RESOLVE EXTRA

Active substance: SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Effervescent Paracetamol and Caffeine Granules
Resolve Extra

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains Paracetamol 1 g, Sodium Bicarbonate 1 .408g and
Caffeine 60mg.

3

PHARMACEUTICAL FORM
Effervescent granules.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Recommended for the relief of headache, including tension headache and migraine,
with gastric upset, particularly associated with over-indulgence in food or drink or
both. Effervescent Paracetamol and Caffeine Granules contain an extra strength pain
relieving formula with an antacid to settle the stomach. It is also recommended for the
treatment of toothache, neuralgia, sore throat, period pains and symptomatic relief of
rheumatic aches and pains, colds and influenza.

4.2

Posology and method of administration
Method of Administration: Oral Administration.
Effervescent Paracetamol and Caffeine Granules should be dissolved in a glass
of water.
Adults:
One sachet up to four times daily.
Do not exceed 4 sachets in 24 hours.

The Elderly:
As for adults.
Children:
Not recommended for children under 18 years.

4.3

Contraindications
Hypersensitivity to paracetamol, caffeine, sodium bicarbonate or any of the
other constituents.

4.4

Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe
renal or severe hepatic impairment. The hazard of overdose is greater in those
with non-cirrhotic alcoholic liver disease.
Excessive intake of tea or coffee should be avoided while taking this product.
This product contains dextrose (glucose) and patients should consult their
physician if they are suffering from diabetes before using this product.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing products
concurrent}y.
If symptoms persist, consult your doctor.
Keep out of reach of children.

4.5

Interaction with other medicinal products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide
or domperidone and absorption reduced by cholyestyramine. 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.

4.6

Fertility, Pregnancy and Lactation
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol and caffeine used in the recommended dosage, but patients should
follow the advice of their doctor regarding its use. Paracetamol and caffeine
are excreted in breast milk but not in a clinically significant amount. Available
published data do not contraindicate breast-feeding.

4.7

Effects on ability to drive and use machines
None

4.8

Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity, including skin rash, may
occur. There have been rare reports of blood dyscrasias including thrombocytopenia
and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9

Overdose
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea,
vomiting, anorexia and abdominal pain. Liver damage may become apparent
12 to 48 hours after ingestion. Abnormalities of glucose metabolism and
metabolic acidosis may occur. In severe poisoning, hepatic failure may
progress to encephalopathy, coma and death. Acute renal failure with acute
tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmia's and pancreatitis have been reported. Liver damage is
possible in adults who have taken 10g or more of paracetamol. It is considered
that excess quantities of a toxic metabolite (usually adequately detoxified by
glutathione when normal doses of paracetamol are ingested) become
irreversibly bound to liver tissue.
Immediate medical advice should be sought in the event of an overdose, even
if you feel well.
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 and any patient who has
ingested around 7.5g or more of paracetamol in the preceding 4 hours should
undergo gastric lavage. Administration of oral methionine or intravenous Nacetylcysteine which may have a beneficial effect up to at least 48 hours after
the overdose, may be required. General supportive measures must be
available.
Overdose of caffeine may produce nervousness, restlessness, insomnia,
excitement, diuresis, facial flushing, muscle twitching, GI disturbance,
tachycardia or cardiac arrhythmia, "rambling" flow of thought and speech,
psychomotor agitation, or periods of inexhaustibility.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
The combination of paracetamol and caffeine is a well-established analgesic
combination.

5.2

Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. It is relatively uniformly distributed throughout most body
fluids and exhibits variable protein binding. Excretion is almost exclusively
renal, in the form of conjugated metabolites.
Caffeine is absorbed readily after oral administration, maximal plasma
concentrations are achieved within one hour and the plasma half-life is about
3.5 hours. 65-80% of administered caffeine is excreted in the urine as I methyluric acid and l-methylxanthine.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are
additional to
that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Citric Acid (anhydrous)
Sodium Carbonate (anhydrous)
Sodium Lauryl Sulphate
Polyvinylpyrrolidone K25
Saccharin Sodium
Dextrose (anhydrous)

Lemon Durarome
Purified Water

6.2

Incompatibilities
None

6.3

Shelf life
60 months.

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
Polythene/foil laminate sachets in cardboard carton outers containing 1, 5, 6 or
10
sachets

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41
7HA.

8

MARKETING AUTHORISATION NUMBER(S)
PL 17905/0081

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
6 October 2000

10

DATE OF REVISION OF THE TEXT
09/06/2006

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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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