Prospecto: information for the user

Atacand Plus 16mg/12,5mg tablets

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 to you and should not be given to other people, even if they have the same symptoms, 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.What is Atacand Plus and for what it is used

2.What you need to know before taking Atacand Plus

3.How to take Atacand Plus

4.Possible adverse effects

5Storage of Atacand Plus

6.Contents of the package and additional information

Your medicine is called Atacand Plus. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: candesartan cilexetilo and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It makes blood vessels relax and dilate. This facilitates a decrease in blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It promotes the body to eliminate water and salt, such as sodium, in the urine. This facilitates a decrease in blood pressure.

Your doctor may prescribe Atacand Plus if your blood pressure has not been adequately controlled with candesartan cilexetilo or hydrochlorothiazide alone.

Do not take Atacand Plus:

• if you are allergic to candesartan cilexetilo or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section6).

• if you are allergic to sulfonamides. If you are unsure if you are in this situation, consult your doctor.
• if you are more than 3months pregnant. (It is best to avoid Atacand Plus during the first months of pregnancy – see section on Pregnancy).
• if you have severe kidney disease.
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• if you have persistent low levels of potassium in your blood.
• if you have persistent high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If you are unsure if you are in any of these situations, consult your doctor or pharmacist before taking Atacand Plus.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atacand Plus:

• if you are diabetic.
• if you have heart, liver, or kidney problems.
• if you have recently had a kidney transplant.
• if you have been vomiting, have had it frequently recently, 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 had an allergy or asthma.
• if you are pregnant (or if you suspect you may be). Atacand Plus is not recommended for use at the start 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 taken from that point onwards (see section on Pregnancy).
• if 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 if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly 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 Atacand Plus.
• siyou 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 increased pressure in the eye, and may occur within a few hours to a week after taking Atacand Plus. This may lead to permanent loss of vision if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Atacand Plus, seek medical attention immediately.

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

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g. potassium), at regular intervals.

See also the information under the heading “Do not take Atacand Plus”.

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are to undergo surgery, inform your doctor or dentist that you are taking Atacand Plus. This is because Atacand Plus, in combination with some anesthetics, may cause excessive lowering of blood pressure.

Atacand Plus may increase your skin's sensitivity to the sun.

Children and adolescents

There is no experience with the use of Atacand Plus in children (under 18years). Therefore, Atacand should not be administered in children.

Taking Atacand Plus with other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Atacand Plus may affect how some medicines work, and some medicines may affect the effect of Atacand Plus. 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, as your doctor may need to adjust your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, medicines containing aliskiren, 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 lower 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).
• Diuretics (medicines to promote urine production).
• Laxatives.
• Penicillin or trimethoprim/sulfamethoxazole (antibiotic medicines).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Prednisolone (a steroid).
• Adrenocorticotropic hormone (ACTH).
• Cancer medicines.
• Amantadine (for the treatment of Parkinson's disease or severe viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or mouth ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Ciclosporin, a medicine used for organ transplants, to prevent organ rejection.
• Other medicines that may increase the antihypertensive effect, such as baclofen (a medicine for muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Atacand Plus” and “Warnings and precautions”).

Taking Atacand Plus with food, drinks, and alcohol

• You can take Atacand Plus with or without food.
• When you are prescribed Atacand Plus, consult your doctor before drinking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Atacand Plus contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Use in athletes: This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.It is essential that you continue taking Atacand Plus every day.

The usual 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.

If you take more Atacand Plus than you should

If you have taken more Atacand Plus 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 Atacand Plus

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

If you interrupt treatment with Atacand Plus

If you stop taking Atacand Plus, your blood pressure may increase again. Therefore, do not stop taking Atacand Plus before consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Atacand Plus may cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. Some side effects of Atacand Plus are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Atacand Plus and see 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 skin itching (with skin rash).

Atacand Plus may 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. Your doctor may perform blood tests from time to time to check if Atacand Plus 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 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.

Infrequent (May affect up to 1 in 100 people)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, diarrhea, constipation, stomach irritation.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin and white of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or pinching in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. 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 that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.

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

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat.
• Itching.
• Back pain, joint pain, and muscle pain.
• Changes in liver function, including inflammation of the liver (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 nearsightedness.
• Decrease in 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).
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, skin rash that may include redness, blisters, exfoliation, and nodules).
• 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 apossibleside effect that does not appear in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep out of the sight and reach of children.

• This medication does not require any special temperature for conservation.
• Do not use Atacand Plus after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Atacand Plus

• The active ingredients are candesartan cilexetilo and hydrochlorothiazide. The tablets contain 16mg of candesartan cilexetilo and 12.5mg of hydrochlorothiazide.
• The other components are calcium carbonate, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, macrogol, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the package

Atacand Plus 16mg/12.5mg is presented in the form of orange-colored, oval-shaped tablets of4.5mm x 9.5mm, biconvex, with a groove on both sides and theengraving A/CS on one side.

Atacand Plus 16mg/12.5mg tablets are presented in plastic bottles of 100 tablets or in blisters of 14, 28, 30, 56, 90, or 98 tablets.

It may not be marketed in all package sizes in all countries.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald

Germany

Responsible for manufacturing:

Klocke Pharma-Service GmbH

Straßburger Str. 77

77767 Appenweier

Germany

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

AstraZeneca AB, SE-152 57, Södertälje, Sweden

Local Representative:

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 01/2025

Other sources of information

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