Beechams Powders GSL

The product may be recommended as an analgesic and antipyretic for:

a) The symptomatic relief of influenza, feverishness, chills and colds, including feverish colds.

b) The relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, rheumatic pain and muscular aches and pains.

Directions for use: Mix the powder with a little water and stir before drinking.

Adults and children aged 16 and over: One powder to be taken every four to six hours as required.

Do not exceed six powders in any period of 24 hours.

Elderly: Use with particular caution in elderly patients who are more prone to adverse events.

Children (under 16 years): Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki's disease).

Product should be discontinued if pain gets worse or lasts more than 10 days (or lasts more than 3 days for fever).

For oral administration only.

The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days.

For migraine indication: use of this medicine is not recommended for children and adolescents under 18 years of age.

Hypersensitivity to aspirin, other salicylates, caffeine or any of the excipients listed in Section 6.1. A history of hypersensitivity reactions (e.g. asthma, bronchospasm, angioedema, rhinitis, urticaria, nasal polyps) in response to aspirin or non-steroidal anti-inflammatory drugs.

 Hypersensitivity to peanut or soya.

Patients with hepatic or renal failure (GFR < 15mL/min/1.73m2). Aspirin is known to cause sodium and water retention which may exacerbate hypertension, congestive heart failure and renal impairment.

 Receiving doses of methotrexate at doses > 15mg/week is not advisable (see 4.5

 Interactions).Patients with active peptic ulceration or a history of peptic ulceration. History of gastrointestinal bleeding or perforation after treatment with aspirin or other NSAIDS.

 A history of haemophilia, hypothrombinaemia or other clotting disorders. A history of gout.

 Doses > 100 mg/day during the third trimester of pregnancy.

Aspirin should be used with caution in patients with hypertension, mild to moderate renal or hepatic impairment, or in patients who are dehydrated or suffering from diabetes mellitus. Aspirin decreases platelet adhesiveness and increases bleeding time, which can contribute to an increased risk of hemorrhage.

 Haematological and haemorrhagic effects can occur, and may be severe. Patients should report any unusual bleeding symptoms to their physician. Due to its inhibitory effect on platelet aggregation aspirin may cause increased bleeding during and after surgery.

Gastrointestinal (GI) bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. These effects generally have more serious consequences in the elderly (see Interactions).

 Aspirin may precipitate acute haemolytic anaemia in patients with G6PDH deficiency.

 Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

 Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 If symptoms persist consult your doctor.

 Contains aspirin.

 Keep out of the reach of children.

There is a possible association between aspirin and Reye's syndrome when given to children, especially during or immediately after a viral illness. Reye's syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason, aspirin should not be given to children under 16 years, particularly during or immediately after chickenpox, influenza, or other viral infections, unless prescribed by a physician or specifically indicated (e.g. Kawasaki's disease).

 Serious hypersensitivity reactions or anaphylaxis can occur. Bronchospasm may be precipitated in patients suffering from or with a previous history of asthma, allergic disease, or nasal polyps.

Other non-steroidal anti-inflammatory drugs (NSAIDs): Do not use in combination with other non-steroidal anti-inflammatory drugs (NSAIDs) as these may increase the risk of adverse effects.

Ibuprofen: Ibuprofen may inhibit the anti-platelet effect of low dose aspirin. Patients on low dose aspirin should be instructed to consult their doctor or pharmacist before taking ibuprofen.

Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of aspirin with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated, and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors, due to the increased risk of nephrotoxicity. Concomitant treatment with potassium-sparing drugs may be associated with increased serum potassium levels, which should therefore be monitored frequently.

Loop diuretics (e.g., furosemide): Aspirin may reduce their activity due to competition and inhibition of urinary prostaglandins. NSAIDs can cause acute kidney failure, especially in dehydrated patients. If a diuretic is administered simultaneously with aspirin, it is necessary to ensure adequate hydration of the patient and to monitor the kidney function and blood pressure, particularly when starting diuretic treatment.

Alcohol: Co-administration of alcohol and aspirin increases the risk of gastrointestinal haemorrhage.

Antacids: Antacids may increase the excretion of aspirin by alkalinisation of the urine.

Anticoagulants (oral) and platelet aggregation inhibitors: Aspirin may enhance the effects of oral anticoagulants such as heparin and coumarins, and of platelet aggregation inhibitors, such as ticlopidine, clopidogrel, and cilostazol, as there is an increased risk of bleeding. Clinical and laboratory monitoring of the bleeding time and prothrombin time should be performed.

Anticonvulsants: Aspirin increases the serum levels of phenytoin; serum phenytoin should be well monitored. Aspirin inhibits the metabolism of valproate and hence could increase its toxicity; valproate levels should be well monitored.

Carbonic anhydrase inhibitors: There is an increased risk of salicylate toxicity when high dose aspirin is co-administered with carbonic anhydrase inhibitors (such as acetazolamide).

Corticosteroids: The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered. Plasma salicylate concentrations may be reduced by concurrent use of corticosteroids, and salicylate toxicity may occur following withdrawal of the corticosteroids.

Antidiabetics, e.g. sulphonylureas: Salicylics may increase the hypoglycaemic effect of sulphonylureas. As a precautionary measure regular monitoring of blood glucose level is highly recommended.

Lithium: Caffeine can increase the elimination of lithium from the body. Concomitant use is therefore not recommended.

Methotrexate: The toxicity of methotrexate may be enhanced by concomitant use of aspirin. In case of concomitant use with aspirin, renal function should be monitored. The concomitant use of methotrexate (at doses > 15mg/week) with aspirin is contraindicated (see Section 4.3).

Selective Serotonin Re-Uptake Inhibitors (SSRIs): Concurrent use of aspirin and SSRIs can increase the risk of gastrointestinal bleeding.

Uricosuric agents: Aspirin diminishes the action of uricosurics such as probenecid and sulfinpyrazone.

There is some evidence that medicinal products that inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. However, no accurate data are available on when the reversibility of fertility effects occur after the treatment is suspended. Caution should be exercised when used by women who are planning on becoming pregnant.

Not recommended for use during pregnancy. This medicine is contraindicated during the third trimester of pregnancy (see Contraindications).

Doses of above 100 mg/day and up to 500 mg/day:

There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.

Doses of 500 mg/day and above:

From the 20th week of pregnancy onward, this medicine use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, this medicine should not be given unless clearly necessary. If this medicine is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to this medicine for several days from gestational week 20 onward. This medicine should be discontinued if oligohydramnios or ductus arteriosus constriction are found.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

• cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);

• renal dysfunction (see above);

the mother and the neonate, at the end of pregnancy, to:

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;

• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, aspirin at doses higher than 100 mg/day is contraindicated during the third trimester of pregnancy (see section 4.3). Doses up to and including 100 mg/day may only be used under strict obstetric monitoring.

Aspirin – caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion and low birth weight associated with total caffeine consumption above 200mg per day.

Lactation

Aspirin is secreted into breast milk in low concentration and should, therefore, be avoided during lactation because of the possible risk of Reye's Syndrome and the fact that high doses could potentially impair platelet function.

Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significantly toxicity has not been observed.

None

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data).

Adverse events are more likely to occur with increasing dose and duration of use.

Aspirin

Caffeine

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard.

Aspirin overdose:

Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Symptoms:

Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases. A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common.

Acidosis may increase salicylate transfer across the blood brain barrier.

Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.

Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Management:

Give activated charcoal if an adult presents within one hour of ingestion of more than 125 mg/ kg. Children and adults who might have ingested 125 mg/kg or more salicylate, or those who are symptomatic, should be referred for medical assessment. The benefit of gastric decontamination using activated charcoal is uncertain. Consider activated charcoal (charcoal dose: 50 g for adults; 1 g/ kg for children) if the patient presents within 1 hour of ingestion of 125 mg/kg or more salicylate, or any amount of methyl salicylate, providing it is safe to do so and the airway can be protected.

The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account.

Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used alone since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Caffeine overdose:

Symptoms: Common features include GI disturbance, epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, “rambling” flow of thought and speech, psychomotor agitation, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions) or periods of inexhaustibility.

Management:

No specific antidote is available, but supportive measures such as beta adrenoceptor antagonists to reverse the cardiotoxic effects may be used.

Aspirin provides the analgesic and antipyretic actions required for the recommended indications.

Caffeine is a mild stimulant.

Aspirin is rapidly absorbed from the upper gastrointestinal tract after oral administration and is rapidly distributed throughout the whole body. It is hydrolysed to its active primary metabolite salicylic acid and completely excreted in the urine, principally as glucuronic acid and glycine conjugates of salicylic acid, but also as salicylic acid itself.

Salicylates are extensively bound to plasma proteins. Maximum plasma concentrations are reached after 10-40 minutes (acetylsalicylic acid) and 0.3 - 2 hours (total salicylate) depending on dosage form. The elimination half life of acetylsalicylic acid is dose-dependent, typically two hours after a single dose of 0.5 g aspirin, 4 hours after 1 gram and 20 hours after 5 grams.

Following administration of acetylsalicylic acid, salicylic acid can be detected in breast milk, cerebral spinal fluid and synovial fluid. The substance crosses the placenta.

Non-clinical safety data on aspirin and caffeine have not revealed findings which are of relevance to the recommended dosage and use of the product and which are not already addressed in the clinical data section (see Pregnancy and Lactation, Contraindications).

Oral administration of caffeine to rats during the period of organogenesis at a dose that was 2.7 fold greater than the clinical dose was reported to cause a decrease in foetal weight and foetal malformations consisting of club foot, ectrodactyly, cleft palate, and retarded ossification. Similar effects, consisting of significant increases in foetal resorptions and foetal malformations that included cleft palate and digital defects, were reported following intraperitoneal administration of caffeine to mice on days 7 through 14 of gestation at a dose that was 3.4 -fold greater than the clinical dose.

Lactose monohydrate

maize starch (dried),

colloidal anhydrous

silica sodium lauryl

sulphate saccharin

sodium sodium

cyclamate

spice flavour blend 17.42.5890 (contains soya protein)

Iron salts, phenobarbital sodium, hexamine, quinine salts, potassium and sodium iodides, free acids, alkali hydroxides, carbonates and stearates.

Three years

Store below 25°C in a dry place.

The product is packed in laminate child resistant senior friendly sachets comprising a complex of PET/ Polyethylene/ Aluminium /Ethylene methacrylic acid (EMAA).

10 sachets (5 pairs) may be contained in a carboard box carton.

Not applicable.