4, 8, 16 and 32 mg tablets 
Candesartan cilexetil


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 Orion is and what it is used for 
2. What you need to know before you use Candesartan Orion 
3. How to take Candesartan Orion 
4. Possible side effects 
5. How to store Candesartan Orion 
6. Contents of the packaging and other information 

What Candesartan Orion is and what it is used for

The name of your medicine is Candesartan Orion. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II antagonists . It causes your blood vessels to relax and dilate. This will help you lower your blood pressure . It also makes it easier for the heart to pump blood to all parts of the body.


This medicine is used to

  • treat high blood pressure ( hypertension ) in adult patients and in children and adolescents aged 6 to 18 years.
  • treat heart failure in adult patients with compromised cardiac function or when ACE inhibitors (angiotensin converting enzyme inhibitors) can not be used or in addition to ACE inhibitors when symptoms persist despite treatment and the MR antagonist s (mineralkortikoidreceptor- antagonist s) can not be used. ( ACE inhibitors and MR antagonists are medicines used to treat heart failure ).

Candesartan cilexetil contained in Candesartan Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 using Candesartan Orion

Do not take Candesartan Orion

  • if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6).
  • if you are more than three months pregnant (it is also best to avoid Candesartan Orion during early pregnancy – see pregnancy section).
  • if you have severe liver disease or gallbladder obstruction (problems with bile drainage from the gallbladder).
  • if the patient is a child under 1 year of age.
  • 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 these apply to you, talk to your doctor or pharmacist before taking Candesartan Orion.

Warnings and cautions

Talk to your doctor or pharmacist before taking Candesartan Orion.

  • if you have heart, liver or kidney problems, or are undergoing dialysis
  • if you have recently had a kidney transplant
  • if you have vomiting, or have recently had severe vomiting or have diarrhea
  • if you have an adrenal disease called Con’s syndrome (also called primary hyperaldosteronism)
  • if you have low blood pressure
  • if you have had a stroke before
  • if you think you are (or might become) pregnant. Candesartan Orion is not recommended during early pregnancy and you must not take Candesartan Orion if you are pregnant after the third month, as it may seriously harm your baby if used during this stage of pregnancy (see section on pregnancy).
  • 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 used to treat heart failure (see ‘Other medicines and Candesartan Orion’).

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 Orion”.

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

Tell your doctor or dentist that you are taking Candesartan Orion if you are having surgery . 
Candesartan Orion, taken with some anesthetic, may lower your blood pressure .

Children and young people

Kandesartan cilexetil has been studied in children. For more information, talk to your doctor. Candesartan Orion must not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Other medicines and Candesartan Orion

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

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 Orion” 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 Orion may affect the way some other medicines work, and some medicines may also affect the way Candesartan Orion works. Your doctor may need to take blood samples from time to time if you are taking certain medicines.

If you are taking any of the following medicines, tell your doctor in particular:

  • other medicines that help you lower your blood pressure such as beta blockers , diazoxides and ACE inhibitors such as enalapril , captopril, lisinopril or ramipril
  • non-steroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen , naproxen or diclofenac , celecoxib or etoricoxib (medicines that relieve pain and inflammation)
  • acetylsalicylic acid (if you take more than 3 g per day) (medicines that relieve pain and inflammation )
  • potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood)
  • heparin (a blood-thinning drug)
  • diuretics ( diuretics )
  • lithium (a drug for mental health problems).

Candesartan Orion with food, drink and alcohol

  • You can take Candesartan Orion with or without food.
  • If you are prescribed Candesartan Orion, talk to your doctor before drinking alcohol. Alcohol can make you feel dizzy and 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 advise you to stop taking Candesartan Orion before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Candesartan Orion. Candesartan Orion is not recommended during early pregnancy and should not be taken if you are pregnant after the third month, as it can seriously harm your baby 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 Orion is not recommended for breastfeeding mothers and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is newborn or born prematurely.

Driving and using machines

Some people may feel tired or dizzy while taking Candesartan Orion. 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 Orion contains lactose

Candesartan Orion contains lactose . If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), contact your doctor before taking this medicine.

How to take Candesartan Orion

Always take Candesartan Orion exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. It is important to take Candesartan Orion every day.

You can take Candesartan Orion with or without food. 
Swallow the tablet with a glass of water. 
Try to take the tablet at the same time each day. It will help you remember to take it.

High blood pressure

  • The recommended dose of Candesartan Orion is 8 mg once a day. Your doctor may increase the dose one up to 16 mg once a day and a further up to 32 mg once a day depending on how your blood pressure is affected.
  • For some patients who have, for example, liver or kidney problems or those who have recently lost body fluids, for example through vomiting, diarrhea or those who take diuretic tablets, the doctor may prescribe a lower starting dose.
  • Some dark-skinned patients may respond less well to this type of medication when given as the only treatment. These patients may therefore need a higher dose .

Use in children and adolescents

Children from 6 to 18 years of age: The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg: In some patients with unsatisfactory blood pressure control, your doctor may decide that your dose needs to be increased to a maximum of 8 mg once daily.

For patients weighing 50 kg or more: In some patients with unsatisfactory blood pressure control, your doctor may decide that your dose needs to be increased to 8 mg once daily and to 16 mg once daily.

Heart failure

The recommended starting dose of Candesartan Orion is 4 mg once a day. Your doctor may increase the dose one by doubling the dose one at least 2 weeks apart up to 32 mg once a day. Candesartan Orion can be taken with other heart failuremedicines and your doctor will decide which treatment is right for you.

If you forget to take Candesartan Orion

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

If you stop taking Candesartan Orion

If you stop taking Candesartan Orion, your blood pressure may rise again. Therefore, do not stop taking Candesartan Orion 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 are aware of what these side effects may be.

Stop taking Candesartan Orion and seek medical help 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 Orion may cause a decrease in the number of white blood cells . Your resistance to infection may deteriorate and you may feel tired, have an infection or fever. If this happens, you should see a doctor as soon as possible so that blood tests can check if Candesartan Orion has had any effect on your blood ( agranulocytosis ).

Other possible side effects are:

Common (may affect up to 1 in 10 people)

  • feeling dizzy
  • headache
  • respiratory tract infection
  • low blood pressure . This can make you feel dull and dizzy.
  • changes in blood test results:
    • an increased amount of potassium in your blood, especially if you already have kidney problems or heart failure . If this is a significant change, you may notice fatigue, weakness, irregular heartbeat or ant crawling.
  • effects on kidney function, especially if you already have kidney problems or heart failure . In very rare cases, kidney failure may occur.

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

  • swelling of the face, lips, tongue and / or throat
  • reduction in the number of red or white blood cells . You may notice tiredness, infection or fever
  • skin rash, itchy lumpy rash ( hives )
  • itching
  • back pain, joint pain and muscle aches
  • changes in liver function, including liver inflammation ( hepatitis ). You may feel tired, have yellow skin and whites of the eyes and flu-like symptoms .
  • nausea
  • changes in blood test results:
    • a reduced amount of sodium in your blood. If there is a significant change,then you may notice weakness, lack of energy or muscle cramps.
  • cough

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

  • diarrhea

Additional side effects in children and adolescents

In children treated for high blood pressure , side effects appear to be similar to those seen in adults, but they occur more frequently. Sore throat is a very common side effect in children that has not been reported in adults. Colds, fever and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effectsdirectly via:

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

By reporting side effects , you can help increase drug safety information.

5. How to store Candesartan Orion

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 label and carton. 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 substance is candesartan cilexetil. 
Each tablet contains either 4 mg, 8 mg, 16 mg or 32 mg candesartan cilexetil. 
The other ingredients are: Lactose monohydrate , maize starch, hypromellose 2910 (E 464), calcium stearate, hydroxypropylcellulose, disodium edetate, microcrystalline cellulose (E 460). 
8 mg, 16 mg and 32 mg tablets also contain red iron oxide (E 172 ).

What the medicine looks like and contents of the pack

4 mg: White to off-white, round, biconvex, uncoated tablet with a score line on one side and smooth on the other side. The tablet can be divided into two equal doses .

8 mg: Pink to reddish brown with a whitish mosaic appearance, round, biconvex, uncoated tablet with a score line on one side and smooth on the other side. The tablet can be divided into two equal doses .

16 mg: Light pink to light red, round, biconvex, uncoated tablet with a score line on one side and smooth on the other side. The tablet can be divided into two equal doses .

32 mg: Light pink to light red, round, biconvex, uncoated tablet with a score line on both sides. The tablet can be divided into two equal doses .

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98, 100 tablets. 
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation 
Orionvägen 1 
FI-02200 Espoo 
Finland

Manufacturer 
Orion Corporation Orion Pharma 
Orionvägen 1 
FI-02200 Espoo 
Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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