PATIENT INFORMATION LEAFLET

Novoter 0.5 mg/g cream

Fluocinonide

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Contents of the leaflet:

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 is NOVOTER CREAM and what is it used for

Novoter cream is an anti-inflammatory medication (a corticosteroid) used on the skin to reduce inflammation, skin allergic reactions, and excessive cell multiplication in the skin (hyperproliferation). Therefore, it reduces skin 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:

• Eczema, from mild to moderate, related to an external cause, such as:
• • Allergic contact dermatitis.
  • Irritant contact dermatitis due to substances commonly used, such as soap.
  • Itchy eruption on hands and feet (dyshidrotic eczema).
  • Unspecified eczema (eczema vulgaris).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Eruption on the skin with inflammation and scaling (seborrheic eczema).
• Psoriasis.

Do not use Novoter cream

• if you are allergic (hypersensitive) to the active ingredient 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)
• on areas of skin affected by red/rosy inflammation in the face (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophy)
• on a skin inflammation that occurs around the mouth (perioral dermatitis)
• on areas of skin that show a vaccination reaction, that is, redness or inflammation after the vaccine
• on the eyes, on mucous membranes (for example, in the mouth) or on open wounds
• on skin infections caused by bacteria or fungi (unless treated additionally with a specific treatment)
• in children under 1 year.

Be especially careful with Novoter cream

• If your doctor diagnoses an additional bacterial or fungal infection; then you must also use the additional treatment prescribed for the infection, because if not, the infection may worsen.
• Novoter cream should be used at the lowest possible dose, especially in children, and only for the strictly necessary time to relieve the skin condition.
• Anti-inflammatory drugs (corticosteroids), such as the active ingredient fluocinonide, have significant effects on the body. Avoid treatment in extensive areas and for long periods of time, because this significantly increases the risk of adverse effects.
• Novoter cream is contraindicated in children under 1 year and is not recommended for use in children under 2 years. Caution is required in children and adolescents in the growth period in whom it is more likely that the corticosteroid will pass through the skin and have 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 (for example, the genital area).
• Do not apply Novoter cream to skin folds, such as the groin or armpits.
• If you have circulatory problems, do not apply corticosteroid medications as it could ulcerate the area.
• Do not use Novoter cream under impermeable materials to air and water, such as bandages, dressings, or diapers, that are poorly breathable. Note that diapers can act as occlusive dressings.
• If you are being treated for psoriasis, it is recommended to have special medical supervision.
• If you use Novoter cream for diseases other than those for which it has been prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription, especially if you are receiving treatment with other steroids. To date, no interactions with Novoter cream have been described.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

If your doctor prescribes Novoter cream during pregnancy, do not use it on extensive areas of your body, or for long periods of time, or use occlusive dressings.

Do not apply Novoter cream to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Driving and operating machinery

The 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 medication may cause skin irritation because it contains propylene glycol.

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

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

The normal dose is:

Adults

Apply a thin layer of Novoter cream to the affected area, two to four times a day, gently rubbing it in. When a favorable response is achieved, the frequency can be reduced to the minimum necessary.

Use in children

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

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

Generally, the treatment duration should not exceed 2 weeks. If you use the medication for any facial condition, do not treat for more than one week. Always make the treatment as short as possible.

In children, the treatment should be as short as possible, in short periods of time, and with the minimum effective amount of the product.

If you use more Novoter cream than you should

No adverse effects can be 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 or go to a medical center, or call the Toxicological Information Service. Phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to use Novoter cream

Do not apply a double dose to compensate for the missed doses.

If you forget to apply the cream, apply the corresponding dose as soon as possible or, if it is close to the next application, wait until then.

If you interrupt the treatment with Novoter cream

The original symptoms of your skin problem may reappear. Please contact your doctor before interrupting the treatment without completing it to the indicated period.

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

Like all medications, Novoter cream may cause adverse effects, although not everyone may experience them.

The use of anti-inflammatory medications (corticosteroids) on the skin may cause adverse effects, especially after prolonged application, in large areas, with bandages or occlusive materials, and/or in children.

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

• Skin thinning (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Redness (erythema)
• Appearance of red spots
• Inflammation of hair follicles (folliculitis)
• Striae (stretch marks)
• Acne
• Infections
• Hair loss
• Excessive hair growth
• Contact dermatitis (skin allergy)
• 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 occurs if the active ingredient passes through the skin into the body. This, for example, may increase eye pressure (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, weakness, etc. (Cushing's syndrome); high blood pressure (hypertension), fluid retention (edema), hyperglycemia, gastric ulcers, cataracts.

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

• Headache
• Nasal congestion.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Novoter cream after the expiration date appearing 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. Ask your pharmacist how to dispose of packaging and unused medicines. In this way, you will help protect the environment.

Composition of Novoter 0.5 mg/g Cream:

• The active ingredient 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), stearic 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 presented in tubes containing 30 and 60 g of cream.

Holder of the Marketing Authorization

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

27010 Valle Salimbene Pavia – Italy

Responsible for Manufacturing

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

This leaflet was approved in August 2010