Candesartan Hydrochlorothiazide ALTER 32 mg/12.5 mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan/Hydrochlorothiazide Alter 32 mg/12.5 mg Tablets EFG

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

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

Your medicine is called Candesartan/Hydrochlorothiazide Alter. It is used for the treatment of high blood pressure (hypertension). It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both work together to lower your blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and widen. This helps to lower your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body get rid of water and salts such as sodium in your urine. This helps to lower your blood pressure.

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

2. What you need to know before you take 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 medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are not sure if this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also better to avoid candesartan/hydrochlorothiazide during the first months of pregnancy – see section on Pregnancy).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problems with the drainage of bile from the gall bladder).
• if you have persistent low potassium levels in your blood.
• if you have persistent high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney impairment and are being treated with a blood pressure 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

Consult your doctor or pharmacist before starting treatment with 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 some 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 a decrease in vision or eye pain, these 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 hours to a week after taking candesartan/hydrochlorothiazide.
• If you have had respiratory or lung 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, tell your doctor if:

• you are diabetic.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you have been vomiting, have had frequent vomiting recently, 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 ever had a stroke.
• you have ever had an allergy or asthma.
• • you are pregnant (or think you might be). Candesartan/hydrochlorothiazide is not recommended during pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section on Pregnancy).

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

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

Talk to 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 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/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 have surgery, tell 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 given to children.

Taking Candesartan/Hydrochlorothiazide Alter with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

In particular, tell your doctor if you are using 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, medicines containing aliskiren, diazoxide, and 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 or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (anti-arrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by potassium levels in the blood, such as certain antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to increase urine production).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines 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.
• Cyclosporin, a medicine used for organ transplants to prevent organ rejection.
• Other medicines that may increase the blood pressure-lowering effect, such as baclofen (a medicine to relieve muscle spasms), amifostine (used in cancer treatment), and certain antipsychotic medicines.
• 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 drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking candesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of candesartan/hydrochlorothiazide. Candesartan/hydrochlorothiazide should not be used during pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want 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 use tools or machines.

Candesartan/Hydrochlorothiazide Alter contains lactose

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

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

3. How to take Candesartan/Hydrochlorothiazide Alter

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

It is important that you take 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 your doctor prescribed, contact your doctor or pharmacist immediately.

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

If you forget to take Candesartan/Hydrochlorothiazide 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/Hydrochlorothiazide Alter

If you stop taking Candesartan/Hydrochlorothiazide Alter, 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 medicine, 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 may 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 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 itching of the skin (with rash).

Candesartan/hydrochlorothiazide may cause a decrease in white blood cells. Your resistance to infection may be decreased and you may feel tired, have an infection, or fever. If this happens, tell your doctor. Your doctor may need to do blood tests from time to time to check that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (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 dizzy or weak.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach upset.
• Rash, itching, sun-related skin reactions.

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 anxiety.
• Tingling or numbness in arms and legs.
• Blurred vision for a short time.
• Abnormal heart rhythms.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis (inflammation of the pancreas). This causes moderate to severe stomach pain.
• Muscle cramps.
• Damaged blood vessels that cause 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 yellowing of the skin and the whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.

• Acute breathing difficulties (the signs include severe breathing difficulties, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine that presents with 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 severe nearsightedness.
• 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 may include redness, blisters, peeling, and bumps).
• Diarrhea.

Reporting of side effects:

If you experience 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 to the Spanish Medicines Agency's Pharmacovigilance System 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/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 indicated month.

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

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Alter

• The active ingredients are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, hydroxypropylcellulose, calcium carmellose, triethyl citrate, yellow iron oxide (E172), and magnesium stearate.

Appearance of the Product and Package Contents

Yellow tablets with white speckles, oblong with a score line 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/