Nurofen Miemshnie i Stavi

Leaflet attached to the packaging: information for the user

Nurofen Muscles and Joints, 50 mg/g, gel

(Ibuprofen)

Table of contents of the leaflet

You should carefully read the contents of the leaflet 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 advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 2 weeks there is no improvement or you feel worse, you should contact your doctor.

• 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 packaging and other information

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

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

2. Important information before using Nurofen Muscles and Joints

When not to use Nurofen Muscles and Joints

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced hypersensitivity reactions, such as asthma, bronchospasm, nasal congestion, angioedema, or urticaria in response to ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• In the last 3 months of pregnancy.
• On damaged skin.

Warnings and precautions

If your symptoms worsen or persist after 2 weeks of treatment, you should consult a doctor. Do not use for more than 14 days without consulting a doctor.
Patients using ibuprofen who have previously experienced asthma or allergic disease may experience bronchospasm.
Patients with asthma who have not previously taken acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs should be advised to consult a doctor before using Nurofen Muscles and Joints gel.
A link has been suggested between the use of topical NSAIDs and renal failure.
Patients with a history of kidney disease should be advised to consult a doctor before using Nurofen Muscles and Joints gel.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have occurred with ibuprofen use. If you experience any symptoms associated with these severe skin reactions, you should stop using Nurofen Muscles and Joints and seek medical help immediately.
Ibuprofen used topically may potentially cause gastrointestinal side effects. Although the risk of such side effects is much lower than with oral ibuprofen, patients with conditions such as active or history of peptic ulcer, inflammatory bowel disease, or bleeding disorders should consult a doctor before using Nurofen Muscles and Joints gel.
Although systemic absorption of topically applied ibuprofen is significantly lower than with oral forms, complications may occur in rare cases. Therefore, patients with active or history of peptic ulcer, inflammatory bowel disease, or bleeding disorders should consult a doctor before using this product.
For external use only.
Nurofen Muscles and Joints gel should be gently rubbed in. Do not apply to damaged or inflamed skin. Avoid contact with eyes and mucous membranes of the mouth. If a rash occurs, discontinue use.
To minimize the risk of photosensitivity, the treated area should be protected from strong natural or artificial light sources during ibuprofen treatment.
The medicine is not intended for use under occlusive dressings.
After application, wash your hands.

Children

Nurofen Muscles and Joints gel should not be used in children under 12 years of age without medical advice.

Pregnancy, breastfeeding, and fertility

Pregnancy
You should avoid using the medicine during the first and second trimester of pregnancy. In the third trimester of pregnancy, the use of the medicine is contraindicated.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice 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 it is 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 whether the same risk applies to Nurofen Muscles and Joints when used on the skin.
Breastfeeding
Ibuprofen passes into breast milk in very small amounts and is unlikely to affect the breastfed infant. Since the systemic availability of topically applied ibuprofen is about 5% of the systemic availability of an oral dose, the amount of medicine ingested by the breastfed infant is considered negligible.
Fertility
No effect on fertility has been observed with topical use.

Driving and using machines

Unknown side effects that may affect the ability to drive or use machines.

Nurofen Muscles and Joints and other medicines

Tell your doctor about all the medicines you have taken recently, including those obtained without a prescription.
Nonsteroidal anti-inflammatory drugs may interact with antihypertensive drugs and may enhance the effects of anticoagulant drugs. However, with proper use, the absorption of ibuprofen into the body is small, so the occurrence of interactions associated with oral ibuprofen is unlikely.
Concomitant use of acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs may increase the frequency of side effects.
This medicine contains 1.25 mg of benzyl alcohol per dose.
Benzyl alcohol may cause allergic reactions.
The medicine may cause mild local irritation.

3. How to use Nurofen Muscles and Joints

This medicine should always be used exactly as described in this patient leaflet. If you are unsure, you should ask your doctor or pharmacist.
Before opening the tube for the first time, check that the protective foil on the nozzle is not damaged. To break it, press on it with the reverse side of the cap. After squeezing out the desired amount of gel, close the tube with the cap.
For topical application to the skin.
For short-term use only. Do not use for more than 14 days without consulting a doctor.

Adults and children over 12 years of age

Squeeze 4 to 10 cm of gel 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 it is absorbed, then wash your hands.
Do not apply the medicine more often than every 4 hours.
Do not apply the medicine more than 4 times a day.
Do not apply the medicine to damaged skin, mucous membranes of the mouth (mouth), or the eye area.
If a rash occurs, discontinue use.
If after 2 weeks of using the medicine the symptoms do not improve or worsen, you should consult a doctor.

Elderly

No special dose adjustment is necessary.

Using more than the recommended dose of Nurofen Muscles and Joints

Overdose after topical application is unlikely.
Symptoms of ibuprofen overdose include dizziness, nausea, vomiting, drowsiness, headache, and hypotension.
If a child accidentally swallows the gel, you should immediately contact a doctor.
If an adult swallows the gel, rinse your mouth. Swallowed gel may cause stomach upset. If necessary, consult a doctor.

Stopping use of Nurofen Muscles and Joints

If you have any doubts about using the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Rare (may affect up to 1 in 1,000 people)

• toxic epidermal necrolysis, erythema multiforme

Frequency not known: frequency cannot be estimated from the available data

• hypersensitivity
• abdominal pain, indigestion
• renal impairment
• reactions at the application site, skin changes (e.g., redness) and tingling at the application site, non-specific allergic and anaphylactic reactions.
• asthma, exacerbation of asthma, and bronchospasm.
• various rashes, urticaria, angioedema
• skin becomes sensitive to light

If you experience any of the following symptoms, you should stop using ibuprofen and seek medical help immediately:

• 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 fever, and enlarged lymph nodes (DRESS syndrome).
• red, peeling rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 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. Storing Nurofen Muscles and Joints

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

6. Contents of the packaging and other information

What Nurofen Muscles and Joints contains

The active substance is ibuprofen.
1 g of Nurofen Muscles and Joints gel contains 50 mg of ibuprofen.
The other ingredients are: hydroxyethylcellulose, sodium hydroxide, benzyl alcohol, isopropyl alcohol, purified water.

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

30 g, 35 g, 50 g, 100 g in aluminum tubes with an internal coating of epoxyphenolic resin, sealed with aluminum foil, closed with a PE cap, in a cardboard box.

Marketing authorization holder and manufacturer/importer

Marketing authorization 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
To obtain more detailed information about this medicine, you should contact the representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Phone: 801 88 88 07

Date of last revision of the leaflet: