Candesartan/Hydrochlorothiazide CombiX 16mg/12.5mg Tablets

Introduction

Package Leaflet:information for the patient

Candesartan/Hydrochlorothiazide Combix 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, as 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 and other information

1. What is Candesartan/Hydrochlorothiazide Combix and what is it used for
2. What you need to know before you take Candesartan/Hydrochlorothiazide Combix
3. How to take Candesartan/Hydrochlorothiazide Combix
4. Possible side effects

5 Storage of Candesartan/Hydrochlorothiazide Combix

1. Contents of the pack and further information

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

The name of this medicine is Candesartan/Hydrochlorothiazide Combix. 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 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 this medicine 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 Combix

Do not take Candesartan/Hydrochlorothiazide Combix

• 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 you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is also best to avoid this medicine during the first months of pregnancy – see section 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 failure and are being treated with a blood pressure-lowering 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you are diabetic.
• if you have heart, liver, or kidney problems.
• if you have recently had a kidney transplant.
• if you have vomiting, have had it frequently lately, or have diarrhea.
• if you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have ever had a disease called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have ever had an allergy or asthma.
• if you are pregnant (or think you might be). It is not recommended to use candesartan/hydrochlorothiazide at the start of pregnancy, and it should not be taken if you are more than three months pregnant, as it can cause serious harm to your baby when administered from that time on (see section “Pregnancy”).
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril, etc.), especially if you have kidney problems related to diabetes.
• aliskiren.
• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medicine.
• 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 hours to a week after taking this medicine. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.
• 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 this medicine, seek medical attention 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. Your doctor will decide whether to continue treatment. Do not stop taking candesartan/hydrochlorothiazide on your own.

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

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, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because this medicine, in combination with some anesthetics, can cause a significant 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, this medicine should not be given to children.

Other medicines and Candesartan/Hydrochlorothiazide Combix

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

Candesartan/hydrochlorothiazide may affect how some medicines work and some medicines may affect the effect of candesartan/hydrochlorothiazide. If you are using certain medicines, 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 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 that contain 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 (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).
• Calcium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rate (antiarrhythmic 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 (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 anti-hypertensive effect, such as baclofen (a medicine for relief of spasms), amifostine (used in cancer treatment), and some 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 Combix” and “Warnings and precautions”).

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

• You can take candesartan/hydrochlorothiazide with or without food.
• When you are prescribed candesartan/hydrochlorothiazide, consult your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use candesartan/hydrochlorothiazide during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

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 Combix contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them 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 Combix

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again. It is important that you continue to take this medicine every day.

The usual 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.

The tablet can be divided into equal doses.

If you take more Candesartan/Hydrochlorothiazide Combix than you should

If you have taken more candesartan/hydrochlorothiazide than prescribed by your doctor, 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 ingested.

If you forget to take Candesartan/Hydrochlorothiazide Combix

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

If you stop taking Candesartan/Hydrochlorothiazide Combix

If you stop taking candesartan/hydrochlorothiazide, your blood pressure may increase again. Therefore, do not stop taking this medicine before consulting your doctor.

If you have any other questions about 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 might be. Some of the side effects of this medicine are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking this medicine 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)

This medicine 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 this medicine 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 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 (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)

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

Frequency not known (frequency cannot be estimated from the available data)

• 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 (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and lumps).
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

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

5. Storage of Candesartan/Hydrochlorothiazide Combix

• Keep out of sight and reach of children.
• Do not store above 30 ºC.
• Do not use this medicine after the expiry date stated on the packaging or blister. The expiry 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 medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Combix

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. The tablets contain 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, calcium stearate, disodium edetate, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Oval, biconvex tablets with a beveled edge, peach to light orange in color, with a score line on both sides. The approximate dimensions of the tablets are 9.50 mm in length and 4.50 mm in width.

Candesartan/Hydrochlorothiazide Combix is available in blister packs of 28 and 30 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

Z.A.C. des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende,

France

or

Laboratori Fundacio Dau

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22, Alcobendas,

28108 Madrid,

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles,

France

Date of Last Revision of this Leaflet: February 2025

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