Candesartan Almus 16 mg Tablets

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

Do not take Candesartan Almus:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant (it is also recommended to avoid this medicine at the start of pregnancy; see the section on pregnancy);
• if you have severe liver disease or biliary obstruction (a problem related to the drainage of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• if you have heart, liver or kidney problems or are on dialysis;
• if you have recently had a kidney transplant;
• if you have been vomiting, have recently had severe vomiting or have diarrhea;
• if you have a disease of the adrenal glands called "Conn's syndrome" (also called primary hyperaldosteronism);
• if you have very low blood pressure;
• if you have ever had a stroke;
• you must inform your doctor if you suspect that you are (or may be) pregnant. Candesartan is not recommended at the start of pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
• if 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), especially if you have kidney problems related to diabetes.
• aliskiren
• if you are taking an ACE inhibitor along with a medicine belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Other medicines and Candesartan Almus").

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Almus. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan 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 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 scheduled for surgery, inform your doctor or dentist that you are taking this medicine. This is because candesartan, when combined with certain anesthetics, can excessively lower blood pressure.

Children and adolescents

This medicine has been studied in children. For more information, talk to your doctor. This medicine should not be given to children under 1 year of age due to a potential risk to the developing kidneys.

Other medicines and Candesartan Almus

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Candesartan may affect the way other medicines work and certain medicines may affect the way this medicine works. If you are using certain medicines, your doctor may want to do blood tests from time to time.

In particular, tell your doctor if you are taking any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

• other medicines to help lower your blood pressure, including beta-blockers, diazoxide, and 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 (a medicine to relieve pain and inflammation);
• potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood);
• heparin (a blood-thinning medicine);
• co-trimoxazole (an antibiotic medicine) also known as trimethoprim/sulfamethoxazole;
• diuretic medicines;
• lithium (a medicine to treat mental health problems).

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Candesartan Almus" and "Warnings and precautions")
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Almus with food, drinks, and alcohol

• You can take this medicine with or without food.
• When your doctor prescribes this medicine, discuss with your doctor whether you can drink alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. The use of this medicine is not recommended in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is a newborn or was premature.

Driving and using machines

Some people may feel tired or dizzy when taking this medicine. If this happens to you, do not drive vehicles or use tools or machines.

Candesartan Almus contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Candesartan Almus

Follow exactly the instructions of administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is important that you take this medicine every day.

You can take this medicine with or without food.

Swallow the tablet with some water.

Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure:

• The recommended dose of this medicine is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day, depending on how your blood pressure responds.
• For some patients, such as those with liver or kidney problems, or those who have recently lost body fluids, for example, due to vomiting or diarrhea, or due to the use of diuretics, the doctor may prescribe lower initial doses.

• Some black patients may have a reduced response to this type of medicine when used as a single treatment and may need higher doses.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:< p>

The recommended starting dose is 4 mg once a day.

For patients weighing <50 kg: in some patients whose blood pressure is not adequately controlled, the doctor may decide to increase dose up a maximum of 8 mg per day.< p>

For patients weighing ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, the doctor may decide to increase the dose to 8 mg once a day and to 16 mg once a day.

Heart failure in adults:

• The recommended initial dose of this medicine is 4 mg once a day. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to 32 mg once a day. Candesartan can be taken with other medicines for heart failure; the doctor will decide what treatment is most suitable for you.

If you take more Candesartan Almus than you should

If you take more candesartan than prescribed, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartan Almus

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

Take the next dose as normal.

If you stop taking Candesartan Almus

If you stop taking this medicine, your blood pressure may increase again. Therefore, do not stop taking this medicine without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It is important that you know what these side effects may be.

Stop taking this medicine 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;
• intense itching of the skin (with the appearance of bumps).

Candesartan may reduce the number of white blood cells in your blood. Your resistance to infections may decrease and you may experience tiredness, infections, or fever. If this happens, contact your doctor. Your doctor may occasionally ask you to have blood tests to check if this medicine has affected your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• Dizziness/lightheadedness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may make you feel weak or dizzy.
• Changes in blood test results:

• Increased potassium levels in the blood, especially if you have had kidney problems or heart failure. If the increase is intense, you may notice tiredness, weakness, irregular heartbeat, or tingling.

• Effects on kidney function, especially if you have had kidney problems or heart failure. In very rare cases, kidney failure may occur.

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

• Swelling of the face, lips, tongue, and/or throat.
• Reduction in the number of red or white blood cells. You may notice tiredness, infection, or fever.
• Skin rash, hives.
• Itching.
• Back, muscle, and joint pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, yellowing of the skin and the whites of the eyes, and flu-like symptoms.
• Nausea.
• Changes in blood test results:

• Decreased sodium levels in the blood. If intense, you may notice tiredness, lack of energy, or muscle cramps.

• Cough.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Diarrhea.

Other side effects in children and adolescents

In children treated for high blood pressure, the side effects seem to be similar to those seen in adults, but occur more frequently. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Almus

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Almus

The active substance is candesartan cilexetil. Each tablet of Candesartan Almus 16 mg contains 16 mg of candesartan cilexetil.

The other ingredients are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, maize starch, diethylene glycol monoethyl ether (Transcutol), and red iron oxide (E172).

Appearance of Candesartan Almus and contents of the pack

The 16 mg tablets are round, pink, and scored on one side.

Candesartan Almus 16 mg tablets EFG are supplied in: transparent ALU/PVC blisters with 7, 14, 15, 20, 28, 30, 50, 50x1 (single-dose units), 56, 98, 98x1 (single-dose units), 100, and 300 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

This medicine is authorised in the Member States of the EEA under the following names:

NL: Candesartan cilexetil Liconsa 16 mg tablets

ES: Candesartan Almus 16 mg tablets EFG

Date of last revision of this leaflet: 03/2025

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