Leaflet: information for the patient

Camlad 16 mg/5 mg/12.5 mg hard capsules

Camlad 16 mg/10 mg/12.5 mg hard capsules

candesartán cilexetilo/amlodipino/hidroclorotiazida

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Your medication is called Camlad. It is used for the treatment of high blood pressure (hypertension) in adult patients. It contains three active ingredients: candesartan cilexetilo, amlodipine besilate, and hydrochlorothiazide that work together to lower blood pressure.

• Candesartan cilexetilo belongs to a group of medications called angiotensin II receptor antagonists. It causes blood vessels to relax and dilate. This facilitates the lowering of blood pressure.
• Amlodipine, which belongs to a group of medications called calcium channel blockers, also acts by relaxing blood vessels, which facilitates the passage of blood through them.
• Hydrochlorothiazide belongs to a group of medications called diuretics. It promotes the body's elimination of water and salt, such as sodium, in the urine. This facilitates the lowering of blood pressure.

The action of these substances contributes to lowering blood pressure.

This medication may be used to treat high blood pressure (hypertension) in adult patients who are adequately controlled with the individual products administered simultaneously at the same dose level as in the combination, but as separate tablets.

Do not take Camlad if:

• You are allergic to candesartan cilexetilo, amlodipine, hydrochlorothiazide, dihydropyridine derivatives, sulfonamides, or any of the other components of this medication (listed in section 6).

If you think you may be allergic to the components of this medication or are unsure if you are in this situation, consult your doctor before taking this medication.

• You have severe kidney disease.
• You are unable to produce urine (anuria).
• You have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• You have low levels of potassium or sodium in your blood or high levels of calcium in your blood that do not improve with treatment.
• You have ever had gout.
• You are more than three months pregnant.
• You have severe liver disease with or without cholestasis (bile secretion is altered or bile drainage from the gallbladder is blocked).
• You have poor blood flow to tissues, with symptoms such as low blood pressure, slow pulse, rapid heart rate, or shock (including cardiogenic shock).
• You have very low blood pressure.
• The blood flow from the heart is slow or blocked. This can occur if the blood vessel or valve that removes blood from the heart is narrowed (aortic stenosis).
• You have low cardiac output after a heart attack (acute myocardial infarction).

Do not take this medication if you are in any of these situations.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Camlad.

Consult your doctorif you are taking any of the following medications used to treat high blood pressure:

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.
• An angiotensin-converting enzyme inhibitor (ACE inhibitor) together with a medication that belongs to the class of medications known as mineralocorticoid receptor antagonists (MRAs). These medications are used to treat heart failure (see "Other medications and Camlad").

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Camlad if."

Consult your doctorif you have any of the following health problems:

• Kidney problems, kidney transplant, or dialysis.
• Liver disease.
• You have had a heart attack or stroke in the past.
• You have coronary or cerebral atherosclerosis.
• Heart failure or problems with heart valves or muscle.
• Severe high blood pressure (hypertensive crisis).
• You have had skin cancer or develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, especially 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 Camlad.
• Intense vomiting, diarrhea, high doses of diuretics, or a low-sodium diet.
• High potassium levels in your blood.
• Problems with the adrenal glands.
• Diabetes.
• Lupus erythematosus (autoimmune disease).
• Allergies or asthma.
• Reactions such as burns or rashes after exposure to the sun or using a tanning bed.

Consult your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor may evaluate your symptoms and decide whether to continue your blood pressure medication.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may occur a few hours or weeks after taking this medication. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this.
• Respiratory or pulmonary problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Camlad. Your doctor will decide whether to continue treatment. Do not stop taking Camlad on your own.

If you are undergoing surgery, inform your doctor or dentist that you are taking this medication. This is because this medication, when combined with certain anesthetics, can cause excessive lowering of blood pressure.

As with any medication that lowers blood pressure, excessive lowering of blood pressure can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

This medication may cause an increase in cholesterol in the blood and uric acid (the cause of gout - painful swelling of the joints). Your doctor may request blood tests to check for this.

This medication may alter the levels of certain substances in the blood called electrolytes. Your doctor will likely want to perform blood tests from time to time to check for this. Signs of electrolyte imbalances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, lethargy, fatigue, sleepiness, or restlessness, nausea, vomiting, decreased need to urinate, rapid heart rate.

Consult your doctor if you experience any of the following symptoms:

If you need to undergo parathyroid function tests, stop taking this medication before the tests are performed.

Inform your doctor if you think you are (or may become) pregnant. This medication is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section "Pregnancy and breastfeeding").

Children and adolescents

This medication is not recommended for children and adolescents under 18 years old.

Other medications and Camlad

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, e.g.

• Other blood pressure-lowering medications, as the effect of this medication may be increased. Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Camlad if" and "Warnings and precautions").

• ACE inhibitor together with some other medications you are taking to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).
• Lithium (a medication used to treat mood changes and certain types of depression), used at the same time as this medication may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Antiepileptic medications such as carbamazepine (medications for epilepsy and seizures).
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, used for tuberculosis and other infections.
• St. John's Wort (Hypericum perforatum), herbal remedy for depression treatment.
• Cisapride, used to increase the movement of food in the stomach and intestines.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Halofantrine, for malaria.
• Vincamine IV, used to improve nervous system circulation.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, diuretics, heparin to thin the blood and prevent clotting.
• Laxatives.
• Glucocorticoids, adrenocorticotropic hormone (ACTH), carbenoxolone (medication used to treat mouth and stomach ulcers), penicillin (antibiotic). The use of these medications at the same time as this medication may alter the concentration of potassium in your blood.
• Trimethoprim / sulfamethoxazole (combination of antibiotics).
• Non-steroidal anti-inflammatory drugs (NSAIDs, medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as this medication may increase the risk of kidney failure. The effect of this medication may be reduced by NSAIDs. In high doses of salicylate, it may increase the toxic effect on the central nervous system.
• Sleeping pills, sedatives, and antidepressants, as the use of these medications with this medication may cause a sudden drop in blood pressure when standing up.
• Cholestyramine hydrochloride, a medication that reduces cholesterol levels in your blood, as the effect of this medication may be reduced. Your doctor may advise you to take this medication at least 4 hours before cholestyramine hydrochloride.
• Certain antacids (remedies for indigestion or stomach acid) as the effect of this medication may be slightly reduced.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Anticholinergic agents such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (infusion for severe body temperature anomalies).
• Simvastatin, used to reduce cholesterol and triglyceride levels in the blood.
• Medications used to control the immune response of your body (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which allow your body to accept the transplanted organ.
• Medications used to treat certain mental health problems, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Medications used to treat hypoglycemia (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), as this medication may affect the functioning of these medications.
• Medications used to treat heart rhythm problems such as dofetilide or ibutilide.
• Medications used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Medications used to treat fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Medications used to treat heart problems such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Medications used to treat cancer such as amifostine, cyclophosphamide, or methotrexate.
• Medications used to increase blood pressure (e.g., norepinephrine) and decrease heart rate.
• Medications used to treat infections, such as tetracyclines or ciprofloxacin, as well as pentamidine.
• Medications used to treat seasonal allergies such as mizolastine or terfenadine.
• Medications used to treat gout such as probenecid, sulfinpyrazone, and allopurinol.
• Medications used to reduce cholesterol and triglyceride levels in the blood, such as cholestyramine and colestipol.
• Medications used to reduce blood sugar levels, such as metformin or insulin.

Taking Camlad with food, drinks, and alcohol,beveragesandalcohol

You can take this medication with or without food.

People taking this medication should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may cause unpredictable lowering of blood pressure.

Be cautious when drinking alcohol while taking this medication, as some people may feel dizzy or lightheaded. If this happens, do not drink alcohol.

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure when increasing the dose to ensure it does not drop too low.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Your doctor will usually recommend that you stop taking this medication before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of this one. This medication is not recommended during pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if used at that stage.

If you become pregnant while taking this medication, inform your doctor and seek medical attention without delay.

Breastfeeding

It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. If you are breastfeeding or plan to start breastfeeding, inform your doctor before taking this medication, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is a newborn or was born prematurely.

Fertility

Insufficient clinical data are available regarding the potential effect of this medication on fertility.

Driving and operating machinery

You may feel drowsy, tired, dizzy, or have headaches during high blood pressure treatment. Do not drive or operate machinery while experiencing symptoms. Ask your doctor for advice.

Camlad contains Lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Camlad contains Yellow Orange S (E110) and Azorubine (E122)

It may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor.

• The recommended dose is one capsule once a day at the concentration proposed by your doctor.
• The capsule can be taken with or without food. Swallow the capsule with some liquid (for example, a glass of water). The capsule should not be chewed. Do not take the capsule with grapefruit juice or with grapefruit.
• Try to take your daily dose at the same time each day, for example, at breakfast time.

Paediatric population

This medication is not recommended for children under 18 years of age, as its safety and efficacy have not been established.

Geriatric patients

Geriatric patients should exercise special caution due to their susceptibility to electrolyte imbalance.

Renal impairment

Regular monitoring of renal function is recommended when using this medication in patients with mild to moderate renal impairment. This medication is contraindicated in patients with severe renal impairment.

Hepatic impairment

Close monitoring of blood pressure and renal function is recommended in patients with hepatic impairment. This medication is contraindicated in patients with severe hepatic impairment.

If you takemore Camlad than you should

If you take more capsules than you should, you may experience hypotension with symptoms such as dizziness, rapid or slow heart rate.

Excess fluid may accumulate in your lungs (pulmonary edema) causing breathing difficulty that may develop up to 24-48 hours after ingestion.

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

If you forget to takeCamlad

If you forget to take a dose, take your normal dose the next day as usual. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Camlad

It is essential that you continue taking this medication unless your doctor tells you to stop.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking this medicineand seek medical attention immediately if you experience any of the following severe side effects after taking this medicine:

• abrupt onset of wheezing, chest pain, shortness of breath, or difficulty breathing.
• swelling of the eyelids, face, or lips.
• swelling of the tongue and throat that causes severe difficulty breathing.
• severe skin reactions such as intense skin rash, urticaria, skin redness all over the body, intense itching, blisters, peeling, and skin swelling, Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions.
• myocardial infarction, abnormal heartbeats.
• pancreatitis that can cause severe abdominal and back pain accompanied by general discomfort.
• This medicine can cause a decrease in the number of 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 this medicine is affecting your blood (agranulocytosis).
• intense and sudden eye pain, red eye, altered or blurred vision, and presence of rings around light sources accompanied by nausea/vomiting. This can be a symptom of fluid retention in the eye (between the choroid and retina) or acute angle-closure glaucoma that can occur when the pressure in the eye increases rapidly. Immediate treatment is necessary to reduce symptoms and prevent permanent vision loss (severe visual impairment).

This medicine is a combination of three active substances. The following information includes known side effects for each substance separately.

To give you an idea of how many patients may experience side effects, they have been classified as very common, common, uncommon, rare, very rare, and unknown.

Very common (may affect more than 1 in 10 people)

• edema (fluid retention).

Common (may affect less than 1 in 10 people)

• hypokalemia (decreased potassium levels in the blood), especially at high doses
• increased serum lipids
• respiratory infection
• hyperglycemia
• hyperuricemia
• drowsiness
• nausea, dizziness, headache
• visual disturbances (including double vision)
• palpitations (abnormal heartbeats)
• skin redness including feeling of heat
• difficulty breathing
• abdominal pain, indigestion, nausea
• alteration of bowel habits, constipation, diarrhea
• skin rash, urticaria
• swelling of ankles
• muscle cramps
• fatigue, weakness

Uncommon (may affect less than 1 in 100 people)

• depression, mood changes (including anxiety), insomnia
• tremors
• vomiting
• disturbance of taste
• syncope
• numbness, paresthesia (abnormal sensation)
• tinnitus
• cardiac arrhythmia (including slow heart rate (bradycardia))
• rapid heartbeats (ventricular tachycardia) and irregular heartbeats (atrial fibrillation)
• hypotension (low blood pressure), orthostatic hypotension (low blood pressure, may increase with alcohol consumption, simultaneous administration of anesthetic or sedative drugs)
• hypomagnesemia, hypercalcemia, hypochloremic alkalosis, hypophosphatemia
• hyponatremia (low sodium levels in the blood)
• cough
• rhinitis
• dry mouth
• hair loss, increased sweating, skin itching, red skin patches,

skin discoloration

• uncomfortable feeling
• chest pain, pain, back pain
• arthralgia (joint pain)
• myalgia (muscle pain)
• urination alterations, nocturia, increased frequency of urination
• impotence, discomfort or enlargement of breasts in men, inability to achieve erection
• decreased appetite,
• weight gain or loss
• photoallergic reactions

Uncommon (may affect less than 1 in 1,000 people)

• thrombocytopenia (abnormally low platelet levels in the blood), sometimes with skin bleeding (purpura)
• difficulty breathing with cough and fatigue or cough with blood
• vasculitis (inflammation and destruction of blood vessels) with symptoms such as skin rash, red skin patches, fever
• gastrointestinal alterations
• pancreatitis
• confusion
• sleep disturbances
• jaundice (yellow or greenish discoloration of the skin and white of the eyes)
• acute renal insufficiency
• fever.

Very rare (may affect less than 1 in 10,000 people)

• blood disorders such as neutropenia (decreased neutrophil levels, a type of white blood cell)
• bone marrow depression (decreased blood cell formation in the bone marrow)
• severe respiratory difficulty
• red skin patches and blisters on the skin with a "target" red appearance, fatigue, fever, joint pain, and kidney problems: these are the most common symptoms of a disease called lupus erythematosus
• skin rash with red scaly patches that do not itch
• hemolytic anemia
• allergic reactions
• vasculitis (inflammation and destruction of blood vessels)
• hyperpotasemia
• muscle hypertonia
• peripheral neuropathy
• gastritis
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• gingival hyperplasia
• increased liver enzymes, liver function alterations, hepatitis.

Unknown (frequency cannot be estimated from available data)

• aplastic anemia (disease in which the bone marrow and hematopoietic system of the blood deteriorate)
• extrapyramidal disorder (clinical syndromes with excessive movement or lack of voluntary and involuntary movements, not related to weakness or spasticity)
• acute renal insufficiency
• skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experience any type of side effect, consult your doctororpharmacist,even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 86°F (30°C).

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Camlad

The active principles are:

Camlad 16 mg/5 mg/12.5 mg hard capsules:

The active principles are 16 mg of candesartan cilexetilo, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide in each capsule.

Camlad 16 mg/10 mg/12.5 mg hard capsules:

The active principles are 16 mg of candesartan cilexetilo, 10 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide in each capsule.

The other components are:

Filling of the capsule: Lactose monohydrate, cornstarch, hydroxypropylcellulose, calcium carmelose, macrogol type 8000, pregelatinized starch, magnesium stearate.

Capsule coating (16 mg/5 mg/12.5 mg):

• Body: Titanium dioxide (E171), Gelatin
• Crown: Yellow-orange S (E110), Titanium dioxide (E171), Gelatin

Capsule coating (16 mg/10 mg/12.5 mg):

• Body: Titanium dioxide (E171), Gelatin
• Crown: Azorubine (E122), Yellow-orange S (E110), Titanium dioxide (E171), Gelatin

Ink: Shellac, Iron oxide black (E172), Propylene glycol, Concentrated ammonia solution, Potassium hydroxide.

Appearance of the product and contents of the package

Camlad 16 mg/5 mg/12.5 mg hard capsules:

Hard gelatin capsule size “0”; white body with black printing, “1”, orange cap with black printing, “CAH”, filled with white to off-white powder.

Camlad 16 mg/10 mg/12.5 mg hard capsules:

Hard gelatin capsule size “0”; white body with black printing, “2”, red cap with black printing, “CAH”, filled with white to off-white powder.

This medicine is available in packages of 30 hard capsules.

Marketing authorization holder and responsible for manufacturing

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Responsible for manufacturing

Adamed Pharma S.A.

Ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice,

Poland

Last review date of this leaflet:December 2024.

Other sources of information

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