Simayla Lisinopril Tablets

SIMAYLA LISINOPRIL belongs to a class of medicines called angiotensin - converting enzyme (ACE) inhibitors. It is used to treat high blood pressure (hypertension). It may be used alone or together with other medicines for high blood pressure. SIMAYLA LISINOPRIL 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 SIMAYLA LISINOPRIL :

• if you are hypersensitive (allergic) to lisinopril, or to any of the other ingredients of SIMAYLA LISINOPRIL.
• 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 SIMAYLA LISINOPRIL may lead to toxic blood concentrations of lithium
• if you are pregnant or breast - feeding (see Pregnancy and breastfeeding)
• 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 SIMAYLA LISINOPRIL Talk to your doctor or pharmacist before taking SIMAYLA LISINOPRIL. SIMAYLA LISINOPRIL should be used with caution in the following conditions:

• You are at high risk of low blood pressure (you may notice this as faintness or dizziness, especially when standing).
• You have been very sick (excessive vomiting) or had bad diarrhoea recently.
• You are on a salt - restricted diet, are taking potassium supplements, potassium - sparing agents (such as spironolactone, triamterene, amiloride), or potassium - containing salt substitutes.
• 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).
• You have any other a heart problem or heart disease.
• You have a condition involving the blood vessels in the brain or blood vessel disease.

Should a woman become pregnant while receiving SIMAYLA LISINOPRIL, 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.

Do not share medicines prescribed for you with any other person. Always take SIMAYLA LISINOPRIL exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with SIMAYLA LISINOPRIL will last. Do not stop treatment early without consulting your doctor. If you have the impression that the effect of SIMAYLA LISINOPRIL is too strong or too weak, tell your doctor or pharmacist.

SIMAYLA LISINOPRIL 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 SIMAYLA LISINOPRIL 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.

Adults: The dose of SIMAYLA LISINOPRIL 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.

Children: SIMAYLA LISINOPRIL should not be given to children.

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

If any of the following happens, stop taking SIMAYLA LISINOPRIL 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 SINOPREN. 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: 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: 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 SINOPREN 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 FUROBE 40 mg TABLETS.

Store all medicines out of reach of children

Store in a cool place at or below 25 ºC. Protect from light and moisture. Do not store in bathrooms in order to protect from light. Do not take the medicine 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).