Corenza-C 2,5 mg and 200 mg White, effervescent tablet.

CORENZA-C is used for the relief of symptoms associated with rhinitis, laryngitis and symptoms of colds and influenza.

Use the lowest effective dose for the shortest possible duration of treatment.

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

Paediatric population: CORENZA-C should not be used in children under the age 12 years (see section 4.3).

Method of administration: For oral use. 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.

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• Dyspepsia, lesions of the gastric mucosa, renal dysfunction or hepatic impairment, haemophilia or other haemorrhagic disorders.
• Patients with severe hyperthyroidism, gout, diabetes mellitus, prostatic hyperplasia, high blood pressure, heart conditions, asthma, chronic urticaria, chronic rhinitis, hypersensitivity to pseudoephedrine and other NSAIDs.
• Patients with heart failure.
• Patients with a history of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including CORENZA-C, and/or active or history of recurrent ulcer/ haemorrhage/ perforations.
• Children under the age of 12 years.
• Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus.

• Acetylsalicylic acid (aspirin) has been implicated in Reye's syndrome, a rare but serious illness, in children and teenagers with chickenpox and influenza. A doctor should be consulted before acetylsalicylic acid (aspirin) is used in such patients.
• Acetylsalicylic acid (aspirin) has been associated with haemolytic anaemia in patients with G6PD deficiency.
• Acetylsalicylic acid (aspirin) may interfere with insulin and glucagon control in diabetics and may cause hepatotoxicity in patients with juvenile idiopathic arthritis or other connective tissue disorders.
• Acetylsalicylic acid (aspirin) prolongs bleeding time and should be stopped several days prior to scheduled surgical procedures.
• Continuous prolonged use of acetylsalicylic acid (aspirin) should be avoided in the elderly, because of the risk of gastrointestinal bleeding.
• Chlorphenamine maleate has antimuscarinic actions and should be used with care in conditions such as angle-closure glaucoma, urinary retention or pyloroduodenal obstruction.
• Phenylephrine hydrochloride should be avoided in phaeochromocytoma.
• Phenylephrine hydrochloride induces tachycardia or reflex bradycardia and should therefore be avoided in severe hyperthyroidism (see Section 4.3).
• Patients with diabetes mellitus or prostatic hyperplasia should also avoid phenylephrine as contained in CORENZA-C (see section 4.3).
• Cross-sensitivity to phenylephrine has been reported in patients hypersensitive to pseudoephedrine (see section 4.3).
• Porphyria: Safety for use in porphyria has not been established.
• Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with CORENZA-C therapy. In view of the productu2019s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, including CORENZA-C, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.
• The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of CORENZA-C, in patients with a history of ulcers, and the elderly.
• When gastrointestinal bleeding or ulceration occurs in patients receiving CORENZA-C, treatment with CORENZA-C should be stopped.
• CORENZA-C should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
• CORENZA-C should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Foetal Toxicity: Limit use of NSAIDs, including CORENZA-C, between 20 to 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction.
• If NSAID treatment is necessary between 20 weeks and 30 weeks gestation, limit CORENZA-C use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if CORENZA-C treatment extends beyond 48 hours. Discontinue CORENZA-C, if oligohydramnios occurs and follow up according to clinical practice. (See section 4.6)
• Do not use for more than 10 days without consulting your doctor.
• Corticosteroids may increase the risk of gastrointestinal perforation, ulceration or bleeding (PUBs).
• Drug Reaction with Eosinophillia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as CORENZA-C. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophillia 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 lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue CORENZA-C and evaluate the patient immediately.
• This medicinal product contains 288,11 mg sodium per effervescent tablet equivalent to 14,4 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

• Vitamin C may increase the absorption of iron in iron-deficiency states.
• Chlorphenamine maleate may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.
• Sedating antihistamines have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and some antidepressants.
• Sedating antihistamines could also mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibacterials.
• Phenylephrine hydrochloride may cause severe hypertension when used concurrently with MAOIs.
• Use of two or more NSAIDs concomitantly could result in an increase in side effects.
• Corticosteroids increase the risk of gastrointestinal perforation, ulceration or bleeding (PUBs).
• Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
• Acetylsalicylic acid (aspirin) may enhance the effects of coumarin anticoagulants (such as warfarin), sulfonylurea hypoglycaemic drugs, zafirlukast, methotrexate, phenytoin and valproate.
• Acetylsalicylic acid (aspirin) diminishes the effects of uricosurics such as probenecid.
• Acetylsalicylic acid (aspirin) may alter the efficacy of mifepristone.
• Griseofulvin might interfere with the absorption of acetylsalicylic acid (aspirin).
• Acetylsalicylic acid (aspirin) may reduce or abolish the hypotensive action of ACE inhibitors.

Interactions with laboratory tests

• Vitamin C interferes with laboratory tests, falsely elevated or false-negative test results may be obtained from plasma, faeces or urine samples.

Safety in pregnancy and lactation have not been established. Use of NSAIDs, including CORENZA-C, can cause premature closure of the foetal ductus arteriosus and foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, the use of CORENZA-C dose and duration between 20 and 30 weeks of gestation should be limited and avoided at around 30 weeks of gestation and later in pregnancy. The onset of labour may be delayed and its duration increased. Acetylsalicylic acid (aspirin) should be given with caution to breastfeeding mothers because of the risk of Reyeu2019s syndrome and metabolic acidosis in nursing infants.

CORENZA-C may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Chlorphenamine maleate can cause CNS depression and the sedative effects can range from slight drowsiness to deep sleep. This can impair a personu2019s ability to drive or operate machinery.

CORENZA-C

Acetylsalicylic acid (aspirin): Nausea, dizziness, vomiting, hyperventilation, fever, restlessness, ketosis, respiratory alkalosis, metabolic acidosis, mental clouding, irritation of gastric mucosa and resultant dyspepsia, haematemesis and melaena. Depression of the CNS may lead to coma; cardiovascular collapse and respiratory failure may also occur. In acute salicylate overdosage, an oral dose of activated charcoal is recommended if the patient is suspected of ingesting more than 125 mg/kg of salicylate. Activated charcoal prevents the absorption of any salicylate remaining in the stomach and aids the elimination of any salicylate that has been absorbed. Forced diuresis by intravenous infusions of saline with sodium bicarbonate or of compound lactate injection or dextrose solution, should be considered. Fluid and electrolyte management is essential to correct acidosis, hyperpyrexia, hypokalaemia, and dehydration. In patients with acute allergic reactions to aspirin (acetylsalicylic acid), epinephrine (adrenaline) and corticosteroids followed by an antihistamine should be given. Respiratory failure to be treated by artificial respiration or respiratory stimulants.

Phenylephrine hydrochloride: Overdosage may result in nausea, vomiting, hyperglycaemia, anorexia, lactic acidosis, headaches, anxiety, fear, restlessness, insomnia, confusion, irritability, mydriasis, tachycardia, reflex bradycardia, high blood pressure, increased salivation, sweating difficulty in micturition, urinary retention and general weakness. Treatment is symptomatic and supportive (see section 4.8).

Vitamin C: Large doses are reported to cause diarrhoea and other gastrointestinal disturbances, hyperoxaluria and tolerance may be induced. Large doses can also cause formation of kidney stones. Treatment is symptomatic and supportive.

Chlorphenamine Maleate: Overdosage with sedating antihistamines is associated with antimuscarinic, extrapyramidal, and CNS effects. When CNS stimulation predominates over CNS depression, which is more likely in children or the elderly, it causes ataxia, excitement, tremors, psychoses, hallucinations, and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults, CNS depression is more common with drowsiness, coma, and convulsions, progressing to respiratory failure and cardiovascular collapse. Treatment is symptomatic and supportive.