CAMLAD 16 mg/10 mg/12.5 mg HARD CAPSULES

Introduction

Package 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

candesartan cilexetil/amlodipine/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 further 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Camlad and what is it used for
2. What you need to know before you take Camlad
3. How to take Camlad
4. Possible side effects
5. Storage of Camlad
6. Contents of the pack and other information

1. What is Camlad and what is it used for

Your medicine is called Camlad. It is used to treat high blood pressure (hypertension) in adult patients. It contains three active substances: candesartan cilexetil, amlodipine besylate, and hydrochlorothiazide, which work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes the blood vessels relax and dilate. This helps to lower blood pressure.
• Amlodipine, which belongs to a group of medicines called calcium antagonists, also acts by relaxing the blood vessels, making it easier for blood to pass through them.
• Hydrochlorothiazide belongs to a group of medicines called diuretics. It helps the body get rid of water and salts like sodium in the urine. This helps to lower blood pressure.

The action of these substances helps to lower blood pressure.

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

2. What you need to know before you take Camlad

Do not take Camlad if:

• you are allergic to candesartan cilexetil, amlodipine, hydrochlorothiazide, dihydropyridines, sulfonamides, or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic to the components of this medicine or if you are not sure whether you are in this situation, consult your doctor before taking this medicine.

• you have severe kidney disease.
• you are unable to produce urine (anuria).
• you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• you have low levels of potassium or sodium in the blood or high levels of calcium in the blood that do not improve with treatment.
• you have ever had gout.
• you are more than 3 months pregnant.
• you have severe liver disease with or without cholestasis (bile secretion is altered or the drainage of bile from the gallbladder is blocked).
• you have poor blood flow to the tissues, with symptoms such as low blood pressure, slow pulse, rapid heartbeat, or shock (including cardiogenic shock).
• you have very low blood pressure.
• blood flow from the heart is slow or blocked. This can happen if the blood vessel or the valve that takes blood out of the heart (aortic stenosis) is narrowed.
• you have low cardiac output after a heart attack (acute myocardial infarction).

Do not take this medicine 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 medicines used to treat high blood pressure:

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

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 Camlad if".

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

• kidney problems, kidney transplant, or dialysis.
• liver disease.
• you have previously had a heart attack or stroke.
• you have cardiac or cerebral atherosclerosis.
• heart failure or problems with the heart valves or heart muscle.
• severe increase in blood pressure (hypertensive crisis).
• you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Camlad.
• severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-salt diet.
• high levels of potassium in the blood.
• problems with the adrenal glands.
• diabetes.
• lupus erythematosus (an autoimmune disease).
• allergies or asthma.
• skin reactions such as burns or rashes after sun exposure or using a sunbed.

Consult your doctorif you experience any of the following symptoms:

• severe, persistent diarrhea that causes significant weight loss. Your doctor may assess your symptoms and decide whether to continue your blood pressure medication.
• decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and can occur a few hours or weeks after taking this medicine. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this.
• If you have experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop any severe shortness of breath or difficulty breathing after taking this medicine, 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 going to have surgery, inform your doctor or dentist that you are taking this medicine. This is because this medicine, when combined with some anesthetics, can cause a significant drop in blood pressure.

As with any medicine that lowers blood pressure, a excessive drop in blood pressure can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

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

It may alter the levels of certain chemicals in the blood called electrolytes. Your doctor will probably want to do a blood test from time to time to check them. Signs of electrolyte disturbances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, laziness, tiredness, sleepiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat.

Consult your doctor if you experience any of the following symptoms

If you need to undergo parathyroid function tests, you should stop taking this medicine before these tests are performed.

You should inform your doctor if you think you are (or might become) pregnant. This medicine is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section "Pregnancy and breast-feeding").

Children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Camlad

Tell your doctor if you are taking, have recently taken, or might take any other medicines, e.g.

• Other blood pressure-lowering medicines, as the effect of this medicine may be increased. It may be necessary for your doctor to change the 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 medicines you are taking for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).
• Lithium (a medicine used to treat mood changes and some types of depression), used at the same time as this medicine, may increase lithium toxicity. If you have to take lithium, your doctor will measure your lithium levels in the blood.
• Antiepileptic medicines such as carbamazepine (medicines for epilepsy and convulsions).
• 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), a herbal remedy for depression.
• Cisapride, used to increase the movement of food in the stomach and intestine.
• Difemanil, used to treat slow heartbeats or reduce sweating.
• Halofantrine, for malaria.
• Vincamine IV, used to improve circulation in the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes that contain potassium, diuretics, heparin to thin the blood and prevent clot formation.
• Laxatives.
• Corticosteroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), penicillin (an antibiotic). The use of these medicines at the same time as this medicine may alter the potassium levels in your blood.
• Trimethoprim/sulfamethoxazole (a combination of antibiotics).
• Non-steroidal anti-inflammatory medicines (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as this medicine, may increase the risk of kidney failure. The effect of this medicine may be reduced by NSAIDs. In the case of high doses of salicylate, it may increase the toxic effect on the central nervous system.
• Sleeping medicines, sedatives, and antidepressants, as the use of these medicines with this medicine may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medicine that lowers the level of cholesterol in your blood, as the effect of this medicine may be reduced. Your doctor may advise you to take this medicine at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion or stomach acid) as the effect of this medicine 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 abnormalities).
• Simvastatin, used to reduce cholesterol and fat (triglycerides) levels in the blood.
• Medicines used to control the immune response of your body (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporin), which allow your body to accept a transplanted organ.
• Medicines used to treat certain mental health problems, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, droperidol, or haloperidol.
• Medicines used to treat hypoglycemia (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), as this medicine may affect the functioning of these medicines.
• Medicines used to treat heart rhythm problems such as dofetilide or ibutilide.
• Medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Medicines used to treat fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Medicines used to treat heart problems such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Medicines used to treat cancer such as amifostine, cyclophosphamide, or methotrexate.
• Medicines used to increase blood pressure (such as noradrenaline) and decrease heart rate.
• Medicines used to treat infections, such as the antibiotics called tetracyclines or sparfloxacin, as well as pentamidine.
• Medicines used to treat seasonal allergic reactions such as mizolastine or terfenadine.
• Medicines used to treat gout such as probenecid, sulfinpyrazone, and allopurinol.
• Medicines used to reduce fat levels in the blood, such as cholestyramine and colestipol.
• Medicines to reduce blood sugar levels, such as metformin or insulin.

Taking Camlad with food, drinks, and alcohol

You can take this medicine with or without food.

People taking this medicine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can cause an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of this medicine.

You should be cautious when drinking alcohol while taking this medicine, as some people feel dizzy or faint. If this happens to you, do not drink alcohol.

Elderly patients

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

Pregnancy, breast-feeding, and fertility

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

Pregnancy

Your doctor will usually advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will recommend that you take a different medicine instead. This medicine is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from this point onwards.

If you become pregnant during treatment with this medicine, inform your doctor and go to see them immediately.

Breast-feeding

Amlodipine and hydrochlorothiazide have been shown to pass into breast milk in small amounts. If you are breast-feeding or plan to start breast-feeding, inform your doctor before taking this medicine. Your doctor may choose a different treatment for you if you want to breast-feed, especially if your baby is a newborn or was born prematurely.

Fertility

Clinical data are insufficient in relation to the potential effect of this medicine on fertility.

Driving and using machines

You may feel drowsy, tired, dizzy, or have a headache during treatment for high blood pressure. Do not drive or use machines while you have these symptoms. Ask your doctor for advice.

Camlad contains lactose

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

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

These may cause allergic reactions.

3. How to Take Camlad

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

• The recommended dose is one capsule once a day of 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 grapefruit.
• If possible, take your daily dose at the same time every day, for example, at breakfast time.

Pediatric Population

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

Elderly Patients

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

Renal Insufficiency

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

Hepatic Insufficiency

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

If You TakeMore Camlad Than You Should

If you take more capsules than you should, you may suffer from arterial hypotension with symptoms such as dizziness, rapid or slow heartbeats.

Excess fluid may accumulate in your lungs (pulmonary edema) causing difficulty breathing that can 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 center or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Miss a Dose ofCamlad

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

If You Interrupt Treatment with Camlad

It is important 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.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Stop taking this medication and go to your doctor immediately if you experience any of the following serious adverse effects after taking this medication:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes great difficulty breathing.
• Severe skin reactions such as intense skin rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, abnormal heartbeats.
• Pancreatitis that can cause intense abdominal and back pain accompanied by general discomfort.
• This medication may produce 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. It is possible that your doctor will perform blood tests from time to time to check that this medication is not affecting your blood (agranulocytosis).
• Severe and sudden eye pain, red eye, altered or blurred vision, and presence of halos around light sources along with nausea/vomiting. This can be a symptom of fluid retention in the eye (between the choroid and retina) or acute narrow-angle glaucoma that can occur when the pressure of the fluid in the eye increases rapidly. Immediate treatment is necessary to reduce symptoms and prevent permanent vision loss (severe visual impairment).

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

To give you an idea of how many patients may suffer from side effects, they have been classified as very frequent, frequent, infrequent, rare, very rare, and unknown.

Very Frequent (May Affect More Than 1 in 10 People)

• Edema (fluid retention).

Frequent (May Affect Less Than 1 in 10 People)

• Hypokalemia (decrease in potassium levels in the blood), especially at high doses.
• Increased serum lipids.
• Respiratory infection.
• Hyperglycemia.
• Hyperuricemia.
• Somnolence.
• Dizziness, vertigo, headache.
• Visual disturbances (including double vision).
• Palpitations (alteration of heartbeats).
• Redness of the skin including a feeling of heat.
• Difficulty breathing.
• Abdominal pain, dyspepsia, nausea.
• Alteration of intestinal habits, constipation, diarrhea.
• Skin rash, hives.
• Swelling of the ankles.
• Muscle cramps.
• Fatigue, weakness.

Infrequent (May Affect Less Than 1 in 100 People)

• Depression, mood changes (including anxiety), insomnia.
• Tremors.
• Vomiting.
• Dysgeusia.
• Syncope.
• Hypoesthesia, paresthesia (abnormal sensation).
• Tinnitus.
• Cardiac arrhythmia (including slow heart rate (bradycardia)).
• Rapid heartbeats (ventricular tachycardia) and irregular heartbeats (atrial fibrillation).
• Hypotension (decrease in blood pressure), orthostatic hypotension (decrease in 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, itching of the skin, red spots on the skin,

skin discoloration.

• Discomfort.
• Chest pain, pain, back pain.
• Arthralgia (joint pain).
• Myalgia (muscle pain).
• Urination disorders, nocturia, increased urination frequency.
• Impotence, discomfort or increased breast size in men, inability to obtain an erection.
• Decreased appetite,
• Weight gain or loss.
• Photosensitive reactions.

Rare (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 with symptoms such as skin rash, red-purple spots on the skin, fever.
• Gastrointestinal disorders.
• Pancreatitis.
• Confusion.
• Sleep disorders.
• Jaundice (yellowish or greenish pigmentation of the skin and the whites of the eyes).
• Renal failure and deterioration.
• Fever.

Very Rare (May Affect Less Than 1 in 10,000 People)

• Blood disorders such as neutropenia (decrease in the number of neutrophils, a type of white blood cell).
• Bone marrow depression (decrease in the blood-forming activities of the bone marrow).
• Severe breathing difficulties.
• Red spots and blisters on the skin with a "bull's-eye" appearance, fatigue, fever, pain or swelling in the joints, and kidney problems: these are the most frequent symptoms of a disease called lupus erythematosus.
• Skin rash with red scaly spots that do not itch.
• Hemolytic anemia.
• Allergic reactions.
• Vasculitis.
• Hyperkalemia.
• Increased muscle tone.
• Peripheral neuropathy.
• Gastritis.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Gingival hyperplasia.
• Increased liver enzymes, altered liver function, hepatitis.

Unknown (Frequency Cannot Be Estimated from Available Data)

• Aplastic anemia (a disease in which the bone marrow and the blood's hematopoietic system deteriorate).
• Extrapyramidal disorder (clinical syndromes with excess movement or scarcity of voluntary and involuntary movements, not related to weakness or spasticity).
• Acute renal failure.
• Skin and lip cancer (non-melanoma skin cancer).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medications for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Camlad

Do not store at a temperature above 30°C.

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Camlad Composition

The active ingredients are:

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

The active ingredients are 16 mg of candesartan cilexetil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide in each capsule.

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

The active ingredients are 16 mg of candesartan cilexetil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide in each capsule.

The other components are:

Capsule filling: Lactose monohydrate, cornstarch, hydroxypropylcellulose, calcium carmellose, macrogol type 8000, pregelatinized starch, magnesium stearate.

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

• Body: Titanium dioxide (E171), Gelatin.
• Cap: Orange-yellow S (E110), Titanium dioxide (E171), Gelatin.

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

• Body: Titanium dioxide (E171), Gelatin.
• Cap: Azorubine (E122), Orange-yellow S (E110), Titanium dioxide (E171), Gelatin.

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

Product Appearance and Packaging Contents

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

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

This medication is available in packages of 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta.

28023 Madrid.

Spain.

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Józefa Pilsudskiego 5.

95-200 Pabianice.

Poland.

Date of the Last Revision of this Prospectus:December 2024.

Other Sources of Information

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