Tribenzor
(Olmesartan Medoxomil/Amlodipine Besylate/Hydrochlorothiazide)

What Tribenzor is and what it is used for

Sevikar HCT contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besilate) 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 lowers blood pressure by relaxing the blood vessels.
• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide is one of a group of medicines called thiazide diuretics (“water tablets”). It lowers blood pressure by helping the body to get rid of extra fluid by making your kidneys produce more urine. The actions of these substances contribute to decrease your blood pressure. 1.3.1.3. Package Leaflet 2 Sevikar HCT is used for the treatment of high blood pressure:
• in adult patients whose blood pressure is not adequately controlled on the combination of olmesartan medoxomil and amlodipine taken as fixed-dose combination, or
• in patients, who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide plus the amlodipine as a single tablet or a fixed-dose combination of olmesartan medoxomil and amlodipine plus hydrochlorothiazide as a single tablet

How to take Tribenzor

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 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.
• If possible, 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 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 HCT If you forget to take a dose take your normal dose the following day as usual. Do not take a double dose to make up for a forgotten dose. If you stop taking Sevikar HCT It is important to continue to take Sevikar HCT 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 side effects 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 with swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Sevikar HCT. If this happens stop taking Sevikar HCT and contact your doctor immediately. 1.3.1.3. Package Leaflet 8 Severe light-headedness or fainting because Sevikar HCT can cause the blood pressure to fall too low in susceptible individuals. If this happens stop taking Sevikar HCT, contact your doctor immediately and lay down flat. Sevikar HCT is a combination of three active substances. The following information firstly gives the other side effects reported so far with the combination Sevikar HCT (besides those already mentioned above) and, secondly, those side effects, which are known for each of the separate substances or when two substances are given together. To give you an idea of how many patients might get side effects, they have been listed as common, uncommon, rare and very rare. These are the other side effects known about so far with Sevikar HCT: If these side effects occur they are often mild and you do not need to stop your treatment.

Common (may affect less than 1 in 10 people) Upper respiratory tract infection; sore throat and nose; urinary tract infection; dizziness; headache; awareness of heartbeat; low blood pressure; nausea; diarrhoea; constipation; cramps; joint swelling; feeling more of an urge to pass urine; weakness; ankle swelling; tiredness; abnormal laboratory values.

Uncommon (may affect less than 1 in 100 people) Dizziness on standing up; vertigo; fast heartbeat; feeling faint; redness and warm feeling of the face; cough; dry mouth; muscular weakness; inability to get or maintain an erection. These are the side effects, which are known for each of the separate substances or when two substances are given together: They may be side effects for Sevikar HCT, even if they have not be 1.3.1.3. Package Leaflet 9

Uncommon (may affect less than 1 in 100 people) Reduced number of a type of blood cells known as platelets, which can result in bruising easily or a prolonged bleeding time; anaphylactic reactions; abnormally reduced appetite (anorexia); problems sleeping; irritability; mood changes including feeling anxious; feeling “down” or depressed; shiver; sleep disturbances; distorted sense of taste; loss of consciousness; reduced sense of touch; tingling sensations; worsening of shortsightedness; ringing in the ears (tinnitus); angina (pain or uncomfortable feeling in the chest, known as angina pectoris); irregular heart beat; rash; loss of hair; allergic inflammation of the skin; redness of skin; purplish spots or patches on the skin due to small haemorrhages (purpura); discolouration of the skin; red itchy bumps (hives); increased sweating; itching; eruption of the skin; skin reactions to light such as sunburn or rash; muscle pain; problems to pass urine; feeling urge to pass urine at night; breast enlargement in men; decreased sexual desire; swelling of the face; feeling unwell; weight increase or decrease; exhaustion.

Rare (may affect less than 1 in 1,000 people) Swollen and sore salivary glands; reduced number of white cells in the blood, which could increase the risk of infections; low red blood cell count (anaemia); bone marrow damage; restlessness; feeling uninterested (apathy); fits (convulsions); objects you look at appearing yellow; dry eyes; blood clots (thrombosis, embolism); fluid accumulation in the lungs; pneumonia; inflammation of blood vessels and small blood vessels in the skin; inflammation of the pancreas; yellowing of the skin and eyes; acute inflammation of the gall bladder; symptoms of lupus erythematosus such as rash, joint pains and cold hands and fingers; 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; impaired movement; acute kidney failure; non-infectious kidney inflammation; poor kidney function; fever. Very

Rare (may affect less than 1 in 10,000 people) High muscle tension; numbness of hands or feet; heart attack; inflammation of the stomach; thickening of the gums; blockage in the gut; inflammation of the liver. Not Known (frequency cannot be estimated from the available data) Decrease in vision or eye pain (possible signs of acute angle-closure glaucoma). Trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk. Skin and lip cancer (Non-melanoma skin cancer). 1.3.1.3. Package Leaflet 10

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 Tribenzor

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, bottle and blister after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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.