The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
PARACETAMOL SOLUBLE TABLETS 500MG
PARACETAMOL SOLUBLE TABLETS 500mg
Take special care with Paracetamol Soluble if:
The name of this medicine is Paracetamol Soluble Tablets 500mg, which will be
referred to as Paracetamol Soluble throughout this leaflet.
Read all of this leaflet carefully because it contains important information for
• This medicine is available without prescription. However, you still need to use
Paracetamol Soluble 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 doctor if your symptoms worsen or do not improve after three
• 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.
Taking a painkiller for headaches too often or for too long can make them worse.
Taking other medicines
Do not take these tablets if you are already taking other medicines containing
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Certain medicines can interfere with the effectiveness of each other. It is particularly
important to tell your doctor or pharmacist before taking this medicine if you are also
• metoclopramide or domperidone (often taken for sickness or stomach problems)
• colestyramine (used to treat high cholesterol)
• blood thinning medicines (anticoagulants) such as warfarin
In this leaflet:
1. What Paracetamol Soluble is and what it is used for
2. Before you take Paracetamol Soluble
3. How to take Paracetamol Soluble
4. Possible side effects
5. How to store Paracetamol Soluble
6. Further information
• chloramphenical an antibiotic to treat eye infections
It may still be all right for you to take Paracetamol Soluble and your doctor will be able
to decide what is suitable for you.
1. WHAT PARACETAMOL SOLUBLE IS AND WHAT IT IS USED FOR
The active ingredient in Paracetamol Soluble is paracetamol.
Paracetamol Soluble is used to relieve pain, including muscular and rheumatic pains,
headache, migraine, neuralgia (severe burning or stabbing pain following the line of a
nerve), toothache, sore throat, period pains, aches and pains, discomfort associated
with influenza (flu), feverishness and feverish colds.
Customer: Fannin PL 20417/0065
Change: Safety Variation RFI
Colour: Pantone Black C
Size: 297 x 210mm Proof: 2
Date: 17 Sep 14
• you have kidney or liver problems, including alcoholic liver disease
2. BEFORE YOU TAKE PARACETAMOL SOLUBLE
Do not take Paracetamol Soluble if you:
• are allergic (hypersensitive) to paracetamol or any of the other ingredients in
the tablets (these are listed in Section 6, Further Information)
• are already taking other medicines containing paracetamol
• are on a low sodium diet
Taking your medicine with food and drink
Paracetamol should be dissolved in at least half a glass of water and can be taken
with or without a meal.
Pregnancy and breast-feeding
Although there is no evidence that these tablets cause any ill effects, your doctor
should advise you about taking them if you are pregnant, likely to become pregnant
or are breast-feeding. Ask your doctor or pharmacist for advice before taking any
Driving and using machinery
The effect of paracetamol on the ability to drive and operate machinery is not known.
If you feel dizzy or drowsy do not drive or operate machinery.
Important information about some of the ingredients of Paracetamol Soluble
Each of these tablets contains about 438 mg of sodium and may interfere if you are
on a low sodium diet.
This product also contains aspartame (a source of phenylalanine), which should not
be given to anyone with phenylketonuria.
3. HOW TO TAKE PARACETAMOL SOLUBLE
5. HOW TO STORE PARACETAMOL SOLUBLE
Do not exceed the recommended doses. If painful symptoms are not relieved in a
few days, consult your doctor.
The usual doses for Paracetamol Soluble are as follows:
Adults and children over 12 years:
Take 1 or 2 tablets up to 4 times a day, or as instructed by your doctor.
The dose should not be repeated more frequently than every 4 hours, and not more
than 4 doses should be taken in any 24-hour period. Do not continue to take these
tablets for more than 3 days unless instructed by your doctor.
Not recommended for children under 12 years of age.
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass
of water before taking them. These tablets are meant to be dissolved first so don’t try
to swallow them whole. Stir before use.
Do not store your tablets above 25°C. Store in the original package and protect from
If you have any further questions about this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Soluble can cause side effects although not
everybody gets them. If you get any of the following symptoms after taking these
tablets, you should contact your doctor immediately:
• any sudden wheeziness, difficulty in breathing or dizziness, swelling of the
eyelids, face, lips or throat
• an acute allergic reaction (anaphylaxis) or swelling of the skin
The following side effects have also been reported:
• Very rare cases of serious skin reactions have been reported.
• Very rare reports of blood problems, so if you notice unusual bleeding, you bruise
more easily than normal, or you seem to be more susceptible to infections than
usual, tell your doctor as soon as possible.
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be
signs of liver problems so tell your doctor if this happens to you) blood tests may
show abnormal liver function.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via United
Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Keep all medicines out of the sight and reach of children.
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 Soluble Tablets 500 mg contain:
The active ingredient is paracetamol. Each tablet contains 500 mg paracetamol.
The other ingredients are anhydrous citric acid (E330), povidone, sodium hydrogen
carbonate (E500), saccharin sodium, anhydrous sodium carbonate, simeticone
(E900), polysorbate 80 (E433), aspartame (E951) (a source of phenylalanine).
Each tablet contains 438 mg of sodium.
What Paracetamol Soluble Tablets 500 mg look like and the contents of the
Paracetamol Soluble Tablets 500 mg are white, circular effervescent tablets.
Your medicine is available in blister packs of 24, 32, 60 and 100 tablets (not all pack
sizes may be marketed).
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive,
Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
This leaflet was last approved in September 2014.
If you take more Paracetamol Soluble than you should:
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Remember to take the pack and any remaining tablets with you.
Do not take this medicine after the expiry date stated on the carton. The expiry date
refers to the last day of that month.
Product Name : Paracetamol PIL (P)
Cordinator : Kanchan
Item Code : 209 GH
Artist : Atul
Item : PIL
Date : 21-05-13 (16-12-13)
Software : Illustrator CS5
Fonts : Convert to curve
BLUE WOOL TEST VALUE 5-8
(LIGHT FASTENING DATA)
Pantone Black C
INK: Oil based Ink from DIC OR MICRO
Spectro-Densitometer Delta-E reading
( E) for colour: NOT MORE THAN dE2.5
(for white surface): NOT LESS THAN 80 %
Supersedes / Reference: 209GG
Unwinding Direction :
Side / Collar flap overlap:
2D code: 209GH
Design : Folded
Material : 54 GSM Maplitho Paper.
Actual Size : 297 x 210mm
Size after Folding : 37 x 210mm
Print repeat length :
Artwork Print Size:
Grain Direction : Parallel to length
Reference / Instructions / Remark / Braille Text Embossing:
Path : F:atul/Pawan/Fannin/Paracetamol Fannin COA PIL/209 GH Paracetamol PIL Fannin COA (P) (Add change) (AXP065FUB) New.ai
File Copied by:
NOTE TO THE PRINTER :
Return approved artwork alongwith the proof.
The proof must be verified against the approved hardcopy, should be certified and signed by an
authorised QA person. The unsigned proof will not be accepted.
Colour scheme must be as approved by packaging development co-ordinator.
Any deviation must be brought to the notice of packaging development co-ordinator immediately.
For any clarification, please contact packaging development co-ordinator immediately.
file loaded in BCT HO
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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.