Nurofen muscles and joints

Nurofen Mięśnie i Stawy, 200 mg, medicated plaster
Ibuprofenum
For use in adults and adolescents aged 16 years and above
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed
by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

1. What Nurofen Mięśnie i Stawy is and what it is used for
2. Important information before using Nurofen Mięśnie i Stawy
3. How to use Nurofen Mięśnie i Stawy
4. Possible side effects
5. How to store Nurofen Mięśnie i Stawy
6. Contents of the pack and other information

1 What is Nurofen Mięśnie i Stawy and what is it used for?
The active substance is ibuprofen. Ibuprofen belongs to a group of medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs), which work by altering the body's response
to pain, swelling, and high temperature. The medicated plaster delivers ibuprofen continuously
to the site of pain over 24 hours after application.
Nurofen Mięśnie i Stawy is indicated for short-term, symptomatic treatment of acute pain
caused by sudden muscle strain or sprain resulting from minor injuries near the joints of the
hands or feet in adults or adolescents aged 16 years and above.

2 Important information before using Nurofen Mięśnie i Stawy

Do not use Nurofen Mięśnie i Stawy:

• if you are allergic to ibuprofen, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the ingredients listed in section 6,
• if you have previously experienced an allergic reaction after taking NSAIDs or acetylsalicylic acid, such as asthma, wheezing, itching, rhinitis, rash, or swelling,
• if you are in the last 3 months of pregnancy.

Do not apply Nurofen Mięśnie i Stawy to damaged skin (e.g. abrasions, cuts,
burns), infected skin, skin affected by exudative dermatitis or eczema, or to the eyes, lips, or mucous membranes.

Special warnings and precautions

Before using Nurofen Mięśnie i Stawy, discuss with your doctor or pharmacist:

• if you have or have ever had asthma or allergies,
• if you have stomach ulcers, intestinal, heart, kidney or liver disease,
• if you are in the first or second trimester of pregnancy or breastfeeding.

While using Nurofen Mięśnie i Stawy

• If any signs of a skin reaction (rash, peeling, blisters) or other allergic symptoms occur, stop using the plaster immediately and consult your doctor.
• Report any unusual gastrointestinal symptoms (especially bleeding) to your doctor.
• Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If you experience any of the symptoms associated with these serious skin reactions described in section 4, stop using Nurofen Mięśnie i Stawy immediately and seek medical help.
• Elderly patients may be more susceptible to adverse effects.
• If there is no improvement, your condition worsens, or new symptoms appear, consult your doctor.
• Avoid exposing the treated area to strong sources of natural and/or artificial light (e.g. sunbeds) during treatment and for one day after removing the plaster, to reduce the risk of photosensitivity.

Children and adolescents
Do not use this medicine in children and adolescents under 16 years of age.

Nurofen Mięśnie i Stawy and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including:

• medicines used to lower blood pressure,
• blood-thinning medicines, e.g. warfarin,
• acetylsalicylic acid or other NSAIDs used for inflammation and pain.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use Nurofen Mięśnie i Stawy during the last 3 months of pregnancy. Do not use Nurofen Mięśnie i Stawy during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is required during this period, use the lowest dose for the shortest possible time.
Oral forms (e.g. tablets) of Nurofen Mięśnie i Stawy may cause adverse effects in the unborn child. It is not known whether the same risk applies when Nurofen Mięśnie i Stawy is applied to the skin.
Do not use the medicine during the first two trimesters of pregnancy due to its effect on prostaglandin synthesis.
No harmful effects of this medicine during breastfeeding are known. However, do not apply the plaster directly to the breast if you are breastfeeding.

Driving and using machines
Effect unknown.

3 How to use Nurofen Mięśnie i Stawy
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults and adolescents aged 16 years and above:
One dose equals one plaster. The maximum dose in any 24-hour period is one plaster.
Do not use in children and adolescents under 16 years of age.
For application to intact skin.
Before applying the plaster, clean and dry the application site thoroughly.
The plaster can be applied at any time of day or night, but should be removed and replaced with a new plaster the next day at the same time.

The plaster is flexible and easily conforms to moving body areas, so it can be applied to or near a joint if needed. The plaster allows normal movement.

Do not:

• cut the plaster; it should be applied whole,
• apply to damaged or injured skin,
• cover with other plasters or impermeable dressings, including bandages,
• wet the plaster.

Instructions for use

1. To remove the medicated plaster, tear or cut the sachet along the dotted line.
2. Remove the plastic film marked (A) and place the adhesive strip in the center of the painful area.
3. Remove the plastic film marked (B), then gently stretch and smooth this part of the plaster onto the skin.
4. Remove the plastic film marked (C).
5. Gently stretch and smooth the remaining part of the plaster onto the skin.

Duration of treatment
Several doses may be used if needed, but only for the shortest time necessary to relieve symptoms. Do not use the medicine for longer than 5 days. If symptoms persist beyond 5 days, consult your doctor.

Use of more than the recommended dose of Nurofen Mięśnie i Stawy
Accidental overdose of the medicated plaster is unlikely.
Seek medical advice. Symptoms of overdose may include nausea or vomiting, stomach pain, or less commonly, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding may also occur.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

• If you experience any of the following symptoms, stop using ibuprofen immediately and seek medical help: signs of allergic reactions such as asthma, unexplained wheezing or breathlessness, itching, rhinitis, or skin rash,
• signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, or skin ulceration,
• red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome),
• red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. These symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).

If any of the following symptoms occur or if you experience any side effects not listed in this leaflet, consult your doctor or pharmacist:
Frequency not known (frequency cannot be estimated from available data)

• skin reactions such as redness, burning, itching, blisters, irritation, or oozing
• skin sensitivity to light
• asthma, breathing difficulties, breathlessness
• stomach pain or other gastrointestinal problems
• kidney disorders

Reporting of side effects
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C,
02-222 Warsaw,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. Reporting side effects helps provide more information on the safety of the medicine.

5 How to store Nurofen Mięśnie i Stawy
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C (2 plasters in sachet).
Do not store above 30°C (4 plasters in sachet).
Store in the original packaging to protect from light.
Shelf life after first opening of the sachet: 6 months.
Do not dispose of used plasters in the toilet.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6 Contents of the pack and other information

What Nurofen Mięśnie i Stawy contains
The active substance is ibuprofen. Each medicated plaster contains 200 mg of ibuprofen.
Other ingredients:

• adhesive layer: polyethylene glycol 400, polyethylene glycol 20000, levomenthol, styrene-isoprene-styrene block copolymer 22, polyisobutylene (PIB) 55k, polyisobutylene (PIB) 1100k, hydrogenated glycerol rosin ester, liquid paraffin
• backing layer: polyethylene terephthalate, woven
• protective layer: silicone-coated polyethylene terephthalate

What Nurofen Mięśnie i Stawy looks like and contents of the pack
The medicated plaster consists of a colourless, self-adhesive drug layer on a flexible, flesh-coloured, woven carrier measuring 10 cm by 14 cm, with a protective layer.
One sachet contains 2 or 4 medicated plasters.
Pack sizes: 2, 4, 6, 8 or 10 medicated plasters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
For further information, contact the representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
Tel: 801 88 88 07

Manufacturer/Importer
Manufacturer
SIA ELVIM
Kurzemes pr. 3G
Riga, LV-1067
Latvia
Importer
RB NL Brands B.V.
WTC Schiphol Airport
Schiphol Boulevard 207
1118 BH Schiphol
The Netherlands

This medicine has been authorized in the European Economic Area (EEA) member countries under the following names: