Famucaps 2 mg Hard capsules.

For the symptomatic relief of sinusitis, rhinitis and allergic conditions of the upper respiratory tract, hay fever and influenza.

DO NOT EXCEED THE RECOMMENDED DOSE.

Adults: 2 capsules 3 times a day.

Children 6 u2013 12 years: 1 capsule 3 times a day.

Not recommended for children under the age of 6 years.

Do not use continuously for more than 10 days without consulting your doctor.

Method of administration

Oral administration only.

• Hypersensitivity to chlorphenamine maleate, phenylephrine hydrochloride, or any of the excipients listed in section 6.1.
• Severe renal impairment.
• Pregnancy and lactation (see section 4.6).
• Heart disease, epilepsy, hypertension, hyperthyroidism or diabetes.
• Phaeochromocytoma.
• Closed angle glaucoma.
• Concomitant use of other sympathomimetic decongestants (see sections 4.4).
• Patients taking tricyclic antidepressants or beta blocking medicines (see section 4.5).
• Patients on monoamine oxidase inhibitors or within 10 days of stopping such treatment (see section 4.5).
• Not recommended for use in children younger than 6 years.
• Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take medicines containing paracetamol, such as FAMUCAPS.

FAMUCAPS contains paracetamol which may be fatal in overdose. 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.

Dosages in excess of the recommended dose can cause severe liver damage. Do not use with any other paracetamol-containing medicines. The concomitant use with other medicines containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure, which may require liver transplant or lead to death.

Concurrent use with medicines which can cause sedation, such as anxiolytics and hypnotics, may cause an increase in sedative effects.

The effects of alcohol may be increased and therefore concurrent use should be avoided.

Care should be taken in patients with:

• Pyloroduodenal obstruction, prostatic hypertrophy, emphysema, bronchitis, bronchiectasis, asthma, porphyria, paradoxical hyperexcitability, nervousness and insomnia.
• Glutathione depletion due to metabolic deficiencies.
• Occlusive vascular disease (e.g. Raynaud's phenomenon).

Children and elderly patients are more likely to experience neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness and nervousness). The use of FAMUCAPS should be avoided in elderly patients with confusion.

FAMUCAPS may lead to drowsiness, dizziness, blurred vision, psychomotor impairment and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant medicines.

Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCARs, treatment with FAMUCAPS must immediately be discontinued and appropriate treatment instituted.

FAMUCAPS contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take FAMUCAPS.

FAMUCAPS contains Sunset Yellow (E 110) and Ponceau 4R (E 124) which may cause allergic reactions.

Enzyme-inducing medicines may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.

Medicines tending to cause extrapyramidal reactions and those with anticholinergic effects may be potentiated. These include atropine, tricyclic antidepressants, maprotiline, reserpine, guanethidine and monoamine oxidase inhibitors.

Sedatives

All sedatives (e.g. hypnotics or anxiolytics), including alcohol, will potentiate depressant effects on the central nervous system if taken with antihistamines, as contained in FAMUCAPS (see section 4.4).

Monoamine oxidase inhibitors (including moclobemide)

Hypertensive interactions occur between sympathomimetic amines, such as phenylephrine and monoamine oxidase inhibitors (see section 4.3).

Phenytoin

Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

Sympathomimetic amines

Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects (see section 4.4).

Beta blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine and methyldopa)

Phenylephrine may reduce the efficacy of beta blockers and other antihypertensive medicines. The risk of hypertension and other cardiovascular side effects may be increased (see section 4.3).

Tricyclic antidepressants (e.g. amitriptyline)

May increase the risk of cardiovascular side effects with phenylephrine (see section 4.3).

Digoxin and cardiac glycosides

Concomitant use of phenylephrine with digoxin or cardiac glycosides may increase the risk of an irregular heartbeat or heart attack.

Ergot alkaloids (e.g. ergotamine and methysergide)

Concomitant use of phenylephrine may cause an increased risk of ergotism.

Warfarin and other coumarins

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged, regular daily use of paracetamol with an increased risk of bleeding. Occasional doses have no significant effect.

Other

Antihistamines may suppress positive skin test results and should be stopped several days before the test.

Pregnant and lactating women should not use FAMUCAPS (see section 4.3).

No fertility data available.

FAMUCAPS may lead to drowsiness, dizziness, blurred vision, psychomotor impairment and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant medicines. Patients should be warned not to drive a motor vehicle, handle heavy machinery or to climb dangerous heights, because impairment of concentration may lead to accidents.

The following side effects were reported:

Phenylephrine hydrochloride

System Organ Class Frequent Frequency unknown

• Blood and lymphatic system disorders: Cerebral haemorrhage.
• Metabolism and nutrition disorders: Appetite may be reduced, altered metabolism (including blood sugar levels).
• Psychiatric disorders: Nervousness, fear, anxiety, restlessness, confusion, irritability, psychotic states.
• Nervous system disorders: Headache, dizziness, insomnia, tremor.
• Cardiac disorders: Hypertension, palpitations, tachycardia, reflex bradycardia, anginal pain in angina pectoris, cardiac arrest.
• Respiratory, thoracic and mediastinal disorders: Dyspnoea, pulmonary oedema.
• Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
• Skin and subcutaneous tissue disorders: Flushing.
• Renal and urinary disorders: Difficulty in micturition, urinary retention.
• General disorders and administration site conditions: Weakness.

Chlorphenamine maleate

System Organ Class Frequency unknown

• Blood and lymphatic system disorders: Haemolytic anaemia, blood dyscrasias including agranulocytosis, leucopenia, thrombocytopenia.
• Immune system disorders: Allergy, anaphylaxis.
• Psychiatric disorders: Confusion, hallucinations, nervousness.
• Nervous system disorders: Sedation, drowsiness, insomnia, incoordination, dizziness, tremors, convulsions, headache, cerebral stimulation (particularly in children).
• Eye disorders: Blurred vision.
• Ear and labyrinth disorders: Tinnitus.
• Cardiac disorders: Tachycardia.
• Vascular disorders: Hypotension.
• Respiratory, thoracic and mediastinal disorders: Thickening of mucus.
• Gastrointestinal disorders: Nausea, vomiting, dry mouth, epigastric pain, diarrhoea, reduction in tone and motility of the gastrointestinal tract, resulting in constipation and increased gastric reflux.
• Skin and subcutaneous tissue disorders: Allergic dermatitis, skin rash, photosensitivity, flushing.
• Musculoskeletal and connective tissue disorders: Extrapyramidal effects with muscle spasm and dystonia, ataxia.
• Renal and urinary disorders: Urinary retention or frequency, dysuria.
• General disorders and administration site conditions: Fatigue, medicine-induced fever, dryness of the nose.

Paracetamol

System Organ Class Frequency unknown

• Blood and lymphatic system disorders: Agranulocytosis, thrombocytopenia, leucopoenia, pancytopenia, neutropenia, anaemia.
• Immune system disorders: Allergic reactions.
• Hepato-biliary disorders: Pancreatitis, hepatitis.
• Skin and subcutaneous tissue disorders: Dermatitis, skin rashes, which is usually erythematous or urticarial, but sometimes more serious and accompanied by fever and mucosal lesions.
• Renal and urinary disorders: Renal colic, renal failure, sterile pyuria.

Post-marketing experience

Phenylephrine hydrochloride

System Organ Class Frequency unknown

• Immune system disorders: Hypersensitivity, allergic dermatitis, urticaria.
• Eye disorders: Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma.
• Skin and subcutaneous tissue disorders: Rash.
• Renal and urinary disorders: Dysuria.

Chlorphenamine maleate

System Organ Class Frequency unknown

• Immune system disorders: Angioedema.
• Metabolism and nutritional disorders: Anorexia.
• Psychiatric disorders: Excitation, irritability, nightmares, depression.
• Nervous system disorders: Somnolence, disturbance in attention.
• Cardiac disorders: Palpitations, dysrhythmias.
• Hepato-biliary disorders: Hepatitis, including jaundice.
• Skin and subcutaneous tissue disorders: Exfoliative dermatitis, urticaria.
• Musculoskeletal and connective tissue disorders: Muscle twitching, muscle weakness.
• General disorders and administration site conditions: Chest tightness.

Paracetamol

System Organ Class Frequency unknown

• Immune system disorders: Anaphylaxis, cutaneous hypersensitivity reactions, angioedema, severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) (see section 4.4).
• Respiratory, thoracic and mediastinal disorders: Bronchospasm.
• Hepato-biliary disorders: Hepatic dysfunction.

Description of selected adverse reactions

Children and elderly patients are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness and nervousness) associated with chlorphenamine maleate. There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Paracetamol dosages in excess to those recommended may cause liver damage.

An overdose may potentially be fatal, particularly in children and elderly patients.

Phenylephrine hydrochloride

Symptoms

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions (see section 4.8). Additional symptoms may include irritability, restlessness, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and dysrhythmias may occur. The amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking medicines, such as phentolamine.

Chlorphenamine maleate

Symptoms

The estimated lethal dose of chlorphenamine is 25 to 50 mg/kg body mass. Overdose may result in drowsiness, sedation or paradoxical excitement of the central nervous system, toxic psychosis, hallucinations, ataxia, incoordination, athetosis, convulsions in susceptible persons and hypotension. Fixed, dilated pupils with a flushed face, sinus tachycardia, dyspnoea, apnoea and urinary retention, dry mouth, fever and dystonic reactions. Terminal: deepening coma, and cardiorespiratory collapse including dysrhythmias. Children and elderly patients are more likely to exhibit anticholinergic and central nervous system stimulant effects. Elderly patients are prone to hypotension.

Treatment

Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions as well as fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and dysrhythmias vigorously. Central nervous system convulsions may be treated with intravenous diazepam. Haemoperfusion may be used in severe cases.

Paracetamol

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 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, acquired immunodeficiency syndrome (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. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Mild symptoms during the first 2 days of acute poisoning, do not reflect the potential seriousness of the overdose.

Liver damage may become apparent 12 u2013 48 hours, or later, after ingestion, initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and non-specific myocardial depression have also occurred. 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.

Treatment

N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible, preferably within 8 hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 mL dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 mL dextrose injection over the next 4 hours and then 100 mg/kg in a 1 000 mL dextrose injection over the next 16 hours. The volume of intravenous fluids should be modified for children. Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every 4 hours for 17 doses. A plasma paracetamol level should be determined 4 hours after ingestion in all cases of suspected overdose. Levels done before 4 hours, unless high, may be misleading. Patients at risk of liver damage and hence requiring continued treatment with N-acetylcysteine, can be identified according to their 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion. Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, should continue N-acetylcysteine treatment with 100 mg/kg intravenous over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage, as identified above, should continue treatment if concentrations are above the u201chigh risk treatment lineu201d. Prothrombin index correlates best with survival. All patients with significant overdose should be monitored for at least 96 hours. Symptoms of liver damage, which may be fatal, may only appear after a few days.