Nurofen muscles and joints

Package leaflet: Information for the user

Nurofen Mięśnie i Stawy, 50 mg/g, gel
(Ibuprofenum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 2 weeks, consult a 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 Nurofen Mięśnie i Stawy is and what it is used for

Nurofen Mięśnie i Stawy is a topical gel for application to the skin. 1 g of gel contains 50 mg of ibuprofen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). When applied topically to the skin, it relieves pain and reduces swelling. The medicine is intended for rapid symptomatic treatment of muscular pain, back pain, and pain associated with musculoskeletal disorders such as: mild forms of arthritis, sprains, sports injuries, fibromyalgia, and neuralgia.

2. Important information before using Nurofen Mięśnie i Stawy

When not to use Nurofen Mięśnie i Stawy

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced hypersensitivity reactions, such as bronchial asthma, bronchospasm, rhinitis, angioedema, or urticaria in response to ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• During the last 3 months of pregnancy.
• On damaged skin.

Warnings and precautions
If symptoms worsen or persist after 2 weeks of treatment, medical advice should be sought.
Do not use for longer than 14 days without consulting a doctor.
In patients using ibuprofen who have previously experienced bronchial asthma or allergic disease, bronchospasm may occur.
Patients with asthma who have not previously taken acetylsalicylic acid or other non-steroidal anti-inflammatory drugs should be advised to consult a doctor before using Nurofen Mięśnie i Stawy gel.
A potential association has been suggested between the topical use of NSAIDs and kidney failure.
Patients with a history of kidney disease should consult a doctor before using Nurofen Mięśnie i Stawy gel.
Serious skin reactions have been reported with the use of ibuprofen, 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). If any of the symptoms associated with these serious skin reactions described in section 4 occur, Nurofen Mięśnie i Stawy should be discontinued immediately and medical help should be sought.
Topically applied ibuprofen may potentially cause gastrointestinal adverse effects. Although the risk of such adverse effects is significantly lower than with oral ibuprofen, patients with conditions such as active or past peptic ulcer disease, inflammatory bowel disease, or bleeding tendency should consult a doctor before using Nurofen Mięśnie i Stawy gel.
Although systemic absorption of topically applied ibuprofen is significantly lower than with oral formulations, complications may rarely occur. Therefore, patients with active or past peptic ulcer disease, inflammatory bowel disease, or bleeding tendency should seek medical advice before using this product.
For external use only.
Nurofen Mięśnie i Stawy gel should be gently massaged into the skin. Do not apply on damaged or inflamed skin. Avoid contact with eyes and mucous membranes of the mouth. If a rash develops, discontinue use of the medicine.
To reduce the risk of photosensitivity, the treated area should be protected from strong sources of natural or artificial light during treatment with ibuprofen.
This medicine is not intended for use under occlusive dressings.
Hands should be washed after application.

Children
Do not use Nurofen Mięśnie i Stawy gel in children under 12 years of age without medical advice.

Pregnancy, breastfeeding and fertility
Pregnancy
Use of this medicine should be avoided during the first and second trimesters of pregnancy. During the third trimester of pregnancy, use of this medicine is contraindicated.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 recommended by a doctor. If treatment is required during this period, the lowest effective dose should be used for the shortest possible duration.
Oral formulations (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.

Breastfeeding
Ibuprofen passes into breast milk in very low concentrations and is unlikely to adversely affect the breastfed infant. Since the bioavailability of topically administered ibuprofen is approximately 5% of the bioavailability of an oral dose, the amount of medicine transferred to the breastfed infant is considered negligible.

Fertility
No effect on fertility has been observed after topical application.

Driving and operating machinery
No adverse effects affecting the ability to drive or operate machinery are known.

Nurofen Mięśnie i Stawy and other medicines
Inform your doctor about all medicines you are currently taking, including those obtained without a prescription.
Non-steroidal anti-inflammatory drugs may interact with antihypertensive medicines and may potentially enhance the effect of anticoagulant medicines. However, with proper use, systemic penetration of ibuprofen is low, making such interactions—commonly associated with oral ibuprofen—unlikely.
Concomitant use of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs may increase the frequency of adverse effects.

This medicine contains 1.25 mg of benzyl alcohol in each dose.
Benzyl alcohol may cause allergic reactions.
The medicine may cause mild local irritation.

3. How to use Nurofen Mięśnie i Stawy

This medicine should always be used exactly as described in this patient information leaflet. If in
doubt, consult a doctor or pharmacist.
Before first opening the tube, check whether the protective foil covering the opening is intact. To
pierce it, press the reverse side of the cap against the foil. After squeezing out the desired amount
of gel, close the tube with the cap.
For topical application on the skin only.
For short-term use only. Do not use for longer than 14 days without medical advice.
Adults and children over 12 years of age
Squeeze 4 to 10 cm of gel from the tube onto the affected area (this amount corresponds to a dose of 50 to
125 mg of ibuprofen). Gently rub the gel into the skin until fully absorbed, then wash hands.
Do not reapply the medicine sooner than 4 hours after the previous application.
Do not use the medicine more than 4 times a day.
Do not apply the medicine to damaged skin, mucous membranes of the oral cavity (mouth), or around the eyes.
If a rash develops, discontinue use of the medicine.
If symptoms persist or worsen after 2 weeks of treatment, consult a doctor.
Elderly patients
No special dose adjustment is necessary.
Overdose of Nurofen Mięśnie i Stawy
Overdose following topical administration does not seem likely.
Symptoms of ibuprofen overdose include: dizziness, nausea, vomiting, drowsiness, headache, and hypotension.
In case of accidental ingestion of the gel by a child, contact a doctor immediately.
If an adult accidentally swallows the gel, rinse the mouth. Swallowed gel may cause gastric disturbances. If necessary, contact a doctor.
Discontinuation of Nurofen Mięśnie i Stawy
If in doubt about the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse symptoms worsen or if any adverse effects not listed in this leaflet occur,
you should inform your doctor or pharmacist.

Rare (may occur in up to 1 in 1,000 people):

• toxic epidermal necrolysis, erythema multiforme

Frequency unknown: frequency cannot be estimated from the available data

• hypersensitivity
• abdominal pain, dyspepsia
• impaired kidney function
• reactions at the application site, skin changes (e.g. redness) and tingling at the application site, non-specific allergic and anaphylactic reactions
• bronchial asthma, worsening of bronchial asthma and bronchospasm
• various rashes, urticaria, angioedema
• skin becomes sensitive to light

If any of the following symptoms occur in the patient, ibuprofen use must be stopped immediately and medical help should be sought:

• red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions 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. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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

5. Storage of Nurofen Mięśnie i Stawy
Store below 30°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Nurofen Mięśnie i Stawy contains
The active substance is ibuprofen.
1 gram of Nurofen Mięśnie i Stawy gel contains 50 mg of ibuprofen.
The other ingredients are: hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

What Nurofen Mięśnie i Stawy looks like and contents of the pack
30 g, 35 g, 50 g, 100 g in aluminium tubes internally coated with epoxyphenolic resin, protected with aluminium foil, closed with a PE cap, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Manufacturer:
FARMASIERRA MANUFACTURING, S.L.
Ctra. de Irun
KM 26200 San Sebastian de los Reyes
28700 Madrid, Spain
Importer:
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Tel: 801 88 88 07