Medinol 10001

PATIENT INFORMATION

MEDINOL

LEAFLET

PAEDIATRIC PARACETAMOL ORAL SUSPENSION 120MG/SML

Please read this leaflet carefully before starting to use Medinol Paediatric Paracetamol Oral Suspension 120mg/ Sml. It gives you important information about this medicine. If you have any questions, or if you are unsure about anything, ask a doctor or pharmacist. WHAT IS IN THE PACK? The name of this medicine is Medinol Paediatric Paracetamol Oral Suspension 120mg/5ml. It is available in 100mL 150ml and 200ml bottles. Each 5ml of liquid contains the active ingredient ParacetamoI120.0mg. It also contains the following inactive ingredients: Tragacanth, lycasin, Methylhydroxybenzoate, Propylhydroxybenzoate, Sodium Saccharin, Sodium Cyclamate, Strawberry Flavour PFW 500253E, Water. WHO SUPPLIESMEDINOL PAEDIATRICPARACETAMOl ORAL SUSPENSION 120MG/5Ml? The marketing authorisation holder is Cupalltd, Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA, U.K. The manufacturer is SSL International pic, Whitehouse Business Park, Traynor Way, Peterlee, Durham, SR8 2RU, UK. WHAT IS MEDINOl PAEDIATRICPARACETAMOl ORAL SUSPENSION 120MG/5ML USED FOR? Medinol POBdiatric Paracetamol· Gral Suspension 120mg/ SrnJ is used for the relief of pain and feverish conditions. BEFORE USING MEDINOL PAEDIATRICPARACETAMOl ORAL SUSPENSION 120MG/5ML The following should be read before using this product. • Has your child ever had a reaction after using Medinol Suspension 120mg/Sml or to any of its ingredients?

Paediatric Paracetamol

Oral

• Does your child suffer from kidney or liver problems? • Is your child currently taking any other medicines containing

paracetamol?

If the answer is YES to any of the above questions, do not use this medicine. doctor or pharmacist.

Talk to a

WARNINGS 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. CAN YOU USE MEDINOl

PAEDIATRICPARACETAMOL ORAL SUSPENSION 120MG/5ML WITH OTHER MEDICINES?

If using Warfarin (and other coumarins), Cholestyramine, Metoclopramide, Domperidone, Barbiturates, anti-convulsants, Tricyclic antidepressants or any products containing paracetamol, please talk to a doctor or pharmacist before using this product.

HOW TO USE MEDINOL PAEDIATRICPARACETAMOL ORAL SUSPENSION 120MG/5ML Follow these instructions carefully and never change the dose yourself. Under 3 months (on doctors advice only): A 2.Sml dose for babies who develop a fever following vaccination at 2 months (1 Omg/kg) Children 3 months to under 1 year:

Half to one Sml spoonful (60-120mg)

Children 1 to under 6 y'ears:

One or two Sml spoonfuls (120-240mg)

Children over 6 y'ears: Three or four Sml spoonfuls (360-480mg) DO NOT GIVE MORE THAN 4 DOSES IN 24 HOURS. PRECAUTIONS • If your baby was born prematurely doctor before using this medicine. • Continual child .

use of this medicine

and is less than 3 months old, please talk to a

without

• Do not give with any other paracetamol • Do not exceed the stated dose.

a doctors supervision containing

may be harmful to your

products.

AFTER YOU HAVE USED MEDINOL PAEDIATRICPARACETAMOL ORAL SUSPENSION 120MG/5ML If your child is still suffering pain or fever after 3 days, please talk to a doctor. SIDE EFFECTS Some side effects have been reported with use of Medinol Paediatric Paracetamol Oral Suspension 120mg/Sml. Reactions with blood, skin rashes and other allergic reactions have been reported. If the correct dose is given, side effects are very rare as most are due to overdosage of Paracetamol. OVERDOSE In cases of accidental or deliberate overdose, contact a doctor or the nearest accident and emergency (casualty) department immediately, even if the child seems well. Take along any medicine that is left and the pack so that the hospital staff can easily tell what medicine has been taken. HOW TO STORE MEDINOL PAEDIATRICPARACETAMOL ORAL SUSPENSION 120MG/5ML • Keep the pack protected

from extremes

of temperature

(below

saC or higher than

25°C). • Do not use this medicine after the expiry date shown on the pack. • Keep Medinol Paediatric reach of children.

Paracetamol

Oral

Suspension

120mg/5ml

well out of the

Date of leaflet revision: May 2005.

S S L International ~ ~

.......J pic

~ Trafford Park, Manchester, M41 7HA. U.K.

Medinol is a Trade Mark of the SSL group

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