Candesartan Alter 32 mg Tablets

Introduction

Package Leaflet: Information for the Patient

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

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

Your medicine is called Candesartan Alter. The active substance is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It also helps your heart to pump blood to all parts of your body.

Candesartan Alter can be 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 Alter

Do not take Candesartan Alter

• 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. (It is also better to avoid this medicine during the first months of pregnancy – see section 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 or kidney impairment and you are 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 Alter.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan Alter

• if you have heart, liver or kidney problems, or if you are on 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 disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant (or if you think you might be). Your doctor will normally advise you to stop taking Candesartan Alter before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to treat your high blood pressure instead. It is not recommended to take Candesartan Alter during the first few months of pregnancy and it must not be takenif you are more than 3 months pregnant, as it may seriously harm your baby.
• if you are taking any of the following medicines used to treat high blood pressure:
• • 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 medicines known as mineralocorticoid receptor antagonists (MRAs) for the treatment of heart failure (see “Taking Candesartan Alter with other medicines”)

Tell your doctor if you get any of the following symptoms: abdominal pain, nausea, vomiting or diarrhea after taking Candesartan Alter. Your doctor will decide whether you should continue treatment. Do not stop taking Candesartan Alter on your own.

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

See also the information under the heading “Do not take Candesartan Alter”.

If you are in any of these situations, your doctor may want to see you more often and do 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 a potential risk to the developing kidneys.

Other medicines and Candesartan Alter

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

Candesartan Alter may affect the way some medicines work and some medicines may affect the way Candesartan Alter works. If you are taking certain medicines, your doctor may need 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 for lowering your blood pressure, including beta-blockers, diazoxide and so-called ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Painkillers or medicines for inflammation, including NSAIDs such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib.
• Aspirin (if you take more than 3 g per day) (a medicine for pain relief and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine for thinning the blood).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that increase the amount of urine you produce).
• Lithium (a medicine for mental health conditions).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Alter” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor together with other specific medicines for your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Alter with food, drinks and alcohol

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

Pregnancy and breast-feeding

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take Candesartan Alter while breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartan Alter 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 Alter

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 that you take candesartan every day.

You can take this medicine with or without food.

Swallow the tablet with a little water.

Try to take the tablet at the same time each day. This will help you to remember to take it.

The score line is only to help you break the tablet if you have difficulty swallowing it whole.

High blood pressure:

• The recommended dose is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then to 32 mg once daily, depending on your response to the treatment.
• In some patients, such as those with liver or kidney problems, or those who have recently lost fluid (e.g. through vomiting, diarrhea, or because you are taking diuretics), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine, when they are used on their own, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure

Children aged 6 to <18 years< p>

The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg daily.

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

Heart failure in adults:

• The usual starting dose is 4 mg once daily. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once daily. Candesartan can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Alter than you should

If you have taken more candesartan than you should, talk to your doctor or pharmacist immediately.

You can also contact the national Poison Information Centre, telephone 91 562 04 20, and quote the medicine and the amount taken.

If you forget to take Candesartan Alter

Do not take a double dose to make up for a forgotten dose. Just take the next dose as normal.

If you stop taking Candesartan Alter

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

If you have any further questions on the use of this product, 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 might be.

Stop taking candesartan and see your doctor immediately if you get 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 in swallowing
• severe itching of the skin (with rash)

Candesartan may cause a decrease in white blood cells. Your resistance to infections may be decreased and you may notice tiredness, infection or fever. If this happens, talk to your doctor. Your doctor may need to do blood tests from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• dizziness
• headache
• respiratory infection
• low blood pressure. This may cause you to feel dizzy or faint.
• changes in blood test results:
• • an increase in the level of potassium in your blood, especially if you already have kidney problems or heart failure. If this becomes serious, you may notice tiredness, weakness, irregular heartbeat or pins and needles.
• effects on your kidney function, especially if you already have kidney problems or heart failure. In rare cases, kidney failure has been reported.

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

• swelling of the face, lips, tongue and/or throat
• a decrease in the number of red or white blood cells. You may notice tiredness, infection or fever.
• rash, itching
• back pain, pain in your joints and muscles
• changes in your liver function, including inflammation of the liver (hepatitis). You may feel tired, have a yellowing of your skin and the whites of your eyes and flu-like symptoms.
• nausea
• changes in blood test results:
• • a decrease in the level of sodium in your blood. If this becomes serious, you may feel weak, lack energy or have 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

In children treated for high blood pressure, side effects seem to be similar to those seen in adults, but they happen more often. 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 get 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 Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Alter

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 carton after EXP. 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 to protect the environment.

6. Contents of the pack and other information

What Candesartan Alter contains

• The active substance is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.
• The other ingredients are lactose monohydrate, pregelatinized maize starch, hydroxypropylcellulose, calcium carboxymethylcellulose, triethyl citrate and magnesium stearate. See section 2 Candesartan Alter contains lactose.

Appearance and packaging

White, oblong tablets with a score line on one side.

Candesartan Alter 32 mg is available in blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet: February 2025.

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