Co-Amilozide Tablets 5/50
CURRENT
CO-AMLOZIDE TABLETS 5/50 PATIENT INFORMATION LEAFLET
Please 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 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 them, even if their symptoms are the same as yours.
In this leaflet:
1. What Co-amilozide 5/50 is and what it is used for
2. Before you take Co-amilozide Tablets 5/50
3. How to take Co-amilozide Tablets 5/50
4. Possible side-effects
5. Storing Co-amilozide Tablets 5/50
Co-Amilozide Tablets 5/50
The active substances are amiloride hydrochloride and hydrochlorothiazide.
The other ingredients of the tablet are rice starch, microcrystalline cellulose, lactose, magnesium stearate, povidone and talc. Marketing Authorisation: Genethics (UK) Limited, 11 Boumpoulinas, 1st Floor, 1060 Nicosia, Cyprus Manufacturer: Medevale Pharma Services Limited, Ashton-Under-Lyne, Lancashire OL7 9RR
1. WHAT Co-AMILOZIDE 5/50 IS AND WHAT IT IS USED FOR
"Co-amilozide" is the generic (common) name for a combination of two active ingredients, the potassium-conserving diuretic amiloride hydrochloride and the thiazide diuretic hydrochlorothiazide.
A diuretic is a substance that increases the amount of urine produced by your kidneys. Each tablet contains 5 mg amiloride hydrochloride and 50 mg hydrochlorothiazide.
Co-amilozide is used to treat:
• high blood pressure
• congestive heart failure (a conhtion where there is ineffective pumping of the heart, leading to accumulation of fluid in the lungs)
• -accumulation of fluid (oedema and ascites) associated with a liver disease called cirrhosis.
Co-amilozide Tablets 5/50 are supplied in packs of 30 or 100 tablets.
2. BEFORE YOU TAKE CO-AMILOZIDE TABLETS 5/50 Do not use Co-amilozide tablets 5/50 if you:
• are allergic to amiloride hydrochloride, hydrochlorothiazide or to any of the other ingredients in the tablets;
• are allergic to thiazide diuretics or related sulphonamide-derived drugs;
• suffer from anuria (inability to produce urine);
• suffer from acute renal (kidney) insufficiency or rapidly advancing renal impairment; suffer from kidney damage caused by diabetes (diabetic nephropathy);
• have seriously reduced hepatic (liver) function;
• suffer from gout;
• have high levels of potassium in your blood (serum levels above 5.5mmol/l);
• are taking any other potassium-sparing drugs;
• are taking potassium supplements, unless serum potassium is carefully monitored;
• are, or planning to become, pregnant or are breast-feeding.
Take special care with Co-amilozide tablets 5/50 if you:
• suffer from kidney or liver problems
• suffer from diabetes
• have ever suffered from gout
CURRENT
You should make sure that you have told your doctor if any of above applies to you.
Your doctor may give you blood tests whilst you are taking Co-amilozide Tablets 5/50, in order to monitor levels of creatinine, serum electrolytes (particularly potassium and sodium), and blood urea nitrogen.
Tell your doctor or pharmacist if you are taking any other medicine that they do not know about before taking Co-Amilozide Tablets 5/50.
Taking Co-amilozide Tablets 5/50 with food and drink
You are advised not to drink alcohol whist taking Co-amilozide Tablets 5/50, as it can increase the effect of the tablets. Your doctor may advise you to avoid foods with a high potassium content, such as bananas.
Pregnancy
You should not take Co-amilozide 5/50 if you are, or are planning to become, pregnant.
Breast-feeding
You should not take Co-amilozide 5/50 if you are breast-feeding.
Driving and using machines
Occasionally, Co-amilozide 5/50 can cause side effects such as a feeling of tiredness or weakness, dizziness, vertigo (see below). If you experience any side-effect like these, you should not drive or operate machines.
Important information about some of the ingredients of Co-amilozide Tablets 5/50
You should not take Co-amilozide Tablets 5/50 if you are allergic to any of the ingredients.
Taking other medicines
It is important that you tell your doctor about any other drugs that you are taking, including those obtained without a prescription. It is especially important that your doctor knows if you are taking:
• any other medicine(s) used to treat high blood pressure, including ACE inhibitors, (e.g. captopril and enalapril), alpha-blockers (e.g. prazocin), beta-blockers (e.g. propranolol, atenolol) and other diuretics;
• a non-steroidal anti-inflammatory agent, such as aspirin or ibuprofen, used to relieve pain, fever and the symptoms of arthritis;
• a narcotic painkiller, such as codeine or morphine;
• a pressor amine, such as adrenaline (epinephrine), used to treat serious allergic reactions;
• a corticosteroid, which may be used to treat a number of different conditions, or ACTH, used to test the function of your adrenal glands;
• a medicine for diabetes, such as chlorpropamide;
• a medicine to treat epilepsy;
• alprostadil, which is used to treat erectile dysfunction and congenital heart defects;
• a barbiturate (e.g. amobarbital), used to treat insomnia or anxiety;
• calcium supplements
• cholestyramine or colestipol, which are used to reduce blood cholesterol levels;
• ciclosporin (cyclosporin), which is used to treat certain autoimmune diseases (such as rheumatoid arthritis) and to prevent rejection after transplant surgery;
• lithium to treat depression;
• oestrogens or combined oral contraceptives;
• potassium supplements, which should not be used with Co-amilozide Tablets 5/50;
• tacrolimus, used to prevent rejection after transplant surgery;
• trilostane, used to treat breast cancer or overactive adrenal glands (e.g. in Cushing's syndrome);
• vitamin D supplements.
Co-amilozide Tablets 5/50 may also interfere with the results of certain laboratory tests.
3. HOW TO TAKE CO-AMILOZIDE TABLETS 2-5/25
Always take Co-amilozide Tablets 5/50 as directed by your doctor.
Swallow Co-Amilozide Tablets 5/50 whole with water.
The dose varies according to the nature and severity of your condition. The usual doses are:
Hypertension: initially half a tablet daily, increasing if necessary to a maximum of 1 tablet daily.
Congestive heart failure: initially half a tablet daily, increasing if necessary to a maximum of 2 tablets daily.
Oedema and ascites in cirrhosis of the liver: initially 1 tablet daily, increasing if necessary to a maximum of 2 tablets daily; the dose should be reduced for long-term use if possible.
If you take more Co-amilozide Tablets 5/50 than you should contact your doctor immediately, or go to the nearest hospital casualty department.
If you forget to take Co-amilozide Tablets 5/50, just take the next dose when it is due - do not take a double dose to make up for a missed dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-amilozide Tablets 5/50 can have side effects, particularly when you first start taking them. Minor side effects are fairly common but serious side effects are rare. The following side effects have been reported:
Allergic reactions: purple or red-brown spots, skin irritation including increased sensitivity to sunlight, rash, itching and rarely, more serious allergic reactions which may result in inflamed blood vessels, problems with breathing or swallowing, collapse, redness, blisters, peeling skin,, muscle pains, chills, a general feeling of being unwell, ulcerated mouth, eyes and genitals.
Heart and circulatory system: irregular heartbeats (which can cause fainting and dizziness), palpitations, increased heart rate, chest pain (angina), a fall in blood pressure (which can cause dizziness or light-headedness when standing up quickly), anaemia (which can cause tiredness and a loss of colour from the skin), other disorders of the blood, which can cause fever, sore throat or prolonged bleeding after injury.
Digestive system: indigestion, feeling or being sick, stomach ache and cramps, diarrhoea, constipation, wind, abdominal illness, loss of appetite, hiccups, thirst, bleeding from the stomach or gut, pancreatitis (swelling of the pancreas, resulting in severe abdominal pain), liver problems including jaundice (yellow coloration of the skin and eyes), swelling of the salivary glands.
Metabolism: dehydration, changes in blood levels of various chemicals (e.g. increase in potassium, decrease in sodium), gout.
Skin/hair: rash, itching, flushing, sweating, hair loss
Muscles and joints: joint pain, aching legs, muscle cramps.
Nervous system: dizziness, vertigo, pins and needles, insomnia, sleepiness, nervousness, confusion, depression, stupor. Respiratory: cough, difficulty in breathing.
Senses: visual disturbances, an increase in pressure within the eye, a bad taste in the mouth, blocked nose, ringing in the ears.
Urogenital: difficulty or pain urinating, an increase in the amount of urine passed, increased frequency of urinating, passing urine at night, incontinence, kidney problems that can lead to a reduction in the amount of urine passed, decreased sex drive, impotence.
Other: headache, weakness, tiredness, a general feeling of being unwell.
If you experience these or any other unwanted effects not mentioned above, please inform your doctor or pharmacist.
5. STORING CO-AMILOZIDE TABLETS 5/50
Keep Co-amilozide Tablets 5/50 out of the reach and sight of children Store in a dry place below 25°C.
Use by date: Do not use the tablets after the date indicated on the pack as ”Exp. Date:"
If there is anything else you would like to know about Co-Amilozide Tablets 5/50, please contact your doctor or your pharmacist.
This leaflet was last revised in February 2009.