Candesartan/hydrochlorothiazide Aurovitas 32 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartán/Hidroclorotiazida Aurovitas 32 mg/25 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.

Contents of the leaflet

1. What Candesartán/Hidroclorotiazida Aurovitas is and what it is used for
2. What you need to know before taking Candesartán/Hidroclorotiazida Aurovitas
3. How to take Candesartán/Hidroclorotiazida Aurovitas
4. Possible side effects
5. How to store Candesartán/Hidroclorotiazida 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 called angiotensin II receptor antagonists. It helps blood vessels to relax and widen, making it easier to 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/Hydrochlorothiazide Aurovitas

Do not take Candesartán/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 unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also advisable to avoid Candesartán/Hydrochlorothiazide 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 blood potassium levels.
• if you have persistently high blood calcium levels.
• if you have ever had gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Candesartán/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 received a kidney transplant.

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

• 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 might be pregnant). Candesartán/Hydrochlorothiazide 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 cancer 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, as these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking candesartán/hydrochlorothiazide. 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 an increased 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 shortness of breath 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 diarrhoea after taking Candesartán/Hydrochlorothiazide Aurovitas. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/Hydrochlorothiazide Aurovitas on your own.

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

If any of these situations apply to you, your doctor may wish to see you more frequently and perform certain tests.

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

Candesartán/Hydrochlorothiazide Aurovitas may increase skin sensitivity to sunlight.

Use in children

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

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

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

• Other blood pressure-lowering medicines, including beta-blockers, medicines containing aliskiren, diazoxide, and 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 used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines used 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 certain antipsychotics.
• Heparin (a medicine used to increase blood fluidity).
• Diuretics (medicines that promote urine elimination).
• Laxatives.
• Penicillin or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (antibiotics).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine used for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines used to treat cancer.
• Amantadine (used to treat Parkinson’s disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (used to treat oesophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine used to relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotics.

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/Hydrochlorothiazide Aurovitas” and “Warnings and precautions”).

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

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

When prescribed Candesartán/Hydrochlorothiazide 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 suspect you may become pregnant). Your doctor will generally advise you to stop taking Candesartán/Hydrochlorothiazide Aurovitas before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán/Hydrochlorothiazide 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 from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartán/Hydrochlorothiazide Aurovitas is not recommended during breastfeeding, and 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/Hydrochlorothiazide Aurovitas. If this happens to you, do not drive or operate tools or machinery.

Candesartán/Hydrochlorothiazide Aurovitas contains lactose

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

3. How to take Candesartan/Hydrochlorothiazide Aurovitas

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

If you have taken more Candesartan/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 Candesartan/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 Candesartan/Hydrochlorothiazide Aurovitas

If you stop taking Candesartan/Hydrochlorothiazide Aurovitas, your blood pressure may rise again. Therefore, do not stop taking Candesartan/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 contact your 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 be reduced, and you may feel tired, have an infection, or develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to check 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 feel tired, weak, have irregular heartbeats, or experience tingling sensations.

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

• Presence of glucose in urine.

• Dizziness, sensation of spinning, 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 heartbeats.
• 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 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, consult 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 stated on the label or packaging after EXP. The expiry date refers to 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 unused medicines and their containers at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other components are monohydrate lactose, hydroxypropyl cellulose, calcium carmellose, magnesium aluminium metasilicate (type IA) (contains aluminium oxide, magnesium oxide and silicon dioxide), red iron oxide (E172), yellow iron oxide (E172), propylene glycol and magnesium stearate (E572).

Nature of the product and contents of the container

Tablet.

Uncoated pink oval-shaped tablets, marked with “J” and “15” 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 blister packs and PEHD bottles.

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

PEHD bottles: 30 and 500 tablets.

Only certain 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 32 mg/25 mg Tabletten

Bulgaria: ????ecap?a? HCT Aurobindo 32 mg/25 mg ?a??e???

Spain: Candesartán/Hidroclorotiazida Aurovitas 32 mg/25 mg comprimidos EFG

Malta: Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets

Poland: Candesartan + Hydrochlorothiazide Vitama

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

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