Candesartan Stadapharm 32 mg Tablets

1. What is Candesartan Stadafarma and what is it used for

The name of your medicine is Candesartan Stadafarma. The active substance is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

Candesartan can be used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to 18 years.
• treatment of adult patients with heart failure with reduced cardiac function when ACE inhibitors (a type of medicine used to treat heart failure) are not tolerated or as an addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (a type of medicine used to treat heart failure) cannot be used.

2. What you need to know before you take Candesartan Stadafarma

Do not take Candesartan Stadafarma:

• if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is also better to avoid Candesartan Stadafarma in early pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney problems and you are treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking candesartan.

Warnings and precautions

Tell your doctor or pharmacist before you start taking this medicine:

• if you have heart, liver or kidney problems, or if you are on dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting or have diarrhoea.
• if you have a condition affecting the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant (or think you might be). Candesartan should not be used in early pregnancy, and must not be used if you are more than 3 months pregnant, as it may seriously harm your baby if used after the third month of pregnancy (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (MRAs) (these medicines are used to treat heart failure) (see “Other medicines and Candesartan Stadafarma”)

Tell your doctor if you get any of the following symptoms: abdominal pain, nausea, vomiting or diarrhoea after taking candesartan. Your doctor will decide whether you should continue to take candesartan. Do not stop taking candesartan without talking to your doctor.

Your doctor may check your kidney function, blood pressure and the levels of electrolytes (such as potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Candesartan Stadafarma”.

If you are about to have surgery or be admitted to hospital, tell your doctor or dentist that you are taking candesartan. This is because candesartan, in combination with some anaesthetics, may cause a severe fall in blood pressure.

Children and adolescents

Candesartan has been studied in children. For more information, talk to your doctor. Candesartan should not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Other medicines and Candesartan Stadafarma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Candesartan may affect the way some other medicines work and some medicines may have an effect on candesartan. If you are taking certain medicines, your doctor may need to do blood tests from time to time.

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

• Other medicines for lowering your blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Aspirin (if you are taking more than 3 g every day) (a medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine for thinning the blood).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that increase the amount of urine you produce).
• Lithium (a medicine for some types of mental illness).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candesartan Stadafarma” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor together with other specific medicines for your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Stadafarma with food, drinks and alcohol

• You can take candesartan with or without food.
• When your doctor prescribes candesartan, ask your doctor if you can take it with alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breast-feeding

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candesartan is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

Some patients may feel tired or dizzy when taking candesartan. If this happens to you, do not drive or use any tools or machines.

Candesartan Stadafarma contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Candesartan Stadafarma

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is important to take candesartan every day.

You can take candesartan with or without food. Swallow the tablet with water.

Try to take the tablet at the same time each day. This will help you to remember to take it.

The tablet can be divided into two equal doses.

High blood pressure:

• The recommended dose of candesartan is 8 mg once daily. Your doctor may increase this dose up to 16 mg once daily and up to 32 mg once daily depending on your blood pressure response.
• In some patients, such as those with liver or kidney problems, or those who have recently lost body fluids (e.g. through vomiting, diarrhoea, or because you are taking diuretics), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine, when used as the only treatment, and may need a higher dose.

Use in children and adolescents:

Children and adolescents aged 6 to 18 years:

The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg daily.

For patients weighing 50 kg or more: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once daily and up to 16 mg once daily.

Heart failure in adults:

• The recommended starting dose of candesartan is 4 mg once daily. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once daily. Candesartan can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Stadafarma than you should

If you have taken more candesartan than you should, talk to a doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the National Poison Information Service on +34 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Candesartan Stadafarma

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

If you stop taking Candesartan Stadafarma

If you stop taking candesartan, your blood pressure may increase again. Therefore, do not stop taking candesartan without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking candesartan and contact 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 in swallowing
• severe itching of the skin (with rash)

Candesartan may cause a decrease in white blood cells. Your resistance to infection may be decreased and you may notice tiredness, infection or fever. If this happens, contact your doctor. It is possible that your doctor will need to do blood tests from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common: may affect up to 1 in 10 people

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause you to feel dizzy or faint.
• Changes in blood test results:
• • An increase in the level of potassium in your blood, especially if you already have kidney problems or heart failure. If this gets serious, you may feel tired, weak, get irregular heart rhythms or get pins and needles.
• Effects on your kidney function, especially if you already have kidney problems or heart failure. In rare cases, kidney failure has been reported.

Rare: may affect up to 1 in 1,000 people

• Swelling of the face, lips, tongue and/or throat.
• A decrease in the number of red or white blood cells. You may notice tiredness, infection or fever.
• Rash, itching.
• Itching.
• Back pain, pain in the joints and muscles.
• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, get yellow skin and eyes and flu-like symptoms.
• Nausea.
• Changes in blood test results:
• • A decrease in the level of sodium in your blood. If this gets serious, you may feel weak, lack energy or get muscle cramps.
• Cough.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known: cannot be estimated from the available data

• Diarrhoea.

Other side effects in children

In children treated for high blood pressure, side effects seem to be similar to those seen in adults, but they happen more often. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Stadafarma

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

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after “EXP”. The expiry date refers to the last day of that month.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Candesartan Stadafarma contains

The active substance is candesartan cilexetil.

The tablets contain 32 mg of candesartan cilexetil.

The other ingredients are: lactose monohydrate, maize starch, hydroxypropylcellulose, calcium carmellose, macrogol 8000, magnesium stearate, red iron oxide (E-172).

Appearance and packaging

Candesartan 32 mg: round tablet, 9.5 mm in diameter, pink (not uniform, possibly with small dark spots or white spots) with a score line on one side and the engraving “32” on the other side.

The tablets are available in:

Blister packs: 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.

Bottles: 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo,7

Pol. Ind. Miralcampo, 19200

Azuqueca de Henares, Guadalajara

Spain

Or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark Candesartan STADA

Austria Candesartan Aliud 32 mg Tabletten

Belgium Candesartan Eurogenerics 32 mg tablets

Luxembourg Candesartan Eurogenerics 32 mg comprimés

Finland Candesartan STADA 32 mg tabletti

France CANDESARTAN EG LABO 32 mg, comprimé sécable

Germany Candesartan STADA 32 mg Tabletten

Portugal Candesartan Ciclum Farma

Slovakia Kandesartan STADA 32 mg tablety

Spain Candesartán STADAFARMA 32 mg comprimidos EFG

Sweden Candesartan STADA 32 mg tabletter

Iceland Candesartan STADA 32 mg töflur

Norway Candesartan STADA 32 mg tabletter

Date of last revision of this leaflet: December 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/