iMedi.co.uk

Vascace 5mg Film-Coated Tablets

S1617 LEAFLET Vascace 20150618

PACKAGE LEAFLET: INFORMATION FOR THE USER VASCACE 5mg FILM-COATED TABLETS (cilazapril)

The name of your medicine is Vascace 5mg Film-coated Tablets but will be referred to as Vascace throughout the following leaflet. Information for other strength of Vascace i.e Vascace 0.5mg, 1mg and 2.5mg Tablets also may be present in this leaflet.

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

1. WHAT VASCACE IS AND WHAT IT IS USED FOR

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

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.

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.

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.

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.

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.

•    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 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

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.

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 “angiotensin receptor 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.

•    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.

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.

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

•    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 any side effects, talk to your doctor, pharmacist or nurse. 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 VASCACE

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    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.

•    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 ingredient is cilazapril.

Each film-coated tablet contains 5mg of cilazapril (as 5.22mg cilazapril monohydrate).

•    The other ingredients are lactose monohydrate, maize starch, talc, sodium stearyl fumarate, hypromellose 2910/3 and 2910/6, red iron oxide (E172), titanium dioxide (E171).

What Vascace looks like and contents of the pack

Vascace is reddish-brown, oval, film-coated tablet marked “CIL 5” on the one side and a score-line on the other. The tablets are scored so that they can easily be broken into halves.

Vascace is available in calendar blister packs of 28 tablets.

Product Licence holder

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

Manufacturer

This product is either manufactured by Roche SRO, Prague, Czech Republic, or,

Roche Pharma AG, Emil-Barell-Strasse 1, D-79639 Grenzach, Wyhlen, Germany.

| POM | PL: 19488/1617 Leaflet revision date: 18 June 2015

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

S1617 LEAFLET Vascace 20150618

Rare (affects less than 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)


S1617 LEAFLET Cilazapril 20150618

PACKAGE LEAFLET: INFORMATION FOR THE USER CILAZAPRIL 5mg FILM-COATED TABLETS (cilazapril)

The name of your medicine is Cilazapril 5mg Film-coated Tablets but will be referred to as Cilazapril Tablets throughout the following leaflet.

Information for other strength of Cilazapril Tablets i.e Cilazapril

0.5mg, 1mg and 2.5mg Tablets also may be present in this leaflet.

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 Cilazapril Tablets are and what they are used for

2.    What you need to know before you take Cilazapril Tablets

3.    How to take Cilazapril Tablets

4.    Possible side effects

5.    How to store Cilazapril Tablets

6.    Contents of the pack and other information

1. WHAT CILAZAPRIL TABLETS ARE AND WHAT THEY ARE USED FOR

Cilazapril Tablets contain a medicine called cilazapril. This belongs to a group of medicines called ‘ACE inhibitors' (Angiotensin Converting Enzyme Inhibitors).

Cilazapril Tablets are 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 Cilazapril Tablets to help treat your condition.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CILAZAPRIL TABLETS

Do not take Cilazapril Tablets

•    if you are allergic (hypersensitive) to cilazapril or any of the other ingredients of Cilazapril Tablets (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 Cilazapril Tablets 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 Cilazapril Tablets if any of the above apply to you. If

you are not sure, talk to your doctor or pharmacist before taking

Cilazapril Tablets.

Warnings and precautions

Check with your doctor or pharmacist before taking Cilazapril

Tablets

•    if you have a heart problem. Cilazapril Tablets are 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 “angiotensin receptor 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.

•    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 Cilazapril Tablets.

You must tell your doctor if you think you are (or might become) pregnant. Cilazapril Tablets are 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

Cilazapril Tablets are not recommended for use in children.

Other medicines and Cilazapril Tablets

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 Cilazapril Tablets can affect the way some medicines work. Also some medicines can affect the way Cilazapril Tablets work.

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

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 Tablets'.

•    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.

•    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 Tablets 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 Cilazapril Tablets before you become pregnant, or as soon as you know you are pregnant, and will advise you to take another medicine instead of Cilazapril Tablets. Cilazapril Tablets are 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. Cilazapril Tablets are 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 Tablets. 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 Tablets contain

Cilazapril Tablets contain 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 CILAZAPRIL TABLETS

Always take Cilazapril Tablets exactly as prescribed. You should

check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take one tablet of Cilazapril Tablets each day.

•    Swallow each tablet with a drink of water.

•    It does not matter what time of day you take Cilazapril Tablets. However, always take it around the same time.

•    Cilazapril Tablets may be taken before or after a meal.

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 Cilazapril Tablets. The usual starting dose of Cilazapril Tablets 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 Cilazapril Tablets than you should

If you take more Cilazapril Tablets 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 lightheaded, shallow breathing, cold clammy skin, being unable to move or speak and a slow heart beat.

If you forget to take Cilazapril Tablets

•    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, Cilazapril Tablets can cause side effects, although not everybody gets them.

Severe reactions:

If you have a severe reaction called angioedema, stop taking Cilazapril Tablets 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

•    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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 TABLETS

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

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

•    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 Cilazapril Tablets contain

•    The active ingredient is cilazapril.

Each film-coated tablet contains 5mg of cilazapril (as 5.22mg cilazapril monohydrate).

•    The other ingredients are lactose monohydrate, maize starch, talc, sodium stearyl fumarate, hypromellose 2910/3 and 2910/6, red iron oxide (E172), titanium dioxide (E171).

What Cilazapril Tablets look like and contents of the pack

Cilazapril Tablets are reddish-brown, oval, film-coated tablets marked “CIL 5” on the one side and a score-line on the other. The tablets are scored so that they can easily be broken into halves. Cilazapril Tablets are available in calendar blister packs of 28 tablets.

Product Licence holder

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

Manufacturer

This product is either manufactured by Roche SRO, Prague, Czech Republic, or,

Roche Pharma AG, Emil-Barell-Strasse 1, D-79639 Grenzach, Wyhlen, Germany.

POM PL: 19488/1617

Leaflet revision date: 18 June 2015

S1617 LEAFLET Cilazapril 20150618

Rare (affects less than 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