Prospect:Information for the User

Candesartán/Hidroclorotiazida STADA 16 mg/12,5 mg Tablets EFG

candesartán cilexetilo/hidroclorotiazida

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 prospect. See section 4.

1. What you need to know before taking Candesartán/Hidroclorotiazida Stada
2. How to take Candesartán/Hidroclorotiazida Stada
3. Possible adverse effects
4. Storage of Candesartán/Hidroclorotiazida Stada

6.Contents of the pack and additional information

Your medicine is called Candesartán/Hidroclorotiazida Stada. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartán cilexetilo and hidroclorotiazida. These 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 helps to lower blood pressure.

Hidroclorotiazida belongs to a group of medicines called diuretics (tablets to make you urinate). It helps the body to get rid of water and salt, such as sodium, in the urine. This helps to lower blood pressure.

Your doctor may prescribe candesartán/hidroclorotiazida if your blood pressure has not been controlled adequately with candesartán cilexetilo or hidroclorotiazida alone.

Do not take Candesartán/Hidroclorotiazida Stada if:

• You are allergic to candesartán cilexetilo or to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).

• You are allergic to sulfonamides. If you are unsure, consult your doctor.
• You are more than 3 months pregnant (it is also best to avoid candesartán/hidroclorotiazida at the beginning of pregnancy - see Pregnancy section).
• You have severe kidney problems.
• You have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskirén.
• You have severe liver disease or biliary obstruction (a problem with the bile flowing out of the gallbladder).
• You have persistent low levels of potassium in your blood.

• You have persistent high levels of calcium in your blood.

• You have ever had gout.

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking candesartán/hidroclorotiazida.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Candesartán/Hidroclorotiazida Stada if:

• You have diabetes.
• You have heart, liver, or kidney problems.
• You have recently had a kidney transplant.
• You have frequent vomiting, have had it recently, or have diarrhea.
• You have a condition called Conn's syndrome (also known as primary aldosteronism).
• You have ever had a condition called systemic lupus erythematosus (SLE).
• You have low blood pressure.
• You have ever had a stroke.
• You have asthma or allergies.
• Inform your doctor if you are pregnant (or if you suspect you may be). Candesartán/hidroclorotiazida is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An ACE inhibitor (such as enalapril, lisinopril, ramipril, etc.), particularly if you have kidney problems related to diabetes.
• Aliskirén

• If you have ever had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking candesartán/hidroclorotiazida.
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and may occur within a few hours to several weeks after taking candesartán/hidroclorotiazida. This may lead to permanent vision loss if not treated. You may be at higher risk of developing this if you have previously had an allergy to penicillin or sulfonamides.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking candesartán/hidroclorotiazida, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán/Hidroclorotiazida Stada if”.

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

If you are undergoing surgery, inform your doctor or dentist that you are taking candesartán/hidroclorotiazida. This is because candesartán/hidroclorotiazida, in combination with some anesthetics, may cause excessive lowering of blood pressure.

Candesartán/hidroclorotiazida may cause increased sensitivity of the skin to the sun.

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

Children and adolescents

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

Use in athletes

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

Other medicines and Candesartán/Hidroclorotiazida Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Candesartán/hidroclorotiazida may affect the way some medicines work, and some medicines may affect candesartán/hidroclorotiazida. If you are using certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medicines, as your doctor may need to modify your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, medicines containing aliskirén, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril (see also the information under the headings “Do not take Candesartán/Hidroclorotiazida Stada if” and “Warnings and precautions”).

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid (if you are taking more than 3 g per day) (medicines to relieve pain and inflammation).

• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood).
• Calcium supplements or vitamin D.
• Medicines to lower 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 that promote urine excretion).
• Laxatives.
• Penicillin or trimethoprim/sulfamethoxazole (antibiotic medicines).
• Ampicillin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems),
• Prednisolone (a steroid).
• 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 diseases or mouth ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, a medicine used in organ transplantation to prevent rejection.
• Other medicines that may intensify the antihypertensive effect, such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.

Taking Candesartán/Hidroclorotiazida Stada with food, drinks, and alcohol

• You can take candesartán/hidroclorotiazida with or without food.

• When you are prescribed candesartán/hidroclorotiazida, consult your doctor before taking alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually advise you to stop taking candesartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of candesartán/hidroclorotiazida. Candesartán/hidroclorotiazida is not recommended at the beginning of pregnancy, and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Candesartán/hidroclorotiazida is not recommended in breastfeeding mothers, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machines

Some people may feel tired or dizzy when taking candesartán/hidroclorotiazida. If this happens, do not drive or operate tools or machines.

Candesartán/Hidroclorotiazida Stada contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

It is essential to continue taking candesartán/hidroclorotiazida every day.

The recommended dose of candesartán/hidroclorotiazida 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.

If you take more Candesartán/Hidroclorotiazida Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount taken.

If you forgot to take Candesartán/Hidroclorotiazida Stada

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

If you interrupt treatment with Candesartán/Hidroclorotiazida Stada

If you stop taking candesartán/hidroclorotiazida, your blood pressure may increase again. Therefore, do not stop taking candesartán/hidroclorotiazida before consulting your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is important that you know which side effects could occur. Some side effects of candesartán/hidroclorotiazida are due to candesartán cilexetilo and others are due to hidroclorotiazida.

Stop taking Candesartán/Hidroclorotiazida Stada and go to your 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 may cause difficulty swallowing.
• Severe skin itching (with skin rash).

Candesartán/hidroclorotiazida may cause a decrease in the number of white blood cells. Your resistance to infections may be reduced and you may notice fatigue, an infection, or fever. If this occurs, inform your doctor. It is possible that your doctor will perform blood tests from time to time to check if candesartán/hidroclorotiazida has had any effect on your blood (agranulocytosis).

Stop taking candesartán/hidroclorotiazida and go to your doctor immediately if you notice the following side effect:

Very rare(may affect up to 1 in 10,000 people):

• Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion)

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:

• • An increase in the amount of cholesterol, sugar, or uric acid in the blood.
• Sugar in the urine.
• Sensation of dizziness/dizziness or weakness.
• Headache.
• Respiratory infection.

Rare (may affect up to 1 in 100 people)

• Low blood pressure. This may make you feel weak or dizzy.
• Loss of appetite, diarrhea, constipation, and stomach irritation.
• Skin rash, hives, light-sensitive skin rash.

Rare (may affect up to 1 in 1,000 people)

• Jaundice (yellowing of the skin and the 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, restlessness.
• Itching or prickling in the arms or legs.
• Temporary blurred vision.
• Abnormal heartbeats.
• Difficulty breathing (including inflammation of the lungs 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.
• A decrease in red blood cells, white blood cells, or platelets. You may notice fatigue, or have an infection, fever, or an increased tendency to bruise.
• Severe skin reaction that develops quickly, causing blisters or skin peeling and possibly mouth ulcers.

Very rare (may affect up to 1 in 10,000 people)

• 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 notice fatigue, yellowing of the skin and the white of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.
• Angioedema intestinal: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (the frequency cannot be estimated from the available data)

• Sudden myopia
• Decreased vision or eye pain due to high pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• SLE and cutaneous lupus (allergic condition that causes fever, joint pain, skin eruptions that may include redness, blisters, exfoliation, and nodules).
• Diarrhea
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of 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 through the Spanish System for the 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 medicine.

• Keep this medication out of the sight and reach of children.

• Do not store at a temperature above 25°C.
• Do not use this medication after the expiration date that appears on the packaging or in the blister pack 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. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Candesartán/ Hidroclorotiazida STADA

The active principles are candesartán cilexetilo and hidroclorotiazida. Each tablet contains 16 mg of Candesartán cilexetilo and 12.5 mg of Hidroclorotiazida.

The other components are: Lactose monohydrate, Cornstarch, Hydroxypropylcellulose, Sodium croscarmellose, Magnesium stearate, and Triethyl citrate.

Appearance of the product and contents of the package

Candesartán/ Hidroclorotiazida STADA are white, biconvex tablets, with a notch on one of the faces and marked with CH16 on the same face. The notch serves to fracture and facilitate swallowing but not to divide into equal doses.

Presentation:

Packages of 7, 7x1 (single-dose), 10, 10x1 (single-dose), 14, 14x1 (single-dose), 28, 28x1 (single-dose), 30, 30x1 (single-dose), 50, 50x1 (single-dose), 56, 56x1 (single-dose), 90, 90x1 (single-dose), 98, 98x1 (single-dose), 100, 100x1 (single-dose), 112, 112x1 (single-dose), 126, 126x1 (single-dose), 140, 140x1 (single-dose), 154, 154x1 (single-dose), 168, 168x1 (single-dose), 182, 182x1 (single-dose), 196, 196x1 (single-dose) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing:

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

Or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

Or

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

Or

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate, Hal Far

BBG3000

Malta

Or

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co.Tipperary

Ireland

Last review date of this prospectus:February 2025

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