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CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50MG/25MG TABLETS

Active substance(s): CAPTOPRIL / HYDROCHLOROTHIAZIDE

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S553 LEAFLET Capozide 20160528

5. How to store Capozide

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the original package.



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.
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.

6. Contents of the pack and other information

®

CAPOZIDE 50mg/25mg TABLETS
(captopril/hydrochlorothiazide)
Your medicine is known as Capozide 50mg/25mg Tablets but will
be referred to as Capozide throughout the following patient
information leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.

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 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.



if you are taking any of the following medicines used to treat
high blood pressure:





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

What Capozide looks like and contents of the pack

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.

5. How to store Capozide
6. Contents of the pack and other information
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, S.r.l.,
Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy.
POM



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

3. How to take Capozide

Capozide is available in blister packs containing 30 tablets.

Talk to your doctor before taking Capozide and if any of the
following applies to you:



What Capozide contains


Warnings and precautions

PL 19488/0553

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.

®

S553 LEAFLET Capozide 20160528

an angiotensin II receptor blocker (ARB) (also known as
sartans - for example valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related kidney problems.

-

aliskiren.

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.

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 “Do not take
CAPOZIDE”.

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 Capozide.

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).

Do not take Capozide

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

Leaflet revision date: 28 May 2016
Capozide Tablets is a registered trade mark of ER Squibb & Sons
LLC, USA.

-



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 develop one of the following, contact your doctor
immediately:



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



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



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.



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,

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



jaundice (yellow skin/eyes),



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




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



if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.

Please inform following persons that you take Capozide:

Driving and using machines



severe dizziness or fainting,



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



severe abdominal pain,





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

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.

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.


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.

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

3. How to take Capozide

Children and adolescents

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

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



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.
Dosage:
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.

This applies in particular if you are also taking



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

unusually fast or irregular heart beat,



sensitivity of the skin to light,

jaundice (yellow skin/eyes),



a reddening of the skin (erythroderma),



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

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


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



pains in the muscles and joints,



kidney problems,

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:



impotence, swelling of the breasts in men,



fever,



sleep disorders,



changes in laboratory test values.



taste impairment, dizziness, dry, irritating (non-productive)
cough, breathing problems,



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



skin problems such as itchiness and rash, hair loss.

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 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:

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:



decrease in performance,



tiredness,



infection,

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

Method of administration



decreased appetite (anorexia),



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

Capozide tablets are for oral use only.







lithium (for the treatment of mental disorders),

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



carbenoxolone (for the treatment of gastrointestinal ulcers),





corticosteroids, corticotrophin (ACTH),

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



some laxatives,

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.

headache, an abnormal sensation on your skin (burning or
prickle),





injections of an antifungal (amphotericin),

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



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),







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

Your doctor may need to change your dose and/or take other
precautions:
If you are taking:


an angiotensin II receptor blocker (ARB) or aliskiren (see also
information under the headings “Do not take CAPOZIDE” and
“Warnings and precautions”).

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

It is important that you continue to take Capozide until your doctor
tells you otherwise.
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 25mg captopril and 12.5mg
hydrochlorothiazide).



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,

swellings of the hands, face, lips or tongue,



restlessness, depression, sleep disturbances,

chest pain, tiredness, feeling unwell.



abnormal sensation on your skin (pins and needles), lightheadedness,



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),

drowsiness,



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:

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:


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

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:


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.

side effects affecting the blood and its components such as:



sensitivity of the skin to light,





rash,



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),

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



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



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

stroke, fainting,



muscle spasm,

blurred vision,



kidney problems,



heart attack,



fever, weakness.



chest problems (including:



confusion, depression,




If you forget to take Capozide
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 on the use of this medicine, ask
your doctor or pharmacist.

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,

difficulty in breathing or wheezing,

Reporting of side effects



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),

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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.



swollen tongue, 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:

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.





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



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

By reporting side effects you can help provide more information on
the safety of this medicine.
S553 LEAFLET Capozide 20160528



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


muscle spasm,



kidney problems,



fever, weakness.

S553 LEAFLET Captopril 20160528

CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50mg/25mg
TABLETS
Your medicine is known as Captopril and Hydrochlorothiazide
50mg/25mg Tablets but will be referred to as Captopril and
Hydrochlorothiazide Tablets throughout the following patient
information leaflet.

Reporting of side effects

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 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 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).



if you suffer from diabetes.
Captopril and Hydrochlorothiazide Tablets may influence the
effect of insulin or other anti-diabetic 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 Captopril and
Hydrochlorothiazide Tablets undergo dialysis with certain
dialysis membranes [so called High-flux-HaemodialysisMembranes 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 and
Hydrochlorothiazide 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 and Hydrochlorothiazide Tablets.
This could be a sign that you are developing glaucoma,
increased pressure in your eye(s). You should discontinue
Captopril and Hydrochlorothiazide Tablets treatment and seek
medical attention.



if you are taking any of the following medicines used to treat
high blood pressure:

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

By reporting side effects you can help provide more information on
the safety of this medicine.



5. How to store Captopril and Hydrochlorothiazide Tablets





Do not store above 25°C. Store in the original package.



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.



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.

6. Contents of the pack and other information
What Captopril and Hydrochlorothiazide 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 and Hydrochlorothiazide Tablets look like and
contents of the pack
Captopril and Hydrochlorothiazide 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.
Captopril and Hydrochlorothiazide Tablets are available in blister
packs containing 30 tablets.
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, S.r.l.,
Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy.



If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1. What Captopril and Hydrochlorothiazide Tablets are and what
they are used for
2. What you need to know before you take Captopril and
Hydrochlorothiazide Tablets
3. How to take Captopril and Hydrochlorothiazide Tablets
4. Possible side effects
5. How to store Captopril and Hydrochlorothiazide Tablets
6. Contents of the pack and other information
1. What Captopril and Hydrochlorothiazide Tablets are and
what they are used for
Captopril and Hydrochlorothiazide Tablet is a combination of two
active substances, captopril and hydrochlorothiazide.
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 Captopril and Hydrochlorothiazide
Tablets work together to decrease blood pressure further than if
either was given alone.
Captopril and Hydrochlorothiazide Tablet 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.
2. What you need to know before you take Captopril and
Hydrochlorothiazide Tablets
Please read the following section attentively. It contains important
information which you and your doctor should observe prior to
taking of Captopril and Hydrochlorothiazide Tablets.
Do not take Captopril and Hydrochlorothiazide Tablets


PL 19488/0553

Leaflet revision date: 28 May 2016
S553 LEAFLET Captopril 20160528

Talk to your doctor before taking Captopril and Hydrochlorothiazide
Tablets and if any of the following applies to you:
if you suffer from excessive vomiting or diarrhoea.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Warnings and precautions



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



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 Captopril and Hydrochlorothiazide 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 diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.



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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

POM



PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 and Hydrochlorothiazide Tablets in early
pregnancy – see pregnancy section.).

-

an angiotensin II receptor blocker (ARB) (also known as
sartans - for example valsartan, telmisartan, irbesartan), in
particular if you have 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 “Do not take
CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS”.
You must tell your doctor if you think you are (or might become)
pregnant. Captopril and Hydrochlorothiazide Tablet 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
Captopril and Hydrochlorothiazide Tablets 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,



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.

Please inform following persons that you take Captopril and
Hydrochlorothiazide Tablets:


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

Breast-feeding

If you forget to take Captopril and Hydrochlorothiazide Tablets



blurred vision,

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

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.



heart attack,



chest problems (including:

Driving and using machines

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

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.
Captopril and Hydrochlorothiazide Tablet 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.



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.

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



Stop taking Captopril and Hydrochlorothiazide Tablets and
seek medical attention immediately if you experience any of
the following:

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:





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

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



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



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

3. How to take Captopril and Hydrochlorothiazide Tablets



severe dizziness or fainting,

Other medicines and Captopril and Hydrochlorothiazide
Tablets

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



severe abdominal pain,

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.



unusually fast or irregular heart beat,



sensitivity of the skin to light,

Your doctor has prescribed Captopril and Hydrochlorothiazide
Tablet 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
and Hydrochlorothiazide Tablets.



jaundice (yellow skin/eyes),



a reddening of the skin (erythroderma),



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



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

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),



lithium (for the treatment of mental disorders),



carbenoxolone (for the treatment of gastrointestinal ulcers),



corticosteroids, corticotrophin (ACTH),



some laxatives,



injections of an antifungal (amphotericin),

Dosage:
The usual dose is 1 tablet Captopril and Hydrochlorothiazide Tablet
a day (corresponding to 50 mg captopril and 25 mg
hydrochlorothiazide). The maximum daily dose of 1 tablet Captopril
and Hydrochlorothiazide Tablet should not be exceeded.
Method of administration
Captopril and Hydrochlorothiazide tablets are for oral use only.



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),

The tablets should be swallowed with a sufficient amount of fluid
(e.g. one glass of water). You can take Captopril and
Hydrochlorothiazide Tablets with or without food. You should try to
take your daily dose at about the same time each day, preferably in
the morning.



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

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




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),



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.

Your doctor may need to change your dose and/or take other
precautions:
If you are taking:


an angiotensin II receptor blocker (ARB) or aliskiren (see also
information under the headings “Do not take CAPTOPRIL AND
HYDROCHLOROTHIAZIDE TABLETS” and “Warnings and
precautions”).

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 and Hydrochlorothiazide 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 and
Hydrochlorothiazide Tablets. Captopril and Hydrochlorothiazide
Tablet 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.

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 and Hydrochlorothiazide
Tablets for you, such as ½ tablet Captopril and Hydrochlorothiazide
Tablets (corresponding to 25mg captopril and 12.5mg
hydrochlorothiazide).
Elderly patients: your doctor may prescribe a lower dose of
Captopril and Hydrochlorothiazide Tablets for you, such as ½ tablet
Captopril and Hydrochlorothiazide Tablets (corresponding to 25mg
captopril and 12.5mg hydrochlorothiazide).
If you have the impression that the effect of Captopril and
Hydrochlorothiazide Tablet is too strong or too weak, talk to your
doctor or pharmacist.

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:

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



pains in the muscles and joints,



kidney problems,



impotence, swelling of the breasts in men,



fever,



changes in laboratory test values.



sleep disorders,



taste impairment, dizziness, dry, irritating (non-productive)
cough, breathing problems,



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

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



skin problems such as itchiness and rash, hair loss.



swollen salivary glands,



side effects affecting the blood and its components which may
cause:

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:



decrease in performance,



tiredness,



decreased appetite (anorexia),



infection,



headache, an abnormal sensation on your skin (burning or
prickle),



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



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



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



swellings of the hands, face, lips or tongue,



chest pain, tiredness, feeling unwell.

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:


drowsiness,



mouth problems such as sore mouth and mouth ulcers,

If you take more Captopril and Hydrochlorothiazide Tablets
than you should



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

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.



kidney problems, increased or decreased urination.

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:

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,



abnormal sensation on your skin (pins and needles), lightheadedness,



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,



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



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:

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



sensitivity of the skin to light,



rash,



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



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



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



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



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.





confusion, depression,



stroke, fainting,

S553 LEAFLET Captopril 20160528

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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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