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CAPOZIDE 50 TABLETS

Active substance(s): CAPTOPRIL / HYDROCHLOROTHIAZIDE

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S553 LEAFLET Capozide 20150721

5. How to store Capozide


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.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPOZIDE 50 TABLETS



Warnings and precautions
Talk to your doctor before taking Capozide and if any of the
following apply to you:

(captopril/hydrochlorothiazide)

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.



if you suffer from excessive vomiting or diarrhoea.

Your medicine is known as Capozide 50 Tablets but will be referred
to as Capozide throughout the following patient information leaflet.



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).

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.

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 have had shock following heart failure (cardiogenic
shock).









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.

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



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.



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.



if you suffer from lupus or lupus-like disorders.



if you have changes in your vision or pain in one or both of your
eyes while taking Capozide. This could be a sign that you are
developing glaucoma, increased pressure in your eye(s). You
should discontinue Capozide treatment and seek medical
attention.

6. Contents of the pack and other 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.

What is in this leaflet
1. What Capozide is and what it is used for
2. What you need to know before you take Capozide
3. How to take Capozide
4. Possible side effects

What Capozide looks like and contents of the pack

5. How to store Capozide

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.

6. Contents of the pack and other information

Capozide is available in blister packs containing 30 tablets.

1. What Capozide is and what it is used for
Capozide is a combination of two active substances, captopril and
hydrochlorothiazide.

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

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.
The two active substances in Capozide work together to decrease
blood pressure further than if either was given alone.
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 19488/0553

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:

Leaflet revision date: 21 July 2015

2. What you need to know before you take Capozide



Capozide Tablets is a registered trade mark of ER Squibb & Sons
LLC, USA.

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

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,



severe dizziness or fainting,

Do not take Capozide



severe abdominal pain,





unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),



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

S553 LEAFLET Capozide 20150721

if you are allergic to captopril or to any other ACE inhibitors or
to any of the other ingredients of this medicine (listed in section
6).



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



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.



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 Capozide in early pregnancy – see pregnancy section.).

Please inform following persons that you take Capozide:


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



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

Children and adolescents

3. How to take Capozide

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

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Other medicines and Capozide
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, 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


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

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.
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:

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.



lithium (for the treatment of mental disorders),
carbenoxolone (for the treatment of gastrointestinal ulcers),

Capozide tablets are for oral use only.



corticosteroids, corticotrophin (ACTH),



some laxatives,



injections of an antifungal (amphotericin),

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.



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



nausea, vomiting, gastric irritations, abdominal pain, diarrhoea,
constipation, dry mouth,
skin problems such as itchiness and rash, hair loss.



pains in the muscles and joints,



kidney problems,



impotence, swelling of the breasts in men,



fever,



changes in laboratory test values.

taste impairment, dizziness,



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

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:

Method of administration



sleep disorders,



Dosage:







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),



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),

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).

Tell your doctor if you are breast-feeding or about to start breastfeeding. Capozide is not recommended for mothers who are breastfeeding.

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.
Capozide contains lactose monohydrate. 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.

restlessness, depression, sleep disturbances,



pins and needles, light-headedness,



problems with the eyes and vision such as ‘yellow vision’ and
blurred vision, decrease in vision and eye pain (possible signs
of acute-angle closure glaucoma),
dizziness,





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

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





kidney problems, increased or decreased urination.

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,



gastric irritation, diarrhoea, constipation, pancreatitis,



jaundice which causes the skin and eyes to turn yellow,



severe skin reactions such as:

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.

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:


side effects affecting the blood and its components such as:


If you forget to take Capozide



confusion, depression,

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.



stroke, fainting,



blurred vision,



heart attack,



chest problems (including:

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.


Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop taking Capozide and seek medical attention immediately
if you experience any of the following:


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



severe dizziness or fainting,



severe abdominal pain,



unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),



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

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,



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



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:


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



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



sensitivity of the skin to light,



a reddening of the skin (erythroderma),



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

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



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



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



muscle spasm,



kidney problems,



fever, weakness.

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 address below. By
reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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



rash,



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

sensitivity of the skin to light,



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



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.



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



4. Possible side effects
Driving and using machines





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.

Breast-feeding

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:

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,

mouth problems such as sore mouth and mouth ulcers,

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

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.

chest pain, tiredness, feeling unwell.







Pregnancy



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

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

Pregnancy and breast-feeding

swellings of the hands, face, lips or tongue,

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



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

carbamazepine (for the treatment of epilepsy)

or any other treatment for high blood pressure.









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

infection,

loss of appetite (anorexia),

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

drugs used to treat psychotic conditions and some
antidepressants,



tiredness



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

decrease in performance,





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).









It is important that you continue to take Capozide until your doctor
tells you otherwise.



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:

S553 LEAFLET Capozide 20150721

S553 LEAFLET Captopril 20150721

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.

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

Warnings and precautions
Talk to your doctor before taking Captopril Tablets and if any of the
following apply to you:


if you suffer from excessive vomiting or diarrhoea.

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.



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).

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



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).

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.

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



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



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



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







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.



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.



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.



if you suffer from lupus or lupus-like disorders.



if you have changes in your vision or pain in one or both of your
eyes while taking Captopril Tablets. This could be a sign that
you are developing glaucoma, increased pressure in your
eye(s). You should discontinue Captopril Tablets treatment and
seek medical attention.

6. Contents of the pack and other information
What Captopril Tablets 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.

What Captopril Tablets looks like and contents of the pack
Captopril Tablets 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.

What is in this leaflet
1. What Captopril Tablets is and what it is used for
2. What you need to know before you take Captopril Tablets
3. How to take Captopril Tablets
4. Possible side effects
5. How to store Captopril Tablets
6. Contents of the pack and other information

Captopril Tablets is available in blister packs containing 30 tablets.

1. What Captopril Tablets is and what it is used for

Product Licence holder

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

Manufacturer

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.

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

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

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

Medicinal products containing lithium should not be taken with
Captopril Tablets without close monitoring by your doctor.

POM

Captopril Tablets 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.

If you develop one of the following, contact your doctor
immediately:

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.

PL 19488/0553

Leaflet revision date: 21 July 2015
S553 LEAFLET Captopril 20150721

2. What you need to know before you take Capozide
Please read the following section attentively. It contains important
information which you and your doctor should observe prior to
taking of Captopril Tablets.
Do not take Captopril Tablets


if you are allergic to captopril or to any other ACE inhibitors or
to any of the other ingredients of this medicine (listed in section
6).



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,



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.



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

Please inform following persons that you take Captopril
Tablets:



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.



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



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



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.).

If you are taking Captopril Tablets for the first time you may feel
light-headed 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.
The hydrochlorothiazide contained in this medicine could produce a
positive result in a doping test.

Children and adolescents

3. How to take Captopril Tablets

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

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Other medicines and Captopril Tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, 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


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

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.

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.
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:

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.



lithium (for the treatment of mental disorders),
carbenoxolone (for the treatment of gastrointestinal ulcers),

Captopril Tablets tablets are for oral use only.



corticosteroids, corticotrophin (ACTH),



some laxatives,



injections of an antifungal (amphotericin),

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.



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



nausea, vomiting, gastric irritations, abdominal pain, diarrhoea,
constipation, dry mouth,
skin problems such as itchiness and rash, hair loss.



pains in the muscles and joints,



kidney problems,



impotence, swelling of the breasts in men,



fever,



changes in laboratory test values.

taste impairment, dizziness,



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

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:

Method of administration



sleep disorders,



Dosage:







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),



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),

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).



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

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



carbamazepine (for the treatment of epilepsy)



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 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
Tell your doctor if you are breast-feeding or about to start breastfeeding. Captopril Tablets is not recommended for mothers who are
breast-feeding.



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).



low blood pressure, impaired circulation in the fingers
(Raynaud’s syndrome), flushing or pale skin,
swellings of the hands, face, lips or tongue,



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:

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.



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,



pins and needles, light-headedness,



problems with the eyes and vision such as ‘yellow vision’ and
blurred vision, decrease in vision and eye pain (possible signs
of acute-angle closure glaucoma),

loss of appetite (anorexia),



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





dizziness,

mouth problems such as sore mouth and mouth ulcers,





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

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





kidney problems, increased or decreased urination.

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,



gastric irritation, diarrhoea, constipation, pancreatitis,



jaundice which causes the skin and eyes to turn yellow,



severe skin reactions such as:

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.
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.

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:


side effects affecting the blood and its components such as:




confusion, depression,

If you forget to take Captopril Tablets



stroke, fainting,

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.



blurred vision,



heart attack,

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



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,

4. Possible side effects
Like all medicines, this medicine 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:
swelling of the arms, legs, ankles, face, lips, tongue and/or
throat with difficulty in swallowing or breathing, sore throat or
fever,



severe abdominal pain,



unusually fast or irregular heart beat,



jaundice (yellow skin/eyes),



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

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



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:



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



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



sensitivity of the skin to light,



a reddening of the skin (erythroderma),



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

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



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



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



muscle spasm,



kidney problems,



fever, weakness.

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 address below. By
reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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

severe dizziness or fainting,





rash,



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

sensitivity of the skin to light,



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





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



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.


Captopril Tablets contains lactose monohydrate. 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.

infection,




Driving and using machines

tiredness



chest pain, tiredness, feeling unwell.

decrease in performance,



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



It is important that you continue to take Captopril Tablets until your
doctor tells you otherwise.



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:

S553 LEAFLET Captopril 20150721

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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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