Candesartan/hydrochlorothiazide Almus 16 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Candesartan/Hydrochlorothiazide Almus is and what it is used for
2. What you need to know before taking Candesartan/Hydrochlorothiazide Almus
3. How to take Candesartan/Hydrochlorothiazide Almus
4. Possible side effects
5. How to store Candesartan/Hydrochlorothiazide Almus
6. Contents of the pack and other information

1. What Candesartán/Hidroclorotiazida Almus is and what it is used for

Your medicine is called Candesartán/Hidroclorotiazida Almus. It is used to treat high blood pressure (hypertension). It contains two active substances: candesartán cilexetilo and hidroclorotiazida. Both work together to lower blood pressure.

• Candesartán cilexetilo belongs to a group of medicines called angiotensin II receptor antagonists. It helps blood vessels relax and widen, making it easier to reduce blood pressure.
• Hidroclorotiazida 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 Candesartán/Hidroclorotiazida Almus if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

2. What you need to know before taking Candesartán/Hidroclorotiazida Almus

Do not take Candesartán/Hidroclorotiazida Almus

• if you are allergic (hypersensitive) to candesartan cilexetil or hydrochlorothiazide or to any of the other components 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 Candesartán/Hidroclorotiazida Almus 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 flow 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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Candesartán/Hidroclorotiazida Almus.

Warnings and precautions

Consult your doctor if:

• you are diabetic.

• you have heart, liver, or kidney problems.

• you have recently received a kidney transplant.

• you are experiencing vomiting, have had frequent vomiting recently, or have diarrhea.

• you have a disorder 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 undergoing tests for thyroid or parathyroid disorders.

• you have ever had a stroke.

• you have had allergies or asthma.

• 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), particularly if you have kidney problems related to diabetes.

• aliskiren

  • 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 Candesartán/Hidroclorotiazida Almus.
  • you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Candesartán/Hidroclorotiazida Almus, seek medical attention immediately.
  • you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartán/Hidroclorotiazida Almus. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán/Hidroclorotiazida Almus on your own.

Your doctor may monitor 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 Candesartán/Hidroclorotiazida Almus”.

If any of these situations apply to you, your doctor may want to see you more frequently and perform certain tests.

If you are scheduled for surgery, inform your doctor or dentist that you are taking Candesartán/Hidroclorotiazida Almus. This is because Candesartán/Hidroclorotiazida Almus, in combination with certain anesthetics, may cause a drop in blood pressure.

If you experience vision changes or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking candesartán/hydrochlorothiazide. This may lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may have an increased risk of developing this condition.

Candesartán/Hidroclorotiazida Almus may increase skin sensitivity to sunlight.

Children and adolescents

There is no experience with the use of Candesartán/Hidroclorotiazida Almus in children (under 18 years of age). Therefore, Candesartán/Hidroclorotiazida Almus should not be administered to children.

Use in athletes

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

Taking Candesartán/Hidroclorotiazida Almus with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Candesartán/Hidroclorotiazida Almus may affect how some medicines work, and some medicines may influence the effect of Candesartán/Hidroclorotiazida Almus. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

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 blood pressure-lowering medicines, 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 for pain and inflammation relief).

• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine for pain and inflammation relief).

• Potassium supplements or potassium-containing salt substitutes (medicines to increase blood potassium levels).

• Calcium or vitamin D supplements.

• 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 certain antipsychotics.

• Heparin (a medicine to increase blood fluidity).

• Diuretics (medicines to promote urine elimination).

• Laxatives.

• Penicillin (an antibiotic).

• Amphotericin (for treating fungal infections).

• Lithium (a medicine for mental health conditions).

• 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 transplants 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 certain antipsychotics.

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Candesartán/Hidroclorotiazida Almus” and “Warnings and precautions”).

Taking Candesartán/Hidroclorotiazida Almus with food, drinks, and alcohol

• You may take Candesartán/Hidroclorotiazida Almus with or without food.
• When prescribed Candesartán/Hidroclorotiazida Almus, consult your doctor before consuming alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking Candesartán/Hidroclorotiazida Almus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán/Hidroclorotiazida Almus is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Candesartán/Hidroclorotiazida Almus is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may feel tired or dizzy when taking Candesartán/Hidroclorotiazida Almus. If this happens to you, do not drive or operate tools or machinery.

Candesartán/Hidroclorotiazida Almus contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult 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 Candesartán/Hidroclorotiazida Almus

Follow exactly the instructions for using Candesartán/Hidroclorotiazida Almus as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

It is important that you continue taking Candesartán/Hidroclorotiazida Almus 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 Candesartán/Hidroclorotiazida Almus than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Candesartán/Hidroclorotiazida Almus

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

If you stop taking Candesartán/Hidroclorotiazida Almus

If you stop taking Candesartán/Hidroclorotiazida Almus, your blood pressure may rise again. Therefore, do not stop taking Candesartán/Hidroclorotiazida Almus 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, Candesartán/Hidroclorotiazida Almus can cause adverse effects, although not everyone experiences them.

It is important that you are aware of the possible adverse effects. These are usually mild and disappear after a short time. Some of the adverse effects of Candesartán/Hidroclorotiazida Almus are due to candesartán cilexetilo, while others are due to hydrochlorothiazide.

Stop taking Candesartán/Hidroclorotiazida Almus and see a 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).

Candesartán/Hidroclorotiazida Almus may cause a reduction in white blood cells. 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 ensure that Candesartán/Hidroclorotiazida Almus is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 patients)

• Changes in blood test results:

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

• Increase or decrease in blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is severe, you may experience tiredness, weakness, irregular heartbeat, or tingling sensations.

• Increase in blood cholesterol, glucose, or uric acid levels.

• Presence of glucose in urine.

• Dizziness or weakness.

• Headache.

• Respiratory infection.

Uncommon (may affect up to 1 in 100 patients)

• Low blood pressure. This may cause dizziness or fainting.
• Loss of appetite, constipation, stomach irritation.
• 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 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.
• Irregular heartbeat.
• Breathing difficulties (including pulmonary 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.
• Reduction in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or bruise easily.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus-like reactions or development 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 inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• 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 diarrhea.

Frequency not known (cannot be estimated from available data)

• Diarrhea.
• Skin and lip cancer (non-melanoma skin cancer).
• Vision loss 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].

Do not be alarmed by this list of possible adverse effects. You are unlikely to experience any of them.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es.

By reporting adverse 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 °C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan/Hydrochlorothiazide Almus

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

• The other components 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 contents of the pack

Candesartan/Hydrochlorothiazide Almus 16/12.5 mg tablets are white, oval, biconvex tablets, engraved with CH and 016 on one side (length 9.6 ± 0.2 mm).

Candesartan/Hydrochlorothiazide Almus 16/12.5 mg tablets are marketed in blisters containing 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 Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

Manufacturer:

Bluepharma Indústria Farmacêutica, S.A.

• Martino do Bispo,
  3045-016 Coimbra,
  Portugal

Date of the most recent revision of this leaflet: 03/2025

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/