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CILAZAPRIL 0.5MG FILM-COATED TABLETS

Active substance(s): CILAZAPRIL MONOHYDRATE / CILAZAPRIL MONOHYDRATE / CILAZAPRIL MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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.
What is in this leaflet
1. What Cilazapril is and what it is used for
2. What you need to know before you take Cilazapril
3. How to take Cilazapril
4. Possible side effects
5. How to store Cilazapril
6. Contents of the pack and other information
1. WHAT CILAZAPRIL IS AND WHAT IT IS USED FOR
Cilazapril belongs to the group of medicines called angiotensin
converting enzyme inhibitors (ACE-inhibitors).
Cilazapril is used in adults 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 Cilazapril
to help treat your condition.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Cilazapril
Do not take Cilazapril:
● If you are allergic to cilazapril or any other ingredients of this
medicine (listed in section 6).
● If you are allergic to other ACE inhibitor medicines. These
include 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 have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.
● If you are more than 3 months pregnant (it is better to avoid
Cilazapril in early pregnancy – see Section 2: Pregnancy and
breastfeeding).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cilazapril:
● If you have a heart problem. Cilazapril 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 kidney problems or have a problem with the blood
supply to your kidneys (renal artery stenosis).
● If you have severe liver problems or if you develop jaundice.
● If you have high levels of potassium in your blood.
● If you are on kidney dialysis.
● If you have recently suffered from vomiting or 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 suffer from diabetes.
● If you have a collagen vascular disease.
● If you have to undergo LDL apheresis with dextrane sulphate.
● If you are taking any of the following medicines used to treat
high blood pressure:
- an “angiotensin II receptor blocker” (ARBs) (also known as
sartans – for example valsartan, telmisartan, irbesartan,
etc.), in particular if you have diabetes-related kidney
problems.
- aliskiren.
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 Cilazapril”.
If any of the above apply to you, or if you are not sure, talk to
your doctor of pharmacist before you take Cilazapril.
You must tell your doctor if you think you are (or might become)
pregnant. Cilazapril 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 Section 2: Pregnancy and breast-feeding).
Children and adolescents
Cilazapril is not recommended for use in children aged below
18 years.
Other medicines and Cilazapril
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes
medicines obtained without a prescription and herbal
medicines. This is because Cilazapril can affect the way some
medicines work. Also some medicines can affect the way
Cilazapril 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 Cilazapril’.
● Medicines called ‘non-steroidal anti-inflammatory drugs’
(NSAIDs). These include aspirin, indomethacin 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, antipyschotics.
● Gold compounds (used to treat rheumatoid arthritis).
● Your doctor may need to change your dose and/or to take
other precautions: if you are taking an angiotensin II receptor
blocker (ARB) or aliskiren (see also information under the
headings “Do not take Cilazapril” and “Take special care with
Cilazapril”.
Cilazapril with food and drink
Tell your doctor or pharmacist if you are taking food
supplements that contain potassium.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will normally advise you to stop taking Cilazapril
before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead
of Cilazapril. Cilazapril 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
Cilazapril 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 Cilazapril. This is more likely to
happen when you first start treatment. If you feel dizzy, do not
drive or use any tools or machines.
Cilazapril contains lactose
Cilazapril contains lactose, which is a type of sugar. If you have
an intolerance to lactose, talk your doctor before taking this
medicinal product.
3. HOW TO TAKE CILAZAPRIL
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
● Take one tablet of Cilazapril each day.
● Swallow each tablet with a drink of water.
● It does not matter what time of day you take Cilazapril.
However, always take it around the same time.
● Cilazapril may be taken before or after a meal.
High blood pressure (hypertension):
● The usual starting dose 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 Cilazapril. The usual starting dose of
Cilazapril 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 once daily.
● If you are elderly, your doctor will probably start you on 0.5 mg
a day.

● If you have kidney or liver problems, your doctor may start
you on a lower dose than normal.
● Your doctor will probably increase your dose to at least 1 mg a
day depending on your response.
● The usual maximum dose is 5 mg once daily.
If you take more Cilazapril than you should
If you take more Cilazapril than you should, or if someone else
takes your Cilazapril 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 Cilazapril
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 to
make up for a forgotten tablet. Take your next dose at the
normal time.
If you stop taking Cilazapril
The treatment of hypertension and heart failure is a long term
treatment and interruption of treatment must be discussed with
the doctor. Interruption or stopping your treatment could cause
your blood pressure to increase, or it could cause your
symptoms to recur if you are being treated for heart failure.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Severe reactions:
If you have a severe reaction called angioedema, stop taking
Cilazapril and tell your doctor immediately or go to the casualty
department of your nearest hospital straightaway.
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 (may affect up to 1 in 10)
● Feeling dizzy
● Coughing
● Nausea
● Feeling tired
● Headache.
Uncommon (may affect up to 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, palpitations
● 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 (may affect 1 in 1,000 people)
● 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)
● Cerebral ischaemia, transient ischaemic attack, ischaemic
stroke (may occur if blood pressure becomes too low)
● 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)
● Low blood sodium levels
● High blood potassium levels
● 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 including in men.
Reporting of side effects
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 any 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.
5. HOW TO STORE Cilazapril
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 the outer packaging after "EXP". The expiry date
refers to the last day of that month.
Do not store above 25ºC.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cilazapril contains
The active substance is cilazapril. One film-coated tablets
contains either 0.5 mg, 1 mg, 2.5 mg, 5 mg of cilazapril as
cilazapril monohydrate.
The other ingredients are as follows:
Tablet core:
Lactose, maize starch, hypromellose 3cp, talc, sodium stearyl
fumarate.
Film-coating:
0.5 mg:
Opadry pink 03B23719: hypromellose 6cp, talc,
titanium dioxide (E171), Macrogol 400, iron oxide
red (E172), iron oxide yellow (E172).
1 mg:
Opadry pink 03B23719: hypromellose 6cp, talc,
titanium dioxide (E171), Macrogol 400, iron oxide
red (E172), iron oxide yellow (E172).
2.5 mg:
Opadry brown 03B26857: hypromellose 6cp, talc,
titanium dioxide (E171), Macrogol 400, iron oxide
red (E172).
5 mg:
Opadry brown 03B26857: hypromellose 6cp, talc,
titanium dioxide (E171), Macrogol 400, iron oxide
red (E172).
What Cilazapril looks like and contents of the pack
0.5 mg:
Pink, oblong presenting a one sided score, weighing
approximately 100 mg, film coated tablets.
1 mg:
Pink, oblong presenting a one sided score, with the
mark C1 engraved on one side, weighing
approximately 200 mg, film coated tablets.
2.5 mg:
Brown, oblong presenting a one sided score, film
coated tablets.
5 mg:
Brown, oblong presenting a one sided score, with
the mark C5 engraved on one side, weighing
approximately 200 mg film coated tablets.
The tablets can be divided into equal halves.
Packaging
Cilazapril 0.5 mg is available in packs of 30 film-coated
(3 blisters x 10 tablets).
Cilazapril 1 mg is available in packs of 30 film-coated
(3 blisters x 10 tablets).
Cilazapril 2.5 mg is available in packs of 28 film-coated
(4 blisters x 7 tablets).
Cilazapril 5 mg is available in packs of 28 film-coated
(4 blisters x 7 tablets).

tablets
tablets
tablets
tablets

Marketing Authorisation Holder
Activase Pharmaceuticals Limited
11 Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus
Manufacturer
Symphar Sp. z o.o.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
DDSA Pharmaceuticals Limited
310 Old Brompton Road, London, SW5 9JQ, United Kingdom
This leaflet was last revised in 07/2017.

A0114-0115-0116-0117/O/PIL/A5

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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