Cilazapril 0.5mg Film-Coated Tablets
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
(Cilazapril)
Read all of this leaflet carefully before you start taking this medicine because if 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 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. 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), which reduce blood pressure. They also make it easier for the heart to pump blood around the body.
CILAZAPRIL is used to treat the following:
• high blood pressure (hypertension)
• heart failure (a condition where the heart is unable to pump enough blood to meet the body’s needs)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CILAZAPRIL
Do not take CILAZAPRIL
• if you are allergic to cilazapril, other ACE inhibitors or any other ingredient of this medicine (listed in section 6).
• if you have previously suffered from swelling of the face, lips, throat or tongue), when treated with other ACE inhibitors (e.g. ramipril), or due to hereditary or unknown reasons.
• If you are more than 3 months pregnant. (It is also better to avoid cilazapril in early pregnancy - see pregnancy section)
• If you are breast feeding
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
Take special care with CILAZAPRIL
CILAZAPRIL is not generally recommended if the following apply, so talk to your doctor before starting to take this medicine or to continue taking this medicine:
• If you are also taking lithium (used to treat mental health problems), potassium - sparing diuretics (“water tablets”), potassium supplements of potassium-containing salts substitutes
• If you have narrow arteries to your kidneys (renal artery stenosis) or only have one functioning kidney
• If jaundice occurs during treatment. You must stop taking this medicine and contact your doctor
• If you have high levels of potassium in your blood
When starting to take this medicine or when the dosage is changed, an excessive decrease of blood pressure might occur, especially if you suffer from heart failure, ischaemic heart disease (angina) or disorders of the blood vessels in the brain (cerebrovascular conditions such as previous stroke).
Tell your doctor before you start to take this medicine:
• If you are on a salt restricted diet or are taking diuretics (“water tablets”)
• If you are over 70 years old
• If you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance). Possible signs are: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, myalgia or cramps, muscle fatigue, a drop in blood pressure, low urine output, tachycardia, nausea and vomiting
• If you have recently suffered from vomiting and/or diarrhoea
• If you have heart muscle diseases (hypertrophic cardiomyopathy) a narrowing of the aortic valve (aortic stenosis ) or heart failure
• If you have or have had liver or kidney problems, or you are undergoing haemodialysis
• If you suffer from diabetes
• If you suffer from connective tissue diseases (e.g. lupus erythematosus, an inflammation-like disease of the skin, intestine, joints, kidneys and heart), use medicines to suppress the immune system (immunosuppressants) or are being treated with allopurinol (a medicine against gout) or procainamide (a medicine for irregular heartbeat)
• If you need to have an anaestethic or major surgery
• If you have to undergo LDL apheresis (removal of cholesterol from the blood by a machine)
• If you have to undergo desensitisation therapy to some insect venoms
• 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”
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 pregnancy section).
Furthermore, this medicine might cause a dry cough. This will disappear after the treatment is stopped.
Other medicines and CILAZAPRIL
Talk to your doctor if you are taking or have recently taken any of the following:
• Lithium salts, which are used to treat mental health problems (see “Take special care with CILAZAPRIL”)
• Potassium-sparing diuretics (“water tablets”), such as spironolactone, triamterene, potassium canrenoate or amiloride
• Potassium salts
• Other medicines to treat high blood pressure, such as beta-blockers (e.g. bisoprolol), calcium channel blockers (e.g. verapamil), methyldopa, nitrates (e.g. glyceryl trinitrate), vasodilators (e.g. minoxidil)
• Other diuretics (“water tablets”)
• Medicines known as sympathomimetics e.g. salbutamol, ephedrine and some medicines for colds, coughs or flu symptoms
• Non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce pain and inflammation, e.g. acetylsalicylic acid (aspirin) or ibuprofen
• Heparins to prevent and disperse blood clots
• Immunosuppressants such as ciclosporin or tacrolimus, which are used following organ transplants
• Corticosteroids, such as beclometasone or prednisolone, which are sometimes used to suppress inflammation caused by allergic reactions
• Allopurinol, which is used to treat gout
• Procainamide, which is used to treat abnormal heart rhythms
• Drugs used to treat diabetes, such as insulin, sulphonamides or metformin
• Antacids, which are used for the relief of indigestion. Doses of cilazapril and antacids should be taken 2 hours apart
• Antidepressants such as imipramine
• Medicines used to treat psychotic illnesses, such as chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpride, tiapride, droperidol, haloperidol or pimozide
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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”.
Taking CILAZAPRIL with food and drink
You should avoid consuming alcohol whilst on this medicine, as the blood pressure-lowering effect could be increased.
Pregnancy and breast-feeding
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking CILAZAPRIL before you become 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. Tell your doctor if you are breast-feeding or about to start 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
Your medicine may occasionally cause light-headedness, low blood pressure or dizziness. If affected, do not drive or operate machinery.
CILAZAPRIL contains lactose monohydrate.
Important information about some of the ingredients of CILAZAPRIL
This product contains lactose monohydrate: if you have been told by your doctor that you have an intolerance to some sugars, contact 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.
Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dosage unless your doctor tells you to do so. CILAZAPRIL may be used on its own or with other medicines which lower blood pressure.
The usual dosage is as follows:
High blood pressure:
• The usual starting dose is 1 mg once daily. In some cases, your doctor may feel that you should start on a lower dose
• If you are elderly, your doctor will probably start you on 0.5 or 1 mg a day
• If you have kidney or liver problems, your doctor may start you on a lower dose than normal
• If you are already taking diuretics (“water tablets”), your doctor may stop you taking the diuretic at all for 2 or 3 days before you start to take CILAZAPRIL. Your doctor may prescribe a starting dose of 0.5 mg of CILAZAPRIL.
• Your doctor will probably increase your dose to between 2.5 and 5 mg a day depending on your response.
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
• You should swallow CILAZAPRIL film-coated tablets with a drink at around the same time each day.
Use in children and adolescents:
• CILAZAPRIL should not be used for children and adolescents below 18 years due to a lack of data on safety and efficacy.
If you take more CILAZAPRIL than you should
If you (or someone else) swallow a lot of tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause low blood pressure, dizziness, hyperventilation, low or high heart rate, palpitations, anxiety and feeling sleepy and confused. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
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, 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.
The following side effects have been reported at the approximate frequencies shown.
If you experience the following, stop taking CILAZAPRIL and tell your doctor immediately or go to the casualty department of your nearest hospital:
• A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing)
This is a serious but rare (affecting fewer than one person in 1,000 but more than one person in 10, 000) side effect, which occurs more frequently in Black-patients than in non-Blacks. You may need urgent medical attention or hospitalisation.
• Jaundice (yellowing of the skin and whites of the eyes caused by liver or blood problems) (see 2. Before you take CILAZAPRIL, Take special care with CILAZAPRIL).
This is a serious but very rare side effect which occurs in fewer than one person in 10, 000.
If you experience the following, contact your doctor immediately:
• An infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems; cilazapril may cause a reduction in the number of white blood cells and your resistance to infection may be decreased.
This is a very rare side effect, which occurs in fewer than one person in 10, 000. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
The following side effects have also been reported:
Common side effects (affecting fewer than one person in 10 but more than one person in 100):
• Headache, dizziness
• Low blood pressure, which may be characterised by light-headedness, weakness, or dizziness when you stand up
• Cough (see 2. Before you take CILAZAPRIL, Take special care with CILAZAPRIL)
• Nausea, diarrhoea, vomiting
• Rash
• Tiredness
Uncommon (affecting fewer than one person in 100 but more than one person in 1, 000):
• Mood changes, fainting, sleep disturbances
• Heart attack, stroke, palpitations, excessively fast heartbeat, transiently reduced blood flow to the limbs (which may be associated with coldness, pallor or numbness of the affected limb)
• Runny nose, chest pain
• Abdominal pain, indigestion, digestive disorders
• Rash with fever, itching
• Impotence
• Weakness
• Increase in the amount of urea or creatinine in the blood
• High blood potassium levels
Rare (affecting fewer than one person in 1, 000 but more than one person in 10, 000):
• Depression, pins and needles, confusion, taste disturbances
• Shortness of breath, difficulty breathing which may be associated with wheezing, sinusitis, allergic lung problems, pneumonia, bronchitis
• Dry mouth, inflammation of the tongue
• Allergic (hypersensitivity) reactions, including angioedema (which is characterised by symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rashes, fainting or dizziness), hives
• Psoriasis (a skin condition in which silvery scales develop on the skin), hair loss
• Muscle and/or joint pain
• Proteinuria, abnormal kidney function
• Uraemia
• Abnormal liver function tests
• Low blood sodium levels
Very rare (affecting fewer than one person in 10, 000)
• Blood abnormalities such as decreased haemoglobin or haematocrit levels, reduced numbers of platelets, red or white blood cells, lymph node swelling or enlargement
• Auto-immune disease (e.g. some forms of arthritis)
• Low blood sugar levels
• Nerve disease, which may be associated with pain
• Inflamed blood vessels
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
• Angioedema (swelling) in the intestines
• Inflammation of the liver (hepatitis), jaundice, liver failure
• Sweating, serious skin rashes or changes
• A cluster of symptoms may occur with fever, inflamed blood vessels, muscle pain, joint pain and/or inflammation, abnormal blood tests, rash, sensitivity of the skin to light and other skin problems
• Acute kidney failure, abnormally low or absent urine production
• Breast enlargement including in men
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 [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 CILAZAPRIL after the expiry date which is stated on the blister and the outside 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 tablet 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.
I 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,
II Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus
Manufacturer
SymPhar Sp. z o.o.
ul. Wtoska 1,00-777 Warsaw,
Poland
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London,
SW5 9JQ, United Kingdom
This leaflet was last revised in: 02/2016
A0114-0117/O/PIL/A4