Efferflu C Cold & Flu 250 mg Effervescent tablets

EFFERFLU C COLD & FLU is indicated for symptomatic relief of runny nose, sneezing, sore throat, headache and generalized aching due to colds and flu.

Posology
DO NOT EXCEED THE RECOMMENDED DOSE.
Adults and children over 12 years: One tablet every 8 hours, if necessary. Consult a doctor if no relief is obtained from the recommended dosage. Do not use EFFERFLU C COLD & FLU for more than 7 days without consulting a doctor.
Paediatric population
The safety and efficacy of EFFERFLU C COLD & FLU in children under the age of 12 years has not been established (see section 4.3).
Method of administration
Dissolve one tablet in a glass of water and drink the contents as soon as the whole tablet has dissolved. Missed dose
Doctors should advise patients who forget to take EFFERFLU C COLD & FLU to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.

EFFERFLU C COLD & FLU is contraindicated in the following patients:
u2022 Hypersensitivity to paracetamol, sodium ascorbate, chlorphenamine maleate or to any of the ingredients of EFFERFLU C COLD & FLU (see section 6.1)
u2022 severe liver function impairment
u2022 coronary disease and cardiovascular disease such as ischaemic heart disease, dysrhythmia or tachycardia
u2022 epilepsy
u2022 children under the age of 12 years
u2022 prior sensitivity to any antihistamine
u2022 patients receiving monoamine oxidase inhibitor (MAO) treatment, or within 14 days of stopping such treatment should not take EFFERFLU C COLD & FLU, as the anticholinergic properties of chlorphenamine are intensified by MAOIs (see sections 4.3 and 4.5).
u2022 patients undergoing anaesthesia with halothane or other halogenated anaesthetics, as they may induce ventricular fibrillation
u2022 patients having acute attacks of asthma. Safety in pregnancy and lactation has not been established (see section 4.6).

Chlorphenamine maleate: Chlorphenamine maleate may produce epileptiform seizures in patients with focal lesions of the cerebral cortex. Allergic reactions and cross-sensitivity to related medicines may be produced. Should be used with caution in patients with prostatic hypertrophy, narrow angle glaucoma, emphysema, chronic bronchitis, porphyria or urinary retention. Paradoxical hyper excitability, nervousness, insomnia, tachycardia, tremors and convulsions may occur in children and in the elderly. Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and anticholinergic effects such as dry mouth and urinary retention. Should be used with care in patients with pyloroduodenal obstruction, epilepsy, severe cardiovascular disorders, bronchiectasis and asthma, hepatic impairment and renal impairment. Avoid use in elderly patients with confusion. EFFERFLU C COLD & FLU may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. EFFERFLU C COLD & FLU may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics. Chlorphenamine may suppress positive skin test results and should be stopped several days before the test.
Paracetamol: Do not use with any other paracetamol-containing medicines. The concomitant use with other medicines containing paracetamol may lead to an overdose. Dosages of EFFERFLU C COLD & FLU in excess of those recommended may cause severe liver damage which may require liver transplant or lead to death. Consult a medical practitioner if pain or fever persists or gets worse at the recommended dosage, if new symptoms occur or if redness and swelling is present, as these could be signs of a more serious condition. Underlying liver disease increases the risk of paracetamol-related liver damage. Do not use EFFERFLU C COLD & FLU continuously for more than 7 days without consulting your doctor. Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take excessive quantities of EFFERFLU C COLD & FLU. Use with caution in renal disease. EFFERFLU C COLD & FLU contains paracetamol which may be fatal in overdosage. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol, have alcohol induced dehydration or have sepsis. In patients with glutathione depleted states and in concomitant administration with flucloxacillin, as the use of paracetamol may increase the risk of metabolic acidosis. Severe cutaneous adverse reactions (SCAR): Severe cutaneous adverse reactions (SCAR) such as toxic epidermal necrolysis (TEN), Steven Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), drug induced hypersensitivity syndrome (DIHS) and fixed dose eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops serious cutaneous adverse reaction, treatment with EFFERFLU C COLD & FLU must immediately be discontinued and appropriate treatment instituted.
Excipients: EFFERFLU C COLD & FLU contains the sugar alcohol, sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains 40 mg of aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Patients sensitive to another antihistamine may be sensitive to EFFERFLU C COLD & FLU (see section 4.3). EFFERFLU C COLD & FLU may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants e.g. sedatives and tranquilizers (see section 4.2).
Paracetamol: Hepatotoxic medicines u2013 Increased risk of hepatotoxicity. Enzyme inducing medicines such as carbamazepine, phenytoin, phenobarbital, rifampicin and St John's wort (Hypericum perforatum) u2013 Increased risk of hepatotoxicity. Possible decrease in therapeutic effects of EFFERFLU C COLD & FLU. Metoclopramide or domperidone u2013 Absorption of EFFERFLU C COLD & FLU may be accelerated. Cholestyramine u2013 Absorption of EFFERFLU C COLD & FLU is reduced if given within one hour of cholestyramine. Prolonged concurrent use of EFFERFLU C COLD & FLU with salicylates increases the risk of adverse renal effects. Excretion may be affected and plasma concentrations altered when given with probenecid. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect. Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risks factors (see section 4.4)
Isoniazid affects the pharmacokinetics of paracetamol with possible potentiation of liver toxicity. Interference with laboratory tests: Paracetamol may affect uric acid tests by wolframato phosphoric acid, and blood sugar tests by glucose-oxidaseperoxidase. Chlorphenamine Maleate: Chlorphenamine maleate may enhance the sedative effect of central nervous system depressants, including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, and antipsychotics. Concurrent use of MAO inhibitors and belladonna may prolong and intensify the anticholinergic and CNS depressant effect of chlorphenamine maleate. Concurrent use is not recommended. Care should be observed when tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, guanethidine, reserpine, methyldopa or atropine are taken concomitantly. Chlorphenamine maleate given with ototoxic medication may mask the symptoms of ototoxicity such as tinnitus, dizziness or vertigo. Chlorphenamine may increase the risk of phenytoin toxicity. Antihistamines may suppress positive skin test results and should be stopped several days before the test.
Vitamin C: Vitamin C should not be given for the first month after starting treatment with desferrioxamine due to increased iron toxicity. Large doses of Vitamin C may increase serum ethinylestradiol concentrations in women taking oral contraceptives. Concomitant use of Vitamin C and fluphenazine may result in decreased serum concentrations of fluphenazine. May interact with warfarin.

Pregnancy
The safety and efficacy in pregnancy has not been established (see section 4.3).
Breastfeeding
The safety and efficacy in lactation has not been established (see section 4.3).
Fertility
There is no data on fertility with EFFERFLU C COLD & FLU.

EFFERFLU C COLD & FLU may lead to drowsiness, dizziness, blurred vision and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

The incidence of adverse reactions tends to increase with increasing dose. The frequencies of adverse events are ranked according to the following: Frequent = (u2265 1/100 to < 1/10). Less frequent = Infrequent (u2265 1/1,000 to < 1/100); Rare (u2265 1/10,000 to < 1/1,000); Very rare (<1/10,000). Frequency not known = cannot be estimated from the available data.
Tabulated list of adverse effects (Paracetamol)
System Organ Class Frequency Side effects
Blood and lymphatic system disorders Less frequent Agranulocytosis, thrombocytopenia, leucopenia, pancytopenia, neutropenia and anaemia, platelet disorders, stem cell disorders, methaemoglobenaemia
Immune system disorders Less frequent Severe cutaneous adverse reactions that may manifest in drug induced hypersensitivity syndrome (DIHS)*, fixed drug eruptions (FDE)*, toxic epidermal necrolysis (TEN), Steven Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS), anaphylaxis
Metabolism and nutrition disorders Less frequent Hypoglycaemia
Psychiatric disorders Less frequent Depression, confusion, hallucinations
Nervous system disorders Less frequent Tremor, headache
Eye disorders Less frequent Abnormal vision
Cardiac disorders Less frequent Oedema
Respiratory, thoracic and mediastinal disorders Less frequent Bronchospasm in patientsu2019 sensitive to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)
Gastrointestinal disorders Less frequent Haemorrhage, abdominal pain, diarrhoea, nausea, vomiting
Hepatobiliary disorders Less frequent Frequency unknown Hepatitis, abnormal hepatic function, hepatic failure, hepatic necrosis, jaundice
Pancreatitis, hepatotoxicity
Skin and subcutaneous tissue disorders Less frequent Frequency unknown Allergic dermatitis, pruritus, rash, sweating, purpura, angioedema, urticaria
Dermatitis
Renal and urinary disorders Less frequent Renal colic, renal failure, sterile pyuria
General disorders and administrative site conditions Less frequent Frequency unknown Dizziness (excluding vertigo), malaise, pyrexia, sedation, drug interaction
Dermatitis, skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and accompanied by fever and mucosal lesions
Injury and poisoning Less frequent Overdose and poisoning
*Post-Marketing Experience
Interstitial nephritis has been reported incidentally after prolonged use of high doses. Some cases of epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, oedema of the larynx, anaphylactic shock, anaemia, liver alteration and hepatitis, renal alteration (severe renal impairment, haematuria, anuresis), gastrointestinal effects and vertigo have been reported.
Tabulated summary of adverse reactions (Chlorphenamine maleate):
System Organ Class Frequency Side effects
Infections and infestations Frequency unknown Allergic reaction, angioedema, anaphylactic reactions
Blood and lymphatic system disorders Less frequent Blood dyscrasias, including agranulocytosis, leukopenia, haemolytic anaemia and thrombocytopenia
Immune system disorders Less frequent Anaphylaxis including tightness of the chest and hypersensitivity reactions (including bronchospasm, angioedema)
Metabolism and nutrition disorders Frequency unknown Anorexia
Psychiatric disorders Frequency unknown Depression, confusion*, excitation*, irritability*, nightmares*
Nervous system disorders Frequent Frequency unknown Drowsiness, central nervous system reactions include sedation, convulsions or seizures, dizziness, increased sweating, abnormal coordination, tremor, lassitude, euphoria, nervousness, insomnia, headache, somnolence
Confusion, hallucinations, paraesthesias and ataxia
Eye disorders Less frequent Blurred vision, diplopia
Ear and labyrinth disorders Frequency unknown Tinnitus
Cardiac disorders Less frequent Frequency unknown Palpitations, dysrhythmia and tachycardia
Hypertension, tightness of the chest, tingling, heaviness and weakness of the hands
Vascular disorders Frequency unknown Hypotension
Respiratory, thoracic and mediastinal disorders Less frequent Frequency unknown Thickening of mucous
Dryness of the respiratory passages, tightness of chest
Gastrointestinal disorders Frequent Frequency unknown Dryness of mouth, nose or throat, gastrointestinal upset, loss of appetite, constipation, diarrhoea, nausea, vomiting
Epigastric pain, gastric reflux
Hepatobiliary disorders Less frequent Frequency unknown Cholestasis, hepatitis or other hepatic function abnormalities, including jaundice
Skin and subcutaneous tissue disorders Less frequent Frequency unknown Exfoliative dermatitis, rashes
Photosensitivity and skin rash, allergic dermatitis, drug fever, hair loss and sweating
Musculoskeletal, connective tissue and bone disorders Frequency unknown Extrapyramidal effects with muscle spasms and dystonia, myalgia, muscular weakness
Renal and urinary disorders Less frequent Frequency unknown Difficult or painful urination, dysuria
Urinary frequency, urinary retention
General disorders and administrative site conditions Less frequent Oedema, fatigue, chest tightness
*Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g., increased energy, restlessness, nervousness).

Paracetamol: Signs and symptoms: Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 u2013 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine. Symptoms of paracetamol overdose in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac dysrhythmias have been reported.
Management of overdose: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.
Chlorphenamine maleate: Signs and symptoms: Central excitatory effects constitute the greatest danger in overdose. Overdosage with EFFERFLU C COLD & FLU may result in anticholinergic effects (paradoxical excitement, hallucinations, ataxia, unsteadiness, severe drowsiness, severe dryness of throat, nose and mouth, redness of face and shortness of breath and athetosis). Fixed dilated pupils with a flushed face, convulsions, sinus tachycardia and cardiac arrhythmias may occur. Overdosage may be fatal, especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults, the usual symptoms are of central nervous system depression with drowsiness, coma and convulsions. Hypotension may also occur. Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects even at the therapeutic doses.
Management of overdose: There is no specific antidote, and treatment is symptomatic and supportive. It may be necessary to treat extrapyramidal reactions with diphenhydramine. The patient must be taken to a doctor or hospital immediately as specialised treatment may be necessary.