Candesartan Liconsa: detailed information

Package leaflet: Information for the patient

Candesartan Liconsa 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

candesartan cilexetil
Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

The name of the medicine is Candesartan Liconsa. The active substance is candesartan cilexetil.
This medicine belongs to a group of medicines called angiotensin II receptor antagonists.
It works by relaxing and widening the blood vessels. This helps lower blood pressure. It also helps the heart pump blood to all parts of the body.
Candesartan Liconsa is used for:

treating high blood pressure (hypertension) in adults 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 Liconsa

Do not take Candesartan Liconsa

if you are allergic to candesartan cilexetil or to 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 using Candesartan Liconsa even in early pregnancy – see section “Pregnancy”);
if you have severe liver disease or a 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 Liconsa.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candesartan Liconsa

if you have heart, liver or kidney problems or are on dialysis;
if you have recently had a kidney transplant;
if you are vomiting, have recently vomited, or have diarrhoea;
if you have a disease of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism);
if you have low blood pressure;
if you have had a stroke in the past;
you must inform your doctor if you think you may be (or may become) pregnant. Candesartan Liconsa 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 when used at this stage (see section “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 Liconsa").

Contact your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Candesartan Liconsa. Your doctor will decide on further management. Do not stop taking Candesartan Liconsa on your own initiative.
Your doctor may check your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.
See also the section “Do not take Candesartan Liconsa”.
Your doctor may want to monitor you more frequently and carry out 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 Liconsa. This is because Candesartan Liconsa, when combined with certain anaesthetics, may cause excessive lowering of blood pressure.
Children and adolescents
Candesartan Liconsa has been studied in children. For further information, please consult your doctor.
Candesartan Liconsa must not be given to children under 1 year of age due to the potential risk to developing kidneys.
Other medicines and Candesartan Liconsa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Candesartan Liconsa may affect how other medicines work, and some medicines may affect Candesartan Liconsa. If you are taking certain medicines, your doctor may need to perform periodic blood tests.
In particular, inform your doctor if you are taking any of the following medicines. Your doctor may consider it necessary to adjust your 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 inflammation);
acetylsalicylic acid (if taking more than 3 g daily) (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);
co-trimoxazole, also known as trimethoprim/sulfamethoxazole (an antibiotic);
water tablets (diuretics);
lithium (a medicine used for mental disorders);
if you are taking an ACE inhibitor or aliskiren (see also section “Do not take Candesartan Liconsa” 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 Liconsa with food, drinks and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be (or may become) pregnant. Your doctor will normally advise you to stop taking Candesartan Liconsa before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Candesartan Liconsa.
Candesartan Liconsa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or about to start breast-feeding. Candesartan Liconsa is not recommended for breastfeeding mothers and your doctor may choose another 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 Liconsa. If this happens to you, do not drive or operate tools or machinery.
Candesartan Liconsa contains lactose
If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Candesartan Liconsa

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. It is important that you take Candesartan Liconsa every day.
You may take Candesartan Liconsa 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.
The 4 mg, 8 mg, 16 mg, and 32 mg tablets may be divided into equal doses.

High blood pressure:

The recommended dose of Candesartan Liconsa is 8 mg once daily. Your doctor may increase the dose to 16 mg once daily and subsequently 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 (for example due to vomiting, diarrhoea, or taking diuretic tablets), your doctor may prescribe a lower initial 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:
Children and adolescents aged between 6 and 18 years:
The recommended starting dose is 4 mg once daily.
For patients weighing less than 50 kg: In some patients whose 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 whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and subsequently to 16 mg once daily.

Heart failure in adults:

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

If you take more Candesartan Liconsa than you should
If you take more Candesartan Liconsa than prescribed by your doctor, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartan Liconsa
Do not take a double dose to make up for a forgotten tablet. Simply take the next dose at your usual time.

If you stop taking Candesartan Liconsa
If you stop taking Candesartan Liconsa, your blood pressure may rise again. Therefore, do not stop taking Candesartan Liconsa without first discussing it with your doctor.

If you have any questions about 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.
Stop taking Candesartan Liconsa 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 skin swelling).

Candesartan Liconsa may cause a reduction in the number of white blood cells. Your resistance to infections may decrease, and you may notice fatigue, infection or fever. If this occurs, contact your doctor. Your doctor may occasionally carry out blood tests to monitor whether Candesartan Liconsa has had any effect on your blood levels (agranulocytosis).
Other possible side effects include:
Common: may affect up to 1 in 10 people:

Dizziness/lightheadedness.
Headache.
Respiratory infection.
Low blood pressure. This may make you feel weak or cause dizziness.
Changes in blood test results:
- Increased levels 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, irregular heartbeat, or a tingling sensation in parts of the body.
Effects on kidney function, particularly if you already have kidney problems or heart failure. In very rare cases, renal failure may occur.

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

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, 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.
Nausea.
Changes in blood test results:
- Reduced levels of sodium in the blood. If this is severe, you may also notice weakness, lack of energy, or muscle cramps.
Cough.
Intestinal angioedema: swelling of the intestine, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency 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 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. Runny nose, fever, and increased heart rate are common side effects 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Candesartan Liconsa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cardboard box and on the label of the blister or bottle 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 Liconsa contains
The active substance is candesartan cilexetil.
Candesartan Liconsa 4 mg tablets contain 4 mg of candesartan cilexetil.
Candesartan Liconsa 8 mg tablets contain 8 mg of candesartan cilexetil.
Candesartan Liconsa 16 mg tablets contain 16 mg of candesartan cilexetil.
Candesartan Liconsa 32 mg tablets contain 32 mg of candesartan cilexetil.
The other components are:
monohydrate lactose, maize 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 the appearance of Candesartan Liconsa and contents of the pack
Candesartan Liconsa 4 mg: white to off-white, round tablet, 7 mm in diameter, with a score line on one side and the number "4" on the other side.
Candesartan Liconsa 8 mg: pink, round tablet, 6.4 mm in diameter (non-uniform with possible small darker or white specks), with a score line on one side and the number "8" on the other side.
Candesartan Liconsa 16 mg: pink, round tablet, 7 mm in diameter (non-uniform with possible small darker or white specks), with a score line on one side and the number "16" on the other side.
Candesartan Liconsa 32 mg: pink, round tablet, 9.5 mm in diameter (non-uniform with possible small darker or white specks), with a score line on one side and the number "32" on the other side.

Tablets are available in:
4 mg packs:
Blister packs: 28, 30, 90 tablets
8 mg packs:
Blister packs: 28, 30 and 90 tablets
16 mg packs:
Blister packs: 28, 30 and 90 tablets
32 mg packs:
Blister packs: 28, 30 and 90 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratorios LICONSA S.A.
Dulcinea s/n,
28805 Alcalá de Henares
Madrid,
Spain

Manufacturer
Laboratorios Liconsa S.A.
Av. De Miralcampo 7
19200 Azuqueca de Henares
Guadalajara, Spain

This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark Candesartan Liconsa
France CANDESARTAN LICONSA 4mg, comprimé sécable
CANDESARTAN LICONSA 8mg, comprimé sécable
CANDESARTAN LICONSA 16mg, comprimé sécable
CANDESARTAN LICONSA 32mg, comprimé sécable
Italy Candesartan Liconsa