Ibucalm 50 mg/g mentholated gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ibucalm 50 mg/g mentholated gel
Read the entire leaflet carefully as it contains important information for you.
- This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist after 7 days of treatment, you should consult a doctor.
- 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.
Leaflet contents:
- What Ibucalm is and what it is used for.
- Before you use Ibucalm
- How to use Ibucalm
- Possible side effects
- How to store Ibucalm
- Further information
1. What Ibucalm is and what it is used for
Ibuprofen, the active ingredient in this medicine, acts as a local analgesic and anti-inflammatory.
It is indicated for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, sprains, torticollis or other muscle spasms, lumbago, and mild sprains resulting from twisting injuries.
2. Before using Ibucalm
Do not use Ibucalm if:
- you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine.
- you have sunburn in the affected area.
- you have had allergic reactions (rhinitis, breathing difficulties or asthma, urticaria, pruritus or others) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Take special care with Ibucalm
- must not be used on mucous membranes or on skin with wounds or eczema.
- if you have asthma or are allergic to any food or medicinal dyes (such as, for example: orange-yellow, tartrazine, etc.), you should consult your doctor before using this medicine.
- avoid contact with the eyes.
- the treated area must not be exposed to sunlight, and bandages must not be used, nor should it be applied over extensive areas.
- do not apply Ibucalm simultaneously to the same area where other medicines have been applied.
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.
Use in children
Do not use this medicine in children under 12 years of age.
Driving and using machines
No effects on the ability to drive vehicles or use machinery have been reported when this medicine is used externally on the skin.
3. How to use Ibucalm
Follow these instructions 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 (on the skin).
The usual dose is:
Over 12 years of age: apply a thin layer of the product to the painful area 3 to 4 times a day and gently massage to aid penetration.
Do not use for more than 7 consecutive days.
If symptoms worsen or persist after 7 days of treatment, you should consult your doctor.
If you use more Ibucalm than you should:
Due to its external use, poisoning is unlikely.
In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 915 620 420), indicating the medicine and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure.
4. Possible adverse effects
Like all medicines, Ibucalm may have adverse effects, although not everyone experiences them.
Uncommon (observed in 1 to 10 out of 1,000 patients): redness, itching, and burning sensation of the skin at the application site, which disappear upon discontinuation of treatment.
Rare (observed in 1 to 10 out of 10,000 patients): dermatitis (skin inflammation) caused by sunlight.
Frequency not known: skin becomes sensitive to light.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
5. Storage of Ibucalm
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container, following EXP:. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Ibucalm
Each gram of gel contains 50 mg of ibuprofen as the active substance.
The other components (excipients) are: ethanol, isopropyl alcohol, hetastarch, diethylene glycol monoethyl ether, caprylic/capric macrogol glycerides, glycerol (E-422), sodium hydroxide (E-524), menthol, fragrance (methyl salicylate and other fragrances), and purified water.
Appearance of the product and contents of the container
This medicine is a clear, colorless gel.
It is supplied in a tube containing 60 grams of gel.
Marketing Authorization Holder:
Teva Pharma, S.L.U.
C/Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid
Manufacturer:
Farmasierra Manufacturing, S.L.
Ctra. de Irún km 26,200
San Sebastián de los Reyes 28700 (Madrid)
This leaflet was approved in: January 2021