4 mg, 8 mg, 16 mg, 32 mg tablet
candesartan cilexetil
What Candesartan Sandoz is and what it is used for
The name of your medicine is Candesartan Sandoz. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor 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 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) cannot be used or in addition to ACE inhibitors when symptoms persist despite treatment and MR antagonists (mineralocorticoid receptor antagonists ) cannot be used. ( ACE inhibitors and MRI antagonists are medicines used to treat heart failure .)
Candesartan cilexetil contained in Candesartan Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Candesartan Sandoz
Do not take Candesartan Sandoz
- if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (see section 6).
- if you are more than three months pregnant (it is also best to avoid Candesartan Sandoz during early pregnancy – see the pregnancy section).
- if you have severe liver disease or gallbladder obstruction (problems with bile drainage from the gallbladder).
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
- if the patient is a child under 1 year.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before taking Candesartan Sandoz:
- if you have heart, liver, or kidney problems, or are undergoing dialysis.
- if you have recently had a kidney transplant.
- if you have vomiting, 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 ).
- 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 take an ACE inhibitor with a drug that belongs to a group of medicines MR antagonists (mineralkortikoidreceptorantagonister). These medicines are for the treatment of heart failure (see “Other medicines and Candesartan Sandoz”).
- You must tell your doctor if you think you are (or might become) pregnant. Candesartan Sandoz is not recommended during early pregnancy and you should not take Candesartan Sandoz after the third month of pregnancy, as it may seriously harm your baby if used during this stage of pregnancy (see the section on pregnancy).
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 Sandoz”.
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 Sandoz if you are having surgery.
Candesartan Sandoz, which is taken with some anesthetic or narcotics, can cause an excessive drop in blood pressure.
Children and young people
Kandesartan cilexetil has been studied in children. Talk to your doctor for more information. Candesartan Sandoz must not be given to children under 1 year of age due to the possible risk of developing kidneys.
Other medicines and Candesartan Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Candesartan Sandoz can affect the way some other medicines work, and some medicines can also affect the effect of Candesartan Sandoz. Your doctor may need to take blood samples from time to time if you are taking certain medicines.
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 drugs that lower blood pressure, e.g. beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
- nonsteroidal anti-inflammatory drugs ( NSAIDs ) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (drugs which relieve pain and inflammation ).
- acetylsalicylic acid (if you take more than 3 grams 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 (blood-thinning drug).
- trimethoprim/sulfamethoxazole (a combination of antibiotics ).
- diuretics ( diuretics ).
- lithium (a drug for mental health problems).
- if you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Sandoz” and “Warnings and precautions”)
- if you are being treated with an ACE inhibitor in combination with certain other heart failure medicines called MR antagonists (mineral corticoid receptor antagonists ) (eg spironolactone, eplerenone).
Candesartan Sandoz with food, drink, and alcohol
- You can take Candesartan Sandoz with or without food.
- If you are prescribed Candesartan Sandoz, talk to your doctor before drinking alcohol. Some people who drink alcohol and take Candesartan Sandoz may experience fainting and dizziness.
Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Candesartan Sandoz before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan Sandoz. Candesartan Sandoz is not recommended during early pregnancy and should not be taken after the third month of pregnancy, 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 Sandoz 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 newborn or born prematurely.
Driving and using machines
Some people may feel tired or dizzy when taking Candesartan Sandoz. 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.
Candesartan Sandoz 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 it is essentially ‘sodium-free’.
How to take Candesartan Sandoz
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 Candesartan Sandoz every day.
You can take Candesartan Sandoz with or without food.
Swallow the tablet with a glass of water.
Always try to take the tablet at the same time each day. It will help you remember to take it.
Sharing the tablets:
If necessary, the tablet can be divided into two equal doses. Place the tablet with the breaker cut upwards on a hard and even surface (eg a table or a plate). Press firmly and simultaneously with both index fingers (or thumbs) on both sides of the notch.
High blood pressure
- The recommended dose of Candesartan Sandoz 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.
- To some patients, e.g. those who have liver or kidney problems or those who have recently lost body fluids, for example through vomiting, diarrhea, or the use of 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 whose blood pressure is not sufficiently controlled, the doctor may decide that the dose needs to be increased to a maximum of 8 mg once daily.
For patients weighing 50 kg or more: In some patients whose blood pressure is not sufficiently controlled, the doctor may decide that the dose needs to be increased to 8 mg once daily and 16 mg once daily.
Heart failure:
If you forget to take Candesartan Sandoz
Do not take a double dose to make up for a forgotten tablet. Take the next dose as usual.
If you stop taking Candesartan Sandoz
If you stop taking Candesartan Sandoz, your blood pressure may rise again. Therefore, do not stop taking Candesartan Sandoz 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 Sandoz 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 Sandoz may cause a decrease in the number of white blood cells. Your resistance to infection may deteriorate and you may feel tired or have an infection or fever. If this happens, consult a doctor as soon as possible. Your doctor may sometimes use blood tests to check if Candesartan Sandoz has had any effect on your blood ( agranulocytosis ).
Other possible side effects are:
Common (may affect up to 1 in 10 people):
- Feeling of dizziness/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 the change is severe, 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 (may affect up to 1 in 10,000 people):
- Swelling of the face, lips, tongue, and/or throat.
- Reduced number of red or white blood cells. You may notice tiredness, infection, or fever.
- Skin rash, lumpy rash ( hives ).
- Itching.
- Back pain, joint pain and muscle aches.
- Changes in liver function, including liver inflammation ( hepatitis ). You may feel tired and have yellow skin and whites of the eyes and flu-like symptoms.
- Nausea.
- Changed blood test results:- A reduced amount of sodium in your blood. If the change is severe, 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 and adolescents
In children treated for high blood pressure, the side effects appear to be similar to those seen in adults, but they occur more often. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been 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 Candesartan Sandoz
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, jar, and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Shelf life after first opening the jar:
3 months.
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.
One tablet contains 4 mg, 8 mg, 16 mg or 32 mg candesartan cilexetil.
4 mg tablet:
The other ingredients are lactose monohydrate, corn starch, povidone K30, carrageenan, croscarmellose sodium, and magnesium stearate.
8, 16, 32 mg tablet:
The other ingredients are lactose monohydrate, corn starch, povidone K30, carrageenan, croscarmellose sodium, magnesium stearate, red iron oxide (E172), and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Tablet.
4 mg tablet:
White, round, biconvex tablet with the marking 4 on one side and a score line on the other.
8 mg tablet:
Light red, speckled, round, biconvex tablet marked 8 on one side and notched on the other.
16 mg tablet:
Light red, speckled, round, biconvex tablet marked 16 on one side and notched on the other.
32 mg tablet:
Light red, speckled, round, biconvex tablet marked 32 on one side and scored on the other.
Pack sizes:
4 mg, 8 mg, and 16 mg tablet:
Al / Al blister pack: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
Al / Al perforated unit dose blister pack: 50 x 1 tablets
Al / Al blister pack with desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
Al / Al perforated unit dose blister pack with desiccant: 50 x 1 tablet
HDPE jar with PP lid and silica gel as a desiccant: 30, 100, 120, 500 tablets
32 mg tablet:
Al / Al blister pack: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
Al / Al blister pack with desiccant: 7, 14, 20, 28, 30, 50, 56, 58, 60, 84, 90, 91, 98, 100, 250, 300 tablets
HDPE jar with PP lid and silica gel as desiccant: 30, 100, 500 tablets
Note! The HDPE can contain desiccant that should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia (16 mg and 32 mg tablets)
Lek Pharmaceuticals dd, Trimlini 2 D, 9220 Lendava, Slovenia (4 mg and 8 mg tablets)