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CO-ZIDOCAPT 25/12.5MG TABLETS

Active substance(s): CAPTOPRIL / HYDROCHLOROTHIAZIDE

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PATIENT INFORMATION LEAFLET

Co-zidocapt 25/12.5mg & 50/25mg Tablets
(Captopril + 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
2
3

1

What Co-zidocapt is and what it is
used for

Co−zidocapt Tablets contain a combination of Captopril
and Hydrochlorothiazide (HCT). Captopril is one of a group
of medicines known as ACE (Angiotensin−Converting
Enzyme) Inhibitors. These work by expanding your blood
vessels making it easier for your heart to pump blood to
your body. Hydrochlorothiazide (HCT) is one of a group of
medicines known as 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.
Captopril + Hydrochlorothiazide Tablets (referred to as Co−
zidocapt throughout this leaflet) are used for the treatment
of mild to moderate high blood pressure (hypertension) in
patients who have been stabilised on the individual
medicines given in the same proportions. The combination
tablet of Captopril and Hydrochlorothiazide is particularly
suitable for older patients and those patients requiring
lower doses. By combining lower doses than might be
required if each component were used alone, side effects
can be minimised.

2

4
5
6

What Co−zidocapt is and what it is used for
What you need to know before you take Co−zidocapt
How to take Co−zidocapt

What you need to know before
you take Co-zidocapt

Do not take Co−zidocapt if:
 You are allergic (hypersensitive) to Captopril,
Hydrochlorothiazide, other ACE Inhibitors, other
Sulphonamides or any of the other ingredients of this
medicine (See Section 6 "Contents of the pack and
other information")
 You are more than 3 months pregnant (It is also better
to avoid Co−zidocapt in early pregnancy − see
Pregnancy section)
 You have suffered from swelling of the deeper layers of
the skin, caused by a build−up of fluid linked to previous
treatment with an ACE Inhibitor (angioedema)
 You are prone to or have a history of red, itchy swelling
of the eyes, lips, tongue, throat or hands
(hereditary/idiopathic angioneurotic oedema)
 You suffer from severe kidney problems
 You suffer from severe liver problems
 You have diabetes or impaired kidney function and you
are treated with a blood pressure lowering medicine
containing aliskiren
Warnings and precautions
Talk to your doctor before taking Co−zidocapt:
 If you are due to have a surgical operation. You should
make sure that the anaesthetist is aware you are taking
Co−zidocapt
 If you are due to take an anti−doping test, a bentiromide
test, thyroid tests or a urine test for acetone (see "Other
medicines and Co−zidocapt")
 If you are suffering from dehydration as a result of
diuretic treatment, low salt diet, diarrhoea, vomiting
(being sick) or dialysis. Symptoms of dehydration
include: dry mouth, thirst, weakness, lack of energy,
drowsiness, restlessness, muscle pain or cramps, low
blood pressure (hypotension), decreased production of
urine (oliguria), faster heartbeat (tachycardia) feeling
(nausea) or being sick (vomiting)
 If you suffer from heart failure or other heart problems
 If you suffer from a condition that affects the circulation
of blood to the brain
 If you suffer from kidney problems or narrowing of the
arteries in the kidneys
 If you are black as black patients receiving ACE inhibitor
treatment have been reported to have a higher
incidence of angioedema (swelling of the deeper layers
of the skin, caused by a build−up of fluid) than in
non−black patients. Additionally, Co−zidocapt may be
less effective in lowering blood pressure in black
patients than in non−black patients
 Patients with a history of angioedema (swelling of the
deeper layers of the skin, caused by a build−up of fluid)
unrelated to ACE inhibitor treatment may be at
increased risk of developing angioedema while taking
Co−zidocapt
 If you are currently suffering from a dry, persistent
cough (this will usually go after stopping treatment with
Co−zidocapt)
 If you suffer from liver problems
 If you have high levels of potassium in the blood
(hyperkalaemia), are currently taking potassium−sparing
diuretics, potassium supplements or
potassium−containing salt substitutes or other medicines
associated with increases in potassium (e.g. heparin)
(see "Other medicines and Co−zidocapt")
 If you are diabetic, especially if you take oral anti−
diabetic medicines or insulin (see "Other medicines and
Co−zidocapt")
 If you suffer from collagen vascular disease (disease
where problems with the immune system cause
inflammation or weakness of collagen [connective
tissue])
 If you are receiving treatment to reduce your immune
response
 If you are taking allopurinol &/or procainamide (see
"Other medicines and Co−zidocapt")
 If you show signs of infection e.g. sore throat, fever
 If you are receiving treatment to reduce the effects of an
allergy to a bee or wasp sting
 If you are on dialysis, especially with high−flux dialysis
membranes
 If you are having treatment to remove high levels of
cholesterol by a procedure called Low−Density
Lipoprotein (LDL) apheresis with dextran sulphate
 If you are currently taking corticosteroids or ACTH
[Adreno CorticoTropic Hormone] (see "Other medicines
and Co−zidocapt")
 If you have high levels of calcium in the blood
(hypercalcaemia)
 If you have an abnormally low level of magnesium in the
blood (hypomagnesaemia)
 If you have a history of allergic reactions or suffer from
bronchial asthma
 If you suffer from Systemic Lupus Erythematosus
(long−term inflammation of skin)
 If you are taking lithium (see "Other medicines and
Co−zidocapt")
 If you are taking any of the following medicines used to
treat high blood pressure:
o
an angiotensin II receptor blocker (ARBs) (also
known as sartans − for example valsartan,
telmisartan, irbesartan), in particular if you have

Hard to Read?

o

Possible side effects
How to store Co−zidocapt
Contents of the pack and other information
diabetes−related kidney problems.
aliskiren

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g. potassium)
in your blood at regular intervals. See also information
under the heading ˆDo not take Co−zidocapt˜
You must tell your doctor if you think you are (or might
become) pregnant. Co−zidocapt tablets are not
recommended in early pregnancy and must not be taken if
you are more than 3 months pregnant, as it may cause
serious harm to your baby if used at that stage (See
Pregnancy section).
Other medicines and Co−zidocapt
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−zidocapt:
 If you are due to have a surgical procedure. You should
make sure that the anaesthetist is aware you are taking
Co−zidocapt
 Clonidine, a medicine used to treat high blood pressure
 Medicines used to increase frequency of urination e.g.
spironolactone, triamterene, amiloride
(Potassium−Sparing Diuretics), Thiazide Diuretics such
as bendrofluazide and Loop Diuretics such as
torasemide
 Potassium−containing supplements or salt substitutes
 Medicines used to treat high blood pressure such as
propranolol (Beta Blockers), verapamil (Calcium
Channel Blockers) and doxazosin (Alpha Blockers)
 Medicines used to treat angina and heart failure e.g.
nitroglycerine, other nitrates and other Vasodilators
(medicines used to widen the blood vessels)
 Medicines used to treat depression such as imipramine
(Tricyclic Antidepressants)
 Medicines used to treat mood disorders e.g. lithium
(Anti−Psychotics)
 Allopurinol, a medicine used to treat gout
 Procainamide, a medicine used to treat irregular
heartbeats (Cardiac Glycosides)
 Medicines used to treat cancer such as
cyclophosphamide (Cytostatics)
 Medicines used to reduce the body’s immunity when
receiving organ transplant e.g. ciclosporin
(Immunosuppressants)
 Medicines used to treat serious allergic reaction
(anaphylaxis) such as epinephrine (Adrenaline)
(Sympathomimetics)
 Medicines used to treat diabetes e.g. insulin,
sulphonylurea (Antidiabetics)
 Amphotericin B, a medicine used to treat fungal
infections
 Carbenoxolone, a medicine used to treat inflammation
of the gullet and oral ulcers
 Medicines used to reduce inflammation such as
prednisolone (Corticosteroids)
 Corticotropin (AdrenoCorticoTropic Hormone − ACTH)
 Medicines used to treat constipation e.g. senna
(Stimulant Laxative)
 Cholestyramine, Colestipol, medicines used to lower
cholesterol. (Co−zidocapt should be taken at least 1
hour before or 4−6 hours after taking these medicines)
 Tubocurarine, a muscle relaxant
 Medicines known to induce Torsades de Pointes such
as erythromycin. This may include some
Anti−Arrhythmics such as amiodarone and some
Anti−Psychotics such as chlorpromazine
 Carbamazepine, a medicine used to treat epileptic
seizures
 Medicines used to treat certain rheumatic disorders e.g.
indomethacin (Non−Steroidal Anti−Inflammatory Drugs
− NSAIDs)
 Medicines associated with increases in serum
potassium e.g. heparin
Your doctor may need to change your dose and/or to take
other precautions:
 If you are taking an angiotensin II receptor blocker
(ARB) or aliskiren (see also information under the
headings "Do not take Co−zidocapt " and "Warnings
and precautions")
Tests
 Hydrochlorothiazide (HCT) contained in this medicine
could produce a positive analytical result in an
anti−doping test
 Hydrochlorothiazide (HCT) contained in this medicine
may cause diagnostic interference of a Bentiromide Test
 Hydrochlorothiazide (HCT) contained in this medicine
may affect thyroid tests
 Captopril contained in this medicine may cause a
false−positive urine test for acetone
Co−zidocapt and alcohol
During treatment with Co−Zidocapt, it is advisable not to
drink alcohol.
Pregnancy and breast−feeding
If you are pregnant or breast−feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Pregnancy
If you are pregnant or breast−feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Your doctor will normally advise you to stop taking Co−
zidocapt before you become pregnant or as soon as you
know you are pregnant and will advise you to take another
medicine instead of Co−zidocapt. Co−zidocapt is not
recommended during pregnancy and must not be taken
when more than 3 months pregnant, as it may cause
serious harm to your baby if used after the third month of
pregnancy.
Breast−feeding
Treatment with Co−zidocapt is not recommended whilst
breast−feeding premature or new−born infants.
In the case of an older baby, the use of Co−zidocapt may
be considered if the treatment is necessary for the mother
and the child is observed for any adverse side effects.
If Co−zidocapt is used during breast feeding, doses should
be kept as low as possible.
An allergy (hypersensitivity) to sulphonamide−derived
medicines, lower level of potassium in the blood than
normal (hypokalaemia) and yellowing of the skin and/or the
whites of the eyes (jaundice) might occur.

Phone

continued....

0800 970 6115

for help
Till−Ver.7.1s

Driving and using machines
The ability to drive and use machines may be reduced, This
is more likely to occur at the start of treatment, when the
dose is changed or if you drink alcohol. If this is
experienced, it may be necessary to avoid driving
oroperating machinery or pursuing any activity in which full
attention is required.









Co−zidocapt contains lactose
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicine.



Confusion
Depression
Stroke (Cerebrovascular Accident [CVA])
Feeling faint (Syncope)
Blurred vision
Heart abruptly stops beating (Cardiac Arrest)
The blood supply being pumped by the heart muscle
needs oxygen (Cardiogenic Shock)
Shortness of breath or difficulty in breathing
(Bronchospasm/Allergic Alveolitis)
Cold−like symptoms; sneezing, itchiness, blocked/runny
nose (Rhinitis)
Collective symptoms of cough, fever, difficulty breathing,
and sweating at night (Eosinophilic Pneumonia)
Inflammation or infection of the tongue (Glossitis)
Stomach ulcer
Inflammation of the pancreas (Pancreatitis)
Liver failure or other liver disorders including Jaundice
(yellowing of skin and eyes)
Skin rashes with the formation of wheals (Urticaria)
Abnormal sensitivity of the skin to sunlight
(Photosensitivity)
Skin disorders (Erythroderma/Exfoliative Dermatitis)
Muscle and/or joint pain (Myalgia/Arthralgia)
Protein in the urine (Nephrotic Syndrome/Proteinuria)
Inability to maintain an erection (Impotence)
Excessive development of the male breast
(Gynaecomastia)
Fever
Frequent wheezing, breathlessness, stomach pain,
diarrhoea, fever, cough and rashes due to an increase in
certain white blood cells (Eosinophilia)
Low blood levels of sodium which can cause tiredness
and confusion, muscle twitching, fits and coma
(Hyponatraemia)
Increase of urea or creatinine in the blood (may be a
sign of kidney problems)
Decrease in levels of haemoglobin (a protein that
transports oxygen) in the blood
Decrease in levels of haematocrit (a blood test [as part
of a complete blood count] that measures the
percentage of red blood cells [depending on the number
and size of red blood cells] of the volume of whole blood)
Increased Erythrocyte Sedimentation Rate [ESR] (a
blood screening test that indirectly measures how much
inflammation is in the body)
Weight loss




3

How to take Co-zidocapt

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:
The usual dose is one tablet daily.
Elderly patients
The dose should be kept as low as possible to achieve
adequate blood pressure control. In some patients, Co−
zidocapt 25/12.5mg may be sufficient.
Patients with severe kidney problems:
Co−zidocapt is not recommended.
Use in children
Do not give this medicine to children.



















If you take more Co−zidocapt 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 are: increased urine output,
imbalance of fluids in the body, severely low blood

pressure, loss of consciousness including coma, fits, loss of
Not known (frequency cannot be estimated from the
movement, irregular heartbeat, slowing of the heart beat,
available data):
kidney failure.
 Serum sickness (a type of delayed allergic reaction)
If you forget to take Co−zidocapt
 Inflammation of the salivary glands (Sialadentitis)
Take it as soon as you remember, unless it is nearly time
 Abnormal condition of the bone marrow in which it is
for your next dose.
unable to produce normal amounts of red blood cells,
If you miss a dose, do not take a double dose to make up
white blood cells, and platelets leaving the immune
for a forgotten dose.
system in a weakened state and vulnerable to infection
(Bone Marrow Depression)
If you stop taking Co−zidocapt
 High blood sugar levels (Hyperglycaemia)
It is important that you keep taking Co−zidocapt for as long
 Glucose in the urine (Glycosuria)
as your doctor has told you to. Do not stop taking the
 Abnormally high level of uric acid in the blood
tablets even though you may feel better. Do not stop or
(Hyperuricaemia)
change your treatment before talking to your doctor.
 Imbalance of fluids in the body. Symptoms include dry
mouth, thirst, weakness, tiredness, drowsiness,
If you have any further questions on the use of this
restlessness, muscle pain, cramps, being/feeling sick
medicine, ask your doctor or pharmacist.
(Electrolyte Imbalance)
 Increased level of fats (cholesterol and triglyceride) in
Possible side effects
your blood
 Restlessness
 Objects appear yellow (Xanthopsia)
Like all medicines, this medicine can cause side effects,
 Feeling of dizziness or "spinning" (Vertigo)
although not everybody gets them.
 Low blood pressure which may cause dizziness,
Stop taking Co−zidocapt and seek medical advice
light−headedness or fainting on standing up (Postural
immediately if you develop the following symptoms:
Hypotension)
 Allergic reactions: swelling of the hands, face, feet,
 Inflammation and damage of the blood vessel walls that
eyelids, lips, tongue, throat, difficulty breathing, itching,
also affects the skin (Necrotising Angiitis)
dizziness (Anaphylaxis)
 Inflammation of the blood vessels often with skin rash
 Blistering of the skin (Toxic Epidermal
(Vasculitis)
Necrolysis/Pemphigus), mouth, eyes or genitals
 Inflammation of the lung (Pneumonitis) or an excess
(Stevens−Johnson Syndrome)
collection of watery fluid in the lungs (Pulmonary
 Fever, general ill feeling, itching, joint aches, multiple
Oedema)
skin lesions (Erythema Multiforme)
 Condition which causes joint pain, skin rashes and fever
 Swelling of the deeper layers of the skin, caused by a
(Lupus Erythematosus)
build−up of fluid (Angioedema)
 Muscle spasm
 Skin rash resulting from bleeding into the skin (Purpura)
Common Side Effects (may affect up to 1 in 10 people):  General weakness
 Sleep disorders
 Loss of taste and/or dry mouth
Reporting of side effects
 Dizziness or lightheadedness
If you get any side effects, talk to your doctor or pharmacist.
 Dry, persistent cough (this should stop after stopping
This includes any possible side effects not listed in this
treatment with Co−zidocapt)
leaflet. You can also report side effects directly via the
 Shortness of breath (Dyspnoea)
internet at (www.mhra.gov.uk/yellowcard). By reporting side
 Feeling or being sick (Nausea/Vomiting)
effects you can help provide more information on the safety
 Upset stomach and/or stomach pain
of this medicine.
 Diarrhoea
 Constipation
How to store Co-Zidocapt
 Itching with or without a rash (Pruritus)
 Skin rashes
 Hair loss (Alopecia)
 Keep this medicine out of the sight and reach of children.
Uncommon Side Effects (may affect up to 1 in 100
 Do not use this medicine after the expiry date which is
people):
stated on the carton/blister after "EXP". The expiry date
 Faster heart beat (Tachycardia/Tachyarrhythmia)
refers to the last date of that month.
 Chest pain (Angina Pectoris)
 Do not store above 25°C.
 Feeling your heartbeat (Palpitations)
 Do not throw away any medicines via wastewater or
 Low blood pressure (Hypotension)
household waste. Ask your pharmacist how to throw
 Tingling or numbness in the fingers, toes, ears or nose
away medicines you no longer use. These measures will
(Raynauds Syndrome)
help to protect the environment.
 Reddening of the face (Flushing) or paling of the skin
Contents of the pack and other
(Pallor)
information
 Chest pain
 Feeling tired (Fatigue)
What Co−zidocapt contains:
 Generally unwell (Malaise)
Each 25/12.5mg tablet contains 25mg of Captopril and
12.5mg of Hydrochlorothiazide
Rare Side Effects (may affect up to 1 in 100 people):
Each 50/25mg tablet contains 50mg of Captopril and 25mg
 Loss of appetite (Anorexia)
of Hydrochlorothiazide
 Drowsiness
 Headache
 Tingling or numbness in the hands or feet (Paraesthesia) The other ingredients are: lactose monohydrate,
magnesium stearate, maize starch, microcrystalline
 Inflammation and/or ulcers in the mouth (Stomatitis)
cellulose and stearic acid.
 Kidney problems including kidney failure and
inflammation of the kidneys (Interstitial Nephritis)
What Co−zidocapt looks like and contents of the pack:
 Passing urine less frequently (Oliguria)
Co−zidocapt 25/12.5mg tablets: white to off−white, round
 Passing urine more frequently (Polyuria)
tablets with an approximate diameter of 7mm with a score
notch
Very Rare Side Effects (may affect up to 1 in 10,000
Co−zidocapt 50/25mg tablets: white to off−white, round
people):
tablets with an approximate diameter of 10mm with a score
 Abnormally low level or decrease of white blood cells in
notch
the blood &/or make infections more likely
Co−zidocapt is available in:
(Neutropenia/Agranulocytosis/Leucopenia)
Co−zidocapt tablets are available in packs of: 20, 28, 50 or
 Severe reduction in blood cells which can cause
100 tablets.
weakness, bruising or make infections more likely
(Pancytopenia), especially in patients suffering from
Not all pack sizes may be marketed.
kidney problems
 Reduction in red blood cells which may cause pale skin
Marketing Authorisation Holder:
and feeling of tiredness (Anaemia)
Tillomed Laboratories Ltd,
 Severe reduction in blood cells which can cause
3 Howard Road, Eaton Socon, St Neots,
weakness, bruising or make infections more likely
Cambridgeshire, PE19 8ET, United Kingdom.
(Aplastic Anaemia)
 Reduction in red blood cells which can make the skin
Manufacturer:
pale yellow and cause weakness or breathlessness
Salutas Pharma GmbH,
(Haemolytic Anaemia)
Otto−von−Guericke−Allee 1,
 Reduction in blood platelets, which increases the risk of
39179 Barleben, Germany.
bleeding or bruising (Thrombocytophenia)
 Swollen/enlarged lymph nodes (Lymphadenopathy)
Product Licence Numbers
 Auto−immune diseases and/or positive ANA−titres (a
Co−zidocapt 25/12.5mg Tablets − PL 11311/0030
positive ANA, [Anti−Nuclear Antibody] titer can be the
indication of a variety of diseases or conditions.This test Co−zidocapt 50/25mg Tablets − PL 11311/0031
is often used to diagnose auto−immune diseases,
This leaflet was last revised in November 2014
especially lupus
 High levels of blood potassium which can cause
abnormal heart rhythm (Hyperkalaemia)
 Low blood sugar (Hypoglycaemia)
 Increased acidity in the blood (Acidosis)

4

5

6

Hard to Read?

Phone

0800 970 6115

for help
Till−Ver.7.1s

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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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