Candesartan Aurobindo

Package leaflet: Information for the user

Candesartan Aurobindo 8 mg tablets

Candesartan Aurobindo 16 mg tablets
Candesartan Aurobindo 32 mg tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Candesartan Aurobindo is and what it is used for

The name of the medicine is Candesartan Aurobindo. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by causing the blood vessels to relax and widen. This helps lower blood pressure. It also allows the heart to pump blood more easily throughout the body.

This medicine is used for:

• treating high blood pressure (hypertension) in adults, and in children and adolescents aged 6 years and above up to but not including 18 years of age.
  Candesartan Aurobindo can be used to treat heart failure in adult patients with reduced heart muscle function when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Candesartan Aurobindo

Do not take Candesartan Aurobindo:

• if you are allergic to candesartan cilexetil or to any of the excipients of this medicine (listed in section 6).
• if you are more than three months pregnant (it is better to avoid Candesartan Aurobindo even in the early stages of pregnancy - see section on pregnancy).
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Candesartan Aurobindo.
Warnings and precautions
Talk to your doctor before taking Candesartan Aurobindo:

• if you have heart, liver or kidney problems or are on dialysis.
• if you have recently undergone a kidney transplant.
• if you are vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have a disease of the adrenal gland known as Conn's syndrome (also called primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Candesartan Aurobindo is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure: or an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes or are taking aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Candesartan Aurobindo").

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under the heading "Do not take Candesartan Aurobindo".
Your doctor may need to see you more often and carry out tests if you have any of these conditions.
If you are about to undergo surgery, tell your doctor or dentist that you are taking Candesartan Aurobindo.
This is because Candesartan Aurobindo, when combined with certain anaesthetics, may cause a drop in blood pressure.
Children and adolescents
Candesartan Aurobindo has been studied in children. For further information, please speak with your doctor.
Candesartan Aurobindo must not be given to children under 1 year of age due to the potential risk to kidney development.
Other medicines and Candesartan Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Candesartan Aurobindo may affect how other medicines work, and some medicines may affect Candesartan Aurobindo. If you are taking certain medicines, your doctor may need to carry out blood tests 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, including 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 used to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood).
• Heparin (a medicine used to thin the blood).
• Tablets that help you pass urine (diuretics).
• Lithium (a medicine used for mental health conditions).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Candesartan Aurobindo" and "Warnings and precautions").
• If you are being treated with an ACE inhibitor together with other medicines used for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Candesartan Aurobindo with food, drinks and alcohol

• You may take Candesartan Aurobindo with or without food.
• When Candesartan Aurobindo is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may make you feel weak or cause dizziness.

Pregnancy, breast-feeding and fertility
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Candesartan Aurobindo before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to Candesartan Aurobindo. Candesartan Aurobindo is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Candesartan Aurobindo is not recommended for women who are breast-feeding, and your doctor may choose a different treatment for you if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy when taking Candesartan Aurobindo. If this happens to you, do not drive or operate tools or machinery.
Candesartan Aurobindo contains lactose monohydrate
Candesartan Aurobindo contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Candesartan Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
It is important to continue taking Candesartan Aurobindo every day.
Candesartan Aurobindo may be taken with or without food.
Swallow the tablet with a glass of water.
Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure:

• The usual dose of Candesartan Aurobindo is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily, and further up to 32 mg once daily, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or who have recently lost fluids due to, for example, vomiting, diarrhoea, or diuretic use, your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this medicine when used as monotherapy and may require 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 <50 kg: in some patients whose blood pressure is not adequately controlled,
your doctor may decide to increase the dose to a maximum of 8 mg once daily.
For patients weighing ≥50 kg: in some patients whose blood pressure is not adequately controlled,
your doctor may decide to increase the dose to 8 mg once daily and 16 mg once daily.

Heart failure in adults:

• The usual starting dose of Candesartan Aurobindo is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan Aurobindo may be taken together with other medicines for heart failure, and your doctor will decide which treatment is most suitable for you.

If you take more Candesartan Aurobindo than you should
If you take more Candesartan Aurobindo than prescribed, contact a doctor or pharmacist immediately for advice.

If you forget to take Candesartan Aurobindo
Do not take a double dose to make up for the missed tablet. Take only the next dose as usual.

If you stop taking Candesartan Aurobindo
If you stop treatment with Candesartan Aurobindo, your blood pressure may rise again.
Therefore, do not stop treatment with Candesartan Aurobindo without first talking to your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Stop taking Candesartan Aurobindo and seek immediate medical help if
you experience 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 cause difficulty swallowing
• Severe itching of the skin (with raised blisters)

Candesartan Aurobindo may cause a reduction in the number of white blood cells in the blood. Your resistance to infections may decrease and you may notice fatigue, infection or fever. If this occurs, contact your doctor. Your doctor may occasionally perform blood tests to monitor whether Candesartan Aurobindo has affected your blood (agranulocytosis).
Other possible side effects include:
Common (affects 1 to 10 users in 100)

• Dizziness/vertigo
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy
• Changes in blood test results:
• increased potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may also notice fatigue, weakness, irregular heartbeat or tingling
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur

Very rare (affects fewer than 1 in 10,000 users)

• Swelling of the face, lips, tongue and/or throat
• Reduction in red or white blood cells. You may notice fatigue, infection or fever
• Skin rash, skin rash with swelling (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in 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
• Changes in blood test results:
• reduced sodium levels in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps

Additional side effects in children and adolescents
In children treated for high blood pressure, side effects appear similar to those observed in adults but 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Candesartan Aurobindo

Keep out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Candesartan Aurobindo contains

• The active substance is candesartan cilexetil. Each tablet contains 8 mg, 16 mg or 32 mg of candesartan cilexetil.
• The other ingredients are monohydrate lactose, hydroxypropylcellulose, calcium carmellose, magnesium aluminium metasilicate, propylene glycol, magnesium stearate, red iron oxide (E172) (only in 8 mg tablets), yellow iron oxide (E172) (only in 16 mg and 32 mg tablets).

Description of the appearance of Candesartan Aurobindo and contents of the pack
Tablet
Candesartan Aurobindo 8 mg tablets
Light pink, biconvex, uncoated, round tablets, marked with “J” and “12” separated by a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Candesartan Aurobindo 16 mg tablets
Yellow, biconvex, uncoated, round tablets, marked with “J” and “13” separated by a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Candesartan Aurobindo 32 mg tablets
Yellow, biconvex, uncoated, round tablets, marked with “J” and “14” separated by a score line on one side and smooth on the other side. The tablet can be divided into two equal doses.
Candesartan Aurobindo tablets are available in PVC/PVdC/aluminium blisters in packs of 28 tablets.
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 Saronno (Varese) - Italy
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD.
United Kingdom
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Italy Candesartan Aurobindo 8 mg/16 mg/32 mg tablets
Portugal Candesartan Ritisca