Candesartan Sun 16 mg Tablets

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN RANBAXY 16 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 Candesartan Ranbaxy is and what it is 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 Candesartan Ranbaxy is and what it is used for

This medicine is called Candesartan Ranbaxy. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and widen. This helps to lower your blood pressure. It also 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 aged 6 to <18 years.< 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 better 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 and kidney impairment and are being treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan Ranbaxy.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Candesartan Ranbaxy:

• you have heart, liver or kidney problems, or are on dialysis
• you have recently had a kidney transplant
• you have vomiting, have recently had severe vomiting or have diarrhea
• if you have an adrenal gland disease 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 together 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”.

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

You must inform your doctor if you are pregnant (or think you might be). It is not recommended to take candesartan at the start of 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 onwards (see 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, talk to 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, including those obtained without a prescription.

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

In particular, tell your doctor if you are taking 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 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) (medicine to relieve pain and inflammation).
• potassium supplements or salt substitutes that contain 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 change 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 together 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 candesartan is prescribed for you, talk to 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 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. It is not recommended to take candesartan at the start of pregnancy, and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that time onwards.

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, talk to your doctor before taking this medicine.

3. How to take Candesartan Ranbaxy

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. It is important that you take candesartan every day.

For high blood pressure:

• The usual dose of candesartan is 8 mg once a day. Your doctor may increase this dose to 16 mg per day and then up to 32 mg once a day, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhea, or because they are taking diuretics), your doctor may prescribe a lower initial dose.
• Some patients of black race 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, your 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, your doctor may decide to increase the dose up to a maximum of 8 mg once a day and 16 mg once a day.

For heart failure:

• The usual initial dose of candesartan is 4 mg once a day. Your doctor may increase this dose by doubling it at intervals of at least two weeks up to a maximum of 32 mg once a day. Candesartan can be taken with other medicines for heart failure, and your doctor will decide what treatment is most suitable for you.

Method of administration:

You can take candesartan with or without food.

Swallow the tablets whole with a glass of water.

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

INCORRECT CORRECT

If you take more Candesartan Ranbaxy 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, call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartan Ranbaxy

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

If you stop taking candesartan, your blood pressure may increase. Therefore, do not stop taking candesartan 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.

Serious side effects

Stop taking Candesartan Ranbaxy and go to your 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 itching of the skin (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.

Headache.

Respiratory infection.

Low blood pressure. This can cause dizziness or fainting.

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 may feel tired, weak, have irregular heartbeats, or have 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, or have an infection or fever.

Skin rash, hives.

Itching.

Back pain, joint and muscle pain.

Changes in liver function, including liver inflammation (hepatitis). You may 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 decrease in sodium levels in the blood. If 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. Nasal discharge, fever, and increased heart rate are also 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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 which is stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Candesartan Ranbaxy

• The active ingredient is candesartan cilexetil.

Each tablet contains 16 mg of candesartan cilexetil.

• The other components are: calcium carmellose, hypromellose, red iron oxide (E-172), lactose monohydrate, magnesium stearate, corn starch, and macrogol 6000.

Appearance of the Product and Packaging Content

Candesartan Ranbaxy 16 mg are capsule-shaped tablets, pink in color, marked with "C" and "11" in low relief on each side of the score line on one face and with a score line on the other face.

This medication is available:

In PVC/PE/PVdC Blisters

Package sizes 7, 14, 15, 20, 28, 30, 50, 56, 90, 98, 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Ranbaxy Laboratories 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 medication is authorized in the member states of the European Economic Area under the following names:

Germany: Candesartan Basics 16 mg Tabletten

Denmark: Candesartan cilexetil Ranbaxy

Greece: Candesartan Ranbaxy

Spain: Candesartan Ranbaxy 16 mg EFG tablets

Netherlands: Candesartan cilexetil Ranbaxy 16 mg tabletten

Sweden: Candesartan Ranbaxy 16 mg tabletter

United Kingdom: Candesartan Ranbaxy 16 mg tablets

Italy: Candesartan Ranbaxy

Poland: Ranacand

Romania: Tandesar 16 mg tablets

Date of the Last Revision of this Leaflet: January 2025

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