Ibudol Roll-on 50 mg/g gel with ball applicator
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ibudol roll-on 50 mg/g gel container with roller-ball applicator
Ibuprofen
Read all of this leaflet carefully because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or those given 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 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 this leaflet
- What Ibudol roll-on is and what it is used for
- What you need to know before using Ibudol roll-on
- How to use Ibudol roll-on
- Possible adverse effects
- How to store Ibudol roll-on
- Contents of the pack and other information
1. What Ibudol roll-on 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, sprains (muscle strains), torticollis (neck pain and stiffness), other muscle spasms, lumbago (lower back pain), and mild sprains resulting from twisting injuries.
2. What you need to know before using Ibudol roll-on
Do not use Ibudol roll-on:
-
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, chest tightness, and in some cases coughing or wheezing).
- Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema).
- Other allergic reactions such as: rhinitis, itching, or hives.
-
If you are in the last 3 months of pregnancy.
Take special care with Ibudol roll-on
- Must not be used on mucous membranes or on skin with wounds or eczema.
- This medicine should be applied only on intact skin.
- If you suffer from asthma or are allergic to food or medicine colorants (for example: sunset 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 under occlusive dressings.
- Do not apply the gel over large areas or for prolonged periods. Use exclusively on the affected area.
- Do not apply Ibudol roll-on simultaneously on the same area of skin where other medicines have been applied.
Skin reactions
Take special care with Ibudol roll-on:
Serious skin reactions have been reported, such as 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), associated with treatment with ibuprofen. Discontinue treatment with Ibudol roll-on and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, especially painkillers, including those obtained without a prescription.
Pregnancy, breastfeeding, and fertility
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 Ibudol roll-on if you are in the last 3 months of pregnancy. You should not use Ibudol roll-on during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest dose for the shortest possible time should be used.
Oral forms (e.g., tablets) of Ibudol may cause adverse effects in the fetus. It is unknown whether the same risk applies to Ibudol roll-on when used on the skin.
Use in children
Do not use this medicine in children under 12 years of age due to lack of data in this population.
Driving and use of machines
No effects on the ability to drive vehicles or operate machinery have been reported with external use on the skin.
3. How to use Ibudol
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 topical use only (for application on the skin only).
The usual dose is:
Adults and children over 12 years: apply a thin layer of the gel to the affected area 3 to 4 times daily and gently massage using the built-in rollerball 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, consult your doctor.
If you use more Ibudolroll-ondel than you should:
Due to its topical use, cases of poisoning are 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, drowsiness, dizziness, spasms (cramps), and low blood pressure.
4. Possible adverse effects
Like all medicines, Ibudol roll-on may have adverse effects, although not everyone experiences them.
Like all medicines, Ibudol roll-on may have adverse effects, although not everyone experiences them.
Stop treatment with Ibudol roll-on 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, or ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
- Widespread skin rash, elevated body temperature, and swollen 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).
You may experience the following adverse effects:
- Uncommon (may affect up to 1 in 100 people): redness, itching, and burning sensation on the skin at the application site, which disappear when treatment is discontinued.
- Rare (may affect up to 1 in 1,000 people): sun-induced dermatitis (skin inflammation).
- 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). Discontinue use of Ibudol roll-on if you experience these symptoms and seek immediate medical attention. See also section 2, skin becomes sensitive to light.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect 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 they are possible adverse effects not listed in this leaflet. You may also report them directly through 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 Ibudol roll-on
Keep out of the reach and sight of children.
No special storage conditions required.
Do not use this medicine after the expiry date stated on the container, following CAD:.
The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ibudolroll-on
Each gram of gel contains 50 mg of ibuprofen as the active substance.
The other components (excipients) are: 96 percent ethanol, isopropyl alcohol, hydroxyethylcellulose, diethylene glycol monoethyl ether, caprylocaproyl macrogol glycerides, glycerol (E-422), sodium hydroxide (E-524) (15% aqueous solution), Levo menthol, Reflex aroma (camphor, iso-menthone, L-menthone, borneol, 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 Reflex odour.
It is presented in containers with a roller-ball applicator containing 30 or 60 grams of gel.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder:
Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain
Manufacturer:
Farmasierra Manufacturing, S.L.
Ctra. de Irún km 26,200
San Sebastián de los Reyes 28706 (Madrid)
Spain
This patient information leaflet was last reviewed in January 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/