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MEDISED FOR CHILDREN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Medised For Children

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 120 mg/5ml
Diphenhydramine HCl 12.5mg/5ml

3

PHARMACEUTICAL FORM
Oral Solution
Clear amber liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of mild to moderate pain, including teething pain, headache, sore
throat, aches and pains.
Symptomatic relief of influenza and feverish colds and the associated symptoms of
runny nose and sneezing.

4.2

Posology and method of administration
Route of administration: Oral
Recommended Doses and Dosage Schedules:
Child’s Age

How Much

How often (in 24 hours)

6 – 8 years

Two 5 mL spoonfuls

3 times

8 – 10 years

Three 5 mL spoonfuls

3 times

10 - 12 years
Four 5 mL spoonfuls
3 times
• Do not give more than 3 doses in any 24 hour period
• Leave at least 4 hours between doses
• Do not give this medicine to your child for more than 3 days without
speaking to your doctor or pharmacist



Medised is contraindicated in children under 6 years of age (see
section 4.3)
Parents or carers should seek medical attention if the child’s condition
deteriorates during treatment.
It is important to shake the bottle for at least 10 seconds before use.
4.3

Contraindications
Hypersensitivity to paracetamol, and/or any other constituents.
Large doses of antihistamines may precipitate fits in epileptics.
Do not take if you are currently taking monoamine inhibitors (MAOIs) or within 14
days of stopping treatment with MAOIs.
Not to be used in children under the age of 6 years.

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
Not more than 3 doses should be taken in 24 hours.
This product should be administered with caution to patients with known renal
or hepatic impairment, prostatic hypertrophy, urinary retention, or
susceptibility to angle-closure glaucoma. The hazards of overdose are greater
in those with alcoholic liver disease.
The label should contain the following statements:


Contains paracetamol.



Do not give this medicine with any other paracetamol-containing product.



For oral use only.



Never give more medicine than shown in the table.



Do not overfill the spoon.



Always use the spoon supplied with the pack.



Do not give to children under 6 years of age



Do not give more than 3 doses in any 24 hour period.



Leave at least 4 hours between doses.



Do not give this medicine to your child for more than 3 days without speaking
to your doctor or pharmacist



As with all medicines, if your child is currently taking any medicine consult
your doctor or pharmacist before taking this product.



Do not store above 25°C. Store in the original package.

4.5



Keep out of the reach and sight of children.



May cause drowsiness.



This product should not be used to sedate a child.



Immediate medical advice should be sought in the event of an overdose, even
if the child seems well (label).



Immediate medical advice should be sought in the event of an overdose, even
if the child seems well, because of the risk of delayed, serious liver damage
(leaflet).
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 cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular daily use of paracetamol with increased risk of bleeding.
May enhance the sedative effects of CNS depressants including barbiturates,
hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.
May have an additive muscarinic actions with other drugs, such as atropine and some
antidepressants.
Not to be used in patients taking MAOIs or within 14 days of stopping treatment as
there is a risk of serotonin syndrome.

4.6

Pregnancy and lactation
Safety in pregnancy has not been established.
Epidemiological studies in human pregnancy have shown no effects due to
paracetamol used in the recommended dosage, but patients should follow the
advice of their doctor regarding its use. Paracetamol is excreted in breast milk,
but not in a clinically significant amount. Available published data does not
contraindicate breast feeding.

4.7

Effects on ability to drive and use machines
May cause drowsiness. If affected do not drive or operate machinery.

4.8

Undesirable effects
Common side effects:
CNS effects: Drowsiness (usually diminishes within a few days), paradoxical
stimulation, headache, psychomotor impairment.

Antimuscarinic effects: Urinary retention, dry mouth, blurred vision, gastrointestinal
disturbances, thickened respiratory tract secretions
Rare side effects:
Hypotention, extrapyramidal effects, dizziness, confusion, depression, sleep
disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions
(including skin rash), blood disorders and liver dysfunction.
There have been a few reports of blood dyscrasias including thrombocytopenia and
agranulocytosis but these were not necessarily causally related to paracetamol.

4.9

Overdose
The features of overdose are: sedation, pallor, nausea, vomiting, diarrhoea,
anorexia, and abdominal pain; liver damage may become apparent within 12
to 48. In some children overdose may cause cerebral stimulation resulting in
convulsions and hyperpyrexia.
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 arrhythmias and pancreatitis have
been reported.
Liver damage is likely in adults who have taken 10g or more of paracetamol. It
is considered that excess quantities of a toxic metabolite (usually adequately
detoxified by gluthathione when normal doses of paracetamol are ingested),
become irreversibly bound to liver- tissue.
Immediate treatment is essential in the management of a 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 N-acetylcysteine which may have a beneficial effect up to at least
48 hours after the overdose, may be required. General supportive measures
must be available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Paracetamol is an antipyretic and analgesic. Diphenhydramine HCl is an
antihistamine with anticholinergic, anti-emetic, anti-allergic and sedative
effects.

5.2

Pharmacokinetic properties
Paracetamol and Diphenhydramine HCl are both readily absorbed from the
gastrointestinal tract. Both are widely distributed throughout the body. Both
are metabolised in the liver and excreted in the urine. As Medised Infant is a
solution, absorption of actives is rapid following oral ingestion.

5.3

Preclinical safety data
Paracetamol and Diphenhydramine HCl are a well established drug substance
whose preclinical profiles have been investigated and are thoroughly
established.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 4000
Glycerol
Propylene Glycol
Sorbitol Solution (non-crystallising) 70%
Lycasin 80/55 (Maltitol Solution)
Sodium Cyclamate
Sodium Saccharin
Nipasept (Methylhydroxybenzoate, Ethylhydroxybenzoate &
Parahydroxybenzoate)
Strawberry Flavour 513805E
Sugar Module 555049E
Water, purified

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25°C. Do not refrigerate. Keep container in outer carton.

6.5

Nature and contents of container
Amber type III glass bottle and plastic clic loc cap with pulp stearan wadding.
20ml, 30ml, 70ml, 100ml, 140ml, 200ml.
All pack sizes have a 5ml plastic spoon.

6.6

Special precautions for disposal
None

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 17905/0090

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/03/2009

10

DATE OF REVISION OF THE TEXT
26/08/2011

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