Candesartan/hydrochlorothiazide Kern Pharma 16 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartan/Hydrochlorothiazide KERN PHARMA 16 mg/12.5 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet:

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

5 Storage of Candesartan/Hydrochlorothiazide Kern Pharma

1. Further information

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

Your medicine is called Candesartán/Hidroclorotiazida Kern Pharma. It is used to treat high blood pressure (hypertension). 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 for blood pressure to decrease.
• 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 Kern Pharma if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

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

Do not take Candesartan/Hydrochlorothiazide Kern Pharma

• if you are allergic (hypersensitive) to candesartan cilexetil or hydrochlorothiazide, or to any of the other ingredients of Candesartan/Hydrochlorothiazide Kern Pharma (see 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 Candesartan/Hydrochlorothiazide 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 (a problem with bile leaving 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 insufficiency 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 Candesartan/Hydrochlorothiazide Kern Pharma.

Warnings and precautions

Before starting treatment with Candesartan/Hydrochlorothiazide Kern Pharma, or while taking it, inform your doctor if:

• you have diabetes.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.
• you have an adrenal gland disorder 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). Candesartan/Hydrochlorothiazide Kern Pharma 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 point onward (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (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 sun exposure and UV rays while taking Candesartan/Hydrochlorothiazide Kern Pharma.
• 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, which may occur within hours to a week after taking Candesartan/Hydrochlorothiazide Kern Pharma.
• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Candesartan/Hydrochlorothiazide Kern Pharma, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., 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 certain 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 without medical advice.

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

Candesartan/Hydrochlorothiazide Kern Pharma 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, Candesartan/Hydrochlorothiazide Kern Pharma must not be given to children.

Taking Candesartan/Hydrochlorothiazide Kern Pharma with other medicines

Inform 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 influence the effect of Candesartan/Hydrochlorothiazide Kern Pharma. If you are taking certain medicines, your doctor may need to carry out 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 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 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 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 (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, such as some antipsychotic medicines.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for treating fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson’s disease or serious 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 biperidene.
• Cyclosporine, a medicine used in organ transplants to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relieving 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 information under the headings “Do not take Candesartan/Hydrochlorothiazide Kern Pharma” and “Warnings and precautions”).

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

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant or suspect you might be. Your doctor will generally advise you to stop taking Candesartan/Hydrochlorothiazide Kern Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan/Hydrochlorothiazide Kern Pharma 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 when administered from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Candesartan/Hydrochlorothiazide Kern Pharma 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 using machines

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

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

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

3. How to take Candesartán/Hidroclorotiazida Kern Pharma

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

If you have any doubts, consult your doctor or pharmacist.

It is important that you continue taking Candesartán/Hidroclorotiazida Kern Pharma 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.

If you take more Candesartán/Hidroclorotiazida Kern Pharma than you should

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

If you forget to take Candesartán/Hidroclorotiazida Kern Pharma

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

If you stop taking Candesartán/Hidroclorotiazida Kern Pharma

If you stop taking Candesartán/Hidroclorotiazida Kern Pharma, your blood pressure may rise again. Therefore, do not stop taking Candesartán/Hidroclorotiazida Kern Pharma without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Candesartán/Hidroclorotiazida Kern Pharma may cause adverse effects, although not everybody experiences them.

It is important that you are aware of the possible adverse effects. Some of the adverse effects of Candesartán/Hidroclorotiazida Kern Pharma are due to candesartán cilexetilo and others are due to hydrochlorothiazide.

Stop taking Candesartán/Hidroclorotiazida Kern Pharma 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).

Candesartán/Hidroclorotiazida Kern Pharma may cause a decrease in white blood cells. Your resistance to infections may be reduced and you may feel tired, have an infection or fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to check that Candesartán/Hidroclorotiazida Kern Pharma is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 patients in 100)

• 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 reduction in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience tiredness, weakness, irregular heartbeats or tingling sensations.
  • An increase in blood levels of cholesterol, glucose or uric acid.

• Presence of glucose in urine.

• Feeling dizzy or weak.

• Headache.

• Respiratory infection.

Uncommon (affects less than 1 in 100 patients)

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

• 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 pins and needles in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• Difficulty breathing (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 that develops rapidly, causing blisters and peeling of the skin and possibly mouth ulcers.
• Worsening of pre-existing lupus-like reactions or development 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 inflammation of the liver (hepatitis).
• You may feel tired, have yellowing of the skin and whites of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulty (symptoms include severe breathlessness, fever, weakness and confusion).
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (cannot be estimated from available data)

• Diarrhoea.
• Skin and lip cancer (non-melanoma skin cancer).
• 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].

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, 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 not listed in this leaflet. You may 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 Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". 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 unused medicines and their containers at the SIGRE collection point in your pharmacy. If you have any doubts, 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/Hidroclorotiazida Kern Pharma

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

Appearance of the product and contents of the pack

Candesartán/Hidroclorotiazida Kern Pharma 16 mg/12.5 mg is presented as white or almost white, round, biconvex tablets in boxes containing 28 tablets and clinical packs containing 300 or 500 tablets.

Not all pack sizes 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 patient information leaflet was approved in February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/