Zido-Co Tablets 5/50
PACKAGE LEAFLET: INFORMATION FORTHE USER
_ _ _ _ _ n nogen PharmaI
.__J
Read all ofthis leaflet carefully before you start taking this medicine because it contains 'important information for you.
» Keep this leaflet. You may need to read it again.
to If you have any further questions, ask your doctor or pharmacist or nurse.
|* This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
|* If you get any side effects, talk to your doctor, pharmacist or nurse. This includes possible side effects not listed in this leaflet. See section 4.
hat is in this leaflet:
|1. What Co-amilozide tablets are and what they are used for
|2. What you need to know before you take Co-amilozide tablets
|3. How to take Co-amilozide tablets
4. Possible side effects
|5. How to store Co-amilozide tablets
6. Contents of the pack and other information
|Co-amilozide tablets contain the active ingredients amiloride hydrochloride and hydrochlorothiazide. |Both ofthese 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-amilozide tablets are also used to treat other conditions where fluid retention occurs, including a |liver disease called hepatic cirrhosis.
Co-amilozide tablets can also be used in patients where loss of potassium in the blood is anticipated .or suspected.
bo not take Co-amilozide tablets if:
• you are allergic (hypersensitive) to amiloride
I hydrochloride, hydrochlorothiazide or any of the I other ingredients in these tablets (listed in I section 6)
• you are allergic to medicines called
I sulphonomides (for the treatment of infections)
• you have been told you have a high level of
' potassium, calcium, urea or creatinine in your I blood
L you are taking other potassium containing i products including supplements and potassium ' rich foods
• you are currently taking other medicines such
1 as spironolactone and triamterene (see section | Other medicines and Co-amilozide tablets)
'• you are not passing water (urine)
» you have severe kidney disease '• you have severe liver failure » you have Addison's disease
• you are taking lithium
to you have diabetic neuropathy (diabetic nerve damage causing pain, weakness or | numbness).
|Co-amilozide tablets should not be used in children under18years ofage
arnings and precautions [Talk to your doctor, pharmacist or nurse before taking this medicine ifyou have:
|* liver cirrhosis with swelling of the abdomen
(ascites) and abnormally high levels of alkalinity in the body (metabolic alkalosis)
• had high levels ofacid in the body (metabolic or respiratory acidosis) caused by heart disease or poorly controlled diabetes.
|* water retention causing swelling (resistant oedema)
|* severe liver disease
• impaired kidney function
|* had surgery affecting nerves
• become pregnant or are breast-feeding
k _had_systemic_lupus.erythematosus_(SLE)_ _
Other medicines and Co-amilozide tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 of soft 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 knowyou are taking Co-amilozide tablets.
Pregnancy
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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Co-amilozide is not recommended for mothers who are breast-feeding.
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.
^Co-amilozide tablets contain lactose and sunset yellow (E110)
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.
^Jways take Co-amilozide tablets exactly as your 'doctor has told you. If you are not sure you should pheck with your doctor or pharmacist before taking.
^Swallow the tablets with a drink ofwater.
treatment of high blood pressure:
|Half a tablet daily
[Treatment of heart failure:
Haifa tablet daily
Treatment of liver cirrhosis:
|One tablet daily
[/our doctor may change the dose depending upon your response to these tablets. Exactly how much you should take will be on the dispensing label of the packet.
Ifyou take too many tablets
|lf you (or someone else) swallow a lot of the tablets all together, or if you think a child has bwallowed 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 bait 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 a dose
Ilf 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 when to take your tablets talk to your doctor.
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 ofstomachl ulcers, bleeding in the stomach or intestines, indigestion, wind, loss or L other appetite changes, constipation or diarrhoea, hiccups, feeling or being sick.
• Liver and pancreas: inflammation of the pancreas (pancreatitis) and changes in liver function, jaundice (yellow skin or eyes).
• Skin: blood spots, bruising and discolouring to the skin (purpura), loss of hair, itching, skin rash, pale or red irregular raised patches with severe itching (hives), flushing, sensitivity of the skin to sunlight or artificial light (e.g. sunbeds), sweating and swelling ofthe 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine
Jfyou stop taking these tablets
You should finish all the tablets your doctor has prescribed. Even ifyou feel betteryou should not btop taking these tablets before talking to your
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist ifyou notice any of the following side effects, they get worse or if you notice anything not listed.
Keep out of the sight and reach 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.
» Altered balance offluid or chemicals in the body (e.g. sodium, potassium, chlorine and
i magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain, fatigue or cramps, low blood pressure, difficulty passing water, fast heart rate, feeling and being sick.
• Blood: altered numbers and types ofblood cells causing increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness ofthe 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.
• Nervous system: depression, difficulty sleeping or sleepiness, confusion, nervousness and restlessness, dizziness, pins and needles or tingling, near unconsciousness including reduced mental activity and reduced response to stimulation (stupor), feeling of dizziness or spinning (vertigo), tremors and brain disease
| (characterised by poor concentration, confusion and delirium).
|* Heart: chest pain (angina), irregular
(arrhythmia), fast (tachycardia) or pounding (palpitation) heart beat, dizziness on standing
What Co-amilozide tablets contain
Co-amilozide tablets contain 5mg of amiloride 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 Pharmaceuticals Limited Charleswood Road, East Grinstead, Sussex RH19 2111, UNITED KINGDOM