CANDESARTAN 8 mg Coated Tablets

Зміст інструкції

1. Candesartan Mylan 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What is Candesartan Mylan and what is it 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. Package Contents and Other Information

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

candesartan cilexetil

Generic medicine

Read this leaflet carefully before you start 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 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 Mylan is and what it is used for
• 2. What you need to know before you take 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 is Candesartan Mylan and what is it 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 the
relaxation and dilation of blood vessels. This helps to reduce blood pressure.
It also ensures that the heart pumps 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 between the ages of 6 and 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 (MRA) cannot be used (ACE inhibitors and MRA 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 pregnant for more than 3 months (it is best to avoid Candesartan Mylaneven in the early stages of pregnancy; see the section on pregnancy).
• if you have a severe liver disease or an 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 if 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, talk to your doctor or pharmacist before
taking Candesartan Mylan.

Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan Mylan:

• 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 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 might become pregnant). Candesartan Mylan is not recommended in the early stages of pregnancy and must not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the 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 (for example enalapril, lisinopril, ramipril), especially if you have kidney problems associated with diabetes
• aliskiren
• if you are taking an ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see “Other medicines and Candesartan Mylan”).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking
Candesartan Mylan. The doctor will decide on further treatment. Do not stop taking
Candesartan Mylan on your own initiative.
The doctor may need to check your kidney function, blood pressure and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under “Do not take Candesartan Mylan”.
The doctor may need to see you more often and request some tests if you experience any of
these conditions.
If you are going to have an operation, tell your doctor or dentist that you are taking Candesartan Mylan.
This is because Candesartan Mylan, when combined with certain anaesthetics, can cause an excessive
reduction in blood pressure.

Children and adolescents
Candesartan Mylan has been studied in children. For more information, talk to your doctor.
Candesartan Mylan should 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 can affect the way other medicines work, and some medicines
can have an effect on Candesartan Mylan. If you are using certain medicines, your doctor
may need to have you undergo blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines, as your doctor
may need to change 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 for relieving pain and inflammation-like conditions).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation-like conditions).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood).
• Heparin (medicine for thinning the blood).
• Cotrimoxazole (antibiotic) also known as trimethoprim/sulfamethoxazole.
• Medicines that help you to urinate (diuretics).
• Lithium (medicine used to treat mental health problems).
• 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 can take Candesartan Mylan with or without food.
• When you are prescribed Candesartan Mylan, talk to your doctor before drinking alcohol. Alcohol can cause you to feel unwell or dizzy.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you suspect you are pregnant (or might become pregnant).
Normally your doctor will advise you to stop taking Candesartan Mylan before starting
pregnancy or as soon as you find out you are pregnant and will advise you to
take other medicines instead of Candesartan Mylan. Candesartan Mylan is not recommended
in the early stages of pregnancy and must not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if used after the third month of pregnancy.
Breastfeeding
Tell 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 newborn or premature.

Driving and using machines
Some people may feel tired or dizzy when taking Candesartan
Mylan. If you experience these sensations, do not drive vehicles or use tools or machines.

Candesartan Mylan contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Candesartan Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. It is important to take Candesartan Mylan every day.
You can 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 to remember to
take it.
The 8 mg, 16 mg and 32 mg tablets can be divided into equal doses.
High blood pressure:

• The recommended dose of Candesartan Mylan is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and further up to 32 mg once a day depending on your blood pressure.
• In some patients, such as patients with liver or kidney problems or those who have recently lost body fluids due to, for example, vomiting, diarrhea or use of medicines that help to urinate, the doctor may prescribe a lower starting dose.
• Some patients belonging to the black population may have a reduced response to this type of medicine when given as single treatment and may need a higher dose.

Use in children and adolescents:
Children and adolescents aged between 6 and 18 years:
The recommended starting dose is 4 mg once a day.
For patients weighing less than 50 kg: in some patients in whom blood pressure
is not adequately controlled, the doctor may decide that the dose should be increased
up to a maximum of 8 mg once a day.
For patients weighing 50 kg or more: in some patients in whom blood pressure is not
adequately controlled, the doctor may decide that the dose should be increased to 8 mg
once a day and to 16 mg once a day.
Heart failure in adults:

• The recommended starting dose of Candesartan Mylan is 4 mg once a day. Your doctor may increase the dose by doubling it at intervals of at least 2 weeks up to 32 mg once a day. Candesartan Mylan 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 Mylan than you should
If you take more Candesartan Mylan than prescribed by your doctor, seek immediate medical
advice from your doctor or pharmacist.

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

If you stop taking Candesartan Mylan
If you stop taking Candesartan Mylan your blood pressure may increase again.
Therefore do not stop taking Candesartan Mylan 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 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 can cause difficulty swallowing
• intense itching of the skin (with skin swellings)

Candesartan Mylan can cause a decrease in the number of white blood cells in the blood. Resistance
to infections may decrease and you may experience fatigue, infections or fever. Tell your
doctor if this happens. Occasionally, your doctor may need to have blood tests to check if 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 faint.
• Headache.
• Respiratory infection.
• Low blood pressure, which can cause a feeling of unwellness or dizziness.
• Changes in blood test results:
• Increased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may experience fatigue, weakness, an irregular heartbeat or a tingling sensation.
• Influence 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.
• Decrease in the number of red blood cells or white blood cells in the blood. You may experience fatigue, infections or fever.
• Skin rash, hives.
• Itching sensation.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You may experience fatigue, yellowish skin or whites of the eyes, or flu-like symptoms.
• Nausea.
• Changes in blood test results:
• Reduced amount 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 that manifests with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Not known: frequency cannot be estimated from available data

• Diarrhea.

Additional side effects in children
In children treated for high blood pressure, side effects are similar to those
observed in adults, but they occur more frequently. Sore throat is a very
common side effect in children but is 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, 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 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 box and blister after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 particular storage conditions.

6. Package Contents and Other Information

What Candesartan Mylan contains
The active ingredient is candesartan cilexetil
Candesartan Mylan 8 mg tablets contains 8 mg of candesartan cilexetil.
Candesartan Mylan 16 mg tablets contains 16 mg of candesartan cilexetil.
Candesartan Mylan 32 mg tablets contains 32 mg of candesartan cilexetil.
The other ingredients are:
Lactose monohydrate, corn starch, hydroxypropylcellulose, calcium carmellose, macrogol 8000,
magnesium stearate. The 8 mg, 16 mg and 32 mg tablets also contain red iron oxide
(E172).

Description of Candesartan Mylan and package contents
Candesartan Mylan 8 mg: round tablet of 6.4 mm, pink in color (non-uniform, with possible
small dark or white spots), with a score line on one side and “8” on the other side.
Candesartan Mylan 16 mg: round tablet of 7 mm, pink in color (non-uniform, with possible
small dark or white spots), with a score line on one side and “16” on the other
side.
Candesartan Mylan 32 mg: round tablet of 9.5 mm, pink in color (non-uniform, with possible
small dark or white spots), with a score line on one side and “32” on the other
side.
The tablets are available in:

Packs of 8 mg:
PVC/aluminum blisters: 28, 30 and 90 tablets

Packs of 16 mg:
PVC/aluminum blisters: 28, 30 and 90 tablets

Packs of 32 mg:
PVC/aluminum blisters: 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 Member States of the European Economic Area under
the following denominations:
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