ARAGEL 50 mg/g GEL

2. What you need to know before starting to use Aragel

Do not use Aragel

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication.

Medication.

• If you have a sunburn in the affected area.
• If you are in the last 3 months of pregnancy.
• If you have had allergic reactions caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as:

non-steroidal anti-inflammatory drugs, such as:

• Asthmatic allergic reactions (difficulty breathing, shortness of breath, chest tightness, and in some cases coughing or wheezing when breathing).
• Swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing (angioedema).
• Other allergic reactions such as: rhinitis, itching, or hives.

Warnings and precautions

Be especially careful with Aragel:

• This medication should only be applied to intact skin.
• Do not use it on mucous membranes or on skin with wounds or eczema.

• If you are asthmatic or allergic to any colorant used in food or medications (such as yellow-orange, tartrazine, etc...), you should consult your doctor before using this medication.

using this medication.

Do not use Aragel in the same area of the skin where other medications have been applied.

• Avoid contact with the eyes and mucous membranes.
• Do not apply the gel to large areas or for prolonged periods. Use exclusively on the affected area.
• Do not use occlusive dressings.
• The treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet lamps (UVA rays).
• Severe skin reactions, 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), have been reported in association with Aragel treatment. Discontinue Aragel treatment and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, especially pain relievers, including those purchased without a prescription.

Pregnancy and breastfeeding

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 medication.

Do not use Aragel if you are in the last 3 months of pregnancy. You should not use Aragel during the first 6 months of pregnancy unless it is clearly necessary and your doctor advises you to do so. If you need treatment during this period, you should use the lowest dose for the shortest possible time.

Oral forms (e.g., tablets) of Ibuprofen may cause adverse reactions in the fetus. It is not known if the same risk applies to Aragel when used on the skin.

Use in children

Do not use this medication in children under 12 years old due to the lack of data in this population.

Driving and using machines

No effects on the ability to drive vehicles or use machinery have been described when used externally on the skin.

3. How to use Aragel

Follow the administration instructions for Aragel exactly as indicated, unless your doctor has told you otherwise. Consult your doctor or pharmacist if you have any doubts.

This medication is for external use only (to be applied only to the skin).

The normal dose is:

Adults and children over 12 years old: apply a thin layer of the gel to the painful area, 3 or 4 times a day.

Instructions for the correct use of the medication:

• In the first administration, you can use the cap to open the tube (invert the cap and pierce).
• Apply the gel by gently massaging to facilitate penetration into the affected area.
• Wash your hands after each application.

If the symptoms worsen or persist after 7 days of treatment, or if irritation or redness of the area occurs, you should discontinue treatment and consult a doctor.

If you use more Aragel than you should

Due to its external use, it is unlikely that intoxication will occur. However, if you have used Aragel more than you should or in case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone: 91 562 04 20), indicating the medication and the amount ingested, as it may cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure. Bring this leaflet with you if possible.

If you forget to use Aragel

If you forgot to apply this medication when it was due, apply the gel as soon as possible and continue the treatment normally.

Do not apply a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, Aragel can cause side effects, although not everyone will experience them.

You may experience the following side effects:

• Uncommon (observed in 1 to 10 out of 1,000 patients): redness, itching, and burning sensation on the skin in the application area, which disappear when treatment is discontinued.
• Rare (observed in 1 to 10 out of 10,000 patients): dermatitis (skin inflammation) caused by the sun.
• Frequency not known (cannot be estimated from available data): the skin becomes sensitive to light. Generalized red scaly rash, with bumps under the skin and blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Aragel if you experience these symptoms and seek immediate medical attention. See also section 2.

Stop using Aragel if you experience these symptoms and seek immediate medical attention. See also section 2.

Discontinue Aragel treatment and seek immediate medical attention if you notice any of the following symptoms:

• Red patches, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Adverse reaction reporting

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aragel

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Aragel after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not use Aragel if you notice visible signs of deterioration (broken gel tube).

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Aragel composition

The active ingredient is ibuprofen.

Each gram of gel contains: 50 mg of ibuprofen.

The other components (excipients) are: isopropyl alcohol, diisopropanolamine 90 percent, macrogol 300, carbomer, levomenthol, and purified water.

Product appearance and package contents

Aragel is a transparent gel with a menthol odor.

It is presented in a 60-gram aluminum tube containing gel.

Marketing authorization holder and manufacturer

ARAFARMA GROUP, S.A.

C/Fray Gabriel de San Antonio 6-10

Pol. Ind. el Henares

19180 Marchamalo (Guadalajara). Spain

Date of the last revision of this leaflet:January 2024