Corenza – C effervescent Effervescent Tablets

CORENZA - C forms part of the group of medicines for the common cold, including nasal decongestants and antihistamines.

CORENZA - C provides relief from the symptoms of colds and flu, such as sneezing, stuffy or runny nose and inflammation of the throat and vocal cords.

Do not take CORENZA - C:

• If you are hypersensitive (allergic) to moroxydine HCl, phenylephrine HCl, chlorphenamine maleate, acetylsalicylic acid (aspirin) or vitamin C (ascorbic acid), or any of the other ingredients of CORENZA - C (listed in section 6).
• If you often suffer from indigestion, or stomach ulcers
• If you have kidney or liver dysfunction
• If you have haemophilia (a disease in which your blood does not clot) or any other bleeding disorders.
• If you have hyperthyroidism (overactive thyroid), gout, diabetes mellitus, prostatic hyperplasia (prostate gland enlargement), high blood pressure, heart conditions, asthma, chronic urticaria (hives), chronic rhinitis (swelling and inflammation inside of the nose), hypersensitivity to pseudoephedrine and other NSAIDs should be cautious
• If you have heart failure
• If they have had a history of gastric holes, ulcers or bleeding related to previous anti-inflammatory medicines use.
• If the patient is a child under 12 years of age (see Warnings and Precautions).
• If you are pregnant, do not use NSAIDs (non-steroidal anti-inflammatory drugs) like acetylsalicylic acid (aspirin) in CORENZA - C at 30 weeks or later in your pregnancy because these medicines may cause problems in your unborn baby.

Warnings and precautions

Special care should be taken with CORENZA - C:

• A doctor should be consulted before giving CORENZA - C to children and teenagers with chickenpox and influenza due to the increased risk of Reye’s syndrome (swelling of the brain and liver) associated with aspirin.
• If you have G6PD deficiency (abnormality in the activity of the red blood cell enzyme, as the active ingredient aspirin can cause haemolytic anaemia (low red blood cell count).
• If you are sensitive to pseudoephedrine hydrochloride.
• If you have connective tissue disorders or in (juvenile idiopathic arthritis) children with arthritis
• You should stop using CORENZA - C several days before a scheduled surgery as aspirin lengthens bleeding time.
• Chronic use of aspirin in the elderly should be avoided due to the increased risk of gastric bleeding.
• If you have angle-closure glaucoma (an eye condition that leads to damage to the optic nerve due to increased pressure in eye), an inability to urinate, or an obstruction in the stomach.
• If you have phaeochromocytoma (a rare tumour of adrenal gland tissue).
• If you have a history of hypertension or heart failure
• When gastrointestinal bleeding or ulceration occurs, which may present as stomach pain and discomfort, vomiting of blood or excretion of dark stools in patients receiving CORENZA - C, treatment with CORENZA - C should be stopped.
• If you have a history of gastrointestinal disease [e.g. ulcerative colitis (inflammation & ulcers in the digestive tract), Crohn’s disease (type of inflammatory bowel disease), hiatus hernia (bulging of an organ), gastro-oesophageal reflux disease (which may present as indigestion, heartburn, regurgitation), angiodysplasia (a vascular malformation of the gut)], CORENZA - C should be administered with caution, as the condition may be worsened.
• Drug Reaction with Eosinophillia and Systemic Symptoms [DRESS] (a severe reaction affecting the skin, blood and internal organs) has been reported in patients taking NSAIDs (medicines that relieve or reduce pain & inflammation) such as CORENZA - C. Some of these events have been life-threatening or could lead to death. DRESS typically, presents with fever, rash, enlarged lymph nodes, and/or facial swelling. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophillia (higher number of a specific type of white blood cell) is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or enlarged lymph nodes, may be present even though rash is not evident. If such signs or symptoms are present, discontinue CORENZA - C and see the doctor immediately.
• Tell your doctor or health care provider if you are pregnant or plan to become pregnant. Taking NSAIDs (like acetylsalicylic acid (aspirin) in CORENZA - C) at around 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of your pregnancy, your health care provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs (like acetylsalicylic acid (aspirin) in CORENZA - C) around 30 weeks of pregnancy or later.

Do not share medicines prescribed for you with any other person. Always take CORENZA - C exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The usual dose is:

• Adults and children older than 12 years: 2 tablets immediately, thereafter 1 tablet 3 to 4 times a day as required.

CORENZA - C should not be used in children under the age 12 years.

Drop the tablet in half a glass of cold water. The tablet quickly dissolves producing an effervescent drink. Drink the mixture as soon as the effervescing has stopped Always use the lowest effective dose. Do not use for more than 10 days without consulting your doctor.

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

If you take more CORENZA - C than you should: You may experience nausea, dizziness, vomiting, mental clouding, stomach irritation and resultant indigestion, vomiting of blood and the passing of dark sticky faeces containing partly digested blood. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take CORENZA - C Do not take / receive a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking CORENZA - C 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 reaction to CORENZA - C. 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:

• chest pain,
• angina,
• changes in the way your heart beats, for example, if you notice it beating faster,
• difficulty breathing,
• signs of recurrent infections such as fever or sore throat,
• less urine than is normal for you,
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Common side effects:

• slight blood loss
• anorexia (eating disorder)
• headache
• CNS depression (slight drowsiness to deep sleep, fatigue, dizziness and incoordination)
• oedema (swelling)
• hypertension (high blood pressure)
• cardiac (heart) failure
• dyspnoea (shortness of breath),
• peptic ulcers (sore on the lining of your stomach, small intestine or esophagus)
• perforation or gastrointestinal bleeding (damage to the gut/intestine),
• nausea, vomiting
• diarrhoea
• flatulence
• constipation
• indigestion
• abdominal pain
• melaena (dark, bloody stools)
• haematemesis (vomiting blood)
• ulcerative stomatitis (inflammation of the mouth)
• worsening of irritable bowel disease
• inflammation of gastric tract (gut)
• weakness

Uncommon side effects:

• Agranulocytosis (low white blood cell count)
• leukopenia (decreased white blood cell count)
• thrombocytopenia (decreased platelet count)
• pancytopenia (reduction in all blood cell count)
• aplastic anaemia (when the body stops producing new blood cells)
• haemolytic anaemia (abnormal breakdown of red blood cells)
• epigastric pain
• rashes.

Side effects of unknown frequency:

• Blood disorders which result in an increase in bleeding time and decreases in ability of blood to clot adequately
• hyperglycaemia (high blood sugar)
• lactic acidosis (lactic acid build up in the blood stream)
• sleep disturbances
• depression and confusion
• anxiety, fear
• restlessness
• insomnia
• irritability
• psychotic states
• convulsions
• paresthesia (tingling feelings or feelings of numbness or ‘pins and needles’)
• involuntary contraction of the muscles, tremor
• tinnitus
• dry mouth, thickened respiratory-tract secretions, blurred vision, urinary difficulty or retention, constipation and increased gastric reflux (‘heartburn’)
• Reye’s syndrome (a serious condition that causes swelling in the liver and brain)
• unresponsive, dilated pupils
• loss of hearing or balance
• low blood pressure
• stomach discomfort
• increased saliva production
• liver problems (which may present as abdominal pain in the upper right portion of the abdomen, yellowing of the skin and whites of the eyes)
• muscle aches and pain
• formation of kidney stones
• difficulty urinating, urinary retention.
• Tolerance (becoming insensitive to the therapeutic effects of the medicine after repeated use with high doses)
• piloerection (‘goosebumps’).

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 SAHPRA website. By reporting side effects, you can help provide more information on the safety of CORENZA - C.

Store all medicines out of reach of children. Store in a cool place at or below 25 °C. Protect from moisture. Do not store in a bathroom. Store in the original container. 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).