Liso 20 mg Tablets

LISO helps reduce your blood pressure by widening your blood vessels, which makes it easier for your heart to pump blood to all parts of your body.

LISO can be used:

• to treat high blood pressure (hypertension)
• to treat heart failure
• if you have recently had a heart attack (myocardial infarction).

Do not take LISO:

• if you are hypersensitive (allergic) to lisinopril or any of the other ingredients of LISO listed in section 6
• if you are taking an antibiotic of the fluoroquinolone group of antibiotics (e.g. ciprofloxacin, moxifloxacin and levofloxacin), to treat a bacterial infection (such as respiratory tract infections, urinary tract infections and skin infections), as taking these medicines while taking Angiotensin Converting Enzyme (ACE) inhibitors, such as LISO, may result in kidney injury, especially if you have kidney problems or if you are elderly.
• Contact your doctor to re-evaluate your treatment if you are treated with an Angiotensin Converting Enzyme (ACE) inhibitor, such as LISO, together with a fluoroquinolone antibiotic.
• if you or anyone in your family have a history of angioedema (swellings similar to hives beneath the surface of the skin) related to previous therapy with LISO or other medicines containing the same active ingredient as LISO or with certain medicines used to treat heart conditions, called ACE-inhibitors (angiotensin-converting enzyme inhibitors), or ARBs (angiotensin receptor blockers). If this is the case you may never take these medicines again (see Take special care with LISO).
• if you suffer from hypertrophic obstructive cardiomyopathy (HOCM - thickening of the muscle of the heart).
• if you have severe kidney disease, narrowing of the blood vessels of both kidneys, are undergoing haemodialysis or you have only one kidney left, of which the blood vessels are narrowed.
• if you have a disease of the heart valves called aortic stenosis in which the opening is narrowed (see Take special care with LISO).
• if you are also being treated with medicines called potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride) that increase the rate of urination.
• if you have porphyria (a rare hereditary disease in which your urine becomes dark and your skin is extremely sensitive to light).
• if you are receiving lithium therapy (a mood stabilizer) concomitant administration with LISO may lead to toxic blood concentrations of lithium.
• if you are pregnant or breastfeeding (see Take special care with LISO and Pregnancy, breastfeeding, and fertility)
• if you are taking renin-inhibiting medicines used for treatment of high blood pressure.

Warnings and precautions

Take special care with LISO:

• if you become pregnant while taking LISO you should stop taking LISO immediately and inform your doctor. Your doctor may have to switch you to a different medicine (see Do not take LISO and Pregnancy, breastfeeding and fertility).
• if you are currently being treated for hypertension with other medicines used to lower blood pressure, such as valsartan, irbesartan and telmisartan, and with water tablets (diuretics)
• if you experience angioedema any time during your treatment. You should stop using LISO immediately and tell your doctor (see Do not take LISO and Possible side effects)
• if you are of black ethnicity you may have a higher risk of angioedema
• if you have impaired kidney function as LISO may result in a very low blood pressure
• if you are elderly, have impaired kidney function and suffer from atherosclerosis (disease caused by build-up of cholesterol inside your artery walls; you may feel pain on your legs when walking)
• if you have lost a lot of fluids due to vomiting, diarrhoea, low salt intake, excessive perspiration or you had dialysis treatment
• if you suffer from low blood pressure (you may feel dizzy or light-headed, especially when standing up)
• if you are going to have major surgery or receive anaesthetic
• if you have diabetes. You should be aware that the use of LISO may cause lowering of your blood sugar levels. Monitor your blood glucose regularly and adjust your diabetic treatment accordingly
• if you are about to receive treatment called LDL apheresis, which removes cholesterol from your blood using a machine
• if you are about to undergo desensitisation therapy (due to an allergy e.g. insect bites). If you take LISO while you are having this treatment, it may cause a severe allergic reaction
• if you develop a persistent cough
• if you have a severe autoimmune disease, such as systemic lupus erythematosus, scleroderma or other collagen vascular disease
• if you bruise more easily, bleed for longer than normal, experience any signs of bleeding (e.g. bleeding from the gums), purple spots blotching on the skin or get infections more easily than usual, sore throat, fever, feel tired, faint, dizzy or have pale skin. These can be signs of blood or bone marrow problems
• if you have liver failure (symptoms include yellowing of the skin and/or eyes (jaundice) along with stomach pain and swelling) which may be caused by an allergic reaction (see Possible side effects)

Children and adolescents

Do not give LISO to children

Do not share medicines prescribed for you with any other person. Always take LISO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is 10 mg once daily. Your doctor will tell you how long your treatment with LISO will last. Do not stop taking the tablets, even if you are feeling well. If you have the impression that the effect of LISO is too strong or too weak, talk to your doctor or pharmacist. For best results, take LISO at the same time each day.

The safety and effectiveness of LISO in children have not been established.

If you take more LISO than you should:

Symptoms of overdosage are serious low blood pressure, circulatory shock (symptoms include agitation or restlessness, bluish lips and fingernails, chest pains, confusion, light-headedness, pale skin, low or no urine output), shortness of breath, rapid or slower heartbeat, dizziness, anxiety, cough, blood tests showing changes in electrolytes (body salts) and possible kidney failure. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of LISO:

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

If you stop taking LISO

LISO has no known withdrawal effects.

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

If any of the following happens, stop taking LISO 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
• a swelling in your gut called ‘intestinal angioedema’: you may experience symptoms like abdominal pain, vomiting and diarrhoea
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LISO. You may need urgent medical attention or hospitalisation. Black patients are at a greater risk of these allergic reactions.

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

• heart attack (common signs include chest pain or discomfort, pressure or tightness in the chest that may spread to your arm, neck, jaw or back), fast or pounding heartbeat
• stroke (common signs include numbness or weakness of the arm, face or leg, especially on the one side of the body, confusion, trouble speaking, loss of balance)
• difficulty breathing and persistent cough due to lung problems
• liver problems, such as yellowing of skin and eyeballs (jaundice)
• no urine or less urine than is normal for you, swelling of legs, ankles or feet, nausea or extreme tiredness (acute kidney failure)
• Stevens-Johnson syndrome or other serious skin disorders (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters)
• you look pale and feel tired and breathless (you may have anaemia where you have less haemoglobin in your blood than is normal)
• bleeding from your gums, nose or mouth, any bleeding that will not stop, reddish or pink urine, unexpected bruising (you may have less platelets in your blood than is normal)

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, headache
• a dry cough that does not go away
• diarrhoea, vomiting

Less frequent side effects:

• blood tests showing a decrease in the number of red blood cells, white blood cells or platelets
• blood tests showing decreases of sodium and sugar levels, as well as increases of potassium levels in your blood
• changes to your mood, confusion, restlessness and depression
• “pins and needles”, vertigo (the sensation of spinning when standing still), difficulty sleeping, hallucinations (strange visions or sounds), fainting, changes in the way things smell
• a very big drop in blood pressure causing you to feel very dizzy and lightheaded, especially if you stand up quickly
• a disorder called Raynaud’s phenomenon – narrowing of the blood vessels in your fingers and toes when exposed to cold; they may look blue or red and feel cold and numb
• swelling and irritation inside your nose, sinusitis, shortness of breath, wheezing, fever and feeling generally unwell
• nausea, stomach pain, indigestion, dry mouth, loss of taste
• upper abdominal pain that radiates into the back, which may be aggravated by eating foods high in fat, swollen and tender abdomen (signs of pancreatitis)
• pain in your upper right abdomen, abdominal swelling or generally feeling unwell (signs of liver problems)
• redness and itchiness of skin, sweating more than usual, hair loss, blisters
• sexual inability in men, development of breasts in men
• fatigue, a feeling of weakness, pain, swelling, heat and a sense of stiffness in your joints, rash, photosensitivity.

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 or nurse. 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. Report all side effects to Unicorn Pharmaceuticals (Pty) Ltd "[email protected]". By reporting side effects, you can help provide more information on the safety of LISO.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Do not store these tablets in the bathroom. Keep blisters in carton until required for further 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).