Lortell 25 mg Tablets

Losartan, the active ingredient of LORTELL, belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

LORTELL tablets are indicated for:

• the treatment of hypertension (high blood pressure)
• to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria ≥ 0,5 g per day (a condition in which urine contains an abnormal amount of protein).

Do not take LORTELL:

• if you are hypersensitive (allergic) to losartan potassium or any of the other ingredients of LORTELL (listed in section 6).
• if you have a history of angio-oedema (an area of swelling of the lower layer of skin and tissue just under the skin or mucous membranes) related to ACE-inhibitors or angiotensin receptor antagonists such as LORTELL
• if you have hypertrophic obstructive cardiomyopathy (a disease where the heart muscle thickens) or other heart problems
• LORTELL is not recommended for patients with severe renal impairment or for patients with hepatic impairment
• concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene and amiloride
• if you are pregnant or a nursing mother
• if you are planning to become pregnant
• if you have a problem with your kidney(s), you should not take an antibiotic (medicine used to treat an infection) from the fluoroquinolone class such as moxifloxacin or levofloxacin, while taking LORTELL.

Warnings and precautions

Take special care with LORTELL:

• if you suffer from liver or kidney problems
• if you have a condition known as ‘aortic stenosis’ or ‘outflow obstruction’
• if you have recently suffered from excessive vomiting or diarrhoea
• if you know you have high levels of potassium in your blood (hyperkalaemia) or you are on a low potassium diet
• if you are elderly or have moderate to severe kidney problems, you should not take an antibiotic (medicine used to treat an infection) from the fluoroquinolone class such as moxifloxacin or levofloxacin, while taking LORTELL as it may cause or aggravate kidney problems (see “Do not take LORTELL”).

If you are pregnant or breastfeeding your baby while taking LORTELL, please consult your doctor, pharmacist or health care professional for advice.

Children

The safety and efficacy of LORTELL in children have not yet been established.

Other medicines and LORTELL

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) If you are taking other medicines on a regular basis, concomitant use of LORTELL tablets may cause undesirable interactions. Please consult your doctor or a pharmacist if you are taking any of the following:

Do not share medicines prescribed for you with any other person. Always take use LORTELL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adult patients with high blood pressure

The usual starting and maintenance dose is 50 mg once daily for most patients. The maximum blood pressure lowering effect is achieved 3-6 weeks after treatment was started. In some patients the dose may be required to be increased to 100 mg once daily.

Adult patients with high blood pressure and Type 2 diabetes

The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily based on your blood pressure response.

Dosage in special patient groups

In certain patients such as those over 75 years of age or those with kidney or liver problems, the doctor may prescribe a lower dose of 25 mg once a day.

Duration of administration

Your doctor will tell you how long your treatment with LORTELL will last. Do not stop treatment early because your blood pressure may increase again. If you have the impression that the effect of LORTELL is too strong or too weak, tell your doctor or pharmacist.

Method of administration

LORTELL should be taken by mouth with or without food. It is recommended that you take your tablet at the time each day.

If you take more LORTELL than you should

The symptoms of an overdosage of LORTELL would be hypotension and fast or irregular heart rate. 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 LORTELL

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LORTELL

Your blood pressure may gradually rise again if treatment is stopped and no medicine is taken for high blood pressure.

LORTELL can have side effects. Not all side effects reported for LORTELL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LORTELL, please consult your health care provider for advice.

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

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are very serious side effects. If you have them, you may have had a serious reaction to LORTELL. 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:

• chest pain
• changes in the way your heart beats, for example, if you notice it beating faster
• difficulty breathing
• signs of recurrent infections such as fever or sore throat
• less urine than is normal for you
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.

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:

• insomnia (sleeplessness)
• headache, dizziness
• cough, nasal congestion, sinus disorder.

Less frequent side effects:

• low blood platelet count
• orthostatic (low blood pressure – you may be feeling dizzy when standing upright from a sitting position)
• diarrhoea, indigestion/heartburn, nausea, abdominal pain
• back pain, muscle cramps, leg pain, muscle pain
• feeling of body fatigue or tiredness
• high blood potassium levels and altered liver enzymes.

Side effects with frequency unknown:

• low blood counts
• migraine
• taste disturbances, vomiting
• skin rash due to sensitivity to sunlight
• joint stiffness
• erectile dysfunction

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LORTELL.

Store in a dry place at or below 25 ºC. Protect from light, heat and moisture. Keep blister packs in carton until required for use. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Return all unused medicines to your pharmacist. Do not dispose of unused medicines in drains or sewerage system (e.g toilets).