IBUCALM 50 mg/g MENTHOLATED GEL

Introduction

Package Leaflet: Information for the Patient

Ibucalm 50 mg/g mentholated gel

Read the entire package leaflet carefully because it contains important information for you.

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

Contents of the package leaflet:

1. What Ibucalm is 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.

1. What Ibucalm is and what it is used for

Ibuprofen, the active ingredient of this medication, acts as a local analgesic and anti-inflammatory.

It is indicated to locally relieve mild and occasional pain and inflammation caused by: minor bruises, blows, strains, torticollis or other contractures, mild lumbalgia and sprains produced as a consequence of a twist.

2. Before using Ibucalm

Do not use Ibucalm if:

• you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medication.
• you have a sunburn in the affected area.
• you have suffered allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, itching or others) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Be careful with Ibucalm:

• it should not be used on mucous membranes, nor on skin with wounds or eczema.
• you should avoid eye contact.
• you should not expose the treated area to the sun, nor use it with bandages or on extensive areas.
• you should not apply Ibucalm simultaneously in the same area where other medications have been applied.

Use of other medications:

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

Pregnancy and Breastfeeding:

Consult your doctor or pharmacist before using any medication.

Use in Children:

Do not use this medication in children under 12 years of age.

Driving and Using Machines:

No effect on the ability to drive vehicles and use machinery has been described when 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 doubts.

This medication is for external use only (on the skin).

The normal dose is:

Over 12 years: apply a thin layer of the product to the painful area 3 to 4 times a day and perform a gentle massage to facilitate its penetration.

Do not use for more than 7 consecutive days.

If symptoms worsen or persist after 7 days of treatment, you should consult a doctor.

If you use more Ibucalm than 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 Toxicology Information Service (Tel: 915 620 420), indicating the medication and the amount ingested, as it can cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure.

4. Possible Side Effects

Like all medications, Ibucalm can have side effects, although not all people experience them.

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

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

Frequency not known: the skin becomes sensitive to light.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this package 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 medication after the expiration date that appears on the packaging, after CAD:. The expiration date is the last day of the month indicated.

Medications should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications 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 ingredient.

The other components (excipients) are: ethanol, isopropyl alcohol, hietelosa, diethylene glycol monoethyl ether, macrogolglycerides of capric/caprylic acid, glycerol (E-422), sodium hydroxide (E-524), menthol, aroma (methyl salicylate and other aromas), and purified water.

Appearance of the product and packaging content:

This medication is a transparent and colorless gel.

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

Marketing authorization holder:

Teva Pharma, S.L.U.

C/Anabel Segura 11 Edificio Albatros B 1ª planta.

28108 Alcobendas, Madrid.

Manufacturer:

Farmasierra Manufacturing, S.L.

Ctra. de Irún km 26,200.

San Sebastián de los Reyes 28700 (Madrid).

This package leaflet was approved in: January 2021.