Novidol 50 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Novidol 50 mg/g gel

Ibuprofen

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

Follow exactly the instructions for using this medicine as described in this leaflet or as directed 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 reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days (5 days in the case of adolescents) of treatment.

Contents of the leaflet:

1. What Novidol is and what it is used for
2. What you need to know before using Novidol
3. How to use Novidol
4. Possible adverse effects
5. How to store Novidol
6. Contents of the pack and other information

1. What Novidol is and what it is used for

Novidol is available as a gel for topical use. This medicine belongs to the group of topical anti-inflammatory agents.

This medicine is indicated in adults and adolescents from 12 years of age for the local relief of pain and mild, occasional 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 or to any other analgesic or non-steroidal anti-inflammatory drug.
• On open wounds, mucous membranes, or eczematous skin.
• If you have sunburn in the affected area.
• In children (under 12 years of age).
• During the last 3 months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Novidol.

• This medicine is for topical use only; do not ingest.

• Apply only to intact, unbroken skin.

• Avoid contact with mucous membranes (nose, mouth) and eyes.

• Do not apply the gel over large areas of skin or for prolonged periods.

• Do not use under tight bandages or apply heat to the area where the product is used. If covering the area where this medicine has been applied, ensure that the covering garment is loosely applied.

• Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet lamps (UVA rays).

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 and adolescents

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

Other medicines and Novidol

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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 using 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 possible dose should be used for the shortest possible time.

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.

Driving and using machines

No effects on the ability to drive vehicles or operate machinery have been reported with external use on the skin.

Novidol contains benzyl alcohol and wild herb essence

This medicine 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 medicine contains wild herb essence with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Amyl cinnamaldehyde, Amylcinnamyl alcohol, Anisyl alcohol, Benzyl alcohol, Benzyl benzoate, Benzyl cinnamate, Benzyl salicylate, Cinnamaldehyde, Cinnamyl alcohol, Citral, Citronellol, Coumarin, d-Limonene, Eugenol, Farnesol, Geraniol, Hexyl cinnamaldehyde, Hydroxycitronellal, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Lilial, Linalool, Methyl heptine carbonate, Oakmoss extract and Moss extract, which may cause allergic reactions.

3. How to use Novidol

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults and adolescents aged 12 years and older is 3 to 4 applications per day.

This medicine is for external cutaneous use only, and must be applied exclusively to intact skin. Apply a thin layer of the gel to the painful area using gentle massage to enhance penetration.

Wash your hands after each application.

If you use more Novidol than you should

Due to its external use, poisoning is unlikely. In case of accidental ingestion, consult 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.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Uncommon (may affect up to 1 in 100 people): redness, skin inflammation (dermatitis), local irritation, and itching 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.

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

• Flat red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genital or eye sores. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, high body temperature, and enlarged 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 it is an adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Novidol

The active substance 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 pack

Clear, colourless or slightly yellowish gel. It is supplied in an aluminium tube closed with a white polyethylene screw cap, containing 60 grams or 100 grams of gel.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/