Candesartan Cilexetil/Hydrochlorothiazide Normon 16 mg/12.5 mg Tablets

Introduction

Package Leaflet: Information for the Patient

Candesartan Cilexetil/Hydrochlorothiazide NORMON 16 mg/12.5 mg Tablets EFGCandesartan Cilexetil/Hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Candesartan Cilexetil/Hydrochlorothiazide NORMON is and what it is used for
2. What you need to know before taking Candesartan Cilexetil/Hydrochlorothiazide NORMON
3. How to take Candesartan Cilexetil/Hydrochlorothiazide NORMON
4. Possible side effects
5. Storage of Candesartan Cilexetil/Hydrochlorothiazide NORMON
6. Package Contents and Additional Information

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

Your medication is called Candesartan Cilexetil/Hydrochlorothiazide NORMON. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medications called angiotensin II receptor antagonists. It makes blood vessels relax and dilate, which helps lower blood pressure.
• Hydrochlorothiazide belongs to a group of medications called diuretics. It helps the body eliminate water and salts, such as sodium, in the urine, which helps lower blood pressure.

Your doctor may prescribe Candesartan Cilexetil/Hydrochlorothiazide NORMON if your blood pressure has not been adequately controlled with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Candesartan Cilexetil/Hydrochlorothiazide NORMON

Do not take Candesartan Cilexetil/Hydrochlorothiazide NORMON

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medication (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 pregnant for more than 3 months (it is also recommended to avoid Candesartan Cilexetil/Hydrochlorothiazide NORMON 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 bile release from 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 medication that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan Cilexetil/Hydrochlorothiazide NORMON.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Candesartan Cilexetil/Hydrochlorothiazide NORMON:

• 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 experience a decrease in vision or eye pain, which 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 a few hours to a week after taking Candesartan Cilexetil/Hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • Aliskiren

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Cilexetil/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan Cilexetil/Hydrochlorothiazide Normon on your own.

Your doctor may monitor 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 Cilexetil/Hydrochlorothiazide NORMON”.

Tell your doctor if you are pregnant (or think you may be pregnant). Candesartan Cilexetil/Hydrochlorothiazide NORMON is not recommended during the first trimester of pregnancy, and it must not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby when administered from that time on (see Pregnancy section).

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 undergo surgery, inform your doctor or dentist that you are taking Candesartan Cilexetil/Hydrochlorothiazide NORMON. This is because Candesartan Cilexetil/Hydrochlorothiazide NORMON, in combination with some anesthetics, can cause a drop in blood pressure.

Candesartan Cilexetil/Hydrochlorothiazide NORMON may increase the sensitivity of your skin to the sun.

Use in Children

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

Use in Athletes

This medication contains hydrochlorothiazide, which can produce a positive result in doping tests.

Taking Candesartan Cilexetil/Hydrochlorothiazide NORMON with Other Medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Candesartan Cilexetil/Hydrochlorothiazide NORMON may affect how some medications work, and some medications may affect the effect of Candesartan Cilexetil/Hydrochlorothiazide NORMON. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

In particular, inform your doctor if you are using any of the following medications:

• Other medications to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory medications (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (medications to increase potassium levels in the blood).
• Calcium or vitamin D supplements.
• Medications to lower cholesterol, such as colestipol or cholestyramine.
• Medications for diabetes (tablets or insulin).
• Medications to control heart rhythm (anti-arrhythmic 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 elimination).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medication for mental health problems).
• Corticosteroids 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.
• Cyclosporine, a medication used for organ transplants to prevent organ rejection.
• Other medications that may increase the anti-hypertensive effect, such as baclofen (a medication for relieving spasms), amifostine (used in cancer treatment), and some antipsychotic medications.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Cilexetil/Hydrochlorothiazide NORMON” and “Warnings and Precautions”)

Taking Candesartan Cilexetil/Hydrochlorothiazide NORMON with Food, Drinks, and Alcohol

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

Your doctor will generally recommend that you stop taking Candesartan Cilexetil/Hydrochlorothiazide NORMON before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medication instead of Candesartan Cilexetil/Hydrochlorothiazide NORMON. Candesartan Cilexetil/Hydrochlorothiazide NORMON is not recommended during the first trimester of pregnancy, and it must not be taken after the third month of pregnancy, as it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan Cilexetil/Hydrochlorothiazide NORMON is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Driving and Using Machines

Some patients may feel tired or dizzy when taking Candesartan Cilexetil/Hydrochlorothiazide NORMON. If this happens to you, do not drive or operate tools or machines.

3. How to Take Candesartan Cilexetil/Hydrochlorothiazide NORMON

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again. It is important that you continue taking Candesartan Cilexetil/Hydrochlorothiazide NORMON every day.

The recommended dose of Candesartan Cilexetil/Hydrochlorothiazide NORMON 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.

The score line is only to help you break the tablet if you find it difficult to swallow it whole.

If You Take More Candesartan Cilexetil/Hydrochlorothiazide NORMON Than You Should

If you take more Candesartan Cilexetil/Hydrochlorothiazide NORMON 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 medication and the amount taken.

If You Forget to Take Candesartan Cilexetil/Hydrochlorothiazide NORMON

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

If You Stop Taking Candesartan Cilexetil/Hydrochlorothiazide NORMON

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

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

4. Possible Adverse Effects

Like all medicines, Candesartan cilexetil/Hydrochlorothiazide NORMON 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 cilexetil/Hydrochlorothiazide NORMON are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan cilexetil/Hydrochlorothiazide NORMON 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).

Candesartan cilexetil/Hydrochlorothiazide NORMON 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 cilexetil/Hydrochlorothiazide NORMON is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (affecting 1 to 10 patients in 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 reduction 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 (affecting less than 1 patient in 100)

• 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 (affecting less than 1 patient in 1,000)

• Jaundice (yellowing of the skin and the 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 anxiety.
• 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.
• 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.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly ulcers in the mouth.
• Worsening of pre-existing lupus-like reactions or appearance of uncommon skin reactions.

Very Rare (affecting less than 1 patient in 10,000)

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

Unknown (frequency cannot be estimated from available data)

• Sudden myopia.
• 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)].
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Candesartan cilexetil/Hydrochlorothiazide NORMON

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 cilexetil/Hydrochlorothiazide NORMON 16 mg/12.5 mg

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 (excipients) are: mannitol (E421), cornstarch, copovidone, glycerol (E422), magnesium stearate, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the Product and Package Contents

Candesartan cilexetil/Hydrochlorothiazide NORMON 16 mg/12.5 mg are uncoated tablets, peach-colored, oval, biconvex (~ 9.5 x 4.5 mm), with a break line on one face.

Candesartan cilexetil/Hydrochlorothiazide NORMON 16 mg/12.5 mg tablets are presented in blisters of 7, 10, 14, 15, 28, 28x1 (unit doses), 30, 50, 50x1 (unit doses), 56, 56x1 (unit doses), 98, 98x1 (unit doses), 100, and 300 tablets.

Not all package sizes may be marketed in all countries.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

Delorbis Pharmaceutical Ltd.

17, Athinon Street, Ergates Industrial Area

2643 Nicosia

Cyprus

HBM Pharma s.r.o.

Sklabinská 30

0363 80 Martin

Slovak Republic

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Candesartan cilexetil/Hydrochlorothiazide NORMON 8 mg/12.5 mg tablets EFG.

Candesartan cilexetil/Hydrochlorothiazide NORMON 32 mg/12.5 mg tablets EFG.

Candesartan cilexetil/Hydrochlorothiazide NORMON 32 mg/25 mg tablets EFG.

Date of the Last Revision of this Prospectus: 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/