Ibuprom Sport sprai

Package Leaflet: Information for the Patient

IBUPROM SPORT SPRAY

50 mg/g, spray for the skin, solution
Ibuprofen

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Package Leaflet

• 1. What is IBUPROM SPORT SPRAY and what is it 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 package and other information

1. What is IBUPROM SPORT SPRAY and what is it used for

IBUPROM SPORT SPRAY is a medicine for topical use on the skin.
It contains 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 occurring in musculoskeletal system diseases, 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 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 using ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you are in the last 3 months of pregnancy.
• Do not use on damaged skin.

Warnings and precautions

If the symptoms of the disease worsen or persist after 14 days of treatment, consult your doctor.
Do not use for more than 14 days without consulting your doctor.
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If you have any of the following diseases or symptoms, you should consult your doctor before using IBUPROM SPORT SPRAY.

• Asthma or allergic disease, especially if you have asthma and have not previously taken acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; after using the medicine, bronchospasm may occur.
• Kidney disease, also occurring in the past; there may be a link between topical use of NSAIDs and kidney failure.
• Active or previously diagnosed stomach ulcer, inflammatory bowel disease, or bleeding disorder; topical use of ibuprofen may cause gastrointestinal side effects.

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 the use of ibuprofen. If you experience any of the symptoms associated with these severe skin reactions described in section 4, stop using IBUPROM SPORT SPRAY and seek medical attention immediately.
The medicine is intended for topical use on the skin only. Do not use on damaged or inflamed skin. Avoid contact with eyes and mucous membranes of the mouth. If a rash occurs, discontinue use of the medicine.
To minimize the risk of photosensitivity, protect the treated area from strong natural or artificial light sources during treatment with ibuprofen spray.
The medicine is not intended for 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 without consulting a doctor.

IBUPROM SPORT SPRAY and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Nonsteroidal anti-inflammatory drugs may interact with antihypertensive drugs and may enhance the effects of anticoagulant drugs. However, if the spray is used correctly, the absorption of ibuprofen into the bloodstream is low, 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.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use IBUPROM SPORT SPRAY in the last 3 months of pregnancy. Do not use IBUPROM SPORT SPRAY during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period, use the smallest dose for the shortest possible time.
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Oral forms (e.g., tablets) of ibuprofen may cause side effects in the unborn child. It is not known whether the same risk applies to ibuprofen when used topically.
Breastfeeding
Ibuprofen passes into breast milk in very small amounts and is unlikely to affect the breastfed infant. The dose of the medicine taken by the infant is considered negligible.
Fertility
No effect on fertility has been observed after topical use.

Driving and using machines

Unknown: the effect on the ability to drive and use machines has not been determined.

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. The medicine may cause local skin irritation. Benzyl alcohol may cause allergic reactions.

3. How to use IBUPROM SPORT SPRAY

This medicine should always be used exactly as described in this package leaflet. If you are unsure, consult your doctor or pharmacist.
For short-term use only.

Dosage

Adults, elderly, and children over 12 years of age
Apply the spray for 1 to 5 seconds (dose equivalent to approximately 35 mg to 175 mg of ibuprofen).
Do not use more frequently than every 4 hours and no more than 3 times a day. Do not exceed the recommended dose.
If after 2 weeks of using the medicine the symptoms do not improve or worsen, consult your doctor.

Method of administration

For topical use on the skin. After applying the spray, gently massage the medicine into the affected area until completely absorbed.
If there is no need to apply the medicine to your hands for therapeutic purposes, wash your hands after each application.

Overdose of IBUPROM SPORT SPRAY

Overdose after topical application is unlikely.
Symptoms of ibuprofen overdose include: nausea, vomiting, abdominal pain, or less frequently diarrhea. Tinnitus, headache, and gastrointestinal bleeding have also been observed, as well as drowsiness, periodic excitement, and disorientation or coma. Seizures, acute kidney failure, and liver damage may occur. Exacerbation of asthma symptoms has also been reported in patients with asthma.
If a child ingests a dose of ibuprofen greater than 400 mg/kg, consult a doctor. The dose causing overdose symptoms in adults has not been determined.
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4. Possible side effects

Like all medicines, IBUPROM SPORT SPRAY can cause side effects, although not everybody gets them.
If any of the side effects get worse or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.
If you experience any of the following symptoms, stop using ibuprofen and seek medical attention immediately:

• red, non-raised, target-like or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. 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 body temperature, 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).

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

• hypersensitivity,
• abdominal pain, nausea,
• kidney function disorders,
• 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,
• asthma, worsening of asthma, and bronchospasm,
• various rashes, urticaria, angioedema.

Additional side effects may occur during long-term treatment.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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

Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store IBUPROM SPORT SPRAY

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Shelf life after first opening: 6 months.
Do not use this medicine after the expiry date stated on the carton and the immediate packaging (month/year). The expiry date refers to the last day of the month.
Labeling used for the container: EXP - expiry date, Lot - batch number.
Pressurized container. Do not pierce or burn, even after use.
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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 IBUPROM SPORT SPRAY contains

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

What IBUPROM SPORT SPRAY looks like and contents of the package

Clear, transparent solution.
Aluminum pressurized container, closed with a spray valve and a polypropylene cap (PP), in a cardboard box.
1 container of 50 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Laboratoires CHEMINEAU
93, route de Monnaie
37210 Vouvray, France
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warsaw
tel. +48 (22) 543 60 00

Date of last revision of the package leaflet:

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