Enalapril Hctz Austell 12,5 mg Tablets

ENALAPRIL HCTZ AUSTELL contains a combination of enalapril maleate and hydrochlorothiazide:

• enalapril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors), which work by widening your blood vessels
• hydrochlorothiazide belongs to a group of medicines known as water tablets (diuretics), which increase the volume of urine you produce.

Do not take ENALAPRIL HCTZ AUSTELL

• if you are allergic to enalapril maleate, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• if you have previously been treated with a medication in the same group of medicines as this medicine (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. You should not take this medicine if you have had these types of reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema
• if you are allergic to any sulfonamide-derived medicines. (Ask your doctor if you are not sure what sulfonamide-derived medicines are.)
• if you are not passing urine
• if you have severe kidney problems
• if you have a condition known as renal artery stenosis (narrowing of the arteries that supply the blood to your kidneys)
• if you have a condition known as aortic stenosis (narrowing of the valve in the large artery in the heart)
• if you are taking other diuretics such as spironolactone, triamterene, amiloride
• if you have a condition known as porphyria (disorders resulting from an accumulation of certain chemicals associated with red blood cell proteins.)
• if you are on lithium therapy
• if you are pregnant or breastfeeding
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
• if you have severe liver problems
• if you are being treated with sacubitril/valsartan, a medicine for heart failure
• if you are being treated with fluoroquinolones (medicines used to treat infections).
• if you have previously had or currently have cancer of the skin and/or lip

Warnings and precautions

Tell your doctor or health care provider before being given ENALAPRIL HCTZ AUSTELL:

• if you have kidney problems, have had a recent kidney transplantation, are a dialysis patient, or are taking water tablets (diuretics)
• if you have blood disorders or liver problems
• if you are on a salt restricted diet, or have suffered from excessive vomiting or diarrhoea recently
• if you have a heart condition called ‘aortic stenosis’, ‘hypertrophic cardiomyopathy’ or ‘outflow obstruction’
• if you have collagen vascular disease, are taking immunosuppressant therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery)
• if you are taking allopurinol, (used for the treatment of gout), or procainamide (used to treat abnormal heart rhythms). If you develop an infection (symptoms may be high temperature or fever), you should let your doctor know immediately. Your doctor may take a blood sample from time to time to check your white blood cell count
• if you have a history of ‘angioedema’ while taking other medicines. The signs may have been itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids
• if you have diabetes and are taking antidiabetic medicines, including insulin to control your diabetes (you should monitor your blood for low blood glucose levels, especially during the first month of treatment)
• if you are taking potassium supplements, potassium containing salt substitutes, or other medicines that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections])
• if you are taking lithium, used for the treatment of some psychiatric illnesses
• if you have been told by your doctor that you have an intolerance to some sugars
• if you think you are (or might become) pregnant (see pregnancy section)
• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking ENALAPRIL HCTZ AUSTELL
• tell your doctor if you are taking an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ) or a medicine containing a neprilysin inhibitor such as sacubitril (available as fixed-dose combination with valsartan), used in patients with heart failure, and racecadotril, used in patients with acute diarrhoea. You may be at increased risk for an allergic reaction called angioedema
• tell your doctor if you are taking either of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor blocker (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan etc), in particular if you have diabetes-related kidney problems
  • fluoroquinolone (medicine used to treat infections)
  • aliskiren.
  Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also information under the heading “Do not take ENALAPRIL HCTZ AUSTELL.”

• any surgery or receive anaesthetics (even at the dentist)
• a treatment called LDL apheresis, to remove cholesterol from your blood using a machine
• desensitisation treatment, to reduce the effect of an allergy to bee or wasp stings.

Do not share medicines prescribed for you with any other person. Always take ENALAPRIL HCTZ AUSTELL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one tablet taken once a day.

Use in children

ENALAPRIL HCTZ AUSTELL is not recommended for use in children.

Method of administration

ENALAPRIL HCTZ AUSTELL can be used with or without food. The tablets should be swallowed whole with a drink of water.

If you take more ENALAPRIL HCTZ AUSTELL than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. The most common signs and symptoms of an overdose are a fall in blood pressure and stupor (a state of almost complete lack of consciousness). Other symptoms may include dizziness or light-headedness due to a fall in blood pressure, forceful and rapid heartbeat, rapid pulse, anxiety, cough, kidney failure, and rapid breathing.

If you forget to take ENALAPRIL HCTZ AUSTELL

If you forget to take a tablet, skip the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking ENALAPRIL HCTZ AUSTELL

Do not stop taking your medicine, unless your doctor tells you to. If you do your blood pressure may increase. If your blood pressure becomes too high, it may affect your heart and kidneys. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

ENALAPRIL HCTZ AUSTELL can have side effects. Not all side effects reported for ENALAPRIL HCTZ AUSTELL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ENALAPRIL HCTZ AUSTELL, please consult your health care provider for advice. If you think you may have any of the following side effects, stop taking ENALAPRIL HCTZ AUSTELL and contact your doctor or go to your nearest hospital emergency room immediately:

• allergic reaction - you may get a rash, short of breath or wheezy and develop swelling of your hands, mouth, throat, face or eyes
• severe hypersensitivity reaction with high fever, skin rash that looks like targets (erythema multiforme); severe skin conditions with reddening, scaling and blistering of the skin (Stevens Johnson syndrome and toxic epidermal necrolysis)
• liver failure or hepatitis. This may cause yellowing of your skin (jaundice). These are all very serious side effects. If you have them, you may have had a serious reaction to ENALAPRIL HCTZ AUSTELL. You may need urgent medical attention or hospitalisation.

• severe dizziness, light-headedness, especially at the start of treatment or when your dose is increased or when you stand up. These are all serious side effects. You may need urgent medical attention.

• blurred vision, cough, feeling sick (nausea), weakness
• low blood pressure (which may make you feel dizzy or light-headed, especially if you stand up quickly)
• headache, depression, fainting (syncope)
• chest pain, heart rhythm changes, angina or chest pain, fast heart beat, shortness of breath
• diarrhoea, pain around your stomach area (abdomen), changes in taste, fluid retention (oedema), feeling tired
• rash, allergic reactions with swelling of the face, extremities, lips, tongue, and/or throat has been reported
• increased blood potassium level, increases in serum creatinine (both are usually detected by a test); low levels of potassium in the blood, increased levels of cholesterol, increased levels of triglycerides, increased levels of uric acid in the blood
• muscle cramps.

• decreased number of red blood cells and low haemoglobin (anaemia) a sense of heightened awareness or a shaky feeling (caused by low blood sugar), confusion, feeling sleepy, difficulty sleeping, feeling nervous, tingling or numbness, feeling like you are spinning (vertigo)
• fast or uneven heart beats (palpitations), heart attack or stroke (in high risk patients)
• runny nose, sore throat and hoarseness, difficulty breathing or asthma
• slow movement of food through your intestine (ileus), inflammation of the pancreas (pancreatitis), being sick, indigestion, constipation, not feeling like eating properly (anorexia), stomach irritation, dry mouth, flatulence, gout
• burning, aching pain with an empty feeling and hunger, particularly when the stomach is empty (caused by a peptic ulcer), increased sweating, itching, hives (urticaria), hair loss, protein in your urine (usually detected by a test)
• impotence, decreased libido, flushing, ringing in your ears, feeling lethargic, high temperature
• increases in blood urea and decreases in blood sodium levels (usually detected by a test), feeling unwell (malaise)
• low level of magnesium in the blood (hypomagnesaemia)
• kidney problems
• joint pain
• strange dreams, sleep problems
• changes in blood test values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets, and/or swollen glands in neck, armpit or groin
• autoimmune diseases, low blood flow to your fingers and toes causing redness and pain (Raynaud’s), accumulation of fluid or other substances in the lungs (as seen on X-rays), runny or sore nose
• eosinophilic pneumonia (signs may be cough, high temperature and difficulty breathing)
• pain, swelling or ulcers in your mouth, infection or pain and swelling of your tongue, kidney problems such as lower back pain and reduction in the volume of urine you pass
• inflammation of the nose
• difficulty breathing, shortness of breath
• liver failure or hepatitis, this may cause yellowing of your skin (jaundice), gall bladder problems
• severe hypersensitivity reaction with high fever, skin rash that looks like targets (erythema multiforme), Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin conditions with reddening, scaling and blistering of the skin), severe skin rash with loss of skin and hair (exfoliative dermatitis), cutaneous lupus erythematosus (an immune disease), red rash with peeling of the skin spots on the skin (purpura)
• development of breasts in men
• increased liver enzymes or blood ‘bilirubin’ (usually detected by a blood test)
• increases in blood sugar
• muscle weakness, sometimes due to low potassium (paresis)
• swelling in your intestine (intestinal angioedema). Signs may include stomach pain, feeling sick and vomiting, elevated calcium level in blood

• infection of salivary glands (sialadenitis) with symptoms such as pain, tenderness, redness, swelling of the gland, fever and chills
• a complex side effect has also been reported which may include some or all of the following signs: fever, inflammation of your blood vessels, pain and inflammation of muscles or joints
• blood disorders affecting the components of your blood (usually detected by a blood test)
• rash, hypersensitivity to sunlight and other effects on your skin
• overproduction of antidiuretic hormone, which causes fluid retention, resulting in weakness, tiredness or confusion
• skin and lip cancer (non-melanoma skin cancer).
• mineral (electrolyte) imbalances, low blood levels of sodium which can cause tiredness and confusion
• restlessness
• yellow vision
• presence of glucose in the urine (glycosuria) after a urine test.

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 ENALAPRIL HCTZ AUSTELL.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original container. Do not put this medicine into another container as it might get mixed up. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.