MAXIMIUM STRENGTH ASPRO CLEAR 500MG/TABLET.

Active substance: ACETYLSALICYLIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Maximum Strength Aspro Clear

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Acetylsalicylic acid (As "Coated Acetylsalicylic acid")

500.0 mg

For excipients, see 6.1

3.

PHARMACEUTICAL FORM
Effervescent Tablet to be dissolved in water.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
1. Symptomatic relief of mild to moderate pain, including headache, migraine
pain, neuralgia, toothache, sore throat, period pain, aches and pains.
2. Symptomatic relief of influenza, feverishness, feverish colds.
3. Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago,
fibrositis, muscular aches and pains, joint swelling and stiffness

4.2

Posology and method of administration
Route of administation:
Oral. The tablets are to be dissolved in water before taking.
Adults:
One or two tablets dissolved in half a glass of water (100ml) every four hours as
required. Do not exceed eight tablets in 24 hours.
Elderly
No special dosage regimen required.

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

4.3

Contraindications
Acetylsalicylic acid must not be used in the following cases:
Hypersensitivity to acetylsalicylic acid or other salicylates, or to any other
components of the product,
a history of hypersensitivity reactions (e.g. asthma, rhinitis, urticaria) induced
by the administration of salicylates or substances with a similar action,
notably non-steroidal anti-inflammatory drugs,
active or a history of peptic ulcers,
haemorrhagic diathesis,
severe renal failure,
severe hepatic failure,
severe cardiac failure,
in combination with methotrexate at doses of 15 mg/week or more (see
interactions with other medicinal products and other forms of interaction),
third trimester of pregnancy.

4.4

Special warnings and special precautions for use
Acetylsalicylic acid should be used with particular caution in the following
cases:
hypersensitivity to analgesics / anti-inflammatory agents / anti-rheumatics
and in the presence of other allergies,
with concomitant treatment with anticoagulants (see interactions with other
medicinal products and other forms of interaction),
impaired renal function,
impaired hepatic function.
Acetylsalicylic acid may precipitate bronchospasm and induce asthma attacks
or other hypersensitivity reactions. Risk factors are pre-existing asthma, hay
fever, nasal polyps, or chronic respiratory disease. This also applies to patients
exhibiting allergic reactions (e.g. cutaneous reactions, itching, urticaria) to
other substances.
Due to its inhibitory effect on platelet aggregation which persists for several
days after administration, acetylsalicylic acid may lead to an increased
bleeding tendency during and after surgical operations (including minor
surgeries, e.g. dental extractions).
At low doses, acetylsalicylic acid reduces the excretion of uric acid. This can
possibly trigger gout attacks in predisposed patients.

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 be given to children
under 16, unless specifically indicated (e.g. Kawasaki’s disease).
This medicinal product contains 298 mg sodium per effervescent tablet. To be
taken into consideration by patients on a controlled sodium diet.
4.5

Interactions with other medicaments and other forms of interactions
Contraindicated Interactions:
Methotrexate used at doses of 15 mg/week or more:
Increased haematological toxicity of methotrexate (decreased renal clearance
of methotrexate by anti-inflammatory agents in general and displacement of
methotrexate from its plasma protein binding by salicylates) (see section 4.3
Contraindications).
Combinations requiring precautions for use:
Methotrexate, used at doses of less than 15 mg/week:
Increased haematological toxicity of methotrexate (decreased renal clearance
of methotrexate by anti-inflammatory agents in general and displacement of
methotrexate from its plasma protein binding by salicylates).
Anticoagulants, thrombolytics/other inhibitors of platelet aggregation/hemostasis:
Increased risk of bleeding.
Other non-steroidal anti-inflammatory drugs with salicylates at higher
doses:
Increased risk of ulcers and gastrointestinal bleeding due to synergistic effect.
Selective Serotonin Re-uptake Inhibitors (SSRIs):
Increased risk of upper gastrointestinal bleeding due to possibly synergistic effect
Digoxin:
Plasma concentrations of digoxin are increased due to a decrease in renal
excretion.
Antidiabetics, e.g. insulin, sulphonylureas:
Increased hypoglycemic effect by high doses of acetylsalicylic acid via
hypoglycaemic action of acetylsalicylic acid and displacement of
sulphonylurea from its plasma protein binding.
Diuretics in combination with acetylsalicylic acid at higher doses:
Decreased glomerular filtration via decreased renal prostaglandin synthesis.

Systemic glucocorticoids, except hydrocortisone used as replacement
therapy in Addison's disease:
Decreased blood salicylate levels during corticosteroid treatment and risk of
salicylate overdose after this treatment is stopped via increased elimination of
salicylates by corticosteroids.
Angiotensin converting enzyme inhibitors (ACE) in combination with
acetylsalicylic acid at higher doses:
Decreased glomerular filtration via inhibition of vasodilatory prostaglandins.
Furthermore, decreased antihypertensive effect.
Valproic acid and Phenytoin:
Increased toxicity of valproic acid due to displacement from protein binding
sites. Phenytoin is also extensively bound to plasma proteins therefore it can
be displaced by acetylsalicylic acid from plasma binding.
Alcohol:
Increased damage to gastro-intestinal mucosa and prolonged bleeding time due
to additive effects of acetylsalicylic acid and alcohol.
Uricosurics such as benzbromarone, probenecid:
Decreased uricosuric effect (competition of renal tubular uric acid
elimination).
4.6

Pregnancy and lactation
Pregnancy
Doses of 500 mg/day and above:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy
and/or the embryo/foetal development. Data from epidemiological studies
suggest an increased risk of miscarriage and of cardiac malformation and
gastroschisis after use of a prostaglandin synthesis inhibitor in early
pregnancy. The absolute risk for cardiovascular malformation was increased
from less than 1%, up to approximately 1.5 %. The risk is believed to increase
with dose and duration of therapy. In animals, administration of a
prostaglandin synthesis inhibitor has been shown to result in increased preand post-implantation loss and embryo-foetal lethality. In addition, increased
incidences of various malformations, including cardiovascular, have been
reported in animals given a prostaglandin synthesis inhibitor during the
organogenetic period. During the first and second trimester of pregnancy,
acetyl salicylic acid should not be given unless clearly necessary. If
acetylsalicylic acid 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.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors
may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus
and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligohydroamniosis;
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, acetylsalicylic acid at doses of 100 mg/day and higher is
contraindicated during the third trimester of pregnancy.
Lactation:
Breast feeding is contraindicated at high doses because of the theoretical risk
of affecting clotting mechanisms.
4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
The listed adverse drug reactions are based on spontaneous reports, thus an
organization according to CIOMS III categories of frequency is not possible.
Blood and lymphatic system disorders
In the context of bleeding: haemorrhagic anaemia, iron deficiency anaemia
with the respective laboratory and clinical signs and symptoms.
Immune system disorders
Hypersensitivity, drug hypersensitivity, allergic edema and angioedema,
anaphylactic reaction, anaphylactic shock with respective laboratory and
clinical manifestations
Nervous system disorders
Cerebral and intracranial haemorrhage, dizziness
Ear and labyrinth disorders
Tinnitus
Cardiac disorders
In the context of severe allergic reactions: cardio-respiratory distress
Vascular disorders
Haemorrhage, perioperative haemorrhage, haematoma, muscle haemorrhage
Respiratory, thoracic and mediastinal disorders
Epistaxis, analgesic asthma syndrome, rhinitis, nasal congestion

Gastrointestinal disorders
Dyspepsia, gastrointestinal pain, abdominal pain, gingival bleeding,
gastrointestinal inflammation, gastrointestinal ulcer, gastrointestinal
haemorrhage, gastrointestinal ulcer perforation with the respective laboratory
and clinical signs and symptoms
Hepatobiliary disorders
Liver disorder, transaminases increased
Skin and subcutaneous tissue disorders
Rash, urticaria, pruritus
Renal and urinary disorders
Urogenital haemorrhage; in patients with pre-existing impaired renal function
or impaired cardiovascular circulation: renal impairment, renal failure acute
Injury, poisoning and procedural complications
See overdose section
4.9

Overdose
Salicylates / aspirin
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
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 ten years or over 70 have increased risk of salicylate
toxicity and may require dialysis at an earlier stage.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Analgesia: Aspirin effects analgesia by virtue of both a peripheral and a central
nervous system effect. Inhibition of prostaglandin synthesis at the site of origin
of pain prevents sensitisation of the pain receptors to mediators of the pain
response, such as bradykinin.
Antipyresis: Aspirin rapidly and effectively lowers the body temperature in
febrile patients, by adjusting the "set point" at which body temperature is
maintained in the hypothalamic nuclei. Heat production is not inhibited, but
heat dissipation is augmented by increased peripheral blood flow and sweating.
Anti-inflammatory action: The basic action of aspirin in rheumatic disease
appears to be concerned with effects on inflammatory and immunological
processes in mesenchymal and connective tissue. The anti-inflammatory effect
of aspirin is due to blockade of an early step in the synthesis of prostaglandins
from precursor fatty acids, by inhibition of prostaglandin synthetase.

5.2

Pharmacokinetic particulars

Absorption of non-ionised aspirin occurs in the stomach and upper intestine.
Hydrolysis to salicylic acid occurs rapidly in the intestine and in the circulation.
Appreciable plasma concentrations are found in less then 30 minutes. After a
single dose, a peak value is reached in about 2 hours and then gradually
declines. Salicylates are extensively bound to plasma proteins (50-90%);
aspirin to a lesser degree. Aspirin and salicylates are rapidly distributed to all
body tissues. They appear in milk and cross the placenta.
The effervescent formulation of Maximum Strength Aspro Clear permits more
rapid absorption of aspirin, as compared to regular hard tablets, and causes less
gastrointestinal irritancy.
Aspirin is excreted mainly by the kidneys as salicylic acid and as glucuronide
conjugates; also as salicyluric and gentisic acids. The biological half life of
aspirin after a small single dose is in the region of 4 hours.
5.3

Preclinical safety data
The preclinical safety profile of acetylsalicylic acid is well documented.
In animal studies, salicylates caused kidney damage at high dosages but no
other organic lesions. Acetylsalicylic acid has been extensively studied in vitro
and in vivo for mutagenicity; no relevant evidence of a mutagenic potential
was found. The same applies to carcinogenicity studies.
Salicylates have exhibited teratogenic effects in animal studies and a number
of different species. Implantation disorders, embryotoxic and foetotoxic
effects and impairment of learning ability in the offspring after prenatal
exposure have been described.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Malic Acid *
Dioctyl sodium sulphosuccinate*
Mannitol*
Povidone*
(* Combined as coated acetylsalicylic acid)
Anhydrous Citric Acid
Sodium Hydrogen Carbonate
Sodium Carbonate
Saccharin Sodium
Lemon Flavour

6.2

Incompatibilities
None.

6.3

Shelf life
3 years.

6.4

Precautions for storage
Store below 25oC. Protect from moisture.

No Data Held
6.5
Nature and contents of container
Tablets are packed in polyethylene-coated, soft tempered, aluminium foil, with
four tablets per strip. These strips are then packed into cardboard cartons to
contain 8, 12, 16, 20, 24 or 60 tablets.

6.6

Instructions for use, handling and disposal
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
Bayer Plc T/A Bayer PLC Consumer Care Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
UK

8.

MARKETING AUTHORISATION NUMBER
PL 00010/0332

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

25/11/2005

10

DATE OF REVISION OF THE TEXT
01/02/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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