PROSPECTO: INFORMATION FOR THE USER

CANDESARTÁN RANBAXY 16 mg tablets EFG

Candesartán cilexetilo

Read this prospectus carefully before starting to take the medicine, as it contains important information for you.

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

2. What you need to know before starting to take Candesartán Ranbaxy

3. How to take Candesartán Ranbaxy

4. Possible adverse effects

5. Storage of Candesartán Ranbaxy

6. Contents of the package and additional information

This medicine is called Candesartán Ranbaxy. The active ingredient is candesartan cilexetilo. This belongs to a group of medicines called angiotensin II receptor antagonists. It makes blood vessels relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping 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 old

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 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)

Do not take Candesartán Ranbaxy

• if you are allergic to candesartán cilexetilo or any of the other ingredients of this medication (listed in section 6).
• if you are more than 3 months pregnant (In any case, it is better to avoid taking candesartán at the beginning of pregnancy - see the Pregnancy section).
• if you have severe liver disease or bile duct blockage (problem with the bile exiting the gallbladder).
• if the patient is less than 1 year old.
• if you have diabetesrenal insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartán Rambaxy.

Warnings and precautions:

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

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

• if you are takingany of the following medications used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACEI) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén
• if you are takingan ACEI together with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Taking Candesartán Ranbaxy with other medications").

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán Ranbaxy”.

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

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking candesartán as soon as you know you are pregnant and will recommend that you take another medication instead of candesartán. Candesartán should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards (see the Pregnancy section).

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

If you are undergoing surgery, inform your doctor or dentist that you are taking candesartán. This is because candesartán, in combination with some anesthetics, may cause a drop in blood pressure.

Children and adolescents

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

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

Taking Candesartán Ranbaxy with other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Candesartán Ranbaxy may affect how some medications work and some medications may influence the effect of Candesartán Ranbaxy. If you are taking certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are taking any of the following medications:

• other medications to lower your blood pressure, including beta blockers, diazoxide, and the so-called ACEIs such as enalapril, captopril, lisinopril, or ramipril.
• anti-inflammatory nonsteroidal medications (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• aspirin, (if you take more than3 gper day) (medication to relieve pain and inflammation).
• potassium supplements or salt substitutes containing potassium (medications that increase potassium levels in the blood).
• heparin (a medication to increase blood fluidity).
• diuretics (medications to promote urine elimination)
• litium (a medication for mental health problems)

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

• If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Candesartán Ranbaxy” and “Warnings and precautions”)
• If you are being treated with an ACEI together with other medications specifically for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone).

Candesartán Ranbaxy with food and drinks (especially alcohol):

• You can take candesartán with or without food.
• When prescribed candesartán, consult your doctor before taking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding:

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking candesartán as soon as you know you are pregnant and will recommend that you take another medication instead of candesartán. Candesartán should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

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

Driving and operating machinery:

Some patients may feel tired or dizzy when taking candesartán. If this happens to you, do not drive or operate tools or machinery.

Candesartán Ranbaxy contains lactose

This medication contains lactose. If your doctorhas indicated that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.It is essential that you continue taking 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 to 32 mg once a day, depending on the blood pressure response.
• 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 taking diuretics, your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medication when given as a single treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18

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 in intervals of at least two weeks up to a maximum of 32 mg once a day. Candesartan can be taken with other medications for heart failure, and your doctor will decide on the most suitable treatment for you.

Administration form:

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.

INCORRECTCORRECT

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 Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartan Ranbaxy

Do not take a double dose to compensate for the missed dose. Simply take the next dose at the usual time.

If you interrupt treatment with Candesartan Ranbaxy

If you stop taking candesartan, your blood pressure may increase. Therefore, do not stop taking candesartan without consulting your doctor first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur.

Severe side effects

Stop taking Candesartán Ranbaxy and see 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 may cause difficulty swallowing.
• Severe skin itching (with skin rash).

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

Your doctor may perform a blood test at regular intervals to check if candesartán is affecting your blood (agranulocytosis).

Other side effects:

Frequent (may affect up to 1 in 10 people)

?Dizziness.

?Headache.

?Respiratory infection.

?Low blood pressure. This may 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 is severe, you will feel tired, weak, have irregular heartbeats, or numbness.

?Effects on kidney function, especially if you already have kidney problems or heart failure. In rare cases, it may cause kidney failure.

Rare (may affect up to 1 in 10,000 people)

?Swelling of the face, lips, tongue, and/or throat.

?Decrease in red or white blood cells. You may feel tired, have an infection, or fever.

?Skin rash, hives.

?Itching.

?Back pain, joint and muscle pain.

?Changes in liver function, including inflammation of the liver (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to 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, which presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data):

?Diarrhea

Additional side effects in children and adolescents

In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Throat pain is a very common side effect in children, but not described in adults. Nasal discharge, fever, and increased heart rate are adverse side effects in children, but not described in adults.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the packaging after the CAD initials. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Candesartán Ranbaxy

• The active ingredient is candesartán cilexetilo.

Each tablet contains 16 mg of candesartán cilexetilo.

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

Appearance of the product and contents of the packaging

Candesartán Ranbaxy 16 mg are capsule-shaped tablets, pink in color, marked with “C” and “11” in low relief on each side of the groove on one face and with a groove on the other face.

This medication is available:

In PVC/PE/PVdC blisters

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

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Ranbaxy S.L.

Passeig de Gràcia, 9

08007 Barcelona

Spain

Responsible 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 with the following names:

Germany: Candesartan Basics 16 mg Tabletten

Denmark: Candesartan cilexetil Ranbaxy

Greece: Candesartan Ranbaxy

Spain: Candesartan Ranbaxy 16 mg comprimidos EFG

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 comprimate

Last review date of this leaflet: January 2025

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