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CILAZAPRIL 1MG TABLETS

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670-2 LEAFLET Vascace 20121126



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.



if you have a collagen vascular disease.



if you undergo LDL apheresis with dextrane sulphate.

PACKAGE LEAFLET: INFORMATION FOR THE USER

VASCACE 1mg TABLETS
CILAZAPRIL 1mg TABLETS
VASCACE 2.5mg TABLETS
CILAZAPRIL 2.5mg TABLETS
VASCACE 5mg TABLETS
CILAZAPRIL 5mg TABLETS
(cilazapril monohydrate)
Your medicine is known by the above names but will be referred to
as Vascace throughout the following leaflet.
Information for other strength of Vascace i.e Vascace 0.5mg
Tablets also may be present in this leaflet.

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’).

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

Children



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

Vascace is not recommended for use in children.



If you have any further questions, ask your doctor or
pharmacist.

Other medicines and Vascace



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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

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.
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 anti-inflammatory 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.

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



Potassium supplements (including salt substitutes) or
potassium-sparing diuretics.



Aldosterone antagonists.

Vascace is used to treat the following:



Sympathomimetics.



High blood pressure ( hypertension)



Anaesthetics, narcotics.



Chronic (long-term) heart failure.



Tricyclic antidepressants, antipsychotics.

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.



Gold compounds (used to treat rheumatoid arthritis).

Your doctor may give you other medicines as well as Vascace to
help treat your condition.

Vascace with food and drink

What is in this leaflet:
1. What Vascace is and what it is used for
2. Before you take Vascace
3. How to take Vascace
4. Possible side effects
5. How to store Vascace
6. Further information
1. WHAT VASCACE IS AND WHAT IT IS USED FOR

Tell your doctor or pharmacist if you are taking food supplements
that contain potassium.

2. 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: Further
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.



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’.)

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.

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 breastfeeding. Vascace is not recommended for mothers who are breastfeeding, 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

Warnings and precautions
Check with your doctor or pharmacist before taking Vascace

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.



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 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.

3. HOW TO TAKE VASCACE



if you have recently been vomiting or have had diarrhoea.



if you arc on a diet to control how much salt (sodium) you take
in.

Always take Vascace exactly as prescribed. You should check with
your doctor or pharmacist if you are not sure.



if you are planning to have treatment to reduce your allergy to
bee or wasp stings (desensitization).

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.

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.

High blood pressure (hypertension)

Rare (affects less than 1 in 1,000 people)



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.

Blood tests showing a decrease in the number of red blood
cells, white blood cells or platelets (anaemia, neutropenia,
agranulocytosis and thrombocytopenia)



A type of severe allergic reaction (anaphylaxis)



If you have problems with your kidneys, or if you are elderly,
your doctor may give you a lower dose.



Cerebral ischaemia, transient ischaemic attack, ischaemic
stroke (may occur if blood pressure becomes too low)



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.



Myocardial infarction (may occur if blood pressure becomes too
low)



Irregular heartbeat



Interstitial lung disease



A disorder resembling systemic lupus erythematosus

Chronic heart failure



Pins and needles or numbness in the hands or feet



The usual starting dose is 0.5 mg per day.



Wheezing



Your doctor will then increase the dose - the usual maintenance
dose is between 1 mg and 2.5 mg per day.



A feeling of fullness or a throbbing pain behind the nose,
cheeks and eyes (sinusitis).



If you have problems with your kidneys, or if you are elderly,
your doctor may give you a lower dose.



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 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 light headed, 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.

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 SIGHT AND REACH OF CHILDREN.



Do not use Vascace after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.



Do not store above 25°C.



Store in the original package.

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:

6. FURTHER INFORMATION

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.

What Vascace contains


Vascace 1mg Tablets: each tablet contains 1mg of the active
ingredient, cilazapril (as the monohydrate).



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.



Vascace 2.5mg Tablets: each tablet contains 2.5mg of the
active ingredient, cilazapril (as the monohydrate).





Low numbers of platelets in your blood. The signs include
bruising easily and nose bleeds.

Vascace 5mg Tablets: each tablet contains 5mg of the active
ingredient, cilazapril (as the monohydrate).



The other ingredients in both strengths of tablets are: lactose,
maize starch, sodium stearyl fumarate, hypromellose, talc and
titanium dioxide (E171).

Feeling dizzy



Vascace 1mg Tablets also includes iron oxide (E172).



Coughing





Nausea

Vascace 2.5mg Tablets also includes red and yellow iron oxide
(E172).



Feeling tired



Other possible side effects:
Common (affects less than 1 in 10 people)


 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

 Vascace 5mg Tablets also includes red iron oxide (E172).
What Vascace looks like and contents of the pack
Vascace 1mg Tablets are pale yellow tablet marked ‘CIL 1’ on one
side with a breakline on the other.
Vascace 2.5mg Tablets are reddish yellow tablet marked ‘CIL 2.5’
on one side with a breakline on the other.
Vascace 5mg Tablets are reddish brown tablet marked ‘CIL 5’ on
one side with a breakline on the other.



Increased heart rate



Feeling weak



Pains in the chest



Breathing problems, including shortness of breath and tightness
in the chest

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



A runny or blocked nose and sneezing (rhinitis)

Manufacturer



Dry or swollen mouth



Lack of appetite

This product is manufactured by F. Hoffmann-La Roche A.G.,
Grenzacherstrasse 124, CH-4070 Basle, Switzerland.



Change in the way things taste



Diarrhoea and vomiting



Skin rash (which may be severe)



Muscle cramps or pain in your muscles or joints

Leaflet revision date: 26 November 2012.



Impotence

Vascace is a registered trade mark of Roche Products Limited, UK.



Sweating more than usual



Flushing



Sleeping problems

Tablets are available in blister packs of 28 and 30.
Product Licence holder

POM

PL No. 8747/0670
PL No. 8747/0671
PL No. 8747/0672

Vascace 1mg Tablets
Vascace 2.5mg Tablets
Vascace 5mg Tablets

670-2 LEAFLET Vascace 20121126

Expand Transcript

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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