Candesartan/Hydrochlorothiazide Almus 16 mg/12.5 mg Tablets

Introduction

PATIENT INFORMATION LEAFLET

Candesartan/Hydrochlorothiazide Almus 16 mg/12.5 mg tablets EFG

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 Candesartan/Hydrochlorothiazide Almus is and what it is used for
2. What you need to know before you take Candesartan/Hydrochlorothiazide Almus
3. How to take Candesartan/Hydrochlorothiazide Almus
4. Possible side effects

5 Storage of Candesartan/Hydrochlorothiazide Almus

1. Package contents and additional information

1. What Candesartan/Hydrochlorothiazide Almus is and what it is used for

Your medicine is called Candesartan/Hydrochlorothiazide Almus. It is used to treat high blood pressure (hypertension). It contains two active ingredients: 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 makes the blood vessels relax and dilate. This helps to lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of water and salts like sodium in the urine. This helps to lower blood pressure.

Your doctor may prescribe Candesartan/Hydrochlorothiazide Almus if your blood pressure has not been controlled adequately with candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before you take Candesartan/Hydrochlorothiazide Almus

Do not takeCandesartan/Hydrochlorothiazide Almus

• if you are allergic (hypersensitive) 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 you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is also best to avoid Candesartan/Hydrochlorothiazide Almus 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 bile leaving the gallbladder).
• if you have persistent low potassium levels in the blood.
• if you have persistent high calcium levels in the blood.
• if you have ever had gout.

if you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

If you are not sure if you are in any of these situations, consult your doctor or pharmacist before taking Candesartan/Hydrochlorothiazide Almus.

Warnings and precautions

Consult your doctor if:

• you are diabetic.
• you have heart, liver, or kidney problems.
• you have recently had a kidney transplant.
• you have vomiting, have had it frequently lately, or have diarrhea.
• you have a disease of the adrenal gland called Conn's syndrome (also known as primary hyperaldosteronism).
• you have ever had a disease called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you are having tests to detect thyroid or parathyroid disorders
• you have ever had a stroke.
• you have ever had an allergy or asthma.
• if you are taking any of the following medicines used to treat high blood pressure:

• a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), 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, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Candesartan/Hydrochlorothiazide Almus.
• 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 Candesartan/Hydrochlorothiazide Almus, go to the doctor immediately.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan/Hydrochlorothiazide Almus. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan/Hydrochlorothiazide Almus 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 Candesartan/Hydrochlorothiazide Almus”.

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

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

If you experience a decrease in vision or eye pain, they 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 a few hours to a week after taking candesartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at greater risk of developing this.

Candesartan/Hydrochlorothiazide Almus may increase the sensitivity of your skin to the sun.

Children and adolescents

There is no experience with the use of Candesartan/Hydrochlorothiazide Almus in children (under 18 years). Therefore, Candesartan/Hydrochlorothiazide Almus should not be given to children.

Athletes

This medicine contains hydrochlorothiazide, which can produce a positive result in doping tests.

Using Candesartan/Hydrochlorothiazide Almus with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines. Candesartan/Hydrochlorothiazide Almus may affect how some medicines work and some medicines may affect the effect of Candesartan/Hydrochlorothiazide Almus. 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 or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control heart rate (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 (an antibiotic).
• 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.
• Cyclosporine, 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 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 Candesartan/Hydrochlorothiazide Almus” and “Warnings and precautions”).

Taking Candesartan/Hydrochlorothiazide Almus with food, drinks, and alcohol

• You can take Candesartan/Hydrochlorothiazide Almus with or without food.
• When you are prescribed Candesartan/Hydrochlorothiazide Almus, consult your doctor before drinking alcohol. Alcohol can make you feel dizzy or faint.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant (or think you may be). Your doctor will generally advise you to stop taking Candesartan/Hydrochlorothiazide Almus before you become pregnant or as soon as you know you are pregnant and will recommend taking another medicine instead of Candesartan/Hydrochlorothiazide Almus. Candesartan/Hydrochlorothiazide Almus is not recommended during the start of pregnancy and should not be taken after the third month of pregnancy, as it can cause serious harm to your baby when taken from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Candesartan/Hydrochlorothiazide Almus is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel tired or dizzy when taking Candesartan/Hydrochlorothiazide Almus. If this happens to you, do not drive or operate tools or machines.

Candesartan/Hydrochlorothiazide Almus contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Candesartan/Hydrochlorothiazide Almus

Follow the instructions for taking Candesartan/Hydrochlorothiazide Almus exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

It is important that you keep taking Candesartan/Hydrochlorothiazide Almus 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 moreCandesartan/Hydrochlorothiazide Almusthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeCandesartan/Hydrochlorothiazide Almus

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

If you stop takingCandesartan/Hydrochlorothiazide Almus

If you stop taking Candesartan/Hydrochlorothiazide Almus, your blood pressure may rise again. Therefore, do not stop taking Candesartan/Hydrochlorothiazide Almus before consulting your doctor.

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

4. Possible side effects

Like all medicines, Candesartan/Hydrochlorothiazide Almus can cause side effects, although not everybody gets them.

It is important that you know what these side effects might be. They are usually mild and go away on their own after a short time. Some of the side effects of Candesartan/Hydrochlorothiazide Almus are due to candesartan cilexetil and others are due to hydrochlorothiazide.

Stop taking Candesartan/Hydrochlorothiazide Almus 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 can cause difficulty swallowing.
• severe itching of the skin (with rash).

Candesartan/Hydrochlorothiazide Almus 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. It is possible that your doctor will perform blood tests from time to time to check that Candesartan/Hydrochlorothiazide Almus is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 patients)

• 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.

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

Uncommon (may affect up to 1 in 100 patients)

• Low blood pressure. This can cause dizziness or fainting.
• Lack of appetite, constipation, stomach upset.
• Skin rash, hives, skin reaction caused by sensitivity to sunlight.

Rare (may affect up to 1 in 1,000 patients)

• 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 pinching 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 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.
• Worsening of pre-existing lupus-like reactions or appearance of uncommon skin reactions.

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

• 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.
• Acute difficulty breathing (signs 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.

Frequency not known (cannot be estimated from the available data)

• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Do not be alarmed by this list of possible side effects. You will probably not get any of them.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use. Website: ww.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Almus

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

Do not store above 30 ºC.

Do not use Candesartan/Hydrochlorothiazide Almus after the expiry date stated on the packaging or blister. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofCandesartan/Hydrochlorothiazide Almus

• The active ingredients are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

• The other ingredients are: sodium docusate, sodium lauryl sulfate, calcium carmellose, pregelatinized corn starch, hydroxypropylcellulose E 463, lactose monohydrate, magnesium stearate E 470b, and purified water.

Appearance of the Product and Package Contents

Candesartan/Hydrochlorothiazide Almus 16/12.5 mg tablets are white, oval, biconvex tablets, with the engraving CHand 016on the same side (length 9.6± 0.2 mm).

Candesartan/Hydrochlorothiazide Almus 16/12.5 mg tablets are marketed in blisters of

7, 14, 28, 56, and 98 tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Bluepharma Indústria Farmacêutica, S.A.

• Martinho do Bispo,

3045-016 Coimbra,

Portugal

Date of the Last Revision of this Leaflet: 03/2025

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