CANDESARTAN 8 mg Coated Tablets

Зміст інструкції

1. Candesartan Aurobindo 8 mg tablets
2. Candesartan Aurobindo 32 mg tablets
   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

Candesartan Aurobindo 8 mg tablets

CandesartanAurobindo 16 mg tablets

Candesartan Aurobindo 32 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 relaxation
and dilation of blood vessels. This helps to reduce blood pressure. Furthermore, it ensures that the
heart pumps blood more easily throughout the body.
This medicine is used for:

• treating high blood pressure (hypertension) in adult patients, and in children and adolescents aged between 6 years and under 18. Candesartan Aurobindo can be used to treat heart failure in adult patients with reduced heart muscle function when ACE inhibitors cannot be used or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) 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 any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than three months (it is best to avoid Candesartan Aurobindo even in the early stages of pregnancy - see section on pregnancy).
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If you are not sure if 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 problems with your heart, liver or kidneys or are on dialysis.
• if you have recently had 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.
• tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Candesartan Aurobindo is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure: an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes or aliskiren
• if you are taking an ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used for the treatment of heart failure (see “Other medicines and Candesartan Aurobindo”).

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also the section "Do not take Candesartan Aurobindo".
Your doctor may need to see you more often and do tests if you experience any of these conditions.
If you are about to have an operation, tell your doctor or dentist that you are taking Candesartan Aurobindo.
This is because Candesartan Aurobindo, when combined with some anaesthetics, can cause a drop
in blood pressure.
Children and adolescents
Candesartan Aurobindo has been studied in children. For more information, talk to your doctor.
Candesartan Aurobindo should 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 can affect the mechanism of action of other medicines, and some medicines can
have an effect on Candesartan Aurobindo. If you are taking certain medicines, your doctor may
need to do blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines:

• Other medicines that help to 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 for relieving pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood).
• Heparin (a medicine for thinning the blood).
• Tablets that help you to pass water (diuretics).
• Lithium (a medicine for mental health problems).

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the section: "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) (for example spironolactone, eplerenone).”

Candesartan Aurobindo with food, drink and alcohol

• You can take Candesartan Aurobindo with or without food.
• When you are prescribed Candesartan Aurobindo, talk to your doctor before drinking alcohol. Alcohol can make you feel dizzy or lightheaded.

Pregnancy, breastfeeding and fertility
Pregnancy
You must tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Usually your doctor will advise you to stop taking Candesartan Aurobindo before
starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Candesartan Aurobindo. Candesartan Aurobindo is not recommended
in the early stages of pregnancy, and must not be taken if you are pregnant for more than three months, as
it can cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Candesartan Aurobindo is not
recommended for women who are breastfeeding and your doctor may choose another treatment for you if
you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Some people may feel tired or dizzy when taking Candesartan Aurobindo. If this happens to
you, do not drive or use tools or machines.

Candesartan Aurobindo contains lactose monohydrate
Candesartan Aurobindo contains lactose monohydrate. 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 Candesartan Aurobindo

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts
ask your doctor or pharmacist.
It is important to continue taking Candesartan Aurobindo every day.
Candesartan Aurobindo can 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 to remember to take it.
High blood pressure:

• The usual dose of Candesartan Aurobindo is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and further to 32 mg once a day depending on the 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, diarrhea or taking diuretics, the doctor may prescribe a lower starting dose.
• Some patients of Black race may respond to this medicine in a reduced manner, when it is given as a single treatment, and may need a higher dose.

Use in children and adolescents with high blood pressure:
Children aged 6 and <18 years:
The recommended starting dose is 4 mg once a day.
For patients with weight <50 kg: in some patients whose blood pressure is not adequately controlled, the
doctor may decide that the dose should be increased to a maximum of 8 mg once a day.
For patients with weight ≥ 50 kg: in some patients whose blood pressure is not adequately controlled,
the doctor may decide that the dose should be increased to 8 mg once a day and 16 mg once a day.
Heart failure in adults:

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

If you take more Candesartan Aurobindo than you should
If you take more Candesartan Aurobindo than prescribed by your doctor, 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 a missed tablet. Take only the next
dose as usual.

If you stop taking Candesartan Aurobindo
If you stop taking Candesartan Aurobindo, your blood pressure may increase again.
Therefore do not stop taking Candesartan Aurobindo without first talking to your doctor.
If you have any further questions on the use of this medicine, 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 Aurobindo and seek immediate medical help if
you experience any of the following allergic reactions:

• difficulty in 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 in swallowing
• severe itching of the skin (with raised blisters)

Candesartan Aurobindo can cause a decrease 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 happens, contact your
doctor. Your doctor may occasionally perform blood tests to check if Candesartan
Aurobindo has had any effects on your blood (agranulocytosis).
Other possible side effects include:

Common (affects 1 to 10 users out of 100)

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

Very rare (affects less than 1 user out of 10,000)

• Swelling of the face, lips, tongue and/or throat.
• A decrease 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:
• a reduced amount of sodium 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
is not reported in adults, and runny nose, fever and increased heart rate are common in children
but are not reported in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Candesartan Aurobindo

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

6. Contents of the pack and other information

What Candesartan Aurobindo contains

• The active ingredient is candesartan cilexetil. Each tablet contains 8 mg, 16 mg or 32 mg of candesartan cilexetil.
• The other ingredients are lactose monohydrate, hydroxypropylcellulose, calcium carmellose, magnesium aluminium metasilicate, propylene glycol, magnesium stearate, red iron oxide (E172) (only for 8 mg tablets), yellow iron oxide (E172) (only for 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, imprinted 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, imprinted 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, imprinted 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 foil blisters in
packs of 28 tablets.

Marketing authorisation 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 authorised in the Member States of the European Economic Area with
the following denominations:
Italy Candesartan Aurobindo 8 mg/16 mg/32 mg tablets
Portugal Candesartan Ritisca