Amias 4mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Amias® 4mg tablets
(candesartan cilexetil)
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.
This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Amias 4mg tablets but will be referred to as Amias throughout this leaflet. Please note that the leaflet also contains information about other strengths Amias 2mg, 8mg, 16mg and 32mg tablets.
What is in this leaflet:
1. What Amias is and what it is used for
2. What you need to know before you take Amias
3. How to take Amias
4. Possible side effects
5. How to store Amias
6. Contents of the pack and other information
1. WHAT AMIAS IS AND WHAT IT IS USED FOR
The name of your medicine is Amias. 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.
This medicine is used for:
• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to under 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIAS
Do not take Amias
• 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 Amias 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 Amias.
Warnings and precautions
Talk to your doctor before taking Amias.
• 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. Amias 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).
• 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.
- aliskiren
• if you 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 Amias’).
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 Amias’.
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 Amias. This is because Amias, when combined with some anaesthetics, may cause an excessive in blood pressure.
Children and adolescents.
Amias has been studied in children. For more information, talk to your doctor. Amias must not be given to children under 1 year of age due to the potential risk to the developing kidneys.
Other medicines and Amias
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines as your doctor may need to change your dose and/or take other precautions:
Amias can affect the way some other medicines work and some medicines can have an effect on Amias. 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 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).
• 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 Amias’ 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 receptors antagonists (MRA)(for example spironolactone, eplerenone).
Amias with food and drink and alcohol.
• You can take Amias with or without food.
• When you are prescribed Amias, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Amias before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amias. Amias 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 breast-feeding. Amias is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy when taking Amias. If this happens to you, do not drive or use any tools or machines.
Amias contains lactose. Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE AMIAS
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 Amias every day. You can take Amias 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.
Amias 4mg, 8mg, 16mg and 32mg tablets: The tablet can be divided into equal doses.
High blood pressure:
• The recommended dose of Amias 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 under 18 years of age:
The recommended starting dose is 4mg once daily.
For patients weighing less that 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 or more: 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 Amias 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. Amias 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 Amias than you should
If you take more Amias than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.
If you forget to take Amias
Do not take a double dose to make up for a forgotten tablet. Just take the next dose as normal.
If you stop taking Amias
If you stop taking Amias, your blood pressure may increase again. Therefore do not stop taking Amias without first talking to your doctor.
If you 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 of what these side effects may be.
Stop taking Amias 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)
Amias 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 Amias has had any effect on your blood (agranulocytosis).
Other possible side effects include:
Common (affects 1 to 10 users in 100)
• Feeling dizzy/spinning sensation.
• Headache.
• 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, an 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).
• Itching.
• 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.
• Cough.
• Nausea.
• 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, 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 AMIAS
• Keep out of the sight and reach of children.
• Do not use Amias after the expiry date which is slated on the carton label and blister foil after ‘Exp’. The expiry date refers to the last day of that month.
• Do not store above 30°C.
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 Amias contains
• The active substance is candesartan cilexetil. Each tablet contains 4mg candesartan cilexetil.
• The other ingredients are carmellose calcium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch and macrogol.
What Amias looks like and contents of the pack
• 4 mg tablets are white, round tablets with a score line on each side.
Amias 4mg tablets come in calendar blister packs containing 28 tablets. Each blister pack contains 7 tablets.
Manufactured by: Takeda Ireland Ltd., Bray Business Park, Kilruddery, Co. Wicklow, Ireland.
Or,
Takeda Italia Farmaceutici, Via Crosa 86, 28065 Cerano (No), Italy.
Procured from within the EU and repackaged by the Product Licence Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Amias® 4mg tablets; PLPI No: 18799/2124 IPOM I
Leaflet date: 17.09.2015
Amias is a registered trademark of Takeda group of Co.