Package leaflet: Information for the user

Cilazapril 0.5 mg, 1 mg, 2.5 mg & 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 of the 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 three months pregnant (it is better to avoid Cilazapril in early pregnancy - see section 2: Pregnancy and breast-feeding).

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 stoke or have problems with the blood supply to your brain.

-    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), 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 you have kidney problems or have a problem with the blood supply to your kidneys called (renal artery stenosis).

-    If you have severe liver problems or if you develop jaundice.

-    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.

-    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 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 the 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.

- Diuretics (‘water tablets’) - see ‘High blood pressure (hypertension)’ in section 3 on ‘How to take Cilazapril’.

-    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 ‘Warnings and precautions’).

-    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.

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

-    Aldosterone antagonists.

-    Sympathomimetics.

-    Anaesthetics, narcotics.

-    Tricyclic antidepressants, antipsychotics.

-    Gold compounds (used to treat rheumatoid arthritis).

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 monohydrate

Cilazapril contains lactose monohydrate, 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 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.

-    The tablet can be divided into equal doses.

High bloodpressure(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 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 0.5mg once daily.

-    If you are elderly, your doctor will probably start you on 0.5mg 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 1mg a day depending on your response.

-    The usual maximum dose is 5mg 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

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 if you are being treated for high blood pressure, 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 medicine, 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 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 (may affect up to 1 in 10 people)

-    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 up to 1 in 1,000 people)

-    Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets (anemia, 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 in men

Reporting of side effects

If you get 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 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 outer packaging. 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 protect the environment.

6.    Contents of the pack and other information What Cilazapril contains

-    The active substance is cilazapril. One film-coated tablet contains either 0.5 mg, 1 mg, 2.5 mg or 5 mg of cilazapril as cilazapril monohydrate.

-    The other ingredients are as follows:

Tablet core: lactose monohydrate, talc, sodium starch glycolate (type A), copovidone, sodium stearyl fumarate

Film-coating: poly(vinyl) alcohol, titanium dioxide (E171) (0.5mg, 1mg & 2.5mg only), macrogol 3350, talc, iron oxide yellow (E172) (1 mg & 2.5 mg only), iron oxide red (E172) (2.5 mg & 5 mg only).

What Cilazapril looks like and contents of the pack

-    Cilazapril 0.5 mg Film-coated Tablets are white to off-white, oval film-coated tablet scored on one side, debossed “C 0.5” on the other side.

-    Cilazapril 1 mg Film-coated Tablets are yellow, oval film-coated tablet scored on one side, debossed “C 1” on the other side.

-    Cilazapril 2.5 mg Film-coated Tablets are pink, oval film-coated tablet scored on one side, debossed “C 2.5” on the other side.

-    Cilazapril 5 mg Film-coated Tablets are brown-red, capsule-shaped film-coated tablet scored on one side, debossed “C 5” on the other side.

The tablets can be divided into equal-doses.

-    Cilazapril 0.5 mg Film-coated Tablets are available in pack sizes of 14, 20, 28, 30, 56, 60, 100.

- Cilazapril 1 mg Film-coated Tablets are available in pack sizes of 14, 20, 28, 30, 50, 56, 60, 100.

- Cilazapril 2.5 mg Film-coated Tablets are available in pack sizes of 10, 14, 20, 28, 30, 50, 56, 60, 90, 100.

-    Cilazapril 5 mg Film-coated Tablets are available in pack sizes of 14, 20, 28, 30, 50, 56, 60, 90, 100. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was revised in November 2014

PL 00289/1014-7