Nurofen Miemshnie i Stavi

PATIENT INFORMATION LEAFLET: USER INFORMATION

Nurofen Muscles and Joints 200 mg, medicinal patch
Ibuprofen
For use in adults and adolescents aged 16 and above

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet

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

1 What is Nurofen Muscles and Joints and what is it used for

The active substance of the medicine is ibuprofen. Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by changing the body's response to pain, swelling, and high temperature. The medicinal patch provides ibuprofen continuously to the site of pain for 24 hours after application.

Nurofen Muscles and Joints is indicated for short-term, symptomatic relief of acute pain caused by sudden muscle strain or sprain resulting from mild injuries near the joints of the hands or feet in adults or adolescents aged 16 and above.

2 Important information before using Nurofen Muscles and Joints

When not to use Nurofen Muscles and Joints:

• if the patient is allergic to ibuprofen, acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs(NSAIDs) or any of the excipients of the medicine (listed in section 6),
• 6),
• if the patient has previously experienced an allergic reaction to nonsteroidal anti-inflammatory drugs(NSAIDs) or acetylsalicylic acid, such as asthma, wheezing, itching, rhinitis, skin rash, and edema,
• if the patient is in the last 3 months of pregnancy,

Do not use Nurofen Muscles and Joints on damaged skin(e.g., abrasions, cuts, burns), infected skin, skin with weeping eczema or dermatitis, on the eyes, lips, or mucous membranes.

Special warnings and precautions

Before using Nurofen Muscles and Joints, discuss with your doctor or pharmacist:

• if the patient has or has had asthmaor allergies,
• if the patient has stomach ulcers, bowel disease, heart, kidney, or liver disease,
• if the patient is in the first or second trimester of pregnancyor breastfeeding.

During use of Nurofen Muscles and Joints

• After the first signs of any skin reaction(rash, scaling, blisters) or other symptoms of an allergic reaction, stop using the patch and consult a doctor.
• Report any unusual symptoms from the gastrointestinal tract (especially bleeding) to your doctor.
• Severe 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 the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, stop using Nurofen Muscles and Joints and seek medical attention.
• If the patient is elderly, they may be more susceptible to side effects.
• If there is no improvement, or if the patient feels worse or new symptoms appear, consult a doctor.
• Avoid exposureof the treated area to strong natural or artificial light sources (e.g., sunlamps) during treatment and for one day after patch removal to reduce the risk of photosensitivity.

Children and adolescents

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

Nurofen Muscles and Joints and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take, including:

• medicines used to lower blood pressure,
• blood-thinning medicines, such as warfarin,
• acetylsalicylic acid or other NSAIDs used for inflammatory and painful conditions.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Do not use Nurofen Muscles and Joints in the last 3 months of pregnancy. Do not use Nurofen Muscles and Joints during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is necessary during this period, use the lowest dose for the shortest possible time.
Oral forms (e.g., tablets) of Nurofen Muscles and Joints may cause side effects in the unborn child. It is not known if the same risk applies to Nurofen Muscles and Joints when used on the skin.
Do not use the medicine in the first two trimesters of pregnancy due to its effect on prostaglandin synthesis.
No harmful effects have been reported with the use of this medicine during breastfeeding. However, do not apply the patch directly to the breast if breastfeeding.

Driving and using machines

Unknown effect.

3 How to use Nurofen Muscles and Joints

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose

Adults and adolescents aged 16 and above:

One dose is equal to one patch. The maximum dose in a 24-hour period is one patch.

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

For use on undamaged skin.
Before applying the patch, wash and dry the application site thoroughly.
The patch can be applied at any time of day or night, but it should be removed and a new patch applied the next day at the same time.
The patch is flexible and easily adapts to moving body surfaces, so it can be applied to a joint or near a joint if necessary. The patch allows for normal movement.
Do not:

• cut the patch, apply it whole,
• use on damaged or injured skin,
• cover with other patches or impermeable dressings, including bandages
• get the patch wet.

Method of use

• 1. To remove the medicinal patch, tear the packet or cut along the dotted line.
• 2. Remove the plastic foil marked (A) and place the adhesive strip in the center of the painful area.
• 3. Remove the plastic foil marked (B) and, stretching gently, smooth this part of the patch onto the skin.
• 4. Remove the plastic foil marked (C).
• 5. Stretching gently, smooth the remaining part of the patch onto the skin.

Duration of treatment

If necessary, several doses can be used, but for the shortest time necessary to relieve symptoms. Do not use the medicine for more than 5 days. If symptoms persist for more than 5 days, consult a doctor.

Using more than the recommended dose of Nurofen Muscles and Joints

Accidental overdose of the medicinal patch is unlikely.
Consult a doctor. Symptoms of overdose may include nausea or vomiting, stomach pain, or less frequently, diarrhea. Ringing in the ears, headaches, and gastrointestinal bleeding may occur.
If you have any further questions about using 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.

• If the patient experiences any of the following symptoms, stop using ibuprofen and seek medical attention:symptoms of allergic reactions, such as asthma, unexplained wheezing or shortness of breath, itching, rhinitis, or skin rash,
• symptoms of hypersensitivity and skin reactions, such as redness, swelling, scaling, blistering, or skin ulcers,
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and 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 body temperature, and enlarged lymph nodes (DRESS syndrome),
• red, scaling rash with bumps under the skin and blisters, with fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If you experience any of the following

symptoms or side effects not listed in the leaflet, consult a doctor or pharmacist:Frequency not known(frequency cannot be estimated from the available data)

• skin reactions, such as redness, burning, itching, blisters, irritation, or discharge
• skin sensitivity to light
• asthma, breathing difficulties, shortness of breath
• stomach pain or other stomach problems
• kidney problems

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
phone: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Nurofen Muscles and Joints

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

6 Contents of the pack and other information

What Nurofen Muscles and Joints contains

The active substance is ibuprofen. Each medicinal patch contains 200 mg of ibuprofen.
The other ingredients are:

• adhesive layer: macrogol 400, macrogol 20000, levomenthol, styrene-isoprene-styrene block copolymer 22, polyisobutylene (PIB) 55k, polyisobutylene (PIB) 1100k, hydrogenated lanolin with glycerol, liquid paraffin
• coating layer: polyethylene terephthalate, woven
• protective layer: siliconized polyethylene terephthalate

What Nurofen Muscles and Joints looks like and contents of the pack

The medicinal patch consists of a colorless, adhesive layer of medicine mounted on a flexible, flesh-colored, woven backing with a protective layer, measuring 10 cm by 14 cm.
One packet contains 2 or 4 medicinal patches.
Pack sizes: 2, 4, 6, 8, or 10 medicinal patches.
Not all pack sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
Okunin 1
05-100 Nowy Dwór Mazowiecki
To obtain more detailed 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
Ryga, LV-1067
Latvia

Importer

RB NL Brands B.V.
WTC Schiphol Airport
Schiphol Boulevard 207
1118 BH Schiphol
Netherlands

The medicine has been authorized in the Member States of the European Economic Area (EEA) under the following names:

Date of last revision of the leaflet: 02/2024