SEVIKAR HCT®

SEVIKAR HCT<sup>®</sup>

SEVIKAR HCT®

Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide

SEVIKAR HCT® 

(20/5/12.5) mg – (40/5/12.5) mg (40/10/12.5) mg – (40/5/25) mg – (40/10/25) mg

Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide

Film-coated tablets for Oral Use

 

Product leaflet summary

Therapeutic Indications

SEVIKAR HCT is used to treat high blood pressure in subjects who are already taking either (a) a fixed-dose combination of Olmesartan medoxomil and Amlodipine (b) a fixed-dose combination of Olmesartan medoxomil and Hydrochlorothiazide plus the Amlodipine as a single tablet or (c) a fixed-dose combination of Olmesartan medoxomil and Amlodipine plus Hydrochlorothiazide as a single tablet.

 

Dosage and Administration

The recommended dose of SEVIKAR HCT is one tablet per day.

The tablet can be taken with or without food. Swallow the tablet with some fluid (such as a glass of water). The tablet should not be chewed. Do not take the tablet with grapefruit juice.

 

Contraindications

You are allergic to Olmesartan, to Amlodipine, to Hydrochlorothiazide, to substances related to any of the 3 components or to any of the other ingredients of this medicine listed in section 6 of this leaflet. If you think you may be allergic to the components of SEVIKAR HCT talk to your doctor before taking SEVIKAR HCT.

SEVIKAR HCT should not be co-administered with aliskiren in patients with diabetes mellitus or renal impairment.

You have severe kidney problems.

You have low potassium, low sodium, high calcium or high uric acid (with symptoms of gout or kidney stones) levels in your blood that have not got better when treated.

You are more than 3 months pregnant. (It is also better to avoid SEVIKAR HCT in early pregnancy – see section “Pregnancy and breastfeeding”.)

You have severe liver problems, if bile secretion is impaired or drainage of bile from the gall bladder is blocked (e.g. by gallstones), or if you are jaundiced (yellowing of the skin and eyes).

You have very low blood pressure.

The blood flow from your heart is impaired. This may happen if the blood vessel or valve that takes blood away from your heart becomes narrow (aortic stenosis).

You have heart failure. Heart failure may make you feel short of breath or cause swelling in your feet and ankles.

Do not take SEVIKAR HCT if any of the above applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before using SEVIKAR HCT. Tell your doctor if you have any of the following health problems:

Dual Blockade of the Renin-Angiotensin-aldosterone System (RAAS):

Combination of SEVIKAR HCT with ACE inhibitors, or aliskiren may cause increased risks of hyperkalemia, worsening of kidney function, and hypotension. Therefore, this combination should not be used, especially in patients with kidney problems.

Kidney problems or a kidney transplant.

Liver disease.

Heart failure or problems with your heart valves or heart muscle.

Severe vomiting, diarrhea, treatment with high doses of “water tablets” (diuretics) or if you are on a low salt diet.

Increased potassium in your blood.

Problems with your adrenal glands

Diabetes.

Lupus erythematosus (an autoimmune disease).

Allergies or asthma.

Skin reactions such as sunburn or rash after being in the sun or using a sunbed.

As with any medicine that reduces blood pressure, an excessive drop in blood pressure may lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully.

SEVIKAR HCT may cause a rise in blood cholesterol and uric acid (the cause of gout – painful swelling of the joints). Your doctor may request blood tests to check.

SEVIKAR HCT may also affect your body’s salt balance. Your doctor may request blood tests to check. Possible symptoms include thirst, dryness of the mouth, muscle pain or cramps, tired muscles, low blood pressure, feeling weak, sluggish, tired, sleepy or restless, nausea, vomiting, less need to pass urine, a rapid heart rate. Tell your doctor if you notice these symptoms.

If you are due to have tests for parathyroid function you should stop taking SEVIKAR HCT before these tests are carried out.

You must tell your doctor if you think that you are (or might become) pregnant. SEVIKAR HCT is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section “Pregnancy and breast-feeding”).

 

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally 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 in early pregnancy, and must not be taken when more than 3 months pregnant as it may cause serious harm to your baby if used after the third month of pregnancy.

If you become pregnant during therapy with SEVIKAR HCT please inform and see your physician without delay.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. SEVIKAR HCT is not recommended for mothers, who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or was born prematurely.

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.

 

Ability to Drive and Use Machinery

You may feel sleepy, sick, or dizzy or get a headache while being treated for your high blood pressure. Do not drive or use machines whilst you have symptoms. Ask your doctor for advice.

 

Package Presentation:

SEVIKAR HCT film-coated tablets are available:

In blister packs of 28 film-coated tablets