CAPOZIDE 50 TABLETS

Active substance: HYDROCHLOROTHIAZIDE

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S553 LEAFLET CAPOZIDE 20121011

5. How to store Capozide


Do not store above 25°C.



Do not take the tablets after the date shown on the carton over
label or blister strip.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.





Take special care with Capozide


if you suffer from excessive vomiting or diarrhoea.



if you are on a low-salt diet and you use salt substitutes or
supplements containing potassium.



if you have any liver or kidney problems (ask your doctor if you
have any doubt).



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPOZIDE 50 TABLETS

if you know that you have reduced blood circulation in the heart
muscle or a narrowing of the aorta (aortic stenosis) or the renal
artery (renal artery stenosis).



if you have had shock following heart failure (cardiogenic
shock).

(captopril/hydrochlorothiazide)
Your medicine is known as Capozide 50 Tablets but will be referred
to as Capozide throughout the following patient information leaflet.
Read all of this leaflet carefully before you start using this
medicine.

If the medicine become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or pharmacist

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.



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.

6. Further Information
What Capozide contains


Each tablet contains 50mg of captopril and 25mg of
hydrochlorothiazide, as the active ingredients.



The tablets also contain microcrystalline cellulose,
pregelatinised starch, stearic acid, magnesium stearate and
lactose.





1. What are Capozide is and what it is used for


3. How to take Capozide
5. How to store Capozide

What Capozide looks like and contents of the pack

6. Further information
1 What are Capozide is and what it is used for

Capozide is available in blister packs containing 30 tablets.


Capozide is a combination of two active substances, captopril and
hydrochlorothiazide.

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Captopril belongs to a group of medicinal products called
Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors
cause blood vessels to relax and the blood pressure to lower.
Hydrochlorothiazide is one of a group of medicinal products called
thiazide diuretics (also known as water tablets). They increase urine
output and hence decrease blood pressure.

Manufacturer

The two active substances in Capozide work together to decrease
blood pressure further than if either was given alone.

Product Licence holder

This product is manufactured by Bristol-Myers Squibb, rue du Dr.
Gilles, 28230 Epernon, France.
POM

Capozide is used in the treatment of high blood pressure (essential
hypertension), if treatment with captopril or hydrochlorothiazide
alone has not led to a sufficient decrease in blood pressure.

PL No. 19488/0553

if you are to have desensitisation treatment for wasp or bee
stings.
There have been some reports of allergic-type reactions when
people using medicinal products such as Capozide have such
desensitisation treatment. Tell your doctor before your
treatment.

4. Possible side effects

Capozide is white to off-white, oval, biconvex tablet; with a breakbar
on one side and engraved with "C H" on the other side. The tablet
can divided into equal halves.

if you are using dialysis.
There have been some reports of allergic-type reactions when
people using medicinal products such as Capozide undergo
dialysis with certain dialysis membranes [so called High-fluxHaemodialysis-Membranes or low density lipoprotein (LDL)apheresis with dextran sulphate absorption]. Tell your doctor
before your next dialysis treatment.

In this leaflet:
2. Before you take Capozide

if you suffer from diabetes.
Capozide may influence the effect of insulin or other antidiabetic medicines. Please ask your doctor for advice.

if you suffer from lupus or lupus-like disorders.

You must tell your doctor if you think you are (or might become)
pregnant. Capozide is 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).
Medicinal products containing lithium should not be taken with
Capozide without close monitoring by your doctor.
If you develop one of the following, contact your doctor
immediately:


swelling of the arms, legs, ankles, face, lips, tongue and/or
throat with difficulty swallowing or breathing,



any sign of infection (such as sore throat or fever) not readily
responding to the usual treatment,



Leaflet revision date: 11 October 2012
Capozide Tablets is a registered trade mark of ER Squibb & Sons
LLC, USA.
S553 LEAFLET CAPOZIDE 20121011

severe dizziness or fainting,

2 Before you take Capozide



severe abdominal pain,

Please read the following section attentively. It contains important
information which you and your doctor should observe prior to
taking of Capozide.



unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),



any sudden, unexplained rash or burning, red or peeling skin.

Do NOT take Capozide
Please inform following persons that you take Capozide:



if you are allergic (hypersensitive) to captopril or to any other
ACE inhibitors or to any of the other ingredients of Capozide.





if you are allergic to hydrochlorothiazide or to any other
sulphonamide derivatives.

the medical staff, especially the anaesthetist (if you are having
an operation) if you are hospitalised.



if you have previously been treated with a medicine in the same
group as Capozide (ACE inhibitors) and have had an allergic
reaction which caused swelling of the arms, legs, ankles, lips,
tongue and/or throat with difficulty in swallowing or breathing
(angioedema) or if a member of your family has had a similar
reaction.

your dentist before you have an anaesthetic for a dental
procedure.

If you are taking Capozide for the first time you may feel
lightheaded or dizzy for a short time and it may help to sit or lie
down. This is unlikely to happen when you are taking the tablets
regularly. If you are worried, contact your doctor.
Note:



if you have severe liver or kidney problems (ask your doctor if
you have any doubt).

The hydrochlorothiazide contained in this medicine could produce a
positive result in a doping test.



If you are more than 3 months pregnant. (It is also better to
avoid Capozide in early pregnancy – see pregnancy section.).



Capozide should not be given to children and adolescents (< 18
years).

Taking Capozide with other medicinal products
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicinal products, including medicinal
products obtained without a prescription. These include medicines
for a cold, cough, hay fever or sinus problems as these may
increase your blood pressure.

This applies in particular if you are also taking

Dosage:



some pain-killers which are also called 'anti inflammatories'
(e.g. indomethacin, ibuprofen),



lithium (for the treatment of mental disorders),

The usual dose is 1 tablet Capozide a day (corresponding to 50 mg
captopril and 25 mg hydrochlorothiazide). The maximum daily dose
of 1 tablet Capozide should not be exceeded.



carbenoxolone (for the treatment of gastrointestinal ulcers),



corticosteroids, corticotrophin (ACTH),



some laxatives,



injections of an antifungal (amphotericin),



muscle relaxants (given at the time of surgery),



cholestyramine resin, colestipol (for lowering blood cholesterol),



allopurinol (for the treatment of gout),



procainamide and digoxin or other cardiac glycosides
(treatment for irregular pulse),



cytostatic or immunosuppressive agents (e.g. azathioprine and
cyclophosphamide),



potassium supplements or salt substitutes containing
potassium, diuretics (water tablets, in particular those so called
potassium sparing), other drugs which can increase potassium
in your body (such as heparin),

Capozide tablets are for oral use only.



dry, irritating (non-productive) cough, breathing problems,



pains in the muscles and joints,

The tablets should be swallowed with a sufficient amount of fluid
(e.g. one glass of water). You can take Capozide with or without
food. You should try to take your daily dose at about the same time
each day, preferably in the morning. It is important that you
continue to take Capozide until your doctor tells you otherwise.



nausea, vomiting, gastric irritations, abdominal pain, diarrhoea,
constipation, dry mouth,



kidney problems,



impotence, swelling of the breasts in men,

skin problems such as itchiness and rash, hair loss.



fever,



changes in laboratory test values.

Special populations: If you suffer from moderate kidney disease,
diabetes, or if you have less salt or water in your body, your doctor
may prescribe a lower dose of Capozide for you, such as ½ tablet
Capozide (corresponding to 25 mg captopril and 12.5 mg
hydrochlorothiazide).
Elderly patients: your doctor may prescribe a lower dose of
Capozide for you, such as ½ tablet Capozide (corresponding to 25
mg captopril and 12.5 mg hydrochlorothiazide).
If you have the impression that the effect of Capozide is too strong
or too weak, talk to your doctor or pharmacist.
If you take more Capozide than you should



drugs used in diabetes (insulin and oral antidiabetics such as
sulphonyl ureas),



drugs used to treat psychotic conditions and some
antidepressants,

If you have accidentally taken too many tablets, or a child has
swallowed some, contact your doctor or pharmacist immediately.
Take the empty container and any remaining tablets with you.

You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Capozide before you become pregnant or as soon as you know you
are pregnant and will advise you to take another medicine instead
of Capozide. Capozide 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Capozide is not recommended for mothers who are breastfeeding.
Driving and using machines
Caution is necessary when driving or operating machinery if side
effects occur such as light-headedness, dizziness or tiredness. This
applies in particular at the start of the treatment, when the dosage is
changed or if you have had any alcohol.

a condition causing the skin to scale or peel (exfoliative
dermatitis),

taste impairment, dizziness,

carbamazepine (for the treatment of epilepsy)

Pregnancy



sleep disorders,



Pregnancy and breast-feeding

a series of skin reactions which can cause fluid-filled patches to
form (pemphigoid reactions),



drugs that reduce blood pressure by widening of the blood
vessels (e.g. minoxidil),

or any other treatment for high blood pressure.

a reddening of the skin (erythroderma),











Method of administration



Following uncommon side effects were observed (occurring in more
than 1in 1000 but fewer than 1 in 100 patients) that may occur with
captopril and other ACE inhibitors:


If you take more than you should you may experience the following:
passing water more frequently, a change in the levels of some
components in your blood, a large drop in your blood pressure, a
reduced awareness of yourself or your surrounding (which includes
coma), fits, a weakness in the muscles, an irregular or slower
heartbeat or reduced kidney function.
If another person has taken too many tablets and has fainted, lay
the person down and rest the person's feet higher than the person's
head.

heart problems such as an unusually fast or irregular heart
beat, chest pain (angina), feeling your heartbeat,

Following side effects that were observed with hydrochlorothiazide,
the second active substance contained in Capozide include:


swollen salivary glands,
side effects affecting the blood and its components which may
cause:



low blood pressure, impaired circulation in the fingers
(Raynaud's syndrome), flushing or pale skin,





swellings of the hands, face, lips or tongue,



decrease in performance,



chest pain, tiredness, feeling unwell.



tiredness



infection,

Following rare side effects were observed (occurring in less than 1
in 1000 but more than 1 in 10.000 patients) that may occur with
captopril and other ACE inhibitors:



sore throat or fever due to a lack of white blood cells,



a reduced ability for the blood to clot which may cause bleeding
or bruising



loss of appetite (anorexia),





drowsiness, headache, an abnormal sensation on your skin
such as a burning or prickle,



mouth problems such as sore mouth and mouth ulcers,

loss of appetite (anorexia), sugar in the urine, abnormal
changes in your blood components such as sugar, uric acid
(gout), sodium, potassium, high levels of cholesterol and other
lipids in the blood,



allergic reaction in the gut causing severe abdominal pain
(intestinal angioedema),



restlessness, depression, sleep disturbances,

calcium salts,



Following side effects were commonly observed (occurring in more
than 1in 100 but fewer than 1 in 10 patients) that may occur with
captopril and other ACE inhibitors:



kidney problems, increased or decreased urination.

Following very rare side effects were observed (occurring in 1 or
less in 10.000 patients including isolated reports) that may occur
with captopril and other ACE inhibitors:



pins and needles, light-headedness,



problems with the eyes and vision such as 'yellow vision' and
blurred vision,



dizziness,



low blood pressure, heart problems such as an irregular heart
beat,



side effects affecting the blood and its components such as:



If you forget to take Capozide



circulation problems such as inflammed blood vessels including
those in the skin and other organs (necrotising angiitis),

If you accidentally miss a daily dose, just take the next dose as
prescribed. Do not take a double dose to make up for the missed
tablet.

anaemia (reduced red blood cell count that may cause
decrease in performance and tiredness),



lung and breathing problems such as respiratory distress,





gastric irritation, diarrhoea, constipation, pancreatitis,



jaundice which causes the skin and eyes to turn yellow,

If you have any further questions about the use of this medicinal
product, ask your doctor or pharmacist.

lack of certain types of white blood cells which may cause
infection, sore throat, fever or bleeding (neutropenia,
agranulocytosis, pancytopenia),



a reduced ability of the blood to clot (thrombocytopenia) which
may cause bleeding or bruising



severe skin reactions such as:



sensitivity of the skin to light,

4 Possible side effects



confusion, depression,



rash,



stroke, fainting,



a condition that causes a characteristic red, blotchy, butterflyshaped rash over the cheeks and nose (lupus and lupus-like
reactions),



allergic reactions which cause the skin to itch and turn red
(urticaria),

Like all medicinal products, Capozide can cause side effects,
although not everybody gets them.



blurred vision,

Stop taking Capozide and seek medical attention immediately
if you experience any of the following:



heart attack,



chest problems (including:





difficulty in breathing or wheezing,





a blocked or runny nose, a type of pneumonia, caused by
changes in the blood or a condition which causes cough, fever,
shortness of breath and wheezing,

an over-reaction of the body's natural defence system
(hypersensitivity reactions),



muscle spasm,





kidney problems,

swollen tongue, stomach ulcers, pancreatitis (inflammation of
the pancreas which may cause a stomach ache),



fever, weakness.

swelling of the arms, legs, ankles, face, lips, tongue and/or
throat with difficulty in swallowing or breathing, sore throat or
fever,

Important information about some of the ingredients of
Capozide



severe dizziness or fainting,

Lactose (lactose monohydrate)



severe abdominal pain,

Capozide contains lactose monohydrate (see “Further information”).
If you have been told by your doctor that you have an intolerance to
some sugars (e.g. lactose), contact your doctor before taking this
medicine.



unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),





sudden unexplained skin reactions such as rash, burning, red
or peeling skin.

impaired liver function, including jaundice which causes the skin
and eyes to turn yellow, and inflammation of the liver (hepatitis),



severe skin reactions such as:



allergic reactions which cause the skin to itch and turn red
(urticaria),



a severe rash all over the body (Stevens-Johnson syndrome),



an allergic rash which causes pink-red patches which may have
clear centres (erythema multiforme),



sensitivity of the skin to light,

3 How to take Capozide
Always take Capozide exactly as your doctor has told you. You
should ask your doctor or pharmacist if you are not sure how to take
these tablets.
Your doctor has prescribed Capozide since previous treatment for
high blood pressure did not provide appropriate blood pressure
reduction. Your doctor will inform you how to switch from the
previous treatment to Capozide.

Below you will find separated side effects presented in order of
decreasing seriousness that were observed with captopril and/or
other ACE inhibitors and side effects that were observed with
hydrochlorothiazide.

If any of the side effects become severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

S553 LEAFLET CAPOZIDE 20121011

S553 LEAFLET captopril 20121011

5. How to store Captopril Tablets


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the carton over
label or blister strip.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.



If the medicine become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Take special care with Captopril Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50mg/25mg



if you suffer from excessive vomiting or diarrhoea.



if you are on a low-salt diet and you use salt substitutes or
supplements containing potassium.



if you have any liver or kidney problems (ask your doctor if you
have any doubt).



if you know that you have reduced blood circulation in the heart
muscle or a narrowing of the aorta (aortic stenosis) or the renal
artery (renal artery stenosis).



if you have had shock following heart failure (cardiogenic
shock).

TABLETS

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

Your medicine is known as Captopril and Hydrochlorothiazide
50mg/25mg Tablets but will be referred to as Captopril Tablets
throughout the following patient information leaflet.
Read all of this leaflet carefully before you start using 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.

6. Further Information



Each tablet contains 50mg of captopril and 25mg of
hydrochlorothiazide, as the active ingredients.



The tablets also contain microcrystalline cellulose,
pregelatinised starch, stearic acid, magnesium stearate and
lactose.

In this leaflet:
1. What are Captopril Tablets are and what they are used for
2. Before you take Captopril Tablets



3. How to take Captopril Tablets
5. How to store Captopril Tablets

Captopril Tablets are white to off-white, oval, biconvex tablet; with a
breakbar on one side and engraved with "C H" on the other side.
The tablet can divided into equal halves.

6. Further information

Captopril Tablets are available in blister packs containing 30
tablets.

1 What are Captopril Tablets are and what they are used for
Captopril Tablets are combination of two active substances,
captopril and hydrochlorothiazide.

if you are to have desensitisation treatment for wasp or bee
stings.
There have been some reports of allergic-type reactions when
people using medicinal products such as Captopril Tablets have
such desensitisation treatment. Tell your doctor before your
treatment.

4. Possible side effects
What Captopril Tablets look like and contents of the pack

if you are using dialysis.
There have been some reports of allergic-type reactions when
people using medicinal products such as Captopril Tablets
undergo dialysis with certain dialysis membranes [so called
High-flux-Haemodialysis-Membranes or low density lipoprotein
(LDL)-apheresis with dextran sulphate absorption]. Tell your
doctor before your next dialysis treatment.

What Captopril Tablets contain


if you suffer from diabetes.
Captopril Tablets may influence the effect of insulin or other
anti-diabetic medicines. Please ask your doctor for advice.



if you suffer from lupus or lupus-like disorders.

You must tell your doctor if you think you are (or might become)
pregnant. Captopril 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).

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Captopril belongs to a group of medicinal products called
Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors
cause blood vessels to relax and the blood pressure to lower.
Hydrochlorothiazide is one of a group of medicinal products called
thiazide diuretics (also known as water tablets). They increase urine
output and hence decrease blood pressure.

Manufacturer

The two active substances in Captopril Tablets work together to
decrease blood pressure further than if either was given alone.



swelling of the arms, legs, ankles, face, lips, tongue and/or
throat with difficulty swallowing or breathing,

Captopril Tablets are used in the treatment of high blood pressure
(essential hypertension), if treatment with captopril or
hydrochlorothiazide alone has not led to a sufficient decrease in
blood pressure.



any sign of infection (such as sore throat or fever) not readily
responding to the usual treatment,



severe dizziness or fainting,



severe abdominal pain,



unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),



any sudden, unexplained rash or burning, red or peeling skin.

Product Licence holder

This product is manufactured by Bristol-Myers Squibb, rue du Dr.
Gilles, 28230 Epernon, France.
POM

PL No. 19488/0553

Leaflet revision date: 11 October 2012

2 Before you take Captopril Tablets
S553 LEAFLET captopril 20121011

Please read the following section attentively. It contains important
information which you and your doctor should observe prior to
taking of Captopril Tablets.

Medicinal products containing lithium should not be taken with
Captopril Tablets without close monitoring by your doctor.
If you develop one of the following, contact your doctor
immediately:

Do NOT take Captopril Tablets

Please inform following persons that you take Captopril
Tablets:



if you are allergic (hypersensitive) to captopril or to any other
ACE inhibitors or to any of the other ingredients of Captopril
Tablets.



the medical staff, especially the anaesthetist (if you are having
an operation) if you are hospitalised.





if you are allergic to hydrochlorothiazide or to any other
sulphonamide derivatives.

your dentist before you have an anaesthetic for a dental
procedure.



if you have previously been treated with a medicine in the same
group as Captopril Tablets (ACE inhibitors) and have had an
allergic reaction which caused swelling of the arms, legs,
ankles, lips, tongue and/or throat with difficulty in swallowing or
breathing (angioedema) or if a member of your family has had a
similar reaction.



if you have severe liver or kidney problems (ask your doctor if
you have any doubt).



If you are more than 3 months pregnant. (It is also better to
avoid Captopril Tablets in early pregnancy – see pregnancy
section.).

Captopril Tablets should not be given to children and adolescents
(< 18 years).

If you are taking Captopril Tablets for the first time you may feel
lightheaded or dizzy for a short time and it may help to sit or lie
down. This is unlikely to happen when you are taking the tablets
regularly. If you are worried, contact your doctor.
Note:
The hydrochlorothiazide contained in this medicine could produce a
positive result in a doping test.
Taking Captopril Tablets with other medicinal products
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicinal products, including medicinal
products obtained without a prescription. These include medicines
for a cold, cough, hay fever or sinus problems as these may
increase your blood pressure.

This applies in particular if you are also taking

Dosage:



some pain-killers which are also called 'anti inflammatories'
(e.g. indomethacin, ibuprofen),



lithium (for the treatment of mental disorders),

The usual dose is 1 tablet Captopril Tablets a day (corresponding to
50 mg captopril and 25 mg hydrochlorothiazide). The maximum
daily dose of 1 tablet Captopril Tablets should not be exceeded.



carbenoxolone (for the treatment of gastrointestinal ulcers),



corticosteroids, corticotrophin (ACTH),



some laxatives,



injections of an antifungal (amphotericin),



muscle relaxants (given at the time of surgery),



cholestyramine resin, colestipol (for lowering blood cholesterol),



procainamide and digoxin or other cardiac glycosides
(treatment for irregular pulse),



cytostatic or immunosuppressive agents (e.g. azathioprine and
cyclophosphamide),



calcium salts,



potassium supplements or salt substitutes containing
potassium, diuretics (water tablets, in particular those so called
potassium sparing), other drugs which can increase potassium
in your body (such as heparin),



drugs that reduce blood pressure by widening of the blood
vessels (e.g. minoxidil),



drugs used in diabetes (insulin and oral antidiabetics such as
sulphonyl ureas),



drugs used to treat psychotic conditions and some
antidepressants,



or any other treatment for high blood pressure.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Captopril Tablets before you become pregnant or as soon as you
know you are pregnant and will advise you to take another medicine
instead of Captopril Tablets. Captopril Tablets are 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Captopril Tablets are not recommended for mothers who
are breast-feeding.

a reddening of the skin (erythroderma),



a series of skin reactions which can cause fluid-filled patches to
form (pemphigoid reactions),



a condition causing the skin to scale or peel (exfoliative
dermatitis),



sleep disorders,



taste impairment, dizziness,

Captopril Tablets are for oral use only.



dry, irritating (non-productive) cough, breathing problems,



pains in the muscles and joints,

The tablets should be swallowed with a sufficient amount of fluid
(e.g. one glass of water). You can take Captopril Tablets with or
without food. You should try to take your daily dose at about the
same time each day, preferably in the morning. It is important that
you continue to take Captopril Tablets until your doctor tells you
otherwise.



nausea, vomiting, gastric irritations, abdominal pain, diarrhoea,
constipation, dry mouth,



kidney problems,



impotence, swelling of the breasts in men,

skin problems such as itchiness and rash, hair loss.



fever,



changes in laboratory test values.

Special populations: If you suffer from moderate kidney disease,
diabetes, or if you have less salt or water in your body, your doctor
may prescribe a lower dose of Captopril Tablets for you, such as ½
tablet Captopril Tablets (corresponding to 25 mg captopril and 12.5
mg hydrochlorothiazide).



Following uncommon side effects were observed (occurring in more
than 1in 1000 but fewer than 1 in 100 patients) that may occur with
captopril and other ACE inhibitors:


heart problems such as an unusually fast or irregular heart
beat, chest pain (angina), feeling your heartbeat,

Following side effects that were observed with hydrochlorothiazide,
the second active substance contained in Captopril Tablets include:


swollen salivary glands,
side effects affecting the blood and its components which may
cause:

If you have the impression that the effect of Captopril Tablets are
too strong or too weak, talk to your doctor or pharmacist.



low blood pressure, impaired circulation in the fingers
(Raynaud's syndrome), flushing or pale skin,




Elderly patients: your doctor may prescribe a lower dose of
Captopril Tablets for you, such as ½ tablet Captopril Tablets
(corresponding to 25 mg captopril and 12.5 mg
hydrochlorothiazide).

carbamazepine (for the treatment of epilepsy)





Method of administration

allopurinol (for the treatment of gout),



Following side effects were commonly observed (occurring in more
than 1in 100 but fewer than 1 in 10 patients) that may occur with
captopril and other ACE inhibitors:

swellings of the hands, face, lips or tongue,



decrease in performance,



chest pain, tiredness, feeling unwell.



tiredness



infection,

Following rare side effects were observed (occurring in less than 1
in 1000 but more than 1 in 10.000 patients) that may occur with
captopril and other ACE inhibitors:



sore throat or fever due to a lack of white blood cells,



a reduced ability for the blood to clot which may cause bleeding
or bruising



loss of appetite (anorexia), sugar in the urine, abnormal
changes in your blood components such as sugar, uric acid
(gout), sodium, potassium, high levels of cholesterol and other
lipids in the blood,



restlessness, depression, sleep disturbances,



loss of appetite (anorexia),

If you take more Captopril Tablets than you should



If you have accidentally taken too many tablets, or a child has
swallowed some, contact your doctor or pharmacist immediately.
Take the empty container and any remaining tablets with you.

drowsiness, headache, an abnormal sensation on your skin
such as a burning or prickle,



mouth problems such as sore mouth and mouth ulcers,



allergic reaction in the gut causing severe abdominal pain
(intestinal angioedema),

If you take more than you should you may experience the following:
passing water more frequently, a change in the levels of some
components in your blood, a large drop in your blood pressure, a
reduced awareness of yourself or your surrounding (which includes
coma), fits, a weakness in the muscles, an irregular or slower
heartbeat or reduced kidney function.
If another person has taken too many tablets and has fainted, lay
the person down and rest the person's feet higher than the person's
head.
If you forget to take Captopril Tablets
If you accidentally miss a daily dose, just take the next dose as
prescribed. Do not take a double dose to make up for the missed
tablet.
If you have any further questions about the use of this medicinal
product, ask your doctor or pharmacist.



kidney problems, increased or decreased urination.

Following very rare side effects were observed (occurring in 1 or
less in 10.000 patients including isolated reports) that may occur
with captopril and other ACE inhibitors:



pins and needles, light-headedness,



problems with the eyes and vision such as 'yellow vision' and
blurred vision,



dizziness,



low blood pressure, heart problems such as an irregular heart
beat,



side effects affecting the blood and its components such as:





anaemia (reduced red blood cell count that may cause
decrease in performance and tiredness),

circulation problems such as inflammed blood vessels including
those in the skin and other organs (necrotising angiitis),



lung and breathing problems such as respiratory distress,



lack of certain types of white blood cells which may cause
infection, sore throat, fever or bleeding (neutropenia,
agranulocytosis, pancytopenia),



gastric irritation, diarrhoea, constipation, pancreatitis,



jaundice which causes the skin and eyes to turn yellow,



severe skin reactions such as:



sensitivity of the skin to light,



a reduced ability of the blood to clot (thrombocytopenia) which
may cause bleeding or bruising



confusion, depression,



rash,



a condition that causes a characteristic red, blotchy, butterflyshaped rash over the cheeks and nose (lupus and lupus-like
reactions),



allergic reactions which cause the skin to itch and turn red
(urticaria),



stroke, fainting,

Driving and using machines

4 Possible side effects



blurred vision,

Caution is necessary when driving or operating machinery if side
effects occur such as light-headedness, dizziness or tiredness. This
applies in particular at the start of the treatment, when the dosage is
changed or if you have had any alcohol.

Like all medicinal products, Captopril Tablets can cause side
effects, although not everybody gets them.
Stop taking Captopril Tablets and seek medical attention
immediately if you experience any of the following:



heart attack,



chest problems (including:



difficulty in breathing or wheezing,







a blocked or runny nose, a type of pneumonia, caused by
changes in the blood or a condition which causes cough, fever,
shortness of breath and wheezing,

an over-reaction of the body's natural defence system
(hypersensitivity reactions),



muscle spasm,





kidney problems,

swollen tongue, stomach ulcers, pancreatitis (inflammation of
the pancreas which may cause a stomach ache),



fever, weakness.



impaired liver function, including jaundice which causes the skin
and eyes to turn yellow, and inflammation of the liver (hepatitis),

Important information about some of the ingredients of
Captopril Tablets
Lactose (lactose monohydrate)

swelling of the arms, legs, ankles, face, lips, tongue and/or
throat with difficulty in swallowing or breathing, sore throat or
fever,

3 How to take Captopril Tablets
Always take Captopril Tablets exactly as your doctor has told you.
You should ask your doctor or pharmacist if you are not sure how to
take these tablets.
Your doctor has prescribed Captopril Tablets since previous
treatment for high blood pressure did not provide appropriate blood
pressure reduction. Your doctor will inform you how to switch from
the previous treatment to Captopril Tablets.

severe dizziness or fainting,



severe abdominal pain,



unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),



severe skin reactions such as:



Captopril Tablets contain lactose monohydrate (see “Further
information”). If you have been told by your doctor that you have an
intolerance to some sugars (e.g. lactose), contact your doctor
before taking this medicine.



sudden unexplained skin reactions such as rash, burning, red
or peeling skin.



allergic reactions which cause the skin to itch and turn red
(urticaria),



a severe rash all over the body (Stevens-Johnson syndrome),



an allergic rash which causes pink-red patches which may have
clear centres (erythema multiforme),



sensitivity of the skin to light,

Below you will find separated side effects presented in order of
decreasing seriousness that were observed with captopril and/or
other ACE inhibitors and side effects that were observed with
hydrochlorothiazide.

If any of the side effects become severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
S553 LEAFLET captopril 20121011

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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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