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PARACETAMOL 1000MG SOLUBLETABLETS

Active substance(s): PARACETAMOL

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Transcript
PATIENT INFORMATION LEAFLET
Parasolve
The name of this medicine is Parasolve, which will be referred to as Paracetamol Soluble
throughout this leaflet.
Read all of this leaflet carefully because it contains important information for you.
• 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 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 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

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.

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)
• if you are already taking other medicines containing paracetamol
• if you are under 12 years of age.
Take special care with Paracetamol Soluble
Ask your doctor before you take this medicine if you:
• have severe liver or kidney disease
• have an alchohol dependency
• are on a low sodium diet.
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
paracetamol.
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 on:
• metoclopramide or domperidone (for sickness or stomach problems)
• colestyramine (used to treat high cholesterol)
• blood thinning medicines (anticoagulants) such as warfarin.
It may still be alright for you to take Paracetamol Soluble and your doctor will be able to
decide what is suitable for you.
Taking your medicine with food and drink
Paracetamol Soluble 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 breastfeeding. Ask your doctor or pharmacist for advice before taking any medicines.
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 586.11 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
Do not exceed the recommended doses. If symptoms persist consult your doctor.
Dosage
The usual doses for Paracetamol Soluble are as follows:
Adults and children over 12 years:
Take 1 tablet 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.
If you take more Paracetamol Soluble than you should:
If you have accidentally taken more than the recommended dose, contact your nearest
hospital casualty department or tell your doctor or pharmacist immediately. Remember to
take the pack and any remaining tablets with you.
Immediate medical advice should be sought in the event of an overdose, even if you feel
well, because of the risk of delayed, serious liver damage. An overdose of paracetamol
can cause serious liver damage, which may not show any signs for a day or two, by which
time your treatment may not be successful.

6. FURTHER INFORMATION
What Paracetamol Soluble 1000mg Tablets contain:
The active ingredient is paracetamol. Each tablet contains 1000mg paracetamol.
The other ingredients are anhydrous citric acid (E330), povidone, sodium bicarbonate
(E500), sodium saccharin, anhydrous sodium carbonate, simeticone (E900), polysorbate
80 (E433) and aspartame (E951).
What Paracetamol Soluble 1000mg Tablets look like and the contents of the pack:
Paracetamol Soluble 1000mg Tablets are white, circular, flat bevelled effervescent tablets,
which are plain on both sides.
Your medicine is available in blister packs of 8, 12, and 16 tablets (not all pack sizes may
be marketed).

If you have any further questions about this product ask your doctor or pharmacist.

Marketing Authorisation Holder:

4. POSSIBLE SIDE-EFFECTS

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Welllingborough,
Northamptonshire, NN8 6GT UK

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:
• Skin rashes
• 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.
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.
5. HOW TO STORE PARACETAMOL SOLUBLE
Do not store your tablets above 25°C. Store in the original package and protect from
moisture.
Do not take this medicine after the expiry date stated on the carton (EXP). The expiry date
refers to the last day of that month.
Keep all medicines out of the reach and sight 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.

Manufacturer responsible for batch release:
Fannin (UK) Limited, 57 High Street, Odiham, Hants, RG29 1LF, UK.
This information is available in alternative formats upon request.
This leaflet was last approved in: November 2011

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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 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.

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