Patient leaflet - Candesartan Cilexetil 32 mg tablets

1. What Candesartan Tablets is and what it is 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 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 Candesartan Tablets

Do not take Candesartan Tablets

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 are taking a blood pressure lowering medicine containing aliskiren and you have diabetes or impaired kidney function. 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 problem, 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 cilexetil 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 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 an excessive drop in blood pressure. Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Candesartan Tablets. Your doctor will decide on further treatment. Do not stop taking Candesartan Tablets on your own

Children and adolescents

Candesartan Tablets has been studied in children. For more information, talk to your doctor. Candesartan Tablets must not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Other medicines and Candesartan Tablets

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: 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 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 Candesartan Tablets" and "Warning 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).

Candesartan tablets with food and 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

Pregnancy

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 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. 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. Candesartan Tablets contain 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.

Candesartan Tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’ Package leaflet: Information for the patient Candesartan cilexetil 2 mg, 4 mg, 8 mg, 16 mg and 32 mg Tablets

(Candesartan cilexetil)

50 mm

123XXXX-V1

Space for PC

3. How to take Candesartan Tablets

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. Candesartan 4 mg, 8 mg 16 mg and 32 mg tablets: The Tablet can be divided into equal doses. High blood pressure:

The recommded dose of Candesartan Tablets 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.

Use in children and adolescents with high blood pressure:

Children 6 to under 18 years of age:

The recommended starting dose is 4 mg once daily. For patients weighing less than 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 Candesartan Tablets 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 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 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 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.
Effect 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.
- Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from the available data)

Diarrhoea
Tinnitus.

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 very common side effect in children. Runny nose, fever and increased heart rate are common side effects in children. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Candesartan Tablets

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. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.

Do not throw away medicine via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Candesartan Tablets contains

The active substance is candesartan cilexetil. Each tablet contains 2 mg, 4 mg, 8 mg 16 mg or 32 mg of candesartan cilexetil.

The other ingredients are: macrogols (PEG-6000), hydroxypropylcellulose, lactose monohydrate, maize starch, croscarmellose sodium, magnesium stearate. What Candesartan Tablets looks like and contents of the pack

2 mg Tablets are White colored, round, flat, beveled edge uncoated tablets debossed as ‘2’ on one side and plain on other side.

4 mg Tablets are: White colored, round, flat, beveled edge uncoated tablets debossed as ‘4’ and score line on one side and score line on other side. 8 mg Tablets are: White colored, round, flat, beveled edge uncoated tablets debossed as ‘8’ and score line on one side and score line on other side. 16 mg Tablets are: White colored, round, flat, beveled edge uncoated tablets debossed as ‘16’ on one side and score line on other side.

32 mg Tablets are: White colored, round, flat, beveled edge uncoated tablets debossed as ‘32’ on one side and score line on other side.

Tablets in Alu/PVC/PVDC blister pack; Blister

2 mg: packs of 7, 10 and 14 tablets.

4 mg, 8 mg and 16 mg: packs of 7, 10, 14, 20, 28, 50, 56, 98, 98x1 (single dose unit), 100 or 300 tablets. 32 mg: packs of 7, 10, 14, 20, 28, 50, 56, 98, 100 or 300 tablets.

HDPE bottle

2 mg, 4 mg and 8 mg: packs of 500’s

16 mg and 32 mg: packs of 500 and 1000’s Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK

E-mail : info@medreich.co.uk

To listen to or request a copy of this leaflet in Braille, large print or audio please call,

020 88311580 (UK only)

Please be ready to give the following information: Product name Reference number Candesartan cilexetil 2 mg Tablets PL 21880/0240 Candesartan cilexetil 4 mg Tablets PL 21880/0241 Candesartan cilexetil 8 mg Tablets PL 21880/0242 Candesartan cilexetil 16 mg Tablets PL 21880/0243 Candesartan cilexetil 32 mg Tablets PL 21880/0244

This leaflet was last revised in 04/2026