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VASCACE 0.5MG FILM-COATED TABLETS

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Vascace® 0.5 mg Film-coated Tablets
Vascace® 1 mg Film-coated Tablets
Vascace® 2.5 mg Film-coated Tablets
Vascace® 5 mg Film-coated Tablets
Cilazapril

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. 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 get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
What is in this leaflet
1. What Vascace is and what it is used for
2. What you need to know before you take
Vascace
3. How to take Vascace
4. Possible side effects
5. How to store Vascace
6. Contents of the pack and other
information

● if you have a collagen vascular disease.
● if you undergo LDL apheresis with
dextrane sulphate.
If any of the above apply to you, or if you
are not sure, talk to your doctor or
pharmacist before you take Vascace.
You must tell your doctor if you think you
are (or might become) pregnant. Vascace
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 the sections on ‘Pregnancy’ and
‘Breast-feeding’).
Children
Vascace is not recommended for use in
children.

1. What Vascace is and what
it is used for

Other medicines and Vascace
Please tell your doctor or pharmacist
if you are taking or have recently taken
any other medicines. This includes
medicines obtained without a prescription
and herbal medicines. This is because
Vascace can affect the way some
medicines work. Also some medicines
can affect the way Vascace works.

Vascace contains a medicine called
cilazapril. This belongs to a group
of medicines called ‘ACE inhibitors’
(Angiotensin Converting Enzyme
Inhibitors).

Do not take Vascace if you have diabetes
mellitus or impaired kidney function and
you are treated with aliskiren a drug used
to lower high blood pressure.

Vascace is used to treat the following:
● High blood pressure (hypertension)
● Chronic (long-term) heart failure.
It works by making your blood vessels
relax and widen. This helps to lower your
blood pressure. It also makes it easier
for your heart to pump blood around your
body if you have chronic heart failure.
Your doctor may give you other medicines
as well as Vascace to help treat your
condition.

2. What you need to know
before you take Vascace
Do not take Vascace
● if you are allergic
(hypersensitive)
to cilazapril or any of
the other ingredients
of Vascace (listed in
section 6: Contents of
the pack and other
information).
● if you are allergic (hypersensitive) to
other ACE inhibitor medicines. These
include captopril, enalapril, lisinopril
and ramipril.
● if you have had a serious side effect
called angioedema after taking other
ACE inhibitor medicines, hereditary
angioedema or angioedema of unknown
cause. The signs include swelling of
the face, lips, mouth or tongue. There is
an increased risk of angioedema if you
are taking some oral medicines to treat
diabetes or medicines to suppress the
immune system.
● if you are more than 3 months pregnant.
(It is also better to avoid Vascace in
early pregnancy - see the sections on
‘Pregnancy’ and ‘Breast-feeding’.)
● if you have diabetes mellitus or
impaired kidney function and you are
treated with aliskiren a drug used to
lower high blood pressure
Do not take Vascace if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Vascace.
Warnings and precautions
Check with your doctor or pharmacist
before taking Vascace
● if you have a heart problem. Vascace
is not suitable for people with certain
types of heart problem.
● if you have had a stroke or have problems
with the blood supply to your brain.
● if you are taking an “angiotensinreceptor blockers” such as valsartan,
telmisartan, irbesartan.
● if you are taking aliskiren a drug used
to lower high blood pressure.
● if you are taking medicines to suppress
the immune system.
● if you have severe liver problems
or if you develop jaundice.
● if you have kidney problems or have
a problem with the blood supply to your
kidneys called renal artery stenosis.
● if you are on kidney dialysis.
● if you have recently been vomiting
or have had diarrhoea.
● if you are on a diet to control how much
salt (sodium) you take in.
● if you are planning to have treatment
to reduce your allergy to bee or wasp
stings (desensitization).
● if you are planning to have an operation
(including dental surgery). This is because
some anaesthetics can lower your blood
pressure and it may become too low.
● if you have a build up of fluid in your
abdomen (ascites).
● if you have diabetes and are taking
medicines to treat diabetes.
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In particular, tell your doctor
or pharmacist if you are taking any
of the following medicines:
● Diuretics (‘water tablets’) – see ‘High
blood pressure (hypertension)’ in
section 3 on ‘How to take Vascace’.
● Any medicines used to treat high blood
pressure.
● Medicines called ‘non-steroidal antiinflammatory drugs’ (NSAIDs). These
include aspirin, indometacin and
ibuprofen.
● Insulin or other medicines used
to treat diabetes.
● Lithium (used to treat depression).
● Steroid medicines (such as
hydrocortisone, prednisolone and
dexamethasone) or other medication
which suppress the
immune system.
● Potassium
supplements
(including salt
substitutes) or
potassium-sparing diuretics.
● Aldosterone antagonists.
● Sympathomimetics.
● Anaesthetics, narcotics.
● Tricyclic antidepressants,
antipsychotics.
● Gold compounds (used to treat
rheumatoid arthritis).
Vascace with food and drink
Tell your doctor or pharmacist if you are
taking food supplements that contain
potassium.
Pregnancy
You must tell your doctor if you think you
are (or might become) pregnant. Your
doctor will normally advise you to stop
taking Vascace before you become
pregnant, or as soon as you know you are
pregnant, and will advise you to take
another medicine instead of Vascace.
Vascace is not recommended in early
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. Vascace is
not recommended for mothers who are
breast-feeding, and your doctor may
choose another treatment for you if you
wish to breast-feed, especially if your
baby is newborn, or was born prematurely.
Driving and using machines
You may feel dizzy while taking Vascace.
This is more likely to happen when you
first start treatment. If you feel dizzy,
do not drive or use any tools or machines.
Vascace contains
Vascace contains lactose, which is a type
of sugar. If you have an intolerance to
lactose, talk to your doctor before taking
this medicine.

3. How to take Vascace
Always take Vascace exactly as
prescribed. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
● Take one tablet of Vascace each day.
● Swallow each tablet with a drink of water.
● It does not matter what time of day
you take Vascace. However, always
take it around the same time.
● Vascace may be taken before or after
a meal.

Please turn over
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High blood pressure (hypertension)
● The usual starting dose for adults is
1 mg per day.
● Your doctor will then increase your
dose until your blood pressure is under
control - the usual maintenance dose
is between 2.5 mg and 5 mg per day.
● If you have problems with your
kidneys, or if you are elderly, your
doctor may give you a lower dose.
● If you are already taking a diuretic
(‘water tablets’), your doctor may tell
you to stop taking it about 3 days
before you start taking Vascace. The
usual starting dose of Vascace is then
0.5 mg per day. Your doctor will then
increase your dose until your blood
pressure is under control.
Chronic heart failure
● The usual starting dose is 0.5 mg
per day.
● Your doctor will then increase
the dose - the usual maintenance
dose is between 1 mg and 2.5 mg
per day.
● If you have problems with your
kidneys, or if you are elderly, your
doctor may give you a lower dose.
● If you have liver cirrhosis without
ascites, your doctor will not give you
a dose of more than 0.5 mg per day
and will carefully monitor your blood
pressure.
If you take more Vascace than you
should
If you take more Vascace than you
should, or if someone else takes your
Vascace tablets, talk to a doctor or go
to a hospital straight away. Take the
medicine pack with you. The following
effects may happen: feeling dizzy or lightheaded, shallow breathing, cold clammy
skin, being unable to move or speak and
a slow heart beat.
If you forget to take Vascace
● If you forget to take a dose, skip the
missed dose. Then take the next dose
when it is due.
● Do not take a double dose (two doses
at the same time) to make up for
a forgotten dose.
If you have any further questions
on the use of this product, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, Vascace can cause side
effects, although not everybody gets
them.
Severe reactions:
If you have a severe reaction called
angioedema, stop taking Vascace and see
a doctor straight
away. The signs may
include:
● Sudden swelling of
the face, throat, lips
or mouth. This can
make it difficult to
breathe or swallow.
Blood problems reported with ACE
inhibitors include:
● Low numbers of red blood cells
(anaemia). The signs include feeling
tired, pale skin, fast or uneven heart beat
(palpitations) and feeling short of breath.
● Low numbers of all types of white
blood cells. The signs include increased
number of infections, for example in
your mouth, gums, throat and lungs.
● Low numbers of platelets in your blood.
The signs include bruising easily and
nose bleeds.
Other possible side effects:
Common (affects less than 1 in 10 people)
● Feeling dizzy
● Coughing
● Nausea
● Feeling tired
● Headache
Uncommon (affects less than
1 in 100 people)
● Low blood pressure. This may make
you feel weak, dizzy or light-headed
and may lead to blurred vision and
fainting. Excessive lowering of blood
pressure may increase the chance of
heart attack or stroke in certain patients
● Increased heart rate
● Feeling weak
● Pains in the chest
● Breathing problems, including
shortness of breath and tightness
in the chest
● A runny or blocked nose and sneezing
(rhinitis)
● Dry or swollen mouth
● Lack of appetite
● Change in the way things taste
● Diarrhoea and vomiting
● Skin rash (which may be severe)
● Muscle cramps or pain in your muscles
or joints
● Impotence
● Sweating more than usual
● Flushing
● Sleeping problems
Rare (affects less than 1 in 1,000 people)

● Myocardial infarction (may occur
if blood pressure becomes too low)
● Irregular heartbeat
● Interstitial lung disease
● A disorder resembling systemic lupus
erythematosus
● Pins and needles or numbness
in the hands or feet
● Wheezing
● A feeling of fullness or a throbbing pain
behind the nose, cheeks and eyes
(sinusitis).
● Soreness of your tongue
● Pancreatitis (inflammation
of the pancreas). The signs include
severe pain in the stomach which
spreads to your back
● Changes in the way your liver
or kidneys work (shown in blood
and urine tests)
● Liver problems such as hepatitis
(inflammation of the liver) or liver
damage
● Severe skin reactions including
blistering or peeling of skin
● Increased sensitivity to light
● Hair loss (which may be temporary)
● Loosening or separation of a nail from
its bed
● Breast enlargement in men
If any of the side effects gets serious,
or if you notice any side effects not listed
in this leaflet, please tell your doctor
or pharmacist.

5. How to store Vascace
Keep out of the reach and sight
of children.
0.5 mg: “Do not store above 25 °C”
1 mg: “Do not store above 25 °C”
2.5 mg: “Do not store above 25 °C”
5 mg: This medicinal product does not
require any special storage conditions.
Do not use Vascace after the expiry
date which is stated on the pack.
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 Vascace contains
● The active substance in Vascace is
cilazapril.
● The other ingredient(s) is (are) lactose
monohydrate, maize starch,
hypromellose 3 cP, talc, sodium stearyl
fumarate,
hypromellose 6 cP,
titanium dioxide
(E171).
Vascace 1 mg: in
addition iron oxide
yellow (E 172)
Vascace 2.5 mg: in addition iron oxide
yellow (E 172) and iron oxide red
(E 172)
Vascace 5 mg: in addition iron oxide
red (E 172)
What Vascace looks like and contents of
the pack
Film-coated tablet:
White, oval, biconvex film-coated tablets
with a score on one side and imprinted
“CIL 0.5” on the other side
Light yellow, oval, biconvex film-coated
tablets with a score on one side and
imprinted “CIL 1” on the other side
Dull red, oval, biconvex film-coated
tablets with a score on one side and
imprinted “CIL 2.5” on the other side
Reddish-brown, oval, biconvex filmcoated tablets with a score on one side and
imprinted “CIL 5” on the other side
The tablet can be divided into equal halves.
Vascace is supplied in blister packs
containing 14, 20, 28, 30, 50, 56, 60,
98 film-coated tablets or glass bottles
containing 28, 100 film-coated tablets.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
This medicinal product is authorised
in the Member States of the EEA
under the following names:
Austria: Inhibace “Roche”
Belgium, Bulgaria, Czech Republic,
Hungary, Luxembourg, Poland, Inhibace
Germany: Dynorm
Greece, Ireland, United Kingdom: Vascace
Italy, Portugal: Inibace
Netherlands: Vascase

● Blood tests showing a decrease in the
number of red blood cells, white blood
This leaflet was last revised in
cells or platelets (anaemia, neutropenia,
November 2013
agranulocytosis and thrombocytopenia)
● A type of severe allergic reaction
Vascace is a registered trade mark.
(anaphylaxis)
● Cerebral ischaemia, transient
ischaemic attack, ischaemic stroke
(may occur if blood pressure becomes
2
too low)
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