Candesartan and hydrochlorothiazide HCS

Patient Information Leaflet: Information for the User

Candesartan and Hydrochlorothiazide HCS 8 mg/12.5 mg tablets, 16 mg/12.5 mg tablets, 32 mg/12.5 mg tablets, 32 mg/25 mg tablets

candesartan cilexetil/hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Candesartan and Hydrochlorothiazide HCS is and what it is used for
2. What you need to know before taking Candesartan and Hydrochlorothiazide HCS
3. How to take Candesartan and Hydrochlorothiazide HCS
4. Possible side effects
5. How to store Candesartan and Hydrochlorothiazide HCS
6. Contents of the pack and other information

1. What Candesartan and Hydrochlorothiazide HCS is and what it is used for

Your medicine is called Candesartan and Hydrochlorothiazide HCS and is used for the treatment of
high blood pressure (hypertension) in adult patients. It contains two active substances: candesartan cilexetil and
hydrochlorothiazide. These active substances work together to reduce blood pressure.
Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It relaxes and widens the blood vessels. This helps lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body eliminate water and salts such as sodium through the urine. This helps reduce blood pressure.
Your doctor may prescribe Candesartan and Hydrochlorothiazide HCS if your blood pressure has not been adequately controlled with either candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan and Hydrochlorothiazide HCS

Do not take Candesartan and Hydrochlorothiazide HCS

• if you are allergic to candesartan cilexetil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, ask your doctor.
• if you are more than three months pregnant (it is also advisable to avoid Candesartan and Hydrochlorothiazide HCS during the first months of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have severe kidney problems.
• if you have severe liver disease or biliary obstruction (problems with bile drainage from the gallbladder).
• if you have persistently low potassium levels in your blood.
• if you have persistently high calcium levels in your blood.
• if you have had gout.
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide HCS.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan and Hydrochlorothiazide HCS

• if you have diabetes,
• if you have heart, liver, or kidney problems,
• if you have recently undergone an organ transplant,
• if you are experiencing vomiting, have recently vomited, or have diarrhea,
• if you have a disorder of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism),
• if you have ever had systemic lupus erythematosus (SLE),
• if you have low blood pressure,
• if you have had a stroke,
• if you have ever suffered from allergies or asthma,
• you must inform your doctor if you are (or might be) pregnant. Candesartan and Hydrochlorothiazide HCS is not recommended during the first months of pregnancy and must not be taken after the third trimester of pregnancy, as it may cause serious harm to the unborn baby when used during this period (see section on pregnancy),
• if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Candesartan and Hydrochlorothiazide HCS,
• if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Candesartan and Hydrochlorothiazide HCS, contact a doctor immediately,
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Candesartan and Hydrochlorothiazide HCS. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you have a higher risk of developing this condition,
• if you are taking any of the following medicines used to treat high blood pressure:
  • an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril, etc.), especially if you have kidney problems related to diabetes,
  • aliskiren.

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

See also the information under the heading "Do not take Candesartan and Hydrochlorothiazide HCS".

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan and Hydrochlorothiazide HCS. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan and Hydrochlorothiazide HCS on your own.

Your doctor may want to monitor you more frequently and perform additional tests if you have any of these conditions.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan and Hydrochlorothiazide HCS. This is because Candesartan and Hydrochlorothiazide HCS, when used in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Candesartan and Hydrochlorothiazide HCS may increase your skin's sensitivity to sunlight.

Children and adolescents

There is no experience with the use of Candesartan and Hydrochlorothiazide HCS in children (under 18 years of age). Therefore, Candesartan and Hydrochlorothiazide HCS must not be given to children.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Candesartan and Hydrochlorothiazide HCS

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

Candesartan and Hydrochlorothiazide HCS may affect how other medicines work, and some medicines may affect Candesartan and Hydrochlorothiazide HCS tablets. If you are taking other medicines, your doctor may occasionally need to perform blood tests.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust the dose and/or take other precautions:

• other medicines that lower blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril,
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxene, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation),
• acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation),
• potassium-containing preparations or potassium-containing salt substitutes (medicines that increase potassium levels in the blood),
• calcium or vitamin D supplements,
• cholesterol-lowering medicines such as cholestyramine or colestipol,
• medicines for diabetes (tablets or insulin),
• medicines to control heart rhythm (antiarrhythmics), such as digoxin and beta-blockers,
• medicines that may be influenced by blood potassium levels, such as antipsychotic medicines,
• heparin (a medicine used to thin the blood),
• diuretics,
• laxatives,
• penicillin or co-trimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines),
• amphotericin (used to treat fungal infections),
• lithium (a medicine used for mental health conditions),
• steroids, such as prednisolone,
• pituitary gland hormone (ACTH),
• medicines used to treat cancer,
• amantadine (used to treat Parkinson’s disease or severe viral infections),
• barbiturates (a type of sedative also used to treat epilepsy),
• carbenoxolone (used to treat esophageal disorders or mouth ulcers),
• anticholinergic agents, such as atropine and hyoscine,
• cyclosporine, a medicine used in organ transplantation to prevent rejection,
• other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine used to relieve muscle spasticity), amifostine (used in cancer treatment), and certain antipsychotic medicines,
• if you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Candesartan and Hydrochlorothiazide HCS" and "Warnings and precautions").

Candesartan and Hydrochlorothiazide HCS with food, drinks, and alcohol

• You may take Candesartan and Hydrochlorothiazide HCS with or without food.
• When Candesartan and Hydrochlorothiazide HCS is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are (or might be) pregnant. Your doctor will usually advise you to stop taking Candesartan and Hydrochlorothiazide HCS before pregnancy or as soon as pregnancy is confirmed and will recommend an alternative medicine. Candesartan and Hydrochlorothiazide HCS is not recommended during the first months of pregnancy and must not be taken after the third trimester of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to breast-feed. Candesartan and Hydrochlorothiazide HCS is not recommended for breastfeeding mothers, and your doctor may suggest an alternative treatment if you wish to breast-feed, particularly if your baby is a newborn or was born prematurely.

Driving and using machines

Some people may experience fatigue or dizziness during treatment with Candesartan and Hydrochlorothiazide HCS. If this occurs, do not drive and do not operate tools or machinery.

Candesartan and Hydrochlorothiazide HCS contains lactose, a type of sugar.

If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Candesartan and Hydrochlorothiazide HCS

Take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. It is important that you take Candesartan and Hydrochlorothiazide HCS every day.
The recommended dose is 1 tablet of Candesartan and Hydrochlorothiazide HCS once daily.
Swallow the tablet with a glass of water.
Try to take the tablet at the same time each day. This will help you remember to take it.
If you take more Candesartan and Hydrochlorothiazide HCS than you should
If you take more Candesartan and Hydrochlorothiazide HCS than prescribed, contact your doctor or pharmacist immediately.
If you forget to take Candesartan and Hydrochlorothiazide HCS
Do not take a double dose to make up for the missed dose.
Take the next dose as usual.
If you stop taking Candesartan and Hydrochlorothiazide HCS
If you stop treatment with Candesartan and Hydrochlorothiazide HCS, your blood pressure may rise again. For this reason, do not stop taking Candesartan and Hydrochlorothiazide HCS without first consulting your doctor.
If you have any questions about how to use 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 these side effects. Some of these side effects of Candesartan and Hydrochlorothiazide HCS are caused by candesartan cilexetil, while others are caused by hydrochlorothiazide.
Stop taking Candesartan and Hydrochlorothiazide HCS and seek immediate medical help if you experience any of the following allergic reactions:

• difficulty 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 difficulty swallowing,
• severe itching of the skin (with skin rashes).

Candesartan and Hydrochlorothiazide HCS may cause a reduction in the number of white blood cells. Resistance to infection may be reduced, and you may notice fatigue, an infection or fever. If this occurs, contact a doctor. Your doctor may occasionally carry out blood tests to check for any effect of Candesartan and Hydrochlorothiazide HCS on the blood (agranulocytosis).
Other possible side effects include:
Common (may affect up to 1 in 10 people)

• changes in blood test results:
• low levels of sodium in the blood. In severe cases, you may notice tiredness, lack of energy or muscle cramps.
• increased or decreased levels of potassium in the blood, especially if you already have kidney problems or suffer from heart failure. In severe cases, you may notice fatigue, tiredness, irregular heartbeat or tingling sensations.
• increased levels of cholesterol, glucose or uric acid in the blood.
• Sugar in the urine.
• Dizziness/vertigo or weakness.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure, which may make you feel weak or cause dizziness.
• Loss of appetite, diarrhoea, constipation, upset stomach.
• Skin rash, rash in the form of bruises (urticaria), rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or whites of the eyes). If this affects you, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or suffer from heart failure.
• Difficulty sleeping, depression, restlessness.
• Prickling or tingling sensations in arms and legs.
• Temporary blurred vision.
• Abnormal heartbeat.
• Difficulty breathing (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas, causing moderate to severe pain in the stomach area.
• Muscle cramps.
• Damage to blood vessels, causing red or purple skin spots.
• Reduction in the number of red blood cells, white blood cells or platelets. This may cause fatigue, infection, fever or increased susceptibility to bruising.
• A severe rash that develops rapidly with blisters or skin peeling and possible mouth blisters.

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

• Swelling of the face, lips, tongue and/or throat.
• Itching.
• Back pain, joint and muscle pain.
• Intestinal angioedema: intestinal swelling presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
• Changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and whites of the 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 onset of myopia. Decreased vision or eye pain due to increased pressure in the eye (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma).

Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes which may include redness, blisters, peeling and lumps).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candesartan and Hydrochlorothiazide HCS

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 packed in PVC/PVDC film blisters with aluminium foil:
Do not store above 30°C.
Tablets packed in laminated OPA/Al/PVC blisters with aluminium foil:
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.
Tablets packed in HDPE tablet containers:
Do not store above 30°C.
After first opening of the container, the product should be used within 3 months.

6. Package contents and other information

What Candesartan and Hydrochlorothiazide HCS contains
The active substances are candesartan cilexetil and hydrochlorothiazide.
Each tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
The excipients are monohydrate lactose, maize starch, macrogol 8000, hydroxypropylcellulose, carmellose
calcium, magnesium stearate, red iron oxide (E172) only for 16 mg/12.5 mg and 32 mg/25 mg, and yellow
iron oxide (E172) only for 32 mg/12.5 mg.
See section 2: "Candesartan and Hydrochlorothiazide HCS contains lactose".

Description of the appearance of Candesartan and Hydrochlorothiazide HCS and contents of the pack
Candesartan and Hydrochlorothiazide HCS 8 mg/12.5 mg tablets are white, biconvex, oval tablets with a score line on one side. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Candesartan and Hydrochlorothiazide HCS 16 mg/12.5 mg tablets are light pink, biconvex, oval tablets with a score line on one side. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Candesartan and Hydrochlorothiazide HCS 32 mg/12.5 mg tablets are yellowish-white, biconvex, oval tablets with a score line on one side. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Candesartan and Hydrochlorothiazide HCS 32 mg/25 mg tablets are pale pink, biconvex, oval tablets with a score line on one side. The tablet may be divided into equal doses.

Packs containing 14, 15, 28, 30, 56, 60, 84, 90, or 98 tablets in blisters are available.
Candesartan and Hydrochlorothiazide HCS 16 mg/12.5 mg tablets
High-density polyethylene (HDPE, white) container with a tamper-evident closure made of polypropylene (PP, white): 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS BV, H Kennisstraat 53, B 2650 Edegem, Belgium

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. - Italy

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: