Novoter 0.5 mg/g cream

Package leaflet: Information for the user

Introduction

PACKAGE INSERT: INFORMATION FOR THE USER

Novoter 0.5 mg/g cream

Fluocinonide

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Package leaflet contents:

1. What Novoter cream is and what it is used for

1. Before using Novoter cream
2. How to use Novoter cream
3. Possible side effects
4. Storage of Novoter cream
5. Additional information

1. What NOVOTER CREAM is and what it is used for

Novoter cream is an anti-inflammatory medicine (a corticosteroid) used on the skin to reduce inflammation, allergic skin reactions, and skin conditions involving excessive cell multiplication (hyperproliferation). Therefore, it reduces redness (erythema), fluid accumulation (edema), and exudate in inflamed skin. It also relieves itching, burning, or pain.

Novoter cream is used in the treatment of acute forms of:

• Mild to moderate eczema related to an external cause, such as:
  • Allergy to a substance that has come into contact with the skin (allergic contact dermatitis).
  • Allergic reaction to commonly used substances such as soap (irritant contact dermatitis).
  • Itchy rash affecting the hands and feet (dyshidrotic eczema).
  • Unspecified eczema (atopic eczema).
• Eczema related to patient-specific factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin rash with inflammation and scaling (seborrheic eczema).
• Psoriasis.

2. Before using NOVOTER CREAM

Do not use Novoter cream

• if you are allergic (hypersensitive) to the active substance fluocinonide, to other corticosteroids, or to any of the other components of Novoter cream (see also section 6. Additional information).
• if you have tuberculosis, syphilis, or viral infections (for example, chickenpox or herpes)
• in areas of skin affected by red/pink facial inflammation (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases associated with thinning of the skin (atrophy)
• in skin inflammation occurring around the mouth (perioral dermatitis)
• in areas of skin showing a vaccination reaction, i.e., redness or inflammation following vaccination
• in the eyes, on mucous membranes (e.g., in the mouth), or on open wounds
• in skin infections caused by bacteria or fungi (unless additionally treated with specific therapy)
• in children under 1 year of age.

Take special care with Novoter cream

• If your doctor also diagnoses a bacterial or fungal infection, you must additionally use the prescribed treatment for the infection, as otherwise the infection may worsen.
• Novoter cream should be used at the lowest possible dose, especially in children, and only for the minimum time necessary to relieve the skin condition.
• Anti-inflammatory drugs (corticosteroids), such as the active ingredient fluocinonide, have significant effects on the body. Treatment over large areas or for prolonged periods should be avoided, as this significantly increases the risk of adverse effects.
• Novoter cream is contraindicated in children under 1 year of age and its use is not recommended in children under 2 years of age. Caution is required in children and adolescents during growth periods, as corticosteroids are more likely to be absorbed into the body through the skin and may cause adverse effects in other parts of the body, especially with excessive application (see section 4 Possible adverse effects).
• Avoid contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area).
• Novoter cream should not be applied to skin folds, such as the groin or armpits.
• If you have circulatory problems, corticosteroid medications should not be used, as ulceration of the area may occur.
• Novoter cream should not be used under materials impermeable to air and water, such as bandages, dressings, or non-breathable diapers. It should be noted that diapers may act as occlusive dressings.
• If you are being treated for psoriasis, close medical supervision is recommended.
• If you use Novoter cream for conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, especially if you are being treated with other steroids. No interactions with Novoter cream have been reported to date.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant, breastfeeding, or planning to become pregnant, you should not use Novoter cream unless your doctor considers it advisable.

As a general rule, during the first trimester of pregnancy, medications containing corticosteroids should not be applied to the skin.

If your doctor prescribes Novoter cream during pregnancy, you should not use it over large areas of the body, for prolonged periods of time, or with occlusive dressings.

Do not apply Novoter cream to the breasts during breastfeeding; avoid contact of the infant with treated areas.

Driving and operating machinery

Treatment with Novoter cream does not affect the ability to drive or operate machinery.

Important information about some of the components of Novoter cream

This medicine may cause skin irritation because it contains propylene glycol.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol.

3. How to use NOVOTER CREAM

Follow exactly the Novoter cream administration instructions provided by your doctor. Consult your doctor if you have any doubts.

The usual dose is:

Adults

Apply a thin layer of Novoter cream to the affected area two to four times daily, rubbing in gently. Once a favorable response has been achieved, the frequency may be reduced to the minimum necessary.

Use in children

• Novoter cream is contraindicated in children under 1 year of age and is not recommended in children under 2 years of age due to limited data on safety and efficacy. It should be used with caution in children and adolescents during growth periods (see sections 2 and 4).
• Children over 2 years:

Apply a thin layer of Novoter cream to the affected area once daily.

In general, treatment duration should not exceed 2 weeks. If using the medicine for a condition affecting the face, treatment should not last longer than 1 week. Always keep treatment duration as short as possible.

In children, treatment should be kept as short as possible, administered in short periods and using the minimum effective amount of the product.

If you use more Novoter cream than you should

No risk is expected after a single overdose of Novoter cream. Repeated overdoses may cause adverse effects (see section 4).

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to a medical center, or call the Toxicology Information Service. Telephone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Novoter cream

Do not apply a double dose to make up for missed doses.

If you forget to apply the cream, apply the missed dose as soon as possible. However, if it is almost time for the next application, wait and apply the next dose at the scheduled time.

If you interrupt treatment with Novoter cream

The original symptoms of your skin condition may reappear. Please contact your doctor before stopping treatment before the indicated period has been completed.

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

4. Possible adverse effects

Like all medicines, Novoter cream can cause side effects, although not everybody will experience them.

The use of anti-inflammatory drugs (corticosteroids) on the skin may cause side effects, especially after prolonged application, over large areas of skin, under dressings or occlusive materials, and/or in children.

The use of corticosteroids on the skin may cause the following adverse effects:

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning sensation
• Redness (erythema)
• Appearance of red spots
• Inflammation of hair follicles (folliculitis)
• Stretch marks (striae)
• Acne
• Infections
• Hair loss
• Increased hair growth
• Allergic skin reaction (contact dermatitis)
• Specific skin inflammation around the upper lip and chin (perioral dermatitis)
• Changes in skin color
• Adverse effects may occur not only in the treated area but also in completely different areas of the body. This may happen if the active ingredient passes into the body through the skin. For example, this could increase pressure in the eye (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome); increased blood pressure (hypertension), fluid retention (edema), hyperglycemia, gastric ulcer, cataracts.

The following adverse effects may also occur with the use of the active ingredient fluocinonide, with unknown frequency:

• Headache
• Nasal congestion

If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if these are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of NOVOTER CREAM

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Novoter cream after the expiry date stated on the container, after EXP.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of Novoter 0.5 mg/g cream:

• The active substance is fluocinonide.

1 g of cream contains 0.5 mg (0.05%) of fluocinonide.

• The other components are: propylene glycol, citric acid, glycerol (E-422), stearyl alcohol, polyethylene glycol 4000 (Macrogol 4000), and dimethicone.

Appearance of the product and contents of the package

Novoter 0.5 mg/g cream is a homogeneous white cream and is supplied in tubes containing 30 and 60 g of cream.

Marketing Authorization Holder

Teofarma S.r.l. Via F.lli Cervi, 8

27010 Valle Salimbene Pavia – Italy

Manufacturer

Teofarma S.r.l. Viale Certosa, 8/A 27010 Pavia – Italy

This leaflet was approved in August 2010