Candesartan cilexetil/hydrochlorothiazide Normon 16 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartan cilexetil/Hydrochlorothiazide NORMON 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Candesartan cilexetil/Hydrochlorothiazide NORMON
6. Contents of the pack and other information

1. What Candesartán cilexetilo/Hidroclorotiazida NORMON is and what it is used for

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 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 causes blood vessels to relax and widen, which helps lower blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps the body eliminate water and salts such as sodium through urine. This helps reduce 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.

2. What you need to know before taking Candesartán cilexetilo/Hidroclorotiazida NORMON

Do not take Candesartán cilexetilo/Hidroclorotiazida NORMON

• if you are allergic to candesartan cilexetil or hydrochlorothiazide 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 this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also 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 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 failure 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 Candesartán cilexetilo/Hidroclorotiazida NORMON.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán cilexetilo/Hidroclorotiazida NORMON:

• if you have diabetes.

• if you have heart, liver, or kidney problems.

• if you have recently received a kidney transplant.

• if you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.

• if you have a disorder 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 had allergies 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 eye pressure, occurring within hours to a week after taking Candesartán cilexetilo/Hidroclorotiazida. This may lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamides, you may have an increased risk of developing this condition.

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • an angiotensin-converting enzyme (ACE) inhibitor (for example 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 radiation while taking Candesartan Cilexetilo/Hydrochlorothiazide.

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

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 Candesartán cilexetilo/Hidroclorotiazida NORMON”.

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Candesartán cilexetilo/Hidroclorotiazida NORMON, seek medical attention immediately.

Inform your doctor if you are pregnant (or suspect you might be). Candesartán cilexetilo/Hidroclorotiazida NORMON 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 stage onward (see Pregnancy section).

If you are in any of these situations, your doctor may want to see you more frequently and carry out certain tests.

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

Candesartán cilexetilo/Hidroclorotiazida NORMON may increase skin sensitivity to sunlight.

Use in children

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

Use in athletes

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

Taking Candesartán cilexetilo/Hidroclorotiazida NORMON with other medicines

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

Candesartán cilexetilo/Hidroclorotiazida NORMON may affect how 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 periodically.

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

• Other blood pressure-lowering medicines, including beta-blockers, diazoxide, and angiotensin-converting enzyme (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 blood potassium levels).
• Calcium or vitamin D supplements.
• Cholesterol-lowering medicines such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
• Medicines that may be affected by blood potassium levels, such as certain antipsychotics.
• Heparin (a medicine to increase blood fluidity).
• Diuretics (medicines to promote urine elimination).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (used to treat fungal infections).
• Lithium (a medicine for mental health disorders).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (used to treat Parkinson’s disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (used to treat esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for muscle spasm relief), amifostine (used in cancer treatment), and certain antipsychotics.

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

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartán cilexetilo/Hidroclorotiazida NORMON” and “Warnings and precautions”)

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

• You may take Candesartán cilexetilo/Hidroclorotiazida NORMON with or without food.
• When prescribed Candesartán cilexetilo/Hidroclorotiazida NORMON, consult your doctor before consuming alcohol. Alcohol may cause dizziness or fainting.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Your doctor will usually advise you to stop taking Candesartán cilexetilo/Hidroclorotiazida NORMON before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán cilexetilo/Hidroclorotiazida NORMON 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 from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartán cilexetilo/Hidroclorotiazida NORMON is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Driving and using 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 machinery.

3. How to take Candesartan cilexetil/Hydrochlorothiazide NORMON

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 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.

The score line is only intended for splitting 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, contact your doctor or pharmacist immediately 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 Candesartan cilexetil/Hydrochlorothiazide NORMON

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

If you stop taking Candesartan cilexetil/Hydrochlorothiazide NORMON

If you stop taking Candesartan cilexetil/Hydrochlorothiazide NORMON, your blood pressure may rise again. Therefore, do not stop taking Candesartan cilexetil/Hydrochlorothiazide NORMON without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Candesartán cilexetilo/Hidroclorotiazida NORMON can produce adverse effects, although not everyone experiences them. It is important that you are aware of the possible adverse effects. Some of the adverse effects of Candesartán cilexetilo/Hidroclorotiazida NORMON are due to candesartan cilexetil, while others are due to hydrochlorothiazide.

Stop taking Candesartán cilexetilo/Hidroclorotiazida NORMON 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 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 periodically perform blood tests to check whether Candesartán cilexetilo/Hidroclorotiazida NORMON is affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (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 have muscle cramps.

• An increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling sensations.

• An increase in blood cholesterol, glucose, or uric acid levels.

• Presence of glucose in urine.

• Feeling dizzy or weak.

• Headache.

• Respiratory infection.

Uncommon (affects less than 1 patient in 100)

• 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 patient in 1,000)

• 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 prickling sensations in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Breathing difficulties (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 developing rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus-like reactions or appearance of uncommon skin reactions.

Very rare (affects 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 whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Not known (frequency cannot be estimated from available data)

• Sudden myopia.
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or (acute angle-closure glaucoma)].
• Diarrhoea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

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

5. Storage 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 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. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán cilexetilo/Hidroclorotiazida NORMON 16 mg/12.5 mg

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

Appearance of the medicine and contents of the pack

Candesartán cilexetilo/Hidroclorotiazida 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 side.

Candesartán cilexetilo/Hidroclorotiazida NORMON 16 mg/12.5 mg tablets are available in blisters of 7, 10, 14, 15, 28, 28x1 (unit dose), 30, 50, 50x1 (unit dose), 56, 56x1 (unit dose), 98, 98x1 (unit dose), 100 and 300 tablets.

Not all pack 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.l.
Sklabinská 30
0363 80 Martin
Slovak Republic

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 EFG.

Candesartán cilexetilo/Hidroclorotiazida NORMON 32 mg/12.5 mg tablets EFG.

Candesartán cilexetilo/Hidroclorotiazida NORMON 32 mg/25 mg tablets EFG.

Date of the most recent review of this leaflet: February 2025

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