Micardis HCT
(Telmisartan/Hydrochlorothiazide)

What Micardis HCT is and what it is used for

Telmisartan/Hydrochlorothiazide is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure.
•Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-II is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
•Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure. High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal rangeTelmisartan/Hydrochlorothiazide (40 mg/12.5 mg, 80 mg/12.5 mg) is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone. Telmisartan/Hydrochlorothiazide (80 mg/25 mg) is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.

How to take Micardis 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 of Telmisartan/Hydrochlorothiazide is one tablet a day. Try to take a tablet at the same time each day. You can take Telmisartan/Hydrochlorothiazide with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan/Hydrochlorothiazide every day until your doctor tells you otherwise. If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day. If you take more Telmisartan/Hydrochlorothiazide than you should If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported. Due to the hydrochlorothiazide component, markedly low blood pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness and muscle cramps and/or irregular heartbeat associated with the concomitant use of drugs such as digitalis or certain anti-arrhythmic treatments. Contact your doctor, pharmacist, or your nearest hospital emergency department immediately. If you forget to take Telmisartan/Hydrochlorothiazide If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses. If you have 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. Some side effects can be serious and need immediate medical attention: You should see your doctor immediately if you experience any of the following symptoms: Sepsis* (often called "blood poisoning"), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema), blistering and peeling of the top layer of skin (toxic epidermal necrolysis); these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal. Increased incidence of sepsis has been observed with telmisartan only, however cannot be ruled out for Telmisartan/Hydrochlorothiazide . Possible side effects of Telmisartan/Hydrochlorothiazide:

Common side effects (may affect up to 1 in 10 people): Dizziness.

Uncommon side effects (may affect up to 1 in 100 people): Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.

Rare side effects (may affect up to 1 in 1,000 people): Inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body’s immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses; feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick(vomiting),inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood. Adverse reactions reported with one of the individual components may be potential adverse reactions with Telmisartan/Hydrochlorothiazide, even if not observed in clinical trials with this product. Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:

Uncommon side effects (may affect up to 1 in 100 people): Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.

Rare side effects (may affect up to 1 in 1,000 people): Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein), somnolence.

Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease) ** * The event may have happened by chance or could be related to a mechanism currently not known. ** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause. Hydrochlorothiazide In patients taking hydrochlorothiazide alone the following additional side effects have been reported:

Common side effects (may affect up to 1 in 10 people): Feeling sick (nausea), low blood magnesium level.

Rare side effects (may affect up to 1 in 1,000 people): Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding), high blood calcium level, headache.

Very rare side effects (may affect up to 1 in 10,000 people): Increased pH (disturbed acid-base balance) due to low blood chloride level. Side effects of unknown frequency (frequency cannot be estimated from the available data): Inflammation of the salivary gland, decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin and peeling , fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.

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 Website: 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

How to Store Micardis HCT

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 or blister after “EXP”. The expiry date refers to the last day of that month. This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. 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.