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CO-AMILOZIDE 2.5 MG/25 MG TABLETS

Active substance: HYDROCHLOROTHIAZIDE

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PATIENT INFORMATION LEAFLET

Co-amilozide 2.5mg/25mg and 5mg/50mg Tablets
(Amiloride Hydrochloride + Hydrochlorothiazide)
Read all of this 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.
• If you have any further questions, ask your doctor or
pharmacist.
• 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Co-amilozide is and what it is used for
2. What you need to know before you take Coamilozide
3. How to take Co-amilozide
4. Possible side effects
5. How to store Co-amilozide
6. Contents of the pack and other information
1 What Co-amilozide is and what it is used for
Co−amilozide Tablets contain a combination of
Amiloride and Hydrochlorothiazide (HCT).
Hydrochlorothiazide (HCT) is one of a group of
medicines known as thiazide diuretics. These work by
increasing the volume of urine you produce, therefore
reducing the water content of your blood and in turn the
volume of blood circulating in your body.
Hydrochlorothiazide can cause potassium to be filtered
out of the blood, which can sometimes cause the level of
potassium in the blood to fall too low.
Amiloride is one of a group of medicines known as
potassium-sparing diuretics. Amiloride is a weaker
diuretic that causes potassium to be retained in the
body. It is used in combination with the
Hydrochlorothiazide in this medicine to prevent the
amount of potassium in the blood from falling too low.
Amiloride + Hydrochlorothiazide Tablets (referred to as
Co-amilozide throughout this leaflet) are used for the
treatment of high blood pressure (hypertension), heart
failure & fluid retention.
2 What you need to know before you take Coamilozide
Do not take Co−amilozide if:
• You are allergic (hypersensitive) to Amiloride,
Hydrochlorothiazide, other Diuretics, other
Sulphonamide-derived medicines or any of the other
ingredients of this medicine (See Section 6
“Contents of the pack and other information”)
• If you have high levels of potassium in the blood
[hyperkalaemia] (especially if you are elderly,
diabetic or suffer from liver or heart failure), are
currently taking potassium-sparing diuretics such as
spironolactone or triamterene (see “Other medicines
and Co-amilozide”), potassium supplements or
potassium-rich foods (unless you have severely low
levels of potassium and you are being carefully
monitored)
• You suffer from kidney failure, kidney disease or
other kidney problems such as anuria (failure of the
kidneys to produce urine)
• You suffer from sever liver failure or severe liver
disease (hepatic cirrhosis)
• You suffer from Addison's disease
• You have high levels of calcium in the blood
(hypercalcaemia). Treatment with Co-amilozide
should be discontinued before carrying out tests for
parathyroid function
• You are taking lithium (see “Other medicines and
Co-amilozide”)
• You suffer from diabetes (see “Warnings and
precautions” section) or diabetic neuropathy (kidney
disease or damage that can occur in people with
diabetes)
• You have high levels of urea or creatinine in the
blood (may be a sign of kidney problems)
Warnings and precautions
Talk to your doctor before taking Co-amilozide:
• If you are diabetic. The status of kidney function
should be determined before Co-amilozide is given
to known or suspected diabetics. Co-amilozide
should be discontinued for at least 3 days before
giving an intravenous (via a tube inserted into one of
your veins) glucose-tolerance test as HCT may
impair the results. Diabetes may be caused or
aggravated by treatment with Co-amilozide. Dosage
adjustment of anti-diabetic medicines, including
insulin, may be required (see “Other medicines and
Co-amilozide”)
• If you suffer from or have previously suffered from
increased acidity in the blood (acidosis)
• If you show signs of fluid and electrolyte imbalance
[symptoms include dry mouth, weakness, lack of
energy, drowsiness, restlessness, fits, confusion,
muscle pain, cramps, low blood pressure
(hypotension), decreased production of urine
(oliguria), faster heartbeat (tachycardia), feeling sick
(nausea) or being sick (vomiting)]:
o Low blood levels of sodium which can cause
tiredness and confusion, muscle twitching,
fits and coma (hyponatraemia)
o Abnormally high alkalinity of the blood and
body fluids (hypochloraemic alkalosis)
o Abnormally low levels of potassium in the
blood (hypokalaemia)
o An abnormally low level of magnesium in
the blood (hypomagnesaemia)
• If you are being severely sick (vomiting)
• If you are receiving fluids intravenously (via a tube
inserted into one of your veins)
• If you suffer from Systemic Lupus Erythematosus
(long-term inflammation of skin)
• If you have a history of allergic reactions or suffer
from bronchial asthma






If you have an abnormally high level of uric acid in
the blood (hyperuricaemia)
If you suffer from gout (pain and swelling in one or
more joints)
If you have increased level of fats (cholesterol and
triglyceride) in your blood
If you have had a surgical procedure to treat
excessive sweating or extreme facial flushing
(sympathectomy)

Other medicines and Co-amilozide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription. This
includes herbal medicines.
Medicines which may interact with Co−amilozide:
• Medicines used to increase frequency of urination
e.g. spironolactone, triamterene (potassium-sparing
diuretics)
• Potassium supplements
• Medicines used to treat mood disorders e.g. lithium
(anti−psychotics)
• Medicines used to treat diabetes e.g. insulin,
chlorpropamide (anti-diabetics)
• Medicines used to treat certain rheumatic disorders
such as aspirin or ibuprofen (Non−Steroidal
Anti−Inflammatory Drugs − NSAIDs)
• Medicines used to reduce the body’s immunity when
receiving organ transplant e.g. ciclosporin,
tacrolimus (immunosuppressants)
• Medicines used to treat Cushing’s syndrome e.g.
trilostane
• Medicines used to treat high blood pressure such as
enalapril (ACE [Angiotensin−Converting Enzyme]
inhibitors). Co-amilozide should be discontinued for
2-3 days before starting treatment with an ACE
inhibitor
• Other medicines used to treat high blood pressure
such as losartan (angiotensin II receptor
antagonists)
• Medicines used to lower cholesterol
e.g.cholestyramine, colestipol
• Medicines used to reduce inflammation such as
prednisolone (corticosteroids)
• Corticotropin (AdrenoCorticoTropic Hormone ACTH)
• Medicines used to treat serious allergic reaction
(anaphylaxis) such as epinephrine (adrenaline) and
noradrenaline (sympathomimetics)
• Tubocurarine, a muscle relaxant
• Barbiturates, a type of sedative medicine that
causes relaxation and sleepiness such as
phenobarbital
• Narcotics, analgesic medicines used to relieve
severe pain such as morphine
Co-amilozide and alcohol
During treatment with Co−amilozide, it is advisable not
to drink alcohol as this may cause you to become dizzy
or faint on standing up from a resting position.
Pregnancy and breast-feeding
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 Coamilozide 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Co-amilozide is not recommended
for mothers who are breast-feeding.
Driving and using machines
Although rare, you may feel weak, tired, dizzy, dazed or
experience a feeling of “spinning” (vertigo), whilst taking
this medicine. If any of these symptoms are
experienced, it may be necessary to avoid driving or
operating machinery or pursuing any activity in which full
attention is required.
Co-amilozide contains lactose
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicine.
3 How to take Co−amilozide
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.




These tablets are to be taken orally as a single dose
in the morning.
These tablets should be taken independently of
meals and with a generous amount of fluid.
The score line is only there to help you break the
tablet if you have difficulty swallowing it whole.

The recommended dose for adults is:
To treat high blood pressure:
Initially, a single daily dose of Co-amilozide 2.5mg/25mg
should be taken.
If necessary, the dose may be increased to Coamilozide 5mg/50mg taken as a single daily dose or in
divided doses.
To treat heart failure:
Initially, a single daily dose of Co-amilozide
2.5mg/25mg. This may be adjusted if required, but
should not exceed four Co-amilozide 2.5mg/25mg
tablets daily. A reduction in dose may be attempted for
maintenance treatment.
To treat liver disease with an excessive
accumulation of body fluid:

ZC-Ver.3.1

Treatment should be started with a low dose. A single
daily dose of two Co-amilozide 2.5mg/25mg tablets may
be increased gradually, but dosage should not exceed
four Co-amilozide 2.5mg/25mg tablets a day.
Maintenance doses may be lower than those required
initially. Dose reduction should be attempted once the
patient’s weight is stabilised.
Elderly patients:
The dose may need to be adjusted depending on how
well your kidneys work and how well you respond to
treatment with this medicine.
Use in children:
Co-amilozide Tablets are not recommended for use in
children under 18 years of age.
If you take more Co−amilozide than you should
If you accidentally take too many tablets, contact your
doctor or nearest emergency department immediately
for advice. Remember to take this leaflet or any
remaining tablets with you.
The symptoms of overdose include: coma, breathing
difficulties. The most common symptoms of overdose
are dehydration and electrolyte imbalance:
• abnormally low levels of potassium in the blood
(hypokalaemia)
• abnormally low level of the chloride ion in the
blood (hypochloraemia)
• low blood levels of sodium which can cause
tiredness and confusion, muscle twitching, fits
and coma (hyponatraemia)
If you forget to take Co−amilozide
Take it as soon as you remember, unless it is nearly
time for your next dose.
If you miss a dose, do not take a double dose to make
up for a forgotten dose.
If you stop taking Co−amilozide
It is important that you keep taking Co−amilozide for as
long as your doctor has told you to. Do not stop taking
the tablets even though you may feel better. Do not
stop or change your treatment before talking to your
doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Seek medical advice immediately if you develop the
following symptoms:
• Allergic reactions: swelling of the face, throat or
tongue, fever, difficulty in breathing, dizziness
• Severe blistering of the skin, mouth, eyes and
genitals (Toxic Epidermal Necrolysis) [TEN]
Side effects (frequency not known)
• Headache
• Feeling of weakness
• Tiredness (fatigue), mental numbness (stupor),
sleepiness or drowsiness (somnolence)
• Generally feeling unwell (malaise),
• Fainting (syncope), dizziness, vertigo (sensation of
whirling and loss of balance, feeling giddy)
• Disrupted heart rhythm (arrhythmias), faster
heartbeat (tachycardia), feeling your heartbeat
(palpitations), partial heart block (electrical pulses
that control the beating of the heart are disrupted)
developing into complete heart block
• Digitalis Toxicity (a poisoning that occurs when you
take too much digitalis [also known as digoxin or
digitoxin], a medication used to treat heart
conditions)
• Low blood pressure (hypotension)
• Chest pain (angina pectoris)
• Loss of appetite (anorexia), disturbed sense of taste,
appetite changes, inflammation of the salivary
glands (sialadenitis)
• Feeling or being sick (nausea, vomiting)
• Diarrhoea
• Constipation
• Stomach pain, cramping or irritation, feeling of a full
stomach, feeling bloated/wind (flatulence), hiccups,
activation of pre-existing stomach ulcer, indigestion
(dyspepsia)
• Inflammation of the pancreas (pancreatitis), bleeding
in the stomach and intestine
• Thirst, dehydration, dry mouth
• Increased blood levels of potassium
• Electrolyte imbalance (electrolytes are minerals
such as calcium, chloride, magnesium, phosphate,
potassium, and sodium. For the body to function
properly, certain minerals need to be maintained in
an even balance)
• Low blood levels of sodium (hyponatraemia)
• Pain and swelling in one or more joints (gout)
• Rash, severe itching (pruritus), skin rashes with the
formation of wheals (urticaria)
• Flushing
• Excessive sweating (diaphoresis), fever
• Leg ache, muscle cramps, chest/back/joint pain,
neck/shoulder ache, pain in arms &/or legs
• Tingling or numbness in the hands or feet
(paraesthesia)
• Difficulty in sleeping (insomnia), restlessness
• Nervousness
• Shakiness (tremors)
• Mental confusion
• Depression
• Shortness of breath or difficulty in breathing
(dyspnoea), pneumonitis (inflammation of the lungs),
excess collection of watery fluid in the lungs
(pulmonary oedema), cough, blocked nose (nasal
congestion)
• Visual disturbances including a condition in which all
objects appear to have a yellowish tinge to them
(xanthopsia), blurred vision, increased pressure
inside the eye
• Inability to maintain an erection (impotence),
decreased libido


















Painful urination (dysuria), a need to wake and pass
urine at night (nocturia), unintentional passing of
urine (incontinence), increased production of urine
(polyuria), bladder spasm, glucose in the urine
(glycoscuria)
Kidney problems including kidney failure,
inflammation of the kidney (interstitial nephritis)
Liver problems including yellowing of the skin or
whites of the eyes (jaundice)
Hair loss (alopecia)
Disorder of the brain (encephalopathy)
Ringing in the ears (tinnitus)
Increased blood sugar levels (hyperglycaemia)
High level of uric acid in the blood (hyperuricaemia)
Abnormally low levels of potassium in blood
(hypokalaemia)
Abnormal sensitivity of the skin to sunlight
(photosensitivity)
Severe reduction in blood cells which can cause
weakness, bruising or make infections more likely
(aplastic anaemia)
Reduction in red blood cells which can make the
skin pale yellow and cause weakness or
breathlessness (haemolytic anaemia)
Reduction in blood cells which may increase the risk
of bleeding or bruising (thrombocytopenia) and/or
make infections more likely (leucopenia,
neutropenia, agranulocytosis)
Inflammation and damage of the blood vessel walls
that also affects the skin (necrotising angiitis,
vasculitis, purpura)

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the internet at
(www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of
this medicine.
5 How to store Co−amilozide
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date which
is stated on the container after "EXP". The expiry
date refers to the last date of that month.
• Store below 25°C. Store in the original package in
order to protect from light.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These
measures will help to protect the environment.
6 Contents of the pack and other information
What Co−amilozide contains:
Each 2.5/25mg tablet contains 2.5mg of Amiloride and
25mg of Hydrochlorothiazide
Each 5/50mg tablet contains 5mg of Amiloride and 50mg
of Hydrochlorothiazide
The other ingredients are: wheat starch, lactose
monohydrate, gelatin, talc and magnesium stearate.
What Co−amilozide looks like and contents of the
pack:
Co−amilozide 2.5/25mg tablets: slightly yellow, round,
scored tablets with a bevelled edge, with an approximate
diameter of 7mm with the code “EZ/3” on one side
Co−amilozide 5/50mg tablets: slightly yellow, round,
scored tablets with a bevelled edge, with an approximate
diameter of 8.5mm with the code “EV/7” on one side
Co−amilozide is available in:
Co−amilozide tablets are available in packs of: 28, 30,
56, 60, 100 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
ZeCare Ltd.
3 Howard Road
Eaton Socon
St Neots
Cambridgeshire
PE19 8ET
United Kingdom
Manufacturer:
A/S GEA Farmaceutisk Fabrik
Kanalholmen 8 - 18
DK-2650 Hvidovre
Denmark
Product Licence Numbers
Co-amilozide 2.5mg/25mg Tablets: PL 24581/0004
Co-amilozide 5mg/50mg Tablets: PL 24581/0005
This leaflet was last revised in January 2014

ZC-Ver.3.1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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