NOVIDOL 50 mg/ml CUTANEOUS SPRAY SOLUTION

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

Do not use Novidol:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you are allergic to acetylsalicylic acid or any other analgesic or non-steroidal anti-inflammatory drug (including after oral administration). The reactions that indicate allergy could be: asthma, allergic rhinitis (nasal allergy), or urticaria (skin allergy).
• On open wounds, mucous membranes, or eczematous skin.
• If you have a sunburn in the affected area.
• If you are in the last 3 months of pregnancy.

Warnings and Precautions

• This medication should only be applied to intact skin.
• Avoid contact with mucous membranes (nose, mouth) and eyes.
• Treated areas should not be exposed to the sun (even when cloudy), nor to ultraviolet lamps (UVA rays).
• Wash your hands after each application, unless it is the area being treated.
• Do not use tight bandages, nor apply heat to the area where this medication is used. If you need to cover the area where you have used this medication, do so in a way that the garment covering the treated area is slightly loose.
• Do not use on extensive areas of the skin.
• If symptoms persist for more than 7 days (5 days in the case of adolescents) of treatment or irritation or worsening occurs, consult your doctor.
• In case of frequent use by a healthcare professional, the use of gloves is recommended.
• Do not apply Novidol simultaneously to the same area of skin where other medications have been applied.

Be especially careful with Novidol:

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 ibuprofen treatment. Discontinue treatment with Novidol and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children

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

Using Novidol with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

Do not apply other topical preparations to the same area of skin where you are using this medication.

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 Novidol if you are in the last 3 months of pregnancy. Do not use Novidol during the first 6 months of pregnancy unless it is clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest effective dose should be used 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 Novidol when used on the skin.

The amount of ibuprofen in breast milk is negligible, and no undesirable effects are expected in the breastfed infant with topical administration under established conditions of use. Do not use during breastfeeding unless advised by a doctor.

Driving and Using Machines

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

Novidol contains propylene glycol (E1520) and benzyl alcohol (E1519)

This medication contains 30 mg of propylene glycol in each milliliter of solution.

This medication contains 10 mg of benzyl alcohol in each milliliter of solution. Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Novidol

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

The recommended dose in adults and adolescents from 12 years old is one application (1 to 3 seconds), 3 or 4 times a day.

This is a medication for external use only (on the skin). To facilitate its penetration, apply the solution through a light and prolonged massage in the painful or inflamed area.

Wash your hands well after each use, unless it is the area being treated.

Treatment is limited to a maximum of 7 days (5 days in the case of adolescents).

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

Respect the frequency and duration of treatment. To reduce symptoms, the lowest effective dose should be used for the shortest possible time.

If you use more Novidol than you should

Rinse abundantly with water.

Due to its external use, it is unlikely that cases of intoxication will occur. In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Novidol

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

The reported side effects are detailed below according to their frequencies:

Uncommon (may affect up to 1 in 100 people): itching (pruritus), skin redness (localized erythema), skin inflammation (dermatitis), local irritation, at the application site that disappears when treatment is discontinued.

Rare (may affect up to 1 in 1,000 people): dermatitis (skin inflammation) caused by the sun.

Frequency not known (cannot be estimated from available data): the skin becomes sensitive to light (photosensitivity) presenting redness and skin inflammation. Generalized red scaly eruption, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using the medication if you present these symptoms and seek immediate medical attention. See also section 2.

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

• Reddish 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 eruptions can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

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

5. Storage of Novidol

Keep this medication out of sight and reach of children.

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

Pressurized container. Protect from sunlight and do not expose to temperatures above 50 °C. Do not puncture or burn, even after use.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Novidol Composition

The active ingredient is ibuprofen. Each milliliter of solution contains 50 mg of ibuprofen.

The other components (excipients) are: isopropyl alcohol, benzyl alcohol (E1519), propylene glycol (E1520), sodium hydroxide, and purified water.

Propellant: nitrogen gas.

Appearance of Novidol and Package Contents

Colorless and translucent solution for cutaneous application in a pressurized container. 50 ml container.

Marketing Authorization Holder

Menarini Consumer Healthcare, S.A.U.

Guifré, 724 E-08918 Badalona (Barcelona), Spain

Manufacturer

Laboratoires Chemineau

93, Route de Monnaie

37210 Vouvray, France

Date of the last revision of this package leaflet: January 2024.

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