Co-Amilozide Tablets 5/50mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER
'Read all of this leaflet carefully before you start
jtaking 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Iln this leaflet:
.1. What Co-amilozide tablets are and what they are used for
2. Before you take Co-amilozide tablets
3. How to take Co-amilozide tablets
4. Possible side effects
5. Storing Co-amilozide tablets
i6. Further information
1. WHAT CO-AMILOZIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Co-amilozide tablets contain the active ingredients ^miloride hydrochloride and hydrochlorothiazide. Both of these actives belong to a group of |medicines called diuretics (water tablets).
|Co-amilozide tablets are used in the treatment of high blood pressure and to treat heart failure. Co-bmilozide tablets are also used to treat other conditions where fluid retention occurs, including a liver disease called hepatic cirrhosis.
bo-amilozide tablets can also be used in patients were loss of potassium in the blood is anticipated or suspected.
2. BEFORE YOU TAKE CO-AMILOZIDE TABLETS
iDo not take Co-amilozide tablets if:
• you are allergic (hypersensitive) to amiloride hydrochloride, hydrochlorothiazide or any ofthe other ingredients in these tablets
|* you are allergic to medicines called
sulphonomides (for the treatment of infections) |* you have been told you have a high level of potassium, calcium, urea or creatinine in your | blood
• you are taking other potassium containing products including supplements and potassium rich foods
L you are currently taking other medicines such as spironolactone and triamterene (see section Taking other medicines)
Cyou are not passing water (urine) you have severe kidney disease
Cyou have severe liver failure you have Addison's disease • you are taking lithium
you have diabetic neuropathy (diabetic nerve damage causing pain, weakness or numbness)
|Co-amilozide tablets should not be used in children under18 years ofage
I
Take special care with Co-amilozide tablets [Talk to your doctor or pharmacist before taking these tablets ifyou have:
|* liver cirrhosis with swelling of the abdomen
(ascites) and abnormally high levels of alkalinity in the body (metabolic alkalosis)
• had high levels of acid in the body (metabolic or respiratory acidosis) caused by heart disease or poorly controlled diabetes.
L water retention causing swelling (resistant I oedema)
L severe liver disease
C impaired kidney function had surgery affecting nerves • become pregnant or are breast-feeding had systemic lupus erythematosus (SLE).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those bought without a prescription.
This is particularly important if you are taking any of the following:
• Diuretics such as spironolactone or triamterene
• Medicines for your heart e.g. ACE inhibitors, beta-blockers e.g. Sotalol, Alpha-blockers e.g. prazosin, calcium channel blockers, angiotensin II antagonists, digoxin, amiodarone, disopyramide, flecainide, quinidine or sympathomimetics,
• Ciclosporin- used to treat psoriasis and used after organ transplants
• Non-steroidal anti-inflammatory drugs (NSAIDs) e.g. indomethacin, used for arthritis and pain relief
• Barbiturates for sleeping problems
• Antidepressants- tricyclics or reboxetine
• Narcotics e.g. dihydrocodeine
• Medicines for diabetes e.g. insulin, chlorpropamide
• Medicines containing Vitamin D (sometimes called calciferol or ergocalciferol for the treatment ofsoft bones) or calcium salts
• Corticosteroids therapy e.g. prednisolone Corticotrophin (ACTH), trilostane
• Medicines or supplements containing potassium
• Alprostadil and moxisylate used for erectile dysfunction
• Amphotericin and fluconazole to treat fungal infections
• Acetazolamine used to treat glaucoma
• Carbenoxolone to treat stomach ulcers
• Terfenadine to treat allergic conditions
• Toremifene and aminogluthethimide to treat breast cancer
• Halofantrine to treat malaria
• Carbamazepine and primozide used to treat epilepsy
• Adrenaline
• Baclofen, tubocurarine and tizanidine muscle relaxants
• Cisplatin, to treat cancer
• Colestyramine or colestipol used to treat high cholesterol
• Medicines containing oestrogen combined pill or HRT treatments
• Lithium used to treat some mental illnesses
You should take care if drinking alcohol while taking these tablets as it may cause you to feel dizzy or faint when standing up.
If you are already taking a medicine to treat high blood pressure, your doctor may have reduced the dose of that medicine before starting you on Co-amilozide tablets. If your doctor decides that you should take Co-amilozide tablets and an ACE-inhibitor at the same time he will want to monitor your condition regularly.
If you are going to have surgery you should let the doctor or nurse know you are taking Co-amilozide tablets as they can interfere with medicines used.
Ifyou need to have a blood or urine test while taking this medicine you should let the doctor or nurse know you are taking Co-amilozide tablets.
Pregnancy and breastfeeding
These tablets are not recommended for use during pregnancy or breastfeeding. Ifyou are pregnant, think you might be pregnant or want to breastfeed you should talk to your doctor before using these tablets.
Driving and using machines
These tablets can cause you to have headaches, visual disturbances, confusion, dizziness and vertigo. If you suffer from any of these while taking these tablets you should not drive or operate machinery until you feel better.
Important information about some of the ingredients in these tablets
These tablets contain lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, you should talk to your doctor before [taking these tablets.
[These tablets contain E110 (sunset yellow) which may cause allergic reactions.
3. HOW TO TAKE CO-AMILOZIDE TABLETS
Always take Co-amilozide tablets exactly as your doctor has told you. If you are not sure you should check with your doctor or pharmacist before taking.
Iswallow the tablets with a drink ofwater.
treatment of high blood pressure:
|Half a tablet daily
Treatment of heart failure:
Half a tablet daily
treatment of liver cirrhosis:
|One tablet daily
[Vour doctor may change the dose depending upon your response to these tablets. Exactly how much ^ou should take will be on the dispensing label of the packet.
Ifyou take too many tablets
|lf you have taken a lot of tablets at the same time, or you think a child may have swallowed any, bontact your nearest hospital casualty department pr tell your doctor immediately.
.If you forget to take a dose
l|f you forget to take your tablet, take the missed dose as soon as you remember unless it is nearly time to take the next one. Never take two doses together. Then continue to take your tablets at the 'correct times. If you have trouble remembering ^hen to take your tablets talk to your doctor.
[Ifyou stop taking these tablets
You should finish all the tablets your doctor has prescribed. Even ifyou feel betteryou should not stop taking these tablets before talking to your doctor.
stomach or intestines, indigestion, wind, loss or other appetite changes, constipation or diarrhoea, hiccups, feeling or being sick.
• Liver and pancreas: inflammation of I the pancreas (pancreatitis) and changes in liverfunction, jaundice (yellow skin or eyes).
• Skin: blood spots, bruising and I discolouring to the skin (purpura), , loss of hair, itching, skin rash, pale or L red irregular raised patches with severe itching (hives), flushing, sensitivity ofthe skin to sunlight or artificial light (e.g. sunbeds), sweating and swelling of the salivary glands.
• Muscles and joints: joint pain, aching legs and muscle cramps.
• Urinary and genital: pain on passing water, getting up in the night to pass water, frequent or copious water production, inability to control bladder movements, bladder pain, impaired kidney function, kidney failure or inflammation, decreased desire for sex and inability to maintain an erection. You should consult your doctor if these are troublesome or continue.
• Senses: bad taste, stuffy nose, ringing in the ears, increased pressure in the eyes, visual disturbances and yellow vision.
• Other: dry mouth, thirst, allergic (anaphylactic) reactions (rash, swelling, difficulty breathing), back chest neck and shoulder pain, pain in the hands and feet, tiredness, a feeling of general discomfort and illness, weakness, fever, headache and fainting.
If any of the side effects gets worse, or if you
notice any side effects not mentioned in this
leaflet, please inform your doctor or
pharmacist.
5. STORING CO-AMILOZIDE TABLETS
4. POSSIBLE SIDE EFFECTS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package.
Do not use Co-amilozide tablets after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed ofvia wastewater of household waste. Ask your pharmacist how to dispose of unwanted medicines no longer required. These measures will help protect the environment.
Like all medicines, Co-amilozide tablets can cause side effects, although not everybody gets them. fTell your doctor or pharmacist ifyou notice any ofthe following side effects, they get worse or if you notice anything not listed.
I Altered balance offluid or chemicals in the I body (e.g. sodium, potassium, chlorine and ' magnesium) causing a dry mouth, weakness,
I tiredness or drowsiness, restlessness, fits,
1 muscle pain, fatigue or cramps, low blood | pressure, difficulty passing water, fast heart rate, feeling and being sick.
|* Blood: altered numbers and types of blood cells causing increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin (you may need a blood test).
|* Metabolism: dehydration, gout, changes in levels of body chemicals (increased blood potassium, glucose or uric acid or decreased blood sodium), glucose in the urine.
I* Nervous system: depression, difficulty
sleeping orsleepiness, confusion, nervousness and restlessness, dizziness, pins and needles , or tingling, near unconsciousness including reduced mental activity and reduced response I to stimulation (stupor), feeling of dizziness or ' spinning (vertigo), tremors and brain disease
I (characterised by poorconcentration,
1 confusion and delirium).
• Heart: chest pain (angina), irregular (arrhythmia), fast (tachycardia) or pounding (palpitation) heart beat, dizziness on standing due to low blood pressure and inflammation of blood vessels (necrotising angiitis).
• Breathing: cough, difficulty breathing, fluid in the lungs and lung inflammation (pneumonitis).
• Stomach and intestines: feeling of stomach fullness, cramps, stomach irritation or pain, activation of stomach ulcers, bleeding in the
6. OTHER INFORMATION
What Co-amilozide tablets contain
Co-amilozide tablets contain 5mg ofamiloride hydrochloride and 50mg of hydrochlorothiazide. The other ingredients are lactose, microcrystalline cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycollate and sunset yellow (E110).
What Co-amilozide tablets look like and contents of the pack
Co-amilozide tablets are flat, pale peach bevelled edged tablets bisected on one side, embossed 'MP3' on the other.
Co-amilozide tablets are available in packs of 28, 50, 100 and 500 tablets
MARKETING AUTHORISATION HOLDER:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
MANUFACTURER:
Sussex Pharmaceticals Limited
Charleswood Road
East Grinstead
Sussex
RH192111
UNITED KINGDOM
This leafletwas last approved in December 2011