32 mg / 12.5 mg and 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 can harm them, even if they show signs of illness 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. See section 4.

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

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

Your medicine is called Candesartan / Hydrochlorothiazide Stada. 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 Stada if your blood pressure has not been adequately controlled on candesartan cilexetil or hydrochlorothiazide alone .

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

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

Do not take Candesartan / Hydrochlorothiazide Stada:

  • 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. Hydrochlorothiazide is a sulfonamide. 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 a good idea to avoid Candesartan / Hydrochlorothiazide Stada, see Pregnancy and breast-feeding).
  • if you have severe kidney problems.
  • if you have diabetes or renal impairment and are being treated with a blood pressure lowering medicine containing aliskiren.
  • 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 gout .

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

Warnings and cautions

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

  • 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 .
  • You must tell your doctor if you think you may be pregnant ( or become pregnant during treatment ). Candesartan / Hydrochlorothiazide Stada is not recommended in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects if used at that stage (see Pregnancy and breast-feeding).
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (eg enalapril , lisinopril, ramipril), especially if you have diabetes-related kidney problems.
    • aliskiren
  • if you are taking an ACE inhibitor with a medicine that belongs to the group of medicines MR antagonist (mineral corticoid receptor antagonist ) These medicines are for the treatment of heart failure (see “Other medicines and Candesartan / Hydrochlorothiazide Stada”).

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

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

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

Candesartan / Hydrochlorothiazide Stada can make your skin more sensitive to sunlight.

Children

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

Other medicines and Candesartan / Hydrochlorothiazide STADA

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Candesartan / Hydrochlorothiazide Stada may affect the way some other medicines work and some other medicines may affect Candesartan / Hydrochlorothiazide Stada. 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:

  • Other medicines that help lower blood pressure include 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 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 rhythm (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 (an antibiotic ).
  • Amphotericin (against fungal infections).
  • Lithium (a medicine for mental illness).
  • Steroids are like prednisolone ( cortisone ).
  • 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.

Your doctor may need to change your dose and/or take other precautions:

  • If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan / Hydrochlorothiazide Stada” and “Warnings and precautions”)
  • If you are being treated with an ACE inhibitor together with certain other medicines that you are taking to treat your heart failure , which are called MR antagonists (mineral corticoid receptor) (eg spironolactone , eplerenone).

Candesartan / Hydrochlorothiazide STADA with food and drink and especially alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will usually suggest that you stop taking Candesartan / Hydrochlorothiazide Stada before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Candesartan / Hydrochlorothiazide Stada 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 if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Candesartan / Hydrochlorothiazide Stada 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 Stada. 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.

How to use Candesartan / Hydrochlorothiazide STADA

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

The recommended dose of Candesartan / Hydrochlorothiazide Stada 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.

Candesartan / Hydrochlorothiazide Stada 32 mg / 12.5 mg:

The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.

Candesartan / Hydrochlorothiazide Stada 32 mg / 25 mg:

The tablet can be divided into two equal doses .

If you forget to take Candesartan / Hydrochlorothiazide STADA

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

If you stop taking Candesartan / Hydrochlorothiazide STADA

If you stop taking Candesartan / Hydrochlorothiazide STADA, your blood pressuremay rise again. Therefore, do not stop taking Candesartan / Hydrochlorothiazide STADA 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 Stada are caused by candesartan cilexetil and some are caused by hydrochlorothiazide .

Stop taking Candesartan / Hydrochlorothiazide Stada 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 Stada may cause a decrease in white blood cells . Your resistance to infection may deteriorate and you may feel tired, have an infectionor fever. If this happens, consult your doctor. Your doctor may take blood tests from time to time to check if Candesartan / Hydrochlorothiazide Stada 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 lumpy 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 a 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.
  • Deterioration of existing lupus erythematosus-like reactions or the occurrence of unusual skin reactions.

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

  • 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 unknown number of users)

  • Sudden myopia
  • Sudden eye pain ( acute narrow-angle glaucoma )
  • Diarrhea

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 STADA

Keep this medicine out of the sight and reach of children.

No special temperature instructions.

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.

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

Candesartan / Hydrochlorothiazide Stada 32 / 12.5 mg:

  • The active substances are candesartan cilexetil and hydrochlorothiazide .
  • Each tablet contains 32 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.
  • The other ingredients are: mannitol (E421), corn starch, copovidone, glycerol , magnesium stearate and yellow iron oxide (E172).

Candesartan / Hydrochlorothiazide Stada 32/25 mg:

  • The active substances are candesartan cilexetil and hydrochlorothiazide .
  • Each tablet contains 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide .
  • The other ingredients are: mannitol (E421), corn starch, copovidone, glycerol , magnesium stearate, yellow iron oxide (E172) and red iron oxide (E172).

What the medicine looks like and contents of the pack

Candesartan / Hydrochlorothiazide Stada 32 mg / 12.5 mg:

Candesartan / Hydrochlorothiazide Stada 32 mg / 12.5 mg tablets are yellow, oval, biconvex (~ 12 x 6 mm), uncoated tablets, with a score line on one side.

Candesartan / Hydrochlorothiazide STADA 32 mg / 12.5 mg tablets are packaged in blister packs of 7, 10, 14, 15, 28, 28×1 (single-dose pack), 30, 50, 50×1 (single-dose pack), 56, 56×1 (single-dose pack), 98, 98×1 (single dose pack), 100 and 300 tablets.

Candesartan / Hydrochlorothiazide Stada 32 mg / 25 mg:

Candesartan / Hydrochlorothiazide STADA 32 mg / 25 mg tablets are peach-colored, oval, biconvex (~ 12 x 6 mm), uncoated tablets, with a score line on one side, debossed with the letters “C” and “H”.

Candesartan / Hydrochlorothiazide STADA 32 mg / 25 mg tablets are packaged in blister packs of 7, 10, 14, 15, 28, 28×1 (single-dose pack), 30, 50, 50×1 (single-dose pack), 56, 56×1 (single-dose pack), 98, 98×1 ( single-dose pack), 100 and 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Delorbis Pharmaceuticals Ltd.

17, Athinon Street, Ergates Industrial Area 

2643 Nicosia

Cyprus

HBM Pharma sro

Sklabinská 30

036 80 Martin

Slovakia

Pharmaceutical Works Polpharma SA

Production Solid Form Department

19, Pelplinska Str.

83-200 Starogard Gdanski

Poland

Iberfar – Indústria Pharmacêutica, SA,

Rua Consiglieri Pedroso, no 121-123,

Queluz de Baixo

Barcarena, 2745-557

Portugal

STADA Arzneimittel GmbH

Muthgasse 36, 1190 Vienna

Austria

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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