Benicar HCT
(Olmesartan/HCTZ)

What Benicar HCT is and what it is used for

Olmetec Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, that are used to treat high blood pressure (hypertension):
• Olmesartan medoxomil is one of a group of medicines called angiotensin II-receptor antagonists. It lowers blood pressure by relaxing the 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. You will only be given Olmetec Plus if Olmetec (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When given together, the two active substances in Olmetec Plus help to lower blood pressure more than if either of them were given alone. You may already be taking medicines to treat your high blood pressure, but your doctor may want you to take Olmetec Plus to lower it more. High blood pressure can be controlled with medicines such as Olmetec Plus tablets. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor.

How to take Benicar HCT

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one Olmetec Plus 20 mg/12.5 mg tablet a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose to one Olmetec Plus 20 mg/25 mg tablet a day. Swallow the tablet with water. If possible, you should take your dose at the same time each day, for example at breakfast time. It is important to continue to take Olmetec Plus until your doctor tells you to stop. If you take more Olmetec Plus than you should If you take more tablets than you should, or if a child accidentally swallows one or more, go to your doctor or nearest accident and emergency department immediately and take your medicine pack with you. If you forget to take Olmetec Plus 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 Olmetec Plus It is important to continue to take Olmetec Plus 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. However, the following two side effects can be serious:
• Allergic reactions that may affect the whole body, with swelling of the face, mouth and/or voice box (larynx) together with itching and rash may occur rarely. If this happens, stop taking Olmetec Plus and contact your doctor immediately.
• Olmetec Plus can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. Light-headedness or fainting may occur uncommonly. If this happens, stop taking Olmetec Plus, contact your doctor immediately and lie down flat. Olmetec Plus is a combination of two active substances and the following information firstly gives the other side effects reported so far with the combination Olmetec Plus (besides those already mentioned above) and, secondly, those which are known about for the separate active substances. These are the other side effects known about so far with Olmetec Plus: If these side effects occur, they are often mild and you do not need to stop your treatment.

Common side effects(may affect up to 1 in 10 people): Dizziness, weakness, headache, tiredness, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon side effects (may affect up to 1 in 100 people): Fluttering of the heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscular pain, pain in joints, arms and legs, back pain, erection difficulties in men, blood in urine. Some changes in blood test results have also been seen uncommonly and include: Rise in blood fat levels, rise in blood urea or uric acid, rise in creatinine, rise or decrease in blood potassium levels, rise in blood calcium levels, rise in blood sugar, increase in levels of liver function. Your doctor will know about these from a blood test and will tell you if you need to do anything.

Rare side effects (may affect up to 1 in 1,000 people): Feeling unwell, disturbances in consciousness, skin lumps (wheals), acute kidney failure. Some changes in blood test results have also been seen in rare cases and include: Rise in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will know about these from a blood test and will tell you if you need to do anything. Further side effects reported with use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmetec Plus or in a higher frequency: Olmesartan medoxomil:

Common side effects (may affect up to 1 in 10 people): Bronchitis, cough, runny or stuffy nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, pain in the joints or bones, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain. Some changes in blood test results have also been seen commonly and include: Rise in blood fat levels, rise in blood urea or uric acid, increase in levels of liver and muscle function.

Uncommon side effects (may affect up to 1 in 100 people): 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), swelling of the face, angina (pain or uncomfortable feeling in the chest; known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin lumps (wheals). Some changes in blood test results have also been seen uncommonly and include: Reduced numbers of a type of blood cell, known as platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people): Impaired kidney function, lack of energy. Some changes in blood test results have also been seen rarely and include: Increase in blood potassium. Hydrochlorothiazide:

Very common side effects (may affect more than 1 in 10 people): Changes in blood results including: Increase in blood fat and uric acid levels.

Common side effects (may affect up to 1 in 10 people): Feeling confused, abdominal pain, stomach upset, bloated feeling, diarrhoea, nausea, vomiting, constipation, excretion of glucose into the urine. Some changes in blood results have also been seen and include: Increase in blood creatinine, urea, calcium and sugar levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase of serum amylase (hyperamylasaemia).

Uncommon side effects (may affect up to 1 in 100 people): Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to light, itching, purplish spots or patches on the skin due to small haemorrhages (purpura), skin lumps (wheals).

Rare side effects (may affect up to 1 in 1,000 people): Swollen and sore salivary glands, decreased number of white blood cells, decreased number of blood platelets, anaemia, bone marrow damage, restlessness, feeling ‘down’ or depressed, problems sleeping, feeling un-interested (apathy), tingling and numbness, fits (convulsions), objects you look at appearing yellow, blurred vision, dry eyes, irregular heartbeat, inflammation of the blood vessels, blood clots (thrombosis or embolism), inflammation of the lung, fluid accumulation in the lungs, inflammation of the pancreas, jaundice, infection in the gall bladder, symptoms of lupus erythematosus such as rash, joint pains and cold hands and fingers, allergic skin reactions, peeling and blistering of the skin, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing impaired movement).

Very rare side effects (may affect up to 1 in 10,000 people): Electrolyte disturbance leading to an abnormally depleted level of chloride in the blood (hypochloraemic alkalosis), blockage in the gut (paralytic ileus).

Not known (frequency cannot be estimated from the available data): Decrease in vision or eye pain (possible signs of acute angle-closure glaucoma). Skin and lip cancer (Non-melanoma skin cancer).

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 Benicar HCT

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton and on the blister strip after EXP. The expiry date refers to the last day of that month. 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