Co-Amilozide Tablets Bp 5/50mg
PAGE 1: FRONT FACE (INSIDE OF REEL)
PAGE 1: FRONT FACE (INSIDE OF REEL)
CO-AMILOZIDE 5/50 mg TABLETS
(Amiloride Hydrochloride and Hydrochlorothiazide)
PACKAGE LEAFLET: INFORMATION FORTHE USER
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 any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Co-Amilozide is and what it is used for
2. Before you take Co-Amilozide
3. How to take Co-Amilozide
4. Possible side effects
5. How to store Co-Amilozide
6. Further information
OWHAT CO-AMILOZIDE IS AND WHAT IT IS USED FOR
• Co-AmilozideTablets are a type of medicine called a thiazide diuretic, which increases the amount of water (urine) passed.
• Co-AmilozideTablets are used to treat:
• heart failure
• high blood pressure
• oedema (water retention).
BEFORE YOU TAKE CO-AMILOZIDE
Do NOT take Co-Amilozide if you:
• are allergic (hypersensitive) to amiloride hydrochloride, hydrochlorothiazide or any of the other ingredients of the medicine
• are allergic (hypersensitive) to any sulphonamide anti-bacterial or antibiotic drugs, such as co-trimoxazole or sulphamethoxazole
• are diabetic
• are taking potassium supplements or are on a potassium rich diet
• have severe liver or kidney failure
• suffer from an imbalance of blood mineral salt in the body
• are pregnant or breast-feeding
• suffer from Addison's Disease
• are unable to pass urine.
Take special care with Co-Amilozide
Tell your doctor before you start to take this
medicine if you:
• have liver or kidney problems
• are allergic to aspirin
• suffer from, or have a history of systemic lupus erythematosus (autoimmune disorder)
• suffer from gout (pain, swelling, redness, warmness and stiffness in the joint).
Your doctor may want to carry out tests to monitor your kidney and liver whilst you are taking these tablets.
Taking other medicines
Do not take Co-Amilozide in combination with
the following:
• potassium supplements, or a special diet of potassium-rich food
• potassium-sparing agents e.g. co-amilofruse
• potassium-sparing diuretics e.g. spironolactone and triamterene
• medicines to treat mental illness e.g. lithium.
Talk to your doctor if you are taking any of the
following:
• non-steroidal anti-inflammatory drugs (NSAID) e.g. diclofenac, ibuprofen or naproxen
• any other medicine for high blood pressure
or heart failure, e.g. captopril or enalapril
• any medicines which relax the muscles, e.g. tubocurarine
• any pain-killers which contain opioids e.g. codeine, diamorphine or pentazocine
• any barbiturates (sedatives) e.g. phenobarbital, or narcotic drugs, such as morphine
• an anti-diabetic drug known as chlorpropamide
• ACTH or any corticosteroids, e.g. hydrocortisone, cortisone or prednisolone
• colestyramine or colestipol
• adrenaline.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Co-Amilozide with food and drink
You should avoid alcohol while taking Co-Amilozide as it may interfere with the action of the tablets.
Pregnancy and breast-feeding You must tell your doctor if you are pregnant or if you think that you are. Usually, your doctor will advise you to take another medicine instead of Co-Amilozide, as Co-Amilozide 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.
Driving and using machines
Your tablets may make you feel weak, less alert, dizzy or tired, if affected do not drive or operate machinery.
Important information about some of the ingredients of Co-AmilozideTablets
Patients who are intolerant to lactose should note that Co-AmilozideTablets contain a small amount of 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.
Q HOW TO TAKE CO-AMILOZIDE
Always take Co-AmilozideTablets exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure. The tablets can be taken with or without food.The tablets should be swallowed preferably with a glass of water.
The usual dose is:
Adults:
For theTreatment of High Blood Pressure
Half a tablet once a day.Your doctor may increase your dose to either one tablet, once a day or half a tablet twice a day.
For theTreatment of Congestive Heart Failure Half a tablet once a day.This may be adjusted by your doctor if necessary.The maximum dose is two tablets a day.
For Fluid Retention Associated with Liver Disease
Usually a single daily dose of one tablet, which may be gradually increased by your doctor, depending on your response to the medication. Your doctor may reduce the dose at a later stage. The maximum dose is two tablets a day.
Elderly:
The dosage will be carefully adjusted by your doctor.
Children:
Co-Amilozide is not recommended for use in children.
Top of page cut-off to middle of registration mark: 44 mm.
If you take more Co-AmilozideTablets than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause dehydration and an imbalance of blood mineral salt in the body (causing abnormal heart rhythm, muscle twitching, muscle weakness, tiredness and confusion). Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Co-AmilozideTablets
Do not take a double dose to make up for a forgotten tablet. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.
If you stop taking Co-AmilozideTablets
Do not stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines, Co-AmilozideTablets can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately, or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor if you experience any of the following whilst taking Co-AmilozideTablets:
• aching legs
• headaches
• muscle weakness, fatigue and a general sense of feeling unwell
• restlessness
• confusion
• depression and nervousness
• dry mouth and thirst
• hiccups
• cough
• tiredness and drowsiness
• fainting and dizziness
• seizures
• difficulty sleeping or a general feeling of sleepiness
• loss of or a change in your appetite
• bad taste
• nausea and vomiting
• indigestion
• diarrhoea or constipation
• abdominal pain or a feeling of fullness and flatulence (wind)
• stomach irritation and black or blood-stained bowel movements
• rash or peeling skin leaving red, raw patches over the body
• a lower level of consciousness
• a yellowing of the skin and in the whites of the eyes
• itching
• flushing
• sweating
• muscle cramps
• back and joint pain
• pins-and-needles
• shaking
• gout
• hair loss
• ringing in the ears
• nasal congestion
• problems with your eyesight
• increased pressure in the eyes
• eye pain and sensitivity to bright light
• liver or kidney problems
• inflammation of the pancreas
• problems with your bladder and passing urine
• increased sugar levels in the blood and urine
• dehydration
• breathing difficulties
• chest pain
• increased pulse rate
• irregular heartbeat and palpitations
• temporary impotence and a decreased sexual desire
• inflammation of the salivary glands or blood vessels.
If you are currently taking digoxin, side effects may be made worse by Co-Amilozide.
There have been reports of blood disorders which may be characterised by pallor, fever or chills, sore throat, ulcers in your mouth or throat, unusual bleeding or unexplained bruising.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
HOWTO STORE CO-AMILOZIDE
Keep out of the reach and sight of children.
These tablets should be stored in the package or container supplied. Do not transfer them to another container. Do not use Co-Amilozide Tablets after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.
Q FURTHER INFORMATION
What Co-AmilozideTablets contain:
• The active substances are amiloride hydrochloride and hydrochlorothiazide.
• The other ingredients are lactose monohydrate, maize starch, povidone
(El201), magnesium stearate (E572) and the colour, sunset yellow (E110).
What Co-AmilozideTablets look like and contents of the pack:
• The tablets are flat, round, bevel-edged tablets, engraved '4K2' on one side, with a breakline on the reverse.
• Co-AmilozideTablets are available in HDPE containers with caps or child resistant closures in packs of 28, 30, 50, 56, 60,100, 250, 500 or 1000 tablets or as blister strips in packs of 10, 28, 30, 56, 60 or 100 tablets. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised: March 2011
PL 00289/0216
TFWTI
60905-W
160x323