Package Insert: Information for the User

SEVIKAR HCT 40 mg/5 mg/25 mg Film-Coated Tablets

Olmesartan medoxomil / Amlodipine / Hydrochlorothiazide

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should 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 package insert. See section 4.

6. Contents of the pack and additional information

Sevikar HCT contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide. The three substances help control high blood pressure.

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

• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine also decreases blood pressure by relaxing blood vessels.

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It decreases blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

The action of these substances contributes to decreasing blood pressure.

Sevikar 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 patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide, along with tablets containing only amlodipine, or a fixed-dose combination of olmesartan medoxomil and amlodipine, along with tablets containing only hydrochlorothiazide.

Do not take Sevikar HCT

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

Inform your doctor before taking Sevikar HCT if you think you may be allergic.

• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also best to avoid Sevikar HCT at the beginning of pregnancy - see the section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile duct drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellow skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• If you have very low blood pressure.
• If your heart's blood flow is slow or blocked. This can happen if the blood vessels or heart valves that capture blood from the heart become narrowed (aortic stenosis).
• If you have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output can make you feel short of breath or have swelling in your feet and ankles.

Do not take Sevikar HCT if any of these cases occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sevikar HCT.

Tell your doctorif you are taking any of the following blood pressure medications:

• 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 electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Sevikar HCT”.

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

• 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 medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after being in the sun or in a tanning bed.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. Treatment with hydrochlorothiazide, particularly 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 sun exposure and UV rays while taking Sevikar HCT.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Sevikar HCT, see your doctor immediately.

Contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur from a few hours to several weeks after taking Sevikar HCT. This can lead to permanent vision loss if not treated.

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

Like any other medication that lowers blood pressure, excessive blood pressure reduction in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Sevikar HCT may cause an increase in lipid and uric acid levels in your blood. Your doctor may want to perform blood tests from time to time to monitor these possible changes.

Changes in the levels of certain substances called electrolytes in your blood may occur. Your doctor may want to perform blood tests from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

If you are scheduled to have parathyroid function tests, stop taking Sevikar HCT before the tests are performed.

Inform athletes that this medication contains a component that may result in a positive analytical test for doping control.

Inform your doctor if you are pregnant (or think you may be). Sevikar HCT is not recommended for use 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 taken during this stage (see the section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Sevikar HCT is not recommended for use in children and adolescents under 18 years.

Use of Sevikar HCT with other medications

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

• Other blood pressure medications, as they may increase the effect of Sevikar 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 the information under the headings “Do not take Sevikar HCT” and “Warnings and precautions”).

• Lithium(a medication used to treat mood changes and some types of depression) if used at the same time as Sevikar HCT may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Diltiazem,verapamil,used for heart rhythm and high blood pressure problems.
• Rifampicin,erythromycin, clarithromycin, tetracyclines, or ciprofloxacin,antibioticsused for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase stomach and intestinal movement.
• Difemanil, used to treat slow heart rhythm or to reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood flow to the nervous system.
• Amantadine,used to treat Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(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 medication for mouth and stomach ulcers), penicillin G sodium (an antibiotic also called benzylpenicillin sodium), some pain relievers such as aspirin or salicylates. Taking these medications at the same time as Sevikar HCT may alter your potassium levels in your blood.
• Thenonsteroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Sevikar HCT may increase the risk of kidney failure. The effect of Sevikar HCT may decrease with NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sedatives, hypnotics, and antidepressants, used with Sevikar HCT may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of Sevikar HCT. Your doctor may advise you to take Sevikar HCT at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly decrease the effect of Sevikar HCT.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and ciclosporin), which allows your body to accept the transplanted organ.

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

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar(e.g., diazoxide) orhigh blood pressure(e.g., beta-blockers, methyldopa), as Sevikar HCT may affect the mechanism of action of these medications.
• Treating heart rhythm problems,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 digital.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressureanddecreasing heart rate,such as norepinephrine.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering cholesterol levels in the blood,such as cholestyramine and colestipol.
• Lowering blood sugar levels,such as metformin or insulin.

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

Taking Sevikar HCT with food and drinks

Sevikar HCT can be taken with or without food.

People taking Sevikar HCT should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the levels of the active ingredient amlodipine in your blood, which may cause an unpredictable increase in the effect of Sevikar HCT to lower blood pressure.

Be careful when drinking alcohol while taking Sevikar HCT, as some people may feel dizzy, nauseous, or lightheaded. If this happens, do not drink any alcohol.

Older adults

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, or if you think you may be. Your doctor will advise you to stop taking Sevikar HCT before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Sevikar HCT. Sevikar HCT is not recommended for use during 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 taken during this stage.

If you become pregnant while taking Sevikar HCT, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Amlodipine and hydrochlorothiazide have been shown to pass into breast milk in small amounts. Sevikar HCT is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

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

Driving and operating machinery

You may feel drowsy, nauseous, or lightheaded, or experience headaches while taking Sevikar HCT for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

If you take more Sevikar HCT than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a rapid or slow heart rate.

If you take more tablets than you should or if a child accidentally ingests some tablets, contact your doctor immediately or go to the nearest emergency center and bring the medication packaging or this leaflet with you.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Sevikar HCT

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

If you interrupt treatment with Sevikar HCT

It is essential to continue taking Sevikar HCT, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

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

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

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

Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, skin itching, even if you started treatment with Sevikar HCT some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

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

To give you an idea of the number of patients who may experience side effects, they have been classified as frequent, infrequent, rare, and very rare.

These are other side effects known so far with Sevikar HCT:

If these side effects occur, they are often mild andit is not necessary to interrupt treatment.

Frequent

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat, and nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation,cramps, joint swelling, sensation of urgency to urinate, weakness, swelling of ankles, fatigue, abnormal laboratory test results.

Infrequent

(may affect up to 1 in 100 people)

Dizziness when getting up, vertigo, rapid heartbeat, sensation of fainting, flushing and sensation of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

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

They may be side effects due to Sevikar HCT, even if they have not been observed so far with Sevikar HCT.

Very frequent

(may affect more than 1 in 10 people)

Edema (fluid retention).

Frequent

(may affect up to 1 in 10 people)

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

Infrequent

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cell called platelets, which can cause easy bruising or prolong bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, sensation of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decrease in sense of touch, sensation of numbness, worsening of myopia, ringing in the ears (tinnitus), angina (pain or uncomfortable sensation in the chest, known as angina pectoris),irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple patches or spots on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, pruritus, skin rash, skin reactions to light, such as sunburn or skin eruption, muscle pain, urination problems, sensation of needing to urinate at night, breast enlargement in men, decreased libido, swelling of the face, sensation of discomfort, weight gain or loss, fatigue.

Rare

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

Salivary gland inflammation and pain, decrease in the number of white blood cells in the blood, which could increase the risk of infections, decrease in the number of red blood cells (anemia), bone marrow damage, restlessness, sensation of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of small blood vessels and skin, pancreatitis, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain and cold hands and fingers,severe skin reactions including intense skin eruption, urticaria, skin redness, severe itching, blisters, peeling, and skin inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, sometimes very severe,movement disorder, acute kidney failure, non-infectious kidney inflammation, kidney function decrease, fever, intestinal angioedema: swelling in the intestine that occurs with 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, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation.

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency side effects

(cannot be estimated from available data)

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

Tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 and blister after“CAD”.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sevikar HCT

The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide.

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

The other components are:

Core of the tablet: Pregelatinized maize starch, silica gel microcrystalline cellulose (microcrystalline cellulose with anhydrous colloidal silicon dioxide), croscarmellose sodium and magnesium stearate.

Coating of the tablet: Poly(vinyl alcohol), macrogol 3350, talc, titanium dioxide (E-171) and iron(III) oxide yellow (E-172).

Appearance of the product and contents of the package

Sevikar HCT 40 mg/5 mg/25 mg film-coated tablets are yellowish clear, oval-shaped tablets of 15 x 7 mm, with the inscription “C54” on one side.

Sevikar HCT film-coated tablets are presented:

• In blister packs of 14, 28, 30, 56, 84, 90, 98 and 10 x 28, 10 x 30 tablets.
• In pre-cut single-dose blister packs of 10, 50 and 500 tablets.
• In HDPE bottles of 7, 30 and 90 tablets.

Not all packages are marketed.

Marketing authorization holder

Daiichi Sankyo España, S.A.

Paseo del Club Deportivo nº1

Edificio 14, Ground floor left

28223 Pozuelo de Alarcón – Madrid

Spain

Responsible for manufacturing

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 member states of the European Economic Area with the following names:

Austria, Germany, Netherlands, Romania, Spain, United Kingdom:

Sevikar HCT 40 mg/5 mg/25 mg

Greece:

Sevikar HCT (40+5+25) mg

Belgium and Luxembourg:

Sevikar/HCT 40 mg/5 mg/25 mg

Denmark, Iceland:

Sevikar Comp 40 mg/5 mg/25 mg

Ireland:

Sevikar Plus 40 mg/5 mg/25 mg

Italy:

Sevitrex 40 mg/5 mg/25 mg

Last review date of this leaflet:January 2025.

Other sources of information

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