CANDESARTAN 4 MG TABLETS

Active substance: CANDESARTAN CILEXETIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Candesartan 2 mg Tablets
Candesartan 4 mg Tablets
Candesartan 8 mg Tablets
Candesartan 16 mg Tablets
Candesartan 32 mg Tablets
Candesartan cilexetil
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you. 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.
In this leaflet:
1. What Candesartan Tablets are and what they are used for
2. Before you take Candesartan
3. How to take Candesartan
4. Possible side effects
5. How to store Candesartan
6. Further information
1. WHAT CANDESARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
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.
This medicine is used for:
- treating high blood pressure (hypertension) in adult patients.
- treating adult heart failure patients with reduced heart muscle function, when used with Angiotensin Converting Enzyme (ACE) inhibitors or when ACE
inhibitors cannot be used (ACE inhibitors are a group of medicines used to treat heart failure).
2. BEFORE YOU TAKE CANDESARTAN TABLETS
Do not take Candesartan Tablets if you
- are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Candesartan Tablets (see section 6).
- are more than 3 months pregnant (it is also better to avoid Candesartan Tablets in early pregnancy – see pregnancy section).
- have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan Tablets.
Take special care with Candesartan Tablets
Before you take, or whilst you are taking Candesartan Tablets, tell your doctor if you
- have heart, liver or kidney problems, or are on dialysis.
- have recently had a kidney transplant.
- are vomiting, have recently had severe vomiting, or have diarrhoea.
- have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
- have low blood pressure.
- have ever had a stroke.
- 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).
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.
Use in children
There is no experience with the use of Candesartan Tablets in children (below the age of 18 years). Therefore Candesartan Tablets should not be given to
children.
Taking other medicines
Please tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including medicines obtained without a prescription.
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:
- 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).
Taking Candesartan Tablets with food and drink (in particular 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 breast-feeding. 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.
Important information about some of the ingredients of Candesartan Tablets
Candesartan Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before
taking this medicine.
3. HOW TO TAKE CANDESARTAN TABLETS
Always take Candesartan Tablets exactly as your doctor has told you. You should 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 usual dose of Candesartan 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.
- 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 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 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Candesartan Tablets 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.
- 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,
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.
- 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CANDESARTAN TABLETS
Keep out of the reach and sight of children.
Candesartan 2 mg, 4 mg, 8 mg Tablets: Do not store above 30°C.
Candesartan 16 mg, 32 mg Tablets: This medical product does not require any special temperature storage conditions.
Do not use Candesartan Tablets after the expiry date which is stated on the carton or blister pack. The expiry date refers to the last day of that month.
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. FURTHER INFORMATION
What Candesartan Tablets contain
The active ingredient is:
Candesartan as candesartan cilexetil.
Each film-coated tablet contains 2 mg candesartan as candesartan cilexetil.
Each film-coated tablet contains 4 mg candesartan as candesartan cilexetil.
Each film-coated tablet contains 8 mg candesartan as candesartan cilexetil.
Each film-coated tablet contains 16 mg candesartan as candesartan cilexetil.
Each film-coated tablet contains 32 mg candesartan as candesartan cilexetil.
The other ingredients are:
Lactose monohydrate
Maize starch
Hypromellose 2910 (E464)
Calciumstearate
Hydroxypropyl cellulose (E463)
Disodium edetate
Microcrystalline cellulose (E460)
For 8 mg, 16 mg and 32 mg additionally: ferric oxide red (E172).
What Candesartan Tablets look like and contents of the pack
Candesartan 2 mg Tablets
White to off-white, round, biconvex, uncoated tablets plain on both sides.
Candesartan 4 mg Tablets
White to off-white, round, biconvex, uncoated tablets with breakline on one side and plain on the other side. The tablets can be divided into equal halves.
Candesartan 8 mg Tablets
Pink to reddish brown colored with whitish mosaic appearance, round, biconvex, uncoated tablets with breakline on one side and plain on other side. The tablets can
be divided into equal halves.
Candesartan 16 mg Tablets
Light Pink to pale red colored, round, biconvex, uncoated tablets with breakline on one side and plain on other side. The tablets can be divided into equal halves.
Candesartan 32 mg Tablets
Light Pink to pale red colored, round, biconvex, uncoated tablets with breakline on both sides. The tablets can be divided into equal halves.
Pack sizes:
Candesartan 2 mg: 7, 10, 14, 28, 30, 50, 56, 60, 98, 100 tablets
Candesartan 4 mg, 8 mg, 16 mg, 32 mg: 10, 14, 28, 30, 50, 56, 60, 98, 100 tablets
Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
Torrent Pharma GmbH
Suedwestpark 50
90449 Nuremberg
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands
Candesartan cilexetil Torrent 2, 4, 8, 16, 32 mg tabletten
Germany
Candesartan Heumann 2, 4, 8, 16, 32 mg Tabletten
Lithuania
Candesartan Torrent 2, 4, 8, 16, 32 mg tabletės
Romania
Candesartan Torrent 2, 4, 8, 16, 32 mg comprimate
United Kingdom
Candesartan 2, 4, 8, 16, 32 mg Tablets
This leaflet was last approved in 01/2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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