Losartan Comp Biotech Film-Coated Tablets

LOSARTAN COMP BIOTECH is a combination of losartan potassium (an angiotensin II receptor type AT 1 antagonist) and hydrochlorothiazide (a diuretic). LOSARTAN COMP BIOTECH is used in the treatment of a condition called hypertension or high blood pressure in patients established on identical doses of the individual components of this medicine.

Do not take LOSARTAN COMP BIOTECH

• If you are hypersensitive (allergic) to losartan potassium, other sulphonamide-derived medicines, due to the hydrochlorothiazide component or to any of the other ingredients of LOSARTAN COMP BIOTECH (listed in section 6).
• If you have a family history, or you previously experienced a severe reaction causing swelling of the face, lips, mouth, tongue or throat (known as angioedema) while taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker, such as LOSARTAN COMP BIOTECH.
• If you have problems with your heart valves or heart muscle.
• If you have a serious liver or kidney disorder.
• If you suffer from renal artery stenosis (a narrowing or blockage of the artery supplying blood to the kidney).
• If you have low levels of potassium in your blood (characterised by muscle weakness or cramps and an abnormal heart rhythm).
• If you have high levels of calcium in your blood (characterised by stomach pain or constipation).
• If you have low levels of sodium in your blood (characterised by muscle cramps, weakness and loss of energy).
• If you have too much uric acid in your blood (characterised by severe pain, redness and swelling of the joints (gout)).
• If you are also taking diuretics (medicines that increase the amount of water that you eliminate through your kidneys (water pills), such as spironolactone, triamterene or amiloride). This may cause your body to retain potassium.
• If you have a condition called porphyria (a disorder resulting from a build-up of natural chemicals that produce porphyrin in your body).
• If you have a condition called Addison’s disease (a disorder in which the adrenal glands do not produce enough of the hormones cortisol and aldosterone).
• If you are unable to pass or produce urine.
• If you are taking lithium medicines.
• If you have diabetes mellitus or impaired kidney function and you are taking blood pressure-lowering medicines containing aliskiren.
• If you are pregnant or breastfeeding.
• if you have previously had or currently have cancer of the skin and/or lip.
• Do not use in children as safety and efficacy of LOSARTAN COMP BIOTECH have not been established.

Warnings and precautions

Take special care with LOSARTAN COMP BIOTECH:

• If you have a fluid or electrolyte imbalance due to excessive perspiration, vomiting or diarrhoea.
• If you are taking diuretics (water pills) or potassium supplements.
• If you are on a salt-restricted diet.
• If you have a kidney or liver disorder.
• If you have received a kidney transplant.
• If you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone from the adrenal gland).
• If you suffer from coronary heart disease or if you have had a stroke.
• If you suffer from heart failure.
• If you are taking medicine to lower blood pressure (such as ACE inhibitors, other angiotensin II receptor blockers or aliskiren).
• If you have diabetes (high blood sugar) or are taking medicine to treat diabetes.
• If you have high cholesterol levels (high levels of fat in your blood).
• If you suffer from gout.
• If you suffer from lupus erythematosus (a chronic autoimmune disease that can cause severe fatigue and joint pain).

Do not share medicines prescribed for you with any other person. Always take LOSARTAN COMP BIOTECH at the same time every day, exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of LOSARTAN COMP BIOTECH 50/12,5 is one (1) film-coated tablet per day to control blood pressure over the 24-hour period. The maximum dose is one (1) LOSARTAN COMP BIOTECH 100/25 film-coated tablet once daily. Your doctor will tell you how long your treatment with LOSARTAN COMP BIOTECH will last.

If you have the impression that the effect of LOSARTAN COMP BIOTECH is too strong or too weak, tell your doctor or pharmacist.

If you take more LOSARTAN COMP BIOTECH than you should

An overdose can cause a drop in blood pressure and changes in the way your heart beats (such as beating slower or faster than normal). In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take LOSARTAN COMP BIOTECH

Take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LOSARTAN COMP BIOTECH

If you have any further questions on the use of LOSARTAN COMP BIOTECH, ask your doctor or pharmacist.

LOSARTAN COMP BIOTECH may have side effects. Not all side effects reported for LOSARTAN COMP BIOTECH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LOSARTAN COMP BIOTECH, please consult your healthcare provider for advice.

If any of the following happens, stop taking LOSARTAN COMP BIOTECH and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, tongue and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to LOSARTAN COMP BIOTECH. 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:

• Narrowing or blockage of your blood vessels due to inflammation (vasculitis including Henoch-Schönlein purpura (symptoms include weight loss, general aches and pain, night sweats, nerve problems such as numbness)).
• Frequent infections, such as fever, severe chills, sore throat or mouth ulcers.
• Bleeding or bruising more easily than normal.
• Angina pectoris (a feeling of tightness in your chest or severe chest pain).
• Changes in the way your heart beats, such as a fast, slow or irregular heartbeat (palpitations).
• Severe constipation (obstipation).
• Liver problems characterised by nausea, yellowing of the eyes and skin (jaundice), dark urine, light coloured bowel movements.
• Breakdown of your muscles known as rhabdomyolysis (unexplained muscle pain with dark (tea-coloured) urine).
• Kidney problems (build-up of fluid in your body causing swelling in your legs, ankles or feet, difficulty to urinate, lower back pain).

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Keep blister strips in outer carton until required for use.
• Return expired medicine or unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).