Candesartan/hydrochlorothiazide Combix 16 mg/12.5 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Candesartan/Hydrochlorothiazide Combix 16 mg/12.5 mg Tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read the entire leaflet carefully before starting to take 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, consult 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, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

The name of this medicine is Candesartán/Hidroclorotiazida Combix. It is used to treat high blood pressure (hypertension). It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both components work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines known as angiotensin II receptor antagonists. It causes the blood vessels to relax and widen, helping to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body eliminate water and salts such as sodium through the urine, which also contributes to lowering 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 taking Candesartán/Hidroclorotiazida Combix

Do not take Candesartán/Hidroclorotiazida Combix

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to 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 this medicine 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 outflow 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 impairment and are being treated with an antihypertensive medicine containing aliskiren.

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have diabetes.
• if you have heart, liver, or kidney problems.
• if you have recently received a kidney transplant.
• if you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.
• if you have a disorder 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 had allergies or asthma.
• if you are pregnant (or suspect you might be). Use of candesartan/hydrochlorothiazide is not recommended in early pregnancy, and you must not take it after the third month of pregnancy as it may cause severe harm to your baby when used from that stage onward (see section “Pregnancy”).
• 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, etc.), 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 this medicine.
• if you experience vision changes 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 a week after taking this medicine. This may lead to permanent vision loss if not treated. Your risk may be higher if you previously had an allergy to penicillin or sulfonamides.
• if you have previously experienced respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking this medicine, seek medical attention immediately.

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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 Candesartán/Hidroclorotiazida Combix”.

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

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This medicine, in combination with certain anesthetics, may cause a significant drop in blood pressure.

Candesartan/hydrochlorothiazide may increase skin sensitivity to sunlight.

Children and adolescents

There is no experience with the use of candesartan/hydrochlorothiazide in children (under 18 years of age). Therefore, this medicine should not be given to children.

Other medicines and Candesartán/Hidroclorotiazida Combix

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

Candesartan/hydrochlorothiazide may affect how certain medicines work, and some medicines may influence the effect of candesartan/hydrochlorothiazide. 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, as your doctor may need to adjust your dose and/or take other precautions:

• 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 for pain and inflammation relief).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine for pain and inflammation relief).
• Potassium supplements or salt substitutes containing potassium (medicines to increase blood potassium levels).
• 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 to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines).
• Amphotericin (for treating fungal infections).
• Lithium (a medicine for mental health disorders).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson's disease or severe 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 biperiden.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for muscle spasm relief), amifostine (used in cancer treatment), and certain antipsychotics.
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartán/Hidroclorotiazida Combix” and “Warnings and precautions”).

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

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

Pregnancy and breastfeeding

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of candesartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Candesartan/Hydrochlorothiazide Combix contains lactose

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

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

3. How to take Candesartán/Hidroclorotiazida Combix

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

The usual dose 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.

The tablet may be divided into equal doses.

If you take more Candesartán/Hidroclorotiazida 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, 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/Hidroclorotiazida Combix

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

If you stop taking Candesartán/Hidroclorotiazida Combix

If you stop taking candesartan/hydrochlorothiazide, your blood pressure may rise again. Therefore, do not stop taking this medicine 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 experiences them.

It is important that you are aware of what these adverse effects could be. Some of the adverse effects of this medicine are due to candesartan cilexetilo and others are due to hydrochlorothiazide.

Stop taking this medicine 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)

This medicine may reduce white blood cell counts. Your resistance to infections may decrease, and you may feel tired, have an infection or fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to check that this medicine 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 have 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 cholesterol, glucose, or uric acid levels.

• Presence of glucose in urine.

• Dizziness 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 caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and 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.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• 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.
• 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 developing rapidly, causing blisters and peeling of the skin, and possibly mouth ulcers.

Very rare (may affect up to 1 in 10,000 people)

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).
• 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.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

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

• Sudden 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 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).

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Combix

• Keep out of the 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point 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 Candesartan/Hydrochlorothiazide Combix

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

• The other components 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 contents of the pack

Oval, biconvex tablets with bevelled edges, peach to light orange in colour, 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 blisters 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,

Spain

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/)