Candesartan/Hydrochlorothiazide Kern Pharma 16mg/12.5mg Tablets

2. What you need to know before you take Candesartan/Hydrochlorothiazide Kern Pharma

Do not take Candesartan/Hydrochlorothiazide Kern Pharma

• if you are allergic (hypersensitive) to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of Candesartan/Hydrochlorothiazide Kern Pharma (see 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 better to avoid Candesartan/Hydrochlorothiazide Kern Pharma during the first months of pregnancy – see section on 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 your blood.
• if you have persistent high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney problems 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 Kern Pharma.

Warnings and precautions

Before starting treatment with Candesartan/Hydrochlorothiazide Kern Pharma, or while you are taking Candesartan/Hydrochlorothiazide Kern Pharma, tell 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 been vomiting frequently lately, or have diarrhea.
• you have a disease 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 ever had an allergy or asthma.
• tell your doctor if you are pregnant (or think you might be). Candesartan/Hydrochlorothiazide Kern Pharma is not recommended during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.
• 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), 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, particularly 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 Candesartan/Hydrochlorothiazide Kern Pharma.
• if you experience vision loss or eye pain, these 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 Candesartan/Hydrochlorothiazide Kern Pharma.
• 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 Candesartan/Hydrochlorothiazide Kern Pharma, seek medical attention immediately.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Candesartan/Hydrochlorothiazide 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 Candesartan/Hydrochlorothiazide Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan/Hydrochlorothiazide Kern Pharma on your own.

If you are going to have surgery, tell your doctor or dentist that you are taking Candesartan/Hydrochlorothiazide Kern Pharma. This is because Candesartan/Hydrochlorothiazide Kern Pharma, in combination with some anesthetics, can cause a drop in blood pressure.

Candesartan/Hydrochlorothiazide Kern Pharma may increase your skin's sensitivity to the sun.

Children and adolescents

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

Using Candesartan/Hydrochlorothiazide Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription. Candesartan/Hydrochlorothiazide Kern Pharma may affect how some medicines work, and some medicines may affect how Candesartan/Hydrochlorothiazide Kern Pharma works. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, tell 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 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 rhythm (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 increase urine production).
• Laxatives.
• Penicillin (an antibiotic).
• 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 blood pressure-lowering effect, such as baclofen (a medicine for relief of spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan/Hydrochlorothiazide Kern Pharma” and “Warnings and precautions”.

Using Candesartan/Hydrochlorothiazide Kern Pharma with food, drink, and alcohol

• You can take Candesartan/Hydrochlorothiazide Kern Pharma with or without food.
• When you are prescribed Candesartan/Hydrochlorothiazide Kern Pharma, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy, breastfeeding, and fertility

Pregnancy

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Candesartan/Hydrochlorothiazide Kern Pharma before you become pregnant or as soon as you find out you are pregnant, and will advise you to take a different medicine instead of Candesartan/Hydrochlorothiazide Kern Pharma. Candesartan/Hydrochlorothiazide Kern Pharma is not recommended during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan/Hydrochlorothiazide Kern Pharma is not recommended during breastfeeding, and your doctor will choose a different 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 Kern Pharma. If this happens to you, do not drive or use tools or machines.

This medicine 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 Kern Pharma

Follow exactly the instructions of administration of Candesartan/Hydrochlorothiazide Kern Pharma given by your doctor.

Consult your doctor or pharmacist if you have any doubts.

It is important that you continue taking Candesartan/Hydrochlorothiazide 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 each day. This will help you remember to take it.

If you take more Candesartan/Hydrochlorothiazide Kern Pharma than you should

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

If you forget to take Candesartan/Hydrochlorothiazide Kern Pharma

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

If you stop taking Candesartan/Hydrochlorothiazide Kern Pharma

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

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

4. Possible Adverse Effects

Like all medicines, Candesartan/Hydrochlorothiazide Kern Pharma can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects might be. Some of the adverse effects of Candesartan/Hydrochlorothiazide Kern Pharma are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop takingCandesartan/Hydrochlorothiazide Kern Pharmaand 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).

Candesartan/Hydrochlorothiazide 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 happens, inform your doctor. Your doctor may perform blood tests from time to time to check that Candesartan/Hydrochlorothiazide Kern Pharma is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (affects 1 to 10 patients out of 100)

• Changes in blood test results:
• • A reduction 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.

Infrequent (affects less than 1 in 100 patients)

• 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 (affects less than 1 in 1,000 patients)

• Jaundice (yellowing of the skin and 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 period.
• Abnormal heartbeats.
• Breathing difficulties (including pulmonary inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damaged 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 easily appear bruised.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly ulcers in the mouth.
• Worsening of pre-existing lupus erythematosus reactions or appearance of uncommon skin reactions.

Very Rare (affects less 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 a yellowish color of the skin and whites of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency Not Known (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 effusion) or acute angle-closure glaucoma].

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of Adverse Effects

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

5. Conservation of Candesartan/Hydrochlorothiazide Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Candesartan/Hydrochlorothiazide Kern Pharma

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

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide 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.

Not all packages may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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 prospectus was approved in February 2025

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