Sevikar

Patient Information Leaflet

SEVIKAR 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets

olmesartan medoxomil/amlodipine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sevikar is and what it is used for

Sevikar contains two substances called olmesartan medoxomil and amlodipine (as amlodipine
besylate). Both help control hypertension.

• Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”. These reduce blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of substances known as “calcium antagonists”. Amlodipine prevents calcium from entering the vessel wall, thereby reducing vessel constriction and lowering blood pressure.

The combined action of both substances helps counteract vascular tension, allowing blood vessels to relax and blood pressure to decrease.
Sevikar is used to treat high blood pressure (also known as “arterial hypertension”) in patients whose
blood pressure is not sufficiently controlled by olmesartan medoxomil or amlodipine alone.

2. What you should know before taking Sevikar

Do not take Sevikar

• if you are allergic to olmesartan medoxomil or amlodipine, or to a specific group of calcium antagonists called dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, speak with your doctor before taking Sevikar.
• if you are more than three months pregnant (it is best to avoid taking Sevikar even in the early stages of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have severe liver problems, if bile secretion is impaired or its outflow from the gallbladder is blocked (for example, by gallstones), or if you develop jaundice (yellowing of the skin and eyes).
• if your blood pressure is very low.
• if you suffer from inadequate blood supply to tissues with symptoms such as low blood pressure, weak pulse, or rapid heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• if blood flow from your heart is obstructed (for example, due to aortic stenosis).
• if you have reduced cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sevikar.
Consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under the section “Do not take Sevikar”.
Consult your doctor if you also have any of the following health conditions:

• Kidney problems or kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-salt diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).

Inform your doctor if you experience severe and prolonged diarrhea accompanied by significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
Contact your doctor if, after taking Sevikar, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether treatment should continue. Do not stop taking Sevikar on your own.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Sevikar is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents
Sevikar is not recommended for children and adolescents under 18 years of age.

Other medicines and Sevikar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including the following:

• Other medicines that lower blood pressure may increase the effect of Sevikar. Your doctor may consider it necessary to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Sevikar” and “Warnings and precautions”).
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood and prevent thrombosis). Taking these medicines together with Sevikar may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Sevikar may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) taken together with Sevikar may increase the risk of kidney failure. The effect of Sevikar may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Sevikar. Your doctor may advise you to take Sevikar at least 4 hours before colesevelam hydrochloride.
• Some antacids (used for indigestion or stomach acidity) may slightly reduce the effect of Sevikar.
• Medicines for HIV/AIDS (for example ritonavir, indinavir, nelfinavir) or for fungal infections (for example ketoconazole, itraconazole).
• Diltiazem, verapamil, medicines used for heart rhythm disorders and high blood pressure.
• Rifampicin, erythromycin, clarithromycin (antibiotics) used for tuberculosis or other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy.
• Dantrolene (infusion for severe disturbances in body temperature).
• Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine, used to control your body’s immune response and allow acceptance of transplanted organs.

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

Sevikar with food and drink
Sevikar can be taken with or without food. The tablet should be swallowed with some liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast.
People taking Sevikar must not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, which could unpredictably enhance the hypotensive effect of Sevikar.

Elderly
If you are over 65 years of age, your doctor will regularly monitor your blood pressure with each dose increase to prevent it from dropping too low.

Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Sevikar may be somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Sevikar before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Sevikar is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
If you become pregnant while taking Sevikar, inform and see your doctor immediately.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts. Sevikar is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
You may experience drowsiness, discomfort, dizziness, or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., it is essentially sodium-free.

3. How to take Sevikar

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

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

If you take more Sevikar than you should
If you take more tablets than you should, you may experience a drop in blood pressure with symptoms such as dizziness, a faster or slower heartbeat.
If you take too many tablets or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency department, taking the medicine pack or this leaflet with you.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

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

If you stop taking Sevikar
It is important to continue taking Sevikar unless your doctor tells you to stop.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If they occur, they are mostly mild and do not require discontinuation of treatment.
Although not occurring in all people, the following side effects can be serious:
during treatment with Sevikar, allergic reactions may occur, which can affect the entire body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash. If this happens, stop taking Sevikar and contact your doctor immediately.
Sevikar may cause excessive lowering of blood pressure in sensitive individuals or as a consequence of an allergic reaction. This could cause severe dizziness or fainting. If this happens, stop taking Sevikar, contact your doctor immediately and remain lying down.
Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Sevikar for a long time, contact your doctor immediately, who will evaluate the symptoms and decide how to continue treatment for high blood pressure.
Other possible side effects of Sevikar:
Common (may affect up to 1 in 10 people):
Dizziness; headache; swelling of ankles, feet, legs, hands or arms; fatigue.
Uncommon (may affect up to 1 in 100 people):
Dizziness upon standing; lack of energy; tingling or numbness in hands or feet; vertigo; awareness of heartbeat; faster heartbeat; low blood pressure with symptoms such as dizziness, feeling of emptiness in the head, difficulty breathing; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth; pain in the upper abdomen; skin rash; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; loss of sexual activity; inability to achieve or maintain erection; weakness.
Some blood test abnormalities have also been observed, including the following: increase or decrease in blood potassium, increase in blood creatinine, increase in blood uric acid, increase in liver function tests (levels of gamma-glutamyl transferase).
Rare (may affect up to 1 in 1,000 people):
Hypersensitivity to the medicine; fainting; flushing and sensation of warmth in the face; red, itchy welts (urticaria); swelling of the face.
Side effects reported with olmesartan medoxomil or amlodipine used alone, but not with Sevikar or with higher frequency:
Olmesartan medoxomil
Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; gastroenteritis; diarrhoea; indigestion; nausea; pain in bones or joints; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain. Laboratory test abnormalities such as increased fats (hypertriglyceridemia); increased plasma urea or uric acid; increased liver and muscle function test values.
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 easier bruising or prolonged bleeding time; immediate allergic reactions which may affect the whole body and may cause breathing difficulties or rapid drop in blood pressure, possibly leading to weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with urticaria, swelling of the face; muscle pain; feeling unwell.
Rare (may affect up to 1 in 1,000 people):
Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and renal failure; lethargy; intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Amlodipine
Very common (may affect more than 1 in 10 people):
Oedema (fluid retention).
Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; flushing and sensation of warmth in the face; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; difficulty breathing.
Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disorders; mood disturbances including anxiety; depression; irritability; tremors; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; stuffy or runny nose; hair loss; red spots or patches on the skin due to small haemorrhages (purpura); skin discolouration; excessive sweating; skin rash; itching; red, itchy welts (urticaria); muscle or joint pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain, discomfort; weight gain or loss.
Rare (may affect up to 1 in 1,000 people):
Confusion.
Very rare (may affect up to 1 in 10,000 people):
Reduction in the number of white blood cells in the blood, which may increase the risk of infections; reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time; increased blood glucose; increased muscle stiffness or increased resistance to passive movements (hypertonia); tingling or numbness in hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach lining; gum enlargement; elevated liver enzyme levels; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions (itching, skin rash, swelling of the face, mouth and/or larynx (site of the vocal cords) together with itching and skin rash), severe skin reactions including intense skin rash, urticaria, reddening of the skin over the entire body surface, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.
Not known (frequency cannot be estimated from the available data):
Tremor, rigid posture, mask-like face, slow movements and a shuffling gait.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sevikar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sevikar contains
The active substances are olmesartan medoxomil and amlodipine (as besylate).
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).
The other components are:
Tablet core: pregelatinized maize starch, silicified microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), and iron (III) oxide (E172, only in Sevikar 40 mg/5 mg and 40 mg/10 mg film-coated tablets).

Description of the appearance of Sevikar and contents of the pack
Sevikar 20 mg/5 mg, film-coated tablets, round, white in colour, marked on one side with the code C73;
Sevikar 40 mg/5 mg, film-coated tablets, round, cream-coloured, marked on one side with the code C75;
Sevikar 40 mg/10 mg, film-coated tablets, round, brownish in colour, marked on one side with the code C77.
Sevikar is available in packs containing 14, 28, 30, 56, 90, 98, 10x28 and 10x30 film-coated tablets, and in packs containing 10, 50 and 500 film-coated tablets with a divisible blister for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Daiichi Sankyo Italia SpA
Via Paolo di Dono, 73
00142 Rome
Italy

Manufacturer responsible for batch release
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands (RMS), Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Iceland, Luxembourg, Norway, Portugal, United Kingdom, Romania, Spain: Sevikar 20 mg/5 mg; 40 mg/5 mg; 40 mg/10 mg