Ranacand

Package Leaflet: Information for the User

Ranacand, 8 mg, tablets

Ranacand, 16 mg, tablets

Candesartan cilexetil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor. See section 4.

Contents of the package leaflet:

• 1. What is Ranacand and what is it used for
• 2. Important information before taking Ranacand
• 3. How to take Ranacand
• 4. Possible side effects
• 5. How to store Ranacand
• 6. Contents of the pack and other information

1. What is Ranacand and what is it used for

Ranacand contains candesartan cilexetil as the active substance.
Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists.
This medicine causes relaxation and widening of blood vessels, which lowers blood pressure and makes it easier for the heart to pump blood to all parts of the body.
This medicine can be used:

• to treat high blood pressure in adults and children and adolescents aged 6 to 18 years,
• to treat adult patients with heart failure with reduced heart function, when ACE inhibitors (angiotensin-converting enzyme inhibitors) cannot be used or as an addition to ACE inhibitor therapy when symptoms of heart failure persist despite treatment, and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. Important information before taking Ranacand

When not to take Ranacand

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• after the third month of pregnancy (you should also avoid taking Ranacand during early pregnancy - see section on pregnancy),
• if you have severe liver disease or bile congestion (problems with bile secretion from the gallbladder),
• in children under 1 year of age,
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren. If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Ranacand.

Warnings and precautions

When to be particularly careful when taking Ranacand

Before taking Ranacand, discuss with your doctor or pharmacist if:

• you have heart, liver, or kidney problems or are on dialysis,
• you have recently undergone a kidney transplant,
• you have vomiting or diarrhea or have recently had severe vomiting,
• you have a condition called Conn's syndrome (also known as primary hyperaldosteronism),
• you have low blood pressure,
• you have ever had a stroke,
• you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren
• you are taking an ACE inhibitor at the same time as a medicine used to treat heart failure, known as a mineralocorticoid receptor antagonist (MRA) (e.g., spironolactone, eplerenone). (See "Ranacand and other medicines" and "When not to take Ranacand"). Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Ranacand, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Ranacand on your own.
If you suspect that you are pregnant (or may become pregnant), inform your doctor. Ranacand should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
In these cases, your doctor may recommend more frequent check-ups or additional laboratory tests.
If you are scheduled for surgery, inform your doctor or dentist that you are taking Ranacand, as Ranacand in combination with certain anesthetics may cause a significant drop in blood pressure.

Children and adolescents

The use of candesartan has been studied in children. For further information, talk to your doctor. Ranacand should not be given to children under 1 year of age due to the potential risk to kidney development.

Ranacand and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those obtained without a prescription.
Ranacand may affect the action of some medicines, and some medicines may affect the effectiveness of Ranacand. When combining certain medicines, your doctor may order blood tests.
It is essential to inform your doctor if you are taking any of the following medicines, as your doctor may recommend a dose change and/or take other precautions:

• blood pressure-lowering medicines, 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 (pain-relieving and anti-inflammatory medicines),
• acetylsalicylic acid (a medicine with anti-inflammatory and pain-relieving properties) if you take more than 3 grams of the medicine per day,
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood),
• heparin (a medicine that thins the blood),
• co-trimoxazole (an antibiotic also known as trimethoprim/sulfamethoxazole),
• diuretics (water pills),
• lithium (a medicine used to treat mental illnesses).
• If you are taking an ACE inhibitor or aliskiren (see also "When not to take Ranacand" and "Warnings and precautions").
• If you are taking an ACE inhibitor at the same time as a medicine used to treat heart failure, known as a mineralocorticoid receptor antagonist (MRA) (e.g., spironolactone, eplerenone).

Ranacand with food, drink, and alcohol

• Ranacand can be taken with or without food.
• If you are taking Ranacand, talk to your doctor before consuming alcohol. After drinking alcohol, you may feel weak or dizzy.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you suspect that you are pregnant (or may become pregnant).
Your doctor will usually recommend stopping Ranacand before planned pregnancy or immediately after confirming pregnancy and recommend taking a different medicine instead of Ranacand.
Ranacand should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Ranacand is not recommended during breastfeeding. If you want to breastfeed, your doctor may recommend a different medicine, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking Ranacand may feel tired or dizzy.
Do not drive or operate machinery if you experience these symptoms.

Ranacand contains lactose

Lactose is a type of sugar. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Ranacand

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist again. It is important to take Ranacand every day.
High blood pressure:

• The recommended dose of Ranacand is 8 mg once daily. The dose can be increased to 16 mg once daily and further to 32 mg once daily, depending on blood pressure.
• If you have liver or kidney disease or have recently lost a lot of fluid (vomiting, diarrhea, diuretics), your doctor may start with a lower dose.
• In some black patients, Ranacand may have a weaker effect if taken as the only blood pressure-lowering medicine. In these patients, a higher dose of the medicine may be necessary.

Treatment of high blood pressure in children and adolescents:
Children aged 6 to less than 18 years:
The recommended starting dose is 4 mg once daily.
Patients with a body weight below 50 kg: in some patients with insufficient blood pressure control, the doctor may decide to increase the dose to a maximum of 8 mg once daily.
Patients with a body weight of 50 kg or more: in some patients with insufficient blood pressure control, the doctor may decide to increase the dose to 8 mg once daily and up to 16 mg once daily.
Heart failure:

• The usual starting dose for the treatment of heart failure is 4 mg once daily. If necessary, the doctor may double the dose at intervals of at least 2 weeks up to 32 mg once daily. Ranacand can be taken with other medicines used to treat heart failure. The doctor will recommend the appropriate therapy.

Method of administration:
Ranacand can be taken with or without food.
Swallow the tablet with water.
It is recommended to take the medicine at the same time every day to help you remember.

NOT LIKE THIS

Taking a higher dose of Ranacand than recommended

If you have taken more than the recommended dose of candesartan, consult your doctor or pharmacist for advice.

Missing a dose of Ranacand

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

Stopping treatment with Ranacand

Do not stop taking Ranacand without consulting your doctor. If you stop taking the medicine, your blood pressure may increase again.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is essential to know the possible side effects.

Severe side effects

Stop taking Ranacand and contact your doctor immediately if you experience any of the following allergic reactions:

• shortness of breath, with swelling of the face, lips, tongue, and/or throat, or without swelling
• swelling of the face, mouth, and/or throat, which may cause difficulty in swallowing
• severe itching of the skin (with lumps).

Ranacand may cause a decrease in the number of white blood cells. You may have a weakened immune system, feel tired, be prone to infections, and have a fever. If you experience any of these, contact your doctor.
Your doctor may order blood tests to check if Ranacand affects your blood test results (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people):

• dizziness or "spinning",
• headache,
• respiratory tract infections,
• low blood pressure. This may cause weakness and dizziness,
• changes in blood test results:
• increased potassium levels in the blood, especially if you have kidney failure or heart failure. If the condition worsens, you may feel tired, weak, have irregular heart rhythm, and experience tingling,
• changes in kidney function, especially if you have kidney failure or heart failure. In very rare cases, the kidneys may stop working.

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

• swelling of the face, lips, tongue, and/or throat,
• decrease in the number of red or white blood cells. You may feel tired, be prone to infections, and have a high temperature,
• rash, hives,
• itching,
• back, joint, and muscle pain,
• changes in liver function, including hepatitis. You may feel tired, notice yellowing of the skin and whites of the eyes, and experience flu-like symptoms.
• nausea,
• cough,
• changes in blood test results:
• decrease in sodium levels in the blood. If the condition worsens, you may experience weakness, lack of energy, and muscle cramps.
• Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• diarrhea

Other side effects in children

Side effects in children treated for high blood pressure are similar to those observed in adults but occur more frequently. Very common in children are sore throat, runny nose, fever, and rapid heart rate, but these side effects have not been observed in adults.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw; phone: 22 49 21 301; fax: 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ranacand

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. This will help protect the environment.

6. Contents of the pack and other information

What Ranacand contains

The active substance is candesartan cilexetil.
Each tablet contains 8 mg or 16 mg of candesartan cilexetil.
The other ingredients are:
lactose monohydrate, cornstarch, hydroxypropylcellulose (low-substituted), macrogol 6000, calcium carmellose, iron oxide, red (E 172), magnesium stearate.

What Ranacand looks like and contents of the pack

Ranacand 8 mg:
Pink, mottled capsule-shaped tablet, approximately 9.1 mm long and 4.6 mm wide,
with the imprint "C" and "10" on either side of the break line on one side and a break line on the other side.
Ranacand 16 mg:
Pink, mottled capsule-shaped tablet, approximately 11.7 mm long and 5.1 mm wide,
with the imprint "C" and "11" on either side of the break line on one side and a break line on the other side.
Packaging - PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack size: 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw

Manufacturer

Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
Netherlands

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

Germany: CANDESARTAN BASICS 4 mg, 8 mg, 16 mg, 32 mg Tabletten
Spain: Candesartan SUN 8 mg, 16 mg, 32 mg comprimidos EFG
Romania: Tandesar 8 mg, 16 mg, 32 mg comprimate
Poland: Ranacand
Date of last revision of the package leaflet:18.06.2025