PROSPECTO: INFORMATION FOR THE USER

Candesartán/Hidroclorotiazida Almus 16 mg/12,5 mg tablets EFG

candesartán cilexetilo/hidroclorotiazida

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Candesartán/Hidroclorotiazida Almus and how it is used

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

3.How to take Candesartán/Hidroclorotiazida Almus

4.Possible adverse effects

5Storage of Candesartán/Hidroclorotiazida Almus

6.Contents of the package and additional information

Your medicine is calledCandesartán/Hidroclorotiazida Almus. It is used for the treatment of high blood pressure (hypertension). It contains two active ingredients: 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 makes blood vessels relax and dilate. This facilitates a decrease in blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It promotes the body to eliminate water and salt, such as sodium, in urine. This facilitates a decrease in blood pressure.

Your doctor may prescribeCandesartán/Hidroclorotiazida Almusif your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

Do not takeAlmus Candesartan/Hydrochlorothiazide

• if you are allergic (hypersensitive) to candesartan cilexetilo or to 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 you are in this situation, consult your doctor.
• if you are more than 3 months pregnant. (It is best to avoid Almus Candesartan/Hydrochlorothiazide during the first months of pregnancy – see the Pregnancy section).
• if you have severe kidney disease.
• if you have severe liver disease or biliary obstruction (problem with the bile flowing out of the gallbladder).
• if you have persistent low levels of potassium in your blood.
• if you have persistent high levels of calcium in your blood.
• if you have ever had gout.

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

If you are unsure whether you are in any of these situations, consult your doctor or pharmacist before taking Almus Candesartan/Hydrochlorothiazide.

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 been vomiting, have had frequent vomiting recently, or have diarrhea.
• you have a condition called Conn's syndrome (also known as primary aldosteronism).
• you have ever had a condition called systemic lupus erythematosus (SLE).
• you have low blood pressure.
• you are undergoing tests to detect thyroid or parathyroid gland disorders
• you have ever had a stroke.
• you have had an allergy or asthma.
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme (ACE) inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskiren

• you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking Almus Candesartan/Hydrochlorothiazide.
• if you have had respiratory or pulmonary 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 Almus Candesartan/Hydrochlorothiazide, seek medical attention immediately.
• if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Almus Candesartan/Hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking Almus Candesartan/Hydrochlorothiazide on your own.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Almus Candesartan/Hydrochlorothiazide”.

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

If you are undergoing surgery, inform your doctor or dentist that you are taking Almus Candesartan/Hydrochlorothiazide. This is because Almus Candesartan/Hydrochlorothiazide, in combination with some anesthetics, may cause a drop in blood pressure.

If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which 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 had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing this.

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

Children and adolescents

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

Use in athletes

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

Use of Almus Candesartan/Hydrochlorothiazide with other medicines

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine. Almus Candesartan/Hydrochlorothiazide may affect the way some medicines work, and some medicines may affect the effect of Almus Candesartan/Hydrochlorothiazide. If you are taking certain medicines, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are taking any of the following medicines, as your doctor may need to modify 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) (medicines 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 colestiramine.
• 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 excretion).
• Laxatives.
• Penicillin (an antibiotic).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).

• Glucocorticoids 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.
• Ciclosporin, 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 muscle spasms), amifostine (used in cancer treatment), and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Almus Candesartan/Hydrochlorothiazide” and “Warnings and precautions”).

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

• You can take Almus Candesartan/Hydrochlorothiazide with or without food.
• When you are prescribed Almus Candesartan/Hydrochlorothiazide, consult your doctor before taking alcohol. Alcohol may cause dizziness or drowsiness.

Pregnancy, breastfeeding, and fertility

Pregnancy

Inform your doctor if you are pregnant (or if you suspect you may be).

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Almus Candesartan/Hydrochlorothiazide contains lactose and sodium

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

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

Follow exactly the administration instructions forCandesartán/Hidroclorotiazida Almusprescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

It is essential to continue takingCandesartán/Hidroclorotiazida Almusevery 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 every day. This will help you remember to take it.

If you take moreCandesartán/Hidroclorotiazida Almusthan you should

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

If you forgot to takeCandesartán/Hidroclorotiazida Almus

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt the treatment withCandesartán/Hidroclorotiazida Almus

If you stop takingCandesartán/Hidroclorotiazida Almus, your blood pressure may increase again. Therefore, do not stop takingCandesartán/Hidroclorotiazida Almusbefore consulting your doctor.

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

Like all medicines, Candesartán/Hidroclorotiazida Almus can cause side effects, although not everyone will experience them.

It is essential that you know which side effects could occur. These are usually mild and disappear over time. Some side effects of Candesartán/Hidroclorotiazida Almus are due to candesartán cilexetilo and others are due to hydrochlorothiazide.

Stop taking Candesartán/Hidroclorotiazida Almus 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 skin itching (with skin rash).

Candesartán/Hidroclorotiazida Almus can 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 occurs, inform your doctor. Your doctor may perform blood tests from time to time to check if Candesartán/Hidroclorotiazida Almus is affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 patients)

• Changes in blood test results:

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

• An increase or decrease in potassium levels in the blood, especially if you have kidney problems or heart failure. If severe, you may feel tired, weak, experience irregular heartbeats, or tingling.
• An increase in cholesterol, glucose, or uric acid levels in the blood.

• Presence of glucose in urine.
• Sensation of dizziness or weakness.
• Headache.
• Respiratory infection.

Infrequent (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 white of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you have kidney problems or heart failure.
• Difficulty sleeping, depression, or restlessness.
• Itching or prickling sensations in arms and legs.
• Blurred vision for a short period.
• Abnormal heartbeats.
• Difficulty breathing (including pulmonary inflammation and fluid in the lungs).
• Fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing red or purple spots on the skin.
• Decrease in red blood cells, white blood cells, or platelets. You may feel tired, have an infection, fever, or easily bruise.
• Severe skin reaction that develops rapidly, causing blisters and skin peeling, and possibly mouth ulcers.
• Worsening of pre-existing lupus erythematosus reactions or appearance of rare 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 yellowing of the skin and white of the eyes, and experience flu-like symptoms.
• Cough.
• Nausea.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown (cannot be estimated from 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 hemorrhage) or acute angle-closure glaucoma].

Do not be alarmed by this list of possible side effects. It is likely that you will not experience any of them.

Reporting side effects

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

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30 °C.

Do not use Candesartán/Hidroclorotiazida Almus after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Candesartán/Hidroclorotiazida Almus

- The active principles are candesartán cilexetilo and hidroclorotiazida. Each tablet contains 16 mg of candesartán cilexetilo and 12.5 mg of hidroclorotiazida.

- The other components are: docusato sódico, lauril sulfato sódico, carmelosa cálcica, almidón de maíz pregelatinizado, hidroxipropilcelulosa E 463, lactosa monohidrato, estearato de magnesio E 470b, and purified water.

Appearance of the product and content of the container

Candesartán /Hidroclorotiazida Almus 16/12.5 mg tablets are white, oval, biconvex tablets with the engraving CH and 016 on the same side (length 9.6 ± 0.2 mm).

Candesartán /Hidroclorotiazida Almus 16/12.5 mg tablets are marketed in blisters of 7, 14, 28, 56, and 98 tablets.

It may not be marketed in all container sizes in all countries.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing:

Bluepharma Indústria Farmacêutica, S.A.

S. Martinho do Bispo,

3045-016 Coimbra,

Portugal

Last review date of this leaflet: 03/2025

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