Candesartan Pensa 8 mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan Pensa 8 mg Tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

The name of this medicine is Candesartan Pensa. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by making the blood vessels relax and widen. This helps to lower blood pressure. This makes it easier for your heart to pump blood to all parts of your body.

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years.< li>
• treatment of adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or in addition to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take Candesartan Pensa

Do not take Candesartan Pensa:

• if you are allergic (hypersensitive) 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 also recommended to avoid Candesartan Pensa at the start of pregnancy; see the section on pregnancy);
• if you have severe liver disease or biliary obstruction (a problem related to the drainage of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Candesartan Pensa.

Warnings and precautions

Talk to your doctor or pharmacist before starting Candesartan Pensa:

• if you have heart, liver or kidney problems or are on dialysis;
• if you have recently had a kidney transplant;
• if you have been vomiting, have recently had severe vomiting or have diarrhea;
• if you have a disease of the adrenal glands called "Conn's syndrome" (also called primary hyperaldosteronism);
• if you have very low blood pressure;
• if you have ever had a stroke;
• if you are pregnant (or think you might be). It is not recommended to use Candesartan Pensa at the start of pregnancy (first 3 months) and it should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if taken after this time (see section Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
• if you are taking an ACE inhibitor along with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Taking Candesartan Pensa with other medicines").

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking candesartan. Your doctor will decide whether to continue treatment. Do not stop taking candesartan on your own.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading "Do not take Candesartan Pensa".

If you are in any of these situations, your doctor may want to see you more often and perform some tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartan Pensa. This is because Candesartan Pensa, when combined with certain anesthetics, can excessively lower blood pressure.

Children and adolescents

Candesartan Pensa has been studied in children. For more information, talk to your doctor. Candesartan Pensa should not be given to children under 1 year of age due to a potential risk to the developing kidneys.

Taking Candesartan Pensa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Candesartan Pensa may affect the way other medicines work and certain medicines may affect the way Candesartan Pensa works. If you are using certain medicines, your doctor may want to do 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 your dose and/or take other precautions:

• other medicines to help lower your 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 to relieve pain and inflammation);

• acetylsalicylic acid, if you take more than 3 g per day (a medicine to relieve pain and inflammation);
• potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood);
• heparin (a blood-thinning medicine).
• Cotrimoxazole (an antibiotic medicine) also known as trimethoprim/sulfamethoxazole.
• diuretic medicines;
• lithium (a medicine to treat mental health problems).

• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Candesartan Pensa" and "Warnings and precautions")
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Candesartan Pensa with food and alcohol

• You can take Candesartan Pensa with or without food.
• When Candesartan Pensa is prescribed, talk to your doctor if you can drink alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Candesartan Pensa before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Candesartan Pensa. Candesartan Pensa is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Candesartan Pensa in breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed, 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 Pensa. If this happens to you, do not drive or use tools or machines.

Candesartan Pensa contains lactose

Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Candesartan Pensa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important to take Candesartan Pensa every day.

You can take Candesartan Pensa 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 tablet can be divided into two equal doses.

High blood pressure:

• The recommended dose of Candesartan Pensa is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day, depending on how your blood pressure responds.
• For some patients, such as those with liver or kidney problems, or those who have recently lost body fluids, e.g. due to vomiting or diarrhea, or due to the use of diuretics, your doctor may prescribe lower initial doses.

• Some black patients may have a reduced response to this type of medicine when used as the only treatment and may need higher doses.

Use in children and adolescents with high blood pressure:

Children from 6 to <18 years of age:< p>

The recommended starting dose is 4 mg once a day.

For patients weighing <50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up a maximum of 8 mg per day.< p>

For patients weighing ≥50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once a day and then to 16 mg once a day.

Heart failure in adults:

• The recommended initial dose of Candesartan Pensa is 4 mg once a day. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to 32 mg once a day. Candesartan Pensa can be taken with other medicines for heart failure; your doctor will decide what treatment is best for you.

If you take more Candesartan Pensa than you should

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

If you forget to take Candesartan Pensa

Do not take a double dose to make up for a forgotten tablet.

Take the next dose as normal.

If you stop taking Candesartan Pensa

If you stop taking Candesartan Pensa, your blood pressure may increase again. Therefore, do not stop taking Candesartan Pensa without talking to your doctor first.

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 know what these side effects may be.

Stop taking Candesartan Pensa and see a 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;
• intense itching of the skin (with hives).

Candesartan Pensa may reduce the number of white blood cells in your blood. Your resistance to infection may be decreased and you may experience tiredness, infections, or fever. If this happens, contact your doctor. Your doctor may occasionally ask you to have blood tests to check if Candesartan Pensa has affected your blood (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 dizzy.
• changes in blood test results:

• increased potassium levels in the blood, especially if you have had kidney problems or heart failure. If the increase is severe, you may notice tiredness, weakness, irregular heartbeat, or tingling.

• effects on kidney function, especially if you have had 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.
• reduction in the number of red or white blood cells. You may notice tiredness, infection, or fever.
• skin rash, hives.
• itching.
• back pain, muscle and joint pain.
• changes in liver function, including liver inflammation (hepatitis). You may feel tired, yellowing of the skin and the whites of the eyes, and flu-like symptoms.
• nausea.
• changes in blood test results:

• reduction of sodium levels in the blood. If severe, you may notice tiredness, lack of energy, or muscle cramps.

• • cough
  • intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency

not known (cannot be estimated from the available data)

• diarrhea

Other side effects in children and adolescents

In children treated for high blood pressure, side effects seem to be similar to those seen in adults, but occur more frequently. Sore throat is a very common side effect in children but has not been 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 effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Pensa

Keep 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. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Pensa

The active substance is candesartan cilexetil. Each Candesartan Pensa 8 mg tablet contains 8 mg of candesartan cilexetil.

The other ingredients are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, maize starch, Transcutol (diethylene glycol monoethyl ether), red iron oxide (E172).

Appearance of Candesartan Pensa and contents of the pack

The 8 mg tablets are biconvex, round, pink, and scored on one side.

Candesartan Pensa 8 mg tablets EFG are supplied in: transparent ALU/PVC blisters with 7, 14, 15, 20, 28, 30, 50, 50x1 (single-dose units), 56, 98, 98x1 (single-dose units), 100, and 300 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Candesartan toLife

Italy: Candesartan Pensa

Spain: Candesartán Pensa

Netherlands: Silardaf

Germany: Candaxiro

This leaflet was approved in: January 2025

"Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/".