NOVIDOL 50 mg/g GEL

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 (included in section 6).
• If you are allergic to acetylsalicylic acid or any other non-steroidal analgesic or anti-inflammatory drug.
• On open wounds, mucous membranes, or eczematous skin.
• If you have a sunburn in the affected area.
• In children (under 12 years of age).
• 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 cutaneous use only, do not ingest.
• Apply only to intact skin, without wounds.
• You should avoid contact with mucous membranes (nose, mouth) and eyes.
• Do not apply the gel to very extensive areas of the skin, nor for a prolonged period.

• Do not use with tight bandages, nor apply heat to the area where it is used. In case of covering the area where this medication has been used, do it in such a way that the garment that covers the treated area remains slightly loose.
• The treated areas should not be exposed to the sun (even if it is cloudy), nor to ultraviolet ray 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), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Interrupt 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 and adolescents

Do not use this medication in children under 12 years of age

Other medications and Novidol

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

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

Pregnancy, breastfeeding, and fertility

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. You should 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, you should 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 Novidol when used on the skin.

Driving and using machines

No effects on the ability to drive vehicles and use machinery have been described when used 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, Amyl cinnamaldehyde, Amyl cinnamaldehyde alcohol, Anisic alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamaldehyde, Cinnamic alcohol, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, Hydroxy methyl pentyl cyclohexene carboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptin carbonate, Oakmoss extract, and Treemoss extract, which may cause allergic reactions.

3. How to use Novidol

Follow the administration instructions of this medication contained in this prospectus or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

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

This medication is for external cutaneous use only, exclusively on intact skin. Apply a thin layer of the gel to the painful area through gentle massage to facilitate penetration.

Wash your hands after each application.

If you use more Novidol than you should

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.

4. Possible side effects

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

Uncommon (may affect up to 1 in 100 people): in the application area, redness, skin inflammation (dermatitis), local irritation, and itching may occur, which disappear when treatment is discontinued.

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

Frequency not known (cannot be estimated from available data): the skin becomes sensitive to light.

Interrupt 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 rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The 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 that does not appear in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for human use: 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.

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.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of 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

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, hydroxyethyl cellulose, benzyl alcohol, wild herb essence, and purified water.

Appearance of the product and package contents

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.

Marketing authorization holder and manufacturer

Marketing authorization holder

MENARINI CONSUMER HEALTHCARE, S.A.U.

Guifré, 724 E-08918 Badalona (Barcelona) Spain

Manufacturer

Industria Química y Farmacéutica VIR S.A

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

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this prospectus: 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/