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Effervescent Paracetamol And Caffeine Granules

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Common Technical Document

Module 1 - Administrative and Prescribing Information

Module 1.3 - Product Information

Resolve Extra

Text to appear on the sachet label

RESOLVE EXTRA

Extra strong relief from headache & upset stomach Contains Paracetamol

Directions: Dissolve the contents of the sachet in a glass of water (150-200 ml).

Dosage: Adults aged 18 years and over: One sachet up to four times daily allowing at least 4 hours between each dose. Do not take more than 4 sachets in any 24 hours.

Not to be given to children under 18 years of age. If symptoms persist, consult your doctor.

DO NOT EXCEED THE STATED DOSE

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

INGREDIENTS: Each 7.9 g sachet of effervescent granules contains: Paracetamol 1000 mg, Sodium Bicarbonate 1408mg, Caffeine 60mg.

Also contains: Citric Acid, Sodium Carbonate, Sodium Lauryl Sulphate, Polyvinylpyrrolidone K25, Saccharin sodium, Dextrose, Lemon Durarome, Purified water. Each sachet contains 454mg of sodium. This may be harmful if you’re on a low sodium diet. Each sachet also contains 4g of dextrose.

If before first use you find the foil sachet is damaged, do not use and return the pack to the address below.

Do not use after the use by date embossed on the edge of the sachet.

CONTAINS PARACETAMOL - DO NOT TAKE WITH ANY OTHER PARACETAMOL -CONTAINING PRODUCTS

KEEP ALL MEDICINES SAFELY AWAY FROM CHILDREN

PL 01074/0247 PL Holder: G R Lane Health Products Ltd. Sisson Road, Gloucester, GL2 0GR, UK.

Resolve and Resolve Extra is a Trade Marks of the SSL group.

Text to appear on the carton Resolve Extra

paracetamol, caffeine, sodium bicarbonate

For relief from over-indulgence in food or drink.

Extra strong Relief from headache & upset stomach Contains Paracetamol

Lemon flavoured 10 sachets (or 5 sachets)

What is Resolve Extra

Resolve Extra contains paracetamol and caffeine, a well established analgesic (pain killer) combination with sodium bicarbonate (an antacid) to help gently settle an upset stomach. The caffeine also acts as a stimulant to relieve tiredness. Resolve Extra offers extra strength pain relief and is particularly effective when you’ve had too much to eat or drink.

Before taking Do not take...

•    If you are allergic to any of the ingredients.

See ‘What Resolve Extra contains’,

DO NOT TAKE WITH ANY OTHER PARACETAMOL CONTAINING PRODUCTS Speak to your doctor or pharmacist...

•    If you are pregnant or breast feeding.

•    If you are taking metoclopramide or domperidone (to treat nausea or vomiting), cholestyramine (to treat high cholesterol) or any other drugs to think the blood e.g.warfarin.

•    If you have kidney or liver problems, including alcoholic liver disease.

•    If you are on a sodium restricted diet. Each sachet contains 454mg sodium.

•    If you suffer from diabetes. Each sachet contains 4g of dextrose (glucose).

•    Avoid drinking too much tea and coffee whilst taking this product.

How to take

Dissolve the contents of the sachet in a glass of water Adults aged 18 years and over:

•    1 sachet every 4 hours daily allowing at least 4 hours between each dose.

•    Do not exceed 4 sachets in any 24 hours.

•    Do not exceed the stated dose.

•    If symptoms persist consult your doctor

Not recommended for children under 18 years of age.

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.

Possible side effects

As with all medicines, these granules can cause side effects in some people.

•    Side effects of paracetmol are rare but allergic reactions, including skin rash, may occur.

•    There have been rare reports of blood disorders

If you feel you are reacting badly to this medicine in any way stop taking and tell your doctor or pharmacist.

How to store

•    Keep out of the reach and sight of children

•    Do not use after the expiry shown the pack

What Resolve Extra contains

Each sachet of effervescent granules contains 1000mg of paracetamol, 1408mg of sodium bicarbonate and 60mg caffeine.

Also contains citric acid, sodium carbonate, sodium lauryl sulphate, polyvinylpyrrolidone K25, saccharin sodium, dextrose and lemon durarome and purified water.

PL 01074/0247

MA Holder

G R Lane Health Products Ltd. Sisson Road, Gloucester, GL2 0GR, UK.

Manufactured by SSL Intsrnational plc Whitehouse Industrial Park, Traynor Way, Peterlee, Co. Durham, SRB 2RU

Resolve and Resolve Extra are trademarks of the SSL group Date of revision: August 2010

January 2015 - LB