SEVIKAR HCT 20 mg/5 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

SEVIKAR HCT 20 mg/5 mg/12.5 mg film-coated tablets

Olmesartan medoxomil / 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 Sevikar HCT and what is it used for
2. What you need to know before you take Sevikar HCT
3. How to take Sevikar HCT
4. Possible side effects
5. Storage of Sevikar HCT

1. Contents of the pack and other information

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

Sevikar HCT contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide. All three substances help to 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 kidneys to remove excess fluid from the body, increasing urine production.

The action of these substances contributes to lowering your 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.

2. What you need to know before you take Sevikar HCT

Do not take Sevikar 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 ingredients of this medicine (listed in section 6).

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

• If you have severe kidney problems.
• If you have diabetes or kidney impairment and are being treated with a blood pressure lowering medicine containing aliskiren.
• If you have low potassium or sodium levels in the blood, high calcium or uric acid levels in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you are more than 3 months pregnant. (It is also recommended to avoid Sevikar HCT at the start of pregnancy - see section “Pregnancy and breast-feeding”).
• If you have severe liver problems, bile secretion problems, 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 insufficient 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 the blood flow to your heart is slow or blocked. This can happen if the blood vessels or valves that capture blood from the heart become narrowed (aortic stenosis).
• If you have poor heart performance after suffering a heart attack (acute myocardial infarction). Poor heart performance can make you feel short of breath or have swelling in your feet and ankles.

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

Warnings and precautions

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

Tell your doctorif you are taking any of the following medicines used to treat high blood pressure (hypertension):

• a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may need to 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 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 the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• High potassium levels 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 being in the sun or using a sunbed.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of certain types of skin 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 lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Sevikar HCT, seek medical attention immediately.

Consult your doctorif you experience any of the following symptoms:

• Severe diarrhea, persistent and causing significant weight loss. Your doctor will assess 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 pressure in the eye and can occur from a few hours to a few weeks after taking Sevikar HCT. This can lead to permanent vision impairment 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.

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 cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Sevikar HCT may cause an increase in lipid and uric acid levels in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test 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 of weakness, slowness, fatigue, drowsiness, or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you must stop taking Sevikar HCT before these tests are performed.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

You must inform your doctor if you are pregnant (or think you might be). Sevikar HCT 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 if taken at this stage (see section “Pregnancy and breast-feeding”).

Children and adolescents (under 18 years)

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

Using Sevikar HCT with other medicines

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

• Other blood pressure lowering medicines, 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 medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken with Sevikar HCT. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclinesor sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for the treatment of depression.
• Cisapride, used to increase food movement in the stomach and intestine.
• Difemanil, used to treat slow heart rate or to decrease sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medicines 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 medicine for the treatment of mouth and stomach ulcers), penicillin G sodium (an antibiotic also called benzylpenicillin sodium), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. The use of these medicines at the same time as Sevikar HCT may alter potassium levels in the blood.
• 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 Sevikar HCT, may increase the risk of kidney failure. The effect of Sevikar HCT may be reduced by NSAIDs. If high doses of salicylates are used, it may increase the toxic effect on the central nervous system.
• Sleep-inducing medicines, sedatives, and antidepressants, used with Sevikar HCT, may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce 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 acidity), as they may slightly reduce the effect of Sevikar HCT.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglycerides) levels in the blood.
• Medicines used to control the body's immune response(e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which allows your body to accept a transplanted organ.

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

Taking Sevikar HCT with food and drink

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 can lead to an increase in the levels of the active ingredient amlodipine in the blood, which may cause an unpredictable increase in the blood pressure lowering effect of Sevikar HCT.

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

Elderly patients

If you are over 65 years old, your doctor will regularly check your blood pressure each time your dose is increased, to ensure that your blood pressure does not drop too much.

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking Sevikar HCT before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Sevikar HCT. Sevikar HCT is not recommended during pregnancy, and must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month of pregnancy onwards.

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

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Sevikar HCT is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed.

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.

Driving and using machines

You may feel drowsy, sick, or dizzy, or have a headache while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. 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 Sevikar HCT

Follow the administration instructions of this medication exactly 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.
• If possible, take your daily dose at the same time every 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 suffer from a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heartbeat.

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

Excess fluid may accumulate in the 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 call the Toxicology 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 stop treatment with Sevikar HCT

It is important 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them. If they occur, they are often mild and do not require stopping treatment.

The following side effects may be serious, although they only affect 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 to you, 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 fainting or severe dizziness. If this happens to you, stop taking Sevikar 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, itching of the skin, even if you started treatment with Sevikar HCT a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Sevikar HCT is a combination of three active substances. The following information describes the side effects reported so far with the Sevikar HCT combination (in addition to those already mentioned) and the side effects known for 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, uncommon, rare, and very rare.

These are other known side effects of Sevikar HCT:

If these effects occur, they are often mild and it is not necessary to stop 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, urge to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test values.

Uncommon

(may affect up to 1 in 100 people)

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

These are the known side effects 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 common

(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, 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 can cause easy bruising or prolonged bleeding, anaphylactic reactions, abnormal loss of appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (pain or unpleasant sensation in the chest, known as angina pectoris), irregular heartbeats, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, red itchy hives (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin rash, muscle pain, urination problems, feeling of need to urinate at night, breast enlargement in men, decreased sexual desire, facial swelling, feeling of discomfort, weight gain or loss, exhaustion.

Rare

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

Inflammation and pain of the salivary glands, 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, feeling 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 blood vessels and small blood vessels in the 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 rash, urticaria, skin redness of the body, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, movement impairment, acute kidney failure, non-infectious inflammation of the kidney, decreased kidney function, 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 (signs include severe respiratory distress, fever, weakness, and confusion).

Side 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 unsteady gait.

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 Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sevikar HCT

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the package and blister after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Sevikar HCT

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

Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

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

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

Appearance of the product and package contents

Sevikar HCT 20 mg/5 mg/12.5 mg film-coated tablets are orange-yellow, round, 8 mm tablets with the inscription "C51" on one side.

Sevikar HCT film-coated tablets are available:

• In blister packs of 14, 28, 30, 56, 84, 90, 98, and 10 x 28, 10 x 30 tablets.
• In 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, Planta baja izquierda

28223 Pozuelo de Alarcón – Madrid

Spain

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 medication is authorized in the member states of the European Economic Area with the following names:

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

Sevikar HCT 20 mg/5 mg/12.5 mg

Greece:

Sevikar HCT (20+5+12.5) mg

Belgium and Luxembourg:

Sevikar/HCT 20 mg/5 mg/12.5 mg

Denmark, Iceland:

Sevikar Comp 20 mg/5 mg/12.5 mg

Ireland:

Sevikar Plus 20 mg/5 mg/12.5 mg

Italy:

Sevitrex 20 mg/5 mg/12.5 mg

Date of the last revision of this leaflet:January 2025.

Other sources of information

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