Candesartan 16 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
• Ifyou 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.
• Ifyou get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet. See section 4.
1. What Candesartan Tablets are and what they are used for
2. What you need to know before you take Candesartan Tablets
3. How to take Candesartan Tablets
4. Possible side effects
5. How to store Candesartan Tablets
6. Contents of the pack and other information
The name of your medicine is Candesartan Tablets. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. 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 to all parts of your body.
Candesartan can be used to:
• treat high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years
• treat adult heart failure patients with reduced heart muscle function when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used. (ACE inhibitors and MRA are medicines used to treat heart failure).
• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is also better to avoid Candesartan Tablets in early pregnancy - see pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan Tablets.
Warnings and precautions
Talk to your doctor before taking Candesartan Tablets:
• if you have heart, liver or kidney problems, or are on dialysis.
• if you have recently had a kidney transplant.
• if you are vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• you must tell your doctor if you think you are (or might become) pregnant. Candesartan 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 pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure:
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
• if you are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are for the treatment of heart failure (see “Other
medicines and Candesartan Tablets”).
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 Candesartan Tablets”.
Your doctor may want to see you more often and do some tests if you have any of these conditions.
If you are going to have an operation, tell your doctor or dentist that you are taking Candesartan Tablets. This is because Candesartan Tablets, when combined with some anaesthetics, may cause a drop in blood pressure.
Candesartan has been studied in children. For more information, talk to your doctor. Candesartan Tablets should not be given to children under 1 year of age due to potential risk to the developing kidneys.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Candesartan Tablets can affect the way some other medicines work and some medicines can have an effect on Candesartan Tablets. If you are using certain medicines, your doctor may need to do blood tests from time to time.
In particular, tell your doctor if you are using any of the following medicines as your doctor may need to change your dose and/or take other precautions:
• Other medicines to help lower your blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3g each day) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine for thinning the blood).
• Water tablets (diuretics).
• Lithium (a medicine for mental health problems).
• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Candesartan Tablets” and “Warnings and precautions”).
• If you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptor antagonists (MRA) (for example: spironolactone, eplerenone).
Candesartan Tablets with food, drink and alcohol
• You can take Candesartan Tablets with or without food.
• When you are prescribed Candesartan Tablets, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.
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 Candesartan Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan Tablets.
Candesartan 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.
Tell your doctor if you are breast-feeding or about to start breastfeeding. Candesartan 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
Some people may feel tired or dizzy when taking Candesartan Tablets. If this happens to you, DO NOT drive or use any tools or machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important to keep taking Candesartan Tablets every day.
You can take Candesartan Tablets with or without food. Swallow the tablet with a drink of water.
Try to take the tablet at the same time each day. This will help you to remember to take it.
High blood pressure:
• The recommended dose of Candesartan Tablets is 8mg once a day.Your doctor may increase this dose to 16mg once a day and further up to 32mg once a day depending on blood pressure response.
• In some patients, such as those with liver problems, kidney problems or those who recently have lost body fluids, e.g., through vomiting or diarrhoea or by using water tablets, the doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine, when given as the only treatment, and these patients may need a higher dose.
Use in children and adolescents with high blood pressure:
Children 6 to <18 years of age:
The recommended starting dose is 4mg once daily.
For patients weighing < 50kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide the dose needs to be increased to a maximum of 8mg once daily.
For patients weighing > 50kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide the dose needs to be increased to 8mg once daily and to 16mg once daily.
Heart failure in adults:
• The recommended starting dose of Candesartan Tablets is 4mg once a day.Your doctor may increase your dose by doubling the dose at intervals of at least 2 weeks up to 32mg once a day.
Candesartan Tablets can be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.
If you take more Candesartan Tablets than you should
If you take more Candesartan Tablets than prescribed by your doctor, contact a doctor or pharmacist IMMEDIATELY for advice.
If you forget to take Candesartan Tablets
DO NOT take a double dose to make up for a forgotten tablet.
Just take the next dose as normal.
If you stop taking Candesartan Tablets
If you stop taking Candesartan Tablets, your blood pressure may increase again. Therefore DO NOT stop taking Candesartan Tablets without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you are aware of what these side effects may be.
STOP taking Candesartan Tablets and seek medical help IMMEDIATELY if you have any of the following allergic reactions:
• difficulties in breathing, with or without swelling of the face, lips, tongue and/or throat
• swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing
• severe itching of the skin (with raised lumps)
Candesartan Tablets may cause a reduction in number of white blood cells.Your resistance to infection may be decreased and you may notice tiredness, an infection or a fever. If this happens contact your doctor. Your doctor may occasionally do blood tests to check whether Candesartan Tablets have had any effect on your blood (agranulocytosis).
Other possible side effects include:
Common (affects 1 to 10 users in 100)
• Feeling dizzy/spinning sensation.
• Respiratory infection.
• Low blood pressure. This may make you feel faint or dizzy.
• Changes in blood test results:
• An increased amount of potassium in your blood, especially if you already have kidney problems or heart failure. If this is severe you may notice tiredness, weakness, irregular heart beat or pins and needles.
• Effects on how your kidneys work, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.
Very rare (affects less than 1 user in 10,000)
• Swelling of the face, lips, tongue and/or throat.
• A reduction in your red or white blood cells.You may notice tiredness, an infection or a fever.
• Skin rash, lumpy rash (hives).
• Back pain, pain in joints and muscles.
• Changes in how your liver is working, including inflammation of the liver (hepatitis). You may notice tiredness, yellowing of your skin and the whites of your eyes and flu like symptoms.
• Changes in blood test results:
• A reduced amount of sodium in your blood. If this is severe then you may notice weakness, lack of energy, or muscle cramps.
In children treated for high blood pressure, side effects appear to be similar to those seen in adults, but they happen more often. Sore throat is a very common side effect in children but not reported in adults and runny nose, fever and increased heart rate are common in children but not reported in adults.
Reporting of side effects
If you get any side effects, talk to your doctor. 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.
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 carton label and blister foil after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
DO NOT throw away any medicine 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.
• The active substance is candesartan cilexetil. Each tablet contains 2mg, 4mg, 8mg 16mg or 32mg of candesartan cilexetil.
• The other ingredients are: mannitol, maize starch, copovidone, glycerol, magnesium stearate, red iron oxide (E172; only for 8mg, 16mg, and 32mg tablets), and microcrystalline cellulose (only for 16mg and 32mg tablets).
What Candesartan Tablets look like and contents of the pack
• 2mg tablets are white to off-white, round tablets (diameter~5.5mm).
• 4mg tablets are white to off-white, round tablets (diameter~7.5mm), with a break-line on one side.
• 8mg tablets are light red, round tablets (diameter~7.5mm), with a break line on one side and debossed with T/T on the same side.
• 16mg tablets are red, round tablets (diameter~7.5mm) with a break-line on one side and debossed with C/C on the same side.
• 32mg tablets are red, round tablets (diameter~10mm) with a break line on one side.
The tablet can be divided into equal doses.
Candesartan 2mg and 4mg tablets come in OPA/Alu/PVC-Alu blister packs containing 7 tablets.
Candesartan 8mg, 16mg and 32mg tablets come in OPA/Alu/PVC-Alu blister packs containing 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED United Kingdom