Atacand Plus 16/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atacand Plus 16mg/12.5mg tablets

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 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 effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Your medicine is called Atacand Plus. It is used to treat high blood pressure (hypertension). It contains two active substances: candesartan cilexetil and hydrochlorothiazide. Both work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It helps blood vessels to relax and widen, making it easier to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of water and salts such as sodium through the urine. This helps reduce blood pressure.

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

2. What you need to know before taking Atacand Plus

Do not take Atacand Plus:

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamides. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is also advisable to avoid Atacand Plus during the first months of pregnancy – see Pregnancy section.)
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have ever had gout.
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Atacand Plus.

Warnings and precautions

Talk to 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 are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.
• if you have a disorder of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• if you have ever had a disease called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have had allergies or asthma.
• if you are pregnant (or think you might be pregnant). Use of Atacand Plus is not recommended in early pregnancy, and you must not take it after the first 3 months of pregnancy as it may cause serious harm to your baby when used from this time onward (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (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, especially 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 Atacand Plus.
• if you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to a week after taking Atacand Plus. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop severe shortness of breath or difficulty breathing after taking Atacand Plus, seek medical help 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 monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium) at regular intervals.

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

If any of the above conditions 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 Atacand Plus. This is because Atacand Plus, in combination with certain anesthetics, may cause excessive lowering of blood pressure.

Atacand Plus may increase skin sensitivity to sunlight.

Children and adolescents

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

Taking Atacand Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Atacand Plus may affect how some medicines work, and some medicines may influence the effect of Atacand Plus. If you are taking certain medicines, your doctor may need to carry out 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 medicines to lower your blood pressure, including beta-blockers, medicines containing aliskiren, diazoxide, and angiotensin-converting enzyme (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 taking more than 3 g per day) (a medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines to increase potassium levels in blood).
• Calcium supplements or vitamin D.
• Cholesterol-lowering medicines 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 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 treating fungal infections).
• Lithium (a medicine for mental health disorders).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (for treating Parkinson's disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (for treating esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used in organ transplantation to prevent organ rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine for relieving spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Atacand Plus” and “Warnings and precautions”).

Taking Atacand Plus with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Breast-feeding

Inform your doctor if you are breast-feeding or planning to start breast-feeding. The use of Atacand Plus is not recommended during breast-feeding, and your doctor will choose an alternative treatment for you if you wish to breast-feed.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

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

Atacand Plus contains lactose

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

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

3. How to take Atacand Plus

Follow exactly the instructions for using this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist. It is important that you continue taking Atacand Plus every day.

The usual dose 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 Atacand Plus than you should

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

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atacand Plus

Do not take a double dose to make up for missed doses. Simply take the next dose as scheduled.

If you stop taking Atacand Plus

If you stop taking Atacand Plus, your blood pressure may rise again. Therefore, do not stop taking Atacand Plus 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, Atacand Plus 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 Atacand Plus are due to candesartan cilexetil, while 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 itching of the skin (with skin rash).

Atacand Plus may reduce white blood cell counts. Your resistance to infections may decrease, and you may feel tired, have an infection, or develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to check that Atacand Plus is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 people)

• Changes in blood test results:

• A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or experience muscle cramps.

• An increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may feel tired, weak, have irregular heartbeats, or experience tingling sensations.

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

• 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 dizziness or fainting.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, hives, skin reaction due to 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 already have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Tingling or prickling sensations in arms and legs.
• Blurred vision for a short period of time.
• Abnormal heartbeats.
• 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 decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• Severe skin reaction developing rapidly, causing blisters and skin peeling, and possibly mouth ulcers.

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

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
• Swelling of the face, lips, tongue and/or throat.
• Itching.
• Back pain, joint pain, 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.

Not known (frequency cannot be estimated from available data)

• Sudden onset of myopia.
• Decreased vision or eye pain due to elevated 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, and skin rashes that may include redness, blisters, peeling, and lumps).
• Diarrhoea.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atacand Plus

• Keep out of sight and reach of children.

• This medicine does not require any special storage temperature.

• Do not use Atacand Plus after the expiry date stated on the packaging or blister. The expiry date is 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 at your pharmacy. If you are in doubt, 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 Atacand Plus

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

Nature of the product and pack contents

Atacand Plus 16 mg/12.5 mg is presented as peach-coloured, oval, biconvex tablets of 4.5 mm x 9.5 mm, with a breakline on both sides and engraved with "A/CS" on one side.

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

Not all pack sizes may be marketed in every country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturers:

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

Date of the most recent review of this leaflet: 01/2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/