Novidol 50 mg/ml solution for cutaneous spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Novidol 50 mg/ml cutaneous spray solution
Ibuprofen
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or as 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if symptoms persist or worsen, or if new disorders appear after 7 days of treatment (5 days in adolescents).
Contents of the leaflet:
- What Novidol is and what it is used for
- What you need to know before using Novidol
- How to use Novidol
- Possible adverse effects
- How to store Novidol
- Contents of the pack and other information
1. What Novidol is and what it is used for
Novidol is available as a cutaneous spray solution (for application on the skin).
This medicine contains ibuprofen, which belongs to the group of topical non-steroidal anti-inflammatory drugs.
This medicine is used in adults and adolescents from 12 years of age for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, sprains, torticollis or other muscle spasms, back pain (lumbago), or mild sprains resulting from twisting injuries.
2. What you need to know before using Novidol
Do not use Novidol:
- If you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to acetylsalicylic acid (aspirin) or to any other analgesic or non-steroidal anti-inflammatory drug (including after oral administration). Reactions indicating allergy may include: asthma, allergic rhinitis (nasal allergy), or urticaria (skin allergy).
- On open wounds, mucous membranes, or eczematous skin.
- If you have sunburn in the affected area.
- If you are in the last 3 months of pregnancy.
Warnings and precautions
- This medicine should only be applied to intact skin.
- Avoid contact with mucous membranes (nose, mouth) and eyes.
- Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet lamps (UV rays).
- Hands must be washed after each application, unless the area being treated is the hands.
- Do not use tight bandages or apply heat to the area where this medicine is used. If covering the treated area, do so loosely with clothing or dressing.
- Do not use over large areas of skin.
- If symptoms persist for more than 7 days (5 days in adolescents) of treatment, or if irritation or worsening occurs, consult your doctor.
- In case of frequent use by healthcare professionals, wearing gloves is recommended.
- Do not apply Novidol simultaneously on the same area of skin where other medicines have been applied.
Take special care with Novidol:
Serious skin reactions have been reported, 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), associated with ibuprofen treatment. Discontinue treatment with Novidol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
Children
Do not use this medicine in children under 12 years of age.
Use of Novidol with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Do not apply other topical preparations to the same area of skin where you are using this medicine.
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 medicine.
Do not use Novidol during the last 3 months of pregnancy. You should not use Novidol during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest dose for the shortest possible time should be used.
Oral forms (e.g., tablets) of ibuprofen may cause adverse effects 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 undesirable effects in the breastfed infant are not expected with topical use under the established conditions of use. However, Novidol should not be used during breastfeeding unless recommended by a doctor.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported when this medicine is used externally on the skin.
Novidol contains propylene glycol (E1520) and benzyl alcohol (E1519)
This medicine contains 30 mg of propylene glycol in each milliliter of solution.
This medicine 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 exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults and adolescents aged 12 years and older is one application (1 to 3 seconds), 3 or 4 times daily.
This is a medicine for external cutaneous use only (on the skin). To facilitate its penetration, apply the solution with a gentle and prolonged massage to the painful or inflamed area.
Wash your hands thoroughly after each use, unless the hands are the area being treated.
Treatment should not exceed 7 days maximum (5 days in the case of adolescents).
If symptoms worsen or persist beyond 7 days of treatment, or if irritation or redness of the area occurs, consult your doctor.
Adhere to the recommended frequency and duration of treatment. To minimize symptoms, use the lowest effective dose for the shortest possible time.
If you use more Novidol than you should
Rinse thoroughly with water.
Due to its external use, cases of poisoning are unlikely. In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Novidol
Do not apply a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects reported are listed below according to their frequency:
Uncommon (may affect up to 1 in 100 people): itching (pruritus), redness of the skin (localized erythema), skin inflammation (dermatitis), local irritation at the application site, which disappear when treatment is stopped.
Rare (may affect up to 1 in 1,000 people): sun-induced dermatitis (skin inflammation).
Frequency not known (cannot be estimated from available data): skin becomes sensitive to light (photosensitivity), presenting redness and inflammation of the skin. Generalized red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using the medicine if you experience 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:
- Flat reddish spots, target-like or circular, on the trunk, often with blisters in the center, peeling skin, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
- Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Novidol
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the container and additional information
Composition of Novidol
The active substance is ibuprofen. Each millilitre 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 contents of the container
Colourless and translucent solution for cutaneous application in a pressurised container. 50 ml container.
Marketing Authorisation Holder
Menarini Consumer Healthcare, S.A.U.
Guifré, 724 E-08918 Badalona (Barcelona), Spain
Manufacturer responsible for production
Laboratoires Chemineau
93, Route de Monnaie
37210 Vouvray, France
Date of the most recent revision of this leaflet: January 2024.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/