Ibustick 50 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ibustick 50 mg/g gel
Ibuprofen
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for using this medicine as described in this leaflet, or those given to you by your doctor, pharmacist, or nurse.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
- What Ibustick is and what it is used for.
- What you need to know before using Ibustick.
- How to use Ibustick.
- Possible adverse effects.
- Storage of Ibustick.
- Contents of the pack and other information.
1. What Ibustick is and what it is used for
Ibuprofen, the active ingredient in this medicine, acts as a local analgesic and anti-inflammatory.
This medicine is indicated for adults and adolescents from 12 years of age for the relief of mild and occasional pain and inflammation caused by: minor bruises, blows, strains (muscle pulls), torticollis (neck pain and stiffness), other muscle contractures, lumbago (low back pain), and mild sprains resulting from twisting injuries.
2. What you need to know before using Ibustick.
Do not use Ibustick:
-
If you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine.
-
If you have sunburn in the affected area.
-
If you have experienced allergic reactions caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), such as:
- Asthma-type allergic reactions (difficulty breathing, suffocation, tightness in the chest, and in some cases coughing or wheezing).
- Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).
- Other allergic reactions such as: rhinitis, itching, or urticaria.
-
If you are in the last 3 months of pregnancy.
Warnings and precautions
- Do not use on mucous membranes or on skin with wounds or eczema.
- This medicine should be applied only on intact skin.
- If you are asthmatic or allergic to any food or medicinal dyes (for example: orange-yellow, tartrazine, etc.), you should consult your doctor before using this medicine.
- Avoid contact with eyes and mucous membranes.
- Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet (UVA) lamps.
- Do not use with occlusive dressings.
- Do not apply the gel over large areas or for prolonged periods. Use only on the affected area.
- Do not apply Ibustick ibuprofen simultaneously to the same area where other medicines have been applied.
- Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Discontinue treatment with Ibustick and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Special caution is recommended with Ibustick 50 mg/g gel.
Skin reactions
Serious skin reactions have been reported with treatment using Ibustick. Stop using Ibustick and consult a doctor immediately if you develop any skin rash, lesions of mucous membranes, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, especially analgesics, including those obtained without a prescription.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Pregnant or breastfeeding women should not use this medicine without consulting their doctor or pharmacist.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not use Ibustick during the last 3 months of pregnancy. You should not use Ibustick during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest effective dose should be used for the shortest possible time.
Oral forms (e.g., tablets) of ibuprofen may cause adverse effects in the fetus. It is unknown whether the same risk applies when ibuprofen is used topically on the skin.
Use in children
Do not use this medicine in children under 12 years of age due to limited data in this population.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported with external use on the skin.
Ibustick contains B.H.T. (butylated hydroxytoluene) (E 321). It may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.
Ibustick contains ethanol. This medicine contains 200 mg of alcohol (ethanol) in each gram of gel. It may cause a burning sensation on damaged skin.
3. How to use Ibustick.
Follow exactly the instructions below, unless your doctor has given you different ones. Consult your doctor or pharmacist if you have any doubts.
This medicine is for cutaneous use only (to be applied on the skin only).
The recommended dose is:
Adults and children over 12 years: apply a thin layer of the product to the painful area 3 to 4 times a day and gently massage with the roll-on applicator to enhance penetration.
Wash your hands after each application. Do not use for more than 7 consecutive days.
If symptoms worsen or persist after 7 days of treatment, or if irritation or redness of the area occurs, you should consult your doctor.
If you use more Ibustick than you should:
Due to its external use, poisoning is unlikely. However, if you have used more of this medicine than recommended, or in case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915620420), indicating the medicine and the amount ingested, as the following may occur: nausea, vomiting, abdominal pain, somnolence, dizziness, spasms (cramps), and low blood pressure.
4. Possible adverse effects
Like all medicines, Ibustick can have adverse effects, although not everyone will experience them.
You may experience the following adverse effects:
-
Uncommon (may affect up to 1 in 100 people): redness, itching, and burning sensation of the skin at the application site, which disappear when treatment is discontinued.
-
Rare (may affect up to 1 in 1,000 people): dermatitis (skin inflammation) caused by sunlight.
-
Frequency “not known”: Widespread red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
Stop using Ibustick if you experience these symptoms and seek immediate medical attention. See also section 2.
The skin becomes sensitive to light.
Discontinue treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:
-
Flat red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, peeling skin, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
-
Generalized skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
-
Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ibustick
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container, after EXP:. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their containers. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Ibustick
Each gram of gel contains 50 mg of ibuprofen as the active substance.
The other components (excipients) are: 96% ethanol, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, caprylocaproyl macrogol glycerides, glycerol (E-422), sodium hydroxide (E-524) (15% aqueous solution), levomenthol, Réflex flavour (camphor, L-menthone, methyl salicylate, B.H.T (E-321)), and purified water.
Appearance of the medicine and contents of the pack
This medicine is a transparent, colourless gel with a Réflex odour.
It is supplied in a roll-on applicator bottle containing 30 or 60 grams of gel.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder:
Farmasierra Laboratorios, S.L.
Ctra. de Irún km 26,200
28709, San Sebastián de los Reyes (Madrid)
Spain
Manufacturer:
Farmasierra Manufacturing, S.L.
Ctra. de Irún km 26,200
28709, San Sebastián de los Reyes
(Madrid)
Spain
This leaflet was last reviewed in December 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/