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Wilko Long Lasting Pain Relief

Document: leaflet BOOTS_PL 16028-0120 change

Information for the user


Ibuprofen Long Lasting 200 mg Capsules

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 Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory medicines, which act to relieve pain and reduce swelling. The Ibuprofen in the capsule is released slowly over 12 hours. It can be used to relieve headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

X Do not take:

•    If you have a stomach ulcer, perforation or bleeding of the stomach, or have had one in

the past (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

•    If you have had perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine

•    If you are allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal anti-inflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)

•    If you are taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines

•    If you have severe heart, kidney or liver failure

•    If you are pregnant

Other important information

Risk of heart attack or stroke:

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the stated dose or duration of treatment.


f Talk to your pharmacist or doctor:


•    If you have asthma, a history of asthma or other allergic disease, stomach or bowel problems

•    If you have other kidney or liver problems (see "Do not take")

•    If you are elderly - you may get more side effects (see back of leaflet)

•    If you are taking any other painkillers or receiving regular treatment from your doctor

•    If you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack "TIA") -see 'Risk of heart attack or stroke1 under Other important information

•    If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker

   Children and adolescents: There is a risk of renal impairment in dehydrated adolescents

Other information

Breastfeeding: You can use this medicine. Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop the medicine.

If you take other medicines

Before you take these capsules, make sure that you tell your doctor or pharmacist about ANY other medicines you might be using at the same time. Ibuprofen may affect or be affected by some other medicines. For example:

•    Aspirin 75 mg (to prevent heart attacks and strokes) - the protection may be reduced when you take ibuprofen

•    Other painkillers

•    Medicines to thin your blood (e.g. warfarin, tidopidine)

•    Mifepristone (for termination of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days

•    Water tablets (diuretics)

•    Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan), medicines for heart problems

•    Corticosteroids, lithium, methotrexate, zidovudine

•    Quinolone antibiotics (for infections)

•    Medicines for depression

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"surgery, or for psoriasis or rheumatism)

Some other medicines may also affect or be affected by the treatment of ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with any other medicines, including herbal and homeopathic remedies.

/How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.


Age

How many to take

How often to take them

Adults and children of 12 years and over

Two capsules

Morning and evening, if you need to.

Don't take more than 4 capsules in 24 hours.

Take the lowest amount for the shortest possible time to relieve your symptoms


Swallow each capsule whole with water.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If your symptoms worsen at any time, talk to your pharmacist or doctor.

In adults: if your symptoms do not go away within 10 days, talk to your pharmacist or doctor.

In children and adolescents (aged 12-18 years): if this medicinal product is required for more than 3 days, talk to your doctor, f If you take too many capsules: Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

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

If you are elderly you may be more likely to have some of these side effects, f If you get any of these serious side effects, stop taking the capsules. 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

•    Stomach problems including pain, indigestion or heartburn


•    Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing

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

» Kidney problems, which may lead to kidney failure

>    Feeling sick or being sick

»Headache, hearing problems

•    Fluid retention, which may cause swelling of the limbs

» Rarely, liver problems, diarrhoea, wind, constipation, worsening of colitis or Crohn's disease, meningitis (e.g. stiff neck, fever and disorientation)

•    Very rarely, tiredness or severe exhaustion, changes in the blood which may cause unusual bruising and an increase in the number of infections that you get (e.g. sore throats, mouth ulcers, flu-like symptoms)

>    A small increased risk of heart attack or stroke if you take large amounts for a long time

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/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Store below 25°C.

Store in the original package.

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.

What is in this medicine

Each modified release hard capsule contains Ibuprofen 200 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain microcrystalline cellulose, Eudragit NE 30D, hypromellose, talc, colloidal silicon dioxide. The capsule shell contains gelatin, titanium dioxide (E171), patent blue V (E131), erythrosine (E127).

The pack contains 8 or 16 pale blue and dear coloured capsules, containing white beads.


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ARTWORK TEXT SIZE


Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by Galpharm International Ltd Elmhirst Park Middle Held Roiad Barnsley South Yorkshire S75 4LS, UK. Marketing Authorisation held by Galpharm Healthcare Ltd Wrafton Braunton Devon EX33 2DL.UK Leaflet prepared November 2015 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


Other formats

To request a copy of this leaflet in Braille, large print or audio please call free of charge: 0800198 5000 (UK only)

Please be ready to give the following information:

Product Name: Boots Ibuprofen Long Lasting

200 mg Capsules

Reference Number: 16028/0120

This is a service provided by the Royal National

Institute of Blind People.

57687-H    4006132


Main Headings:    12pt

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PACK MOCK LIP

Product Name: Boots Ibuprofen Long lasting 200 mg capsules

Product Licence No.: PL 16028/0120

Wording Ref: MHRA Approved, VI,dated 11/02/2014(BTC129999actionC) Status: Internally Approved Pack Details: AI/PVC blister packs in a carton

Pack Size:

8,16 capsules

Version No.

Date Issued

Reason For Change

1

19/11/15

Mandatory safety update to add PRAC warnings to SPC ft PIL


Category:

Healthcare

Sub-Category:

Analgesics

Brand:

Core

Pack Type:

Leaflet

Variant:

Long Lasting Ibuprofen Capsules Lft

Action:

B

Date:

20/11/15

Country:

UK

Component Code:

4006132

Item Code:

40-04-313

CAD Ref No:

As per BTC129999 Action C

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White Paper

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Colours

PAMONE280 C

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TECHM1CAL 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.


STUDIO USE ONLY    v1.0