Document: spc-doc_PL 44673-0017 change

• spc-doc_PL 00079-0177R
• spc-doc_PL 00079-0205
• spc-doc_PL 44673-0017
• spc-doc_PL 44673-0018
• spc-doc_PL 44673-0183

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Beechams Powders

2. Qualitative and Quantitative Composition

Each sachet contains:

Active constituents:

Aspirin 600 mg Caffeine 50 mg.

Excipients with known effect:

Lactose

Spice blend flavour 17.42.5890 (contains soya protein)

3    PHARMACEUTICAL FORM

Powder

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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.

4.2 Posology and method of administration

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

Adults and children aged 16 years and over:

One powder to be taken every three to four 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).

4.3 Contraindications

Hypersensitivity to aspirin, other salicylates, caffeine or any of the excipients.

A history of hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, urticaria, nasal polyps) in response to aspirin or non-steroidal anti-inflammatory drugs. Hypersensitivity to peanut or soya.

Patients with severe hepatic or renal failure. Aspirin is known to cause sodium and water retention which may exacerbate hypertension, congestive heart failure and renal impairment.

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.

4.4 Special warnings and precautions for use

Aspirin should be used with caution in patients with hypertension, mild to moderate renal or hepatic impairment, or in patients who are dehydrated.

Aspirin decreases platelet adhesiveness and increases bleeding time.

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.

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. 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 aged under 16 years unless specifically indicated (e.g. for Kawasaki’s disease).

If you suffer from asthma, allergic disease, kidney or liver problems consult your doctor before taking this product.

4.5 Interaction with other medicinal products and other forms of interaction

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.

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

Angiotensin-converting enzyme inhibitors (ACE inhibitors): Aspirin can diminish the effects of ACE inhibitors.

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

Anticoagulants (oral): Aspirin may enhance the effects of oral anticoagulants such as heparin and coumarins.

Anticonvulsants: Aspirin may enhance the activity of phenytoin and valproate.

Beta-blockers: Aspirin can reduce antihypertensive effect of beta-blockers.

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.

Diuretics: There is a risk of a reduced diuretic effect especially in patients with existing renal or cardiovascular disease.

Hypogylcaemic agents (oral): Aspirin may enhance the effects of oral hypoglycaemic agents of the sulphonylurea type.

Methotrexate: The toxicity of methotrexate may be enhanced by concomitant use of aspirin.

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.

4.6 Fertility, Pregnancy and lactation

The use of aspirin should be avoided during pregnancy, particularly during the third trimester. If aspirin is administered during pregnancy, the dose should be the lowest possible and the duration of treatment as short as possible.

Aspirin increases the risk of peripartum haemorrhage. Aspirin may also delay the onset and increase the duration of labour. With high doses, there may be premature closure of the ductus arteriosus.

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.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

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).

Aspirin

Body System	Undesirable effect
Gastrointestinal disorders	Nausea, vomiting, dyspepsia. Gastrointestinal ulceration, gastrointestinal haemorrhage and gastritis.
Renal and urinary disorders	Renal dysfunction, increased blood uric acid levels.
Hepatobiliary disorders	Elevation in aminotransferase levels.
Blood and lymphatic system disorders	Prolonged bleeding time. Thrombocytopenia. Ecchymosis
Metabolism and Nutrition disorders	Sodium and fluid retention.
Immune system disorders	Hypersensitivity reactions e.g. rhinitis, angioedema, urticaria, bronchospasm, skin reactions and anaphylaxis.
Respiratory, thoracic and mediastinal disorders	Bronchospasm in patients sensitive to aspirin and other NSAIDs
Ear and labyrinth disorders	Tinnitus, temporary hearing loss.

Caffeine
Body System	Undesirable effect
Central nervous system	Nervousness and dizziness.

When the recommended aspirin-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of

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.

4.9 Overdose

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 250 mg/kg. 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Caffeine is a mild stimulant.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

None stated

Pharmaceutical Particulars

6.1 List of excipients

Lactose

maize starch (dried), colloidal anhydrous silica sodium lauryl sulphate saccharin sodium sodium cyclamate

spice flavour blend 17.42.5890 (contains soya protein)

6.2 Incompatibilities

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

6.3 Shelf life

Three years

6.4 Special precautions for storage

Store below 25 °C in a dry place.

6.5 Nature and contents of container

Glazed paper wrapper. Wrappers are contained in a boxboard carton with a cellophane overwrap. Ten wrappers are contained in a box board carton.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS