FLUTICREM 0.05 % Cream

Зміст інструкції

1. Fluticrem 0.05% cream
   1. WHAT IS Fluticrem AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING Fluticrem
   3. HOW TO USE Fluticrem
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE Fluticrem
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Fluticrem 0.05% cream

Fluticasone propionate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT IS Fluticrem AND WHAT IS IT USED FOR

Fluticrem 0.05% cream belongs to the group of medicines known as corticosteroids
which, when used locally, are characterized by a high anti-inflammatory power.
Fluticasone is a potent corticosteroid that is applied to the skin to treat a wide range of
inflammatory skin diseases. It is used to relieve inflammation, redness and itching
associated with various non-infectious skin diseases and sensitive to corticosteroids.

2. WHAT YOU NEED TO KNOW BEFORE USING Fluticrem

Do not use Fluticrem

• If you are allergic to fluticasone or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from rosacea (redness and inflammation of the facial skin), common acne or perioral dermatitis (redness and inflammation around the mouth).
• If you suffer from skin infections caused by viruses (e.g. herpes simplex or varicella), bacteria, fungi or yeasts.
• If you suffer from genital or perianal itching (itching near the anus and genitals).
• If you suffer from skin ulcers, atrophy (thinning of the skin) or fragility of skin vessels.
• If you suffer from ichthyosis (disorders characterized by dryness and scaling of the skin).
• If you suffer from juvenile dermatoses (all skin diseases characterized by inflammation) or infantile dermatitis (which appears in children under 1 year of age), including dermatitises (skin inflammations) and diaper rash.
• If you suffer from ulcerative lesions. Warnings and precautionsTalk to your doctor or pharmacist before using Fluticrem
• If you are or think you might be pregnant, if you are breastfeeding (see section Pregnancy and breastfeeding).
• If you use this medicine on large areas of the body for prolonged periods, especially in the treatment of children, as this may increase the absorption of the medicine and the risk of toxicity.
• If you use the medicine on the face, as this may induce atrophic changes (e.g. thinning of the skin). It is important to avoid getting the cream into your eyes.
• If you use the medicine on parts of the body covered. Do not use the medicine with occlusive dressings; the treated area must be exposed to the air and must not be covered by dressings, tight clothing or similar items. In young children, the diaper can act as an occlusive dressing. Wash the skin before applying a dressing. If your doctor has prescribed a cream for the treatment of psoriasis. At periodic intervals, regularly visit your doctor who will assess the progress of your condition
• If you are using other products (including any cosmetics) on the affected skin areas, as these may negatively affect the activity of the medicine. If you have any doubts, consult your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

children:
Do not use the medicine in the treatment of children under 1 year of age.
If the symptoms do not improve after one or two weeks of treatment, inform your doctor.
When you notice an improvement in the condition of the skin (usually within one to two
weeks), reduce the frequency of applications. Continuous daily treatment for more than 4 weeks
is not recommended.
Fluticrem should be used in children only to relieve skin inflammation,
redness and itching from atopic dermatitis and under the supervision of a specialist doctor.
Before using Fluticrem in other types of dermatitis in children, consult a dermatologist.

other medicines and Fluticrem
Tell your doctor if you are taking, have recently taken, or will take any other medicines,
including those available without a prescription.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant or if you are planning to have a baby,
ask your doctor for advice before taking this medicine.
Pregnancy
Fluticrem should be used during pregnancy only if the expected benefits for the mother outweigh the
possible risks to the unborn child.
Breastfeeding
It is not known whether fluticasone is excreted in breast milk. Fluticrem should be used during
breastfeeding only if the expected benefits for the mother outweigh the possible risks to the unborn child.

Driving and using machines
There is no evidence of a negative influence of fluticasone on the ability to drive vehicles or operate
machinery.

Fluticrem contains cetostearyl alcohol, imidurea and propylene glycol.
The medicine contains cetostearyl alcohol which may induce local skin reactions (e.g. contact dermatitis)
This medicine contains the preservative imidurea. Imidurea decomposes and releases a small
amount of a chemical called formaldehyde. Formaldehyde can cause allergic reactions
such as skin rash or itching when applied to the skin. The medicine contains propylene glycol which may
irritate the skin.

3. HOW TO USE Fluticrem

Your doctor will prescribe the appropriate dosage for your condition.
Always use this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
For adults and children from one year of age, apply a thin film of Fluticrem to the
affected skin areas one or two times a day, unless otherwise indicated by your doctor. Ask your
doctor for information about the duration of treatment.
In some conditions (psoriasis, atopic dermatitis, etc.), abrupt discontinuation of
treatment is not recommended; the number of applications should be reduced gradually.
Follow your doctor's instructions carefully.
In case of relapse and recurrence of symptoms, your doctor will indicate the appropriate dosage.
The common dosage is one application per day, 2 days a week.
In some skin diseases, such as psoriasis or atopic dermatitis, it is not recommended to
interrupt treatment. Ask your doctor for the best way to achieve optimal results.
Instructions for use:
1 Wash your hands
2 Apply a thin layer of cream and massage gently until it completely disappears
3 Wash your hands unless the cream is being used to treat the same area.
If skin problems do not improve within one or two weeks of starting treatment, inform your
doctor.

If you use more Fluticrem than you should
If you have used more Fluticrem than you should, especially in the treatment of
children, wash the affected areas thoroughly to remove all the cream and contact your
doctor or pharmacist. In case of accidental ingestion, contact your doctor or pharmacist.

If you forget to use Fluticrem
Do not use a double dose to make up for a missed dose.
If you forget to apply the cream, apply the correct dose when you remember or near
the next application and wait for the next application.

If you stop using Fluticrem
Do not stop treatment even if you feel better, unless your doctor tells you to.
If you have any doubts about the use of the medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect more than 1 in 100 people but less than 1 in 10 people):

• Itching. Uncommon side effects (may affect more than 1 in 1,000 people but less than 1 in 100 people):
• Local burning. Very rare side effects (may affect more than 1 in 10,000 people but less than 1 in 1,000 people): Secondary infections, particularly when using occlusive dressings or when skin folds are involved. Hypersensitivity. Stop treatment with Fluticrem if a hypersensitivity reaction occurs. Hypercortisolism (increased levels of corticosteroids) due to prolonged use of large amounts of corticosteroids or treatment of extensive areas. This effect is more likely to occur in neonates and children and if occlusive dressings are used. Dilatation of superficial blood vessels due to prolonged and intensive treatment with potent corticosteroid preparations. Allergic contact dermatitis (allergic skin reactions). Worsening of signs and symptoms of dermatoses (skin reaction involving skin inflammation). Pustular psoriasis due to treatment or its discontinuation. Local atrophic changes of the skin such as thinning, appearance of striae, hypertrichosis (excessive hair growth in a specific region of the body) and hypopigmentation (skin discoloration), due to prolonged and intensive treatment with potent corticosteroid preparations. Frequency not known (the frequency cannot be estimated on the basis of the available data): Vascular purpura (group of skin disorders characterized by purplish or brownish-red discoloration). Skin fragility. Perioral dermatitis (inflammation of the skin around the mouth)

Acne rosacea (redness and inflammation of the facial skin)
Scabies
Lower limb ulcers
Blurred vision
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in

5. HOW TO STORE Fluticrem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after ‘EXP’. The expiry date
refers to the last day of the month.
Do not store at a temperature above 30ºC.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Do not use Fluticrem if you notice visible signs of deterioration.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluticrem contains
The active ingredient is fluticasone propionate. 100 g of cream contain 0.05 g of fluticasone
propionate.
The other components are macrogol cetostearyl ether, cetostearyl alcohol, isopropyl myristate,
liquid paraffin, purified water, propylene glycol, citric acid monohydrate, disodium phosphate anhydrous,
imidazolidinyl urea.

Description of the appearance of Fluticrem and contents of the pack
Fluticrem is a white, viscous cream, contained in an aluminium tube of 30 g or 60 g with a screw cap.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DIFA COOPER SpA
Via Milano 160
21042-Caronno Pertusella (Varese)
Italy

Manufacturer responsible for batch release:
INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
Ctra. Cazoña-Adarzo, s/n
39011Santander
Spain

This medicinal product is authorised in the Member States of the European Union with
the following denominations:
Belgium: Fluticrem 0.05% cream
Italy: Fluticrem 0.05% cream
Netherlands: Fluticrem 0.5 mg/g cream
Portugal: Fluticrem 0.5 mg/g cream
Spain: Fluticrem 0.5 mg/g cream