Tesar Co 12,5 mg Tablets

TESAR CO is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both 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.

TESAR CO is used to treat mild to moderate high blood pressure. Your doctor will usually prescribe TESAR CO when your blood pressure has already been controlled after taking both the individual active ingredients of this medicine separately.

Do not take TESAR CO:

• if you are hypersensitive (allergic) to telmisartan, hydrochlorothiazide or other sulphonamide-derived medicines, or to any of the ingredients of TESAR CO (see section 6)
• if you have or have ever had skin and lip cancer
• if you suffer from severe kidney disease or you have problems passing water
• if you suffer from severe liver disease such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease
• if your doctor determines that you have low potassium or sodium levels or high calcium levels in your blood that do not get better with treatment
• if you have high levels of uric acid in your blood or are experiencing symptoms of gout
• if you suffer from a severe kidney disorder, narrowing of the blood vessels of both kidneys; or you have only one kidney left, of which the blood vessels are narrowed
• if you suffer from heart disease, including a heart condition known as hypertrophic obstructive cardiomyopathy (HOCM – thickening of the muscle of the heart)
• if after previously taking other angiotensin receptor blockers (ARBs) or ACE inhibitors you have experienced swelling of your face, lips, eye lids, mouth, tongue or throat. You must never take these medicines (including TESAR CO) again
• if you have a disease of the heart valves called aortic stenosis in which the opening is narrowed
• if you are currently taking water tablets containing spironolactone, triamterene or amiloride (medicines that increase the rate of urination)
• if you have Addison’s disease (a hormonal disorder)
• if you have porphyria (a rare hereditary blood disorder)
• if you are currently taking lithium (used to treat depression or mood disorders). Concomitant administration with TESAR CO may lead to toxic blood concentrations of lithium
• if you are being treated with ACE inhibitors/angiotensin receptor blockers (to treat high blood pressure) together with a fluoroquinolone antibiotic
• if you are being treated with a blood pressure lowering medicine called aliskiren
• if you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with TESAR CO:

• if you have high blood pressure caused by kidney disease
• if you have kidney problems, have had a kidney transplant or have a single kidney (see Do not take TESAR CO)
• if you your body lacks salt due to a low salt diet, or you have recently lost a lot of body fluids, through taking strong water tablets, or due to vomiting or diarrhoea
• if are already taking other medicines which lower blood pressure medicines including a medicine containing aliskiren (see Do not take TESAR CO)
• if you have been diagnosed with diabetic neuropathy (a type of nerve damage that can occur in diabetics)
• contact your doctor to re-evaluate your treatment if you are being treated with ACE inhibitors/angiotensin receptor blockers (to treat high blood pressure) together with a fluoroquinolone antibiotic (see Do not take TESAR CO)
• if you have high aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals) (aldosterone is a hormone that helps regulate blood pressure)
• if you have heart problems (irregular heartbeats, angina, chest pain, or had a heart attack or stroke) (see Do not take TESAR CO)

Should you become pregnant while taking TESAR CO, stop taking the tablets immediately and contact your doctor. Your doctor may consider switching your medicine to a different treatment (see Do not take TESAR CO).

Do not share medicines prescribed for you with any other person. Always take TESAR CO exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Two strengths of TESAR CO tablets are available: 40/12,5 mg and 80/12,5 mg. Your doctor will decide which strength is best for you.

Adults: The usual dose is one TESAR CO tablet daily, with or without food. Usually, treatment will be continued for at least 4 to 8 weeks, to obtain the maximum effect of lowering your blood pressure in the long term.

Children: TESAR CO is not recommended for use in children. Your doctor will tell you how long your treatment with TESAR CO will last. Do not stop treatment early because your high blood pressure may return.

If you have the impression that the effect of TESAR CO is too strong or too weak, tell your doctor or pharmacist.

If you take more TESAR CO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include: a heartbeat which is too fast, too slow or irregular, dizziness, feeling faint, feeling sick or be sick, drowsiness, or experiencing muscle spasms.

If you forget to take TESAR CO, take the missed dose as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TESAR CO Suddenly stopping your treatment may lead to your symptoms getting worse. Do not stop taking TESAR CO unless your doctor tells you to. It is recommended that TESAR CO should be gradually reduced before stopping treatment.

TESAR CO can have side effects. Not all side effects reported for TESAR CO are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using TESAR CO, please consult your doctor, pharmacist or other healthcare professional for advice.

The below listed side effects include those that are related to taking TESAR CO as well as those of the active ingredients telmisartan and hydrochlorothiazide, if taken individually.

If any of the following happens, stop using TESAR CO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• sepsis (blood poisoning - 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 are all very serious side effects. If you have them, you may have had a serious allergic reaction to TESAR CO. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• low blood pressure or fainting when getting up from a lying or sitting position (orthostatic hypotension/dizziness)
• changes in the way your heart beats (for example if you notice it is beating faster or you experience chest pain)
• weakness, fatigue, weight loss, headache (symptoms of a condition called vasculitis)
• kidney problems (passing less urine than is normal for you), abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine, kidney failure
• difficulty breathing, shortness of breath (interstitial lung disease)
• liver problems resulting in yellowing of the skin and/or eyes (jaundice). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• dizziness
• electrolyte imbalance, dehydration
• nausea.
• Less frequent side effects:
• sore throat, chest infection, bladder infection including cystitis
• anaemia (reduced number of red blood cells with symptoms such as feeling generally tired or lethargic, pale skin), low blood platelet count (thrombocytopenia), reduction in blood platelets, which increases risk of bleeding or bruising, decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count
• abnormal breakdown of red blood cells (haemolytic anaemia), inability of the bone marrow to work properly, reduction of white blood cells (leukopenia, agranulocytosis)
• decreased blood potassium (hypokalaemia), sodium (hyponatraemia) and glucose (hypoglycaemia), and increased uric acid levels in the blood, causing gout (hyperuricaemia)
• depression, anxiety, restlessness
• insomnia (sleep disorder), sleep disturbances, pins-and-needles sensation, drowsiness, headache
• abnormal or yellow vision, temporary blurred vision
• vertigo (sensation of spinning)
• diarrhoea, dry mouth, flatulence, stomach pain/discomfort, constipation, indigestion, vomiting, taste disturbance or loss
• liver problems
• sensitivity of skin to light, itching, eczema, rash or swelling of the skin, increased sweating, hives, skin blistering or peeling
• back pain, muscle spasm or cramps, leg pain, joint pain, muscle pain, leg cramps
• problems with sexual performance
• chest pain, general pain, influenza, abnormal physical weakness or lack of energy
• abnormal blood test results
• cough.
• The following side effects have been reported but the frequency for them to occur is not known:
• inflammation of salivary glands inflammation of the back of the throat (pharyngitis), sinusitis
• lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body’s immune system attacks the body)
• inflammation of the lining of the stomach (gastritis)
• pancreatitis (inflammation of the pancreas with symptoms such as stomach pain, increased heart rate and fever)
• increase in certain white blood cells (eosinophilia)
• rhabdomyolysis (a condition affecting the muscles with symptoms such as dark urine and difficulty in moving the arms or legs)
• tendon pain (tendinitis), weakness, joint pain (arthrosis)
• skin and lip cancer (non-melanoma skin cancer), with abnormal growth of skin, bumps or sores on the lips that persist for a long period of time
• loss of diabetic control
• anorexia, loss of appetite, increased cholesterol and glucose levels in the blood
• light headedness
• yellow vision (xanthopsia), increased pressure in the eye (acute angle-closure glaucoma)
• inflammation of blood vessels (vasculitis necrotising)
• kidney inflammation or impaired kidney function, glucose in the urine (glycosuria)
• fever.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TESAR CO. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 °C. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).