatment of gout), colestyramine or colestipol (used to help lower cholesterol level), non-steroidal
anti-inflammatory drugs (for the treatment of arthritis and other painful conditions e.g. ibuprofen, aspirin), barbiturates
(for sleeping problems), opioid analgesics (for the treatment of severe pain e.g. morphine) or adrenaline?
- Any medicines for diabetes (e.g. insulin, chlorpropamide), for heart failure or palpitations/irregular heart beat (e.g. digoxin)
or medicines containing Vitamin D (also sometimes called calciferol or ergocalciferol for the treatment of soft bones)?
- Steroid therapy (for the treatment of allergic and inflammatory disorders e.g. prednisolone), the drug trilostane (for
the treatment of conditions where the adrenal gland is overactive) or the drug ciclosporin (used to prevent rejection
of an organ following transplant)?
If you are taking any of the above please tell your doctor or pharmacist.
Also tell your doctor or pharmacist if you are taking any other medicines, including ones you have bought yourself without a
prescription.

Exactly how many tablets, and how often you must take them, will be written on the dispensing label. Please read the label
carefully. You should finish all the tablets your doctor has prescribed. Even if you feel better, you should still take all the tablets
you have been given. It may be dangerous to stop taking the medicine without your doctor’s advice.
Co-amilozide tablets are not recommended for children under 18 years of age.
IF YOU HAVE TAKEN MORE THAN YOU SHOULD:
If you (or someone else) swallows a lot of tablets, contact your nearest hospital casualty department or doctor immediately.
IF YOU FORGET TO TAKE A DOSE:
If you have missed a dose, take it as soon as you remember, unless it is nearly time to take the next one. Never take two doses
together. Take the remaining tablets at the correct times.
POSSIBLE SIDE-EFFECTS:
Like all medicines, Co-amilozide can cause some side-effects, particularly when you first start to take it.
If you get any of the following:
• Skin troubles such as rashes or itching for the first time, soon after taking these tablets.
• Difficulty breathing, vomiting, fainting, headache, fits or drowsiness.
• Difficulties or pain in passing urine.
STOP taking the tablets and tell your doctor IMMEDIATELY.
The side effects which may occur are:
- Headache, weakness, tiredness, sleepiness, feeling unwell, chest or back pain, fainting, dizziness, vertigo, fever, pins and
needles, bad taste in the mouth, changes in vision, nasal congestion.
- Changes in normal heart rhythm (irregular or quickened), angina, drop in blood pressure on standing up (making you feel
dizzy or faint). In patients with partial heart block it is possible this medicine may aggravate the condition.
- Loss or change of appetite, feeling sick, vomiting, diarrhoea, constipation, abdominal pain or fullness, flatulence, indigestion,
hiccups, dry mouth, thirst, bleeding of the stomach/intestines (symptoms of black tarry stools or bleeding from the rectum),
activation of pre-existing peptic ulcers.
- Gout, persistent thirst, flushing, sweating, trembling, muscle cramps, neck, shoulder or joint pains, aching legs, pain in hands
or feet.
- Insomnia, nervousness, confusion, depression.
- Respiratory problems including breathlessness and lung disorders which may result in a dry cough and breathing difficulties.
- Incontinence, kidney and bladder problems, passing urine more frequently including during the night.
- Cough, decreased sex drive, impotence, hair loss, ringing in the ears, glaucoma (high pressure in the eye).
- Anaemia and other blood disorders which may result in fever, tiredness, bruising, bleeding under the skin, sores in the mouth,
paleness, unexplained infection such as persistent or recurring sore throat.
- Swelling of the pancreas (symptoms are severe abdominal pain moving to the back and fever), excessive sugar levels in the
blood or sugar in the urine.
- Sensitivity to light, restlessness, inflammation of the mouth, jaundice (causing yellowing of the skin and whites of the eyes).
This medicine can also cause increased blood levels of cholesterol and of a waste product produced by the body called urea. It
can also alter the blood levels of minerals such as sodium and potassium.

HOW SHOULD YOU STORE THIS MEDICINE?
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store below 25°C. Protect from light and moisture.
Do not use the tablets after the expiry date shown on the label.
This leaflet was revised February 2006.

If your doctor decides that you should take Co-amilozide and an ACE inhibitor at the same time, your condition is likely
to be checked regularly.

IAZTN1

If you do notice any side-effects, including any not mentioned in this leaflet, please inform your doctor or pharmacist.

If you are already taking another medicine to reduce your blood pressure, your doctor may have reduced the dose of that
medicine before you start taking Co-amilozide tablets.

If your doctor decides that you should take Co-amilozide and an NSAID at the same time, your kidney function and blood
potassium levels should be checked regularly.

Be careful when drinking alcohol because it may cause you to become dizzy or faint, on standing up from a resting position.

IAZTN1

If you see another doctor or go into hospital, tell them what medicine you are taking. This is important if you have an operation
because Co-amilozide can interfere with medicines used during an operation to relax muscles. If you are to have any blood or
urine tests it is important that you tell the doctor that you are taking Co-amilozide as this medicine may affect the result.

Co-pharma

Ipca Laboratories Ltd.

Regd. Off.: 48, Kandivli Ind. Estate, Mumbai 400 067
PRODUCT

Co Amilozide leaflet

DIMENSIONS

120 x 210mm

FLAP WIDTH
NO. OF FOLDS
SIZE AFTER FOLDING
PHARMA CODE VALUE

630 Mini

PHARMACODE
READ DIRECTION
LAYOUT NO. OF
CHANGE PART
PANTON NOS.

Black

MATERIAL
ARTIST SIGN

PDC SIGN

DATE

DATE

Graphic Creations

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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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