Candesartan Cilexetil/Hydrochlorothiazide Normon 32 mg/12.5 mg Tablets

2. What you need to know before you take 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 medicine (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 more than 3 months pregnant (it is also better to avoid Candesartan Cilexetil/Hydrochlorothiazide NORMON 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 the blood.
• if you have persistent high calcium levels in the blood.
• if you have ever had gout.
• if you have diabetes or kidney problems and are being treated with a blood pressure 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 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 been vomiting, have been vomiting 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, they 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 been allergic to penicillin or sulfonamides, you may be at higher risk of developing it.

• if you are taking any of the following medicines 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 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 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 must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this point (see section on Pregnancy).

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 have surgery, tell 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 given to children.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Taking Candesartan Cilexetil/Hydrochlorothiazide NORMON with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

In particular, tell your doctor if you are using any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Non-steroidal anti-inflammatory medicines (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 colestyramine.
• 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 certain 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).
• Steroids 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 to relieve spasms), amifostine (used in cancer treatment), and certain antipsychotic medicines.

Your doctor may need to change your dose and/or take other 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 drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking Candesartan Cilexetil/Hydrochlorothiazide NORMON before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Candesartan Cilexetil/Hydrochlorothiazide NORMON. Candesartan Cilexetil/Hydrochlorothiazide NORMON is not recommended during the first trimester of pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby when taken after this point.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan Cilexetil/Hydrochlorothiazide NORMON is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want 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 use tools or machines.

3. How to take Candesartan Cilexetil/Hydrochlorothiazide NORMON

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important that you take 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 each day. This will help you remember to take it.

The score line is only to help you break the tablet if you have difficulty swallowing it whole.

If you take more Candesartan Cilexetil/Hydrochlorothiazide NORMON than you should

If you take more Candesartan Cilexetil/Hydrochlorothiazide NORMON than your doctor has prescribed, 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, telephone: 91 562 04 20, indicating the medicine 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 without consulting your doctor.

If you have any further questions on the use of this medicine, 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 (affect 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 (affect 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 (affect less than 1 patient in 1,000)

• 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 anxiety.
• Tingling or pinching in arms and legs.
• Blurred vision for a short time.
• Abnormal heartbeats.
• Difficulty breathing (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 bruise easily.
• 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 (affect 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 whites of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.
• Acute difficulty breathing (signs 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.

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 down the drain or into the trash. 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 32 mg/12.5 mg

The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

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

Appearance of the Product and Package Contents

Candesartan cilexetil/Hydrochlorothiazide NORMON 32 mg/12.5 mg are uncoated, yellow, oval, biconvex tablets (~ 12 x 6 mm), with a break line on one face.

Candesartan cilexetil/Hydrochlorothiazide NORMON 32 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 16 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/