Lysin Tablets

LYSIN belongs to a class of medicines called angiotensin-converting enzyme (ACE) inhibitors. It is used to treat mild to moderate blood pressure (hypertension). It may be used alone or together with other medicines for high blood pressure. LYSIN may also be used to treat heart failure or may be used after a heart attack to prevent the development of heart failure.

Do not take LYSIN:

• if you are hypersensitive (allergic) to lisinopril, or to any of the other ingredients of LYSIN (listed in section 6).
• if you ever had an allergic reaction to another ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema)
• if a member of your family has had severe allergic reactions (angioedema) to an ACE inhibitor or you have had severe allergic reactions (angioedema) without a known cause
• if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy)
• if you have severe kidney dysfunction
• if you have a narrowing (stenosis) of the kidney artery
• if you have a narrowing (stenosis) of the aorta (an artery in your heart)
• if you are also taking potassium sparing diuretics such as spironolactone, triamterene, amiloride
• if you have a hereditary condition called porphyria
• if you are also receiving lithium therapy: Administration together with LYSIN may lead to toxic blood concentrations of lithium
• if you are pregnant or breast-feeding (see Pregnancy, breastfeeding and fertility)
• if you are taking a blood pressure lowering medicine containing aliskiren.
• If you are taking fluoroquinolones (medicines to treat infections) and you have impaired kidney function.

If you are not sure about any of these please consult your doctor.

Warnings and precautions

Take special care with LYSIN:

• if you are at high risk of low blood pressure (you may notice this as faintness or dizziness, especially when standing).
• if you have been very sick (excessive vomiting) or had bad diarrhoea recently.
• if you are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents (such as spironolactone, triamterene, amiloride), or potassium-containing salt substitutes.
• if you have a condition known as congestive heart failure (your heart fails to pump blood strongly enough to supply all the blood needed throughout the body).
• if you have any other a heart problem or heart disease.
• if you have a condition involving the blood vessels in the brain or blood vessel disease.

Should a woman become pregnant while receiving LYSIN, the treatment must be stopped promptly and changed to a different medicine. If a woman is contemplating pregnancy, a different class of medicine should be used.

• if you have any other kidney problems (including kidney transplantation). These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of LYSIN or monitor your blood level of potassium.
• if you are having dialysis.
• if you have a liver problem.
• if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in your blood can also be higher.
• if you are of black origin as LYSIN may be less effective. You may also more readily get the side-effect ‘angioedema’ (a severe allergic reaction).
• if you have high levels of cholesterol and you are having a treatment called ‘LDL apheresis’.
• if LYSIN is given to children as the safety and efficacy of LYSIN in children have not been established.
• if you are taking fluoroquinolones used to treat infections; in particular if you are elderly or have kidney problems; your doctor may check your kidney function at regular intervals. See also information under the heading “Do not take LYSIN”.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking LYSIN.

Treatment for allergies such as insect stings:

Tell your doctor if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). If you take LYSIN while you are having this treatment, it may cause a severe allergic reaction.

Operations:

If you are going to have an operation (including dental surgery) tell the doctor or dentist that you are taking LYSIN. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking LYSIN.

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

Adults: The usual dose of LYSIN depends on your medical condition and whether you are taking any other medicines. The usual dose varies from 2,5 – 20 mg once a day depending on the condition being treated. If you are elderly, have kidney problems or are taking diuretic medicines, your doctor may give you a lower dose than the usual dose. LYSIN may be taken before, during or after meals. Try to take your tablets at the same time each day. Take special care when you take your first dose of LYSIN as it may cause a greater fall in blood pressure than later doses. This may make you feel dizzy or light-headed. If this happens, it may help to lie down. Your doctor will tell you how long your treatment with LYSIN will last. Do not stop treatment early without consulting your doctor. If you have the impression that the effect of LYSIN is too strong or too weak, tell your doctor or pharmacist.

Children: LYSIN should not be given to children.

If you take more LYSIN than you should

In the event of overdosing, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center. Take the LYSIN medicine pack with you.

If you forget to take LYSIN

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking LYSIN

Do not stop taking LYSIN, even if you are feeling better, unless your doctor tells you to. If you have any further questions on the use of LYSIN, ask your doctor or pharmacist.

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

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

• severe allergic reactions. The signs may include sudden onset of swelling of the face, lips, tongue or throat; difficulty breathing; severe or sudden swelling of your hands, feet and ankles,
• severe skin disorders, like a sudden, unexpected rash or burning, red or peeling skin.

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

• stroke; heart attack (symptoms may include chest discomfort, pain in one or both arms, shortness of breath, cold sweat, nausea or light-headedness,
• fast heartbeat,
• a very big drop in blood pressure may happen in people with the following conditions: coronary heart disease; narrowing of the aorta (a heart artery), kidney artery or heart valves; an increase in thickness of the heart muscle. If this happens, you may feel dizzy or light-headed, especially if you stand up quickly,
• sudden kidney failure; passing less water (urine) than normal or passing no water,
• liver failure, yellowing of the skin or whites of the eyes (jaundice),
• fainting.

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:

• headache,
• feeling dizzy or light-headed, especially if you stand up quickly,
• diarrhoea,
• a dry cough that does not go away,
• being sick (vomiting),
• kidney problems (shown in a blood test).

Less frequent side effects:

• mood changes,
• change of colour in your fingers or toes; or numbness or tingling in your fingers or toes,
• changes in the way things taste,
• feeling sleepy,
• spinning feeling (vertigo),
• having difficulty sleeping,
• runny nose,
• feeling sick (nausea); stomach pain or indigestion,
• skin rash or itching,
• being unable to get an erection (impotence),
• feeling tired or feeling weak (loss of strength),
• changes in blood tests that show how well your liver and kidneys are working,
• feeling confused,
• a lumpy rash,
• dry mouth,
• hair loss,
• psoriasis (a skin problem),
• changes in the way things smell,
• development of breasts in men,
• changes to some of the cells or other parts of your blood. Your doctor may take blood samples from time to time to check whether LYSIN have had any effect on your blood,
• sinusitis,
• wheezing,
• low levels of sugar in your blood,
• inflammation of your lungs,
• inflammation of the liver or pancreas,
• severe skin disorders,
• symptoms of depression.

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. By reporting side effects, you can help provide more information on the safety of LYSIN.

Store all medicines out of reach of children

Store in a cool place at or below 30 ºC. Protect from light.

Do not store in a bathroom.

Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).