ATACAND PLUS FORTE 32 mg/25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Atacand Plus Forte 32mg/25mg 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 Forte and what is it used for
2. What you need to know before you take Atacand Plus Forte
3. How to take Atacand Plus Forte
4. Possible side effects
5. Storing Atacand Plus Forte
6. Contents of the pack and other information

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

Your medicine is called Atacand Plus Forte. It is used to treat 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 like sodium in your urine. This helps to lower your blood pressure.

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

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

Do not take Atacand Plus Forte:

• 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 if this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also better to avoid Atacand Plus Forte 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 (problem with the bile flow from the gallbladder).
• if you have persistent low potassium levels in your blood.
• if you have persistent high calcium levels in your blood.
• if you have ever had gout.
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Atacand Plus Forte:

• if you are diabetic.
• if you have heart, liver or kidney problems.
• if you have recently had a kidney transplant.
• if you have vomiting, have had it recently or have diarrhea.
• if you have a condition of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).
• 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.
• if you are pregnant (or think you might be). It is not recommended to take Atacand Plus Forte during the first months of pregnancy, and you must not take it if you are more than 3 months pregnant, as it may harm your baby if taken after this time (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 notice any unexpected changes in your skin during treatment. Treatment with hydrochlorothiazide, especially 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 Forte.
• 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 increased pressure in the eye, and can occur within hours to a week after taking Atacand Plus Forte. 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 higher 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 severe shortness of breath or difficulty breathing after taking Atacand Plus Forte, seek medical attention immediately.

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

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 Forte. This is because Atacand Plus Forte, in combination with some anesthetics, can cause a significant drop in blood pressure.

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

Children and adolescents

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

Taking Atacand Plus Forte 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 Forte may affect the way some medicines work and some medicines may affect the effect of Atacand Plus Forte. 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 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) (medicine 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 cholestyramine.
• 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 elimination).
• 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 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 anti-hypertensive effect, such as baclofen (a medicine for the relief of 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 Forte” and “Warnings and precautions”).

Taking Atacand Plus Forte with food, drinks, and alcohol

• You can take Atacand Plus Forte with or without food.
• When you are prescribed Atacand Plus Forte, consult your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy and breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Atacand Plus Forte during breastfeeding, and your doctor will choose a different 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 Forte. If this happens to you, do not drive or use tools or machines.

Atacand Plus Forte contains lactose

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

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist. It is important that you keep taking Atacand Plus Forte 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 Forte than you should

If you have taken more Atacand Plus Forte than your doctor prescribed, contact your doctor or pharmacist immediately.

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

If you forget to take Atacand Plus Forte

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

If you stop taking Atacand Plus Forte

If you stop taking Atacand Plus Forte, your blood pressure may increase again. Therefore, do not stop taking Atacand Plus Forte without consulting your doctor first.

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

4. Possible side effects

Like all medicines, Atacand Plus Forte 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 Forte are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Atacand Plus Forte 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 itching of the skin (with rash).

Atacand Plus Forte 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 happens, tell your doctor. Your doctor may perform blood tests from time to time to check that Atacand Plus Forte 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 tingling.
• An increase in cholesterol, glucose, or uric acid levels in the blood.

• Glucose in the urine.
• Feeling dizzy or weak.
• Headache.
• Respiratory infection.

Uncommon (may affect up to 1 in 100 people)

• Low blood pressure. This can cause dizziness or fainting.
• Lack of appetite, diarrhea, constipation, stomach upset.
• 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 pulmonary inflammation and fluid in the lungs).
• High temperature (fever).
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels that produce 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 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 a 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 to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Atacand Plus Forte

• Keep out of the sight and reach of children.

• This medicine does not require any special storage temperature.
• Do not use Atacand Plus Forte after the expiry date 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 proper disposal. If you have any doubts, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atacand Plus Forte

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. The tablets contain 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide.
• The other components are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Container Content

Atacand Plus Forte 32 mg/25 mg tablets are presented in the form of pink, oval-shaped tablets, 6.5 mm x 11 mm in size, with a score line and the engraving A/CD 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 Forte 32 mg/25 mg tablets are presented in blisters of 28, 56, 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 InformationDetailed 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/