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Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension

Active Ingredient:
paracetamol
Company:  
THE BOOTS COMPANY PLC See contact details
About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
{info_black}
Last updated on emc: 09 Oct 2019

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 16028/0118.

Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension

Information for the user

Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to give it 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 contact a pharmacist or doctor if your child’s symptoms worsen or do not improve after 3 days
  • The leaflet is written in terms of giving this medicine to your child, but if you are an adult who is intending to take this medicine yourself the information in this leaflet will apply to you as well
What this medicine is for

This medicine contains Paracetamol which belongs to a group of medicines called analgesics and antipyretics, which act to relieve pain and reduce fever.

It can be used to relieve mild to moderate pain including toothache, teething pain, headache and other pains. It can also be used to relieve the symptoms of colds and flu and to reduce fever, including fever after vaccination at 2 months of age.

Before you give this medicine

This medicine can be given to children from the age of 2 months and over. However, some children should not be given this medicine or you should seek the advice of their pharmacist or doctor first.

Do not give:
  • If your child is under 2 months
  • If your child is allergic to any of the ingredients (see “What is in this medicine”)
  • If your child has an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol and sorbitol)
Talk to your pharmacist or doctor:
  • If your child has liver or kidney problems
  • If your child takes any other medicines (see “If your child takes other medicines”)
Other important information

Information about some of the ingredients in this medicine: Maltitol and sorbitol may have a mild laxative effect. This medicine contains 3.3 g of a hydrogenated glucose syrup (containing maltitol and sorbitol) per 5 ml spoonful. This provides 8 kcal per 5 ml spoonful.

Sodium propylparaben (E217) and sodium methylparaben (E219) may cause allergic reactions (possibly delayed).

Information for adults intending to take this medicine

This medicine may be harmful if you are dependant on alcohol or have alcoholic liver disease. Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.

Pregnancy and breastfeeding

Pregnancy: if necessary, this medicine can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.

Breast-feeding: Do not take this medicine, unless your pharmacist or doctor tells you to.

If your child takes other medicines

Do not give anything else containing paracetamol while giving this medicine.

Before you give this medicine, make sure that you tell your pharmacist about ANY other medicines you might be giving your child at the same time, particularly the following:

  • Domperidone or metoclopramide (for feeling sick or being sick)
  • Colestyramine (to reduce blood fat levels)
  • Medicines to thin the blood (e.g. warfarin)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for your child, including herbal and homeopathic remedies.

How to give this medicine

Check the sachet is not broken before use. If it is, do not give that sachet.

Check the tables on the back of the leaflet to see how much of the medicine to give to your child. Never give more medicine than shown in the table.

It is important to massage the sachet for at least 10 seconds before use in order to mix the contents.

Always use the spoon supplied with the pack to measure the correct amount of medicine from the sachet.

The spoon can be used to measure 2.5 ml (the small end) or 5 ml (the large end). Do not overfill the spoon.

Give this medicine to your child to swallow. (For oral use only).

If you only give 2.5 ml from a sachet dispose of the remaining medicine in the sachet safely, out of the sight and reach of children.

Children aged 3 months – 12 years

Age 3 months up to 6 months take 2.5 ml up to 4 times in any 24 hours. Leave at least 4 hours between doses

Age 6 months up to 2 years take 5 ml up to 4 times in any 24 hours. Leave at least 4 hours between doses

Age 2 years up to 4 years take 7.5 ml (5 ml + 2.5 ml) up to 4 times in any 24 hours. Leave at least 4 hours between doses

Age 4 up to 8 years take 10 ml (5 ml + 5 ml) up to 4 times in any 24 hours. Leave at least 4 hours between doses

Age 8 years up to 10 years take 15 ml (5 ml + 5 ml + 5 ml) up to 4 times in any 24 hours. Leave at least 4 hours between doses

Age 10 years up to 12 years take 20 ml (5 ml + 5 ml + 5 ml + 5 ml) up to 4 times in any 24 hours. Leave at least 4 hours between doses

Don’t give more than 4 times in any 24 hours

Do not give more medicine than the label tells you to. If your child does not get better, talk to your doctor.

Do not give this medicine to your child for more than 3 days, unless your doctor or pharmacist tells you to.

If symptoms do not go away talk to your doctor.

Other uses

For the relief of fever after vaccination at 2, 3 and 4 months

2.5 ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.

Possible side effects

Most people will not have problems, but some may get some.

If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:
  • Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
  • Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.
If your child gets any of the following side effects, see your pharmacist or doctor:
  • Other allergic reactions (e.g. skin rash)
  • Unusual bruising, or infections such as sore throats. This may be a sign of very rare changes in the blood
Reporting of side effects

If you or your child get any side effects, talk to your doctor, pharmacist or nurse. 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. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C. Store in the original package, in order to protect from light.

Do not refrigerate.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or printed on the sachet. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each 5 ml of oral suspension contains Paracetamol 120 mg, which is the active ingredient.

As well as the active ingredient, the suspension also contains hydrogenated glucose syrup (contains maltitol (E965) and sorbitol (E420)), glycerol (E422), microcrystalline cellulose, carmellose sodium, xanthan gum, sodium methylparaben (E219), acesulfame potassium, citric acid anhydrous, purified water, saccharin sodium, sodium propylparaben (E217), strawberry flavour, colour (containing carmine (E120)).

The pack contains 10 sachets of a pink strawberry-flavoured syrupy suspension.

Who makes this medicine

Manufactured by

Galpharm International Ltd
Elmhirst Park
Middle Field Road
Barnsley
South Yorkshire
S75 4LS
UK

Marketing Authorisation held by

Galpharm Healthcare Ltd
Wrafton
Braunton
Devon
EX33 2DL
UK

Text revised: August 2019

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension

Reference number: 16028/0118

This is a service provided by the Royal National Institute of Blind People.

Artwork Reference BTC198356D

THE BOOTS COMPANY PLC
Company image
Address
1 Thane Road West, Beeston, Nottingham, NG2 3AA
Telephone
+44 (0)1159 595 165
Fax
+44 (0)1159 592 565