4 mg, 8 mg, 16 mg and 32 mg tablets
candesartan cilexetil
1. What Atacand is and what it is used for
The name of your medicine is Atacand. 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.
Atacand can be used to
- treat high blood pressure ( hypertension ) in adult patients and in children and adolescents aged 6 to 18 years.
- treat adult patients with heart failure and reduced heart muscle function 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 Atacand 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 take Atacand
Do not take Atacand
- 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 Atacand during early pregnancy – see the section on pregnancy).
- if you have severe liver disease or bile 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 Atacand.
Warnings and cautions
Talk to your doctor before taking Atacand
- 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 Conn’s syndrome (also called primary hyperaldosteronism).
- if you have low blood pressure.
- if you have had a stroke ( stroke ).
- You must tell your doctor if you think you are (or might become) pregnant. Atacand is not recommended during early pregnancy and you should not take Atacand if you are pregnant after the third month, as it may seriously harm your baby if used during this stage of pregnancy (see the 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 medicine that belongs to the group of medicines MR antagonist er (mineral corticoid receptor antagonist er). These medicines are for the treatment of heart failure (see “Other medicines and Atacand”).
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 Atacand”.
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 Atacand if you are having surgery. Atacand taken with some anesthetic may lower your blood pressure.
Children and young people
Atacand has been studied in children. For more information, talk to your doctor. Atacand should not be given to children under 1 year of age due to the potential risk to the developing kidneys.
Other medicines and Atacand
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Atacand may affect the way other medicines work, and some medicines may also affect the effect of Atacand. Your doctor may need to take blood samples from time to time if you are taking certain medicines.
Tell your doctor especially if you are taking any of the following medicines. Your doctor may need to change your dose and/or take other precautions:
- Other medicines that help you lower your blood pressure such as beta-blockers, diazoxide, 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 thinner).
- Trimethoprim/sulfamethoxazole (a combination of antibiotics ).
- Diuretics ( diuretics ).
- Lithium (a medicine for mental health problems).
- If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Atacand” 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 is called MR antagonists (mineral corticoid receptor) (eg spironolactone, eplerenone).
Atacand with food, drink, and alcohol
- You can take Atacand with or without food.
- If you are being prescribed Atacand, talk to your doctor about alcohol habits. Some people who drink alcohol and take Atacand may experience fainting and dizziness.
Pregnancy, breastfeeding, and fertility
| PregnancyYou must tell your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Atacand before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Atacand. Atacand 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. Atacand is not recommended for breastfeeding mothers and your doctor may choose another treatment 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 while taking Atacand. 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 sharpened 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.
Atacand contains lactose
Lactose is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Atacand
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
It is important to take Atacand every day.
You can take Atacand 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 Atacand 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 liver or kidney problems or those who have recently lost body fluids, for example through vomiting, diarrhea, or those taking diuretic tablets, the doctor may prescribe a lower starting dose.
- Some black 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 with high blood pressure
Children aged 6 to 18 years
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 in adults
- The recommended starting dose of Atacand is 4 mg once a day. Your doctor may increase the dose by doubling the dose one at least 2 weeks apart up to 32 mg once a day. Atacand can be taken with other heart failure medications and your doctor will decide which treatment is right for you.
If you forget to use Atacand
Do not take a double dose to make up for a forgotten tablet. Take the next dose as usual.
If you stop taking Atacand
If you stop taking Atacand, your blood pressure may rise again. Therefore, do not stop taking Atacand 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 Atacand 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)
Atacand 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 Atacand has had any effect on your blood ( agranulocytosis ).
Other possible side effects are:
Common (affects 1 to 10 users in 100)
- Feeling of dizziness.
- 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.
- Impact on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.
Very rare (affects less than 1 patient in 10,000)
- Swelling of the face, lips, tongue, and/or throat.
- A decrease in red or white blood cell count. 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 noticeable change, 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 are in children
The side effects in children treated for high blood pressure appear to be comparable to those observed in adults, but they occur more frequently. Sore throat is a very common side effect in children but not reported in adults and runny nose, fever and increased heart rate are common in children but not reported in adults.
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 Atacand
- 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, blister or can after “EXP”. The expiration date is the last day of the specified month.
- No special temperature 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 substance is candesartan cilexetil. The tablets contain 4 mg, 8 mg, 16 mg or 32 mg candesartan cilexetil.
- The other ingredients are carmellose calcium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, corn starch, and macrogol. The 8 mg, 16 mg, and 32 mg tablets also contain iron oxide (E172).
What the medicine looks like and the contents of the pack
- The 4 mg tablets are white, round tablets with a scoreline and the label A / CF on one side and 004 on the other.
- The 8 mg tablets are light pink, round tablets with a scoreline and the label A / CG on one side and 008 on the other.
- The 16 mg tablets are pink, round tablets with a scoreline and the label A / CH on one side and 016 on the other.
- The 32 mg tablets are pink, round tablets with a scoreline and the label A / CL on one side and 032 on the other.
The tablet can be divided into equal doses using the breaker notch.
The tablets are packaged in a plastic jar of 100 or 250 tablets or blister packs of 7, 14, 15, 15×1, 20, 28, 30, 30×1, 50, 50×1, 56, 90, 98, 98×1, 100 or 300 tablets.
Not all pack sizes may be marketed in all countries.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Finland: AstraZeneca Oy, Självstyrelsegränden 4, 02600 Espoo, Finland
Manufacturer:
AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Germany,
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA
UK,
AstraZeneca Dunkirk Production, AstraZeneca Reims Production, Pompelle Industrial Park, Chemin de Vrilly, 51100 Reims, France
This medicinal product is authorized under the European Economic Area under the names:
| Member State | Name |
| Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, UK | Atacand |
| Italy | Ratacand |