SIX PLUS PARAPAED PARACETAMOL SUSPENSION 250MG/5ML

Active substance: PARACETAMOL

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PATIENT INFORMATION LEAFLET ASDA 6+ PARACETAMOL ORAL SUSPENSION 250 mg/5 ml 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 Asda 6+ Paracetamol Oral Suspension 250 mg/5 ml 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 childs 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 Suspension is and what it is used for 2. Before you give Paracetamol Suspension to your child 3. How to give Paracetamol Suspension to your child 4. Possible side effects 5. How to store Paracetamol Suspension 6. Further information 1. WHAT PARACETAMOL SUSPENSION IS AND WHAT IT IS USED FOR

Your medicine is called Asda 6+ Paracetamol Oral Suspension 250 mg/5 ml. It will be referred to throughout this leaflet as Paracetamol Suspension. Paracetamol Suspension contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Suspension can be used in children aged 6 years and older 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 SUSPENSION TO YOUR CHILD

DO NOT give Paracetamol Suspension if your child is taking any other paracetamol containing products, other flu, cold, cough or decongestant products, or alcohol. DO NOT give Paracetamol Suspension to your child if he/she: is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol 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 with Paracetamol Suspension If the symptoms persist consult your doctor or pharmacist. Taking other medicines Tell your doctor or pharmacist if your child is taking, or has recently taken, any other medicine, even those obtained without a prescription, but especially medicines which: are to treat flu or a cold, containing paracetamol and/or a decongestant thin the blood (e.g. warfarin) control nausea and vomiting (e.g. domperidone or metoclopramide) reduce levels of cholesterol and other fats in the blood (e.g. colestyramine) treat epilepsy (e.g. anti-convulsants) have been prescribed by your doctor to improve sleep (e.g. barbiturates), or for anxiety or depression (e.g. tricyclic antidepressants) are used to prevent pregnancy (e.g. oral steroidal contraceptives) The effects of alcohol may be increased whilst taking Paracetamol Suspension. Avoid alcohol when taking this medicine. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breast-feeding. Driving and using machines Paracetamol Suspension is not expected to affect your ability to drive or operate machinery. Important information about some of the ingredients of Paracetamol Suspension Paracetamol Suspension contains: Ethanol: This medicinal product contains up to 0.15 g per 5 ml dose of ethanol (alcohol), equivalent to 3.6 ml beer or 1.5 ml wine per 5 ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy. Hydrogenated glucose syrup (E965): if you or your child have an intolerance to some sugars, contact your doctor before giving this medicine. Sunset yellow (E110): may cause allergic reactions. 23LF01037PW

3.

HOW TO GIVE PARACETAMOL SUSPENSION TO YOUR CHILD

Check the table below to see how much of the medicine to use For oral use only It is important to shake the bottle for at least 10 seconds before use 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 this medicine with any other paracetamol-containing product Childs Age 6 - 8 years 8 - 10 years How Much How often (in 24 hours) One 5 ml spoonful (large end) 4 times One 5 ml spoonful (large end) and 4 times one 2.5 ml spoonful (small end) 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 If symptoms persist, please consult your doctor 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. If your child takes more of this medicine than they should: 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. If you forget to give this medicine: If you miss a dose give it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the missed dose. 4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Suspension can cause side effects although not everybody gets them. You or your child may notice the following: rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing, which may be signs of an allergic reaction. STOP giving Paracetamol Suspension to your child immediately. blood disorders If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE PARACETAMOL SUSPENSION

Keep all medicines out of reach and sight of children. Do not store above 25C. Store in the original container. Keep the container in the outer carton. Do not use this medicine after the expiry date which is stated on the label and/or carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION

What Paracetamol Suspension contains Each 5 ml of Paracetamol Suspension contains: The active ingredient: paracetamol 250 mg. The other ingredients are: ethanol, sorbitan monooleate, glycerol (E422), magnesium aluminium silicate, hydrogenated glucose syrup (E965), saccharin sodium (E954), xanthan gum, sunset yellow (E110), orange flavour, sodium benzoate (E211), citric acid monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information). What Paracetamol Suspension looks like and contents of the pack: Paracetamol Suspension is an orange to orange/brown suspension with orange odour and taste presented in 70 ml, 100 ml, 150 ml and 200 ml amber glass bottles with pilfer-proof screw caps. A 2.5 ml/5 ml measuring spoon is provided. Marketing Authorisation Holder and Manufacturer: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland. Product Licence Number: PL 04917/0010 Date of revision: February 2012 23LF01037PW

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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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