CAPOZIDE 50MG/25MG TABLETS

Active substance: HYDROCHLOROTHIAZIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PAG 3

PAG 1

1

Diecut

Stellucci
30.06.2014

Black
Printing Colours:

Technical Colours:
Min. Font Size Text: 8 pt
Proof No.:
2
Pag.1/2

 you are allergic to captopril or to any other ACE inhibitors
if
or to any of the other ingredients of this medicine (listed
in section 6).
 you are allergic to hydrochlorothiazide or to any other
if
sulphonamide derivatives.
 you have previously been treated with a medicine in the
if
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.
 you have severe liver or kidney problems (ask your
if
doctor if you have any doubt).
 you are more than 3 months pregnant. (It is also better
If
to avoid Capozide in early pregnancy – see pregnancy
section.).

10%

Product Code:
9424A1
Barcode Type:
Format/Dimension: (2 x 148) x 211,8 mm
Tech. Drawing No.:

Do not take CAPOZIDE

MOCK UP LFT CAPOZIDE TAB

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

Anagni
Parisi

2. What you need to know before you take
CAPOZIDE

Talk to your doctor before taking Capozide and if any of the
following apply to you:
 you suffer from excessive vomiting or diarrhoea.
if
 you are on a low-salt diet and you use salt substitutes
if
or supplements containing potassium.
 you have any liver or kidney problems (ask your doctor
if
if you have any doubt).
 you know that you have reduced blood circulation in the
if
heart muscle or a narrowing of the aorta (aortic stenosis)
or the renal artery (renal artery stenosis).
 you have had shock following heart failure (cardiogenic
if
shock).
 you suffer from diabetes.
if
Capozide may influence the effect of insulin or other
anti-diabetic medicines . Please ask your doctor for advice.
 you are using dialysis.
if
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.
 you are to have desensitisation treatment for wasp or
if
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.
 you suffer from lupus or lupus-like disorders.
if
 you have changes in your vision or pain in one or both
if
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.
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.

Production Site:
CTM:

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

Product Name:

3

1. What CAPOZIDE is and what it is used
for

No


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

nausea, vomiting, gastric irritations, abdominal pain,
diarrhoea, constipation, dry mouth,
 problems such as itchiness and rash, hair loss.
skin
Following uncommon side effects were observed(occurring
in more than 1in 1000 but fewer than 1 in 100 patients) that
may occur with captopril and other ACE inhibitors:

heart problems such as an unusually fast or irregular
heart beat, chest pain (angina), feeling your heartbeat,
 blood pressure, impaired circulation in the fingers
low
(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:
 of appetite (anorexia),
loss

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

mouth problems such as sore mouth and mouth ulcers,

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

kidney problems, increased or decreased urination.
Following very rare side effects were observed (occurring in

RETINO
SCREENED

£

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

FRONT

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 /

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

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.
 you have any further questions, ask your doctor or pharmacist.
If
 medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
This
illness are the same as yours.
 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
If
leaflet. See section 4.

S

4. Possible side effects

50 mg captopril/ 25 mg hydrochlorothiazide

GB/IE

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

Capozide tablets

Live Text:
Country:

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.

Package leaflet: Information for the patient

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

If you forget to take Capozide

1 or less in 10,000 patients including isolated reports) that
may occur with captopril and other ACE inhibitors:
 effects affecting the blood and its components such as:
side

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

confusion, depression,

stroke, fainting,

blurred vision,

heart attack,

chest problems (including:

difficulty in breathing or wheezing,
 blocked or runny nose, a type of pneumonia, caused
a
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:

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

a
severe
rash
all
over
the
body
(Stevens-Johnson-syndrome),
 allergic rash which causes pink-red patches which
an
may have clear centres (erythema multiforme),

sensitivity of the skin to light,
 reddening of the skin (erythroderma),
a
 series of skin reactions which can cause fluid-filled
a
patches to form (pemphigoid reactions),
 condition causing the skin to scale or peel (exfoliative
a
dermatitis),

pains in the muscles and joints,

kidney problems,

impotence, swelling of the breasts in men,

fever,

changes in laboratory test values.
Following side effects that were observed with
hydrochlorothiazide, the second active substance contained
in Capozide include:

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

decrease in performance,

tiredness

infection,
 throat or fever due to a lack of white blood cells,
sore
 reduced ability for the blood to clot which may cause
a
bleeding or bruising
 of appetite (anorexia), sugar in the urine, abnormal
loss
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,
 and needles, light-headedness,
pins

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

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

Senso di svolgimento

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

If you 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.

PAG 2


The active substances are captopril and
hydrochlorothiazide. Each tablet of CAPOZIDE contains
50 mg captopril and 25 mg hydrochlorothiazide.

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

What Capozide looks like and contents of the
pack

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.

PAG 4

9424A1

Diecut

Black

Technical Colours:

Stellucci

What Capozide contains

30.06.2014

6. Contents of the pack and other
information

Min. Font Size Text: 8 pt
Proof No.:
2
Pag.2/2

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

This leaflet was last revised in March 2014

10%

Product Code:
9424A1
Barcode Type:
Format/Dimension: (2 x 148) x 211,8 mm
Tech. Drawing No.:

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).

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.

Printing Colours:

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

5. How to store CAPOZIDE

Capozide forte
Ecazide
Capozide 50
Superace
Capozide
Aceplus
Lopiretic
Ecazide
Capozide

MOCK UP LFT CAPOZIDE TAB

Method of administration

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Austria
France
Germany
Greece
Ireland
Italy
Portugal
Spain
UK

Anagni
Parisi

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

Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL Dublin 2
Tel: +353 1 6764971; 
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

Product Name:

2

Dosage:

RETINO
SCREENED

Production Site:
CTM:

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),

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,

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,
 any other treatment for high blood pressure.
or

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

No

Other medicines and 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.

Manufacturer

£

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

3. How to take 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
address below. By reporting side effects you can help
provide more information on the safety of this medicine.

BACK

Yes /

Children and adolescents

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.

Reporting of side effects

UK
E.R. Squibb & Sons Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
United Kingdom
Tel: 0800 7311736
Ireland
Bristol-Myers Squibb Pharmaceuticals Ltd.
Swords,
County Dublin
Ireland
Tel: 1-800-749-749

S

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

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.

Marketing Authorisation Holder

GB/IE

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.

Driving and using machines

Not all pack sizes may be marketed.

Live Text:
Country:

• 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.

 and breathing problems such as respiratory distress,
lung

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,
 condition that causes a characteristic red, blotchy,
a
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),
 over-reaction of the body’s natural defence system
an
(hypersensitivity reactions),

muscle spasm,

kidney problems,

fever, weakness.

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

Please inform following persons that you take
CAPOZIDE:

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
breast-feeding. Capozide is not recommended for mothers
who are breast-feeding.

Senso di svolgimento


swelling of the arms, legs, ankles, face, lips, tongue
and/or throat with difficulty swallowing or breathing,
 sign of infection (such as sore throat or fever) not
any
readily responding to the usual treatment,

severe dizziness or fainting,

severe abdominal pain,

unusually fast or irregular heart beat,

jaundice (yellow skin/eyes),
 sudden, unexplained rash or burning, red or peeling
any
skin.

Pregnancy and breast-feeding

F.P.O.

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

Expand view ⇕

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.

Hide
(web3)