CANDESARTAN AND HYDROCHLOROTHIAZIDE 16 MG / 12.5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CANDESARTAN AND HYDROCHLOROTHIAZIDE 16 MG / 12.5 MG TABLETS

What is in this leaflet

1. What Candesartan and Hydrochlorothiazide Tablets are and what they are used for

2. What you need to know before you take Candesartan and Hydrochlorothiazide Tablets

3. How to take Candesartan and Hydrochlorothiazide Tablets

4. Possible side effects

5. How to store Candesartan and Hydrochlorothiazide Tablets

6. Contents of the pack and other information

1. What Candesartan and Hydrochlorothiazide Tablets are and what they are used for

The full name of your medicine is Candesartan and Hydrochlorothiazide 8mg/12.5mg, 16mg/12.5mg, 32mg/12.5mg or 32mg/25mg Tablets, but within the leaflet it will be referred to as Candesartan and Hydrochlorothiazide Tablets.

Candesartan and Hydrochlorothiazide Tablets are used for treating high blood pressure (hypertension) in adult patients. They contain two active substances: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure.

Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blood pressure.

Your doctor may prescribe Candesartan and Hydrochlorothiazide Tablets if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. what you need to know before you take candesartan and hydrochlorothiazide tablets if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).

if you are allergic to sulphonamide medicines. If you are not sure if this applies to you, please ask your doctor.
if you are more than 3 months pregnant (it is also better to avoid Candesartan and Hydrochlorothiazide Tablets in early pregnancy – see pregnancy section).
if you have severe kidney problems.
if you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gall bladder).
if you have persistently low levels of potassium in your blood.
if you have persistently high levels of calcium in your blood.
if you have ever had gout.
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 and Hydrochlorothiazide Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide Tablets if:

you have diabetes.
you have heart, liver or kidney problems.
you have recently had a kidney transplant.
you are vomiting, have recently had severe vomiting, or have diarrhoea.
you have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
you have ever had a disease called Systemic Lupus Erythaematosus (SLE).
you have low blood pressure.
you have ever had a stroke.
you have ever had allergy or asthma.
you must tell your doctor if you think you are (or might become) pregnant. Candesartan and Hydrochlorothiazide 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).
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.
you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartan and Hydrochlorothiazide.
you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Candesartan and Hydrochlorothiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicilin or sulfonamide allergy, you can be at higher risk of developing this.
you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Candesartan and Hydrochlorothiazide Tablets, seek medical attention immediately.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

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 and Hydrochlorothiazide Tablets. This is because Candesartan and Hydrochlorothiazide Tablets, when combined with some anaesthetics, may cause an excessive drop in blood pressure.

Candesartan and Hydrochlorothiazide Tablets may cause increased sensitivity of the skin to sun.

See also information under the heading “Do not take Candesartan and Hydrochlorothiazide Tablets”.

Children

There is no experience with the use of Candesartan and Hydrochlorothiazide Tablets in children (below the age of 18 years). Therefore Candesartan and Hydrochlorothiazide Tablets should not be given to children.

Other medicines and Candesartan and Hydrochlorothiazide Tablets

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Candesartan and Hydrochlorothiazide Tablets can affect the way some other medicines work and some medicines can have an effect on Candesartan and Hydrochlorothiazide 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, aliskiren-containing medicines, diazoxide and Angiotensin Converting Enzyme (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).
calcium or Vitamin D supplements.
medicines to lower your cholesterol, such as colestipol or cholestyramine.
medicines for diabetes (tablets or insulin).
medicines to control your heart beat (antiarrhythmic agents) such as digoxin and beta-blockers.
medicines that can be affected by potassium blood levels such as some antipsychotic medicines.
heparin (a medicine for thinning the blood).
water tablets (diuretics).
laxatives.
penicillin (an antibiotic).
amphotericin (for the treatment of fungal infections).
lithium (a medicine for mental health problems).
steroids such as prednisolone.
pituitary hormone (ACTH).
medicines to treat cancer.
amantadine (for the treatment of Parkinson’s disease or for serious infections caused by viruses).
barbiturates (a type of sedative also used to treat epilepsy).
carbenoxolone (for treatment of oesophageal disease, or oral ulcers).
anticholinergic agents such as atropine and biperiden.
cyclosporine, a medicine used for organ transplant to avoid organ rejection.
other medicines that may lead to enhancement of the antihypertensive effect such as baclofen (a medicine for relief of spasticity), amifostin (used in cancer treatment) and some antipsychotic medicines.
if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Candesartan and Hydrochlorothiazide Tablets” and “Warnings and precautions”).

Candesartan and Hydrochlorothiazide Tablets with food, drink and alcohol

You can take Candesartan and Hydrochlorothiazide Tablets with or without food.
When you are prescribed Candesartan and Hydrochlorothiazide 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 and Hydrochlorothiazide 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 and Hydrochlorothiazide Tablets. Candesartan and Hydrochlorothiazide Tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they 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 and Hydrochlorothiazide 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 new born, or was born prematurely.

Driving and using machines

Some people may feel tired or dizzy when taking Candesartan and Hydrochlorothiazide Tablets. If this happens to you, DO NOT drive or use any tools or machines.

3. how to take candesartan and hydrochlorothiazide 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 and Hydrochlorothiazide Tablets every day.

The recommended dose of Candesartan and Hydrochlorothiazide Tablets is one tablet once a day.

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.

If you take more Candesartan and Hydrochlorothiazide Tablets than you should

If you take more Candesartan and Hydrochlorothiazide Tablets than prescribed by your doctor, contact a doctor or pharmacist IMMEDIATELY for advice.

If you forget to take Candesartan and Hydrochlorothiazide 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 and Hydrochlorothiazide Tablets

If you stop taking Candesartan and Hydrochlorothiazide Tablets, your blood pressure may increase again. Therefore DO NOT stop taking Candesartan and Hydrochlorothiazide 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. Some of the side effects of Candesartan and Hydrochlorothiazide Tablets are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

STOP taking Candesartan and Hydrochlorothiazide 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 and Hydrochlorothiazide 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 and Hydrochlorothiazide Tablets have had any effect on your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

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.
an increased or reduced 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 heartbeat or pins and needles.
an increased amount of cholesterol, sugar or uric acid in your blood.
sugar in your urine.
feeling dizzy/spinning sensation or weak.
headache.
respiratory infection.

Uncommon (may affect up to 1 in 100 people)

low blood pressure. This may make you feel faint or dizzy.
loss of appetite, constipation, stomach irritation.
skin rash, lumpy rash (hives), rash caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 people)

jaundice (yellowing of the skin or the whites of your eyes). If this happens to you, contact your doctor IMMEDIATELY.
effects on how your kidneys work, especially if you have kidney problems or heart failure.
difficulty in sleeping, depression, being restless.
tingling or prickling in your arms or legs.
blurred vision for a short time.
abnormal heart beat.
breathing difficulties (including lung inflammation and fluid in the lungs).
high temperature (fever).
inflammation of the pancreas. This causes moderate to severe pain in the stomach.
muscle cramps.
damage to blood vessels causing red or purple dots in the skin.
a reduction in your red or white blood cells or platelets. You may notice tiredness, an infection, fever or easy bruising.
a severe rash that develops quickly, with blistering or peeling of the skin and possibly blistering in the mouth.

Very rare (may affect up to 1 in 10,000 people)

swelling of the face, lips, tongue and/or throat.
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.
Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)

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

sudden shortsightedness
systemic and cutaneous lupus erythematosus (allergic condition which causes fever, joint pain, skin rashes which may include redness, blistering, peeling and lumps)
diarrhoea
skin and lip cancer (Non-melanoma skin cancer)
decrease in vision or pain in eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma.

Reporting of side effects

If you 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 the Yellow Card Scheme at: 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 and hydrochlorothiazide tablets

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

This medicinal product does not require any special temperature storage conditions.

DO NOT use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

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

6. contents of the pack and other information the active substances are candesartan cilexetil and hydrochlorothiazide. each tablet contains either 8mg, 16mg or 32mg of candesartan cilexetil and either 12.5mg or 25mg of hydrochlorothiazide.

The other ingredients are mannitol, maize starch, copovidone, glycerol and magnesium stearate. Candesartan and Hydrochlorothiazide 16mg/12.5mg and 32mg/25mg Tablets also contain ferric oxide red. Candesartan and Hydrochlorothiazide 16mg/12.5mg, 32mg/12.5mg and 32mg/25mg Tablets also contain ferric oxide yellow.

What Candesartan and Hydrochlorothiazide Tablets look like and contents of the pack

Candesartan and Hydrochlorothiazide 8mg/12.5mg Tablets are white or off white, oval, biconvex (~9.5 × 4.5 mm) tablets, with a break line on one side. The tablet can be divided into equal doses.

Candesartan and Hydrochlorothiazide 16mg/12.5mg Tablets are peach, oval, biconvex (~9.5 × 4.5 mm) tablets, with a break line on one side. The tablet can be divided into equal doses.

Candesartan and Hydrochlorothiazide 32mg/12.5mg Tablets are yellow, oval, biconvex (~12 × 6 mm) tablets, with a break line on one side. The tablet can be divided into equal doses.

Candesartan and Hydrochlorothiazide 32mg/25mg Tablets are peach, oval, biconvex (~12 × 6 mm) tablets, with a break line on one side and debossed with the letters “C” and H”. The tablet can be divided into equal doses.

Candesartan and Hydrochlorothiazide Tablets are available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Limited

Units 3 & 4, Quidhampton Business Units,

Polhampton Lane, Overton,

Hampshire RG25 3ED

United Kingdom

This leaflet was last revised in 12/2021.