Paracetamol 250mg/5ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Rosemont Pharmaceuticals Ltd

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

50mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5016119039294 5016119039591

Patient Information leaflet

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JOB INFORMATION
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JOB SPECIFICATION
MAIN BODY TEXT
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
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AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
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NO
N/A
TICK APPLICABLE BOX
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Univers Roman
UNIVERS BOLD
250mg/5ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
UKL412
501
210 x 300mm
N/A
30 x 150mm
1
1 of 2
10pt
No
100ml / 500ml
125ml / 508ml
N/A
E3B98RBJ2
E3B98RBJ1
N/A
1095825
Paracetamol 250mg/5ml Oral Suspension
17/09/19
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DH
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3
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IF YOU GET ANY OF THE FOLLOWING SIDE EFFECTS, STOP TAKING THIS
MEDICINE AND SEE YOUR DOCTOR AS
SOON AS POSSIBLE:
n
bruising more easily, sore throat or other signs of infection (these
may be signs of a blood
disorder)
n
severe pain in the abdomen and back, with fever (high temperature),
loss of appetite,
nausea and vomiting (these may be signs of pancreas inflammation)
n
very rare cases of serious skin reactions have been reported.
TELL YOUR DOCTOR IF YOU GET ANY OF THESE SIDE EFFECTS:
n
Skin rash
If paracetamol is taken for a long time, it may lead
to liver and kidney problems but if the right
amount is taken over a short period of time there
should be no problems.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card
Scheme at www.mhra.gov.uk/Yellowcard or search for MHRA Yellow Card in
the Google Play
or Apple App Store. By reporting side effects you can help provide
more information on the
safety of this medicine.
5. HOW TO STORE PARACETAMOL ORAL SUSPENSION
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Keep out of the sigh

Summary of Product characteristics

OBJECT 1
PARACETAMOL 250MG/5ML ORAL
SUSPENSION
Summary of Product Characteristics Updated 24-Oct-2019 | Rosemont
Pharmaceuticals Limited
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1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Paracetamol 250mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Paracetamol 250mg/5ml
Excipients with known effect:
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Propylene Glycol
Sucrose 3g/5ml
Sorbitol (E420)
Carmoisine (E122)
Tartrazine (E102)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Suspension
Off-white cream suspension
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of mild to moderate pain, including headache,
migraine, neuralgia, toothache, sore
throat, period pains, aches and pains.
For the reduction of fever and to be used as an adjunctive treatment
to relieve symptoms of cold and flu.
4.2 Posology and method of administration
For oral administration only
It is important to SHAKE THE BOTTLE for at least