Paracetamol 250mg/5ml Oral Suspension

Document: leaflet MAH GENERIC_PL 00427-0078 change

Rnsemont'

Patient Information Leaflet

Tell your doctor if you get any of these side effects:

■ 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.

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.

Paracetamol 250mg/5ml Oral Suspension

5. How to store Paracetamol Oral Suspension

■ Keep out of the reach and sight of children.

■ Do not store above 25°C. Protect from light. Store in the original package.

■ Do not use after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.

■ If it is out of date or you no longer want it, take it back to the pharmacy.

■ Do not use Paracetamol Suspension if you notice anything wrong with the medicine. Talk to your pharmacist.

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

■ Keep this leaflet. You may need to read it again

■ Ask your pharmacist if you need more information or advice

■ You must contact a doctor if your symptoms worsen or do not improve

■ If any of these 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 take Paracetamol Oral Suspension

3. How to take Paracetamol Oral Suspension

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

What Paracetamol Suspension contains The active substance is paracetamol.

The other ingredients are methyl and propyl parahydroxybenzoate (E218 and E216), propylene glycol (E1520), xanthan gum (E415), liquid sorbitol (E420), sucrose, mango flavour, pineapple flavour (containing tartrazine (E102) and carmoisine (E122)), sweetness enhancer, sodium citrate and purified water.

What Paracetamol Suspension looks like and contents of the pack

Paracetamol Suspension is a white to off-white liquid which smells of mango and pineapple.

It comes in a brown glass bottle holding 100ml or 500ml of suspension. A 2.5ml/5ml double ended spoon is provided to measure the dose.

The Marketing Authorisation Holder and Manufacturer is:

Rosemont Pharmaceuticals Ltd,

Yorkdale Industrial Park,

Braithwaite Street,

Leeds, LS11 9XE, UK.

Tel: + 44 (0) 113 244 1400

Paracetamol belongs to a group of medicines called pain-killers or analgesics.

■ It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains.

■ It is also used to relieve the symptoms of cold and flu

■ It is also used to help reduce a fever (high temperature).

2. Before you take Paracetamol Oral Suspension

Do not take this medicine if you have:

■ had an allergic reaction to paracetamol or any of the ingredients listed in section 6. An allergic reaction can include a rash, itching or shortness of breath.

■ a liver disorder

Speak to your doctor or pharmacist if any of these apply to you.

Take special care with this medicine if you have:

■ kidney problems

■ liver problems, including those due to drinking too much alcohol.

You may be more at risk of the side effects of paracetamol.

Speak to your doctor or pharmacist if any of these apply to you.

Continued overleaf

This leaflet was last approved in December 2014

P0764

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Third Party Approval Required YES O NO | |

Tick

applicable

box

Product:	Paracetamol 250mg/5ml Oral Suspension			Date:	15.12.14	Name:
Strength:	250mg/5ml			Proof Number:	ONE	Signature: Date: / /
New Item Code:	P0764			Page:	1 of: 2
Previous Item Code:	P0574			New Pharmacode: 244		Regulatory Sign-off
Design Icon:
	-	Sugar-Free	NO			Name:
Cutter Ref:	-	Pack Size	100ml & 500ml	Barcode:
Dimensions:	210 x 300mm (f	olded 150 x 30	mm)			Signature: Date: / /
Number of colours used:	ONE Black \| Keyline

Artwork produced by:

Ptarmigari*

pronounced design

Tel: 0113 261 3172 info@ptarmigan-design.co.uk

Pregnancy and Breast-feeding:

If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.

Driving and using machines:

This medicine should not affect your ability to drive or use machines.

Important information about some of the ingredients of Paracetamol Suspension

This medicine contains:

■ Tartrazine and carmoisine - these may cause allergic reactions.

■ Methyl and propyl parahydroxybenzoates - some people are allergic to these (the allergy may happen some time after starting the medicine).

■ Sucrose (2.5g per 5ml spoonful). This should be taken into account if you have diabetes.

■ Sorbitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.

Taking other medicines:

You must not take any other medicines that contain paracetamol while you are taking this medicine.

Tell your doctor if you are taking any of these medicines:

■ barbiturates (sleeping tablets)

■ tricyclic antidepressants (such as amitriptyline)

■ colestyramine (used to treat high cholesterol)

■ warfarin (used to thin the blood and prevent clotting)

■ zidovudine (used in HIV infections and AIDS)

■ domperidone and metoclopramide (used to treat nausea and vomiting)

■ anticonvulsants (medicines used to treat epilepsy or fits)

■ oral contraceptives "the pill".

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

How much to take

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
12 - 16 years	Two to three 5 mL spoonfuls (large end)	4 times
Adults and children over 16 years	Two to four 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.

Do not exceed the stated dose. You must see a doctor if your symptoms worsen or do not

improve after 3 days.

If you take more paracetamol than you should (overdose):

■ Immediate medical advice should be sought in the event of an overdose, even if you or your child seem well, because of the risk of delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.

■ There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.

If you forget to take this medicine:

Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.

3. How to take Paracetamol Oral Suspension

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.

Taking this medicine

Check the table below to see how much medicine to use

■ This medicine contains 250mg of paracetamol in one 5ml spoonful.

■ Take this medicine by mouth only.

■ Never give more medicine than shown in the table.

■ It is important to shake the bottle for at least 10 seconds before use.

■ Always use the spoon supplied with the pack. Do not overfill the spoon.

■ Do not give this medicine with any other paracetamol-containing product.

4. Possible side effects

P0764

Like all medicines, paracetamol can cause side effects, although not everybody gets them. The side effects below may sometimes happen.

If you have an allergic reaction to this medicine see a doctor straight away.

An allergic reaction may include:

■ skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever.

■ sudden wheezing, fluttering or tightness of the chest or collapse.

If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:

■ bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder)

■ severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation)

■ very rare cases of serious skin reactions have been reported. Continued overleaf