Candesartan Mylan Pharma: detailed information

Package leaflet: information for the patient

Candesartan Mylan Pharma 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

candesartan cilexetil
Generic 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Candesartan Mylan Pharma is and what it is used for
What you need to know before taking Candesartan Mylan Pharma
How to take Candesartan Mylan Pharma
Possible side effects
How to store Candesartan Mylan Pharma
Contents of the pack and other information

1. What Candesartan Mylan Pharma is and what it is used for

Candesartan Mylan Pharma contains the active substance candesartan cilexetil, which belongs to a group of
medicines called angiotensin II receptor antagonists. It works by causing relaxation and dilation of blood
vessels. This helps lower blood pressure. It also enables the heart to pump blood more easily throughout the body.
Candesartan Mylan Pharma can be used to:

treat high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to less than 18 years.
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 Mylan Pharma

Do not take Candesartan Mylan Pharma if:

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

Warnings and precautions
Before taking Candesartan Mylan Pharma, speak with your doctor or pharmacist:

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;
if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
- aliskiren;
if you are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see "Other medicines and Candesartan Mylan Pharma").

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Candesartan Mylan Pharma is not recommended during early pregnancy, and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).

Contact your doctor if, after taking Candesartan Mylan Pharma, you experience abdominal pain, nausea, vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Candesartan Mylan Pharma on your own.
Your doctor may need to check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under "Do not take Candesartan Mylan Pharma".
Your doctor may want to see you more frequently and request certain 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 Mylan Pharma.
This is because Candesartan Mylan Pharma, when combined with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents
Candesartan Mylan Pharma has been studied in children. For further information, please consult your doctor.
Candesartan Mylan Pharma must not be given to children under 1 year of age due to the potential risk to kidney development.

Other medicines and Candesartan Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candesartan Mylan Pharma may affect how other medicines work, and some medicines may affect Candesartan Mylan Pharma. If you are taking certain medicines, your doctor may need to carry out occasional blood tests.
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) or aliskiren (see also information in the sections “Do not take Candesartan Mylan Pharma” and “Warnings and precautions”);
an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone and eplerenone);
non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, 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);
co-trimoxazole (an antibiotic), also known as trimethoprim/sulfamethoxazole;
tablets that help you pass urine (diuretics);
lithium (a medicine used to treat mental health conditions).

Candesartan Mylan Pharma and alcohol
When Candesartan Mylan Pharma is prescribed for you, talk to your doctor before drinking alcohol. Alcohol during treatment with Candesartan Mylan Pharma may make you feel weak or dizzy.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will normally advise you to stop taking Candesartan Mylan Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan Mylan Pharma is not recommended during early pregnancy, and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breastfeeding
Candesartan Mylan Pharma is not recommended for women who are breastfeeding. Your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Some people may feel tired or dizzy while taking Candesartan Mylan Pharma. If this happens to you, do not drive or operate tools or machinery.

Candesartan Mylan Pharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Candesartan Mylan Pharma

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking Candesartan Mylan Pharma every day.
Candesartan Mylan Pharma may be taken with or without food.
Swallow the tablet with a glass of water.
The break line is included only to help you split the tablet if you have difficulty swallowing it whole.
Try to take the tablet at the same time each day. This will help you remember to take it.
The recommended dose is as follows:
High blood pressure in adults:
The recommended dose of Candesartan Mylan Pharma is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and further increase it 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 taking tablets that help increase urine output, 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 less than 50 kg: in some patients in whom blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg once daily.
For patients weighing 50 kg or more: in some patients in whom blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and further to 16 mg once daily.
Heart failure in adults:
The recommended starting dose of Candesartan Mylan Pharma is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least two weeks up to 32 mg once daily. Candesartan Mylan Pharma may be taken together with other medicines for heart failure, and your doctor will decide the most appropriate treatment for you.
If you take more Candesartan Mylan Pharma than you should
If you take more Candesartan Mylan Pharma than prescribed, contact your doctor or pharmacist immediately for advice. Your blood pressure may become low and you may feel dizzy.
If you forget to take Candesartan Mylan Pharma
Do not take a double dose to make up for the forgotten tablet. Take only the next dose as usual.
If you stop taking Candesartan Mylan Pharma
If you stop treatment with this medicine, your blood pressure may rise again. Therefore, do not stop treatment with Candesartan Mylan Pharma without first discussing it with 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 gets them.
Stop taking Candesartan Mylan Pharma and contact your doctor or go to the nearest hospital Emergency Department
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
An increased number of infections which may cause fever, severe chills, sore throat, mouth ulcers, and productive cough. These may be due to a low number of white blood cells
Liver function abnormalities that may present as nausea, vomiting, loss of appetite, general malaise, fever, chills, yellowing of the skin or whites of the eyes, pale stools or dark urine. These may be signs of serious liver problems
A decrease in kidney function which may present as reduced or no urine output, cloudy urine or blood in the urine, pain when urinating, or back pain. These may be signs of serious kidney problems.

Other possible side effects include:
Common (may affect up to 1 in 10 people)

Dizziness/lightheadedness when lying down (vertigo)
Headache
Respiratory infection
Low blood pressure. This may make you feel weak or dizzy.
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 in the hands or feet.

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

Rash
Severe skin rash with swelling (urticaria)
Itching
Back pain, joint pain and muscle pain
Nausea
Changes in blood test results: such as
Reduced sodium levels in the blood or increased liver enzymes in the blood
Cough
Intestinal swelling causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea (intestinal angioedema)

Not known (frequency cannot be estimated from the available data):

Diarrhoea

Additional side effects in children and adolescents
In children treated for high blood pressure, side effects appear to be 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 have not been reported in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Candesartan Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after {EXP.}. The expiry date refers to the
last day of the month.
For 4 mg and 8 mg only: Do not store above 25°C.
For 16 mg and 32 mg only: This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Mylan Pharma contains
The active substance is candesartan cilexetil.
Each tablet of Candesartan Mylan Pharma 4 mg contains 4 mg of candesartan cilexetil.
Each tablet of Candesartan Mylan Pharma 8 mg contains 8 mg of candesartan cilexetil.
Each tablet of Candesartan Mylan Pharma 16 mg contains 16 mg of candesartan cilexetil.
Each tablet of Candesartan Mylan Pharma 32 mg contains 32 mg of candesartan cilexetil.
The other excipients are sodium docusate, lauryl sulfate, calcium carmellose, pregelatinized corn starch,
hydroxypropylcellulose, lactose monohydrate, magnesium stearate (E572), iron oxide red (E172) (only for 16 mg and 32 mg tablets).

Description of the appearance of Candesartan Mylan Pharma and contents of the pack
Candesartan Mylan Pharma 4 mg is available in the following pack sizes:
Blister packs containing 7, 14, 28, 56, 98 white, round, biconvex tablets, marked CC on one side and 04 on the other, with a score line on both sides. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Candesartan Mylan Pharma 8 mg is available in the following pack sizes:
Blister packs containing 7, 14, 28, 56, 98 white, round, biconvex tablets, marked CC on one side and 08 on the other, with a score line on both sides. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Candesartan Mylan Pharma 16 mg is available in the following pack sizes:
Blister packs containing 7, 14, 28, 56, 98 light red, round, biconvex tablets, marked CC on one side and 16 on the other, with a score line on both sides. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Candesartan Mylan Pharma 32 mg is available in the following pack sizes:
Blister packs containing 7, 14, 28, 56, 98 light red, oval, biconvex tablets, marked CC and 32 on the same side, with a score line on both sides. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturers responsible for batch release:
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho do Bispo, 3045-016 Coimbra
Portugal
Mylan Hungary Kft.
H-2900 Komarom,
Mylan utca 1,
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy:
Candesartan Mylan Pharma 4 mg tablets
Candesartan Mylan Pharma 8 mg tablets
Candesartan Mylan Pharma 16 mg tablets
Candesartan Mylan Pharma 32 mg tablets