Ibuprom sport spray

Patient Information Leaflet

IBUPROM SPORT SPRAY
50 mg/g, cutaneous spray, solution
Ibuprofen
Please read all of this leaflet carefully before using the 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
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

1. What IBUPROM SPORT SPRAY is and what it is used for
IBUPROM SPORT SPRAY is a medicine intended for topical application to the skin.
It contains ibuprofen, which belongs to a group of medicines called 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 mild musculoskeletal disorders such as mild forms of arthritis, sprains, sports injuries, fibromyalgia, and neuralgia.

2. Important information before using IBUPROM SPORT SPRAY

When not to use IBUPROM SPORT SPRAY

• If you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced hypersensitivity reactions, such as asthma, bronchospasm, rhinitis, angioedema, or urticaria, after taking ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you are in the last three months of pregnancy.
• Do not apply on damaged skin.

Warnings and precautions
If your symptoms worsen or persist after 14 days of treatment, consult your doctor.
Do not use for longer than 14 days without consulting a doctor.
If you have any of the conditions or symptoms described below, you should consult your doctor before starting treatment with IBUPROM SPORT SPRAY.

• Asthma or allergic disease, especially if you have asthma and have not previously taken acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); bronchospasm may occur after using the medicine.
• Kidney disease, even if it occurred in the past; there may be an association between topical use of NSAIDs and kidney failure.
• Active peptic ulcer, history of peptic ulcer, inflammatory bowel disease, or bleeding tendency; topical application of ibuprofen may cause gastrointestinal side effects.

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 the use of ibuprofen. If you experience any of the symptoms related to these serious skin reactions described in section 4, stop using IBUPROM SPORT SPRAY immediately and seek medical help.
This medicine is intended for topical use on the skin only. Do not apply it to damaged or inflamed skin. Avoid contact with eyes and mucous membranes of the mouth. If a rash occurs, discontinue use of the medicine.
To reduce the risk of photosensitivity, during treatment with ibuprofen spray applied to the skin, protect the treated area from strong sources of natural or artificial light.
Do not use under occlusive dressings.
Wash your hands after applying the medicine.

Children and adolescents
Do not use IBUPROM SPORT SPRAY in children under 12 years of age
unless advised by a doctor.

Other medicines and IBUPROM SPORT SPRAY
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Non-steroidal anti-inflammatory drugs may interact with antihypertensive medicines and may enhance the effect of anticoagulants. However, when the spray is used correctly, systemic absorption of ibuprofen is minimal, so such interactions as seen with oral ibuprofen are unlikely.
Concomitant use of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs may increase the frequency of adverse reactions.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use IBUPROM SPORT SPRAY during the last three months of pregnancy. Do not use
IBUPROM SPORT SPRAY during the first six months of pregnancy unless absolutely necessary and
recommended by your doctor. If treatment is required during this period, use the lowest dose for the shortest possible duration.
Oral forms (e.g. tablets) of ibuprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies when ibuprofen is used topically on the skin.

Breastfeeding
Ibuprofen passes into breast milk in very low concentrations and is unlikely to have harmful effects on the breastfed infant. The amount of medicine ingested by the infant is considered negligible.

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

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

IBUPROM SPORT SPRAY contains propylene glycol and benzyl alcohol
The medicine contains 30 mg of propylene glycol and 10 mg of benzyl alcohol in each 1 g of solution. It may cause local skin irritation. Benzyl alcohol may cause allergic reactions.
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3. How to use Ibuprom Sport spray

This medicine should always be used exactly as described in this leaflet. If in doubt, consult a doctor or pharmacist.
For short-term use only.

Dosage
Adults, elderly patients, and children aged 12 years and above
Apply the spray for 1 to 5 seconds (a dose corresponding to approximately 35 mg to 175 mg of ibuprofen).
Do not use the medicine more frequently than every 4 hours and no more than 3 times daily. Do not exceed the recommended dose.
If symptoms persist or worsen after 2 weeks of treatment, consult a doctor.

Method of administration
For topical application to the skin. After applying the spray, gently massage the medicine into the affected area until completely absorbed.
If hands are not being treated, wash hands thoroughly after each application.

Overdose of Ibuprom Sport spray
Overdose following topical administration does not appear likely.
Symptoms of ibuprofen overdose may include: nausea, vomiting, epigastric pain or, less commonly, diarrhoea. Tinnitus, headache, and gastrointestinal bleeding have also been observed, as well as drowsiness, periodic agitation, disorientation, or coma. Seizures, acute renal failure, and liver damage may occur. Exacerbation of bronchial asthma symptoms has been reported in patients with asthma.
In case of accidental ingestion of ibuprofen exceeding 400 mg/kg body weight by a child, contact a doctor immediately. The dose causing overdose symptoms in adults has not been established.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur,
you should inform your doctor or pharmacist.
If any of the following symptoms occur in a patient, ibuprofen use must be stopped immediately and
medical help should be sought:

• red, flat, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genital organs, 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 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).

Frequency unknown: frequency cannot be estimated from the available data:

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

Additional adverse reactions may occur during prolonged treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet,
you should consult your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 reactions can also be reported to the Marketing Authorization Holder.
Reporting adverse reactions allows the collection of further information on the safety of using the medicine.

5. How to store the medicine I S

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Shelf life after first opening the immediate packaging: 6 months.
Do not use this medicine after the expiry date stated on the carton and immediate packaging (month/year). The expiry date refers to the last day of the specified month.
Labelling applied to the container: EXP – expiry date, Lot – batch number.
Pressurised container. Do not pierce or throw into fire, even when empty.
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Protect from sunlight. Do not expose to temperatures above 50°C.
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 package and other information

What the medicine contains
The active substance is ibuprofen. 1 g of solution contains 50 mg of ibuprofen.
Other ingredients: isopropyl alcohol, benzyl alcohol, propylene glycol, sodium hydroxide, purified water, propellant: nitrogen.

What the medicine looks like and contents of the pack
A clear, transparent solution.
Aluminium pressurised container fitted with a spray valve and a polypropylene (PP) cap, packed in a cardboard box.
1 container of 50 g.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław, Poland

Manufacturer
Laboratoires CHEMINEAU
93, route de Monnaie
37210 Vouvray, France

For further information on this medicine, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa, Poland
tel. +48 (22) 543 60 00
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