CORTIFLAM 2,250 MG Cataplasm

Зміст інструкції

1. CORTIFLAM 2,250 mg medicated patch
   1. WHAT IS CORTIFLAM AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING CORTIFLAM
   3. HOW TO USE CORTIFLAM
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CORTIFLAM
   6. PACKAGE CONTENTS AND OTHER INFORMATION

CORTIFLAM 2,250 mg medicated patch

Betamethasone valerate

Read this leaflet carefully before using this medicine as 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 they have the same symptoms as you, as it may 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 CORTIFLAM is and what it is used for.
• 2. What you need to know before you use CORTIFLAM.
• 3. How to use CORTIFLAM.
• 4. Possible side effects.
• 5. How to store CORTIFLAM.
• 6. Contents of the pack and other information.

1. WHAT IS CORTIFLAM AND WHAT IS IT USED FOR

CORTIFLAM is a medicated patch to be applied to the skin. CORTIFLAM contains betamethasone
valerate, a potent corticosteroid. When applied to the skin, it reduces redness, swelling and
itching.
CORTIFLAM should be used to treat inflammatory skin conditions that do not respond to
less potent corticosteroids, such as eczema and psoriasis, although your doctor may prescribe it for the
treatment of other localized skin conditions.
CORTIFLAM is suitable for the treatment of mild to moderate psoriasis (isolated red patches
covered with whitish scales) located in areas difficult to treat such as elbows and
knees.
Overall, the area treated with CORTIFLAM should not exceed 5 times the palm of
your hand.

2. WHAT YOU NEED TO KNOW BEFORE USING CORTIFLAM

Do not use CORTIFLAM:

• If you are allergic to betamethasone valerate or any of the other ingredients of this medicine (listed in section 6).
• If your skin condition is caused by a viral infection (herpes zoster, herpes simplex, vaccinia pustules), fungal or bacterial infection (e.g. skin lesions from syphilis).
• If the area of skin to be treated is affected by acne, rosacea, perioral dermatitis (around the mouth), skin ulcers, burns, frostbite or where the skin is damaged, with or without fluid leakage (serum).

Warnings and precautions
Consult your doctor before using CORTIFLAM.

• If you need to use it for a long period of time and on large areas of the body, as this situation can cause increased absorption of the corticosteroid into the bloodstream. The use of an occlusive bandage, especially with plastic material, can increase this effect, whose symptoms are: facial redness, changes in body weight (increased localized fat mass at the level of the trunk and face, decrease at the level of the legs and arms), reddish streaks at the level of the stomach, headache, menstrual changes or increased unwanted hair on the face and body. In such situations, consult your doctor immediately and do not interrupt treatment without first consulting them.
• If you decide to stop treatment, you should be aware that in psoriasis, abrupt discontinuation of treatment can worsen symptoms. Discontinuation should occur gradually and under strict medical supervision.
• If your condition worsens during use, consult your doctor - you may be experiencing an allergic reaction, have an infection or your condition may require different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within two weeks, do not start using CORTIFLAM again without consulting your doctor. If your condition has resolved, but during the recurrence the redness spreads beyond the initially treated area and you feel a burning sensation, consult your doctor before restarting treatment.
• If you suffer from widespread psoriasis or widespread eczema or if your lesions are located in skin folds (e.g. inner elbow or knee, armpits, groin, genital area). In these cases, the use of CORTIFLAM for long periods of time is not recommended (except for the treatment of isolated plaques), as these conditions can lead to increased absorption of the corticosteroid into the bloodstream.
• CORTIFLAM works by reducing inflammation, but used for a long period of time it could irritate the skin or cause sensitization reactions. Furthermore, it could damage and thin the skin, inhibiting its natural repair process.
• If you are to undergo a test known as the tetrazolium blue (NBT) test, to check for bacterial infections. The corticosteroid contained in the medicated patch may alter the results of this test.
• If your body is unable to cope with infections as it should or if you are taking medications that decrease the ability to fight disease (immunosuppressants). These drugs are used to prevent rejection after a transplant and may also be prescribed to treat skin diseases that could be treated with CORTIFLAM.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children
The use of CORTIFLAM is only indicated in adults.

Other medicines and CORTIFLAM
Tell your doctor if you are taking, have recently taken or might take any other medicine.
Since only a minimal amount of corticosteroid is absorbed into your body, it is unlikely that
CORTIFLAM will interact with other medicines.

CORTIFLAM with food and drink
Since only a minimal amount of corticosteroid is absorbed into your body, it is unlikely that
CORTIFLAM will interact with food and drink.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.

Driving and using machines
CORTIFLAM does not impair the ability to drive vehicles or use machines.

CORTIFLAM contains
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These substances may
cause allergic reactions (even delayed ones).

3. HOW TO USE CORTIFLAM

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor
or pharmacist.
The recommended dose is:
Apply CORTIFLAM to the skin area to be treated once a day. Do not use more than 6 medicated patches
simultaneously.
The application of a new medicated patch should be repeated every 24 hours, and it is recommended to allow
an interval of at least 30 minutes between one application and the next.
Do not use CORTIFLAM for more than 30 days.

Use in children and adolescents
Since there is no clinical data available regarding paediatric use of the drug, do not use CORTIFLAM
if you are under 18 years of age.

Method of administration
Before using CORTIFLAM, you must thoroughly clean and dry the skin area where
you will apply the medicated patch.
Open the sachet and, if necessary, cut the medicated patch to fit the size of the area
to be treated, then remove the protective film and apply the medicated adhesive part to the area
affected. The unused part of the patch should be placed back in the sachet, so that it is preserved
and can be used for a next application (see paragraph 5).
Once removed, the medicated patch should not be reapplied.
The medicated patch should not be wetted: it is advisable to take a bath or shower between two
successive applications. In case of application to particularly mobile areas (e.g. elbow,
knee), if you notice lifting of the edges of the medicated patch, apply the adhesive patches
for fixing dressings included in the package of the medicine. Do not apply to the face.
In no case should you completely cover the medicated patch with plastic or occlusive bandage.

If you use more CORTIFLAM than you should
Use CORTIFLAM always in accordance with what is prescribed by your doctor. If one day you should
use more medicated patches than prescribed by your doctor by mistake, do not worry, but
avoid repeating it.

If you forget to use CORTIFLAM
If you forget to apply the medicated patch one day, apply it normally the next day.
Do not apply two patches to the same area in one day to make up for the forgetfulness.

If you stop using CORTIFLAM
If you are following the therapy correctly without noticing any improvement, consult your doctor
before deciding to stop treatment with CORTIFLAM.
If you have any doubts about the use of CORTIFLAM, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur with the use of CORTIFLAM relate to changes in the skin limited to the
area where the patch is applied. These include: redness, itching, boils, skin rashes with or without
pus, thinning of the skin, appearance of small red spots of various shapes caused by dilation of
superficial blood vessels and erosion of the skin.
These side effects are common.
Side effects that have not been observed with CORTIFLAM but have occurred with other topical
corticosteroids include: swelling, allergic reactions, skin irritation, dryness and flaking of the skin,
feeling of skin tightness, stretch marks caused by thinning of the skin, increased hair growth, redness
of the skin in the area around the mouth and hair follicles, burning and skin discoloration.
Blurred vision may occur, with frequency unknown.
Interruption, following prolonged treatments at high doses, can lead to a worsening of psoriasis,
including significant skin reactions with the presence of pus.
In such situations, consult your doctor immediately and do not stop treatment without consulting
him/her first.
Prolonged treatment at high doses can increase the absorption of the medicine with possible
increase in side effects. These effects disappear quickly and completely once treatment is stopped.
Steroid withdrawal reaction
If CORTIFLAM is used continuously for prolonged periods of time, when treatment is stopped, withdrawal
reactions may occur with some or all of the following characteristics: redness of the skin that may
extend beyond the initially treated area, a burning and/or stinging sensation, intense itching, skin
flaking and open wounds with secretion (see paragraph 2). The steroid withdrawal reaction may occur
with unknown frequency.
If you notice a worsening of your condition during treatment, you may be allergic to CORTIFLAM or
require a different therapy. In this case, consult your doctor immediately.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CORTIFLAM

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. If the expiry date is stated as month/year, the expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if you notice visible signs of deterioration.
Keep the medicated patch in its original envelope to preserve its integrity (note the date of
opening in the appropriate space on the inner envelope).
After opening the envelope, the medicated patch is valid for 1 month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What CORTIFLAM contains:
Each medicated patch 7.5 cm x 10 cm contains:
2.250 mg of betamethasone valerate (equivalent to 1.845 mg of Betamethasone).
The excipients are:
Support: non-woven fabric (composed of polypropylene/polyethylene fiber and rayon) laminated with
an ethylene-methyl methacrylate resin.
Adhesive layer: sodium hyaluronate, 1-3 butylene glycol, glycerol, disodium edetate, tartaric acid,
aluminum glycinate, polyacrylic acid, sodium polyacrylate, hydroxypropylcellulose, sodium carboxymethylcellulose,
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), purified water.
Protective film: polyethylene terephthalate film.

Description of the appearance of CORTIFLAM and contents of the pack
This medicine is a medicated patch consisting of a colorless support. Each medicated patch
is covered with a removable protective film.
Each medicated patch is individually packaged in a sachet in packs containing 4, 8 or 16
patches.
Each pack of medicine contains adhesive patches for fixing dressings (medical
device).
Not all pack sizes may be marketed

Marketing Authorisation Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi

Batch Release Responsible
Altergon Italia S.r.l., Zona Industriale, 83040 Morra de Sanctis (AV), Italy

This leaflet was last updated on: