CANDESARTAN/HYDROCHLORTHIAZIDE 32 MG / 12.5 MG TABLETS - patient leaflet, side effects, dosage

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 or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Candesartan/Hy­drochlorothia­zide is and what it is used for

• 2. What you need to know before you take Candesartan/Hy­drochlorothia­zide

• 3. How to take Candesartan/Hy­drochlorothia­zide

• 4. Possible side effects

• 5. How to store Candesartan/Hy­drochlorothia­zide

• 6. Contents of the pack and other information

1. what candesartan/hydrochlorothiazide is and what it is used for

The name of your medicine is Candesartan/Hy­drochlorothia­zide. It is used for treating high blood pressure (hypertension) in adult patients. It contains two active ingredients: 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/Hy­drochlorothia­zide 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/hydrochlorothiazide- 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/Hy­drochlorothia­zide 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 the 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/Hy­drochlorothia­zide.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan/Hy­drochlorothia­zide.

• – if you have diabetes.

• – if you have heart, liver or kidney problems.

• – 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 ever had a disease called systemic lupus erythematosus (SLE).

• – if you have low blood pressure.

• – if you have ever had a stroke.

• – if you have ever had allergy or asthma.

• – you must tell your doctor if you think you are (or might become) pregnant.

Candesartan/Hy­drochlorothia­zide 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 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/Hy­drochlorothia­zide.

• – if 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/Hy­drochlorothia­zide, seek medical attention immediately.

• – if 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 weeks of taking Candesartan/Hy­drochlorothia­zide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

• – if you are taking any of the following medicines used to treat high blood pressure:

• – an ACE-inhibitor (for example enalapril, lisinopril, ramipril, etc.,), in particular if you have diabetes-related kidney problems.

• – aliskiren.

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/Hy­drochlorothia­zide”

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

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

Children and adolescents

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

Other medicines and Candesartan/Hydrochlorothiazide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Candesartan/Hy­drochlorothia­zide can affect the way some other medicines work and some medicines can have an effect on Candesartan/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 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).

• – 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 or co-trimoxazole also known as trimethoprim/sul­famethoxazole (antibiotic

medicines).

• – 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/Hy­drochlorothia­zide” and “Warnings and precautions”).

Candesartan/Hydrochlorothiazide with food, drink and alcohol

• – You can take Candesartan/Hy­drochlorothia­zide with or without food.

• – When you are prescribed Candesartan/Hy­drochlorothia­zide, 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/Hy­drochlorothia­zide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan/Hy­drochlorothia­zide. Candesartan/Hy­drochlorothia­zide 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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candesartan/Hy­drochlorothia­zide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

Driving and using machines

Some people may feel tired or dizzy when taking Candesartan/Hy­drochlorothia­zide. If this happens to you, do not drive or use any tools or machines.

Candesartan/Hy­drochlorothia­zide contains lactose , which 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 medicinal product.

3. how to take candesartan/hydrochlorothiazide

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

It is important to keep taking Candesartan/Hy­drochlorothia­zide every day.

The recommended dose of Candesartan/Hy­drochlorothia­zide 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/Hydrochlorothiazide than you should

If you take more Candesartan/Hy­drochlorothia­zide than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take Candesartan/Hy­drochlorothia­zide Do not take a double dose to make up for a forgotten dose. Just take the next dose as normal.

If you stop taking Candesartan/Hydrochlorothiazide

If you stop taking Candesartan/Hy­drochlorothia­zide, your blood pressure may increase again. Therefore do not stop taking Candesartan/Hy­drochlorothia­zide 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/Hy­drochlorothia­zide are caused by candesartan cilexetil and some are caused by hydrochlorothi­azide.

Stop taking Candesartan/Hydrochlorothiazide 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/Hy­drochlorothia­zide 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 tell your doctor. Your doctor may occasionally do blood tests to check whether Candesartan/Hy­drochlorothia­zide has 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 heart beat 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, diarrhoea, 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 your 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 already 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)

• – Skin and lip cancer (Non-melanoma skin cancer).

• – Sudden short-sightedness.

• – Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid

accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

• – Systemic and cutaneous lupus erythematosus (allergic condition which causes fever, joint pain,

skin rashes which may include redness, blistering, peeling and lumps).

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 Yellow Card Scheme, Website: 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/hydrochlorothiazide

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 packaging after EXP. The expiry date refers to the last day of that month.

Tablets packaged in blisters of PVC/PVDC film and aluminium foil:

Do not store above 30°C.

Tablets packaged in blisters of laminated OPA/Al/PVC foil and aluminium foil:

This medicinal product does not require any special storage conditions.

Tablets packaged in HDPE tablet container:

Do not store above 30°C.

After first opening of the container, the product should be used within 3 months.

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 8 mg candesartan cilexetil and 12.5 mg hydrochlorothi­azide.

Each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothi­azide.

Each tablet contains 32 mg candesartan cilexetil and 25 mg hydrochlorothi­azide.

Each tablet contains 32 mg candesartan cilexetil and 12.5 mg hydrochlorothi­azide.

• – The other ingredients are lactose monohydrate, maize starch, macrogol 8000,

What Candesartan/Hydrochlorothiazide looks like and contents of the pack

Candesartan/Hy­drochlorothia­zide 8 mg/12.5 mg tablets are white, biconvex, oval, with a score on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Candesartan/Hy­drochlorothia­zide 16 mg/12.5 mg tablets are pale pink, biconvex, oval, with a score on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Candesartan/Hy­drochlorothia­zide 32 mg/12.5 mg tablets are yellowish white, biconvex, oval, with a score on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Candesartan/Hy­drochlorothia­zide 32 mg/25 mg tablets are pale pink, biconvex, oval, with a score on one side.

The tablet can be divided into equal doses.

Boxes of 14, 15, 28, 30, 56, 60, 84, 90, 98 tablets in blisters are available.

Candesartan/Hy­drochlorothia­zide 16 mg/12.5 mg tablets:

High density polyethylene (HDPE, white) container with polypropylene (PP, white) tamper-evident closure: 100 tablets, in a carton box

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia th (UK) Ltd, No. 1 Church Road, Richmond upon Thames, Surrey. TW9 2QE

This leaflet was last revised in December 2021.