Candesartan/hydrochlorothiazide Forte Stada 32 mg/25 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Candesartan/Hydrochlorothiazide Forte Stada 32 mg / 25 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, because it may harm them.

• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Candesartan/Hydrochlorothiazide Forte Stada is and what it is used for

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

3. How to take Candesartan/Hydrochlorothiazide Forte Stada

4. Possible side effects

5. How to store Candesartan/Hydrochlorothiazide Forte Stada

6. Contents of the pack and other information

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

Your medicine is called candesartán/hidroclorotiazida. 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 known as 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 promotes the elimination of water and salts, such as sodium, through the urine. This helps reduce 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 taking Candesartán/Hidroclorotiazida Forte Stada Genéricos

DO NOT take Candesartán/Hidroclorotiazida Forte Stada Genéricos:

• • if you are allergic to candesartán cilexetil or hydrochlorothiazide or 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 advisable to avoid candesartán/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 situations apply to you, consult your doctor or pharmacist before taking candesartán/hydrochlorothiazide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán/Hidroclorotiazida Forte Stada Genéricos:

• 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 pregnant). Use of candesartán/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 stage 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 a class of drugs known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see "Taking Candesartán/Hidroclorotiazida Forte Stada Genéricos 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 candesartán/hydrochlorothiazide.
  • 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 weeks after taking candesartán/hydrochlorothiazida. 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 Candesartán/Hidroclorotiazida Forte Stada Genéricos”.

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

Candesartán/hydrochlorothiazide may increase skin sensitivity to sunlight.

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

Children

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

Other medicines and Candesartán/Hidroclorotiazida Forte Stada Genéricos

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

Candesartán/hydrochlorothiazide may affect how some medicines work, and some medicines may influence the effect of candesartán/hydrochlorothiazida. 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 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 blood).

• Calcium supplements or vitamin D.

• 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 antipsychotic medicines.

• Heparin (a medicine to increase blood fluidity).

• Medicines that promote urine elimination (diuretics).

• Laxatives.

• Penicillin (an antibiotic).

• Amphotericin (for treatment of fungal infections).

• Lithium (a medicine for mental health disorders).

• Steroids such as prednisolone.

• Pituitary hormone (ACTH).

• Medicines for cancer treatment.

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

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

• Carbenoxolone (for treatment of 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 certain 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 Candesartán/Hidroclorotiazida Forte Stada Genéricos” and “Warnings and precautions”).
• If you are being treated with an ACEI together with specific medicines for heart failure known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone).

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

• You may take candesartán/hydrochlorothiazide with or without food.
• Consult your doctor before drinking alcohol while taking candesartán/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 candesartán/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of candesartán/hydrochlorothiazide is not recommended during early pregnancy, and it 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. Use of candesartán/hydrochlorothiazida during breastfeeding is not recommended; your doctor will choose an alternative treatment if you intend to breastfeed.

Driving and using machines

Some patients may feel tired or dizzy when taking candesartán/hydrochlorothiazida. If this happens to you, do not drive or operate tools or machinery.

3. How to take Candesartán/Hidroclorotiazida Forte Stada

Follow exactly the instructions for use of this medicine as 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 tablet may be divided into equal doses.

If you take more Candesartán/Hidroclorotiazida Forte 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 Forte 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 Forte 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 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 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 lumps).

Candesartan/hydrochlorothiazide may reduce white blood cells. This may lower your resistance to infections, and you may feel tired, have an infection or fever. If this occurs, inform your doctor. Your doctor may carry out blood tests from time to time to check 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 reduction in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may experience tiredness, weakness, irregular heartbeat, 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, diarrhoea, 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 prickling sensations in arms or legs.
• Blurred vision for a short period of time.
• Irregular 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 infections, 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 diarrhoea.

Not known (frequency cannot be estimated from available data)

• Sudden onset of myopia.
• Decreased vision or eye pain due to increased 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 adverse effect, talk to 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 Forte 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and 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 Candesartan/Hydrochlorothiazide Forte Stada Generics

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other components are mannitol (E421), corn starch, copovidone, glycerol, magnesium stearate, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the pack

Candesartan/Hydrochlorothiazide Forte Stada Generics 32 mg/25 mg tablets are peach-coloured, oval, biconvex (~12 x 6 mm), uncoated tablets with a score line on one side and the letters “C” and “H” engraved on it.

Candesartan/Hydrochlorothiazide Forte Stada Generics 32 mg/25 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

STADA Generics, 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 FARMACEUTICA, 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 the EEA Member States under the following names:

Portugal: Candesartan + Hidroclorotiazida Ciclum

Austria: Candesartan/HCT STADA GmbH 32 mg/25 mg Tabletten

Spain: Candesartán /Hidroclorotiazida Forte STADA Genéricos 32 mg/25 mg comprimidos EFG

Italy: Candesartan e Idroclorotiazide EG STADA 32 mg/25 mg compresse

Sweden: Candesartan/Hydrochlorothiazide STADA 32 mg/25 mg tabletter

Date of the most recent revision 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/