DILTIX 47 mg/ml CUTANEOUS SPRAY SOLUTION

2. What you need to know before using Diltix

Do not use Diltix

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6.1)
• if you have a sunburn in the affected area.
• if you have suffered allergic reactions (rhinitis, difficulty breathing or asthma, urticaria, itching or other) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• if you are in the last 3 months of pregnancy.

Warnings and Precautions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Diltix and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

• It should not be used on mucous membranes, nor on skin with wounds or eczema.
• If you are asthmatic or allergic to any colorant used in food or medicine (such as yellow-orange tartrazine, etc.), you should consult your doctor before using this medicine.
• You should avoid eye contact.
• Do not expose the treated area to the sun, nor use with bandages or on large areas.
• Do not apply Diltix simultaneously in the same area where other medicines have been applied.

Skin Reactions

Severe skin reactions have been reported with Diltix treatment. Stop using Diltix and seek medical attention immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See also section 2.

Use of Other Medicines

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

Pregnancy, Breastfeeding, and Fertility

Pregnancy:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use ibuprofen if you are in the last 3 months of pregnancy. Do not use ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and advised by your doctor. If you need treatment during this period, 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 unknown if the same risk applies to ibuprofen when used on the skin.

Breastfeeding:

Women who are breastfeeding should consult their doctor or pharmacist before using this medicine.

Children and Adolescents

Do not use this medicine in children (under 12 years old).

Important Information about Some Components of Diltix Cutaneous Spray Solution

As it contains ethanol as an excipient, frequent applications may cause skin irritation and dryness.

3. How to Use Diltix

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Diltix is a medicine for external use only (on the skin).

Adults and adolescents over 12 years old: Place the container in a vertical position at a distance of 10-15 cm and apply a thin layer of the product to the painful area 3 to 4 times a day, performing a gentle massage to facilitate penetration.

Wash your hands after each application.

Do not use for more than 7 consecutive days.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you use more Diltix than you should

Due to its external use, it is unlikely to cause poisoning cases. In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Tel: 91.562.04.20), indicating the medicine and the amount ingested, as it can cause: nausea, vomiting, abdominal pain, drowsiness, dizziness, spasms, and low blood pressure.

If you forget to use Diltix:

Do not use a double dose to make up for forgotten doses, simply continue with the usual treatment as soon as possible.

Do not exceed the recommended application frequency or treatment duration.

If you stop treatment with Diltix

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Diltix can cause side effects, although not everyone may experience them.

• Uncommon (may affect up to 1 in 100 patients): 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 patients): dermatitis (skin inflammation) caused by the sun.
• Very rare (may affect up to 1 in 10,000 people): red, non-raised, target-like or circular spots 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].
• Frequency not known: Generalized skin rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome). The skin becomes sensitive to light. Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). Stop using Diltix if you present these symptoms and seek immediate medical attention. See also section 2.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the notification system included in the Spanish Pharmacovigilance System for Human Use Medicines.

Website: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

If you consider that any of the side effects you suffer from is serious or if you notice any side effect not mentioned in the package leaflet, inform your doctor or pharmacist.

5. Storage of Diltix

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use Diltix after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Diltix Cutaneous Spray Solution

• The active substance is ibuprofen. Each ml of Diltix cutaneous spray solution contains 46.9 mg of ibuprofen.

• The other components (excipients) are: diethylene glycol monoethyl ether, caprylocapric glycerides, propylene glycol laurate, ethanol 40% v/v, and purified water.

Appearance of the Product and Package Contents

Colorless solution with a characteristic odor.

High-density polyethylene bottles with a dosing system that includes a polyethylene and polypropylene pump, a polypropylene actuator, and a high-density polyethylene cap.

It is presented in containers that contain 60 and 125 ml of cutaneous spray solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Laboratorios Italfármaco

C/ San Rafael, nº 3

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Package Leaflet: December 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/