Candesartan Hydrochlorothiazide ALTER 16 mg/12.5 mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan/Hydrochlorothiazide Alter 16 mg/12.5 mg Tablets EFG

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

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

Contents of the Package Leaflet

1. What is Candesartan/Hydrochlorothiazide Alter and what is it used for
2. What you need to know before taking Candesartan/Hydrochlorothiazide Alter
3. How to take Candesartan/Hydrochlorothiazide Alter
4. Possible side effects
5. Storage of Candesartan/Hydrochlorothiazide Alter
6. Package Contents and Additional Information

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

Your medication is called Candesartan/Hydrochlorothiazide Alter. It is used to treat high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medications called angiotensin II receptor antagonists. It makes blood vessels relax and dilate. This helps lower blood pressure.
• Hydrochlorothiazide belongs to a group of medications called diuretics. It helps the body eliminate water and salts like sodium in the urine. This helps lower blood pressure.

Your doctor may prescribe Candesartan/Hydrochlorothiazide Alter if your blood pressure has not been adequately controlled with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan/Hydrochlorothiazide Alter

Do not take Candesartan/Hydrochlorothiazide Alter

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medication (listed in section 6).
• if you are allergic to sulfonamides. If you are not sure if you are in this situation, consult your doctor.
• if you are pregnant for more than 3 months. (It is also recommended to avoid candesartan/hydrochlorothiazide during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problem with bile exiting the gallbladder).
• if you have persistent low potassium levels in the blood.
• if you have persistent high calcium levels in the blood.
• if you have ever had gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking this medication.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Candesartan/Hydrochlorothiazide Alter

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartan/Hydrochlorothiazide Alter.
• If you experience vision loss or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within a few hours to a week after taking candesartan/hydrochlorothiazide.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartan/Hydrochlorothiazide Alter, seek medical attention immediately.

Before starting treatment with candesartan/hydrochlorothiazide, or while taking candesartan/hydrochlorothiazide, inform your doctor if:

• you are diabetic.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you have vomiting, have had it frequently lately, or have diarrhea.
• you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• you have ever had a disease called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you have had a stroke.
• you have had an allergy or asthma.
• • you are pregnant (or think you may be). Candesartan/hydrochlorothiazide is not recommended during the start of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby when administered from that time on (see Pregnancy section).

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril, etc.), especially if you have diabetes-related kidney problems.
• aliskiren.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan/Hydrochlorothiazide Alter. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan/Hydrochlorothiazide Alter on your own.

Your doctor may monitor 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/Hydrochlorothiazide 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 going to undergo surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with some anesthetics, can cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may increase the sensitivity of your skin to the sun.

Children and Adolescents

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

Taking Candesartan/Hydrochlorothiazide Alter with Other Medications

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

Candesartan/hydrochlorothiazide may affect how some medications work and some medications may affect the effect of candesartan/hydrochlorothiazide. If you are using certain medications, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are using any of the following medications, as your doctor may need to adjust your dose and/or take other precautions:

• Other medications to lower your blood pressure, including beta-blockers, medications containing aliskiren, 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 (medications to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications to increase potassium levels in the blood).
• Calcium or vitamin D supplements.
• Medications to lower cholesterol, such as colestipol or cholestyramine.
• Medications for diabetes (tablets or insulin).
• Medications to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medications that may be affected by potassium levels in the blood, such as some antipsychotic medications.
• Heparin (a medication to increase blood fluidity).
• Diuretics (medications to promote urine elimination).
• Laxatives.
• Penicillin or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (antibiotic medications).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medication for mental health problems).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medications for cancer treatment.
• Amantadine (for the treatment of Parkinson's disease or 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.
• Cyclosporine, a medication used for organ transplants to prevent organ rejection.
• Other medications that may increase the anti-hypertensive effect, such as baclofen (a medication for relief of spasms), amifostine (used in cancer treatment), and some antipsychotic medications.
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Candesartan/Hydrochlorothiazide Alter” and “Warnings and Precautions”).

Taking Candesartan/Hydrochlorothiazide Alter with Food, Drinks, and Alcohol

You can take candesartan/hydrochlorothiazide with or without food.

When prescribed candesartan/hydrochlorothiazide, consult your doctor before consuming alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you are pregnant (or think you may be). Your doctor will usually advise you to stop taking candesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medication instead of candesartan/hydrochlorothiazide. Candesartan/hydrochlorothiazide is not recommended during the start of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Driving and Using Machines

Some patients may feel tired or dizzy when taking candesartan/hydrochlorothiazide. If this happens to you, do not drive or operate tools or machines.

Candesartan/Hydrochlorothiazide Alter Contains Lactose

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

Use in athletes: this medication contains hydrochlorothiazide, which can produce a positive result in doping tests.

3. How to Take Candesartan/Hydrochlorothiazide Alter

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

It is important that you continue taking Candesartan/Hydrochlorothiazide 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 each day. This will help you remember to take it.

If You Take More Candesartan/Hydrochlorothiazide Alter Than You Should

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

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

If You Forget to Take Candesartan/Hydrochlorothiazide Alter

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

If You Stop Taking Candesartan/Hydrochlorothiazide Alter

If you stop taking Candesartan/Hydrochlorothiazide 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

It is important that you know what these side effects might be. Some of the side effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide and go to the 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 can cause difficulty swallowing.
• severe skin itching (with rash).

Candesartan/hydrochlorothiazide 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, inform your doctor. It is possible that your doctor will perform blood tests from time to time 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)

• 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.
• An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you may feel tired, weak, have irregular heartbeats, or tingling.
• An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Feeling of dizziness or weakness.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This can cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and the whites of the eyes). If this happens, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Tingling or pinching in arms and legs.
• Blurred vision for a short time.
• Abnormal heartbeats.
• Breathing difficulties (including pulmonary inflammation and fluid in the lungs).
• High fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• A severe skin reaction that develops rapidly, causing blisters and peeling of the skin, and possibly ulcers in the mouth.

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

• Swelling of the face, lips, tongue, and/or throat.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have a yellowing of the skin and the whites of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.

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

Not Known (frequency cannot be estimated from the available data)

• Skin and lip cancer (non-melanoma skin cancer).
• Sudden onset of myopia.
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Systemic lupus erythematosus and cutaneous lupus (an allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps).
• Diarrhea.

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Candesartan/Hydrochlorothiazide Alter

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging or blister pack, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Alter

• The active ingredients are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, hydroxypropylcellulose, calcium carmellose, triethyl citrate, red iron oxide (E172), and magnesium stearate.

Appearance of the Product and Packaging Contents

Pink tablets with white speckles, round with a notch on one side.

The tablets are presented in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the Last Revision of this Leaflet: February 2025

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