CILAZAPRIL 5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - 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.

5. how to store cilazaprildo 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 25°C.

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 tablets (3 blisters x 10 tablets).

Cilazapril 1 mg is available in packs of 30 film-coated tablets (3 blisters x 10 tablets).

Cilazapril 2.5 mg is available in packs of 28 film-coated tablets (4 blisters x 7 tablets).

Cilazapril 5 mg is available in packs of 28 film-coated tablets (4 blisters x 7 tablets).

Marketing Authorisation Holder

Activase Pharmaceuticals Limited

11 Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus

Manufacturer

Symphar Sp. z o.o.

ul. Chelmzynska 249, 04–458 Warsaw, Poland

DDSA Pharmaceuticals Limited

84 Pembroke Road, London, W8 6NX, UK

This leaflet was last revised in 12/2017.

A0114–0115–0116–0117/O/PIL/A7