16 mg / 12.5 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 you will find information about: 
1. What Candesarstad Comp is and what it is used for 
2. What you need to know before using Candesarstad Comp 
3. How to use Candesarstad Comp 
4. Possible side effects 
5. How to store Candesarstad Comp 
6. Contents of the package and other information 

1. What Candesarstad Comp is and what it is used for

Your medicine is called Candesarstad Comp. 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 your urine. This helps to lower your blood pressure.

Your doctor may prescribe Candesarstad Comp if your blood pressure has not been adequately controlled on candesartan cilexetil or hydrochlorothiazide alone.

Candesartan cilexetil and hydrochlorothiazide contained in Candesarstad Comp may also be authorized 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.

2. What you need to know before using Candesarstad Comp

Do not use Candesarstad Comp

  • if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (see also 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 are pregnant for more than three months. Pregnant women should not use Candesarstad Comp during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Candesarstad Comp, see Pregnancy and breastfeeding)
  • 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 ever had gout .

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Candesarstad Comp.

Warnings and cautions

Talk to your doctor or pharmacist before taking Candesarstad Comp especially about:

  • you have diabetes
  • you have heart, liver, or kidney problems
  • you have recently undergone a kidney transplant
  • you vomit, have recently had severe vomiting or have diarrhea
  • 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 erythematosus ( SLE )
  • you have low blood pressure
  • you have ever had a stroke
  • you have ever had allergies or asthma
  • If you think you may be pregnant or become pregnant during treatment, consult your doctor. Candesarstad Comp is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, 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 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 Candesarstad Comp
  • you get 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 a few hours to weeks after taking Candesarstad Comp. This can lead to permanent visual impairment if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.

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 Candesarstad Comp”.

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 Candesarstad Comp if you are going to have any type of surgery. The reason is that Candesarstad Comp in combination with certain anesthetics or anesthetics can cause a sharp drop in blood pressure.

Candesarstad Comp can make the skin more sensitive to sunlight.

Children and young people

There is no experience of using Candesarstad Comp in children (under 18 years of age). Therefore, Candesarstad Comp should not be given to children.

Other medicines and Candesarstad Comp

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Candesarstad Comp may affect the way some other medicines work and some other medicines may affect Candesarstad Comp. 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, including beta-blockers, aliskiren-containing medicines, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril (see also information under the headings “Do not take Candesarstad Comp” and “Warnings and precautions”).
  • 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 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.

Candesarstad Comp with food, drinks and alcohol

  • You can take Candesarstad Comp with or without food.
  • After you have been prescribed Candesarstad Comp, you should discuss this with your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy, breastfeeding and fertility

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

If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor will suggest that you stop taking Candesarstad Comp before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Candesarstad Comp 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. Candesarstad Comp is not recommended for breastfeeding mothers, and your doctor may choose another medicine for you if you wish to breast-feed, especially if your baby is a newborn or born prematurely.

Driving and using machines

Some people may feel tired or dizzy when taking Candesarstad Comp. 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.

Candesarstad Comp contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

3. How to use Candesarstad Comp

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 Candesarstad Comp every day.

The recommended dose of Candesarstad Comp 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 Candesarstad Comp

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

If you stop using Candesarstad Comp

If you stop taking Candesarstad Comp, your blood pressure may rise again. Therefore, do not stop taking Candesarstad Comp without first talking to your doctor.

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 Candesarstad Compare caused by candesartan cilexetil and some are caused by hydrochlorothiazide .

Stop taking Candesarstad Comp 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).

Candesarstad Comp 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 samples from time to time to check if Candesarstad Comp 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.

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 an unknown number of users)

  • 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 ).
  • Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, rash that may include redness , blistering, dandruff and lumps).
  • Diarrhea.
  • Skin and lip cancer (Non- melanoma skin cancer).

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 Candesarstad Comp

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton or 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

The active substances in Candesarstad Comp are candesartan cilexetil and hydrochlorothiazide . Each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide .

The other ingredients are lactose monohydrate, corn starch, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, and triethyl citrate.

What the medicine looks like and contents of the pack

Candesarstad Compare white biconvex tablets with a notch on one side and marked with CH16 on the same side. The breaker is only for you to be able to divide the tablet if you have difficulty swallowing it whole. However, the tablet cannot be divided into two equal doses .

Pack sizes: 7, 7×1 (single dose blisters), 10, 10×1 (single dose blisters), 14, 14×1 (single dose blisters), 28, 28×1 (single dose blisters), 30, 30×1 (single dose blisters), 50, 50×1 (single dose blisters), 56, 56×1 (single dose blisters) , 90, 90×1 (endosblister), 98, 98×1 (endosblister), 100, 100×1 (endosblister), 112, 112×1 (endosblister), 126, 126×1 (endosblister), 140, 140×1 (endosblister), 154, 154×1 (endosblister), 168, 168×1 (endosblister), 182, 182×1 (endosblister), 196, 196×1 (endosblister) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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