Package Leaflet: Information for the User Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster

For use in adults and adolescents aged 16 years and over Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster is and what it is used for

2.    What you need to know before you use Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster

3.    How to use Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster

4.    Possible side effects

5.    How to store Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster

6.    Contents of the pack and other information

1    WHAT NUROFEN JOINT & MUSCULAR PAIN RELIEF 200MG MEDICATED PLASTER IS AND WHAT IT IS USED FOR

The active substance is ibuprofen. Ibuprofen belongs to a group of medicines called NonSteroidal Anti-Inflammatory Drugs (NSAIDs), which work by changing how the body responds to pain, swelling and high temperature. The medicated plaster locally delivers ibuprofen continuously at the site of pain over the 24 hours of application.

Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster is indicated for the short-term symptomatic treatment of local pain in acute muscular strains, or sprains in benign traumas close to the joint of the upper or lower limb in adults or adolescents aged 16 years and older.

2    WHAT YOU NEED TO KNOW BEFORE YOU USE NUROFEN JOINT & MUSCULAR PAIN RELIEF 200MG MEDICATED PLASTER

Do not use Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster if you:

•    are allergic to ibuprofen, acetylsalicylic acid, other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or any of the ingredients of this medicine (listed in section 6).

•    have had a previous allergic reaction after taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or acetylsalicylic acid; such as asthma, wheezing, itching, runny nose, skin rashes, swelling

•    are in the last three months of pregnancy.

Do not use Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster on injured skin (such as skin abrasions, cuts, burns), infected skin, skin affected by exudative dermatitis or eczema, eyes, lips or mucosa.

Warnings and precautions

Talk to your doctor or pharmacist before using Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster if you:

•    have or have ever had asthma or suffer from allergies.

•    have gastric ulcer, bowel, heart, kidney or liver problems.

•    are in the first 6 months of pregnancy or breastfeeding.

Whilst using Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster

•    At the first sign of any skin reaction (rash, peeling, blistering) or other sign of an allergic reaction, stop using the medicated plaster and consult a doctor at once.

•    Report any unusual abdominal symptoms (especially bleeding) to your doctor.

•    If you are elderly you may be more likely to have side effects

•    If you do not get better, you get worse, or develop new symptoms, talk to a doctor.

•    Avoid exposing the treated area to strong sources of natural and/or artificial light (e.g. tanning lamps) during treatment and for one day after removal of the medicated plaster, in order to reduce the risk of sensitivity to light.

Children and adolescents

This medicine should not be used by children or adolescents under the age of 16 years.

Other medicines and Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster

Please tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines especially if you are taking any of the following:

•    medicines to lower blood pressure

•    medicines to thin the blood e.g. warfarin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Do not use this medicine if you are in the last 3 months of pregnancy.

If you are in the first 6 months of pregnancy speak to your doctor before using this medicine.

No harmful effects are known when using this medicine whilst breast-feeding. However, as a precautionary measure, do not apply a medicated plaster directly on to the breast if you are breast-feeding.

Driving and using machines

None Known.

3 HOW TO USE NUROFEN JOINT & MUSCULAR PAIN RELIEF 200MG MEDICATED PLASTER

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose

Adults and adolescents aged 16 years and over:

One dose is equal to one medicated plaster. The maximum dose for a single 24 hour period is one medicated plaster,

Do not use this medicine in children or adolescents under 16 years.

For cutaneous use on intact skin.

It is recommended to carefully wash and dry the area to be treated before applying the plaster The plaster can be applied at any time during the day or night, but should be removed and a new plaster re-applied at the same time on the following day.

The plaster is flexible and conformable, and if necessary can be applied on or near a joint and will allow for normal movement.

Do not:

•    cut the plaster, it should be used whole.

•    apply to broken or damaged skin.

•    cover with other plasters or non-breathable dressings/bandages

•    get the plaster wet

Method of application:

1.    To remove a medicated plaster, tear or cut along the dotted line on the sachet.

2.    Remove the plastic film marked (A) and place the adhesive strip over the middle of the pain area.

3.    Remove plastic film marked (B) and stretching slightly, smooth this part of the medicated plaster onto your skin.

4.    Remove plastic film marked (C).

5.    Stretching slightly, smooth the rest of the medicated plaster onto your skin.

Duration of Treatment:

You should use as few doses as you need for the shortest time necessary to relieve your symptoms. Do not use this medicine for more than 5 days unless instructed to do so by your doctor.

If you use more Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster than you should

Accidental overdose with the medicated plaster is unlikely.

Seek medical advice. Signs of overdose may include feeling sick or being sick, stomach ache or more rarely, diarrhoea. Ringing in the ears, headache and gastrointestinal bleeding is also possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP USING this medicine and contact a doctor immediately if you develop:

•    signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose, or skin rashes.

•    signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, flaking or ulceration of skin.

Tell your doctor or pharmacist if you notice any of the following effects or any effects not listed:

Not known (frequency cannot be estimated from the available data)

•    skin reactions such as redness, burning, itching, blistering, sore or weeping

•    asthma, difficulty breathing, shortness of breath;

•    stomach pain or other stomach problems

•    kidney problems

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report any side effects directly via theYellow Card Scheme Website: www.mhra.gov.uk/yellowcard

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

5 HOW TO STORE NUROFEN JOINT & MUSCULAR PAIN RELIEF 200MG MEDICATED PLASTER

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from light.

Shelf-life after first opening of the sachet: 6 months.

Do not flush the used plaster down the toilet.

Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster contains:

The active substance is ibuprofen. One medicated plaster contains 200 mg of ibuprofen.

The other ingredients are:

Adhesive layer:

Macrogol 400, Macrogol 20000, Levo-Menthol, Styrene-Isoprene-Styrene Block Copolymer, Polyisobutylene, Hydrogenated Rosin Glycerol Ester, Liquid Paraffin,

Backing layer:

Woven Polyethylene Terephthalate (PET).

Release liner:

Silicone coated Polyethylene Terephthalate (PET)

What Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster looks like and contents of the pack

The medicated plaster is comprised of colourless, self-adhesive formulation layer mounted onto a 10cm by 14cm flexible flesh-coloured woven support, with a release liner.

Each sachet contains 2 or 4 medicated plasters. Pack size: 2, 4, 6, 8 or 10 medicated plasters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Reckitt Benckiser Healthcare UK Limited,

103-105 Bath Road,

Slough,

SL1 3UH United Kingdom

Manufacturer

Reckitt Benckiser Healthcare International Limited 1 Thane Road,

Nottingham NG90 2DB United Kingdom

This leaflet was last revised in

May 2016