Candesartan/hydrochlorothiazide Aurovitas 16 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartan/Hydrochlorothiazide Aurovitas 16 mg/12.5 mg tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What Candesartán/Hidroclorotiazida Aurovitas is and what it is used for

Your medicine is called Candesartán/Hidroclorotiazida Aurovitas. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: candesartán cilexetilo and hidroclorotiazida. Both work together to lower blood pressure.

• Candesartán cilexetilo belongs to a group of medicines known as angiotensin II receptor antagonists. It helps blood vessels to relax and widen, which helps reduce blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps the body get rid of water and salts, such as sodium, through the urine. This also helps reduce blood pressure.

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

2. What you need to know before taking Candesartán/Hidroclorotiazida Aurovitas

Do not take Candesartán/Hidroclorotiazida Aurovitas:

• if you are allergic to candesartán cilexetil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also advisable to avoid Candesartán/Hidroclorotiazida Aurovitas during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Candesartán/Hidroclorotiazida Aurovitas.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if:

• you have diabetes.

• you have heart, liver, or kidney problems.

• you have recently received a kidney transplant.

• you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.

• you have a disorder 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 had allergies or asthma.

• inform your doctor if you are pregnant (or suspect you may be pregnant). Candesartán/Hidroclorotiazida Aurovitas is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

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

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

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking candesartán/hydrochlorothiazide.

• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking candesartán/hydrochlorothiazida. This may lead to permanent vision loss if not treated. If you have previously had or currently have an allergy to penicillin or sulfonamides, you may have a higher risk of developing this adverse effect.

• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking candesartán/hydrochlorothiazide, seek medical attention immediately.

Your doctor may monitor 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 Candesartán/Hidroclorotiazida Aurovitas. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/Hidroclorotiazida Aurovitas on your own.

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

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

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartán/Hidroclorotiazida Aurovitas. This is because Candesartán/Hidroclorotiazida Aurovitas, in combination with certain anesthetics, may cause an excessive drop in blood pressure.

Candesartán/Hidroclorotiazida Aurovitas may increase skin sensitivity to sunlight.

Use in children

There is no experience with the use of Candesartán/Hidroclorotiazida in children (under 18 years of age). Therefore, Candesartán/Hidroclorotiazida Aurovitas must not be administered to children.

Taking Candesartán/Hidroclorotiazida Aurovitas with other medicines

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

Candesartán/Hidroclorotiazida Aurovitas may affect how some medicines work, and some medicines may influence the effect of Candesartán/Hidroclorotiazida Aurovitas. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

In particular, inform your doctor if you are taking any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide, and so-called angiotensin-converting enzyme (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 taking more than 3 g per day) (a 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.
• Cholesterol-lowering medicines such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, 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 treating fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson's disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for treating esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplants to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relieving spasticity), amifostine (used in cancer treatment), and some antipsychotic medicines.

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

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartán/Hidroclorotiazida Aurovitas” and “Warnings and precautions”).

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

You may take Candesartán/Hidroclorotiazida Aurovitas with or without food.

When prescribed Candesartán/Hidroclorotiazida Aurovitas, consult your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or think you might be). Your doctor will usually advise you to stop taking Candesartán/Hidroclorotiazida Aurovitas before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán/Hidroclorotiazida Aurovitas is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartán/Hidroclorotiazida Aurovitas is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy when taking Candesartán/Hidroclorotiazida Aurovitas. If this happens to you, do not drive or operate tools or machinery.

Candesartán/Hidroclorotiazida Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Candesartán/hydrochlorothiazide Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, check with your doctor or pharmacist again.

It is important that you continue taking Candesartán/Hydrochlorothiazide Aurovitas every day.

The recommended dose of Candesartán/Hydrochlorothiazide Aurovitas is one tablet once daily.

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 Candesartán/Hydrochlorothiazide Aurovitas than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartán/Hydrochlorothiazide Aurovitas

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

If you stop taking Candesartán/Hydrochlorothiazide Aurovitas

If you stop taking Candesartán/Hydrochlorothiazide Aurovitas, your blood pressure may rise again. Therefore, do not stop taking Candesartán/Hydrochlorothiazide Aurovitas without first consulting your doctor.

If you have any further questions about 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 everyone will experience them.

It is important that you are aware of what these adverse effects might be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Aurovitas are due to candesartan cilexetil, while others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Aurovitas and see a doctor immediately if you experience 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 skin 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 develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to ensure that Candesartan/Hydrochlorothiazide Aurovitas is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:

• A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or experience muscle cramps.

• An increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling sensations.

• An increase in blood levels of cholesterol, glucose, or uric acid.

• Presence of glucose in urine.

• Dizziness/vertigo or weakness.

• Headache.

• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, hives, skin reaction due to sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or whites of the eyes). If this occurs, 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 prickling sensations in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeat.
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• Severe skin reaction developing 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 pain, and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

• Sudden onset of myopia.
• Decreased vision or eye pain due to elevated 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 (an allergic condition causing fever, joint pain, and skin rashes that may include redness, blisters, peeling, and lumps).
• Diarrhoea.
• Skin and lip cancer (non-melanoma skin cancer).
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Aurovitas

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 label or packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán/Hydrochlorothiazide Aurovitas

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are monohydrate lactose, hydroxypropyl cellulose, calcium carmellose, aluminum 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 contents of the pack

Tablet.

Pink, capsule-shaped, uncoated tablets, marked with “J” and “05” on either side of the score line on one side, and smooth with a score line on the other side of the tablet. The tablet can be divided into equal doses.

Candesartán/Hydrochlorothiazide Aurovitas tablets are available in blisters and HDPE bottles.

Blisters: 14, 28, 30, 56, 98, 100 and 300 tablets

HDPE 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

Telephone: 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 medicinal product 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: ????ecap?a? HCT Aurobindo 16 mg/12,5 mg ?a??e???

Spain: Candesartán/Hydrochlorothiazide Aurovitas 16 mg/12.5 mg tablets EFG

Malta: Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets

Poland: Candesartan + Hydrochlorothiazide Vitama

Date of the most recent review of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/