Package Insert: Information for the Patient

Candesartán cilexetilo/Hidroclorotiazida NORMON 32 mg/25 mg Tablets EFG

Candesartán cilexetilo/Hidroclorotiazida

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Your medicine is called Candesartán cilexetilo/Hidroclorotiazida NORMON. It is used for the treatment of high blood pressure (hypertension) in adult patients. 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 cilexetilo/Hidroclorotiazida NORMON if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

Do not take Candesartán cilexetilo/Hidroclorotiazida NORMON

• if you are allergic to candesartán cilexetilo or to hidroclorotiazida or to any of the other ingredients of this medicine (listed in 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 best to avoid Candesartán cilexetilo/Hidroclorotiazida NORMON during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of 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 medicine that contains aliskirén.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán cilexetilo/Hidroclorotiazida 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 had it frequently recently or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism).
• if you have ever had a condition called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have had an allergy or asthma.
• if you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking Candesartán cilexetilo/Hidrocloritiazida. This can lead to permanent loss of vision 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 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.
  • Aliskirén
  • if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its 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 exposure to the sun and UV rays while taking Candesartan Cilexetilo/Hidroclorotiazida.

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

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 takeCandesartán cilexetilo/Hidroclorotiazida NORMON”.

• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Candesartán cilexetilo/Hidroclorotiazida NORMON, see your doctor immediately.

Inform your doctor if you are pregnant (or if you suspect you may be), do not use Candesartán cilexetilo/Hidroclorotiazida NORMON at the beginning 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 in any of these situations, your doctor may want to see you more frequently and perform some tests.

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

Candesartán cilexetilo/Hidroclorotiazida NORMON may increase your skin's sensitivity to the sun.

Use in children

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

Use in athletes

This medicine contains hidroclorotiazida which may produce a positive result in doping control tests.

Taking Candesartán cilexetilo/Hidroclorotiazida NORMON with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Candesartán cilexetilo/Hidroclorotiazida NORMON may affect the way some medicines work and some medicines may influence the effect of Candesartán cilexetilo/Hidroclorotiazida NORMON. If you are taking certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are taking any of the following medicines:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide and the so-called ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Anti-inflammatory non-steroidal 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) (medicines to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to reduce cholesterol, such as colestipol or colestiramine.
• 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 promote urine excretion).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Cancer medicines.
• Amantadine (for the treatment of Parkinson's disease or for 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 medicine used for organ transplants, to prevent organ rejection.
• Other medicines that may increase the anti-hypertensive effect such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment) and some antipsychotic medicines.

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

- If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not takeCandesartán cilexetilo/Hidroclorotiazida NORMON” and “Warnings and precautions”)

Taking Candesartán cilexetilo/Hidroclorotiazida NORMON with food, drinks and alcohol

• You can take Candesartán cilexetilo/Hidroclorotiazida NORMON with or without food.
• When you are prescribed Candesartán cilexetilo/Hidroclorotiazida NORMON, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be, consult your doctor before using this medicine.

Pregnancy

Your doctor will usually recommend that you stop taking Candesartán cilexetilo/Hidroclorotiazida NORMON before becoming pregnant or as soon as you know you are pregnant, and recommend taking another medicine instead of Candesartán cilexetilo/Hidroclorotiazida NORMON. It is not recommended to use Candesartán cilexetilo/Hidroclorotiazida NORMON at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy 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. It is not recommended to use Candesartán cilexetilo/Hidroclorotiazida NORMON during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is essential that you continue to take Candesartán cilexetilo/Hidroclorotiazida NORMON every day.

The recommended dose of Candesartán cilexetilo/Hidroclorotiazida 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 groove is only for breaking the tablet if it is difficult for you to swallow it whole.

If you take more Candesartán cilexetilo/Hidroclorotiazida NORMON than you should

If you take more Candesartán cilexetilo/Hidroclorotiazida 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Candesartán cilexetilo/Hidroclorotiazida NORMON

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

If you interrupt treatment with Candesartán cilexetilo/Hidroclorotiazida NORMON

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

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

Like all medications, Candesartán cilexetilo/Hidroclorotiazida NORMON 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 cilexetilo/Hidroclorotiazida NORMON are due to candesartán cilexetilo and others are due to hidroclorotiazida.

Stop taking Candesartán cilexetilo/Hidroclorotiazida NORMON and 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 cilexetilo/Hidroclorotiazida 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 occurs, inform your doctor. Your doctor may perform blood tests from time to time to check if Candesartán cilexetilo/Hidroclorotiazida NORMON is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affecting 1 to 10 patients in 100)

• Changes in blood test results:

• A decrease 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 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.

Rare (affecting less than 1 patient in 100)

• 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.

Very rare (affecting less than 1 patient in 1,000)

• Jaundice (yellowing of the skin and white of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or pinching 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 (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 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.

Unknown (frequency cannot be estimated from available data)

• Sudden nearsightedness.
• 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)].
• Diarrea
• Skin and lip cancer (non-melanoma skin cancer).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 the 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 cilexetilo/Hidroclorotiazida NORMON 32 mg/25 mg

The active principles are candesartán cilexetilo and hidroclorotiazida. Each tablet contains 32 mg of candesartán cilexetilo and 25 mg of hidroclorotiazida.

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 content of the packaging

Candesartán cilexetilo/Hidroclorotiazida NORMON 32 mg/25 mg are non-coated tablets, orange in color, oval, biconvex (~ 12 x 6 mm), with a breaking bar on one face, printed with the letters “C” and “H”.

Candesartán cilexetilo/Hidroclorotiazida NORMON 32 mg/25 mg tablets are presented in blister packs 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 packaging sizes may be marketed in all countries.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Responsible for Manufacturing

Delorbis Pharmaceutical Ltd.

17, Athinon Street, Ergates Industrial Area

2643 Nicosia

Cyprus

HBM Pharma s.r.i

Sklabinská 30

0363 80 Martin

Republic of Slovakia

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Candesartán cilexetilo/Hidroclorotiazida NORMON 8 mg/12.5 mg tablets

Candesartán cilexetilo/Hidroclorotiazida NORMON 16 mg/12.5 mg tablets

Candesartán cilexetilo/Hidroclorotiazida NORMON 32 mg/12.5 mg tablets

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/