Candesartan Sun 32 mg Tablets

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN RANBAXY 32 mg TABLETS EFG

Candesartan cilexetil

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 pack:

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

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

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

Candesartan is used for:

• Treatment of high blood pressure (hypertension) in adults and in children and adolescents from 6 to <18 years of age.< li>
• Treatment of adult patients with heart failure with reduced muscular function of the heart when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or added 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 Ranbaxy

Do not take Candesartan Ranbaxy

• 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 (in any case, it is recommended to avoid taking candesartan at the start of pregnancy - see the section on Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes, kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking Candesartan Ranbaxy.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Candesartan Ranbaxy:

• you have heart, liver or kidney problems or are undergoing dialysis
• you have recently had a kidney transplant
• you have vomiting, have recently had severe vomiting or have diarrhea
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism)
• you have low blood pressure
• you have ever had a stroke

• 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 Ranbaxy with other medicines").

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 Ranbaxy”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Ranbaxy. Your doctor will decide whether you should continue treatment. Do not stop taking Candesartan Ranbaxy on your own.

You must inform your doctor if you are pregnant (or if you think you might be). Candesartan is not recommended during pregnancy, and in no case should it be administered if you are more than three months pregnant, as it may cause serious harm to your baby when administered from that time on (see the section on Pregnancy).

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

If you are going to have surgery, tell your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For more information, consult your doctor.

Candesartan should not be given to children under 1 year of age, due to the potential risk to the developing kidneys.

Taking Candesartan Ranbaxy with other medicines:

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those obtained without a prescription.

Candesartan Ranbaxy may affect the way some medicines work and some medicines may affect the effect of Candesartan Ranbaxy. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines:

• other medicines to lower your blood pressure, including beta blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• non-steroidal anti-inflammatory medicines (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) (medicine to relieve pain and inflammation).
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood).
• heparin (a medicine to increase blood fluidity).
• diuretics (medicines to promote urine elimination)
• lithium (a medicine for mental health problems)

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Ranbaxy” 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 Ranbaxy with food and drinks (especially alcohol):

• You can take candesartan with or without food.
• When you are prescribed candesartan, consult your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding:

Pregnancy

You must inform your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking candesartan before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of candesartan. Candesartan is not recommended during pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines:

Some patients may feel tired or dizzy when taking candesartan. If this happens to you, do not drive or use tools or machines.

Candesartan Ranbaxy contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Candesartan Ranbaxy

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is important that you continue taking candesartan every day.

You can take candesartan with or without food.

The tablets should be swallowed with the help of water.

Try to take the tablets every day at the same time. This will help you remember to take them.

For dosages that cannot be achieved with Candesartan Ranbaxy tablets, there are other medicines that contain other doses of candesartan cilexetil.

For high blood pressure

The usual dose is 8 mg once a day. The dose may be increased to 16 mg per day and subsequently to 32 mg per day depending on the response of the blood pressure.

In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids, for example due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.

Some patients of black descent may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

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

The recommended initial dose is 4 mg once a day.

Patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, the doctor may decide to increase the dose up to a maximum of 8 mg once a day.

Patients weighing 50 kg or more: In some patients whose blood pressure is not adequately controlled, the doctor may decide to increase the dose up to a maximum of 8 mg once a day and 16 mg once a day.

Heart failure:

The usual initial dose in heart failure is 4 mg once a day. If necessary, the dose may be doubled at intervals of at least two weeks up to 32 mg once a day. Candesartan can be taken with other medicines for the treatment of heart failure; your doctor will decide which treatment is most suitable for you.

If you take more Candesartan Ranbaxy 32 mg than you should

If you have taken more candesartan than prescribed by your doctor, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartan Ranbaxy 32 mg

Do not take a double dose to make up for the forgotten dose. Simply take the next dose at the usual time.

If you stop taking Candesartan Ranbaxy 32 mg

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan before consulting your doctor.

If you have any other 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.

It is important that you know what these side effects may be.

Serious side effects

Stop taking Candesartan Ranbaxy and go to the doctor immediately if you have 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.
• severe skin itching (with rash).

Candesartan may cause a decrease in white blood cells. Your resistance to infections may decrease and you may feel tired, have an infection, or have a fever. If this happens, contact your doctor.

It is possible that your doctor will perform a blood test from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other side effects:

Common (may affect up to 1 in 10 people)

Dizziness sensation.

Headache.

Respiratory infection.

Low blood pressure. This can cause you to feel dizzy or faint.

Changes in blood test results:

• An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you will notice fatigue, weakness, irregular heartbeats, or tingling.

Effects 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.

A decrease in red or white blood cells. You may feel tired, have an infection, or have a fever.

Skin rash, hives.

Itching.

Back pain, joint and muscle pain.

Changes in liver function, including liver inflammation (hepatitis). You will feel tired, have a yellowish color of the skin and the whites of the eyes, and symptoms similar to those of the flu.

Nausea.

Cough

Changes in blood test results:

A reduction in sodium levels in the blood. If it is severe, you may feel weak, lack energy, or have muscle cramps.

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

Additional side effects in children and adolescents

In children treated for high blood pressure, the side effects seem to be similar to those observed in adults, but they occur more frequently. Sore throat is a very common side effect in children, but it is not described in adults. In turn, runny nose, fever, and increased heart rate are adverse side effects in children, but they are not described in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Ranbaxy

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the packaging after the abbreviation EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Ranbaxy

• The active substance is candesartan cilexetil.

Each tablet contains 32 mg of candesartan cilexetil.

• The other ingredients are: calcium carmellose, low-viscosity hypromellose, red iron oxide (E-172), lactose monohydrate, magnesium stearate, cornstarch, and macrogol 6000.

Appearance of the product and packaging contents

Candesartan Ranbaxy 32 mg are oval, pink tablets, marked with “C” and “12” in low relief on each side of the score line on one face and with a score line on the other face.

This medicine is available:

In PVC/PE/PVdC-Alu blisters

Package sizes: 7, 8, 10, 12, 14, 15, 20, 28, 30, 40, 50, 56, 60, 70, 90, 95, 98, 100, 150 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Ranbaxy S.L.

Passeig de Gràcia, 9

08007 Barcelona

Spain

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

TERAPIA S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

This medicine is authorized in the EEA Member States with the following names:

Germany: CANDESARTAN BASICS 32 mg Tabletten

Spain: Candesartan Ranbaxy 32 mg tablets EFG

Italy: Candesartan Ranbaxy 32 mg tablets

Date of last revision of this leaflet: January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es