Prospect: Information for the User

Candesartán/Hidroclorotiazida Forte Stada Generics 32 mg / 25 mg Tablets EFG

Candesartán cilexetilo/Hidroclorotiazida

Read this prospect carefully before starting to take this medicine, as 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. How to take Candesartán/Hidroclorotiazida Forte Stada Generics
2. Possible adverse effects

1. Storage of Candesartán/Hidroclorotiazida Forte Stada Generics

1. Contents of the package and additional information

Your medicine is called candesartán/hidroclorotiazida. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active ingredients: 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 makes blood vessels relax and dilate. This facilitates the lowering of blood pressure.

• Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes the elimination of water and salts, such as sodium, in urine. This facilitates the lowering of blood pressure.

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

Do not take Candesartán/Hidroclorotiazida Forte Stada Genéricos:

• • if you are allergic to candesartán cilexetilo or to 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 you are in this situation, please consult your doctor.
• if you are more than 3 months pregnant (it is best to avoid candesartán/hidroclorotiazida during the first months of pregnancy – see Pregnancy section).
• if you have severe kidney disease.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medication that contains aliskirén.

• if you have a severe liver disease or biliary obstruction (a problem with the drainage of bile from the gallbladder).
• if you have persistent low levels of potassium in the blood.
• if you have persistent high levels of calcium in the blood.
• if 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 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 had a kidney transplant.
• if you have vomiting, have recently had intense vomiting, or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism).
• 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 an allergy or asthma.
• You must inform your doctor if you are pregnant (or if you suspect you may be), as candesartán/hidroclorotiazida is not recommended for use 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 when administered from that point onwards (see Pregnancy section).
• if you are taking any of the following blood pressure lowering medications:

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

-aliskirén

• if you are taking an ACE inhibitor together with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Taking Candesartán/Hidroclorotiazida Forte Stada Genéricos with other medicines").
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its 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, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, which can occur within a few hours to several weeks after taking candesartán/hidroclorotiazida. This can 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.

Your doctor may monitor your kidney function, blood pressure, and 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 to undergo surgery, inform your doctor or dentist that you are taking candesartán/hidroclorotiazida. This is because candesartán/hidroclorotiazida, in combination with some anesthetics, can cause a drop in blood pressure.

Candesartán/hidroclorotiazida may increase your skin's sensitivity to the sun.

Children

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

Other medicines and Candesartán/Hidroclorotiazida Forte Stada Genéricos

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

Candesartán/hidroclorotiazida may affect how some medicines work, and some medicines may influence the effect of candesartán/hidroclorotiazida. If you are taking certain medicines, your doctor may need to perform blood tests at regular intervals.

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and the so-called 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 you take more than 3 g per day) (medicines 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 reduce 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).
• Medicines that promote urine excretion (diuretics).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Glucocorticoids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines 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 disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, a medicine used in organ transplants to prevent rejection.
• Other medicines that may increase the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment), and some antipsychotic medicines.

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

• If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán/Hidroclorotiazida Forte Stada Genéricos” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor together with other specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

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

• You can take candesartán/hidroclorotiazida with or without food.
• Consult your doctor before drinking alcohol while taking candesartán/hidroclorotiazida. 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

Your doctor will usually recommend that you stop taking candesartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medicine instead of candesartán/hidroclorotiazida. Candesartán/hidroclorotiazida is not recommended for use 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 when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Candesartán/hidroclorotiazida is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Driving and operating machines

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. It is essential to continue taking candesartán/hidroclorotiazida every day.

The recommended dose 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.

The tablet can be divided into equal doses.

If You Take More Candesartán/Hidroclorotiazida Forte Stada Generics Than You Should

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

You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Candesartán/Hidroclorotiazida Forte Stada Generics

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

If You Interrupt Treatment with Candesartán/Hidroclorotiazida Forte Stada Generics

If you stop taking candesartán/hidroclorotiazida, your blood pressure may increase again. Therefore, do not stop taking candesartán/hidroclorotiazida without 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 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 bumps that protrude).

Candesartán/hidroclorotiazida can 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. It is possible that your doctor will perform blood tests at regular intervals to check if candesartán/hidroclorotiazida is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Changes in blood test results:
• • A reduction in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.
  • An increase or decrease in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may feel tired, weak, have irregular heartbeats, or experience numbness.
  • An increase in cholesterol, glucose, or uric acid levels in the blood.
• Presence of glucose in urine.
• Sensation of 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, 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 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.
• Tickling or pinching sensations in arms or legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• Respiratory difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever)
• Pancreatitis inflammation. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction, which develops rapidly, causing blisters or skin peeling and, possibly, mouth ulcers.
• Worsening of existing lupus erythematosus 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 white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.

Unknown (frequency cannot be estimated from 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 hemorrhage) or acute angle-closure glaucoma
• Diarrhea
• Skin and lip cancer (non-melanoma skin cancer)

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister 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 unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Candesartán/Hidroclorotiazida Forte Stada Genéricos

• The active principles are candesartán cilexetilo and hidroclorotiazida. Each tablet contains 32 mg of candesartán cilexetilo and 25 mg of hidroclorotiazida.
• The other components are manitol (E421), cornstarch, copovidona, glicerol, magnesium stearate, yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the package

Candesartán/Hidroclorotiazida Forte Stada Genéricos 32 mg/25 mg tablets are orange-colored, oval, biconvex (~12 x 6 mm), uncoated, with a notch on one side, with the letters “C” and “H” engraved.

Candesartán/Hidroclorotiazida Forte Stada Genéricos 32 mg/25 mg tablets are presented in blisters of 7, 10, 14, 15, 28, 28x1 (single-dose), 30, 50, 50x1 (single-dose), 56, 56x1 (single-dose), 98, 98x1 (single-dose), 100 and 300 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

STADA Genéricos, S.L.

Frederic Mompou, 5

08960- Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

STADA ARZNEIMITTEL AG

Stadastrasse 2- 18

D-61118 Bad Vilbel

Germany

O

IBERFAR INDUSTRIA FARMACEUTICA, S.A.

R. Consigliery Pedroso, 121-123 Queluz de Baixo

2745-557 Barcarena

Portugal

O

PHARMACEUTICAL WORKS POLPHARMA S.A.

Business Unit Chemicals, 19 Pelplinska street

83-200 Starogard Gdanski

Poland

O

HBM PHARMA S.R.O.

Sklabinská 30

03680 Martin

Slovakia

O

DELORBIS PHARMACEUTICALS LTD

17 Athinon Str., Ergates Industrial Area

2643 Ergates, Lefkosia

Cyprus

O

STADA ARZNEIMITTEL GMBH.

Muthgasse 36

A-1190 Vienna

Austria

This medicine is authorized in the EEA member states with the following names:

PortugalCandesartan + 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 Eurogenerici 32 mg/25 mg compresse

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

Date of the last review of this prospectus:September 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/