Candesartan/hydrochlorothiazide Alter 16 mg/12.5 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Candesartan/Hydrochlorothiazide Alter 16 mg/12.5 mg tablets EFG

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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Your medicine is called Candesartán/Hidroclorotiazida Alter. 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 causes blood vessels to relax and widen, which helps reduce blood pressure.
• Hidroclorotiazida belongs to a group of medicines called diuretics. It helps the body get rid of excess water and salts such as sodium through the urine. This helps lower blood pressure.

Your doctor may prescribe Candesartán/Hidroclorotiazida Alter if your blood pressure has not been adequately controlled with candesartán cilexetilo or hidroclorotiazida alone.

2. What you need to know before taking Candesartan/Hydrochlorothiazide Alter

Do not take Candesartan/Hydrochlorothiazide Alter

• 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 candesartan/hydrochlorothiazide 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 blood potassium levels.
• if you have persistently high blood calcium levels.
• 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 these situations apply to you, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartan/Hydrochlorothiazide Alter

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 radiation while taking Candesartan/Hydrochlorothiazide Alter.
• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, and may occur within hours to one week after taking candesartan/hydrochlorothiazide.
• If 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 Candesartan/Hydrochlorothiazide Alter, seek medical attention immediately.

Before starting treatment with candesartan/hydrochlorothiazide, or while taking it, inform your doctor if:

• you have diabetes.

• 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 condition called systemic lupus erythematosus (SLE).

• you have low blood pressure.

• you have ever had a stroke.

• you have had allergies or asthma.

  • you are pregnant (or suspect you might be). Candesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause severe harm to your baby when used from that point onward (see Pregnancy section).

• you are taking any of the following medicines for high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril, etc.), particularly if you have kidney problems related to diabetes.

• aliskiren.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan/Hydrochlorothiazide Alter. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan/Hydrochlorothiazide Alter without medical advice.

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 Candesartan/Hydrochlorothiazide Alter”.

If any of these conditions 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 candesartan/hydrochlorothiazide. This is because candesartan/hydrochlorothiazide, in combination with certain anesthetics, may cause a drop in blood pressure.

Candesartan/hydrochlorothiazide may increase skin sensitivity to sunlight.

Children and adolescents

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

Taking Candesartan/Hydrochlorothiazide Alter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Candesartan/hydrochlorothiazide may affect how some medicines work, and some medicines may influence the effect of candesartan/hydrochlorothiazide. 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 used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (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 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 conditions).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for cancer treatment.
• Amantadine (used to treat Parkinson's disease or serious viral infections).
• Barbiturates (a type of sedative, also used to treat epilepsy).
• Carbenoxolone (used to treat esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• 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 certain antipsychotic medicines.
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Candesartan/Hydrochlorothiazide Alter” and “Warnings and precautions”).

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

You may take candesartan/hydrochlorothiazide with or without food.

When prescribed candesartan/hydrochlorothiazide, consult your doctor before drinking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Candesartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Driving and using machines

Some patients may feel tired or dizzy while taking candesartan/hydrochlorothiazide. If this happens to you, do not drive or operate tools or machinery.

Candesartan/Hydrochlorothiazide Alter contains lactose

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

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

3. How to take Candesartan/Hydrochlorothiazide Alter

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

It is important that you continue taking Candesartan/Hydrochlorothiazide Alter every day.

The recommended 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 Candesartan/Hydrochlorothiazide Alter than you should

If you have taken more Candesartan/Hydrochlorothiazide Alter 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 medication and the amount ingested.

If you forget to take Candesartan/Hydrochlorothiazide Alter

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

If you stop taking Candesartan/Hydrochlorothiazide Alter

If you stop taking Candesartan/Hydrochlorothiazide Alter, your blood pressure may rise again. Therefore, do not stop taking this medicine 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, this medicine can cause adverse effects, although not everyone experiences them.

It is important that you are aware of the possible adverse effects. Some of the adverse effects of candesartan/hydrochlorothiazide are due to candesartan cilexetil, while others are due to hydrochlorothiazide.

Stop taking candesartan/hydrochlorothiazide 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).

Candesartan/hydrochlorothiazide may cause a decrease 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 periodic blood tests to check that candesartan/hydrochlorothiazide 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:

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

• Increased or decreased levels of potassium in the blood, especially if you already have kidney problems or heart failure. If this condition is severe, you may feel tired, weak, have irregular heartbeats, or tingling sensations.

• Increased levels of cholesterol, glucose, or uric acid in the blood.

• Presence of glucose in the 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 caused by 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 pins and needles 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.
• Decrease 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 peeling of the skin, and possibly mouth ulcers.

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

• 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 whites of the eyes, and flu-like symptoms.
• Cough.
• Nausea.
• Acute breathing difficulty (signs 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.

Not known (frequency cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).
• 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 and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rashes that may include redness, blisters, peeling, and lumps).
• Diarrhoea.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan/Hydrochlorothiazide Alter

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container or blister pack, following EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Alter

• 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: monohydrate lactose, pregelatinized corn starch, hydroxypropylcellulose, calcium carmellose, triethyl citrate, red iron oxide (E172), and magnesium stearate.

Appearance of the product and contents of the pack

Pink tablets with white specks, round, with a score line on one side.

The tablets are supplied in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date 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/