Leaflet: information for the user

Novidol 50 mg/ml skin spray solution

Ibuprofen

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if the symptoms persist or worsen, or if new disorders appear after 7 days of treatment (5 days in the case of adolescents).

1. What isNovidoland what it is used for

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

3. How to useNovidol

4. Possible side effects

5. Storage ofNovidol

6. Contents of the pack and additional information

Novidol is presented in the form of a topical skin spray solution.

This medication contains ibuprofen, which belongs to the group of topical nonsteroidal anti-inflammatory drugs.

This medication is used in adults and adolescents aged 12 years and above for the local relief of mild and occasional pain and inflammation caused by: small bruises, blows, strains, torticollis or other contractures, back pain (lumbalgias) or mild sprains resulting from a twist.

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 nonsteroidal anti-inflammatory drug (including after oral administration).Reactions that indicate allergy may be:asthma, allergic rhinitis (nasal allergy) or urticaria (skin allergy).
• On open wounds, mucous membranes or eczematous skin.
• If you have a sunburn on 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 on cloudy days), nor to ultraviolet lamps (UVA rays).
• Wash your hands after each application, unless it is the area to be treated.
• Do not use tight bandages, or apply heat to the area where this medication is used. If you need to cover the area, do it in a way that the clothing 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 case of adolescents) of treatment or irritation or worsening occurs, consult your doctor.
• In case of frequent use by a healthcare professional, it is recommended to use gloves.
• Do not apply simultaneouslyNovidolin the same area of the 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), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue Novidol treatment and seek medical attention immediately 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.

Use of Novidol with other medications

Inform your doctor or pharmacist if you are using, have used recently 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 the skin where this medication is being used.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or planning to become pregnant, 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 your doctor advises it. If treatment is needed 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 whether 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 infant with topical administration under the established conditions of use. Do not use during breastfeeding unless medically advised.

Driving and operating machinery

No effects on the ability to drive vehicles and use machineryhave been described when using Novidol 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.

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

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

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

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

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

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

Respect the frequency and duration of treatment. To reduce symptoms, use the most effective dose for the shortest time possible.

If you use more Novidol than you should

Wash abundantly with water.

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

If you forgot to use Novidol

Do not apply a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The recorded adverse effects are detailed below according to their frequencies:

Rare (may affect up to 1 in 100 people): itching (pruritus), localized skin redness (erythema), skin inflammation (dermatitis), localized irritation, at the site of application that disappear upon suspending treatment.

Rare (may affect up to 1 in 1000 people): dermatitis (skin inflammation) caused by the sun.

Unknown frequency (cannot be estimated from available data): the skin becomes sensitive to light (photosensitivity) presenting with skin redness and inflammation. Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop using the medication if you experience these symptoms and seek medical attention immediately. See also section 2.

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

• Flat, red, target-shaped, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting Adverse Effects

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

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

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.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Novidol

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 Novidoland contents of the packaging

Colourless and transparent solution for topical application in a pressurized container. Packaging of 50 ml.

Marketing Authorization Holder

Menarini Consumer Healthcare, S.A.U.

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

Responsible for Manufacturing

Laboratoires Chemineau

93, Route de Monnaie

37210 Vouvray, France

Last review date of this leaflet: January 2024.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/