Candesartan Alter 16 mg Tablets

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 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 this medicine.

Warnings and precautions

Talk to your doctor before taking Candesartan Alter

• if you have heart, liver or kidney problems, or 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 think you might be). Your doctor will normally advise you to stop taking Candesartan Alter before you become pregnant or as soon as you find out you are pregnant, and will advise you to take another medicine to lower your blood pressure instead. It is not recommended to take Candesartan Alter during the first few months of pregnancy and it must not be taken after the third month of pregnancyas it may harm your baby if taken after this time (see section Pregnancy).
• 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”)

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

Your doctor may want to 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 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 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).
• Aspirin (if you take more than 3 g a day) (a medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine to increase the fluidity of the blood).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote the elimination of urine).
• Lithium (a medicine for mental health problems).
• 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 the treatment of 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 breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to take Candesartan Alter while 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 Alter. If this happens to you, do not drive or use tools or 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 remember to take it.

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

High blood pressure:

• The recommended dose is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day depending on your blood pressure response.
• In some patients, such as those with liver or 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 starting dose.
• Some black patients may have a reduced response to this type of medicine, when given as the only treatment, 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 a day.

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

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

Heart failure in adults:

• The recommended starting dose is 4 mg once a day. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. 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 prescribed by your doctor, contact your doctor or pharmacist immediately.

You can also contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Candesartan Alter

Do not take a double dose to make up for forgotten doses. 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.

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 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 feel tired, get an infection, or have a fever. If this happens, talk to your doctor. Your doctor may do a blood test 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 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 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, get an infection, or have a fever.
• Rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and the whites of the eyes, and flu-like symptoms.
• Nausea.
• Changes in blood test results:
• • A decrease in sodium levels in the blood. If this is severe, 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, the side effects seem to be similar to those seen in adults, but they occur 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 Medicines and Healthcare Products Agency (AEMPS) website: 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 protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Alter

• The active substance is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.

The other ingredients are lactose monohydrate, pregelatinized corn starch, hydroxypropyl cellulose, calcium carboxymethyl cellulose, triethyl citrate, and magnesium stearate. See section 2 Candesartan Alter contains lactose.

Appearance and packaging

White, round, biconvex tablets with a score line on one side.

Candesartan Alter 16 mg is available in blister packs of 28 tablets.

Marketing authorization 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 Healthcare Products (AEMPS) http://www.aemps.gob.es/