Paracetamol 250mg/5ml oral suspension sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

Pinewood Healthcare

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: 5099186001845 5099186001852 5099186002385 5099186002392 5099186004037

Patient Information leaflet

Front
Back
PATIENT INFORMATION LEAFLET
PARACETAMOL 250 MG/5 ML ORAL SUSPENSION
PARACETAMOL 250 MG/5 ML
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU AND YOUR CHILD.
This medicine is available without prescription; however, you still
need to give Paracetamol 250 mg/5 ml Oral Suspension
carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your child’s symptoms worsen or do not
improve after 3 days.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Paracetamol Oral Suspension is and what it is used for
2.
Before you give Paracetamol Oral Suspension to your child
3.
How to give Paracetamol Oral Suspension to your child
4.
Possible side effects
5.
How to store Paracetamol Oral Suspension
6.
Further information
1.
WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Paracetamol 250 mg/5 ml Oral Suspension (“Paracetamol Oral
Suspension”) contains paracetamol to relieve pain and reduce
high temperatures. Paracetamol Oral Suspension can be used in children
and adults for the treatment of mild or moderate pain
and feverishness associated with teething, toothache, headache, colds
and flu. It is suitable for adults who have difficulty
swallowing tablets.
2.
BEFORE YOU GIVE PARACETAMOL ORAL SUSPENSION TO YOUR CHILD
DO NOT GIVE PARACETAMOL ORAL SUSPENSION IF YOUR CHILD IS TAKING ANY
OTHER PARACETAMOL-CONTAINING PRODUCTS, OTHER
FLU, COLD, COUGH OR DECONGESTANT PRODUCTS, OR ALCOHOL.
DO NOT GIVE PARACETAMOL ORAL SUSPENSION TO YOUR CHILD IF HE/SHE:
•
is allergic (hypersensitive) to paracetamol, or any of the other
ingredients of Paracetamol Oral Suspension
_(see _
_ _
_Section 6 and end of Section 2)._
•
has kidney or liver problems
If you are not sure about any of the above, please consult your
doctor.
TAKE SPECIAL CARE W

Summary of Product characteristics

OBJECT 1
PARACETAMOL 250 MG/5 ML ORAL SUSPENSION
(COLOUR FREE)
Summary of Product Characteristics Updated 11-Sep-2014 | Pinewood
Healthcare
1. Name of the medicinal product
Paracetamol 250 mg/5 ml Oral Suspension
2. Qualitative and quantitative composition
Each 5 ml spoonful contains Paracetamol Ph. Eur 250 mg
For excipients, see 6.1
3. Pharmaceutical form
Oral Suspension.
Cream to brown oral suspension with orange odour and taste.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of mild to moderate pain and as an anti-pyretic.
Used for the relief of pain and
feverishness associated with teething, toothache, headache, colds and
flu.
4.2 Posology and method of administration
CHILD'S AGE
HOW MUCH
HOW OFTEN
(IN 24 HOURS)
6 – 8 years
One 5 ml spoonful (large end)
4 times
8 – 10 years
One 5.0 ml spoonful (large end) and one 2.5 ml
spoonful (small end)
4 times
10 – 12 years
Two 5 ml spoonfuls (large end)
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
• Do not give to children under the age of 6 years
Children aged 12 - 16 years: Two – three 5 ml spoonfuls (large end)
up to 4 times a day.
Adults and children over 16 years: Two – four 5 ml spoonfuls (large
end) up to 4 times a day.
It is important to SHAKE THE BOTTLE for at least 10 seconds before
use.
4.3 Contraindications
Hypersensitivity to Paracetamol 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 hazards of overdose are greater in those with
(non-cirrhotic) 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 overfil