Package Insert: Information for the Patient

Candesartán/Hidroclorotiazida Alter 16 mg/12.5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Your medicine is called Candesartán/Hidroclorotiazida Alter. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: candesartán cilexetilo and hidroclorotiazida. Both work together to lower blood pressure.

• Candesartán cilexetilo 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.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes the body to eliminate water and salt, such as sodium, in urine. This facilitates a decrease in blood pressure.

Your doctor may prescribe Candesartán/Hidroclorotiazida Alter if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

Do not take Candesartán/Hidroclorotiazida Alter

• if you are allergic to candesartán cilexetilo or to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is best to avoid candesartán/hidroclorotiazida during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• if you have persistent low levels of potassium in the blood.
• if you have persistent high levels of calcium in the blood.
• if you have ever had gout.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskirén.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán/Hidroclorotiazida Alter

Before starting treatment with candesartán/hidroclorotiazida, or while taking candesartán/hidroclorotiazida, inform your doctor if:

• you are diabetic.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you have frequent vomiting, have had vomiting recently, or have diarrhea.
• you have a condition called Conn's syndrome (also known as primary aldosteronism).
• you have ever had a condition called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have allergies or asthma.
• • you are pregnant (or if you suspect you may be). Candesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

• you are taking any of the following medicines used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril, etc.), particularly if you have kidney problems related to diabetes.
• aliskirén.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán/Hidroclorotiazida Alter. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/Hidroclorotiazida Alter in monotherapy.

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

See also the information under the heading “Do not take Candesartán/Hidroclorotiazida Alter”.

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

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

Candesartán/hidroclorotiazida may increase your skin's sensitivity to the sun.

Children and adolescents

There is no experience with the use of candesartán/hidroclorotiazida in children (under 18 years). Therefore, candesartán/hidroclorotiazida should not be administered to children.

Taking Candesartán/Hidroclorotiazida Alter with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Candesartán/hidroclorotiazida may affect the way some medicines work and some medicines may influence the effect of candesartán/hidroclorotiazida. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicines, as your doctor may need to modify your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, medicines containing aliskirén, diazoxide, and the so-called 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 containing potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Cholesterol-lowering medicines, such as colestipol or colestiramine.
• Diabetes medicines (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in the blood, such as some antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine production).
• Laxatives.
• Penicillin or trimethoprim/sulfamethoxazole (antibiotic medicines).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Cancer medicines.
• Amantadine (for the treatment of Parkinson's disease or for severe viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, a medicine used for organ transplants, to prevent organ rejection.
• Other medicines that may lead to an increased anti-hypertensive effect such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment) and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán/Hidroclorotiazida Alter” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida Alter with food, drinks, and alcohol

You can take candesartán/hidroclorotiazida with or without food.

When you are prescribed candesartán/hidroclorotiazida, consult your doctor before taking alcohol. Alcohol may cause dizziness or drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant, consult your doctor or pharmacist before using this medicine.

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/hidroclorotiazida as soon as you know you are pregnant, and will recommend taking another medicine instead of candesartán/hidroclorotiazida. Candesartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant 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 breastfeeding. Candesartán/hidroclorotiazida is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Driving and operating machinery

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

Candesartán/Hidroclorotiazida Alter contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Use in athletes: this medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential to continue taking Candesartán/hidroclorotiazida Alter every day.

The recommended dose is one tablet once a day.

Swallow the tablet with a glass of water. Try to take the tablet at the same time every day. This will help you remember to take it.

If you take more Candesartán/Hidroclorotiazida Alter than you should

If you have taken more Candesartán/hidroclorotiazida Alter than prescribed by your doctor, contact your doctor or pharmacist immediately.

You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Candesartán/Hidroclorotiazida Alter

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt treatment with Candesartán/Hidroclorotiazida Alter

If you stop taking Candesartán/hidroclorotiazida Alter, your blood pressure may increase again. Therefore, do not stop taking this medication before consulting your doctor.

If you have any other questions 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 important that you know which side effects could occur. Some side effects of candesartan/hydrochlorothiazide are due to candesartan cilexetilo and others are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide and see 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 may cause difficulty swallowing.
• Severe skin itching (with skin rash).

Candesartan/hydrochlorothiazide can 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 occurs, inform your doctor. It is possible that your doctor will perform blood tests at regular intervals to check that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

Rare (may affect up to 1 in 100 people)

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

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

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown (frequency cannot be estimated from available data)

Reporting of 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 the 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.

This medication does not require special storage conditions.

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

Do not dispose of medications through drains or in the trash. Dispose of the packaging and medications you no longer need 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/Hidroclorotiazida Alter

• The active principles are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are: lactose monohydrate, maize pregelatinized starch, hydroxypropylcellulose, calcium carmelose, triethyl citrate, iron(III) oxide (E172) and magnesium stearate.

Appearance of the product and contents of the packaging

Pink tablets with white specks, round with a notch on one face.

The tablets are presented in blister packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/