In Treatment of Hypertension (high blood pressure)

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will decide on the appropriate dose of Losartan Potassium/Hydrochlorothiazide depending on your condition and whether you are taking other medicines. It is important to continue taking this medicine for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

High Blood Pressure: The recommended dose for most patients with high blood pressure is 1 tablet of Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of 50 mg/12.5 mg or changed to 1 tablet daily of 100 mg/25 mg per day. The maximum daily dose is 2 tablets per day of 50 mg/12.5 mg or 1 tablet daily of 100 mg/25 mg.

Use in elderly patients: Losartan Potassium/Hydrochlorothiazide works equally well in and is equally well tolerated by most older and younger adult patients. Most older patients require the same dose as younger patients.

Use in children and adolescents: There is no experience with the use of Losartan Potassium & Hydrochlorothiazide in children. Therefore, Losartan Potassium/Hydrochlorothiazide should not be given to children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Diuretic agents such as the hydrochlorothiazide contained in Losartan Potassium/Hydrochlorothiazide may interact with other medicines.

You should avoid taking Losartan Potassium/Hydrochlorothiazide with: lithium, potassium supplements, potassium-sparing diuretics, potassium salts.

It is also important for your doctor to know if you are taking:

• other medicines to reduce your blood pressure such as ACE-inhibitors, other diuretics, medicines for the treatment of gout, medicines to control heart rhythm, steroids or ACTH, medicines to treat cancer, pain killers such as non-steroidal anti-inflammatory drugs or high dose salicylates, medicines for treatment of fungal infections, arthritis medicines, resins used for high cholesterol, medicines which relax your muscles, sleeping tablets, opioid medicines, ‘pressor amines’ such as adrenaline or other medicines from the same group, oral agents for diabetes (e.g. metformin) or insulins, medicines to treat neurological disorders such as depression, anxiety, and schizophrenia including tricyclic antidepressants and neuroleptics, medicines which may give you a dry mouth or blurred vision, medicines for mouth ulcers, immunosuppressants, some laxatives (e.g. senna, bisacodyl), some laxatives (e.g. senna, bisacodyl), digoxin or other cardiac glycosides, bepridil, cisapride or diphemanil, erythromycin by injection, rifampicin, halofantrine, terfenadine or mizolastine, pentamidine, vincamine by injection, calcium including calcium supplements, carbamazepine, glycyrrhizin if taken in large amounts.

Also inform your doctor if you are taking Losartan Potassium/Hydrochlorothiazide and you will be undergoing a radiographic procedure and will be given iodine contrast media.

Your doctor may need to change your dose and/or to take other precautions:

Losartan Potassium/Hydrochlorothiazide with food, drink and alcohol

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium/Hydrochlorothiazide tablets may increase each other’s effects. Dietary salt in excessive quantities may counteract the effect of Losartan Potassium/Hydrochlorothiazide tablets. Large amounts of glycyrrhizin which is contained in liquorice and some cough medicines can affect how well Losartan Potassium & Hydrochlorothiazide works.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking Losartan Potassium/Hydrochlorothiazide tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

Common (may affect up to 1 in 10 people): Abnormal kidney function including inflammation of the kidneys and kidney failure.

Uncommon (may affect up to 1 in 100 people): Angina (chest pain), abnormal heartbeat, cerebrovascular accident (Transient ischemic attack (TIA), “mini-stroke”), heart attack, Blood problems including: reduction in white blood cells leading to an increase in infections, anemia, red or brownish spots on the skin, clotting problems and bruising, Jaundice (yellowing of the eyes and skin), inflammation of the pancreas, pneumonia, water on the lungs , Severe skin reaction associated with painful red areas, large blisters, peeling of layers of skin. This is accompanied by fevers and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis).

The following other side effects have been reported:

Common (may affect up to 1 in 10 people): Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder, Diarrhea, abdominal pain, nausea, indigestion, Muscle pain or cramps, leg pain, back pain, Difficulty sleeping (insomnia), headache, dizziness, Weakness, tiredness, chest pain, Increased potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels, Decreased sugar in the blood (hypoglycemia).

Uncommon (may affect up to 1 in 100 people): Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels, Anxiety, nervousness, panic disorder, confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment, Pins and needles sensation, numbness or weakness of the arms and legs, tremor, migraine, fainting, Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow, Ringing, buzzing, roaring or clicking in the ears, dizziness and spinning sensation, Low blood pressure, which may be associated with changes in posture, palpitations, changes in the rhythm or rate of the heart beat (arrhythmias),

Rare (may affect up to 1 in 1,000 people): Abnormal liver function tests.

Not known (frequency cannot be estimated from the available data):

• Flu-like symptoms, Low levels of sodium in the blood (hyponatremia), Generally feeling unwell (malaise), Disturbed taste (dysgeusia).

Do not take Losartan potassium & Hydrochlorothiazide Tablets if you are:

• if you are allergic to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine
• if you are allergic to other sulfonamide-derived substances
• if you have severely impaired liver function
• if you have a blockage, or reduced flow of bile, such as cholestasis causing jaundice, dark urine, pale stools and itching of the skin
• if you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
• if you are suffering from gout
• if you are more than 3 months pregnant.
• if you have severely impaired kidney function or your kidneys are not producing any urine.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions:

You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium/Hydrochlorothiazide is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan Potassium/Hydrochlorothiazide. 

It is important to tell your doctor before taking Losartan Potassium/Hydrochlorothiazide

• if you have previously suffered from swelling of the face, lips, throat or tongue or if you take diuretics or on a salt-restricted diet or have or have had severe vomiting and/or diarrhoea or are dehydrated
• if you have heart failure or cerebrovascular disease or your liver function is impaired or narrow arteries to your kidneys or only have one functioning kidney, or you have recently had a kidney transplant
• if you have narrowing of the arteries (atherosclerosis), angina pectoris or have ‘aortic or mitral valve stenosis’  or ‘hypertrophic cardiomyopathy’ or diabetes or gout
• if you have or have had an allergic condition, asthma or a condition that causes joint pain, skin rashes and fever or have high calcium or low potassium levels or you are on a low potassium diet or have high fat levels in your blood as the hydrochlorothiazide in this medicine may cause these to increase
• if you need to have an anesthetic (even at the dentist) or before surgery, or if you are going to have tests to check your parathyroid function, you must tell the doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland)
• if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes related kidney problems.
  • aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

Losartan Potassium/Hydrochlorothiazide with food, drink and alcohol:

You are advised not to drink alcohol whilst taking these tablets: alcohol and Losartan Potassium/Hydrochlorothiazide tablets may increase each other’s effects. Dietary salt in excessive quantities may counteract the effect of Losartan Potassium/Hydrochlorothiazide tablets. Large amounts of glycyrrhizin which is contained in liquorice and some cough medicines can affect how well Losartan Potassium & Hydrochlorothiazide works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Your doctor will normally advise you to stop taking Losartan Potassium/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of it. Losartan Potassium & Hydrochlorothiazide is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding: Losartan Potassium/Hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or born prematurely.

Driving and using machines: When you begin treatment with this medication, you should not perform tasks which may require special attention (for example, driving an automobile or operating dangerous machinery) until you know how you tolerate your medicine. You may feel dizzy or drowsy, especially at the beginning of your treatment or when the dose is increased.