Capenon HCT 40 mg/5 mg/25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CAPENON HCT 40 mg/5 mg/25 mg film-coated tablets

Olmesartan medoxomil / Amlodipine / Hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Capenon HCT is and what it is used for
2. What you need to know before taking Capenon HCT
3. How to take Capenon HCT
4. Possible adverse effects
5. How to store Capenon HCT

Pack contents and other information

1. What Capenon HCT is and what it is used for

Capenon HCT contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate), and hydrochlorothiazide. These three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists", which lower blood pressure by relaxing blood vessels.

• Amlodipine belongs to a group of medicines called "calcium channel blockers". Amlodipine also lowers blood pressure by relaxing blood vessels.

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The combined action of these substances helps reduce your blood pressure.

Capenon HCT is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine taken as a fixed-dose combination, or
• in adult patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide together with tablets containing amlodipine alone, or a fixed-dose combination of olmesartan medoxomil and amlodipine together with tablets containing hydrochlorothiazide alone.

2. What you need to know before taking Capenon HCT

Do not take Capenon HCT:

• If you are allergic to olmesartan medoxomil, amlodipine, or a special group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medicine (listed in section 6).

If you think you may be allergic, inform your doctor before taking Capenon HCT.

• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also advisable to avoid Capenon HCT in early pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If you have very low blood pressure.
• If blood flow from your heart is slow or blocked. This may occur if blood vessels or heart valves that carry blood away from the heart are narrowed (aortic stenosis).
• If you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may make you feel short of breath or have swelling in your feet and ankles.

Do not take Capenon HCT if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Capenon HCT.

Tell your doctor 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), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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 Capenon HCT”.

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

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after sun exposure or use of sunbeds.
• 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Capenon HCT.
• If you have previously experienced breathing 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 Capenon HCT, seek medical attention immediately.

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

• Severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• 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, which may occur from a few hours to several weeks after taking Capenon HCT. This may lead to permanent vision loss if not treated.

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

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Capenon HCT may cause increased levels of lipids and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may want to perform blood tests periodically to monitor for these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to perform blood tests periodically to monitor for this possible change. Some signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, tired muscles, fatigue, weakness, slowness, tiredness, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for tests of parathyroid function, you must stop taking Capenon HCT before these tests are performed.

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

Inform your doctor if you are pregnant (or think you might be). Use of Capenon HCT is not recommended in early pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

Use of Capenon HCT is not recommended in children and adolescents under 18 years of age.

Taking Capenon HCT with other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Other blood pressure-lowering medicines, as they may enhance the effect of Capenon HCT.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Capenon HCT” and “Warnings and precautions”).

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Capenon HCT. If you need to take lithium, your doctor will monitor lithium blood levels.
• Diltiazem, verapamil, used for heart rhythm disorders and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase movement of food through the stomach and intestine.
• Difemethane, used to treat slow heart rate or to reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, medicines that increase urine output (diuretics), heparin (to thin the blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACE inhibitors) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also known as sodium benzylpenicillin), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Using these medicines together with Capenon HCT may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Capenon HCT, may increase the risk of kidney failure. The effect of Capenon HCT may be reduced by NSAIDs. High doses of salicylates may increase toxic effects on the central nervous system.
• Sleep-inducing medicines, sedatives, and antidepressants, used together with Capenon HCT, may cause a sudden drop in blood pressure upon standing.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Capenon HCT. Your doctor may advise you to take Capenon HCT at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of Capenon HCT.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (administered intravenously for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body’s immune response (e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which help the body accept a transplanted organ.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines for:

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since Capenon HCT may affect the mechanism of action of these medicines.
• Treating heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressure and decreasing heart rate, such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering blood fat levels, such as cholestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

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

Taking Capenon HCT with food and drinks:

Capenon HCT can be taken with or without food.

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

Be cautious when drinking alcohol while taking Capenon HCT, as some people may feel faint or dizzy. If this happens, avoid alcohol.

Elderly patients:

If you are over 65 years of age, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure that your blood pressure does not drop too low.

Pregnancy and breastfeeding:

Pregnancy

You must inform your doctor if you are pregnant, or think you may be pregnant. Your doctor will advise you to stop taking Capenon HCT before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Capenon HCT. The use of Capenon HCT is not recommended during pregnancy, and it must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

If you become pregnant while being treated with Capenon HCT, inform and consult your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Capenon HCT is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

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.

Driving and use of machines:

You may feel drowsy, unwell, dizzy, or experience headache while being treated for high blood pressure. If this occurs, do not drive or operate machinery until these symptoms have resolved. Consult your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Capenon HCT

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose of Capenon HCT is one tablet per day.
• The tablets may be taken with or without food. Take the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more Capenon HCT than you should:

If you take more tablets than you should, you may experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department and bring the medicine packaging or this leaflet with you.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Capenon HCT:

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

If you stop taking Capenon HCT:

It is important to continue taking Capenon HCT unless your doctor tells you to stop treatment.

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 will experience them. If they do occur, they are often mild and do not require stopping treatment.

The following adverse effects may be serious, although they affect only a small number of people:

During treatment with Capenon HCT, allergic reactions may occur, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking Capenon HCT and consult your doctor immediately.

Capenon HCT may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens to you, stop taking Capenon HCT, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching—even if you started treatment with Capenon HCT some time ago—contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Capenon HCT is a combination of three active substances. The information below first describes the adverse effects reported so far with the Capenon HCT combination (in addition to those already mentioned), and second, the known adverse effects of each active substance individually, or when two of the substances are taken together.

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

These are the other adverse effects known so far with Capenon HCT:

If these effects occur, they are often mild and you do not need to stop treatment.

Common

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nasal pain, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, feeling of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon

(may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, facial flushing and sensation of warmth, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

These are the known adverse effects for each of the active substances individually or when two of the substances are taken together:

These may be adverse effects due to Capenon HCT, even if they have not yet been observed with Capenon HCT.

Very common

(may affect more than 1 in 10 people)

Edema (fluid retention).

Common

(may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time, anaphylactic reactions, abnormally decreased appetite (anorexia), difficulty sleeping, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, altered sense of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (pain or discomfort in the chest, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, redness of the skin, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin eruption, muscle pain, difficulty urinating, feeling of needing to urinate at night, enlargement of the breasts in men, decreased sexual desire, facial swelling, feeling of malaise, weight gain or weight loss, exhaustion.

Rare

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

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), attacks (seizures), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pains, and coldness in hands and fingers, severe skin reactions including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, deterioration of movement, acute kidney failure, non-infectious inflammation of the kidney, decreased kidney function, fever, intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare

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

High muscle tension, numbness of hands or feet, heart attack, inflammation of the stomach, gum thickening, intestinal obstruction, inflammation of the liver.

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects of unknown frequency

(cannot be estimated from the available data)

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Tremors, rigid posture, mask-like face, slow movements, and shuffling gait.

Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Capenon HCT

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP.". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and any unused medicines at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Capenon HCT

The active substances are olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide.

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

The other components are:

Tablet core: Pregelatinized maize starch, silicified microcrystalline cellulose (microcrystalline cellulose with colloidal anhydrous silicon dioxide), sodium croscarmellose and magnesium stearate.

Tablet coating: Poly (vinyl alcohol), macrogol 3350, talc, titanium dioxide (E-171) and yellow iron oxide (E-172).

Appearance of the product and pack contents

Capenon HCT 40 mg/5 mg/25 mg film-coated tablets are light yellow, oval-shaped tablets measuring 15 x 7 mm, with the imprint “C54” on one side.

Capenon HCT film-coated tablets are available in:

• Blister packs containing 14, 28, 30, 56, 84, 90, 98, 10 x 28, and 10 x 30 tablets.
• Unit-dose precut blister packs containing 10, 50 and 500 tablets.
• HDPE bottles containing 7, 30 and 90 tablets.

Not all pack sizes are marketed.

Marketing Authorization Holder

Daiichi Sankyo España, S.A.

Paseo del Club Deportivo nº1,

Edificio 14, Planta baja izquierda

28223 Pozuelo de Alarcón - Madrid

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

or

Menarini – Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Italy: Giantrix 40 mg/5 mg/25 mg

Netherlands: Capenon HCT 40 mg/5 mg/25 mg

Spain: Capenon HCT 40 mg/5 mg/25 mg

Date of the most recent review of this leaflet: January 2025.

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.