Patient Information Leaflet: Ibucalm 50 mg/g Mentholated Gel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• This medicine can be obtained without a prescription. However, for the best results, it should be used properly.
• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If your symptoms worsen or persist after 7 days of treatment, you should consult your doctor.
• If you consider that any of the side effects you are experiencing are severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

1. What is Ibucalm and what it is used for.

2. Before using Ibucalm.

3. How to use Ibucalm.4. Possible side effects.

5. Storage of Ibucalm.

6. Additional information.

The ibuprofen, active principle of this medication, acts as a local analgesic and anti-inflammatory.

It is indicated to relieve locally mild and occasional pain and inflammation caused by: small bruises, blows, strains, torticollis or other contractures, lower back pain and mild sprains caused as a result of a twist

Do not use Ibucalm if:

• is allergic (hypersensitive) to ibuprofen or to any of the other components of this medication.
• has a sunburn on the affected area
• has experienced allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, pruritus, or others) caused by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

Be especially careful with Ibucalm

• should not be used on mucous membranes, or on skin with wounds or eczema.
• if you are asthmatic or allergic to any food coloring or medication (such as yellow-orange, tartrazine, etc.) consult your doctor before using this medication.
• should avoid contact with the eyes.
• should not expose the treated area to the sun, or use with bandages or on large areas.
• should not apply simultaneously Ibucalm in the same area where other medications have been applied.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, especially analgesics, even those purchased without a prescription.

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medication.

Use in children

Do not use this medication in children under 12 years old.

Driving and operating machinery

No effects on the ability to drive vehicles and operate machinery have been described when using externally on the skin.

Follow these instructions, unless your doctor has given you different ones. Consult your doctor or pharmacist if you have any doubts.

This medication is for external use only on the skin.

The normal dose is:

Over 12 years old: Apply a thin layer of the product to the painful area 3 to 4 times a day and gently massage it in to help it penetrate.

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 moreIbucalmthan you should:

Due to its external use, it is unlikely that cases of intoxication will occur.

In case of accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (Tel: 915 620 420), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, muscle spasms, and low blood pressure.

Like all medicationsIbucalmmay have adverse effects, although not all people will experience them.

Rarely (observed in 1 to 10 of every 1,000 patients): redness, itching, and a burning sensation on the skin in the application area, which disappear when treatment is discontinued.

Uncommon (observed in 1 to 10 of every 10,000 patients): dermatitis (skin inflammation) caused by the sun.

Unknown frequency: the skin becomes sensitive to light.

If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date appearing on the packaging, after CAD:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition ofIbucalm

Each gram of gel contains 50 mg of ibuprofen as the active ingredient.

The other components (excipients) are: ethanol, isopropyl alcohol, petrolatum, diethylene glycol monoethyl ether, caprylocaproyl macrogolglycerides, 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 package

This medication is a transparent and colorless gel.

It is presented in a tube containing 60 grams of gel.

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/Anabel Segura 11 Edificio Albatros B 1st floor

28108 Alcobendas, Madrid

Responsible for manufacturing:

Farmasierra Manufacturing, S.L.

Irún km 26,200 road

San Sebastián de los Reyes 28700 (Madrid)

This leaflet was approved in: January 2021