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CAPOZIDE 50MG/25MG TABLETS

Active substance(s): CAPTOPRIL / HYDROCHLOROTHIAZIDE

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

Product Code:
1264510A4
Barcode Type:
2/5: 0126451004
Format/Dimension: (2 x 148) x 211,8 mm
Tech. Drawing No.:

Do not take Capozide

LFT CAPOZIDE TAB

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

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

Product Name:

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:
§ sleep disorders,
§ 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.

2. What you need to know before you take
Capozide

Talk to your doctor before taking Capozide and if any of the
following applies to you:
§ 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).
§ if you suffer from diabetes.
Capozide 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 Capozide
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 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:
- 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.

Anagni
Parisi Emiliano

§ 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.
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.

Capozide 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 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.

Warnings and precautions

Production Site:
CTM:

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

1. What Capozide is and what it is used for

No

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

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
5. How to store Capozide
6. Contents of the pack and other information

Yes /

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.

Read all of this leaflet carefully before you start taking this medicine because it contains important information
for you.
§ Keep this leaflet. You may need to read it again.
§ If you have any further questions, ask your doctor or pharmacist.
§ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
§ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.

GB

If you forget to take Capozide

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:
§ 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
§ confusion, depression,
§ stroke, fainting,
§ blurred vision,
§ 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),
§ 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:
§ 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,
§ 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),
§ pains in the muscles and joints,
§ kidney problems,
§ impotence, swelling of the breasts in men,
§ fever,
§ changes in laboratory test values.

Capozide tablets

50 mg captopril/ 25 mg hydrochlorothiazide

Live Text:
Country:

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.
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.

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,
§ allergic reaction in the gut causing severe abdominal
pain (intestinal angioedema),
§ kidney problems, increased or decreased urination.

Package leaflet: Information for the patient

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

If you take more Capozide than you should

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:
§ decreased appetite (anorexia),
§ headache, an abnormal sensation on your skin (burning
or prickle),
§ 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.

Senso di svolgimento

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).
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.

Capozide tablets are for oral use only.
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.

6. Contents of the pack and other information
§ The active substances are captopril and
hydrochlorothiazide. Each tablet of Capozide contains
50 mg captopril and 25 mg hydrochlorothiazide.
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1264510A4

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What Capozide contains

05.10.2015 Pollutri

5. How to store Capozide
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the blister and carton. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Store in the original package.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

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Method of administration

This leaflet was last revised in September 2015

Product Code:
1264510A4
Barcode Type:
2/5: 0126451004
Format/Dimension: (2 x 148) x 211,8 mm
Tech. Drawing No.:

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.

Capozide forte
Ecazide
Capozide 50
Superace
Capozide
Aceplus
Lopiretic
Ecazide
Capozide

LFT CAPOZIDE TAB

Dosage:

Austria
France
Germany
Greece
Ireland
Italy
Portugal
Spain
UK

Product Name:

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),
§ 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,

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

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

This medicinal product is authorised in the
Member States of the EEA under the following
names:

Anagni
Parisi Emiliano

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.

Reporting of side effects

Manufacturer
Bristol-Myers Squibb
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy

Production Site:
CTM:

Other medicines and Capozide

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.

E.R.Squibb & Sons Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
United Kingdom
Tel: 0800 7311736

No

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

Driving and using machines

Marketing Authorisation Holder

Yes /

Children and adolescents

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

Capozide tablets are white to off-white, oval, biconvex; with
a breakbar on one side and engraved with “C H” on the
other side. The tablet can be divided into equal halves.
Capozide tablets are supplied PVC/PVDC/Aluminium foil
blisters, containing 10, 12, 20, 28, 30, 42, 60, 84, 98, 90,
100 tablets.
Not all pack sizes may be marketed.

GB

• 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
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.

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.

What Capozide looks like and contents of the
pack

Live Text:
Country:

Please inform following persons that you take
Capozide:

Pregnancy and breast-feeding

§ The other ingredients are microcrystalline cellulose,
lactose monohydrate, pregelatinised cornstarch, stearic
acid, magnesium stearate.

Phone contact: +39 0692708387
e-mail contact: artwork@grafimed.it
www.grafimed.it

§ 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.

§ side effects affecting the blood and its components
which may cause:
§ decrease in performance,
§ tiredness,
§ infection,
§ 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,
§ abnormal sensation on your skin (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,
§ 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:
§ 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),
§ an over-reaction of the body’s natural defence system
(hypersensitivity reactions),
§ muscle spasm,
§ kidney problems,
§ fever, weakness.

0126451004

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

§ 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”).

Senso di svolgimento

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”.
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.

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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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