(Amlodipine Besylate/Olmesartan Medoxomil)
Brand Name Choices
What Azor is and what it is used for
Sevikar contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both of these 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 the blood vessels.
• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening thereby also reducing blood pressure. The actions of both these substances contribute to stopping the tightening of blood vessels, so that blood vessels relax and blood pressure decreases. Sevikar is used for the treatment of high blood pressure in patients whose blood pressure is not controlled enough with either olmesartan medoxomil or amlodipine alone.
How to take Azor
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose of Sevikar is one tablet per day.
• The tablets 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 them with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time. If you take more Sevikar than you should If you take more tablets than you should you may experience low blood pressure with symptoms such as dizziness, fast or slow heart beat. If you take more tablets than you should or if a child accidentally swallows some, go to your doctor or nearest emergency department immediately and take your medicine pack or this leaflet with you. If you forget to take Sevikar If you forget to take a dose, take your normal dose on the following day as usual. Do not take a double dose to make up for a forgotten dose. If you stop taking Sevikar It is important to continue to take Sevikar unless your doctor tells you to stop. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped. Although not many people may get them, the following two side effects can be serious: Allergic reactions, that may affect the whole body, with swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Sevikar. If this happens stop taking Sevikar and talk to your doctor immediately. Sevikar can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. This could cause severe light-headedness or fainting. If this happens stop taking Sevikar, talk to your doctor immediately and lie down flat. Other possible side effects with Sevikar:
Common (may affect less than 1 in 10 people): Dizziness; headache; swelling of ankles, feet, legs, hands, or arms; tiredness.
Uncommon (may affect less than 1 in 100 people): Dizziness on standing up; lack of energy; tingling or numbness of hands or feet; vertigo; awareness of heart beat; fast heart beat; low blood pressure with symptoms such as dizziness, light-headedness; difficult breathing; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth, upper abdominal pain; skin rash; cramps; pain in arms and legs; back pain; feeling more of an urge to pass urine; sexual inactivity; inability to get or maintain an erection; weakness. Some changes in blood test results have also been seen and include the following: increased as well as decreased blood potassium levels, increased blood creatinine levels, increased uric acid levels, increases in a test of liver function (gamma glutamyl transferase levels).
Rare (may affect less than 1 in 1,000 people): Drug hypersensitivity; fainting; redness and warm feeling of the face; red itchy bumps (hives); swelling of face. Side effects reported with use of olmesartan medoxomil or amlodipine alone, but not with Sevikar or in a higher frequency: Olmesartan medoxomil
Common (may affect less than 1 in 10 people): Bronchitis; sore throat; runny or stuffy nose; cough; abdominal pain; stomach flu; diarrhoea; indigestion; nausea; pain in the joints or bones; back pain; blood in the urine; infection of the urinary tract; chest pain; flu-like symptoms; pain. Changes in blood test results as increased fat levels (hypertriglyceridaemia), blood urea or uric acid increased and increase in tests of liver and muscle function.
Uncommon (may affect less than 1 in 100 people): Reduced number of a type of blood cells, known as platelets, which can result in easily bruising or prolonged bleeding time; quick allergic reactions that may affect the whole body and may cause breathing problems as well as a rapid fall of blood pressure that may even lead to fainting (anaphylactic reactions); angina (pain or uncomfortable feeling in the chest, known as angina pectoris); itching; eruption of the skin; allergic skin rash; rash with hives; swelling of the face; muscular pain; feeling unwell.
Rare (may affect less than 1 in 1,000 people): Swelling of the face, mouth and/or larynx (voice box); acute kidney failure and kidney insufficiency; lethargy. Amlodipine
Very common (may affect more than 1 in 10 people): Oedema (fluid retention)
Common (may affect less than 1 in 10 people): Abdominal pain; nausea; ankle swelling; feeling sleepy; redness and warm feeling of the face, visual disturbance (including double vision and blurred vision), awareness of heartbeat, diarrhoea, constipation, indigestion, cramps, weakness, difficult breathing.
Uncommon (may affect less than 1 in 100 people): Trouble sleeping; sleep disturbances; mood changes including feeling anxious; depression; irritability; shiver; taste changes; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (pain or uncomfortable feeling in the chest); irregular heartbeat; runny or stuffy nose; loss of hair; purplish spots or patches on the skin due to small haemorrhages (purpura); discoloration of the skin; excessive sweating; eruption of the skin; itching; red itchy bumps (hives); pain of joints or muscles; problems to pass urine; urge to pass urine at night; increased need to urinate (pass urine); breast enlargement in men; chest pain; pain, feeling unwell; increase or decrease in weight.
Rare (may affect less than 1 in 1,000 people): Confusion
Very rare (may affect less than 1 in 10,000 people): Reduction in the number of white cells in the blood, which could increase the risk of infections; a reduction in the number of a type of blood cells known as platelets, which can result in easily bruising or prolonged bleeding time; increase in blood glucose; increased tightness of muscles or increased resistance to passive movement (hypertonia); tingling or numbness of hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or the pancreas; inflammation of stomach lining; thickening of gums; elevated liver enzymes; yellowing of the skin and eyes; increased sensitivity of the skin to light; allergic reactions: itching, rash, swelling of the face, mouth and/or larynx (voice box) together with itching and rash, severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis), sometimes life-threatening.
Not known (frequency cannot be estimated from the available data): Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Azor
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage condition. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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