Candesartan/Hydrochlorothiazide Aurovitas 16mg/12.5mg Tablets

Introduction

Package Leaflet: Information for the User

Candesartan/Hydrochlorothiazide Aurovitas 16 mg/12.5 mg Tablets EFG

candesartan cilexetil/hydrochlorothiazide

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

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

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

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

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

2. What you need to know before you take Candesartan/Hydrochlorothiazide Aurovitas

Do not take Candesartan/Hydrochlorothiazide Aurovitas:

• if you are allergic to candesartan cilexetil, 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 you are in this situation, consult your doctor.
• if you are pregnant for more than 3 months (it is also better to avoid Candesartan/Hydrochlorothiazide Aurovitas 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 (problem with bile leaving 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 problems and are being treated with a blood pressure medicine that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• you have diabetes.
• you have heart, liver or kidney problems.
• you have recently had a kidney transplant.
• you have been vomiting, have been vomiting 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 ever had a stroke.
• you have ever had an allergy or asthma.

• tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Candesartan/Hydrochlorothiazide Aurovitas before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Candesartan/Hydrochlorothiazide Aurovitas. Candesartan/Hydrochlorothiazide Aurovitas should not be used at the start of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this time (see section on Pregnancy).

• if you are taking any of the following medicines to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren.

• if you have had skin cancer or if you get an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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.
• 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 an increase in pressure in the eye and can occur within hours to weeks after taking candesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously had or have an allergy to penicillin or sulfonamide, you may be at greater risk of developing this side effect.
• 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 shortness of breath or severe difficulty breathing after taking candesartan/hydrochlorothiazide, see your doctor immediately.

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

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

See also the information under the heading “Do not take Candesartan/Hydrochlorothiazide Aurovitas”.

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 Aurovitas. This is because Candesartan/Hydrochlorothiazide Aurovitas, in combination with some anesthetics, can cause a significant drop in blood pressure.

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

Use in children

There is no experience with the use of Candesartan/Hydrochlorothiazide in children (under 18 years). Therefore, Candesartan/Hydrochlorothiazide Aurovitas should not be given to children.

Taking Candesartan/Hydrochlorothiazide Aurovitas with other medicines

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

Candesartan/Hydrochlorothiazide Aurovitas may affect the way some medicines work and some medicines may affect the effect of Candesartan/Hydrochlorothiazide Aurovitas. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, medicines that contain aliskiren, diazoxide, and the so-called angiotensin-converting enzyme inhibitors (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 that contain potassium (medicines to increase potassium levels in the blood).
• Caesium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or colestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rate (anti-arrhythmic 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 elimination).
• Laxatives.
• Penicillin or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (antibiotics).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids such as prednisolone.
• Adrenocorticotropic hormone (ACTH).
• Medicines for the treatment of cancer.
• 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.
• Cyclosporin, a medicine used for organ transplants, to prevent organ rejection.
• Other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for the relief of spasticity), amifostine (used in cancer treatment), and some antipsychotic medicines.

Your doctor may need to change your dose and/or take other precautions:

• 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 Aurovitas” and “Warnings and precautions”)

Taking Candesartan/Hydrochlorothiazide Aurovitas with food, drinks, and alcohol

You can take Candesartan/Hydrochlorothiazide Aurovitas with or without food.

When Candesartan/Hydrochlorothiazide Aurovitas is prescribed for you, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or planning to become pregnant). Your doctor will normally advise you to stop taking Candesartan/Hydrochlorothiazide Aurovitas before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Candesartan/Hydrochlorothiazide Aurovitas. Candesartan/Hydrochlorothiazide Aurovitas should not be used at the start of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this time (see section on Pregnancy).

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan/Hydrochlorothiazide Aurovitas is not recommended during breastfeeding, and your doctor may 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/Hydrochlorothiazide Aurovitas. If this happens to you, do not drive or use tools or machines.

Candesartan/Hydrochlorothiazide Aurovitas contains lactose

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

3. How to take Candesartan/Hydrochlorothiazide Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

It is important that you keep taking Candesartan/Hydrochlorothiazide Aurovitas every day.

The recommended dose of Candesartan/Hydrochlorothiazide Aurovitas 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 Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan/Hydrochlorothiazide Aurovitas

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

If you stop taking Candesartan/Hydrochlorothiazide Aurovitas

If you stop taking Candesartan/Hydrochlorothiazide Aurovitas, your blood pressure may increase again. Therefore, do not stop taking Candesartan/Hydrochlorothiazide Aurovitas before consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects might be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Aurovitas are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Aurovitas 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.
• Intense itching of the skin (with rash).

Candesartan/Hydrochlorothiazide Aurovitas 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 Aurovitas is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:

• A reduction 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/rotation or weakness.
• Headache.
• Respiratory infection.

Infrequent (may affect up to 1 in 100 people)

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

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

• Jaundice (yellowing of the skin or 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 pinching in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• High temperature (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.
• Severe skin reaction that develops rapidly, causing blisters or peeling of the skin, and possibly blisters 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 difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion).

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

• Sudden myopia.
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps).
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Candesartan/Hydrochlorothiazide Aurovitas

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Aurovitas

• The active ingredients 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, hydroxypropyl cellulose, calcium carmellose, aluminum and magnesium metasilicate (type IA) (contains aluminum oxide, magnesium oxide, and silicon dioxide), red iron oxide (E172), yellow iron oxide (E172), propylene glycol, and magnesium stearate (E572).

Appearance of the Product and Package Contents

Tablet.

Pink, capsule-shaped tablets without a coating, marked with "J" and "05" on either side of the score line on one face and smooth with a score line on the other face of the tablet. The tablet can be divided into equal doses.

Candesartan/Hydrochlorothiazide Aurovitas tablets are available in blisters and PEAD bottles.

Blister packs: 14, 28, 30, 56, 98, 100, and 300 tablets

PEAD bottles: 30 and 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Candesartan comp. Aurobindo 16 mg/12.5 mg Tabletten

Bulgaria: ?????? HCT Aurobindo 16 mg/12.5 mg ???????

Spain: Candesartán/Hidroclorotiazida Aurovitas 16 mg/12.5 mg comprimidos EFG

Malta: Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets

Poland: Candesartan + Hydrochlorothiazide Vitama

Date of the Last Revision of this Prospectus:February 2025

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