Candesartan Mylan

Patient Information Leaflet: Information for the Patient

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

candesartan cilexetil
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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

The name of the medicine is Candesartan Mylan. The active substance is candesartan cilexetil. It belongs to
a group of medicines called angiotensin II receptor antagonists. It works by causing relaxation and dilation of blood vessels.
This helps to lower blood pressure. It also allows the heart to pump blood more easily throughout the body.
Candesartan Mylan can be used for:

• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to 18 years.
• treating 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

Do not take Candesartan Mylan:

• 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 3 months pregnant (it is better to avoid Candesartan Mylan even in the early stages of pregnancy; see the 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 Mylan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan Mylan:

• 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 experienced severe vomiting, or have diarrhoea.
• if you have a disease of the adrenal glands known as Conn's syndrome (also called primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• you must inform your doctor if you suspect you are pregnant (or if you might become pregnant). Candesartan Mylan is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see the section on pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (e.g. 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 (MRAs). These medicines are used to treat heart failure (see "Other medicines and Candesartan Mylan").

Contact your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Candesartan Mylan. Your doctor will decide on further treatment. Do not stop taking Candesartan Mylan on your own initiative.
Your doctor may need to regularly monitor your kidney function, blood pressure and levels of electrolytes (such as potassium) in your blood.
See also the information under "Do not take Candesartan Mylan".
Your doctor may need to examine you more frequently and order certain tests if you have any of these conditions.
If you are about to undergo surgery, inform your doctor or dentist that you are taking Candesartan Mylan.
This is because Candesartan Mylan, when combined with certain anaesthetics, may cause excessive lowering of blood pressure.
Children and adolescents
Candesartan Mylan has been studied in children. For further information, consult your doctor.
Candesartan Mylan must not be given to children under 1 year of age due to the potential risk to developing kidneys.
Other medicines and Candesartan Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Candesartan Mylan may affect how other medicines work, and some medicines may affect Candesartan Mylan. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.
In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust the dose and/or take other precautions:

• 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, diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammatory conditions).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (a medicine used to relieve pain and inflammatory conditions).
• Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood).
• Heparin (a medicine used to thin the blood).
• Cotrimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic).
• Medicines that help you urinate (diuretics).
• Lithium (a medicine used to treat mental health disorders).
• If you are taking an ACE inhibitor or aliskiren (see also the information under "Do not take Candesartan Mylan" and "Warnings and precautions").
• If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone).

Candesartan Mylan with food, drinks and alcohol

• You may take Candesartan Mylan with or without food.
• When Candesartan Mylan is prescribed for you, talk to your doctor before drinking alcohol. Alcohol may cause feelings of discomfort or dizziness.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you suspect you are pregnant (or if you might become pregnant).
Your doctor will normally advise you to stop taking Candesartan Mylan before becoming pregnant or as soon as you find out you are pregnant, and will recommend alternative treatment. Candesartan Mylan is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Candesartan Mylan 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 a newborn or was born prematurely.
Driving and using machines
Some people may experience tiredness or dizziness when taking Candesartan Mylan. If you experience these symptoms, do not drive or operate tools or machinery.
Candesartan Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Candesartan Mylan

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 take Candesartan Mylan every day.
You may take Candesartan Mylan with or without food. Swallow the tablet with water.
Try to take the tablet at the same time each day. This will help you remember to take it.
The 8 mg, 16 mg, and 32 mg tablets may be divided into equal doses.

High blood pressure:

• The recommended dose of Candesartan Mylan 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.
• In some patients, such as those with liver or kidney problems or those who have recently lost body fluids (e.g. due to vomiting, diarrhoea, or use of medicines that increase urine output), your doctor may prescribe a lower starting dose.
• Some patients of Black origin may have a reduced response to this type of medicine when used as monotherapy and may require a higher dose.

Use in children and adolescents:
Children and adolescents 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 then to 16 mg once daily.

Heart failure in adults:

• The recommended starting dose of Candesartan Mylan is 4 mg once daily. Your doctor may double the dose at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Candesartan Mylan 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 Mylan than you should
If you take more Candesartan Mylan than prescribed by your doctor, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartan Mylan
Do not take a double dose to make up for a forgotten tablet. Take only the next dose at the usual time.

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

If you have any questions about how to use 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 possible side effects might be.
Stop taking Candesartan Mylan and contact your doctor immediately 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 skin swellings)

Candesartan Mylan may cause a reduction in the number of white blood cells in the blood. Resistance
to infections may decrease and you may experience tiredness, infections or fever. Inform your
doctor if this occurs. Occasionally, your doctor may need to carry out blood tests to check whether
Candesartan Mylan has had any effect on the blood (agranulocytosis).
Other possible side effects include:
Common: may affect up to 1 in 10 people:

• Dizziness/feeling dizzy
• Headache
• Respiratory infection
• Low blood pressure, which may cause a feeling of discomfort or dizziness
• Changes in blood test results:
  • Increased levels of potassium in the blood, especially if you already have kidney problems or suffer from heart failure. If this is severe, you may experience tiredness, weakness, irregular heartbeat or a tingling sensation.
• Impaired kidney function, especially if you already have kidney problems or suffer from 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 neck
• Reduction in the number of red or white blood cells in the blood. You may experience tiredness, infections or fever
• Skin rash, urticaria
• Itching sensation
• Back pain, joint and muscle pain
• Changes in liver function, including inflammation of the liver (hepatitis). You may experience tiredness, yellowing of the skin or whites of the eyes, or flu-like symptoms
• Nausea
• Changes in blood test results:
  • Reduced levels of sodium in the blood. If this is severe, you may experience weakness, lack of energy or muscle cramps
• Cough
• Intestinal angioedema: swelling of the intestine which presents with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Not known: frequency cannot be estimated from the available data

• Diarrhoea

Additional side effects in children
In children treated for high blood pressure, side effects are 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, while 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, 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 https://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 Mylan

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 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.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Candesartan Mylan contains
The active substance is candesartan cilexetil.
Candesartan Mylan 8 mg tablets contain 8 mg of candesartan cilexetil.
Candesartan Mylan 16 mg tablets contain 16 mg of candesartan cilexetil.
Candesartan Mylan 32 mg tablets contain 32 mg of candesartan cilexetil.
The other excipients are:
Monohydrate lactose, maize starch, hydroxypropylcellulose, calcium carmellose, polyethylene glycol 8000,
magnesium stearate. The 8 mg, 16 mg and 32 mg tablets also contain red iron oxide (E172).

Description of the appearance of Candesartan Mylan and contents of the pack
Candesartan Mylan 8 mg: round tablet 6.4 mm in size, pink in colour (non-uniform, with possible small darker or white specks), with a score line on one side and "8" on the other side.
Candesartan Mylan 16 mg: round tablet 7 mm in size, pink in colour (non-uniform, with possible small darker or white specks), with a score line on one side and "16" on the other side.
Candesartan Mylan 32 mg: round tablet 9.5 mm in size, pink in colour (non-uniform, with possible small darker or white specks), with a score line on one side and "32" on the other side.

The tablets are available in:
Pack sizes of 8 mg:
PVC/aluminium blister packs: 28, 30 and 90 tablets
Pack sizes of 16 mg:
PVC/aluminium blister packs: 28, 30 and 90 tablets
Pack sizes of 32 mg:
PVC/aluminium blister packs: 28 and 30 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer
Laboratorios Liconsa S.A.,
Avda. Miralcampo, Nº7, Pol. Ind. Miralcampo,
19200- Azuqueca de Henares - Guadalajara, Spain

This medicinal product is authorised in the European Economic Area countries under the
following names:
Denmark Candesartan Viatris
Italy Candesartan Mylan
France Candesartan Viatris Santé 4 mg, comprimé sécable
Candesartan Viatris Santé 8 mg, comprimé sécable
Candesartan Viatris Santé 16 mg, comprimé sécable
Candesartan Viatris Santé 32 mg, comprimé sécable
Germany Candesartan Mylan 4 Tabletten