ATACAND PLUS 32 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Atacand Plus 32mg/12.5mg tablets

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Atacand Plus and what is it used for
2. What you need to know before you take Atacand Plus
3. How to take Atacand Plus
4. Possible side effects
5. Storage of Atacand Plus
6. Contents of the pack and other information

1. What is Atacand Plus and what is it used for

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

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and widen. This helps to lower your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps your body get rid of water and salts such as sodium in your urine. This helps to lower your blood pressure.

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

2. What you need to know before you take Atacand Plus

Do not take Atacand Plus:

• if you are allergic to candesartan 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 not sure, consult your doctor.
• if you are more than 3 months pregnant. (It is also better 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 biliary obstruction (problems with the drainage of the bile from the gall bladder).
• if you have persistently low potassium levels in your blood.
• if you have persistently high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney disease and are being treated with a medicine for high blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Atacand Plus:

• 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 vomiting or have diarrhea.
• if you have a condition of the adrenal gland called primary hyperaldosteronism (also known as Conn's syndrome).
• 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 allergy or asthma.
• if you are pregnant (or might become pregnant). It is not recommended to take Atacand Plus during the first few months of pregnancy, and you must not take it if you are more than 3 months pregnant as it may harm your baby if used after the third month of pregnancy (see section on Pregnancy).
• 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, etc.), especially 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. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Atacand Plus.
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to a week after taking Atacand Plus. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of developing it.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Atacand Plus, seek medical attention immediately.

Talk to 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 check 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 Atacand Plus”.

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

If you are going to have surgery, tell your doctor or dentist that you are taking Atacand Plus. This is because Atacand Plus, in combination with some anesthetics, can cause a significant drop in blood pressure.

Atacand Plus may increase the sensitivity of your skin to the sun.

Children and adolescents

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

Taking Atacand Plus with other medicines

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

Atacand Plus may affect the way some medicines work and some medicines may affect the way Atacand Plus works. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

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

• Other medicines to lower your blood pressure, including beta-blockers, medicines that contain 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) (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes that contain potassium (medicines to increase potassium levels in the blood).
• Calcium supplements or vitamin D.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control your heart rate (anti-arrhythmic 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 cotrimoxazole also known as trimethoprim/sulfamethoxazole (antibiotic medicines).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Corticosteroids 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.
• Cyclosporin, a medicine used for organ transplants, to prevent organ rejection.
• Other medicines that may increase the blood pressure-lowering effect of Atacand Plus, such as baclofen (a medicine to relieve muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an angiotensin-converting enzyme inhibitor (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 prescribed Atacand Plus, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or faint.

Pregnancy and breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or will start breastfeeding soon. It is not recommended to use Atacand Plus during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Atacand Plus contains lactose

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

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

3. How to take Atacand Plus

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important that you take 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 each 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 your doctor prescribed, contact your doctor or pharmacist immediately.

You can also contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atacand Plus

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Atacand Plus

If you stop taking Atacand Plus, your blood pressure may increase again. Therefore, do not stop taking Atacand Plus without consulting 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, Atacand Plus can cause side effects, although not everybody gets them.

It is important that you know what these side effects may be. Some of the side effects of Atacand Plus are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Atacand Plus and go to the 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 itching of the skin (with 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 have a fever. If this happens, tell your doctor. Your doctor may perform blood tests from time to time to check that Atacand Plus is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:

• A decrease 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 situation is severe, you may feel tired, weak, have irregular heartbeats, or have tingling sensations.
• An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Feeling dizzy or weak.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This may cause you to feel dizzy or faint.
• Lack of appetite, diarrhea, constipation, stomach upset.
• 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 the whites of the eyes). If this happens, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Tingling or numbness in arms and legs.
• Blurred vision for a short time.
• Abnormal heartbeats.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that cause red or purple spots on the skin.
• A decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• A severe skin reaction that develops rapidly, causing blisters and peeling of the skin, and possibly ulcers in the mouth.

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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• 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 the whites of the eyes, and have flu-like symptoms.
• Cough.
• Nausea.

Not known (frequency cannot be estimated from the 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 lupus erythematosus and cutaneous lupus (a condition that causes fever, joint pain, skin rashes that can include redness, blisters, peeling, and bumps).
• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atacand Plus

• Keep out of the sight and reach of children.

• This medicine does not require any special storage temperature.
• Do not use Atacand Plus after the expiry date which is stated on the packaging or blister. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atacand Plus

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. The tablets contain 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.
• The other components are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol, and yellow iron oxide (E172).

Appearance of the Product and Container Content

Atacand Plus 32 mg/12.5 mg is presented in the form of yellow, oval-shaped tablets, 6.5 mm x 11 mm in size, with a score line and the engraving A/CJ on one side and a pressure-sensitive score line on the other. The tablet can be divided into two equal halves by breaking along the score line.

Atacand Plus 32 mg/12.5 mg tablets are presented in blisters of 28 or 98 tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CHEPLAPHARM Arzneimittel GmbHZiegelhof 2417489 Greifswald

Germany

Manufacturer:

Klocke Pharma-Service GmbH

Straßburger Str. 77

77767 Appenweier

Germany

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

AstraZeneca AB, S-152 57, Södertälje, Sweden

Local Representative:

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet: 01/2025

Other Sources of Information

Detailed and updated 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/