Medine.co.uk

Paramed Extra Power Pain Reliever Tablets

Document: leaflet BOOTS_PL 12063-0009 change

139.7 mm

139.7 mm

150 mm


f


1



Irrformation for the user


i


Aspirin Extra Tablets

(Aspirin, Caffeine, Paracetamol)


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

This medicine is available without prescription to treat minor conditions. However, you still need to take it 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

What this medicine is for

This medicine contains Aspirin and Paracetamol, which belong to a group of medicines called analgesics, which act to relieve pain and reduce fever and inflammation. Caffeine helps to increase the pain relief.

It can be used to treat mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, relief of the symptoms of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. It can also be used to relieve the symptoms of colds and flu and reduce a fever.

Before you take this medicine

This medicine can be taken by adults and children aged 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

A Do not take:

If you are under 16 years old

If you are allergic to any of the ingredients If you have ever had a bad reaction to aspirin or any other non-steroidal anti-inflammatory drugs (you have ever had asthma, swelling of the lips or face, itchy skin or runny nose after taking them)

If you have a stomach ulcer, or have had one If you have haemophilia, a blood clotting disorder

If you are taking other blood thinners (e.g. warfarin)

•    If you suffer from gout

•    If you have an intolerance to some sugars,

unless your doctor tells you to (this medicine contains sorbitol)

•    If you are pregnant or breastfeeding

? Talk to your pharmacist or doctor:

•    If you have asthma

•    If you have severe kidney or liver problems (including alcoholic liver disease), or dehydration

Other important information

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine.

There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children under the age of 16 years unless on the advice of a doctor.

If you take other medicines

? This medicine contains paracetamol and aspirin.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Antacids and adsorbents (e.g. kaolin)

•    Mifepristone (for termination of pregnancy)

•    Spironolactone (a water tablet or diuretic)

•    Heparin, phenindione, warfarin or other blood thinners

•    Domperidone or metoclopramide (for feeling sick or being sick)

•    Phenytoin or sodium valproate (for epilepsy)

•    Methotrexate (for cancer and some skin conditions)

•    Colestyramine (for reducing blood fat levels)

•    Medicines for gout (e.g. probenicid and sulphinpyrazone)

I


If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.


Age

How many to take

How often to take

Adults and children of 16 years and over

One or two

Every 4 hours, if you need to. Don’t take more than 6 tablets in 24 hours.

| Do not take more often than every 4 hours


)f How to take this medicine

i Check the foil is not broken before use. If it is, do 1 not take that tablet.


•    Worsening of gout if you suffer from this

•    Skin rash

•    Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.Qov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each tablet contains Aspirin 300 mg, Caffeine 45 mg, Paracetamol 200 mg, which are the active ingredients. As well as the active ingredients, the tablets also contain maize starch, methyl cellulose, microcrystalline cellulose, sorbitol (E420), sodium laurilsulfate, hydrogenated cotton seed oil.

The pack contains 16 tablets.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Umited Braunton Devon EX33 2DL Leaflet prepared November 2015 If you would like any further information about this medicine, please contact The Boots Company _ _PJ-C Nottingham NG2 3AA__________2754471


Swallow each tablet with water.

Do not give to children under 16 years, unless your doctor tells you to.

Do not take more medicine that the table tells you to. If you do not get better, talk to your doctor.

f 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these side effects, stop taking this medicine. See a doctor at once:

•    You are sick and it contains blood or dark particles that look like coffee grounds

•    Pass blood in your stools or pass black tarry stools

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you get any of the following side effects see your pharmacist or doctor:

•    Stomach irritation

•    Increased bleeding time if you cut yourself


Information for the user


Aspirin Extra Tablets

(Aspirin, Caffeine, Paracetamol)


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

This medicine is available without prescription to treat minor conditions. However, you still need to take it 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

What this medicine is for

This medicine contains Aspirin and Paracetamol, which belong to a group of medicines called analgesics, which act to relieve pain and reduce fever and inflammation. Caffeine helps to increase the pain relief.

It can be used to treat mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, relief of the symptoms of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. It can also be used to relieve the symptoms of colds and flu and reduce a fever.

Before you take this medicine

This medicine can be taken by adults and children aged 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

•    If you are under 16 years old

•    If you are allergic to any of the ingredients

•    If you have ever had a bad reaction to aspirin or any other non-steroidal anti-inflammatory drugs (you have ever had asthma, swelling of the lips or face, itchy skin or runny nose after taking them)

•    If you have a stomach ulcer, or have had one

•    If you have haemophilia, a blood clotting disorder

   If you are taking other blood thinners (e.g. warfarin)

•    If you suffer from gout

•    If you have an intolerance to some sugars,

unless your doctor tells you to (this medicine contains sorbitol)

•    If you are pregnant or breastfeeding

? Talk to your pharmacist or doctor:

•    If you have asthma

•    If you have severe kidney or liver problems (including alcoholic liver disease), or dehydration

Other important information

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine.

There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children under the age of 16 years unless on the advice of a doctor.

If you take other medicines

f This medicine contains paracetamol and aspirin.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Antacids and adsorbents (e.g. kaolin)

•    Mifepristone (for termination of pregnancy)

•    Spironolactone (a water tablet or diuretic)

•    Heparin, phenindione, warfarin or other blood thinners]

•    Domperidone or metoclopramide (for feeling sick or, being sick)

•    Phenytoin or sodium valproate (for epilepsy)

•    Methotrexate (for cancer and some skin conditions)

•    Colestyramine (for reducing blood fat levels)

•    Medicines for gout (e.g. probenicid and sulphinpyrazone)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.


/ How to take this medicine

i Check the foil is not broken before use. If it is, do ' not take that tablet.


Age

How many to take

How often to take

Adults and children of 16 years and over

One or two

Every 4 hours, if you need to. Don’t take more than 6 tablets in 24 hours.

| Do not take more often than every 4 hours


Swallow each tablet with water.

Do not give to children under 16 years, unless your doctor tells you to.

Do not take more medicine that the table tells you to. If you do not get better, talk to your doctor.

f 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these side effects, stop taking this medicine. See a doctor at once:

•    You are sick and it contains blood or dark particles that look like coffee grounds

•    Pass blood in your stools or pass black tarry stools

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you get any of the following side effects see your pharmacist or doctor:

•    Stomach irritation

•    Increased bleeding time if you cut yourself


•    Worsening of gout if you suffer from this

•    Skin rash

•    Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowoard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each tablet contains Aspirin 300 mg, Caffeine 45 mg, Paracetamol 200 mg, which are the active ingredients. As well as the active ingredients, the tablets also contain maize starch, methyl cellulose, microcrystalline cellulose, sorbitol (E420), sodium laurilsulfate, hydrogenated cotton seed oil.

The pack contains 16 tablets.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Umited Braunton Devon EX33 2DL Leaflet prepared November 2015


ARTWORK ONLY


If you would like any further information about this medicine, please contact The Boots Company _PLC Nottingham NG2 3AA__________2754471


i


Category:

Healthcare

Sub-Category:

Analgesics

Brand:

Core

Pack Type:

Leaflet

Variant:

Aspirin Extra Tablets

Action:

D

Date:

17/11/15

Country:

UK

Component Code:

2754471

Item Code:

45-01-748

CAD Ref No:

L101 (139.7 x 150mm)

Printer:

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By:

N/A

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

10100111(422)

Technical ft Non Printing Items Cutter | Guides


ARTWORK TEXT SIZE


Colours

PAMONE280 C

=


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Main Headings:    11.5pt

Sub Headings:    9.5pt

Body Copy:    7.5pt

PACK MOCK UP

Product Name: Aspirin Extra Tablets Product Licence No.: 12063/0009

Wo rd i ng Ref: Internallya pproved, V1 dated 24/06/15 (BTC191B18, action B) Status: Internally App roved Pack Details: Foil blisters Pack Size: 16 tablets

Version No.

Date Issued

Reason For Change

1

24/06/2015

Addition of PRAC, Paracetamol Warnings and deletion of duplicate ADR text

2

13/11/15

clinical update to add warnings for gout, dehydration and update side effects to include skin reactions. Perrigo code ft pharma code changed.


STUDIO USE ONLY    v1.0