Camlad 16 mg/5 mg/12.5 mg hard capsules

Package leaflet: Information for the user

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 the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Camlad is and what it is used for

Your medicine is called Camlad. It is used for the treatment of 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 known as angiotensin II receptor antagonists. It causes blood vessels to relax and widen, thereby helping to reduce blood pressure.
• Amlodipine, which belongs to a group of medicines known as calcium antagonists, also relaxes blood vessels, making it easier for blood to flow through them.
• Hydrochlorothiazide belongs to a group of medicines known as diuretics. It helps the body eliminate water and salts such as sodium through the urine. This contributes to lowering blood pressure.

The action of these substances helps reduce blood pressure.

This medicine 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 levels as in the combination, but as separate tablets.

2. What you need to know before taking Camlad

Do not take Camlad if:

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

If you think you may be allergic to any of the components of this medicine or are unsure whether this applies to you, consult your doctor before taking this medicine.

• you have severe kidney disease.
• you are unable to produce urine (anuria).
• you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing 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 three months pregnant.
• you have severe liver disease, with or without cholestasis (bile secretion is impaired or bile drainage from the gallbladder is blocked).
• you have poor blood perfusion to 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 may occur if the blood vessel or valve carrying blood away from the heart is narrowed (aortic stenosis).
• you have low cardiac output following a myocardial infarction (acute myocardial infarction).

Do not take this medicine if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting Camlad.

Consult your doctor if 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), particularly if you have kidney problems related to diabetes.
• Aliskiren.
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) together with a medicine belonging to the class known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Camlad").

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 Camlad if”.

Consult your doctor if you have any of the following health conditions:

• kidney problems, kidney transplant, or dialysis.
• liver disease.
• you have previously had a myocardial infarction or stroke.
• you have cardiac or cerebral atherosclerosis.
• heart failure or problems with heart valves or heart muscle.
• severe increase in blood pressure (hypertensive crisis).
• you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 rays while taking Camlad.
• severe vomiting, diarrhea, treatment with high-dose diuretics, or if you are on a low-salt diet.
• elevated potassium levels in the blood.
• adrenal gland disorders.
• diabetes.
• lupus erythematosus (an autoimmune disease).
• allergies or asthma.
• skin reactions such as burns or rashes after sun exposure or use of a tanning bed.

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

• severe, persistent diarrhea leading to 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 eye pressure and may occur within hours or weeks of taking this medicine. This may lead to permanent vision impairment if not treated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• If you have previously experienced respiratory or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking this medicine, seek immediate medical attention.

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 medicine. This is because this medicine, when combined with certain anesthetics, may cause excessive lowering of blood pressure.

As with any medicine that lowers blood pressure, excessive reduction in blood pressure may lead to myocardial infarction or stroke. Therefore, your doctor will carefully monitor your blood pressure.

This medicine may cause increased blood cholesterol levels and elevated uric acid (the cause of gout – painful joint swelling). Your doctor may request blood tests to monitor this.

It may alter blood levels of certain chemicals called electrolytes. Your doctor will likely perform periodic blood tests to check these. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), weakness, lethargy, fatigue, drowsiness, restlessness, nausea, vomiting, reduced need to urinate, and rapid heartbeat.

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

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

Inform your doctor if you think you are (or may become) pregnant. This medicine 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 if used at that stage (see section "Pregnancy and lactation").

Children and adolescents

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

Other medicines and Camlad

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

• Other antihypertensive medicines, as their effects may be enhanced. Your doctor may need to adjust your dose and/or take other precautions:

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

• An ACE inhibitor together with 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 disorders and certain types of depression), used concurrently with this medicine may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
• Antiepileptic medicines such as carbamazepine (medicines for epilepsy and seizures).
• Diltiazem, verapamil, used for heart rhythm disorders 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 gastrointestinal motility.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Halofantrine, for malaria.
• IV vincamine, used to improve nervous system circulation.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, diuretics, heparin used to thin the blood and prevent clotting.
• Laxatives.
• Steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), penicillin (antibiotic). Using these medicines together with this medicine may alter potassium levels in your blood.
• Trimethoprim/sulfamethoxazole (combination antibiotics).
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used together with this medicine may increase the risk of kidney failure. The effect of this medicine may be reduced by NSAIDs. With high doses of salicylate, central nervous system toxicity may increase.
• Sleeping pills, sedatives, and antidepressants, as using these medicines with this medicine may cause a sudden drop in blood pressure upon standing.
• Colestipol hydrochloride, a medicine that lowers cholesterol levels 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 colestipol hydrochloride.
• Certain antacids (remedies for indigestion or stomach acidity), 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 lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control your body’s immune response (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which help your body accept a transplanted organ.
• Medicines used to treat certain mental health conditions, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, 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 how these medicines work.
• Medicines used to treat heart rhythm disorders 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 conditions 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 reduce heart rate.
• Medicines used to treat infections, such as 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 lower blood fat levels, such as cholestyramine and colestipol.
• Medicines to lower blood sugar, such as metformin or insulin.

Taking Camlad with food, drinks, and alcohol

You may 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 may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of this medicine.

Exercise caution when drinking alcohol while taking this medicine, as some people may feel dizzy or faint. If this occurs, do not drink alcohol.

Elderly patients

If you are over 65 years of age, 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will generally advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during pregnancy and must not be used after the third month of pregnancy, as it may cause severe harm to your baby if used from that point onward.

If you become pregnant while taking this medicine, inform your doctor immediately.

Breastfeeding

It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, inform your doctor before taking this medicine. Your doctor may choose an alternative treatment, especially if your baby is a newborn or was born prematurely.

Fertility

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

Driving and use of machines

You may feel drowsy, tired, dizzy, or have headaches during hypertension treatment. Do not drive or operate machinery while experiencing these symptoms. Seek advice from your doctor.

Camlad contains Lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Camlad contains the colouring agents Sunset Yellow FCF (E110) and Azorubine (E122)

These may cause allergic-type reactions.

3. How to take Camlad

Follow exactly the administration instructions for this medicine as given by your doctor.

• The recommended dose is one capsule once daily of the strength prescribed by your doctor.
• The capsule may be taken with or without food. Swallow the capsule with a liquid (for example, a glass of water). The capsule must not be chewed. Do not take the capsule with grapefruit juice or grapefruit.
• If possible, take your daily dose at the same time each day, for example, at breakfast time.

Paediatric population

This medicine 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 impairment

Periodic monitoring of renal function is recommended when this medicine is used in patients with mild to moderate renal impairment. This medicine 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 medicine is contraindicated in patients with severe hepatic impairment.

If you take more Camlad than you should

If you take more capsules than you should, you may experience hypotension with symptoms such as dizziness, fast or slow heartbeat.

Excess fluid may accumulate in your lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.

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

If you forget to take Camlad

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

If you stop taking Camlad

It is important that you continue taking this medicine unless your doctor tells you to stop.

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

4. Possible adverse effects

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

Stop taking this medicine and contact your doctor immediately if you experience any of the following serious adverse effects after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat causing severe difficulty breathing.
• Severe skin reactions such as intense rash, hives, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, abnormal heartbeats.
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by general malaise.
• This medicine may 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 periodically to check that this medicine is not affecting your blood (agranulocytosis).
• Sudden, severe eye pain, red eye, blurred or altered vision, seeing halos around lights, together with nausea/vomiting. This may be a symptom of fluid retention in the eye (between the choroid and retina) or acute narrow-angle glaucoma, which can occur when the pressure of the fluid in the eye increases rapidly. Immediate treatment is necessary to relieve 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 of the substances individually.

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 up to 1 in 10 people)

• Hypokalemia (decreased potassium levels in blood), especially at high doses
• Increase in serum lipids
• Respiratory infection
• Hyperglycemia
• Hyperuricemia
• Somnolence
• Dizziness, vertigo, headache
• Visual disturbances (including double vision)
• Palpitations (irregular heartbeat)
• Skin redness including sensation of warmth
• Difficulty breathing
• Abdominal pain, dyspepsia, nausea
• Changes in bowel habits, constipation, diarrhea
• Skin rash, urticaria
• Swelling of ankles
• Muscle cramps
• Fatigue, weakness

Uncommon (may affect up to 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 (low blood pressure), orthostatic hypotension (decreased blood pressure, which may be increased by alcohol consumption, or concomitant administration of anesthetic or sedative drugs)
• Hypomagnesemia, hypercalcemia, hypochloremic alkalosis, hypophosphatemia
• Hyponatremia (low sodium levels in blood)
• Cough
• Rhinitis
• Dry mouth
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Malaise
• Chest pain, pain, back pain
• Arthralgia (joint pain)
• Myalgia (muscle pain)
• Urinary disturbances, nocturia, increased frequency of urination
• Impotence, discomfort or enlargement of breasts in men, inability to achieve an erection
• Decreased appetite
• Weight gain or weight loss
• Photosensitivity reactions

Uncommon (may affect up to 1 in 1,000 people)

• Thrombocytopenia (abnormally low platelet count), sometimes with skin bleeding (purpura)
• Breathing difficulty with cough and fatigue or coughing up blood
• Inflammation of blood vessels with symptoms such as skin rash, purple-red spots on the skin, fever
• Gastrointestinal disturbances
• Pancreatitis
• Confusion
• Sleep disorders
• Jaundice (yellowish or greenish pigmentation of the skin and whites of the eyes)
• Renal failure and kidney impairment
• Fever.

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

• Blood disorders such as neutropenia (decreased number of neutrophils, a type of white blood cell)
• Bone marrow depression (reduced blood-forming activity of the bone marrow)
• Severe breathing difficulty
• Red, bull's-eye-like blisters on the skin, fatigue, fever, joint pain or swelling, 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)
• Hyperkalemia
• Increased muscle tone
• Peripheral neuropathy
• Gastritis
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhea
• Gingival hyperplasia
• Increased liver enzymes, liver function abnormalities, hepatitis.

Not known (frequency cannot be estimated from available data)

• Aplastic anemia (a condition in which the bone marrow and blood-forming system deteriorate)
• Extrapyramidal disorder (clinical syndromes with excessive movement or lack of voluntary and involuntary movements, unrelated to weakness or spasticity)
• Acute renal failure
• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Camlad

Do not store above 30°C.

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

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Camlad

The active substances are:

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

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

The other components are:

Capsule filling: Lactose monohydrate, corn starch, hydroxypropylcellulose, calcium carmellose, polyethylene glycol 8000, pregelatinized starch, magnesium stearate.

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

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

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

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

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

Appearance of the product and contents of the pack

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 almost 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 imprint “CAH”, filled with white to almost white powder.

This medicine is available in packs of 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 - 2nd floor
28023 Madrid
Spain

Manufacturer

Adamed Pharma S.A.
Ul. Marszalka Józefa Pilsudskiego 5
95-200 Pabianice,
Poland

Further information about this medicine can be obtained by contacting the local representative of the Marketing Authorization Holder:

Atika Pharma S.L.
Calle Viera y Clavijo, 30, 2nd floor
35002 Las Palmas de Gran Canaria
Spain

Date of the most recent review of this leaflet: December 2024.

Other sources of information

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