Leaflet: information for the user

Novidol 50 mg/g gel

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 your symptoms worsen or do not improve after 7 days (5 days in the case of adolescents) of treatment.

1. What is Novidol and 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 gel form for topical use. This medication belongs to the group of topical anti-inflammatory agents.

This medication is indicated 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.
• On open wounds, mucous membranes, or eczematous skin.
• On a sunburned area.
• In children (under 12 years old).
• If you are in the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Novidol.

• This medication is for topical use only, do not ingest.
• Apply only on intact skin, without wounds.
• You should avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel to extensive areas of the skin, or for a prolonged period.

• Do not use with tight bandages, or apply heat to the area where it is used. If you cover the area where you have used this medication, do it in a way that the garment covering the treated area is slightly loose.
• The treated areas should not be exposed to the sun (even on cloudy days), or to ultraviolet lamps (UVA rays).

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 and adolescents

Do not use this medication in children under 12 years old

Other medications and Novidol

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are 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 you to do so. 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 whether the same risk applies to Novidol when used on the skin.

Driving and operating machinery

No effects on the ability to drive vehicles and operate machinery have been described when using Novidol externally on the skin.

Novidol contains benzyl alcohol and wild herb essence

This medication contains 10 mg of benzyl alcohol in each gram of gel. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

This medication contains wild herb essence with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amilcinamaldehyde, Amylcinnamaldehyde alcohol, Anisyl alcohol, Benzyl alcohol, Benzoate of benzyl, Cinnamoyl benzyl, Salicylate of benzyl, Cinnamaldehyde, Cinnamyl alcohol, Citral, Citronello, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Extract of redwood moss, and Extract of moss, which may cause allergic reactions.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults and adolescents 12 years of age and older is 3 to 4 applications per day.

This medication is for external use on the skin only, on intact skin.Apply a thin layer of the gel to the painful area by gently massaging it in to facilitate penetration.

Wash your hands after each application.

If you use more Novidol than you should

Due to its external use, cases of overdose are unlikely. In the event 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.

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

Rarely (may affect up to 1 in 100 people): redness, inflammation of the skin (dermatitis), local irritation, and itching at the application site, which disappear when treatment is suspended.

Uncommon (may affect up to 1 in 1,000 people): sun-induced dermatitis (inflammation of the skin).

Unknown frequency (cannot be estimated from available data): skin becomes sensitive to light.

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

• Flat, red spots, 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 flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash with skin protuberances and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly to 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.

No special storage conditions are required.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Novidol

The active ingredient is ibuprofen. Each gram of gel contains 50 mg of ibuprofen.

The other components (excipients) are: sodium hydroxide, isopropyl alcohol, hydroxyethylcellulose, benzyl alcohol, wild herb essence, and purified water.

Appearance of the product and contents of the packaging

Transparent, colorless, or slightly yellowish gel. It is presented in a closed aluminum tube with a white polyethylene screw cap containing 60 grams or 100 grams of gel.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

MENARINI CONSUMER HEALTHCARE, S.A.U.

Guifré, 724 E-08918 Badalona (Barcelona) Spain

Responsible for manufacturing

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR S.A

C/ Laguna 66-70, Polígono Industrial Urtinsa II,

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: January 2024.

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