8 mg / 12.5 mg, 16 mg / 12.5 mg, 32 mg / 12.5 mg, 32 mg / 25 mg tablets 
candesartan cilexetil / hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Candesartan / Hydrochlorothiazide Krka is and what it is used for 
2. What you need to know before you use Candesartan / Hydrochlorothiazide Krka 
3. How to use Candesartan / Hydrochlorothiazide Krka 
4. Possible side effects 
5. How to store Candesartan / Hydrochlorothiazide Krka 6. Contents of the pack 
and other information 

What Candesartan / Hydrochlorothiazide Krka is and what it is used for

Your medicine is called Candesartan / Hydrochlorothiazide Krka. It is used to treat high blood pressure ( hypertension ) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. They work together to lower your blood pressure.

Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes your blood vessels to relax and dilate, which helps lower your blood pressure.

Hydrochlorothiazide is a group of medicines called diuretics ( diuretic agent). It helps your body get rid of water and salts, such as sodium, in the urine. This helps to lower your blood pressure.

Your doctor may prescribe Candesartan / Hydrochlorothiazide Krka if your blood pressure has not been adequately controlled on candesartan cilexetil or hydrochlorothiazide alone.

Candesartan cilexetil and hydrochlorothiazide contained in Candesartan / Hydrochlorothiazide Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Candesartan / Hydrochlorothiazide Krka

Do not use Candesartan / Hydrochlorothiazide Krka

  • 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 sulfonamide-containing medicines. If you have any further questions on the use of this product, ask your doctor.
  • if you have been pregnant for more than three months (even earlier in pregnancy, it is good to avoid Candesartan / Hydrochlorothiazide Krka, see Pregnancy and breast-feeding).
  • if you have severe kidney problems.
  • if you have severe liver disease or biliary obstruction (a condition in which bile is difficult to get out of the gallbladder).
  • 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 renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Candesartan / Hydrochlorothiazide Krka.

Warnings and cautions

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

Before taking or taking Candesartan / Hydrochlorothiazide Krka, tell your doctor:

  • if you have diabetes.
  • if you have heart, liver, or kidney problems.
  • if you have recently had a kidney transplant.
  • if you vomit, have recently had severe vomiting, or have diarrhea.
  • 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 erythematosusSLE ).
  • if you have low blood pressure .
  • if you have ever had a stroke.
  • if you have ever had allergies or asthma.
  • If you think you may be pregnant or become pregnant during treatment, consult your doctor. Candesartan / Hydrochlorothiazide Krka is not recommended in early pregnancy and should not be used after the third month of pregnancy, as it may cause birth defects, see Pregnancy and breast-feeding.
  • if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin and lip cancer (non- melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Candesartan / Hydrochlorothiazide Krka.
  • if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Candesartan / Hydrochlorothiazide Krka. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at greater risk of developing this.
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (such as enalapril, lisinopril, ramipril, etc.), especially if you have diabetes-related kidney problems.
    • aliskiren

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

See also the information under the heading “Do not take Candesartan / Hydrochlorothiazide Krka”.

Your doctor may want to see you more often and take some samples if you have any of these conditions.

Tell your doctor or dentist that you are taking Candesartan / Hydrochlorothiazide Krka if you are having any type of surgery. The reason is that Candesartan / Hydrochlorothiazide Krka in combination with certain anesthetics or anesthetics may cause a sharp drop in blood pressure.

Candesartan / Hydrochlorothiazide Krka may make your skin more sensitive to sunlight.

Children and young people

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

Other medicines and Candesartan / Hydrochlorothiazide Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candesartan / Hydrochlorothiazide Krka may affect the way some other medicines work and some other medicines may affect Candesartan / Hydrochlorothiazide Krka. If you are taking certain medicines, your doctor may need to take blood samples from time to time.

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

  • Other medicines that help lower blood pressure include beta-blockers, aliskiren-containing medicines, 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 that relieve pain and inflammation).
  • Acetylsalicylic acid (if you take more than 3 g a day) (a drug that relieves pain and inflammation ).
  • Potassium supplements or salt substitutes that contain potassium (medicines that increase the amount of potassium in the blood).
  • Calcium – or vitamin D supplementation.
  • Drugs that lower cholesterol, such as colestipol or cholestyramine.
  • Medicines for diabetes (tablets or insulin ).
  • Drugs to control heart rhythms (antiarrhythmic drugs) such as digoxin and beta-blockers.
  • Drugs that can be affected by the potassium content in the blood, such as certain antipsychotic drugs.
  • Heparin (a blood thinner).
  • Diuretics ( diuretics ).
  • Laxative.
  • Penicillin or trimethoprim/sulfamethoxazole (a combination of antibiotics ).
  • Amphotericin (against fungal infections).
  • Lithium (a medicine for mental illness).
  • Steroids are like prednisolone.
  • Pituitary hormone (ACTH).
  • Medicines for cancer.
  • Amantadine (for Parkinson’s disease or for severe viral infections).
  • Barbiturates (a type of sedative that is also used for epilepsy ).
  • Carbenoxolone (for esophageal disease or mouth ulcers).
  • Anticholinergic agents such as atropine and biperiden.
  • Cyclosporine, a drug used when transplanting organs to prevent organ rejection.
  • Other drugs that can cause an increase in the blood pressure-lowering effect, such as baclofen (a drug that relieves spasticity (muscle cramps)), amifostine (for cancer), and certain antipsychotic drugs.
  • If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan / Hydrochlorothiazide Krka” and “Warnings and precautions”).

Candesartan / Hydrochlorothiazide Krka with food, drink, and alcohol

  • You can take Candesartan / Hydrochlorothiazide Krka with or without food.
  • After you have been prescribed Candesartan / Hydrochlorothiazide Krka, talk to your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you think you may be pregnant (or may become pregnant) during treatment, consult your doctor. Usually your doctor will suggest that you stop taking Candesartan / Hydrochlorothiazide Krka before pregnancy or as soon as you know you are pregnant and will recommend another medicine for you. Candesartan / Hydrochlorothiazide Krka should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.

Breast-feeding

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

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Candesartan / Hydrochlorothiazide Krka contains lactose

Candesartan / Hydrochlorothiazide Krka 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 medicine.

How to use Candesartan / Hydrochlorothiazide Krka

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. It is important that you continue to take Candesartan / Hydrochlorothiazide Krka every day.

The recommended dose of Candesartan / Hydrochlorothiazide Krka is one tablet once a day.

Swallow the tablet with a little water.

Try to take the tablet at the same time each day. This makes it easier to remember to take it.

If you forget to use Candesartan / Hydrochlorothiazide Krka

Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

If you stop using Candesartan / Hydrochlorothiazide Krka

If you stop taking Candesartan / Hydrochlorothiazide Krka, your blood pressure may rise again. Therefore, do not stop taking Candesartan / Hydrochlorothiazide Krka without talking to your doctor first.

If you have any further questions on the use of this product, 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 know what the side effects may be. Some of the side effects of Candesartan / Hydrochlorothiazide Krka are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking Candesartan / Hydrochlorothiazide Krka and seek medical advice immediately if you get 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 make it difficult to swallow.
  • severe skin itching (with raised rash).

Candesartan / Hydrochlorothiazide Krka may cause a decrease in white blood cells. Your resistance to infection may deteriorate and you may feel tired, have an infection or fever. If this happens, consult your doctor. Your doctor may take blood tests from time to time to check if Candesartan / Hydrochlorothiazide Krka has had any effect on your blood ( agranulocytosis ).

Other possible side effects are:

Common (may affect up to 1 in 10 people)

  • Altered results of some blood tests:
    • Decreased amount of sodium in the blood. If the decrease is sharp, you may feel weakness, lack of energy, or muscle cramps.
    • Increased or decreased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If the change is severe, you may feel tiredness, weakness, irregular heartbeat, or tingling and numbness in the skin.
    • An increased amount of cholesterol, sugar, or uric acid in the blood.
  • Sugar in the urine.
  • Feeling of dizziness or weakness.
  • Headache.
  • Respiratory tract infection.

Uncommon (may affect up to 1 in 100 people)

  • Low blood pressure . It can make you feel weak or dizzy.
  • Loss of appetite, diarrhea, constipation, irritation of the stomach.
  • Skin rash, itchy raised rash ( hives ), rash due to sensitivity to sunlight.

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

  • Jaundice (yellowing of the skin or whites of the eyes). If you get this, contact your doctor immediately.
  • Impact on kidney function, especially if you have kidney problems or heart failure.
  • Difficulty sleeping, depression, restlessness.
  • Tingling or tingling in arms or legs.
  • Blurred vision for a short time.
  • Abnormal heart rhythm.
  • Breathing difficulties (including pneumonia and fluid in the lungs).
  • Fever.
  • Inflammation of the pancreas ( pancreatitis ). This gives moderate to severe pain in the abdomen.
  • Muscle cramps.
  • Damage to blood vessels that cause red or purple spots on the skin.
  • Reduction in the number of red or white blood cells or platelets. You may then notice fatigue, infection , fever, or that you easily get bruises.
  • Severe rash that develops rapidly, with blisters and skin flaking and possibly blisters in the mouth.

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

  • Swelling of the face, lips, tongue and/or throat.
  • Itching.
  • Pain in the back, joints, or muscles.
  • Altered 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.

Has been reported (occurs in an unknown number of users)

  • Skin and lip cancer (Non- melanoma skin cancer).
  • Sudden myopia.
  • Decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ).
  • The systemic and cutaneous lupus erythematosus (an allergic condition that causes fever, joint pain, a rash that may include redness, blistering, dandruff, and lumps).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Candesartan / Hydrochlorothiazide Krka

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 and blister after EXP. The expiration date is the last day of the specified month.

PVC / PVDC film and aluminum foil blisters:

Do not store above 30 ° C.

Laminated OPA / Al / PVC foil and aluminum foil blisters:

No special storage instructions.

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. Contents of the packaging and other information

Content declaration

The active substances of Candesartan / Hydrochlorothiazide Krka are candesartan cilexetil and hydrochlorothiazide.

8 mg / 12.5 mg: Each tablet contains 8 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide .

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

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

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

The other ingredients are lactose monohydrate, maize starch, macrogol 8000, hydroxypropyl cellulose, carmellocalcium, magnesium stearate, red iron oxide (E172) only for 16 mg / 12.5 mg and 32 mg / 25 mg tablets, and yellow iron oxide (E172) only for 32 mg / 12, 5 mg tablets.

See section 2: “Candesartan / Hydrochlorothiazide Krka contains lactose”.

What the medicine looks like and the contents of the pack

Candesartan / Hydrochlorothiazide Krka 8 mg / 12.5 mg are white, biconvex, oval with a notch on one side. The breaker is not for dividing the tablet into equal doses, but only to facilitate swallowing.

Candesartan / Hydrochlorothiazide Krka 16 mg / 12.5 mg tablets are light pink, biconvex, oval with a notch on one side. The breaker is not for dividing the tablet into equal doses, but only to facilitate swallowing.

Candesartan / Hydrochlorothiazide Krka 32 mg / 12.5 mg tablets are light yellow, biconvex, oval, with a score line on one side. The breaker is not for dividing the tablet into equal doses, but only to facilitate swallowing.

Candesartan / Hydrochlorothiazide Krka 32 mg / 25 mg tablets are light pink, biconvex, oval, with a score line on one side. The tablet can be divided into two equal doses.

Blister packs of 14, 15, 28, 30, 56, 60, 84, 90, 98 tablets are available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Muhammad Nadeem

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