Co-Amilozide 2.5 Mg/25 Mg Tablets
Out of date information, search anotherPatient Information Leaflet
Co-amilozide 2.5mg/25mg and 5mg/50mg
What you should know about Co-amilozide Tablets
Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information available on your medicine. If you would like further information, have any questions or are not sure about anything, ask your doctor or pharmacist.
The name of your medicine is Co-amilozide 2.5mg/25mg or 5mg/50mg Tablets.
What is in your medicine?
The 2.5mg/25mg tablet contains 2.5mg amiloride hydrochloride and 25mg
hydrochlorothiazide. The 5mg/50mg tablet contains 5mg
amiloride hydrochloride and
50mg hydrochlorothiazide. The other ingredients
include: wheat starch (may be
harmful to people with coeliac disease), gelatin, talc,
magnesium stearate and lactose
monohydrate.
These tablets are supplied in packs of 28, 30,56, 60, 100 and 500.
The active ingredients, amiloride hydrochloride and hydrochlorothiazide, belong to a group of medicines known as diuretics which promote the excretion of water and salts in the urine. Hydrochlorothiazide on its own may cause potassium loss, so hydrochlorothiazide is used in combination with amiloride hydrochloride which helps to prevent potassium loss.
The product licence holder is:
ZeCare Ltd.
Unit 5 Blenheim Court, Brownfields, Welwyn Garden City, Hertfordshire, AL7 1AN, UK.
The manufacturer is:
A/S GEA Farmaceutisk Fabrik,
Kanalholmen 8 - 18, DK-2650 Hvidovre,
Denmark.
Uses
Co-amilozide is used to treat conditions which result in accumulation of fluid in the body tissues. These include heart failure and a liver disease called hepatic cirrhosis which causes
accumulation of fluid in the abdomen.
Co-amilozide is also used to treat high blood pressure
Before taking your medicine
DO NOT take this medicine before telling your doctor if:
• you are, or might be pregnant, or are breastfeeding
• you have ever had an allergic reaction to the ingredients of this medicine, including amiloride hydrochloride and hydrochlorothiazide or to other sulphonamide-derived medicines
• you suffer from kidney or liver problems. This medicine must not be taken if you have acute kidney failure or severe kidney or liver problems
• you have a pre-coma associated with severe liver disease (hepatic cirrhosis)
• you suffer from Addison's disease
• you have been told you have high levels of urea, creatinine, potassium or calcium in your blood
• you are taking any other potassium-conserving diuretics such as spironolactone or triamterene or potassium supplements
• you are eating potassium-rich foods rich (unless you have a severe low levels of potassium and you are being carefully monitored)
• you suffer from suffer from diabetes or diabetic neuropathy (diabetic nerve damage causing
pain, weakness or numbness), gout, systemic lupus erthyematosos
• you have problems passing urine
• you are severely ill and may have a high level of acidity in your blood (metabolic or respiratory acidosis) caused by heart disease or poorly controlled diabetes
• you have a history of allergy or asthma
• you are taking lithium (used for depression)
• the patient is a child (see ‘Taking your medicine’)
• you are elderly
• you have recently suffered from severe vomiting
• you are being given fluids by a tube inserted into one of your veins
It is very important that you tell your doctor if you are taking any other medication, particularly:
• potassium supplements
• other diuretic medicines (water tablets)
• non-steroidal anti-inflammatory drugs (NSAID's), such as aspirin or ibuprofen (used to treat arthritis, pain or to reduce a high temperature (fever))
• strong pain-killers such as morphine or dihydrocodeine
• barbiturates (sleeping tablets or for the treatment of epilepsy)
• lithium (used to treat depression)
• muscle relaxants, in particular tubocurarine
• other drugs to treat high blood pressure, including ACE inhibitors, such as enalapril and angiotensin II receptor antagonists, such as losartan
• triolstane (for Cushing’s syndrome)
• ciclosporin or tacrolimus (used after organ transplant)
• medicines for diabetes (taken orally or by injection) such as insulin or chlorpropamide
• cholestyramine and colestipol resins (for lowering cholesterol)
• corticosteroids (used to treat different conditions, such as rheumatism, arthritis, allergic conditions, skin problems or asthma)
• ACTH (used to test if your adrenal glands are working properly)
• adrenaline and noradrenaline (used for allergic reactions)
Co-amilozide should be discontinued for at least 3 days before a glucose-tolerance test is performed. It should also be withdrawn before carrying out tests for thyroid function.
Co-amilozide should be discontinued for 2-3 days before starting treatment with an ACE inhibitor (for high blood pressure).
In a majority of cases regular check-ups of your condition may be necessary, especially in elderly patients.
Be careful when drinking alcohol as this may cause you to become dizzy or faint on standing up from a resting position.
Pregnancy and breast-feeding
Do not take Co-amilozide if you are pregnant, are planning to become pregnant or you are breast-feeding.
Driving or using machinery
Although infrequent, you may feel weak, tired dizzy, have a lack of awareness or a feeling of dizziness or “spinning” (vertigo), whilst taking this medicine. If affected do not drive or use machinery.
Taking your medicine
Always follow your doctor's instructions as to how and when to take your medicine, your pharmacist may be able to advise if you are not sure. Exactly how many tablets, and how often you must take them, will be written on the label. Please read it carefully.
The recommended doses are given below. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with the doctor, if you have not already done so.
Adults:
For high blood pressure:
Initially one Co-amilozide 2.5mg/25mg tablet or half a Co-amilozide 5mg/50mg tablet should be taken once a day. If necessary your doctor may increase the dosage to two Co-amilozide 2.5mg/25mg tablets or one Co-amilozide 5mg/50mg tablet to be taken once a day or in divided doses.
To treat heart failure or hepatic cirrhosis (liver disease): To begin with your doctor will prescribe one Co-amilozide 2.5mg/25mg tablet or half a Co-amilozide 5mg/50mg tablet. Should a higher dose be necessary, your doctor may increase this up to four Co-amilozide 2.5mg/25mg tablets or two Co-amilozide 5mg/50mg tablets.
Eventually your doctor may decide to lower your dose. Children:
Co-amilozide 2.5mg/25mg and 5mg/50mg Tablets are not recommended for use in children under 18 years of age.
Elderly patients:
Your doctor will decide the correct dosage for you to take, depending on how well your kidneys function and also how you respond to this medicine.
Do not stop taking your medicine without consulting your doctor as the original symptoms may return.
If you have forgotten to take your medicine, do not make up for it by taking extra tablets. When you remember, take the next prescribed dose and continue with the treatment. If you are concerned, consult your doctor or pharmacist.
If you take an unintentional extra dose, this should not be of too much concern, but you will pass a lot more urine than usual. If you are concerned or you or some one else has taken a large overdose, consult your doctor or pharmacist.
Symptoms of an overdose include, dehydration, and changes in the levels of certain chemicals in the blood.
As with all medicines, some people may experience some side effects.
Contact your doctor immediately if you experience any of the symptoms below. Your treatment with Co-amilozide may need to be stopped.
• Feeling tired
• Feeling weak
• Shortness of breath
• Chest pain
• Abnormal heart beat
• Loss of muscular movement
The side effects above are symptoms of hyperkalaemia which is common in diabetic patients. It is also more likely to occur in patients who are elderly, seriously ill, undergoing vigorous diuretic therapy, have liver disease, heart failure or kidney problems.
• Swollen ankles or high blood pressure (symptoms of kidney problems)
• Difficulty in breathing or dizziness (symptoms of anaphylactic reaction)
• Blistering of the skin (symptoms of toxic epidermal necrolysis)
The following side effects have also been reported.
Body as a whole: headache*, weakness*, feeling tired or generally unwell, chest pain, back pain, fainting, neck or shoulder ache, pain in the extremities, fever
Heart: irregular or faster heart beat, high levels of digitalis in the body, usually associated with taking digitoxin for heart problems, fall in blood pressure on standing up which causes dizziness, chest pain (angina pectoris), light-headedness or fainting, heart block, feeling your heart beat (palpitations), inflammation of the blood vessels (necrotising angiitis)
Stomach & digestive: loss of weight*, feeling sick*, being sick, diarrhoea, constipation, stomach irritation or pain, appetite changes, feeling of stomach fullness, wind (flatulence), feeling thirsty, cramps, hiccups, bleeding in the stomach which may cause blood in your faeces or a darker colour of faeces, abnormal liver function (detected through a blood test), activation of existing stomach ulcer, indigestion, yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice), inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
Metabolism: low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma, gout, dehydration, changes in the levels of various chemicals (usually detected by blood or urine tests), glucose in the urine, high blood sugar (glucose) level which can cause increased thirst, urination and fatigue, high level of uric acid in the blood, low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm
Muscles: leg ache, muscle cramps, joint pain
Nervous system: dizziness*, feeling of dizziness or ‘spinning’ (vertigo), tingling or numbness in the hands or feet, lack of awareness (stupor), shaking, type of brain disorder (encephalopathy), which may cause poor concentration, confusion and delirium
Psychiatric: difficulty sleeping, nervousness, feeling confused, depression, feeling sleepy, minor mental or behavioural changes, decrease sexual desire, restlessness
Breathing: breathlessness, cough, fluid in the lungs and lung inflammation (pneumonitis)
Senses: bad taste, transient visual changes such as blurred vision, yellow vision, increased pressure in the eyes, blocked nose, ringing in the ears (tinnitus)
Urinary and genital: inability to have or maintain an erection, getting up in the night to pass urine, inability to control bladder movements, kidney problems and/or failure, frequent or copious urine production, bladder pain
Blood: severe reduction in blood cells which can cause weakness, bruising, bleeding or make infections more likely, skin rash
Other: rash*, itching, flushing, excessive sweating, dry mouth, hair loss, increased sensitivity of the skin to sunlight, inflammation of the salivary gland which may cause swelling, pain, redness, and tenderness, itchy rash
Although rare and reversible, abnormal liver function tests have been observed.
* Side effects marked with an asterix
These side effects have been reported more frequently
during controlled clinical trials
If any of these effects become severe or upsetting, or you experience any other unexpected effects which you think could be due to taking Co-amilozide, consult your doctor or pharmacist.
Storing your medicine
Do not take Co-amilozide Tablets after the expiry date shown on the label. Return any unused medicines to the pharmacist.
Store your medicine in a dry place below 25°C and protect from light.
If you notice any visible signs of deterioration in your medicine, take it to your pharmacist for advice.
Keep all medicines out of the reach of children. Your medicines can harm them.
Remember this medicine is for you. Never give it to others. It may harm them even if their symptoms are the same as yours.
PL 24581/0004- Co-amilozide 2.5mg/25mg Tablets PL 24581/0005- Co-amilozide 5mg/50mg Tablets
Date of last revision: December 2011
ZeC are“
ZCVer.2.3