Candesartan/hydrochlorothiazide Stada 16/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartan/Hydrochlorothiazide STADA 16 mg/12.5 mg tablets EFG

candesartan cilexetil/hydrochlorothiazide

Read the entire 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

3. How to take Candesartan/Hydrochlorothiazide STADA

4. Possible side effects

5. How to store Candesartan/Hydrochlorothiazide 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 Stada. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains two active substances: 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 causes the blood vessels to relax and widen. This helps to reduce blood pressure.

Hidroclorotiazida belongs to a group of medicines called diuretics (water tablets). It helps the body to eliminate water and salts such as sodium through the urine. This helps to lower blood pressure.

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

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

DO NOT take Candesartán/Hydrochlorothiazide Stada if:

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

• you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.

• you are more than 3 months pregnant (it is also advisable to avoid candesartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).

• you have severe kidney problems.

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

• you have severe liver disease or biliary obstruction (a problem with bile flow from the gallbladder).

• you have persistently low levels of potassium in your blood.

• you have persistently high levels of calcium in your blood.

• 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, pharmacist, or nurse before taking Candesartán/Hydrochlorothiazide Stada if:

• you have diabetes.

• you have heart, liver, or kidney problems.

• you have recently had a kidney transplant.

• you are experiencing vomiting, have recently vomited frequently, or have diarrhoea.

• you have an adrenal gland disorder 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 allergies.

• inform your doctor if you are pregnant (or suspect you might be). The use of candesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used during this time (see Pregnancy section).

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

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

• aliskiren

• 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 exposure to sunlight and UV rays 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 untreated. Your risk may be higher if you have previously been allergic to penicillin or sulfonamides.

• if you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking candesartan/hydrochlorothiazide, seek medical help immediately.

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/Hydrochlorothiazide Stada if”.

If any of these situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with certain anaesthetics, may cause excessive lowering of blood pressure.

Candesartan/hydrochlorothiazide may increase skin sensitivity to sunlight.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 given to children.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce positive results in doping tests.

Other medicines and Candesartán/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Candesartan/hydrochlorothiazide may affect how some medicines work, and some medicines may affect candesartan/hydrochlorothiazide. If you are taking certain medicines, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• Other blood pressure-lowering medicines, including beta-blockers, medicines containing aliskiren, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril, or ramipril (see also information under the headings “DO NOT take Candesartán/Hydrochlorothiazide Stada if” and “Warnings and precautions”).

• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to relieve pain and inflammation).

• Acetylsalicylic acid (if taking more than 3 g per day) (medicines used to relieve pain and inflammation).

• Potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood).

• Calcium or vitamin D supplements.

• 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 certain antipsychotics.

• Heparin (a medicine to increase blood fluidity).

• Diuretic tablets (medicines that increase urine output).

• Laxatives.

• Penicillin or cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines).

• Amphotericin (used to treat fungal infections).

• Lithium (a medicine for mental health conditions).

• Steroids such as prednisolone.

• Pituitary hormone (ACTH).

• Medicines for cancer treatment.

• Amantadine (used to treat Parkinson’s disease or serious viral infections).

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

• Carbenoxolone (used to treat oesophageal disorders or mouth ulcers).

• Anticholinergic agents such as atropine and biperidene.

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

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

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

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

• When prescribed candesartan/hydrochlorothiazide, consult your doctor before drinking alcohol. 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

Inform your doctor if you are pregnant (or suspect you might be). 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 taken after the third month of pregnancy, as it may cause serious harm to your baby if used from this stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Candesartan/hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

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 machinery.

Candesartán/Hydrochlorothiazide Stada contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Candesartan/Hydrochlorothiazide Stada

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose of candesartan/hydrochlorothiazide 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.

If you take more Candesartan/Hydrochlorothiazide Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine 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 rise again. Therefore, do not stop taking candesartan/hydrochlorothiazide 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 and others are due to hydrochlorothiazide.

Stop taking Candesartán/Hidroclorotiazida Stada 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 skin rash).

Candesartan/hydrochlorothiazide may reduce the number of white blood cells. Your resistance to infections may decrease, and you may feel tired, develop an infection or fever. If this occurs, inform your doctor. Your doctor may perform blood tests from time to time to check whether candesartan/hydrochlorothiazide has affected your blood (agranulocytosis).

Stop taking candesartan/hydrochlorothiazide and contact your doctor immediately if you notice the following adverse effect:

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

• acute breathing difficulty (symptoms include severe shortness of breath, 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 experience weakness, lack of energy or muscle cramps.

• An increase or decrease in the amount of potassium in the blood, especially if you already have kidney problems or heart failure. In severe cases, you may feel tired, weak, have irregular heartbeats or tingling sensations.

• • An increase in the levels of cholesterol, glucose or uric acid in the blood.

• Sugar in the urine.

• Dizziness/vertigo 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 and stomach irritation.
• Skin rash, hives, rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and 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 itching in arms or legs.
• Temporary blurred vision.
• 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 reduction in red blood cells, white blood cells or platelets. You may feel tired, develop an infection or fever, or bruise more easily.
• Severe skin reaction that develops rapidly, causing blisters or peeling of the skin 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 liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency 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)
• Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes which may include redness, blisters, peeling and lumps).
• Diarrhoea
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them 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.

• Do not store above 25°C.

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

6. Contents of the pack and other information

Composition of Candesartan/Hydrochlorothiazide STADA

The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

The other components are: monohydrate lactose, corn starch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate and triethyl citrate.

Appearance of the product and contents of the pack

Candesartan/Hydrochlorothiazide STADA are white, biconvex tablets, with a score line on one side marked with "CH16". The score line is intended to facilitate breaking the tablet for ease of swallowing, but not for dividing into equal doses.

Pack sizes:

Blister packs containing 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 certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio 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

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

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/