CAPOZIDE 50MG/25MG TABLETS

Active substance: HYDROCHLOROTHIAZIDE

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function.
If another person has taken too many tablets and has fainted,
lay the person down and rest the person's feet higher than
the person's head.

If you forget to take 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 about the use of this
medicinal product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicinal products, Capozide 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.
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,
• 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.
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,
• 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:
• loss of appetite (anorexia),
• drowsiness, headache, an abnormal sensation on your
skin such as a burning or prickle,
• mouth problems such as sore mouth and mouth ulcers,
• allergic reaction in the gut causing severe abdominal pain
(intesti¬nal angioedema),
• kidney problems, increased or decreased urination.
Following very rare side effects were observed (occurring in
1 or less in 10.000 patients including isolated reports) that
may occur with captopril and other ACE inhibitors:
• 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, 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),
• 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.
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:
• 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,
• pins and needles, light-headedness,
• problems with the eyes and vision such as 'yellow vision'
and blurred vision,
• dizziness,
• low blood pressure, heart problems such as an irregular
heart beat,
• 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,

PACKAGE LEAFLET: INFORMATION FOR THE USER

Capozide tablets
50mg captopril/ 25mg hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1. What Capozide is and what it is used for
2. Before you take Capozide
3. How to take Capozide
4. Possible side effects
5. How to store Capozide
6. Further information

1. WHAT CAPOZIDE IS AND WHAT IT IS USED
FOR ?
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.

2. 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.

Do NOT take CAPOZIDE
• if you are allergic (hypersensitive) to captopril or to any
other ACE inhibitors or to any of the other ingredients of
Capozide.
• if you are allergic to hydrochlorothiazide or to any other
sulphonamide derivatives.
• 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.).
Capozide should not be given to children and adolescents
(< 18 years).

Take special care with CAPOZIDE
• if you suffer from excessive vomiting or diarrhoea.
• if you are on a low-salt diet and you use salt substitutes
or supplements containing potassium.
• if you have any liver or kidney problems (ask your doctor
if you have any doubt).
• 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.
You must tell your doctor if you think you are (or might
become) pregnant. Capozide is not recommended in early
pregnancy, and must not be taken if you are more than 3
months pregnant, as it may cause serious harm to your baby
if used at that stage (see pregnancy section).
Medicinal products containing lithium should not be taken
with Capozide without close monitoring by your doctor.

If you develop one of the following, contact your
doctor immediately:
• swelling of the arms, legs, ankles, face, lips, tongue and/or
throat with difficulty swallowing or breathing,
• any sign of infection (such as sore throat or fever) not
readily responding to the usual treatment,
• severe dizziness or fainting,

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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
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.

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

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

Important information about some of the
ingredients of CAPOZIDE

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

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

Taking CAPOZIDE with other medicinal products

3. HOW TO TAKE CAPOZIDE?

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

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

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,
• or any other treatment for high blood pressure.

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.

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

If you take more CAPOZIDE than you should

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.






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







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.

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

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
France
Germany
Greece
Ireland
Italy
Portugal
Spain
UK

Capozide 50
Ecazide
Capozide 50
Superace
Capozide
Aceplus
Lopiretic
Ecazide
Capozide

This leaflet was last approved in July 2012

5. HOW TO STORE CAPOZIDE
Keep out of the reach and sight of children!
Do not use Capozide 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.
Medicinal products should not be disposed of via wastewater
or household waste. Ask your pharmacist how to dispose of
medicinal products no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What CAPOZIDE contains
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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
E.R. Squibb & Sons Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
Bristol-Myers Squibb Pharmaceuticals Ltd.
Swords,
County Dublin
Tel.: 1-800-749-749
Manufacturer
Bristol-Myers Squibb S.r.l.
Contrada Fontana del Ceraso
03012 Anagni (FR)
Italy
1264510A2

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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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