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MEDINOL UNDER 6 PARACETAMOL ORAL SUSPENSION BP 120MG/5ML

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Medinol For Children 120mg/5ml Oral Suspension
Medinol Paediatric Paracetamol Oral Suspension BP 120mg/5ml

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 120.00mg/5ml
Excipients with known effect:
Lycasin (Maltitol Syrup)
Propylhydroxybenzoate (E216)
Methylhydroxybenzoate (E218).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of pain and to relieve or reduce fever.

4.2

Posology and method of administration
Route of administration: oral
Age

Dose

For post-vaccination
fever for babies aged
between 2 – 3 months

2.5 mL.
If necessary, after 4-6 hours, give a
second 2.5 mL dose



Do not give to babies less than 2 months of age



Do not give more than 2 doses



Leave at least 4 hours between doses



If further doses are needed, talk to your doctor or pharmacist

Child’s Age

How Much

How often (in 24
hours)

3 – 6 months

2.5 mL

4 times

6 – 24 months

5 mL

4 times

2 – 4 years

7.5 mL

4 times

4 – 8 years

10 mL

4 times

8 – 10 years

15 mL

4 times

10 - 12 years

20 mL

4 times



Do not give more than 4 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

It is important to shake the bottle for at least 10 seconds before use.

4.3

Contraindications
Hypersensitivity to paracetamol and/or other constituents.
Impaired kidney or liver function.

4.4

Special warnings and precautions for use
1.

If pain or fever persists for more than 3 days consult a doctor.

2.

Prolonged use without medical supervision may be harmful.

3.

Do not give with other product containing paracetamol concurrently.

4.

If your baby was born prematurely and is less than 3 months old consult your
doctor before use.

5.

In cases of accidental overdose seek medical attention immediately.

6.

Care is advised in the administration of paracetamol to patients with severe renal
or severe hepatic impairment. The hazards of overdose are greater in those with
(non-cirrhotic) alcoholic liver disease.

7.

Keep out of the reach of children.

8.

Do not exceed the stated dose.

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 or syringe supplied with the pack.
Do not give to babies less than 2 months of age
For infants 2-3 months no more than 2 doses should be given
Do not give more than 4 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.
Keep out of the reach and sight of children.
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).

Patients with rare hereditary problems of fructose intolerance should not take this
medicine.

This product contains sodium propylhydroxybenzoate (E217) and sodium
methylhydroxylbenzoate (E219) which may cause allergic reactions (possibly
delayed).

4.5

Interaction with other medicinal products and other forms of interaction
Cholestyramine may reduce absorption of paracetamol. Metochlopramide and
doperidone may accelerate the absorption of paracetamol. Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase the hepatatoxicity of
paracetamol particularly after an overdose.
The anticoagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular use of paracetamol with increased risk of bleeding; occasional
doses have no significant effect.

4.6

Pregnancy and lactation
Epidemiological studies in human pregnancy have shown no ill 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 do not contraindicate breast feeding.

4.7

Effects on ability to drive and use machines
None stated.

4.8

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

4.9

Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol.
Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has
risk factors (see below).
Risk Factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin,
primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV
infection, starvation, cachexia.

Symptoms
Symptoms of paracetamol overdosage 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,
haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with

acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria,
may develop even in the absence of severe liver damage. Cardiac arrhythmias and
pancreatitis have been reported.

Management
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. Symptoms may be limited to nausea or vomiting and
may not reflect the severity of overdose or the risk of organ damage. Management
should be in accordance with established treatment guidelines, see BNF overdose
section.
Treatment with activated charcoal should be considered if the overdose has been
taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours
or later after ingestion (earlier concentrations are unreliable). Treatment with Nacetylcysteine may be used up to 24 hours after ingestion of paracetamol, however,
the maximum protective effect is obtained up to 8 hours post-ingestion. The
effectiveness of the antidote declines sharply after this time. If required the patient
should be given intravenous N-acetylcysteine, in line with the established dosage
schedule. If vomiting is not a problem, oral methionine may be a suitable alternative
for remote areas, outside hospital. Management of patients who present with serious
hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or
a liver unit.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Analgesic/ Antipyretic.

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tragacanth BP

Lycasin (Maltitol Syrup)
Methylhydroxybenzoate BP
Propyl Parahydroxybenzoate
Sodium Saccharin BP
Sodium Cyclamate 1968 BP
Strawberry Flavour PFW 500253E
Water for injection

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Avoid extremes of temperatures
Store in the original container
Do not refrigerate
Do not store above 25oC

6.5

Nature and contents of container
Amber glass sirop or winchester bottle with tamper evident cap with fitted polycone
liner containing 50, 70, 100, 140, 150 or 200ml of product.
The 70ml and 140ml size will also be cartoned.
30ml universal amber glass bottle fitted with a child-resistant cap containing 20, 25 or
30ml of product.
Amber glass winchester bottle with polypropylene cap with EPE wad containing 500
or 1000ml of product.
A 5ml/2.5ml CE marked polypropylene double-ended measuring spoon or a 5ml CE
marked syringe is also included with each pack of suspension.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Cupal Ltd
Venus, 1 Old Park Lane
Trafford Park
Manchester
M41 7HA
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00338/0033

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/02/1977

10

DATE OF REVISION OF THE TEXT
29/03/2012

Expand Transcript

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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