Candesartan Cilexetil 16 Mg Tablets
|
TEVA UK Ref: 231-30-17781-D LEA CANDESARTAN CILEXETIL 8MG, 16MG & 32MG TABS TUK |
Version: 1 |
04 November 2014 |
PAGE 1: FRONT FACE (INSIDE OF REEL)
CANDESARTAN CILEXETIL 8 mg TABLETS CANDESARTAN CILEXETIL 16 mg TABLETS CANDESARTAN CILEXETIL 32 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 onto others. It may harm them, even if their signs of illness are the same as yours.
• Ifyou get the side effects talkto 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 Candesartan cilexetil is and what it is used for
2. What you need to know before you take Candesartan cilexetil
3. How to take Candesartan cilexetil
4. Possible side effects
5. How to store Candesartan cilexetil
6. Contents of the pack and other information
OWhat Candesartan cilexetil is and what it is used for
The name ofyour medicine is Candesartan cilexetil.The active ingredient is Candesartan cilexetil.This belongs toagroupof 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 H pump blood to all parts ofyour body.
This medicine is used for:
• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6to <18 years • treating 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 MRAs are medicines used to treat heart failure).
©What you need to know before you take Candesartan cilexetil
Do not take Candesartan cilexetil
• ifyou are allergic to Candesartan cilexetil oranyoftheother ingredients of Candesartan cilexetil this medicine (listed in section 6)
• ifyou are more than 3 months pregnant (it is also better to avoid Candesartan cilexetil in early pregnancy- see section 2: Pregnancy and breast-feeding)
• ifyou have severe liver disease or biliary obstruction
(a problem with the drainage ofthe bile from the gall bladder)
• if the patient is a child under 1 year of age • ifyou have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Ifyou are not sure if any ofthese apply to you, talkto your doctor or pharmacist before taking Candesartan cilexetil.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan cilexetil:
• ifyou have heart, liver or kidney problems, or are on dialysis • if you have recently had a kidney transplant • ifyou are vomiting, have recently had severe vomiting, or have diarrhoea
• ifyou have a disease ofthe adrenal gland called Conn's syndrome (also called primary hyperaldosteronism)
• ifyou have low blood pressure • ifyou have ever had a stroke
• you must tell your doctor ifyouthinkyouare (or might become) pregnant. Candesartan cilexetil is not recommended in early pregnancy, and must not be taken ifyou 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).
• ifyou are taking any ofthe following medicines used to treat high blood pressure:
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular ifyou have diabetes-related kidney problems • aliskiren
• ifyou are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptors antagonists (MRA).These medicines are for the treatment of heart failure (see 'Other medicines and Candesartan cilexetil').
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 cilexetil'.
Your doctor may want to see you more often and do some tests if you have any of these conditions.
Ifyou are going to have an operation, tell your doctor or dentist that you are taking Candesartan cilexetil. This is because Candesartan cilexetil when combined with some anaesthetics, may cause a drop in blood pressure.
Children and adolescents
Candesartan has been studied in children. For more information, talk to your doctor. Candesartan must not be given to children
Other medicines and Candesartan Cilexetil
Tell your doctor or pharmacist ifyou are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Candesartan cilexetil can affect the way some other medicines work and some medicines can have an effect on Candesartan cilexetil. Ifyou are using certain medicines, your doctor may need to do blood tests from time to time.
In particular, tell your doctor ifyou are using any ofthe following medicines:
• other medicines to help lower your blood pressure, including beta-blockers and diazoxide
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation)
• acetylsalicylicacid (ifyou aretaking morethan 3 g 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)
• watertablets(diuretics)
• lithium (a medicine for mental health problems).
Your doctor may need to change your dose and/or to take other precautions:
• Ifyouare taking an ACE-inhibitor or aliskiren (see also information under the headings 'Do not take Candesartan cilexetil' and 'Warnings and precautions')
• Ifyouare being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone).
Candesartan cilexetil with food, drink and alcohol
• You can take Candesartan cilexetil with or without food
• When you are prescribed Candesartan cilexetil, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.
Pregnancy and breast-feeding
Ifyou are pregnant or breast-feeding,thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor ifyou think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Candesartan cilexetil before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan cilexetil. Candesartan cilexetil 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 ifyou are breast-feeding or about to start breast-feeding. Candesartan cilexetil is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you ifyou wish to breast-feed, especially if your baby is newborn orwas born prematurely.
Driving and using machines
Some people may feel tired or dizzywhen taking Candesartan cilexetil. If this happens to you, do not drive or use anytools or machines.
Candesartan cilexetil contains lactose which is a type ofsugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Candesartan cilexetil
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure. It is important to keep taking Candesartan cilexetil every day.
You can take Candesartan cilexetil with or without food.
Swallow the tablet with adrink ofwater.
Try to take the tablet at the same time each day. This will help you to remember to take it.
High blood pressure
• The usual dose of Candesartan cilexetil is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and further up to 32 mg once a day depending on blood pressure response.
Top of page cut-off to middle of registration mark: 44 mm.
REG0094649
Version 3.2
Approved
Page 2 of 4
|
TEVA UK Ref: 231-30-17781-D LEA CANDESARTAN CILEXETIL 8MG, 16MG & 32MG TABS TUK |
Version: 1 |
04 November 2014 |
PAGE 2: REAR FACE (OUTSIDE OF REEL)
a
• 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.
Heart failure
• The usual starting dose of Candesartan cilexetil is 4 mg once a day.Your doctor may increase your dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Candesartan cilexetil can be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.
Use in children and adolescents with high blood pressure:
Children 6to<18 years of age:
The recommended starting dose is 4 mg once daily.
For patients weighing < 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide the dose needs to be increased to a maximum of 8 mg once daily.
For patients weighing > 50 kg: In some patients whose blood pressure is not adequately controlled, your doctor may decide the dose needs to be increased to 8 mg once daily and to 16 mg once daily.
If you take more Candesartan cilexetil than you should
Ifyou take more Candesartan cilexetil than prescribed byyour doctor, contact a doctor or pharmacist immediately for advice.
If you forget to take Candesartan cilexetil
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 cilexetil
Ifyou stop taking Candesartan cilexetil, your blood pressure may increase again.Therefore do not stop taking Candesartan cilexetil without first talking to your doctor.
Ifyou 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.
It is important that you are aware ofwhat these side effects may be.
Stop taking Candesartan cilexetil and seek medical help immediately if you have any of the following allergic reactions:
• difficulties in breathing, with or without swelling ofthe face, lips, tongue and/or throat
• swelling ofthe face, lips, tongue and/or throat, which may cause difficulties in swallowing
• severe itching ofthe skin (with raised lumps).
Candesartan cilexetil may cause a reduction in number ofwhite 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 checkwhether Candesartan cilexetil has had an effect on your blood (agranulocytosis).
Other possible side effects include:
Common (may affect up to 1 in 10 people)
• Feeling dizzy/spinning sensation
• Headache
• Respiratory infection
• Low blood pressure.This may make you feel faint or dizzy.
• Changesinbloodtestresults:
• An increased amount of potassium in your blood, especially if you already have kidney problems or heart failure. Ifthis is severe you may notice tiredness, weakness, irregular heart beat or pins and needles.
• Effects on how your kidneys work, especially ifyou already have kidney problems or heart failure. In very rare cases, kidney failure may occur.
Very rare (may affect up to 1 in 10,000 people)
• Swelling ofthe face, lips, tongue and/or throat
• A reduction inyour red or white blood cells. You may notice tiredness, an infection or a fever.
• Skin rash, lumpy rash (hives)
• Itching
• Cough
• 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 ofyour skin and the whites ofyour eyes and flu like symptoms.
• Nausea
• Changesinbloodtestresults:
• A reduced amount of sodium in your blood. Ifthis is severe then you may notice weakness, lack of energy, or muscle cramps.
Additional side effects in children and adolescents
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
Ifyou 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 side effects directly via theYellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety ofthis medicine.
How to store Candesartan cilexetil
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 blister foil and carton after {EXP}.The expiry date refers to the last day ofthat month.
Do not store above 30°C. Store in original packaging protect from moisture.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use.These measureswill helpto protectthe environment.
^4 Contents of the pack and other information
What Candesartan cilexetil contains
• The active substance is Candesartan cilexetil.
Each Candesartan cilexetil 8 mgTablet contains 8 mg of Candesartan cilexetil.
Each Candesartan cilexetil 16 mgTablet contains 16 mg of Candesartan cilexetil.
Each Candesartan cilexetil 32 mgTablet contains 32 mg of Candesartan cilexetil.
• The other ingredients are pregelatinized maize starch, povidone K-30, carmellose calcium, microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, poloxamer 188 and red iron oxide (E172).
What Candesartan cilexetil looks like and contents of the pack
• Candesartan cilexetil 8 mgTablet is a pink, capsule shaped tablet, 7.7 mm in length and 3.5 mm in width, scored on both sides. One side ofthe tablet is debossed with "C | 8" and the other side is debossed with "8 | C"
• Candesartan cilexetil 16 mgTablet is a pink, capsule shaped tablet, 9.7 mm in length and 4.3 mm in width, scored on one side. One side ofthe tablet is debossed with the number "16" The other side ofthe tablet is debossed with "C | C"
• Candesartan cilexetil 32 mgTablet is a pink, capsule shaped tablet, 12.2 mm in length and 5.4 mm in width, scored on one side. One side ofthe tablet is debossed with the number "32" The other side ofthe tablet is debossed with "C | C"
Candesartan cilexetil Tablets are available in OPA/Aluminium/PVC - PVC/PVAC/Aluminium/OPA blisters in pack sizes of 7,14,15, 20, 28, 30, 50, 50 x 1 unit dose blisters (hospital pack), 56, 60, 84, 90, 98,100, 250 & 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne BN22 9AG
This leaflet was last revised in 10/2014
PL 00289/1176 PL 00289/1177 PL 00289/1178
T7W71
17781-D 323x 200
REG0094649
Version 3.2
Approved
Page 3 of 4