Lisoretic Tablets

Lisinopril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE I). It works by making your blood vessels widen. Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body get rid of water and salts, like sodium, in your urine. LISORETIC is used to treat mild to moderate high blood pressure (hypertension). Your doctor will usually prescribe LISORETIC when your blood pressure has already been controlled after taking both the individual active ingredients of this medicine separately.

Do not take LISORETIC:

• if you are hypersensitive (allergic) to lisinopril, hydrochlorothiazide, or any of the other ingredients of LISORETIC (see section 6)
• if you have had skin cancer or you develop an unexpected skin lesion during the treatment with LISORETIC
• if you are hypersensitive (allergic) to sulphonamides (used to treat certain infections) and medicines made from sulphonamide
• 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 LISORETIC or other medicines containing the same active ingredients as LISORETIC 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.
• if you suffer from hypertrophic obstructive cardiomyopathy (HOCM – thickening of the muscle of the heart)
• if you don’t pass or pass very little urine per day
• if you have anuria (a condition where your kidneys cannot produce urine, and you stop passing urine)
• 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
• if you are also being treated with medicines called potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride) that increases 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 have Addison’s disease (a hormone disease with symptoms such as chronic fatigue, loss of appetite and weight loss)
• if you are receiving lithium therapy (a mood stabilizer) concomitant administration with LISORETIC may lead to toxic blood concentrations of lithium
• if you have severely impaired liver function or liver cirrhosis (an advanced liver disease with symptoms such as yellowing of the skin, easy bruising and fatigue)
• if you suffer from biliary obstruction (a problem with the drainage of the bile from the gall bladder)
• if you are taking a blood pressure medicine containing aliskiren
• if you are taking antibiotic medicine containing fluoroquinolones (e.g. ciprofloxacin, levofloxacin) and have a history of moderate or severe kidney injury
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased
• if you are, or think you may be, pregnant or if you are planning to become pregnant or if you are breastfeeding.

Warnings and precautions

Take special care with LISORETIC: If you become pregnant while taking LISORETIC, you should stop taking LISORETIC immediately and inform your doctor. He/ she may have to switch you to a different medicine.

Do not share medicines prescribed for you with any other person. Always take LISORETIC exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: The usual dose is one tablet once daily, taken at the same time every day with or without food. The dose of LISORETIC can be increased to 2 tablets per day, depending on your blood pressure response. Your doctor will decide on the dose depending on your condition. The tablets should be swallowed with sufficient fluid.

Patients on diuretic (water tablets) therapy: Inform your doctor if you are taking water tablets as he may want to stop your water tablet before starting you on LISORETIC therapy.

Patients with severe kidney disease: LISORETIC is not recommended for patients with severe kidney problems (See Do not take LISORETIC).

Use in the elderly: No dosage reduction is usually necessary in the elderly.

Children: LISORETIC is not recommended for use in children and adolescents due to a lack of data on safety and efficacy. Your doctor will tell you how long your treatment with LISORETIC will last. Do not stop treatment early because your high blood pressure may return.

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

If you take more LISORETIC 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:

• hypotension (dizziness, fainting, nausea), rapid breathing (hyperventilating), pale or sweaty skin, bluish lips and nails (circulatory shock), decreased urine output, fluid retention, causing swelling in your legs, ankles or feet, abnormally slow, fast or irregular heart rate or anxiety and cough.

The most common signs of overdosage, related to decreased electrolytes in the body, are weakness, tiredness, cramping of muscles, tingling or numbness, bloating or constipation, dehydration, diarrhoea or vomiting, confusion, seizures and dehydration due to frequent passing of urine. Your healthcare provider will advise you on precautionary measures to take in the case of overdose.

If you forget to take LISORETIC: If you forget to take LISORETIC, take one as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the tablet or tablets at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LISORETIC: It is important that you continue the course of treatment even if you begin to feel better after a few days.

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

If any of the following happens, stop using LISORETIC 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.

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

• fever, unexplained wide spread of skin pain, red or purple rash that spreads or blisters on your skin and the mucous membranes of your mouth, nose, eyes, genitals or shedding of your skin within days after blisters form which are symptoms for Stevens-Johnson syndrome
• jaundice (yellow discolouration of the skin and eyes)
• heart attack or stroke
• increased or fast heartbeat (tachycardia)
• low blood pressure or fainting when getting up from a lying or sitting position (orthostatic hypotension/dizziness)
• chest pain (angina)
• weakness, fatigue, weight loss, headache (symptoms of a condition called vasculitis)
• kidney problems (passing less urine than is normal for you)
• hepatitis (inflammation of the liver with symptoms such as nausea, mild fever, abdominal pain).

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
• cough
• changes in the levels of certain chemicals in the blood and urine which are usually detected by blood and urine tests (electrolyte imbalance)
• vertigo (loss of balance), dizziness, tingling sensation in hands, feet or lips (feeling of “pins and needles”), sleep disturbances, light-headedness
• stomach pain or discomfort, constipation
• skin rash.

Less frequent side effects:

• increased immune response (autoimmune disease)
• problems with your bone marrow or a reduced number of blood cells and/or platelets in your blood. You may notice tiredness, an infection (which may be serious), fever, feeling breathless or that you bruise or bleed more easily
• changes to some of the cells or other parts of your blood, abnormal blood test results including anaemia
• low levels of sugar in your blood (hypoglycaemia)
• pancreatitis (inflammation of the pancreas with symptoms such as stomach pain, increased heart rate and fever)
• deficiency of potassium, sodium and magnesium, increased cholesterol levels and excess of uric acid in the bloodstream (seen through blood tests)
• insomnia, sleep disturbances, mood changes, anxiety, depression, confusion, hallucinations (seeing or hearing things that are not there), restlessness, changes to your sense of smell
• flushing, change of colour in your fingers or toes
• upper respiratory tract infections, nasal congestion, sinus disorders, sore throat
• stomach pain or discomfort, inflammation of the stomach, bloating, flatulence (gas)
• wind, stomach spasms, inflammation of a salivary gland
• diarrhoea, vomiting, dry mouth, nausea, indigestion
• abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite, yellow eyes or skin), liver failure
• muscle cramps, spasms, weakness or pain
• hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, blistering or peeling of the skin, hair loss
• abnormal kidney function including inflammation of the kidneys, urinary infection, sugar in the urine, increased protein levels in the urine, liver failure
• blurred vision, worsening eyesight, seeing things in yellow
• problems with your sight for a short time, eye pain with redness
• vertigo (loss of balance)
• problems with sexual performance, enlarged breasts in men.

The following side effects have been reported but the frequency for them to occur is not known:

• skin and lip cancer (non-melanoma skin cancer), with abnormal growth of skin, bump or sores on the lips that persist for a long period of time
• inflammation of a salivary gland
• sudden eye pain and visual loss.

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 the SAHPRA. By reporting side effects, you can help provide more information on the safety of LISORETIC. 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. Protect from light. 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).