Candesartan/hydrochlorothiazide Stada 32 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Candesartán/Hidroclorotiazida Stada 32 mg / 12.5 mg tablets EFG

Candesartan cilexetil/Hydrochlorothiazide

Read all of this 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, ask 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, since 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.

Contents of the leaflet

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

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

3. How to take Candesartán/Hidroclorotiazida Stada

4. Possible side effects

5. How to store Candesartán/Hidroclorotiazida Stada

6. Contents of the pack and other information

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

Your medicine is called candesartán/hidroclorotiazida. It is used to treat 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 reduce blood pressure.

• Hidroclorotiazida belongs to a group of medicines called diuretics. It increases the removal of water and salts, such as sodium, through the urine. This helps lower blood pressure.

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

2. What you need to know before starting to take Candesartan/Hydrochlorothiazide Stada Generics

DO NOT take Candesartan/Hydrochlorothiazide Stada Generics:

• • 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, please consult your doctor.

• if you are more than 3 months pregnant (it is also best to avoid candesartan/hydrochlorothiazide during the first months of pregnancy – see Pregnancy section).

• if you have severe kidney disease.

• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

• if you have severe liver disease or biliary obstruction (a problem with bile drainage from 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 are unsure whether any of these apply to you, consult your doctor or pharmacist before taking candesartan/hydrochlorothiazide.

Warnings and precautions

Talk to your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Stada Generics:

• 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 recently had severe vomiting, 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 condition called systemic lupus erythematosus (SLE).

• if you have low blood pressure.

• if you have ever had a stroke.

• if you have ever had allergies or asthma.

• you must inform your doctor if you are pregnant (or suspect you might be). Candesartan/hydrochlorothiazide 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 point onward (see Pregnancy section).

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

• an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren

  • if you are taking an ACEI together with a medicine belonging to the class known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see "Taking Candesartan/Hydrochlorothiazide Stada Generics with other medicines").
  • if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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/hydrochlorothiazide.
  • if you experience vision changes 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 weeks after taking candesartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

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 Candesartan/Hydrochlorothiazide Stada Generics”.

If you are undergoing surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with certain anesthetics, may cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may increase your skin's sensitivity to sunlight.

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

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

Other medicines and Candesartan/Hydrochlorothiazide Stada Generics

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

Candesartan/hydrochlorothiazide may affect how some medicines work, and some medicines may influence the effect of candesartan/hydrochlorothiazide. 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 medicines to lower your blood pressure, 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 to relieve pain and inflammation).

• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine 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 lower cholesterol, 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 some antipsychotics.

• Heparin (a medicine to increase blood fluidity).

• Medicines that promote urine elimination (diuretics).

• Laxatives.

• Penicillin (an antibiotic).

• Amphotericin (for treating fungal infections).

• Lithium (a medicine for mental health conditions).

• Steroids such as prednisolone.

• Pituitary hormone (ACTH).

• Medicines for cancer treatment.

• Amantadine (for treating Parkinson’s disease or serious viral infections).

• Barbiturates (a type of sedative, also used to treat epilepsy).

• Carbenoxolone (for treating esophageal disease or oral ulcers).

• Anticholinergic agents such as atropine and biperidene.

• Cyclosporine, a medicine used in organ transplants to prevent rejection.

• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment), and some antipsychotics.

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also information under the headings “DO NOT take Candesartan/Hydrochlorothiazide Stada Generics” and “Warnings and precautions”).
• If you are being treated with an ACEI together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone).

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

• You may take candesartan/hydrochlorothiazide with or without food.
• Consult your doctor before drinking alcohol while taking candesartan/hydrochlorothiazide. Alcohol may 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 medicine.

Pregnancy

Your doctor will usually advise you to stop taking candesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby from that stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of candesartan/hydrochlorothiazide during breastfeeding is not recommended; your doctor will choose an alternative treatment if you wish to breastfeed.

Driving and use of machines

Some patients may feel tired or dizzy while taking candesartan/hydrochlorothiazide. If this happens to you, do not drive or operate tools or machinery.

3. How to take Candesartán/Hidroclorotiazida Stada

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking candesartán/hidroclorotiazida every day.

The recommended dose 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 mark is intended only for breaking the tablet if you have difficulty swallowing it whole.

If you take more Candesartán/Hidroclorotiazida Stada than you should

If you have taken more candesartán/hidroclorotiazida than prescribed by your doctor, contact your doctor or pharmacist immediately.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartán/Hidroclorotiazida Stada

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

If you stop taking Candesartán/Hidroclorotiazida Stada

If you stop taking candesartán/hidroclorotiazida, your blood pressure may rise again. Therefore, do not stop taking candesartán/hidroclorotiazida 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, this medicine can cause adverse effects, although not everyone will experience them. It is important that you are aware of the possible adverse effects. Some of the adverse effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil, while others are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide 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 raised bumps).

Candesartan/hydrochlorothiazide may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to ensure that candesartan/hydrochlorothiazide is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Frequent (may affect up to 1 in 10 people)

• 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 feel tired, weak, have irregular heartbeats, or tingling sensations.
  • An increase in blood levels of cholesterol, glucose, or uric acid.
• Presence of glucose in urine.
• Dizziness or weakness.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may make you feel weak or dizzy.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives (urticaria), skin reaction caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or whites 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.
• Tingling or pins and needles in arms or legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• 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.
• A severe skin reaction, developing rapidly, causing blisters or skin peeling, and possibly mouth ulcers.
• Worsening of existing lupus erythematosus-type reactions or appearance of unusual skin reactions.

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

• Swelling of the face, lips, tongue, and/or throat.
• Itching.
• Back, joint, and muscle pain.
• Changes in liver function, including inflammation (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Not known (frequency cannot be estimated from available data)

• Sudden onset of 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.
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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/Hydrochlorothiazide Stada

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and blister 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán/Hydrochlorothiazide Stada Genéricos

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are mannitol (E421), corn starch, copovidone, glycerol, magnesium stearate and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Candesartán/Hydrochlorothiazide Stada Genéricos 32 mg/12.5 mg tablets are yellow, oval-shaped, biconvex (~12 x 6 mm), uncoated tablets with a score line on one side.

Candesartán/Hydrochlorothiazide Stada Genéricos 32 mg/12.5 mg tablets are available in blister packs containing 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.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

STADA Genéricos, S.L.
Frederic Mompou, 5
08960 - Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer:

STADA ARZNEIMITTEL AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

OR

IBERFAR INDUSTRIA FARMACÊUTICA, S.A.
Consigliery Pedroso, 121-123 Queluz de Baixo
2745-557 Barcarena
Portugal

OR

PHARMACEUTICAL WORKS POLPHARMA S.A.
Business Unit Chemicals, 19 Pelplinska street
83-200 Starogard Gdanski
Poland

OR

HBM PHARMA S.R.O.
Sklabinská 30
03680 Martin
Slovakia

OR

DELORBIS PHARMACEUTICALS LTD
17 Athinon Str., Ergates Industrial Area
2643 Ergates, Lefkosia
Cyprus

OR

STADA ARZNEIMITTEL GMBH
Muthgasse 36
A-1190 Vienna
Austria

This medicinal product is authorized in EEA Member States under the following names:

Portugal: Candesartan + Hydrochlorothiazide Ciclum
Austria: Candesartan/HCT STADA GmbH 32 mg/12.5 mg Tabletten
Bulgaria: Repido Plus (32mg/12.5mg tablets)
Spain: Candesartán /Hydrochlorothiazide STADA Genéricos 32 mg / 12.5 mg tablets EFG
Italy: Candesartan e Idroclorotiazide EG STADA 32 mg/12.5 mg compresse
Sweden: Candesartan/Hydrochlorothiazide STADA 32 mg/12.5 mg tabletter

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/