Candesartan/Hydrochlorothiazide Stada 16/12.5 mg Tablets

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

DO NOT take Candesartan/Hydrochlorothiazide Stada if:

• you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medication (listed in section 6).

• you are allergic to sulfonamides. If you are not sure if it affects you, consult your doctor.
• you are pregnant for more than 3 months (it is also best to avoid candesartan/hydrochlorothiazide at the start of pregnancy - see section Pregnancy).
• you have severe kidney problems.
• you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• you have severe liver disease or biliary obstruction (a problem with the bile outlet from the gallbladder).
• you have persistently low potassium levels in the blood.

• you have persistently high calcium levels in the blood.

• you have ever had gout.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Candesartan/Hydrochlorothiazide Stada if:

• you have diabetes.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you have vomited, have vomited frequently recently, or have diarrhea.
• you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• you have ever had a disease called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have had asthma or an allergy.
• tell your doctor if you are pregnant (or if you think you might be). Candesartan/hydrochlorothiazide is not recommended at the start of pregnancy, and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril, etc.), especially if you have kidney problems related to diabetes.
• aliskiren

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/Hydrochlorothiazide 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 going to undergo surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with some anesthetics, can cause a marked decrease in blood pressure.

Candesartan/hydrochlorothiazide may cause increased skin sensitivity to the sun.

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

Children and adolescents

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

Use in athletes

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

Other medications and Candesartan/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication. Candesartan/hydrochlorothiazide may affect how some medications work and some medications may affect candesartan/hydrochlorothiazide. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

In particular, tell your doctor if you are using any of the following medications, as your doctor may need to modify your dose and/or take other precautions:

• Other medications to lower your blood pressure, including beta-blockers, medications that contain aliskiren, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril (see also the information under the headings "DO NOT take Candesartan/Hydrochlorothiazide Stada if" and "Warnings and precautions").

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

• Potassium supplements or salt substitutes that contain potassium (medications that increase the amount of potassium 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 (antiarrhythmic 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).
• Diuretic tablets.
• Laxatives.
• Penicillin or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (antibiotic medications).
• 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 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.
• Cyclosporine, a medication used in organ transplantation to prevent rejection.
• Other medications that may enhance the antihypertensive effect, such as baclofen (a medication for relief of spasms), amifostine (used in cancer treatment), and some antipsychotic medications.

Taking Candesartan/Hydrochlorothiazide Stada with food, drinks, and alcohol

• You can take candesartan/hydrochlorothiazide with or without food.

• When you are prescribed candesartan/hydrochlorothiazide, consult your doctor before taking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy and breastfeeding

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

Pregnancy

Tell your doctor if you are pregnant (or if you think you might be). Your doctor will generally advise you to stop taking candesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of candesartan/hydrochlorothiazide. Candesartan/hydrochlorothiazide is not recommended at the start of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Some people may feel tired or dizzy when taking candesartan/hydrochlorothiazide. If this happens to you, do not drive or operate tools or machines.

Candesartan/Hydrochlorothiazide 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 medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Candesartan/Hydrochlorothiazide Stada

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

It is important that you continue to take candesartan/hydrochlorothiazide every day.

The recommended dose of candesartan/hydrochlorothiazide 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.

If you take more Candesartan/Hydrochlorothiazide Stada than you should

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

If you forget to take Candesartan/Hydrochlorothiazide Stada

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

If you stop taking Candesartan/Hydrochlorothiazide Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine 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/hydrochlorothiazide are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Stada 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/hydrochlorothiazide 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 happens, inform your doctor. Your doctor may perform blood tests from time to time to check if candesartan/hydrochlorothiazide has had any effect on your blood (agranulocytosis).

Stop taking candesartan/hydrochlorothiazide and go to the doctor immediately if you notice the following adverse 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 adverse effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:

• A reduction in the amount of sodium in the blood. If severe, you may notice weakness, lack of energy, or have muscle cramps.

• An increase or reduction in the amount of potassium in the blood, especially if you already have kidney problems or heart failure. In severe cases, you may notice fatigue, weakness, irregular heartbeats, or tingling.

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

Infrequent (may affect up to 1 in 100 people)

• Low blood pressure. This can make you feel weak or dizzy.
• Lack of appetite, diarrhea, constipation, and stomach irritation.
• Skin rash, hives, skin rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and the whites of the eyes). If this happens, contact your doctor immediately.
• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, restlessness.
• Tingling or itching in arms or legs.
• Temporary blurred vision.
• Abnormal heartbeats.
• Breathing difficulties (including inflammation of the lungs 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 notice fatigue, or have an infection, fever, or an increased tendency to bruise.
• Severe skin reaction that develops rapidly, causing blisters or peeling of the skin and possibly ulcers in the mouth.

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 liver inflammation (hepatitis). You may notice fatigue, yellowing of the skin and the whites of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (frequency cannot be estimated from the 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)
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps).
• Diarrhea
• 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 that is not listed in this prospectus. You can also report them 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/Hydrochlorothiazide Stada

• Keep this medicine out of sight and reach of children.

• Do not store above 25°C.
• Do not use this medicine after the expiration date that appears on the packaging or on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. 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/Hydrochlorothiazide STADA

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 are: Lactose monohydrate, Corn starch, Hydroxypropylcellulose, Croscarmellose sodium, Magnesium stearate, and Triethyl citrate.

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide STADA are white, biconvex tablets with a notch on one side and marked with CH16 on the same side. The notch serves to fractionate and facilitate swallowing but not to divide into equal doses.

Presentation:

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer:

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

O

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

O

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

O

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

O

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate, Hal Far

BBG3000

Malta

O

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co. Tipperary

Ireland

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/