NOVOTER 0.5 mg/g CREAM

Contents of the leaflet

1. Introduction
2. PROSPECTUS: INFORMATION FOR THE USER
3. Read the entire prospectus carefully before starting to use the medication.
4. Contents of the prospectus:
5. What is Novoter cream and what is it used for
7. Before using NOVOTER CREAM
8. Do not use Novoter cream
9. Be careful with Novoter cream
10. Use of other medications
11. Pregnancy and breastfeeding
12. Driving and using machines
13. Important information about some components of Novoter cream
14. How to use NOVOTER CREAM
15. Follow the administration instructions of Novoter cream indicated by your doctor. Consult your doctor if you have doubts.
16. If you use more Novoter cream than you should
17. If you forget to use Novoter cream
18. If you interrupt the treatment with Novoter cream
19. Possible adverse effects
21. Reporting adverse effects
22. Storage of NOVOTER CREAM
23. Additional information
25. Appearance of the product and packaging content
26. Marketing authorization holder
27. Manufacturer
28. This prospectus was approved in August 2010

Introduction

PROSPECTUS: INFORMATION FOR THE USER

Novoter 0.5 mg/g cream

Fluocinonide

Read the entire prospectus carefully before starting to use the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus:

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

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

1.

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

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

• Eczema, mild to moderate, 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 substances of habitual use, such as soap (irritant contact dermatitis).
  • Itchy eruption on hands and feet (dyshidrotic eczema).
  • Eczema unspecified (vulgar eczema).
• Eczema related to patient factors (endogenous eczema), such as atopic dermatitis or neurodermatitis.
• Skin eruption 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 ingredient fluocinonide, other corticosteroids, or any of the other components of Novoter cream (see also section 6. Additional information).
• if you have tuberculosis, syphilis, or viral infections (e.g., chickenpox or herpes)
• in areas of skin affected by red/pink inflammation on the face (rosacea), ulcers, inflammation of the sebaceous glands (acne), or skin diseases with skin thinning (atrophy)
• in a skin inflammation that occurs around the mouth (perioral dermatitis)
• in areas of the skin that show a vaccination reaction, i.e., redness or inflammation after 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 they are also treated with specific treatment)
• in children under 1 year of age.

Be careful with Novoter cream

• If your doctor diagnoses a bacterial or fungal infection, you should also use the additional treatment prescribed for the infection, as the infection may worsen if not treated.
• 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 medications (corticosteroids), such as the active ingredient fluocinonide, have significant effects on the body. Treatment in extensive areas and for long 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 is not recommended for use in children under 2 years of age. Caution is required in children and adolescents during the growth period, as the corticosteroid is more likely to pass through the skin and have adverse effects on other areas of the body, especially with excessive application (see section 4. Possible adverse effects).
• Eye contact, mouth, open wounds, or mucous membranes (e.g., genital area) should be avoided.
• Novoter cream should not be applied to skin folds, such as the groin or armpits.
• If you have circulatory problems, you should not apply medications with corticosteroids, as the area may become ulcerated.
• Novoter cream should not be used under impermeable materials to air and water, such as bandages, dressings, or diapers, which are not very breathable. It should be noted that diapers can act as occlusive dressings.
• If you are being treated for psoriasis, medical supervision is recommended.
• If you use Novoter cream for diseases other than those for which it has been prescribed, you may mask the symptoms and make it difficult to diagnose and treat correctly.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including 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, you should not use Novoter cream unless your doctor considers it appropriate.

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 on extensive areas of your body, nor for long periods, nor use occlusive dressings.

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

Driving and using machines

Treatment with Novoter cream does not affect the ability to drive or use machines.

Important information about some 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.

3. How to use NOVOTER CREAM

Follow the administration instructions of Novoter cream indicated by your doctor. Consult your doctor if you have doubts.

The normal dose is:

Adults

Apply a thin layer of Novoter cream to the affected area, 2 to 4 times a day, rubbing gently. 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 of age and is not recommended for children under 2 years of age due to the lack of safety and efficacy data. It should be used with caution in children and adolescents during 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.

In general, the treatment duration should not exceed 2 weeks. If you use the medication for a condition on the face, 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, and with 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 produce 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 Toxicology Information Service. Phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to use Novoter cream

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

If you forget to apply the cream, apply the corresponding dose as soon as possible or, if the next application is near, 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 having completed the indicated period.

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

4. Possible adverse effects

Like all medications, Novoter cream can produce adverse effects, although not all people experience them.

The use of anti-inflammatory medications (corticosteroids) on the skin can produce adverse effects, especially after prolonged application, in extensive areas, with dressings or occlusive materials, and/or in children.

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

• Thinning of the skin (atrophy)
• Dryness or cracking of the skin
• Itching or burning
• Redness (erythema)
• Appearance of red spots
• Inflammation of the hair follicles (folliculitis)
• Stretch marks
• Acne
• Infections
• Hair loss
• Increased hair growth
• Allergic skin reaction (contact dermatitis)
• Inflammation of the skin 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. For example, it can increase eye pressure (glaucoma) or produce 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 an unknown frequency:

• Headache
• Nasal congestion.

If you consider that any of the adverse effects you are experiencing is serious 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 Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 expiration date shown on the packaging, after CAD.

The expiration date is the last day of the month indicated.

Medications should not be thrown away through the drains or into the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

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 packaging content

Novoter 0.5 mg/g cream is a homogeneous white cream and is presented 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 prospectus was approved in August 2010