DESIGN

STUDY

DESIGN STUDY LIMITED 45 DOWNS COURT ROAD PURLEY SURREY CR8 1BF

TELEPHONE: 020 8763 2582 FAX: 020 8668 7432 ISDN: 020 8763 2748

Checked by RUSCO:

DATE APPROVED BY RUSCO:

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DATE LOADED: NOTES:

Please note: This is an Epson proof and colours may differ slightly from the final printed label/carton.

INGREDIENTS: Each 5ml of oral solution contains: Active Ingredient 120mg Paracetamol. Inactive Ingredients: Ethanol (8.4% w/v), Propylene Glycol, Potassium Sorbate (E202) Sorbitol (E420), Glycerol (E422), Saccharin Sodium, Raspberry flavour, Citric Acid Hydrated (E330) Ariavit Amaranth (E123) & Water.

WARNINGS: Do not give to your child if they are hypersensitive to Paracetamol or any of the other ingredients (check the list above). Please consult your doctor before taking this medicine if you are suffering from kidney or liver disorders or if you are pregnant or planning to become pregnant or breast-feeding. This medicinal product contains 8.4% vol of Ethanol (alcohol), i.e. up to 421mg per dose, equivalent to 8.4ml beer, 3.5ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. This product contains 1.72g of Sorbitol. When taken according to dosage recommendation each dose supplies up to 6.9g of Sorbitol. If your child has an intolerance to some sugars, contact your doctor before giving this medicinal product. May have a mild laxative effect. Calorific value 2.6 Kcal/g Sorbital. This product contains Amaranth, which may cause allergic reactions. This product contains Propylene Glycol, which may cause alcohol-like symptoms. It also contains Glycerol which may cause headache, stomach upset and diarrhoea. INTERACTIONS: Paracetamol may interact with metodopramide, domperidone, colestyramine, warfarin or other blood thinning medicines, antiepileptic drugs, rifampicin or alcohol.

SIDE EFFECTS: Side effects are rare but blood disorders, skin rashes, hives, serious allergic reaction which causes difficulty in breathing or dizziness and other allergic reactions may occasionally occur. If you notice any of these or any other sidejffect please contact your doctor or pharmacist immediately. Do not use after the expiry date shown. Ws AoU Date of preparation: 06ffift£R-20tJ7 MA Holder: LPG^tedkat^UKf-Ud, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, UK.

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Paracetamol i20mg/5ml Elixir

For oral administation. for the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, teething pains, sore throats & aches. Relieves the symptoms of influenza, feverishness and feverish colds.

HOW MUCH TO GIVE

00 NOT EXCEED THE STATED DOSE. NOT SUITABLE FOR DIABETICS.

AGE    DOSAGE

CHILDREN 6 TO 12 YEARS Two to four 5ml teaspoons every four hours. CHILDREN 1 TO 6 YEARS One to two 5ml teaspoons every four hours. CHILDREN 3 TO 12 MONTHS Half to one 5ml teaspoon every four hours. CHILDREN UNDER 3 MONTHS Not to be given except on medical advice.

PAGE

NUMBER:

For Paediatric Use ■ Sugar Fttee

200 ml 0 0

DO HOI STORE ABOVE 25^CC. KEEP THE BOTTLE TIGHTLY CLOSED, STORE IN THE ORIGINAL CONTAINER, KEEP OUT OF THE REACH AND SIGHT Of CHILDREN

EXP:

IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR "CONTAINS PARACETAMOL ■ Do not give with any other Paracetamol-containing products.

IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHTIN THE EVENT OF AN OVERDOSE, EVEN IF THE CHILD SEEMS WELL, BECAUSE Of THE RISK OF DELAYED, SERIOUS LIVER DAMAGE.

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3. HOW TO GIVE PARACETAMOL ELIXIR

Always give Paracetamol Elixir exactly as the doctor has told you. For oral use only,

Children:

6-12 years: two to four 5ml spoonfuls every 4 hours 1 - 6 years: one to two 5ml spoonfuls every 4 hours 3-12 months: half to one 5ml spoonful every 4 hours Under 3 months: not to be given, except on medical advice.

The dose should not be repeated more frequently than 4 hourly intervals. If symptoms persist, speak to the doctor.

If you give more Paracetamol Elixir than you should

It is extremely important to follow the dosage instructions that have been given. Do not change the dose without discussing it with the doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If your child accidentally takes more than the recommended dose, contact their doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.

4. POSSIBLE SIDE EFFECTS

5. HOWTO STORE PARACETAMOL ELIXIR

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IMMEDIATE MEDICAL ADVICE SHOULD BESOUGHT IN THE EVENT OF AN OVERDOSE, EVEN IF YOUR CHILD FEELS WELL, BECAUSE OF THE RISK OF DELAYED, SERIOUS LIVER DAMAGE

WARNING: DO NOT EXCEED THE STATED DOSE Contains paracetamol. Do not give with other paracetamol containing products.

If you forget to give Paracetamol Elixir

If your child misses a dose, give it as soon as you remember. NEVER give a double dose to make up for the dose that has been forgotten. Ifyou have any further questions on the use -Ofthispnoduct_r_aslcthedoctOLor-pharmacist._

Like all medicines, Paracetamol Elixir can cause side effects, although not everybody gets them.

Your child may suffer an allergic reaction, symptoms of which include skin rashes and itching. If this happens, stop giving the medicine immediately and seek urgent medical help.

The following have also been reported:

♦    blood abnormalities, but these were not necessarily due to the Paracetamol treatment

•    kidney disorders.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the doctor.

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original container and keep the bottle tightly dosed. _

Do not use Paracetamol Bixir after the expiry date shown. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer requ'red. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Paracetamol Elixir contains

The active substance is Paracetamol, 120mg per 5ml of Elixir. | The other ingredients are Alcohol 96% (Ethanol 8.4% w/v), Propylene Glycol, Potassium Sorbate(E202), Sorbitol (E420), Glycerol (E422), Saccharin Sodium, Raspberry Flavour (IFF 17.40.0478), Citric Add Hydrated (E330), Amaranth Ariavit 311801 (E123), Purified Water (see also 1

end of Section 2 on 'Important information about some of the ingredients of Paracetamol Bixir').

What Paracetamol Elixir looks like and contents of the pack

This medidne is a clear red oral solution with raspberry flavouring. It is supplied in an amber glass bottle in packs of 60ml, 100ml and 200ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

i, 30 Chaul End Lane, Luton,

Bedfordshire, LU48EZ, UK. M 01582 560393 Fax: 01582 569009 e-mail: iRfeetpephamaiOom* Manufacturer:

SidefantBrftada Guin6,26 • 2689-514_ »    1.

Prior Vslho - Portigak^^    '

JTO Date of last revision: April 2098—

Please read the Package Leaflefbefore use on the reverse of this labeC

DO NOT EXCEED THE STATED DOSE.

AGE    DOSAGE

CHILDREN 6 TO 12 YEARS Two to four 5ml spoonfuls eveiy four hourc. j CHILDREN 1 TO 6 YEARS One to two 5ml spoonfuls every four hours, j CHILDREN 3 TO 12 MONTHS Half to one 5ml spoonful every four hours. | CHILDREN UNDER 3 MONTHS Not to be given except on medical advice, j |IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR)

CONTAINS PARACETAMOL - Do not give with any other Paracetamol-containing products.

IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHT IN THE EVENT OF AN OVERDOSE, EVEN IF THE CHILD SEEMS WELL,

I BECAUSE OF THE RISK OF DELAYED, SERIOUS LIVER DAMAGE.

|D0 NOT STORE AKVE 25'C KEEP THE BOTTLE TIGHTLY CLOSED. STOKE IK THE ORIGINAL CONTAINER.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

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