Leaflet: information for the user

Candesartán/Hidroclorotiazida KERN PHARMA 16 mg/12,5 mg tablets EFG

Candesartán cilexetilo/Hidroclorotiazida

Read 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 questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

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

3.How to take Candesartán/Hidroclorotiazida Kern Pharma

4.Possible side effects

5Storage of Candesartán/Hidroclorotiazida Kern Pharma

6.Additional information

Your medicine is called Candesartán/Hidroclorotiazida Kern Pharma. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: 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 makes blood vessels relax and dilate. This facilitates a decrease in blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes the body to eliminate water and salt, such as sodium, in urine. This facilitates a decrease in blood pressure.

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

Do not take Candesartán/Hidroclorotiazida Kern Pharma

• if you are allergic (hypersensitive) to candesartán cilexetilo or to hydrochlorothiazide or to any of the other components of Candesartán/Hidroclorotiazida Kern Pharma (see section 6).
• if you are allergic to sulfonamides. If you are unsure whether you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is better to avoid Candesartán/Hidroclorotiazida Kern Pharma during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problem with the bile flow from the gallbladder).
• if you have persistent low levels of potassium in the blood.
• if you have persistent high levels of calcium in the blood.
• if you have ever had gout.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskirén.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Candesartán/Hidroclorotiazida Kern Pharma.

Warnings and precautions

Before starting treatment with Candesartán/Hidroclorotiazida Kern Pharma, or while taking Candesartán/Hidroclorotiazida Kern Pharma, inform your doctor if:

• you are diabetic.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you have been vomiting, have had frequent vomiting lately, or have diarrhea.
• you have a condition called Conn's syndrome (also known as primary aldosteronism).
• you have ever had a condition called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have allergies or asthma.
• inform your doctor if you are pregnant (or if you suspect you may be). Do not use Candesartán/Hidroclorotiazida Kern Pharma at the start of pregnancy, and do not take it if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).
• if you are taking any of the following blood pressure-lowering medications:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskirén.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartán/Hidroclorotiazida Kern Pharma.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within a few hours to a week after taking Candesartán/Hidroclorotiazida Kern Pharma.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartán/Hidroclorotiazida Kern Pharma, seek medical attention immediately.

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

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

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán/Hidroclorotiazida Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/Hidroclorotiazida Kern Pharma in monotherapy.

If you are undergoing surgery, inform your doctor or dentist that you are taking Candesartán/Hidroclorotiazida Kern Pharma. This is because Candesartán/Hidroclorotiazida Kern Pharma, in combination with some anesthetics, may cause a drop in blood pressure.

Candesartán/Hidroclorotiazida Kern Pharma may increase your skin's sensitivity to the sun.

Children and adolescents

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

Use of Candesartán/Hidroclorotiazida Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Candesartán/Hidroclorotiazida Kern Pharma may affect how some medications work, and some medications may influence the effect of Candesartán/Hidroclorotiazida Kern Pharma. If you are taking certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are taking any of the following medications, as your doctor may need to modify your dose and/or take other precautions:

• other blood pressure-lowering medications, including beta-blockers, medications containing aliskirén, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen,
• diclofenac, celecoxib, or etoricoxib (pain-relieving and anti-inflammatory medications).
• aspirin (if you take more than 3 g per day) (pain-relieving and anti-inflammatory medication).
• potassium supplements or salt substitutes containing potassium (medications to increase potassium levels in the blood).
• calcium supplements or vitamin D.
• cholesterol-lowering medications, such as colestipol or colestiramine.
• diabetes medications (tablets or insulin).
• heart rate-controlling medications (antiarrhythmic agents) such as digoxin and beta-blockers.
• medications that may be affected by potassium levels in the blood, such as some antipsychotic medications.
• heparin (a medication to increase blood fluidity).
• diuretics (medications to promote urine excretion).
• laxatives.
• penicillin (an antibiotic).
• amphotericin (for the treatment of fungal infections).
• lithium (a medication for mental health problems).
• steroids such as prednisolone.
• pituitary hormone (ACTH).
• medications 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.
• ciclosporin, a medication used for organ transplants, to prevent organ rejection.
• other medications that may increase the antihypertensive effect, such as baclofen (a medication for muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medications.
• if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán/Hidroclorotiazida Kern Pharma” and “Warnings and precautions”.

Use of Candesartán/Hidroclorotiazida Kern Pharma with food, drink, and alcohol

• You can take Candesartán/Hidroclorotiazida Kern Pharma with or without food.
• When you are prescribed Candesartán/Hidroclorotiazida Kern Pharma, consult your doctor before taking alcohol. Alcohol may cause dizziness or drowsiness.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Candesartán/Hidroclorotiazida Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medication instead of Candesartán/Hidroclorotiazida Kern Pharma. It is not recommended to use Candesartán/Hidroclorotiazida Kern Pharma at the start of pregnancy, and in any case, it should not be administered from the third month of pregnancy onwards as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use Candesartán/Hidroclorotiazida Kern Pharma during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

This medication contains lactose, if your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions for Candesartán/Hidroclorotiazida Kern Pharma as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

It is essential to continue taking Candesartán/Hidroclorotiazida Kern Pharma 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 every day. This will help you remember to take it.

If you take moreCandesartán/Hidroclorotiazida Kern Pharmathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeCandesartán/Hidroclorotiazida Kern Pharma

Do not take a double dose to compensate for the missed dose. Simply take the next dose.

If you interrupt treatment withCandesartán/Hidroclorotiazida Kern Pharma

If you stop taking Candesartán/Hidroclorotiazida Kern Pharma, your blood pressure may increase again. Therefore, do not stop taking Candesartán/Hidroclorotiazida Kern Pharma before consulting your doctor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Candesartán/Hidroclorotiazida Kern Pharma may cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects of Candesartán/Hidroclorotiazida Kern Pharma are due to candesartán cilexetilo and others are due to hydrochlorothiazide.

Stop takingCandesartán/Hidroclorotiazida Kern Pharmaand see 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 skin itching (with skin rash).

Candesartán/Hidroclorotiazida Kern Pharma 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 occurs, inform your doctor. Your doctor may perform blood tests from time to time to check if Candesartán/Hidroclorotiazida Kern Pharma is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 patients out of every 100)

• Changes in blood test results:
• • A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If severe, you may feel tired, weak, experience irregular heartbeats, or tingling.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache.
• Respiratory infection.

Occasional (affects fewer than 1 in 100 patients)

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

Rare (affects fewer than 1 in 1,000 patients)

• Jaundice (yellowing of the skin and white 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.
• Itching or prickling in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce 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 easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus erythematosus reactions or appearance of rare skin reactions.

Very rare (affects fewer than 1 in 10,000 patients)

• 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 yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown (cannot be estimated from available data)

• Diarrhea.

• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Candesartán/Hidroclorotiazida Kern Pharma

• The active principles are: candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are: maize starch, lactose monohydrate, triethylcitrate (E-1505), hydroxypropyl cellulose (E-463), sodium croscarmellose and magnesium stearate.

Appearance of the product and content of the packaging

Candesartán/Hidroclorotiazida Kern Pharma 16 mg/12.5 mg is presented in the form of white or almost white, round and biconvex tablets in packs of 28 tablets and clinical packaging of 300 or 500 tablets.

It may not be marketed all packaging.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate

(P.O. Box 14)

BBG 3000 Hal Far

Malta

This leaflet has been approved in February 2025

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http:// www.aemps.gob.es /